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Part A National Assessment - Germany
Goltix Titan AG-QMM1-565 SC
Registration Report –Central Zone
Page 1 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
REGISTRATION REPORT
Part A
EXTENSION OF USES
Risk Management
Product code: Goltix Titan
(AG-QMM1-565 SC)
Active Substances: Metamitron 525 g/L and
Quinmerac: 40 g/L
COUNTRY: Germany
Central Zone
Zonal Rapporteur Member State: Germany
NATIONAL ASSESSMENT
Applicant: ADAMA Deutschland GmbH
Date: 01/06/2015
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 2 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
Table of Contents
PART A – Risk Management 4
1 Details of the application 4
1.1 Application background 4
1.2 Annex I inclusion 4
1.3 Regulatory approach 6
1.4 Data protection claims 6
1.5 Letters of Access 6
2 Details of the authorisation 6
2.1 Product identity 6
2.2 Classification and labelling 7
2.2.1 Classification and labelling under Directive 99/45/EC 7
2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 8
2.2.3 Standard phrases under Regulation (EC) No 547/2011 9
2.3 Other phrases notified under Regulation (EC) No 547/2011 9
2.3.1 Restrictions linked to the PPP 9
2.3.2 Specific restrictions linked to the intended uses 10
2.4 Product uses 11
3 Risk management 13
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles 13
3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 13
3.1.2 Methods of analysis (Part B, Section 2, Point 5) 13
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 13
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 14
3.1.3 Mammalian Toxicology 14
3.1.3.1 Acute Toxicity 14
3.1.3.2 Operator, Worker, Bystander, and Resident Exposure Exposure 14
3.1.3.3 Groundwater Metabolites 14
3.1.4 Residues and Consumer Exposure 15
3.1.4.1 Residues 15
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 15
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 15
3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 19
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 19
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 19
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 3 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
20
3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)
20
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 20
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 20
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)
(Part B, Section 6, Point 10.8) 20
3.1.7 Efficacy (Part B, Section 7, Point 8) 21
3.2 Conclusions 23
3.3 Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation 23
Appendix 1 – Copy of the product authorisation 24
Appendix 2 – Copy of the product label 28
Appendix 3 – Letter of Access 29
Part A National Assessment - Germany
Goltix Titan AG-QMM1-565 SC
Registration Report –Central Zone
Page 4 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
PART A – Risk Management
This document describes the acceptable use conditions required for the extension of uses on Goltix Titan
containing metamitron and quinmerac in Germany. This evaluation is required subsequent to the approval
of metamitron and quinmerac.
The risk assessment conclusions are based on the information, data and assessments provided in
Registration Report, Part B Sections 1-8 and Part C and where appropriate the addendum for Germany.
The information, data and assessments provided in Registration Report, Parts B includes assessment of
further data or information as required at national registration by the EU review. It also includes
assessment of data and information relating to Goltix Titan where that data has not been considered in the
EU review. Otherwise assessments for the safe use of Goltix Titan have been made using endpoints
agreed in the EU review of metamitron and quinmerac.
This document describes the specific conditions of use and labelling required for Germany for the
extension of uses of Goltix Titan.
Appendix 1 of this document provides a copy of the final product authorisation in Germany.
Appendix 2 of this document is a copy of the approved product label for Germany
The submitted draft product label has been checked by the competent authority. The applicant is
requested to amend the product label in accordance with the decisions made by the competent authority.
The final version of the label has to fulfil the requirements according to Article 16 of Directive
91/414/EEC.
Appendix 3 of this document contains copies of the letters of access to the protected data / third party data
that was needed for evaluation of the formulation.
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
1 Details of the application
1.1 Application background
This application was submitted by Feinchemie Schwebda GmbH on 30/01/2014. However, during the
registration process the name of the applicant was changed to ADAMA Deutschland GmbH.
The application was for extension of uses of AG-QMM1-565 SC (in Germany: Goltix Titan), a
suspension concentrate containing 525 g/L Metamitron and 40 g/L Quinmerac, for use as herbicide
against annual monocotyledonous weeds, Galium aparine and other annual dicotyledonous weeds in
splitting applications.
1.2 Annex I inclusion
Metamitron
The active substance Metamitron was listed on Annex I of Directive 91/414 with effect date 1 September
2009 (Commission Directive 2008/125/EC) and implemented under Regulation (EU) No 540/2011. Only
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 5 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
uses as herbicide may be authorised. The applicant informs that MAK-FSG was main notifier (see
SANCO/208/08 final – 06/01/2009).
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance Metamitron, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this
overall assessment:
In this overall assessment Member States must pay particular attention to:
- operator safety and ensure that conditions of use prescribe the application of adequate personal
protective equipment where appropriate;
- the protection of groundwater, when the active substance is applied in regions with vulnerable
soil and/or climatic conditions;
- the risk to birds and mammals and non-target terrestrial plants.
The Member States concerned shall request the submission of further information:
- on the impact of soil metabolite M3 on groundwater,
- on residues in rotational crops
- on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may
be contaminated by the intake of water in field
They shall ensure that the notifier at whose request metamitron has been included in this Annex provide
such information to the Commission by 31 August 2011 at the latest. These data have been submitted in
the meantime.
Quinmerac
The active substance Quinmerac was listed on Annex I of Directive 91/414 with effect date 1 May 2011
(Commission Directive 2010/89/EU) and implemented under Regulation (EU) No 540/2011. Only uses as
herbicide may be authorised.
.
The applicant informs that MAK-FSG has submitted data to support their own source of Quinmerac to the
RMS UK for equivalence evaluation. The RMS UK has assessed the active substance source of MAK-
FSG as being equivalent to the notified source of Quinmerac. The decision was taken on 16 December
2010 and is published on CIRCA for the other Member States.
Further to this MAK-FSG owns an Annex II data compensation dossier, to match protected data
according to the published “List of Annex II studies which were considered as relied upon for the
evaluation with a view to Annex I inclusion and for which the main data submitter has claimed data
protection, version 2, February 2011, RMS UK”, which has been submitted on 19 April 2011 to RMS
UK.
On 13 September 2011 the RMS UK confirmed that they considered the MAK-FSG Annex II data
package to be complete. The evaluation of the RMS UK is available for other MS on CIRCA.
The Annex II compensation data for Quinmerac however already have been summarised and are
submitted with this dossier.
For the implementation of the Uniform Principles of Annex VI, the conclusions of the review report on
Quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 28 October 2010 shall be taken into account.
In this overall assessment Member States must pay particular attention to:
- the protection of groundwater when the active substance is applied in regions with vulnerable soil
and/or climatic conditions;
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
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Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
- the dietary exposure of consumers to residues of Quinmerac (and its metabolites) in succeeding
rotational crops;
- the risk to aquatic organisms and the long term risk for earthworms
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of information as regards:
- the potential of plant metabolism to result in an opening of the quinoline ring;
- residues in rotational crops and the long term risk for earthworms due to the metabolite
BH 518-5.
They shall ensure that the applicant provides such confirmatory data and information to the Commission
by 30 April 2013.
Concerns that are relevant for this application have been addressed within this submission.
1.3 Regulatory approach
To obtain extension of uses the product Goltix Titan must meet the conditions of Annex I inclusion and
be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to
Uniform Principles, using Annex I agreed end-points.
This application was submitted in order to allow extension of uses of an already approved product in
Germany accordance with the above.
1.4 Data protection claims
Where protection for data is being claimed for information supporting registration of Goltix Titan, it is
indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1-8 and
Part C.
1.5 Letters of Access
A letter of access isn’t necessary. ADAMA is the holder of the main authorisation.
2 Details of the authorisation
2.1 Product identity
Product Name Goltix Titan
Authorization Number
(for re-registration)
007529-00/01
Function Herbicide
Applicant ADAMA Deutschland GmbH
Composition 525 g/L metamitron and 40 g/L quinmerac
Formulation type Suspension concentrate [Code: SC]
Packaging 1, 5, 10 and 20 L HDPE bottle or canister
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 7 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
2.2 Classification and labelling
2.2.1 Classification and labelling under Directive 99/45/EC
The following labelling is proposed in accordance with Directive 1999/45/EC:
Symbol(s)/Indication(s) of danger:
N Dangerous for the environment
Risk phrases:
R 51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
environment
RA105 Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.
Safety phrases:
S2 Keep out of the reach of children
S24 Avoid contact with skin
S36/37 Wear suitable protective clothing and gloves.
S35 This material and its container must be disposed of in a safe way.
S46 If swallowed, seek medical advice immediately and show this container or label
S57 Use appropriate container to avoid environmental contamination.
SP001 To avoid riks to man and the environment, comply with the instructions for use.
Specific labelling requirement:
To avoid risks to man and the environment, comply with the instructions for use.
Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 8 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
2.2.2 Classification and labelling under Regulation (EC) No 1272/2008
The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:
Hazard classes and categories:
Hazard pictograms:
GHS09 environment
Signal word:
Hazard statements:
H411 Toxic to aquatic life with long lasting effects.
Precautionary statemtents:
Not proposed by zRMS Germany, to be decided by applicant
Special rule for labelling of PPP:
EUH401 To avoid risks to man and the environment, comply with the instructions for use.
Further labelling statements under Regulation (EC) No 1272/2008:
EUH 208-0098 - Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions.
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 9 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
2.2.3 Standard phrases under Regulation (EC) No 547/2011
None
2.3 Other phrases notified under Regulation (EC) No 547/2011
2.3.1 Restrictions linked to the PPP
The authorization of the PPP is linked to the following conditions (mandatory labelling):
Human health protection
SB001 Avoid any unnecessary contact with the product. Misuse can lead to health
damage.
SB005 If medical advice is needed, have product container or label at hand.
SB110 The directive concerning requirements for personal protective gear in plant
protection, "Personal protective gear for handling plant protection products" of
the Federal Office of Consumer Protection and Food Safety must be observed.
SB166 Do not eat, drink or smoke when using this product.
SB199 When applying the product with tractor-mounted, trailed or self-propelled
application equipment, only vehicles with closed pressurized cabins (e.g. cabin
category 3, if no respiratory protective equipment or particle-filtering masks are
necessary or category 4, if gas-tight respiratory protective equipment is needed
acc. to EN 15695-1 and -2) are suited to replace personal protective equipment
during application. During all other activities outside of the cabin the prescribed
personal protective equipment must be worn. In order to avoid contamination of
the cabin, it is not permitted to enter the cabin with contaminated personal
protective equipment (it should be deposited e.g. in an appropriate storage
facility). Contaminated gloves should be washed before removing the gloves and
hands should be washed before entering the cabin with pure water, respectively.
SF1891 Re-entering the treated areas/crops are only possible on the day of application
wearing personal protective equipment which is specified for applying the
particular product. Successive work on/in treated areas/crops may fundamentally
not be carried out until 24 hours after applying the product. Within the first 48
hours, protective suits against pesticides and standard protective gloves (plant
protection) are to be worn.
SS110 Wear standard protective gloves (plant protection) when handling the undiluted
product.
SS120 Wear standard protective gloves (plant protection) when handling/applying the
product ready for application.
SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)
when handling the undiluted product.
SS2202 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots)
when applying/handling the product ready for application.
Integrated pest management (IPM)/sustainable use
WMC1 Mode of action (HRAC-group): C1 (for metamitron)
WMO Mode of action (HRAC-group): O (for quinmerac)
WH951 The risk of resistance has to be indicated on the package and in the
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 10 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
instructions of use. Particularly measures for an appropriate risk management
have to be declared.
NB6641 The product is classified as non-hazardous to bees, even when the maximum
application rate, or concentration if no application rate is stipulated, as stated for
authorisation is applied. (B4)
Ecosystem protection
NW 262 The product is toxic for algae.
NW 263 The product is toxic for aquatic invertebrates.
NW 265 The product is toxic for higher aquatic plants.
NW468 Fluids left over from application and their remains, products and their remains,
empty containers and packaging, and cleansing and rinsing fluids must not be
dumped in water. This also applies to indirect entry via the urban or agrarian
drainage system and to rain-water and sewage canals.
The authorization of the PPP is linked to the following conditions (voluntary labelling):
Integrated pest management (IPM)/sustainable use
NN1001 The product is classified as non-harmful for populations of relevant beneficial insects.
NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory
mites and spiders.
2.3.2 Specific restrictions linked to the intended uses
The authorised use no. 001 is linked to the following conditions (mandatory labelling):
See 2.4 (Product uses)
Efficacy
WH9161 The instructions for use must include a summary of weeds which can be controlled
well, less well and insufficiently by the product, as well as a list of species and/or
varieties showing which crops are tolerant of the intended application rate and which
are not.
Ecosystem protection
NW 642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters.
Irrespective of this, the minimum buffer zone from surface waters stipulated by state law
must be observed. Violations may be punished by fines of up to 50 000 EUR.
NG404 Between treated areas with an incline of more than 2% and surface water - except only
occasionally but including periodically water-bearing surface water - there must be a
border under complete plant cover. The border's protective function must not be impaired
by the use of implements. It must be at least 20 m wide. This border is not necessary if: -
sufficient catching systems are available for the water and soil transported by run-off,
which do not flow into surface water or are not connected with the urban drainage system
or - the product is used for mulch or direct drilling methods.
Part A National Assessment - Germany
Goltix Titan
Registration Report –Central Zone
Page 11 of 29
Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016
2.4 Product uses
GAP-Table of intended uses for Germany
GAP rev. (No), date: 2014-04-14
PPP (product name/code) Goltix Titan
active substance 1 Metamitron
active substance 2 Quinmerac
Formulation type: SC
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Applicant: Feinchemie Schwebda GmbH
Zone(s): central/EU
professional use X
non professional use
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days) Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
Method /
Kind Timing / Growth
stage of crop &
season
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
kg, L product /
ha
a) max. rate per
appl.
b) max. total rate
per crop/season
g, kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water L/ha
min / max
001 DE Sugar beet
BEAVA
fodder beet
BEAVC
F Annual
monocotyledonous
weeds
TTTMS
Annual dicotyledonous
weeds
TTTDS
Spraying
splitting 4
applications
Spring
BBCH 00 – 19
1st treatment before-
emergence
2nd to 4th treatment
after emergence
a) 4
b) 4
the 2nd to 4th
treatment with
an interval of 5
to 10 days
a)
timing 1: 3 L/ha
timing 2: 1 L/ha
timing 3: 1 L/ha
timing 4: 1 L/ha
a)
timing 1:
Metamitron
1575 g as/ha
Quinmerac
120 g as/ha
timing 2:
Metamitron
200 - 400 *XF WH9161
‚Annual
monocotyledonous
weeds‘ are withdrawn by the
applicant, because not
enough data regarding
efficacy available.
NG404, NW 642-1
Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016
b) 6 L/ha
maximum
application rate
for the intented
crop per year
525 g as/ha
Quinmerac
40 g as/ha
timing 3:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
timing 4:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
b)
Metamitron
3150 g as/ha
Quinmerac
240 g as/ha
maximum
application rate
for the intented
crop per year
*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI
in days is not required resp.
Remarks: (1) Numeration of uses in accordance with the application/as verified by MS
(2) Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(8) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g. g or kg / ha)
(12) The range (min/max) of water volume under practical conditions of use must be given
(L/ha)
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
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3 Risk management
3.1 Reasoned statement of the overall conclusions taken in accordance with the
Uniform Principles
3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4)
Overall Summary:
AG-QMM1-565 SC is an off-white homogenous suspension with characteristic odour. It has no explosive
and oxidising properties. AG-QMM1-565 SC has a self-ignition temperature of 505 °C and it is a surface
active mixture. Results of the technical tests (spontaneity of dispersion, suspensibility, wet sieve test,
pourability and particle size distribution) showed that AG-QMM1-565 SC fulfils the general requirements
of the FAO/WHO manual (2010). The formulation is stable when stored for 2 years in the commercial
packaging at ambient temperature and after 14 days at 54° C.
The technical characteristics are acceptable for a SC formulation.
Implications for labelling: none
Compliance with FAO specifications:
There is no FAO specifications for quinmerac. For metamitron only specifications for TC, TK, WP and
WG formulations are published.
Compliance with FAO guidelines:
The product AG-QMM1-565 SC complies with the general requirements according to the FAO/WHO
manual (2010).
Compatibility of mixtures:
A complete report regarding physical and chemical compatibility of the tank mixes with Powertwin Plus,
Oleo FC, Debut, Arma, Lontrel 100, Agil-S, Belvedere Extra and Kontakt 320 SC has been submitted
which has demonstrated compatibility. These tank mixes can therefore be mentioned on the product label
for AG-QMM1-565 SC.
.
Nature and characteristics of the packaging:
Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,
leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents
of the packaging, have been submitted, evaluated and is considered to be acceptable.
Nature and characteristics of the protective clothing and equipment:
Information regarding the required protective clothing and equipment for the safe handling of GOLTIX
TITAN has been provided and is considered to be acceptable.
3.1.2 Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)
The analytes are determined by HPLC on an Inertsil ODS-3V column. Detection is performed with a UV
detector at 238 nm. The mobile phase consists of acetonitrile : acidified water 40:60 (v/v).
With respect to precision, accuracy, linearity and specificity the method provided is suitable for the
determination of metamitron and quinmerac in the SC-formulation.
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Applicant: ADAMA Deutschland GmbH Evaluator: DE
Date: 01/06/2016
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
Concerning the analytical methods for the determination of residues there is no change with respect to the
main application. Adequate analytical methods are available to monitor all compounds given in the
respective residue definition, i.e. metamitron in food of plant and animal origin, soil, water and air, and
quinmerac in food of plant and animal origin and quinmerac and its metabolites BH 518-2 and BH 518-5
in soil and water.
Metamitron residues can be monitored in food of plant and animal origin, soil, water and air by LC-
MS/MS. Additionally, adequate validation data for the QuEChERS method (European Standard EN
15662:2008) are published in EURL Data Pool (http://www.crl-pesticides-datapool.eu/) for food of plant
origin.
Quinmerac residues can be monitored in food of plant and animal origin, soil and water by LC-MS/MS.
An analytical method for quinmerac in air is not required because it is not classified as Xi, Xn, T or T+.
Methods for body fluids and tissues are also not required since metamitron and quinmerac are not
classified as toxic or highly toxic.
3.1.3 Mammalian Toxicology
3.1.3.1 Acute Toxicity
Acute toxicity studies of Goltix Titan were not evaluated as part of the EU review of metamitron and
quinmerac. Therefore, all relevant data were provided and are considered adequate.
Goltix Titan, containing 525 g/L metamitron and 40 g/L quinmerac, has a low toxicity in respect to acute
oral and dermal toxicity and is not irritating to the rabbit eye. It has been found to be not irritating to
rabbit skin and is not a skin sensitiser to the guinea pig. Taking into account all submitted data some
safety phrases are considered necessary due to the conent of 1,2-benzisothiazole-3(2H)-one (see 2.2).
3.1.3.2 Operator, Worker, Bystander, and Resident Exposure Exposure
The risk assessment according to the German model has shown that the estimated exposure towards
metamitron and quinmerac in Goltix Titan will not exceed the particular systemic AOEL for operators,
workers, bystanders and residents. Operator and worker exposure will be below the systemic AOEL only,
if prescribed PPE is worn.
The risk assessment according to the UK-POEM has shown that the estimated exposure towards
metamitron in Goltix Titan exceeds the particular systemic AOEL for operators. The risk assessment
according to an exposure study has shown that the estimated exposure towards metamitron in Goltix Titan
will not exceed the particular systemic AOEL for operators. Operator exposure will be below the
systemic AOEL only, if prescribed PPE is worn.
The risk assessment according to the UK-POEM has shown that the estimated exposure towards
quinmerac in Goltix Titan will not exceed the particular systemic AOEL for operators.
If the product is used properly and according to the intended conditions of use, adverse health effects for
operators, workers, bystanders and residents will not be expected.
Implications for labelling resulting from operator, worker, bystander assessments:
See 2.2 and 2.3
3.1.3.3 Groundwater Metabolites
The quinmerac metabolites BH518-2 and BH518-5 are predicted to occur in groundwater in
concentrations above 0.1 µg/L. The toxicological relevance assessment of these groundwater metabolites
according to the EC guidance document SANCO/221/2000 –rev.10 is presented in Section 8 of the RR.
Concentrations of these metabolites can be accepted up to the trigger value of 10 µg/L.
Part A National Assessment - Germany
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3.1.4 Residues and Consumer Exposure
3.1.4.1 Residues
Regarding aspects of seasonal application rates the cGAP of application 007529-00/01 is comparable to
that of the basic application of the product on sugar/fodder beets (007529-00/00). Hence, the statement
basically apply also for application 007529-00/01.
The available data is considered sufficient for risk assessment. An exceedance of the current MRLs of
0.2 mg/kg for metamitron and 0.5 mg/kg for quinmerac in sugar beet as laid down in Reg. (EU) No
396/2005 is not expected.
A no-residue situation is indicated from the supervised residue trials for both actives and regarding both
roots and leaves with tops. It is therefore not anticipated that the intended uses impact residues in
commodities of animal origin.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the respective
ADIs/ARfDs below 100 %.
Substance ADI/ARfD Model / Diet ADI/ARfD
Consumption
Metamitron ADI: 0.03 mg/kg bw TMDI, EFSA PRIMo, UK
toddler
26.5 %
ARfD: 0.1 mg/kg bw IESTI, EFSA PRIMo, UK
children aged 4-6 years
3 %
Quinmerac ADI: 0.08 mg/kg bw TMDI, EFSA PRIMo, UK
toddler
18.4 %
ARfD: 0.3 mg/kg bw IESTI, EFSA PRIMo, UK
children aged 4-6 years
3 %
The chronic and the short-term intake of metamitron and quinmerac residues are unlikely to present a
public health concern.
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)
A full exposure assessment for the plant protection product GOLTIX TITAN in its intended uses in beets
(sugar and fodder) is documented in detail in the core assessment of the plant protection product GOLTIX
TITAN dated from May 2015 performed by the applicant.
The following chapters summarize specific exposure assessment for soil and surface water and the
specific risk assessment for groundwater for the authorization of GOLTIX TITAN in Germany according
to its intended use in beets (sugar and fodder) (use No. 01-001).
Metabolites
Metamitron
No new study on the fate and behaviour of metamitron has been performed. The risk assessment for the
metabolite desamino-metamitron of metamitron has already been performed for EU approval (see EFSA
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Scientific Report(2008) 185,1-95). The metabolite desamino-metamitron is considered ecotoxicologically
not relevant. The metabolite desamino-metamitron did not penetrate into groundwater.
For details see Part B, core assessment, section 5.3.3 (Metabolites of metamitron).
However, in the EU review report for the inclusion of metamitron in Annex I of Directive 91/414/EEC in
the list of studies to be generated, information as regards the impact of soil metabolite M3 on
groundwater is postulated (SANCO/208/08 final, 6 January 2009, point 7). The metabolite M3 did
penetrate into groundwater with a default Koc value of 0.
Quinmerac
No new laboratory studies on the degradation of quinmerac in soil and water/sediment have been
performed. The risk assessment for the metabolites of of quinmerac has already been performed for EU
approval (see EFSA Journal 2010; 8(3):1523). The metabolites are considered ecotoxicologically not
relevant. Therefore no new risk assessment hence no exposure assessment for these metabolites is
necessary.
For details see Part B, core assessment, section 5, chapter 5.4.3 (metabolites of quinmerac).
The soil metabolites BH 518-2 and BH 518-5 of quinmerac were also included in the groundwater risk
assessment considering the entry path surface run-off and drainage with subsequent bank filtration.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5) For the intended use of the plant protection product GOLTIX TITAN in beets (sugar and fodder)
according to use No 01-001 PECsoil was calculated for the active substances quinmerac and metamitron
considering a soil depth of 2.5 cm. Due to the fast degradation of the active substances quinmerac and
metamitron in soil the accumulation potential was not considered. Details are given in Part B National
Addendum-Germany, Section5, chapter 5.6.
The results for PECsoil for the active substances and their metabolites were used for the ecotoxicological
risk assessment.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,
Section 5, Point 9.6)
1. Direct leaching into groundwater
Metamitron
According to the results of the groundwater simulation with FOCUS-PELMO 5.5.3, a groundwater
contamination of the active substance metamitron in concentrations of ≥ 0.1 µg/L is not expected for the
intended use in sugar beet.
For the metabolite desamino-metamitron, a groundwater concentration of ≥ 0.1 µg/L can be excluded for
the application in sugar beet according to the results of the groundwater simulation with FOCUS-PELMO
5.5.3.
For the metabolite M3 a groundwater concentration of ≥ 0.1 µg/L cannot be excluded for the application
in sugar beet according to the results of the groundwater simulation with FOCUS-PELMO 5.5.3. In the
EU review report for the inclusion of metamitron in Annex I of Directive 1107/2009 (SANCO/208/08
final document, 6 January 2009) information as regards the impact of soil metabolite M3 on groundwater
was postulated in the list of studies to be generated. The inclusion directive (2008/125/EC resp. regulation
540/2011) lists the missing data on M3 as confirmatory data to be delivered to the Commission till
August 2011. The evaluation of the information by the RMS is still ongoing. Therefore the relevance of
the metabolite M3 for groundwater cannot be evaluated. No information is available concerning the
ecotoxicological activity. However, subject to the provisions of the confirmatory data, the risk for
organisms exposed via groundwater is expected to be low, because the PECgw was calculated using a
worst case default Koc value of 0.
Quinmerac
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Results of modelling show that the active substance quinmerac is not expected to penetrate into
groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites BH 518-2
and BH 518-5 concentrations of ≥ 0.1 µg/L in groundwater cannot be excluded in all of the FOCUS
groundwater scenarios in the intended use.
Higher tier leaching studies indicate a lower leaching potential of metabolite BH 518-5 as expected from
the lower tier modelling. It has to be considered that the degradation rate used for modeling of DT50 =
601.5 d is a geomean that includes several default values of 1000 d.
However the metabolites BH 518-2 and BH 518-5 are classified as not relevant for groundwater.
For details see Part B, National Addendum-Germany, Section 5, chapter 5.8.1.
Consequences for authorization:
As published in Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 the Member
States concerned shall request the submission of further information on the impact of soil metabolite M3
on groundwater. According to the applicant these confirmatory data have been submitted to the
Commission (dRR Part B, Sect. 5, Core Assessment, Oct.2011).
2. Ground water contamination by bank filtration due to surface water exposure via run-off and
drainage
Metamitron
According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by
the active substance metamitron due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 20
m) are applied.
Quinmerac
According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by
the active substance quinmerac and its metabolites BH 518-2 and BH 518-5 due to surface run-off and
drainage into the adjacent ditch with subsequent bank filtration can be excluded.
For details see Part B, National Addendum-Germany, Section 5, chapter 5.8.1.
Consequences for authorization:
The authorisation of the plant protection product GOLTIX TITAN is linked with following labeling:
Use No. 001 NG404
Between treated areas with an incline of more than 2% and surface water - except only occasionally
but including periodically water-bearing surface water - there must be a border under complete plant
cover. The border's protective function must not be impaired by the use of implements. It must be at
least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the
water and soil transported by run-off, which do not flow into surface water or are not connected with
the urban drainage system or - the product is used for mulch or direct drilling methods.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section
5, Points 9.7 and 9.8)
For the intended use of the plant protection product GOLTIX TITAN in beets (sugar and fodder)
according to use No 01-001 PECsw was calculated for the active substances metamitron and quinmerac
considering the two routes of entry (i) spraydrift and (ii) run-off, drainage separately. The vapour pressure
at 20 °C of the active substances metamitron and quinmerac is < 10-5 Pa. Hence the active substances are
regarded as non-volatile. Therefore exposure of surface water by the active substances metamitron and
quinmerac due to deposition following volatilization was not considered as relevant.
Details are given in Part B, National Addendum-Germany, Section5, chapter 5.7.
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The results for PECsw for the active substances and their metabolites were used for the ecotoxicological
risk assessment.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point
9.9)
The vapour pressures of the active substances metamitron and quinmerac are < 10-5 Pa. Hence the active
substances are regarded as non-volatile.
Implications for labelling resulting from environmental fate assessment
For the authorisation of the plant protection product GOLTIX TITAN following labeling and conditions
of use are mandatory:
Classification and labelling
Based on the data on the active substances metamitron and quinmerac of the plant protection product
GOLTIX TITAN are considered to be not readily degradable in the sense of the CLP regulation.
The formulation GOLTIX TITAN is regarded as a candidate for R 53.
Standard Phrases for special risks and safety precautions under Regulation (EU) 547/2011 Annex II and
III / conditions of use
Use No. 001:
NG404 Between treated areas with an incline of more than 2% and surface
water - except only occasionally but including periodically water-
bearing surface water - there must be a border under complete plant
cover. The border's protective function must not be impaired by the use
of implements. It must be at least 20 m wide. This border is not
necessary if: - sufficient catching systems are available for the water
and soil transported by run-off, which do not flow into surface water or
are not connected with the urban drainage system or - the product is
used for mulch or direct drilling methods.
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3.1.6 Ecotoxicology (Part B, Section 6, Point 10)
A full risk assessment according to Uniform Principles for the plant protection product GOLTIX TITAN
in its intended uses in beets (sugar and fodder) is documented in detail in the core assessment of the plant
protection product GOLTIX TITAN dated from October 2011 performed by Feinchemie Schwebda
GmbH. The intended use of GOLTIX TITAN in Germany is generally covered by the uses evaluated in
the course of the core assessment by zonal rapporteur member state Germany.
The following chapters summarise specific risk assessment for non-target organisms and hence risk
mitigation measures for the authorisation of GOLTIX TITAN in Germany according to its intended use in
beets (sugar and fodder) (use No. 01-001).
Only information relevant for the prescription of national labelling and environmental restrictions are
mentioned in the following chapters. Details of ecotoxicological studies and risk assessment are described
in the Core Assessment and the National Addendum Germany, Part B, Section 6, respectively.
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
There is no unacceptable risk for terrestrial vertebrates.
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.2 (birds) and 6.3
(terrestrial vertebrates other than birds) and National Addendum Germany, Section 6, Point 6.1 (birds)
and Point 6.2 (other terrestrial vertebrates), respectively.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.4 and National
Addendum Germany, Section 6, Point 6.3 respectively.
Based on the intrinsic properties of the active substances metamitron and quinmerac, following national
labelling and environmental restrictions are prescribed as mandatory:
Risk mitigation measures:
Use No.
001
NW642:
The product is not authorized for use in or in the immediate vicinity of surface waters or
coastal waters (§ 6 (2) 'PflschG' [Plant Protection Act]). Irrespective of this fact, the binding
minimum buffer zone to be kept from surface waters, provided for by state law, must be
observed. Violations may be punished by fines of up to Euro 50.000.
Use No.
001
NW468:
Fluids left over from application and their remains, products and their remains, empty
containers and packaging, and cleansing and rinsing fluids must not be dumped in water.
This also applies to indirect entry via the urban or agrarian drainage system and to rain-
water and sewage canals.
Labelling:
Because of the toxicity of the active ingredients as well as the formulation following labels must be given:
NW262: The product is toxic for algae.
NW263: The product is toxic for aquatic invertebrates.
NW265: The product is toxic for higher aquatic plants.
Studies of the acute toxicity of GOLTIX TITAN for algae [EbC50Metamitron = 0.4 mg/L (P. subcapitata;
EC50Goltix Titan = 2.0 mg/L (P. subcapitata)], daphnia [LC50Metamitron = 5.7 mg/L (D. magna)] and aquatic
plants [EbC50Metamitron = 0.4 mg/L (L. gibba); EbC50Goltix Titan = 0.86 mg/L (L. gibba)] showed that this
product should be labelled as very toxic for aquatic organisms.
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3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and
10.5)
Bees
In the honey bee risk assessment for the main application it was concluded that the risk to bees is
acceptable when Goltix Titan (AG-QMM1-565 SC) is used up to 6 L product/ha in pre-emergence or
early post-emergence fodder and sugar beet fields. Since the recommended application rate does not
exceed this rate no further risk assessment is required. Labelling phrase NB6641 is applied.
Other non-target arthropods
No risk management measures are required for other arthropod species for the intended use pattern.
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.5 and 6.6 and National
Addendum Germany, Section 6, Point 6.4 and 6.5 respectively.
3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point
10.6)
No risk management measures are required for the protection of earthworms and other soil macro-
organisms for the intended use pattern.
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.7 and National
Addendum Germany, Section 6, Point 6.6 respectively.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.7.8.
No risk management measures are required for the protection of earthworms and other soil macro-
organisms for the intended use pattern.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
No risk management measures are required for the protection of non-target soil micro-organisms for the
intended use pattern.
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.8.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna) (Part B, Section 6, Point 10.8)
No risk management measures are required for the protection of non-target plants for the intended use
pattern.
For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.9.
Implications for labelling resulting from ecotoxicological assessment:
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Relevant toxicity data
Goltix Tiitan
EyC50 = 1.5 mg/L (Lemna gibba)
EyC50 = 1.99 mg/L (P. subcapitata)
Classification & Labelling according directives 67/548/EEC, 78/631/EEC and 1999/45/EEC
Danger Symbol N, dangerous for the environment
Risk Phrases R 51/53
C&L according directive 1272/2008
Danger Symbol GHS 09
Hazard Statements H 411
3.1.7 Efficacy (Part B, Section 7, Point 8)
Information on the active ingredients (Uptake and mode of action) Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used
in fodder- and sugar beet for the control of mono- and dicotyledonous weeds. Primarily it is taken up by
plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the
leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron
transport at the photosystem II receptor site (Hill-reaction). Selectivity of weeds is based on different
metabolisation. Susceptible weed seedlings become chlorotic, exhibit yellowed and cleared discolouration
and finally get withered. Metamitron is highly selective in fodder and sugar beets. Metamitron is readily
degraded by aqueous photolysis. The major metabolite in sugar beet is deaminated metamitron. Mode of
action (HRAC-group): C1
Labelling phrase WMC1
Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily
via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake
by roots and the onset of activity. Uptake by leaves depends on the concentration of the active ingredient
and time. Its mode of action has been proposed as root growth inhibition which exhibits auxin type effects
(similar to phenoxycarboxylic acids). Based on the auxin effects quinmerac stimulates the formation of
the phytohormone ethylene in sensitive plants, leading to epinasty, altered uptake and other effects. In the
biosynthesis the enzymatic activity of 1-aminocyclopropane-1-carboxylic-acid synthase will be induced.
As a result an accumulation of abscisic acid (ABA) in the plant tissue occurs. The consequences are:
deformation of plants, occlusion of stomata, inhibition of transpiration, CO2-assimilation and growth as
well as the death of plant cells. The selective effect is based on plant tissue/target location selectivity in
crop plants. In sugar beet the tolerance is supported by a faster degradation. Uptake and translocation has
no great significance for herbicide efficacy. Mode of action (HRAC-group): O
Labelling phrase WMO
Minimum effective dose
The dose response results against some weed species show that there is a trend that for most of the weed
species the efficacy is reduced and the variability of the level of control is increased, if rates lower than 3
+ 3 x 1 L/ha of AG-QMM1-565 SC are applied.
Efficacy
A total of 17 efficacy trials were carried out in 2010, 2011, and 2012 in Belgium, Germany and the
Netherlands.. The applied application rate of AG-QMM1-565 SC was 3 L/ha pre-emergence followed by
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up to 3 post-emergence splitting applications of 1 L/ha each. It can be concluded that AG-QMM1-565 SC
provides sufficient control of a number of annual dicotyledonous weed species in fodder and sugar beets.
POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous weed species
didn’t occur in the efficacy trials. So no final evaluation for annual monocotyledonous weed species
could be done.
Labelling phrase: WH9161.
Effect on the yield and quality
Based on the results of 8 selectivity trials carried out in sugar beets in Germany and the Netherlands in
2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant
products in sugar or fodder beets if the product is applied at the intended target application rates, even if
the product is applied at double rate.
Effects on the Processing Procedure Neither from trial experience nor from practical use of the active ingredients metamitron and quinmerac
any cases were reported about negative influences on parameters influencing the processing procedure of
sugar beets. Thus no special trials were carried out for the assessment of these criteria.
Effects on the yield of treated plants and plant products
There are no indications for a negative impact on quantity of yield in sugar or fodder beets if AG-QMM1-
565 SC is applied at the intended target application rates. Even at the double rate there is no substantial
risk for an impact on yield quantity.
Phytotoxicity to host crop
The effects AG-QMM1-565 SC applied in splitting applications (3 L/ha pre-emergence + 3 x 1 L/ha post-
emergence) on the target crop were rated in a total of 25 trials.The results show that the product is
tolerated well by sugar beets. For this indication only one year results (2013) are available from trials
carried out with the double rate included under almost weed free conditions.
Impacts on succeeding and on adjacent crops
According to EPPO standard PP1/207 no unacceptable risk for all succeeding crops in common crop
rotations could be shown.
Information on the possible Occurrence of the Development of Resistance or Cross-Resistance
The evaluation of the inherent risk for resistance development of AG-QMM1-565 SC shows that for the
active ingredient metamitron there is a high risk for the development of weed resistance while the
inherent risk of target weeds to develop resistance against quinmerac is considered low to medium.
The applicant claims that the risk for the development of resistant weed biotypes in major sugar beet
production areas is considered medium because of the fact that despite many years of intensive use of
metamitron only very occasional proven problems with weed resistance are reported in Europe, and that
no proven problems of quinmerac with this active ingredient are reported. This conclusion cannot be fully
followed. As the number of metamitron resistance cases reported for Chenopodium album has
substantially increased in the last years, the resistance risk for metamitron has to be rated as high
especially for Germany and Belgium. As the spectrum of weed species controlled by metamitron and
quinmerac is not overlapping and because the above mentioned high risk weed species (especially
Chenopodium album) are nor controlled by quinmerac, the resistance risk of the herbicide has to be rated
a medium to high. Due to this resistance risk, management strategies are required. The applicant claims
that basic recommendations for resistance risk management will be clearly recommended on the label.
Labelling phrase: WH951.
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Adverse effects on beneficial organisms other than bees
Under extended laboratory test conditions effects of less than 25 % at the proposed application rate of
maximum 6 L/ha per year were demonstrated. The herbicide AG-QMM1-565 SC is therefore considered
to be harmless for Aphidius rhopalosiphi and Typhlodromus pyri.
Besides the two indicator species, only the rove beetle Aleochara bilineata was tested with SC-
formulations of the both active ingredients of the test product, metamitron and quinmerac. Metamitron
was shown to be slightly harmful with an effect between 30 – 80 % under worst case conditions. No
effects occurred in a laboratory study with the combination product AG-QM2-500 SC and in an extended
laboratory study with metamitron, but the latter test did not fulfil the validity criteria. Thus it could not be
excluded, that the test product can be slightly harmful for Aleochara bilineata.
On the basis of the results of an extended laboratory study with Metamitron, the test product has to be
considered as slightly harmful for the ladybird beetle Coccinella septempunctata.
Labelling phrases: NN1001, NN1002.
3.2 Conclusions
With respect to physical, chemical and technical properties and analytical methods (formulation, residues)
an authorisation can be granted
Regarding toxicology, residues and consumer protection an authorisation can be granted.
With respect to efficacy an authorization can be granted for the control of annual dicotyledonous
weeds. Due to the letter of the applicant dated 2015-01-13 the control of annual monocotyledonous
weeds is no longer pursued.
Concerning fate and ecotoxicology an authorisation can be granted.
The product is classified as non-hazardous to bees.
An authorisation can be granted.
3.3 Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation
No further information is required.
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Appendix 1 – Copy of the product authorisation
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Date: 01/06/2016
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Date: 01/06/2016
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Date: 01/06/2016
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Date: 25/09/2015
Appendix 2 – Copy of the product label
The submitted draft product label has been checked by the competent authority. The applicant is
requested to amend the product label in accordance with the decisions made by the competent
authority. The final version of the label has to fulfil the requirements according to Article 16 of
Directive 91/414/EEC.
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Appendix 3 – Letter of Access
Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
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REGISTRATION REPORT
Part B
Section 1: Identity, physical and chemical
properties, other information
Detailed summary of the risk assessment
Product code: Goltix Titan
(AG-QMM1-565 SC)
Active Substance: Metamitron 525 g/L
Quinmerac 40 g/L
Central Zone
Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: ADAMA Deutschland GmbH
Submission Date: January 2014
Date : February 2016
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
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Table of Contents
IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT .............................. 6
IIIA 1.1 Applicant ................................................................................................................ 6
IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the
Active Substance(s) ............................................................................................... 6
IIIA 1.2.1 Manufacturer(s) of the preparation .................................................................... 6
IIIA 1.2.2 Manufacturer(s) of the active substance(s) ......................................................... 7
IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the
active substance(s) ................................................................................................. 7
IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation .......... 7
IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition
of the Preparation .................................................................................................. 7
IIIA 1.4.1 Content of active substance and formulants ....................................................... 7
IIIA 1.4.2 Certified limits of each component ...................................................................... 8
IIIA 1.4.3 Common names and code numbers for the active substance(s) ........................ 8
IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name,
specification and function. .................................................................................... 8
IIIA 1.4.5 Formulation process .............................................................................................. 9
IIIA 1.4.5.1 Description of formulation process ...................................................................... 9
IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern .................. 9
IIIA 1.5 Type of Preparation and Code ............................................................................. 9
IIIA 1.6 Function .................................................................................................................. 9
IIIA 1.7 Other/Special Studies ............................................................................................ 9
IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF
THE PLANT PROTECTION PRODUCT ....................................................... 10
IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15.......... 13
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
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IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION
PRODUCT ........................................................................................................... 13
IIIA 3.1 Field of Use ........................................................................................................... 13
IIIA 3.2 Nature of the Effects on Harmful Organisms ................................................... 13
IIIA 3.3 Details of Intended Use ....................................................................................... 13
IIIA 3.3.1 Details of existing and intended uses ................................................................. 13
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 13
IIIA 3.3.2 Details of harmful organisms against which protection is afforded ............... 13
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 13
IIIA 3.3.3 Effects achieved ................................................................................................... 13
Please refer to Part B Section 7. ................................................................................................. 13
IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ................. 13
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 13
IIIA 3.5 Concentration of the Active Substance in the Material Used ......................... 13
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 13
IIIA 3.6 Method of Application, Type of Equipment Used and Volume of
Diluent .................................................................................................................. 13
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 13
IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop
and Harmful Organism) and Duration of Protection ...................................... 14
IIIA 3.7.1 Maximum number of applications and their timings ...................................... 14
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 14
IIIA 3.7.2 Growth stages of crops or plants to be protected ............................................. 14
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 14
IIIA 3.7.3 Development stages of the harmful organism concerned ................................ 14
Please refer to Appendix 2 – Critical Uses – and Part B Section 7. ........................................ 14
IIIA 3.7.4 Duration of protection afforded by each application ....................................... 14
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
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Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
Please refer to Part B Section 7. ................................................................................................. 14
IIIA 3.7.5 Duration of protection afforded by the maximum number of
applications .......................................................................................................... 14
Please refer to Part B Section 7. ................................................................................................. 14
IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic
Effects on Succeeding Crops .............................................................................. 14
IIIA 3.8.1 Minimum waiting periods or other precautions between last application
and sowing or planting succeeding crops .......................................................... 14
Please refer to Part B Section 7. ................................................................................................. 14
IIIA 3.8.2 Limitations on choice of succeeding crops ........................................................ 14
Please refer to Part B Section 7. ................................................................................................. 14
IIIA 3.8.3 Description of damage to rotational crops ........................................................ 14
Please refer to Part B Section 7. ................................................................................................. 14
IIIA 3.9 Proposed Instructions for Use as Printed on Labels ........................................ 14
IIIA 3.10 Other/Special Studies .......................................................................................... 14
IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION
PRODUCT ........................................................................................................... 15
IIIA 4.1 Packaging and Compatibility with the Preparation ........................................ 15
IIIA 4.2 Procedures for Cleaning Application Equipment ............................................ 15
IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment ............... 15
IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop ...................................... 15
IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed ......................... 15
IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces
treated ................................................................................................................... 15
IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs ................................... 15
IIIA 4.3.5 Waiting period (in days) between application and handling of treated
products ................................................................................................................ 15
IIIA 4.3.6 Waiting period (in days) between last application and sowing or
planting succeeding crops ................................................................................... 15
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 5 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
IIIA 4.3.7 Information on specific conditions under which the preparation may or
may not be used ................................................................................................... 15
IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and
Precautions and Handling Procedures to Minimise Those Risks ................... 15
IIIA 11 FURTHER INFORMATION............................................................................. 15
IIIA 11.1 Information of Authorisations in Other Countries .......................................... 15
IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other
Countries .............................................................................................................. 15
IIIA 11.3 Justified Proposals for Classification and Labelling ........................................ 16
IIIA 11.4 Proposals for Risk and Safety Labels ............................................................... 16
IIIA 11.5 Proposed Label .................................................................................................... 16
IIIA 11.6 Specimens of Proposed Packaging ..................................................................... 16
Appendix 1: List of data used in support of the evaluation .................................................. 17
Appendix 2: Critical Uses – justification and GAP tables ..................................................... 18
Introduction
This document summarises the information related to the identity, the physical and chemical properties,
the data on application, further information and the classification for the product AG-QMM1-565 SC
containing the active substances metamitron and quinmerac which were approved according to
Regulation (EC) No 1107/2009.
This product was not the representative formulation. The product has not been previously evaluated
according to Uniform Principles.
Where appropriate this document refers to the conclusions of the EU review of metamitron and
quinmerac. This will be where:
• the active substance data are relied upon in the risk assessment of the formulation; or when
• the EU review concluded that additional data/information should be considered at national re-
registration.
New annex II data of quinmerac have been generated to match protected data. These data are summarised
in Annex 4 of this section.
The SANCO report for Metamitron (SANCO/208/08 final – 6 Januar 2009) and Quinmerac
(SANCO/12192/2010 final – 7 December 2010) are considered to provide the relevant review
Part B – Section 1
Core Assessment –
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AG-QMM1-565 SC
Goltix Titan
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Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
information or a reference to where such information can be found. Each section will begin with a table
providing the EU endpoints to be used in this evaluation.
This Part B document only reviews data (Annex II or Annex III) and additional information that has not
previously been considered within the EU review process, as part of the Annex I inclusion decision.
The following table provides the EU endpoints to be used in the evaluation.
Agreed EU End-points
End-Point Metamitron
(Reg. (EU) No. 540/2011) Quinmerac
(Reg. (EU) No. 540/2011)
Purity of active substance min 960 g/kg min 980 g/kg
Appendix 1 of this document contains the list of references included in this document for support of the
evaluation.
Appendix 2 of this document is the table of intended uses for AG-QMM1-565 SC.
Information on the detailed composition of AG-QMM1-565 SC can be found in the confidential dossier
of this submission (Registration Report - Part C).
IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT
IIIA 1.1 Applicant
ADAMA Deutschland GmbH
Edmund-Rumpler-Straße 6
D-51149 Köln
Germany
IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active
Substance(s)
IIIA 1.2.1 Manufacturer(s) of the preparation
Name: ADAMA Agan Ltd.
Address: Industrial Zone
P.O. Box 262,
Ashdod, 77102, Israel
Part B – Section 1
Core Assessment –
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Goltix Titan
Registration Report – Central Zone
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Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
Contact:
E-mail:
Dr. Tali Ehrlich
Tel.: +972 7 32321330
Location of manufacturing site
CONFIDENTIAL information – data provided separately (Part C).
IIIA 1.2.2 Manufacturer(s) of the active substance(s)
Confidential information - data provided separately (Part C).
IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active
substance(s)
Metamitron: minimum 980 g/kg
Quinmerac: minimum 980 g/kg
Further information/justification is provided in Part C.
IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation
Trade name: Goltix Titan for Germany.
Company code number:
development code: AG-QMM1-565 SC
FSG-code: FSG 02122 H
IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the
Preparation
IIIA 1.4.1 Content of active substance and formulants
The formulation was not the representative formulation.
Pure active substance:
content of pure metamitron: 525 g/L
content of pure quinmerac: 40 g/L
limits metamitron: 500 – 550 g/L
limits quinmerac: 36 – 44 g/L
Part B – Section 1
Core Assessment –
Germany
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Goltix Titan
Registration Report – Central Zone
Page 8 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
Technical active substance:
content of technical metamitron
at minimum purity (98.0 %):
535.7 g/L
content of technical quinmerac
at minimum purity (98.0 %):
40.8 g/L
None of the active substances in the formulation are present in the form of a salt, ester, anion or cation.
Further information on the active substances and on the certified limits of formulants is considered
confidential and is provided separately (Part C).
IIIA 1.4.2 Certified limits of each component
This is not an EC data requirement/ not required by regulation (EU) 2011/545.
IIIA 1.4.3 Common names and code numbers for the active substance(s)
Data
Point
Type Name/Code Number
1.4.3.1 ISO common name Metamitron Quinmerac
1.4.3.2 CAS No. 41394-05-2 90717-03-6
1.4.3.2 EINECS No. 255-349-3 None
1.4.3.2 CIPAC No. 381 563
1.4.3.2 ELINCS None 402-790-6
1.4.3.3 Salt, ester anion or cation
present
None None
IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and
function.
CONFIDENTIAL information - data provided separately (Part C).
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 9 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
IIIA 1.4.5 Formulation process
IIIA 1.4.5.1 Description of formulation process
This is not an EC data requirement/ not required regulation (EU) 2011/545.
IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern
There are no relevant impurities in the technical active Substances metamitron and quinmerac as
manufactured and the manufacturing process of the formulation AG-QMM1-565 SC is such that no new
relevant impurities can be formed.
IIIA 1.5 Type of Preparation and Code
Type : Suspension concentrate Code : SC
IIIA 1.6 Function
The product will be used as herbicide.
IIIA 1.7 Other/Special Studies
None.
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 10 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT
The product AG-QMM1-565 SC is already registered in Germany, Belgium and Netherlands. The complete set of studies on physical, chemical properties
of the product has been evaluated and accepted. The storage stability at ambient temperature over a period of 2 years was submitted post authorisation. The
results are adequate and demonstrate that the technical characteristics of AG-QMM1-565 SC are acceptable for the suspension concentrate formulation.
This study is presented in the following table:
Test or study
& Annex point
Method
used /
deviations
Test material purity
and specification
Findings GLP
Y/N
Reference Acceptability /
comments
Ambient
temperature
shelf life
(IIIA 2.7.5)
Standard
Operating
procedures
of AGAN,
based on
CIPAC
methods.
Quinmerac 40 g/L +
Metamitron 525 g/L
SC
batch K6001
41.3 g/L quinmerac
540.2 g/L metamitron
The product was stable during a two-year storage
stability test when stored in original HDPE commercial
containers:
1. Appearance and stability of packaging:
Initial results: off-white suspension, characteristic
odour
Final results: same as initial.
After storage slight bleeding (~15 %) and slight
sedimentation. Nonetheless the product was
homogenous after five inversions.
2. A.I. content (g/L)
Initial results:
Metamitron 540 g/L (46.45%)
Quinmerac 41.2 g/L (3.54%)
Final results:
Metamitron 541.31 g/L (46.33%)
Quinmerac 41.0 g/L (3.53%)
Y Edelson, 2012,
(F10-03/5)
2205911
Acceptable
Part B – Section 1
Core Assessment –
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Goltix Titan
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Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
Test or study
& Annex point
Method
used /
deviations
Test material purity
and specification
Findings GLP
Y/N
Reference Acceptability /
comments
3. pH 1% in deionized water
Initial result:3.7
Final result: 3.8
4. pH undiluted
Initial result:4.4
Final result: 4.3
4. Spontaneity of dispersion (%)
(water D) 5% v/v
Initial result:
Quinmerac 94%, Metamitron 95%
Final results:
Quinmerac 96%, Metamitron 98%
5. Suspensibility (%), water D at 0.5% and at 2.0%
Initial results at 0.5%
Quinmerac 94%, Metamitron 98%
Final result at 0.5%:
Quinmerac 90%, Metamitron 97%
Initial results at 2.0%:
Quinmerac 88%, Metamitron 93%
Final result at 2.0%:
Quinmerac 85%, Metamitron 93%
6. Wet sieve residue (%)
Initial results: 0.017
Final results: 0.025
Part B – Section 1
Core Assessment –
Germany
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Goltix Titan
Registration Report – Central Zone
Page 12 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
Test or study
& Annex point
Method
used /
deviations
Test material purity
and specification
Findings GLP
Y/N
Reference Acceptability /
comments
7. Particle size distribution (%)
Initial results:
D (0.9) 9.44
D (0.5) 3.08
D (0.1) 0.81
Final results:
D (0.9) 11.31
D (0.5) 2.28
D (0.1) 0.55
8. Pourability (%)
Initial results: 3.05
Final results: 2.17
. Rinsed (%)
Initial result: 0.17
Final result: 0.23
Conclusion: The product was stable during a two-year
storage stability test when stored in original HDPE
commercial containers.
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 13 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15
The storage stability at ambient temperature over a period of 2 years showed good stability in terms of
active substance content and product characteristics.
In the present application the lowest in use concentration is 0.25 % (1 L in 400 L water), while in the
main application the lowest in use concentration is 0.5 %. No information is available on the
suspensibility at 0.25 %, but this is considered acceptable, as the results at 0.5 % are > 90 %.
IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT
IIIA 3.1 Field of Use
The application was for approval of AG-QMM1-565 SC (in Germany: Goltix Titan), a suspension
concentrate containing 525 g/L Metamitron and 40 g/L Quinmerac, for use as herbicide against annual
monocotyledonous weeds, Galium aparine and other annual dicotyledonous weeds in splitting
applications.
IIIA 3.2 Nature of the Effects on Harmful Organisms
Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used
in fodder- and sugar beet for the control of mono- and dicotyledonous weeds. Primarily it is taken up by
plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the
leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron
transport at the photosystem II receptor site (Hill-reaction). Mode of action (HRAC-group): C1
Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily
via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake
by roots and the onset of activity. Uptake by leaves depends on the concentration of the active ingredient
and time. Light increases the uptake rate. In contrast dependence on temperature is slight. Its mode of
action has been proposed as root growth inhibition which exhibits auxin type effects (similar to
phenoxycarboxylic acids). Mode of action (HRAC-group): O
IIIA 3.3 Details of Intended Use
IIIA 3.3.1 Details of existing and intended uses
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.3.2 Details of harmful organisms against which protection is afforded
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.3.3 Effects achieved
Please refer to Part B Section 7.
IIIA 3.4 Proposed Application Rates (Active Substance and Preparation)
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.5 Concentration of the Active Substance in the Material Used
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 14 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful
Organism) and Duration of Protection
IIIA 3.7.1 Maximum number of applications and their timings
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.7.2 Growth stages of crops or plants to be protected
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.7.3 Development stages of the harmful organism concerned
Please refer to Appendix 2 – Critical Uses – and Part B Section 7.
IIIA 3.7.4 Duration of protection afforded by each application
Please refer to Part B Section 7.
IIIA 3.7.5 Duration of protection afforded by the maximum number of applications
Please refer to Part B Section 7.
IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding
Crops
IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or
planting succeeding crops
Please refer to Part B Section 7.
IIIA 3.8.2 Limitations on choice of succeeding crops
Please refer to Part B Section 7.
IIIA 3.8.3 Description of damage to rotational crops
Please refer to Part B Section 7.
IIIA 3.9 Proposed Instructions for Use as Printed on Labels
Please refer to Registration Report – Part A, Appendix 2 for the relevant country.
IIIA 3.10 Other/Special Studies
This is not an EC data requirement/ not required by Directive 91/414/EEC.
Part B – Section 1
Core Assessment –
Germany
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Goltix Titan
Registration Report – Central Zone
Page 15 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
IIIA 4.1 Packaging and Compatibility with the Preparation
There is no change compared to the main application. Therefore no further evaluation is necessary.
IIIA 4.2 Procedures for Cleaning Application Equipment
There is no change compared to the main application. Therefore no further evaluation is necessary.
IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment
IIIA 4.3.1 Pre-harvest interval (in days) for each relevant crop
See section 4.
IIIA 4.3.2 Re-entry period (in days) for livestock, to areas to be grazed
See section 4.
IIIA 4.3.3 Re-entry period (in hours or days) for man to crops, buildings or spaces treated
See section 4.
IIIA 4.3.4 Withholding period (in days) for animal feeding stuffs
See section 4.
IIIA 4.3.5 Waiting period (in days) between application and handling of treated products
See section 4.
IIIA 4.3.6 Waiting period (in days) between last application and sowing or planting succeeding crops
See section 4.
IIIA 4.3.7 Information on specific conditions under which the preparation may or may not be used
See section 4.
IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions
and Handling Procedures to Minimise Those Risks
There is no change compared to the main application. Therefore no further evaluation is necessary.
IIIA 11 FURTHER INFORMATION
IIIA 11.1 Information of Authorisations in Other Countries
An overview of the existing approvals in EC member states of metamitron and quinmerac is given in
Appendix 3A and Appendix 3B, respectively.
IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries
MRLs set at European Level are stated in the Regulation (EC) No 396/2005 (see: EU Pesticides database,
as published on June 8, 2010, Internet: http://ec.europa.eu/sanco_pesticides/public/
index.cfm). See also Table 8.7.2-1 and Table 8.7.2-7 in chapter 8.7.
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Registration Report – Central Zone
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Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
MRLs established in exporting countries for pyraclostrobin and epoxiconazole are given in
Appendix 3C and Appendix 3D, respectively.
IIIA 11.3 Justified Proposals for Classification and Labelling
Proposals for classification and labelling of AGG-QMM1-565 SC in accordance with the EC Directive on
dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below:
Physico - chemical properties
There is no change compared to the main application. Therefore no further evaluation is necessary.
Toxicology
Please refer to Registration Report – Part B section 3.
Ecotoxicology/Environment
Please refer to Registration Report – Part B section 6.
IIIA 11.4 Proposals for Risk and Safety Labels
Please refer to Registration Report – Part A.
IIIA 11.5 Proposed Label
Please refer to Registration Report – Part A.
IIIA 11.6 Specimens of Proposed Packaging
Specimens of the packaging were not provided as there was no request.
.
Part B – Section 1
Core Assessment –
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Goltix Titan
Registration Report – Central Zone
Page 17 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
Appendix 1: List of data used in support of the evaluation
Annex point/
reference No
Author(s) Year Title
Source (where different from
company)
Report-No.
GLP or GEP status (where relevant)
Data
protection
claimed
Owner How
considered in
dRR
Study-Status /
Usage*
KIIIA 2.7.5 Edelson, T.,
Nahmoud, S.
2012 Determination of storage stability and
phys-chem properties of (quinmerac
40 g/l + metamitron 525 g/l) SC
stored at ambient temperature for two
years
AGAN Chemical Manufacturers,
Ltd., Ashdod, Israel
Quena Plant Protection N.V.,
F10-03/5,
GLP: Yes
Published: No
yes ADAMA 1
* 1 accepted (study valid and considered for evaluation)
2 not accepted (study not valid and not considered for evaluation)
3 not considered (study not relevant for evaluation)
4 not submitted but necessary (study not submitted by applicant but necessary for evaluation)
5 supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
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Appendix 2: Critical Uses – justification and GAP tables
GAP-Table of intended uses for Germany
GAP rev. (No), date: 2014-04-14
PPP (product name/code) Goltix Titan
active substance 1 Metamitron
active substance 2 Quinmerac
Formulation type: SC
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Applicant: Feinchemie Schwebda GmbH
Zone(s): central/EU
professional use X
non professional use
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days) Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
Method /
Kind Timing / Growth
stage of crop &
season
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
kg, L product /
ha
a) max. rate per
appl.
b) max. total rate
per crop/season
g, kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water L/ha
min / max
001 DE Sugar beet
BEAVA
fodder beet
BEAVC
F Annual
monocotyledonous
weeds
TTTMS
Annual dicotyledonous
weeds
TTTDS
Spraying
splitting 4
applications
Spring
BBCH 00 – 19
1st treatment before-
emergence
2nd to 4th treatment
after emergence
a) 4
b) 4
the 2nd to 4th
treatment with
an interval of 5
to 10 days
a)
timing 1: 3 L/ha
timing 2: 1 L/ha
timing 3: 1 L/ha
timing 4: 1 L/ha
a)
timing 1:
Metamitron
1575 g as/ha
Quinmerac
120 g as/ha
timing 2:
Metamitron
200 - 400 *XF WH9161
‚Annual
monocotyledonous
weeds‘ are withdrawn by the
applicant , because not
enough data regarding
efficacy available.
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b) 6 L/ha
maximum
application rate
for the intented
crop per year
525 g as/ha
Quinmerac
40 g as/ha
timing 3:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
timing 4:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
b)
Metamitron
3150 g as/ha
Quinmerac
240 g as/ha
maximum
application rate
for the intented
crop per year
*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI
in days is not required resp.
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Remarks: (1) Numeration of uses in accordance with the application/as verified by MS
(2) Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(8) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g. g or kg / ha)
(12) The range (min/max) of water volume under practical conditions of use must be given
(L/ha)
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 21 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
GAP-Table of intended uses for all cMS (without Germany), not verified by zRMS
PPP (product name/code) AG-QMM1-565 SC
active substance 1 Metamitron
active substance 2 Quinmerac
active substance
safener -
synergist -
Formulation type: SC (suspension concentrate)
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Conc. of as:
Conc. of safener: -
Conc. of synergist: -
Applicant: Feinchemie Schwebda GmbH
Zone(s): central/EU
professional use
non professional use
Verified by MS: no
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination
/ purpose of crop)
F
G
or
I
Pests or Group of
pests controlled
(additionally:
developmental
stages of the pest or
pest group)
Application Application rate PHI (days)
Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
Method /
Kind
Timing /
Growth
stage of crop
& season
Max. number (min.
interval between
applications)
a) per use
b) per crop/ season
kg, L product / ha
a) max. rate per
appl.
b) max. total rate
per crop/season
g as/ha
a) max. rate per
appl.
b) max. total
rate per
crop/season
Water
L/ha
min /
max
1 NL, BE Beets (sugar and F GALAP and other
annual spraying BBCH 10- a) 1-3 (5) a) 2
a) Metamitron:
1050
200 /
400 F
Max. 2.0 L product/ha per
treatment
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 22 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
fodder)
Use already
authorised
dicotyledonous
weed species
19 b) 3 b) 6 Quinmerac: 80
b) Metamitron:
3150
Quinmerac: 240
Total 6.0 L product/ha
Max. once per three years
on same field
2 NL, BE
Beets (sugar and
fodder) F
Poa annua
POAAN,
Galium aparine
GALAP ,
annual
dicotyledonous
weeds (TTTDS)
spraying
BBCH 00-
09 a) 1
b) 1
a) 3
b) 3
a) Metamitron:
1575
Quinmerac: 120
b) Metamitron:
1575
Quinmerac: 120
200 /
400 F
Total 6.0 L product/ha
Max. once per three years
on same field
BBCH 10-
19 a) 1-3 (5)
b) 3
a) 1
b) 3
a) Metamitron:
525 Quinmerac:
40
b) Metamitron:
1575
Quinmerac: 120
200 /
400 F
3 NL, BE
Beets (sugar and
fodder)
withdrawn by
applicant on 14
February 2014
F
POAAN, GALAP
and other annual
dicotyledonous
weed species spraying
BBCH 00-
09 a) 1
b) 1
a) 3
b) 3
a) Metamitron:
1575
Quinmerac: 120
b) Metamitron:
1575
Quinmerac: 120
200 /
400 F
Pre-emergence:
1 × 3.0 L fp/ha
Post-emergence:
Max. individual application
rate: 3.0 L fp/ha,
E.g. 1× 3.0 L;
1 × 1.25 L + 1 × 1.0 L + 1 ×
1.0 L;
1 × 1.5 L + 1 x 1.75 L fp/ha;
or combinations of other
uses with 0.75 L/ha min).
Max. total post-emergence
applied of 3.25 L fp/ha
Max use rate of 250 g/ha
Quinmerac is restricted on
BBCH 10-
19 a) 1-4 (5)
b) 4
a) 1,25
b) 3,25
a) Metamitron:
656 Quinmerac:
50
b) Metamitron:
1706
Quinmerac: 130
200 /
400 F
BBCH 10-
19
a) Metamitron:
525 Quinmerac:
40
b) Metamitron:
1575
Quinmerac: 120
200 /
400 F
Part B – Section 1
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Titan
Registration Report – Central Zone
Page 23 of 23
Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016
the same field per year.
withdrawn by applicant
on 14 February 2014
4 NL, BE
Beets (sugar and
fodder)
withdrawn by
applicant on 14
February 2014
F
POAAN, GALAP
and other annual
dicotyledonous
weed species spraying
BBCH 10-
19 a) 1 (5)
b) 6
a) 0,75
b) 1,25
a) Metamitron:
394 Quinmerac:
30
b Metamitron:
656 Quinmerac:
50
200 /
400 F
Max. individual application
rate: 1.25 L fp/ha, e.g.
5 × 1.25 L fp/ha or uses in
between
Max use rate of 250 g/ha
Quinmerac is restricted on
the same field per year.
withdrawn by applicant
on 14 February 2014
Indication 1 is already authorised
Indication 3 and 4 only as national addendum – withdrawn by applicant on 14 February 2014
Part B Section 2
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Gold
Registration Report –Central Zone
Page 1 of 4
Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015
REGISTRATION REPORT
Part B
Section 2 Analytical Methods
Detailed summary of the risk assessment
Product code: Goltix Titan
(AG-QMM1-565 SC)
Active Substance: Metamitron 525.0 g/L
Quinmerac 40.0 g/L
Central Zone
Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Feinchemie Schwebda GmbH
Submission Date: October 2011
Date: June 2015
Part B Section 2
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Gold
Registration Report –Central Zone
Page 2 of 4
Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015
Table of Contents
IIIA 5 METHODS OF ANALYSIS ....................................................................... 3
IIIA 5.1 Analytical Standards and Samples ......................................................... 3
IIIA 5.2 Methods for the Analysis of the Plant Protection Product ................... 3
IIIA 5.3 Description of Analytical Methods for the Determination of Residues ................................................................................................... 3
IIIA 5.4 Other/Special Studies .............................................................................. 3
Appendix 1 – List of data submitted in support of the evaluation ..................... 4
Part B Section 2
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Gold
Registration Report –Central Zone
Page 3 of 4
Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015
IIIA 5 METHODS OF ANALYSIS
This document summarises the information related to the analytical methods for the product Goltix Titan
(AQMM1-565 SC) containing the active substances metamitron and quinmerac which were approved
according to Regulation (EC) No 1107/2009.
This product was not the representative formulation. The product has not been previously evaluated
according to Uniform Principles.
Where appropriate this document refers to the conclusions of the EU review of metamitron and
quinmerac. This will be where:
• the active substance data are relied upon in the risk assessment of the formulation; or when
• the EU review concluded that additional data/information should be considered at national re-
registration.
The SANCO report for Metamitron (SANCO/208/08 final – 6 Januar 2009) and Quinmerac
(SANCO/12192/2010 final – 7 December 2010) are considered to provide the relevant review
information or a reference to where such information can be found.
This Part B document only reviews data (Annex II or Annex III) and additional information that has not
previously been considered within the EU review process, as part of the Annex I inclusion decision.
The Annex I Inclusion Directive for Metamitron (2008/125/EC) and Quinmerac (2010/89/EU) provides
specific provisions under Part B which need to be considered by the applicant in the preparation of their
submission and by the MS prior to granting an authorisation.
However, these provisions do not pertain the methods of analysis of the active ingredients and the
authorization of the product AG-QMM1-565 SC.
Appendix 1 of this document contains the list of references included in this document for support of the
evaluation.
Information on the detailed composition of AG-QMM1-565 SC can be found in the confidential dossier
of this submission (Registration Report - Part C).
IIIA 5.1 Analytical Standards and Samples
There is no change compared to the main application. Therefore, no further evaluation is necessary.
IIIA 5.2 Methods for the Analysis of the Plant Protection Product
There is no change compared to the main application. Therefore, no further evaluation is necessary.
IIIA 5.3 Description of Analytical Methods for the Determination of Residues
There is no change compared to the main application. Therefore, no further evaluation is necessary.
IIIA 5.4 Other/Special Studies
None
Part B Section 2
Core Assessment –
Germany
AG-QMM1-565 SC
Goltix Gold
Registration Report –Central Zone
Page 4 of 4
Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015
Appendix 1 – List of data submitted in support of the evaluation
Annex
point
OECD
Author Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
protection
claimed
Yes/No
Owner
- - - - - -
GOLTIX TITAN – ZV1 007529-00/01
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REGISTRATION REPORT
Part B
Section 3: Mammalian Toxicology
Detailed summary of the risk assessment
Product name/code: GOLTIX TITAN
Active Substances: Metamitron (525 g/L)
Quinmerac (40 g/L)
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: ADAMA Deutschland GmbH
Date: April 2016
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Table of Contents
3 Mammalian Toxicology (IIIA 7) ................................................................. 3
3.1 Summary ......................................................................................................... 3
3.2 Toxicological Information on Active Substances........................................... 5
3.3 Toxicological Evaluation of Plant Protection Product ................................... 5
3.4 Toxicological evaluation of groundwater metabolites ................................... 5
3.5 Dermal Absorption (IIIA 7.6) ......................................................................... 5
3.5.1 Justification for proposed values - metamitron .............................................. 6
3.5.2 Justification for proposed values - quinmerac ................................................ 6
3.6 Exposure Assessment of Plant Protection Product ......................................... 6
3.6.1 Selection of critical use and justification ........................................................ 7
3.6.2 Operator exposure (IIIA 7.3) .......................................................................... 7
3.6.2.1 Estimation of operator exposure ..................................................................... 7
3.6.2.2 Measurement of operator exposure ................................................................ 8
3.6.3 Worker exposure (IIIA 7.5) ............................................................................ 8
3.6.3.1 Estimation of worker exposure ....................................................................... 8
3.6.3.2 Measurement of worker exposure .................................................................. 8
3.6.4 Bystander and resident exposure (IIIA 7.4) .................................................... 8
3.6.4.1 Estimation of bystander and resident exposure .............................................. 8
3.6.4.2 Measurement of bystander and/or resident exposure ..................................... 9
3.6.5 Statement on combined exposure ................................................................... 9
Appendix 1 Exposure calculations ................................................................................. 10
A 1.1 Operator exposure calculations (IIIA1 7.3.1) ............................................... 10
A 1.1.1 Calculations for metamitron ......................................................................... 10
A 1.1.2 Calculations for quinmerac ........................................................................... 13
A 1.2 Worker exposure calculations (IIIA1 7.5.1) ................................................. 17
A 1.2.1 Calculations for metamitron ......................................................................... 17
A 1.2.2 Calculations for quinmerac ........................................................................... 18
A 1.3 Bystander and resident exposure calculations (IIIA1 7.4.1)......................... 18
A 1.3.1 Calculations for metamitron ......................................................................... 18
A 1.3.2 Calculations for quinmerac ........................................................................... 20
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3 Mammalian Toxicology (IIIA 7)
3.1 Summary
Table 3.1-1: Information on Goltix Titan/AG-QMM1-565 SC *
Product name and code Goltix Titan/AG-QMM1-565 SC (ADD-02122-H-0-SC)
Formulation type Suspension concentrate
Active substances (incl. content) Metamitron; 525 g/L
Quinmerac; 40 g/L
Function Herbicide
Product already evaluated as the ‘representative
formulation’ during the Annex I inclusion
No
Toxicity and other GAPs for this product previously
evaluated according to Uniform Principles
Yes, in Germany
* Information on the detailed composition of Goltix Titan/AG-QMM1-565 SC can be found in the
confidential Part C of the RR (main application).
Justified proposals for classification and labelling
In accordance to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of
the Council of 16 December 2008 the following classification and labelling with regard to toxicological
data is proposed for the preparation:
Table 3.1-2: Justified proposals for classification and labelling
C&L according to Regulation (EC) No 1272/2008
Hazard classes, categories: None
Signal word: None
Hazard statements: None
Precautionary statements: None
Additional labelling phrases: To avoid risks to human health and the environment, comply with the instructions
for use. [EUH401]
'Contains 1,2-Benzisothiazol-3-(2H)-one (CAS No. 2634-33-5). May produce an
allergic reaction.' [EUH208] *
* This phrase is necessary due to the concentration of this compound (> 0.005 %) in the formulation according to Regulation
(EC) No 286/2011 in conjunction with Regulation (EC) No 1272/2008
Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents
for Goltix Titan/AG-QMM1-565 SC
Result PPE / Risk mitigation measures
Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to
health damage. [SB001]
- If medical advice is needed, have product container or label at hand.
[SB005]
- Keep out of children's reach. [SB010]
- The directive concerning requirements for personal protective gear in
plant protection, "Personal protective gear for handling plant protection
GOLTIX TITAN – ZV1 007529-00/01
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products" of the Federal Office
of Consumer Protection and Food Safety must be observed. [SB110]
- Do not eat, drink or smoke when using this product. [SB166]
- When applying the product with tractor-mounted, trailed or self-
propelled application equipment, only vehicles with closed pressurized
cabins (e.g. cabin category 3, if no respiratory protective equipment or
particle-filtering masks are necessary or category 4, if gas-tight
respiratory protective equipment is needed acc. to EN 15695-1 and -2)
are suited to replace personal protective equipment during application.
During all other activities outside of the cabin the prescribed personal
protective equipment must be worn. In order to avoid contamination of
the cabin, it is not permitted to enter the cabin with contaminated
personal protective equipment (it should be deposited e.g. in an
appropriate storage facility). Contaminated gloves should be washed
before removing the gloves and hands should be washed before entering
the cabin with pure water, respectively. [SB199]
- Wear standard protective gloves (plant protection) when handling the
undiluted product. [SS110]
- Wear standard protective gloves (plant protection) when
handling/applying the product ready for application. [SS120]
- Wear a protective suit against pesticides and sturdy shoes (e.g. rubber
boots) when handling the undiluted product. [SS2101]
- Wear a protective suit against pesticides and sturdy shoes (e.g. rubber
boots) when applying/handling the product ready for application.
[SS2202]
Workers Acceptable - Re-entering the treated area(s)/crop(s) is only possible on the day of
application wearing personal protective equipment which is specified for
applying the particular product. Successive work on/in treated
areas/crops may fundamentally not be carried out until 24 hours after
applying the product. Within the first 48 hours, protective suits against
pesticides and standard protective gloves (plant protection) are to be
worn. [SF1891]
Bystanders Acceptable None
Residents Acceptable None
The risk assessment according to the German model has shown that the estimated exposure towards
metamitron and quinmerac in Goltix Titan/AG-QMM1-565 SC within this extended application will not
exceed the particular systemic AOEL for operators, workers, bystanders and residents. Operator and
worker exposure will be below the systemic AOEL only, if prescribed PPE is worn.
The risk assessment according to the UK-POEM has shown that the estimated exposure towards
metamitron and quinmerac in Goltix Titan/AG-QMM1-565 SC within this extended application will
exceed the particular systemic AOEL for operators even if PPE is worn.
Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous
substances regulations.
A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and
bystanders/residents is presented in Table 3.1-4.
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Table 3.1-4: Critical uses and overall conclusion of exposure assessment
1 2 3 4 5 6 7 8
Crops 1) and
situation
(e.g. growth
stage of crop)
F/G
or I 2)
Application Application rate Remarks:
(e.g. surfactant (L /ha))
critical gap for operator,
worker, bystander or
resident exposure based
on [Exposure model]
Acceptability of
exposure
assessment
Method / Kind
(incl.
application
technique 3))
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
kg as/ha
a) max. rate per
appl.
b) max. total rate
per crop/season
Water
L/ha
min / max
Op
era
tor
Wo
rker
By
sta
nd
er
Res
iden
ts
Sugar and
fodder beet
(BBCH 00-19),
1st application
pre-emergence,
2nd to 4th appli-
cation post-
emergence
F Spraying,
splitting: 4
applications;
LCTM
a) 4
b) 4
(2nd to 4th
application:
5-10 days)
a) Metamitron:
1st: 1.575 kg/ha
2nd: 0.525 kg/ha
3rd: 0.525 kg/ha
4th: 0.525 kg/ha
Quinmerac:
1st: 0.120 kg/ha
2nd: 0.040 kg/ha
3rd: 0.040 kg/ha
4th: 0.040 kg/ha
b) Metamitron:
3.150 kg/ha
Quinmerac:
0.240 kg/ha
200 - 400 German model
UK POEM
Exposure acceptable without PPE / risk mitigation measures
Further refinement and/or risk mitigation measures required
Exposure not acceptable/ Evaluation not possible 1) Pooled critical GAPS with the same max. application rate per application and using the same application technique 2) F: field or outdoor application, G: greenhouse application, I: indoor application 3) LC: low crops, TM: tractor-mounted
3.2 Toxicological Information on Active Substances
For the toxicological information on the active substances quinmerac and metamitron it is referred to the
RR in the context of the main application.
3.3 Toxicological Evaluation of Plant Protection Product
For the toxicological evaluation for Goltix Titan/AG-QMM1-565 SC it is referred to the RR in the
context of the main application. The resulting classification and labelling for Goltix Titan/AG-QMM1-
565 SC is given above in Table 3.1-2.
3.4 Toxicological evaluation of groundwater metabolites
The quinmerac metabolites BH 518-2 and BH 518-5 are predicted to occur in groundwater in
concentrations above 0.1 µg/L. The toxicological relevance assessment of these groundwater metabolites
according to the EC guidance document SANCO/221/2000 –rev.10 is presented in Section 8 of the dRR.
3.5 Dermal Absorption (IIIA 7.6)
A summary of the dermal absorption endpoints for the active substances in Goltix Titan/AG-QMM1-565
SC is presented in Table 3.5-1.
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Table 3.5-1: Dermal absorption endpoints used for the risk assessment for active
substances in Goltix Titan/AG-QMM1-565 SC
Metamitron Quinmerac
Value Reference Value Reference
Concentrate 1 % EFSA Conclusion for
Goltix SC 700
75 % Default according to EFSA
Guidance on Dermal
Absorption, EFSA Journal
2012; 10(4): 2665
Dilution
(1 : 400)
20 % EFSA Conclusion for
Goltix SC 700
75 % Default according to EFSA
Guidance on Dermal
Absorption, EFSA Journal
2012; 10(4): 2665
3.5.1 Justification for proposed values - metamitron
Proposed endpoints for metamitron are based on dermal absorption studies with the very similar
formulation Goltix 700 SC containing 700 g/L metamitron. The studies were summarised in the EFSA
conclusion on metamitron (EFSA Scientific Report (2008) 185, 1-95, ASB2012-3584). Goltix 700 SC, in
comparison to Goltix Titan, contains the same or similar co-formulants in similar amounts. It is noted that
the highest tested dilution in the studies was 1:200 (3.5 g/L metamitron) whereas the highest dilution for
this use is 1:400 (1.3 g/L).
Since the studies have already been assessed and accepted at EU level no summaries are provided.
3.5.2 Justification for proposed values - quinmerac
Since the composition of the product tested in the dermal absorption study submitted for the main
application of Goltix Titan, i.e. an SC formulation containing 125 g/L quinmerac and 375 g/L
metazachlor (Fuego Top, 007459-00), cannot be considered comparable to Goltix Titan according to the
criteria by EFSA Guidance on Dermal Absorption (content of co-formulants exceeds ± 25 % w/w of that
in the reference formulation), the results of this study (ASB2011-9378) cannot be used for this risk
assessment. Therefore, default values are taken into account for the risk assessment within this extended
authorisation. Thus, 75 % dermal absorption have to be considered for the concentrate (< 5 % w/w of
active substance in the product) as well as for the dilution.
In contrast to the present evaluation, bridging of the submitted dermal absorption study on Fuego Top was
accepted for the risk assessment during the main application procedure, because this was carried out prior
to implementation of the criteria laid down in the EFSA Guidance on Dermal Absorption.
3.6 Exposure Assessment of Plant Protection Product
Table 3.6-1: Product information and toxicological reference values used for exposure
assessment
Product name and code Goltix Titan/AG-QMM1-565 SC (ADD-02122-H-0-SC)
Formulation type Suspension concentrate
Category Herbicide
Container sizes, short
description
Bottles (1 L) and canisters (5-20 L), HDPE, openings 46-67.2 mm
Active substance(s)
(incl. content) Metamitron
525 g/L Quinmerac
40 g/L
AOEL systemic 0.036 mg/kg bw/d 0.08 mg/kg bw/d
Inhalative absorption 100 % 100 %
Oral absorption 100 % 100 %
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Dermal absorption Concentrate: 1 %
Dilution: 20 % (tested: 3.5 g/L)
Goltix SC 700
Concentrate: 75 % (active substance <
5 % w/w in the product)
Dilution: 75 % (active substance < 5 %
w/w in the spray dilution)
Both values defaults
3.6.1 Selection of critical use and justification
The critical GAP used for the exposure assessment within the scope of this approval extension for the
plant protection product is shown in Table 3.1-4.
3.6.2 Operator exposure (IIIA 7.3)
3.6.2.1 Estimation of operator exposure
A summary of the exposure models used for estimation of operator exposure to the active substances
during application of Goltix Titan/AG-QMM1-565 SC according to the critical use presented in Table
3.6-2. Outcome of the estimation is presented in Table 3.6-3. Detailed calculations are in Appendix 1.
Table 3.6-2: Exposure models for intended uses
Critical use Sugar and fodder beets (max. 3 L product/ha)
Model German model
[Uniform Principles for Safeguarding the Health of Applicators of Plant Protection
Products (Uniform Principles for Operator Protection), Mitteilungen aus der
Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277,
1992]
Critical use Sugar and fodder beets (max. 3 L product/ha)
Model Revised UK-POEM
[Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific
subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel
Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0,
(UK MAFF), 1992]
Table 3.6-3: Estimated operator exposure
Metamitron Quinmerac
Model data Level of PPE Total
absorbed dose
(mg/kg/day)
% of
systemic
AOEL
Total absorbed
dose
(mg/kg/day)
% of
systemic
AOEL
Tractor mounted boom spray application outdoors to low crops
Application rate: 1.575 kg a.s./ha
0.120 kg a.s./ha
German Model Body weight: 70 kg
no PPE1) 0.195120 542.0 0.114226 142.8
+ Gloves mixing/loading
and application as well as
protective suit
application)
0.013770 38.3 0.004370 5.5
UK POEM
Application volume:
200 L/ha
Container: 10 L,
63 mm closure
Body weight: 60 kg
no PPE2) 1.164188 3233.9 0.687225 859.0
+ Gloves mixing/loading
and application 0.180469 501.3 0.067725 84.7
1) no PPE: Operator wearing T-shirt and shorts 2) no PPE: Operator wearing long sleeved shirt, long trousers (“permeable”) but no gloves
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3.6.2.2 Measurement of operator exposure
Since the operator exposure estimations carried out according to the German model indicated that the
acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a
study to provide measurements of operator exposure was not necessary and was therefore not performed.
3.6.3 Worker exposure (IIIA 7.5)
3.6.3.1 Estimation of worker exposure
Table 3.6-4 shows the exposure model used for estimation of worker exposure after entry into a
previously treated area or handling a crop treated with Goltix Titan/AG-QMM1-565 SC according to the
critical use. Outcome of the estimation is presented in Table 3.6-5. Detailed calculations are in
Appendix 1.
Table 3.6-4: Exposure models for intended uses
Critical use Sugar and fodder beets (max. 6 L product/ha and year *), ‘worst case’
Model German re-entry model, Krebs et al. (2000)
[Uniform Principles for Safeguarding the Health of Workers Re-entering Crop
Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut.
Pflanzenschutzdienst., 52(1), p. 5-9]
* maximum application rate in theses crops per year irrespective of number of applications
Table 3.6-5: Estimated worker exposure
Metamitron Quinmerac
Model data Level of PPE Total absorbed
dose
(mg/kg/day)
% of systemic
AOEL
Total absorbed
dose
(mg/kg/day)
% of systemic
AOEL
Max. application rate per year: 3.150 kg a.s./ha 0.240 kg a.s./ha
2 hours/day 1),
TC: 2500 cm2/person/h 2)
Body weight: 60 kg
no PPE 3) 0.052500 145.8 0.015000 18.8
with PPE 4) 0.002625 7.3 0.000750 0.9
1) 2 h/day for professional applications for maintenance, inspection or irrigation activities etc. 2) US-EPA policy paper [EPA, Science Advisory Council for Exposure; 2000; Agricultural Default Transfer Coefficients,
Policy # 003.1, May 7 1998 revised 7 August 2000]. 3) no PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 4) with PPE: see 'Instructions for use'
3.6.3.2 Measurement of worker exposure
Since the worker exposure estimations carried out indicated that the acceptable operator exposure level
(AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of
worker exposure was not necessary and was therefore not performed.
3.6.4 Bystander and resident exposure (IIIA 7.4)
3.6.4.1 Estimation of bystander and resident exposure
Table 3.6-6 shows the exposure model used for estimation of bystander and resident exposure to
metamitron and quinmerac. Outcome of the estimation is presented in Table 3.6-7. Detailed calculations
are in Appendix 1.
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Table 3.6-6: Exposure models for intended uses
Critical use Sugar and fodder beets (max. 3 L product/ha (bystander) or 6 L product/ha and year,
‘worst case’, with 4 applications * (resident), respectively)
Model Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and
Residents Exposed to Plant Protection Products During and After Application; J. Verbr.
Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06
January 2012, Issue No. 4, pp. 75-76
* maximum application rate in theses crops per year irrespective of number of applications
Table 3.6-7: Estimated bystander and resident exposure
Metamitron Quinmerac
Model data Total absorbed
dose (mg/kg/day)
% of systemic
AOEL
Total absorbed
dose (mg/kg/day)
% of systemic
AOEL
Tractor mounted boom spray application outdoors to low crops
Application rate: 1.575 kg a.s./ha
0.120 kg a.s./ha
Bystanders (adult)
Drift rate: 2.77 % (1 m)
Body weight: 60 kg
0.014550 40.4 0.004156 5.2
Bystanders (children)
Drift rate: 2.77 % (1 m)
Body weight: 16.15 kg
0.011361 31.6 0.003243 4.1
Tractor mounted boom spray application outdoors to low crops
Application rate: 3.150 kg a.s./ha
0.240 kg a.s./ha
Residents (adult)
Drift rate: 1.85 % *(1 m)
Body weight: 60 kg
0.001418 3.9 0.000405 0.5
Residents (children)
Drift rate: 1.85 % *(1 m)
Body weight: 16.15 kg
0.002778 7.7 0.000605 0.8
* for 4 applications
3.6.4.2 Measurement of bystander and/or resident exposure
Since the bystander and/or resident exposure estimations carried out indicated that the acceptable operator
exposure level (AOEL) for metamitron and quinmerac will not be exceeded under conditions of intended
uses, a study to provide measurements of bystander/resident exposure was not necessary and was
therefore not performed.
3.6.5 Statement on combined exposure
The product is a mixture of two active substances.
From a scientific point of view it is regarded necessary to take into account potential combination effects.
However, the evaluation of cumulative or synergistic effects as requested by §4 (3b) of Regulation (EC)
No. 1107/2009 should only be performed, if harmonised scientific methods accepted by the authorities
are available.
The combined toxicological effect of metamitron and quinmerac has not been investigated with regard to
repeated dose toxicity.
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Appendix 1 Exposure calculations
A 1.1 Operator exposure calculations (IIIA1 7.3.1)
A 1.1.1 Calculations for metamitron
Table A 1: Input parameters considered for the estimation of operator exposure
Formulation type: SC Application technique:
Field Crop Tractor
Mounted (FCTM) Application rate (AR): 1.575 kg a.s./ha
Area treated per day (A): 20 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s.
Dermal absorption (DA): 1 % (concentr.) Dermal hands appl. (DA(H)): 0.38 mg/person/kg a.s.
20 % (dilution) Dermal body appl. (DA(B)): 1.6 mg/person/kg a.s.
Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 0.06 mg/person/kg a.s.
Body weight (BW): 70 kg/person Inhalation m/l (IM): 0.0006 mg/person/kg a.s.
AOEL 0.036 mg/kg bw/d Inhalation appl. (IA): 0.001 mg/person/kg a.s.
Table A 2: Estimation of operator exposure towards metamitron using the German
model
Without PPE With PPE
Operators: Systemic dermal exposure after application in sugar and fodder beets
Dermal exposure during mixing/loading
Hands Hands
SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW
(2.4 x 1.575 x 20 x 1%) / 70 (2.4 x 1.575 x 20 x 0.01 x 1%) / 70
External dermal
exposure 75.6 mg/person
External dermal
exposure 0.756 mg/person
External dermal
exposure 1.08 mg/kg bw/d
External dermal
exposure 0.0108 mg/kg bw/d
Systemic dermal
exposure 0.0108 mg/kg bw/d
Systemic dermal
exposure 0.000108 mg/kg bw/d
Dermal exposure during application
Hands Hands
SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW
(0.38 x 1.575 x 20 x 20%) / 70 (0.38 x 1.575 x 20 x 0.01 x 20%) / 70
External dermal
exposure 11.97 mg/person
External dermal
exposure 0.1197 mg/person
External dermal
exposure 0.171 mg/kg bw/d
External dermal
exposure 0.00171 mg/kg bw/d
Systemic dermal
exposure 0.0342 mg/kg bw/d
Systemic dermal
exposure 0.000342 mg/kg bw/d
Body Body
SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE 2) x DA) / BW
(1.6 x 1.575 x 20 x 20%) / 70 (1.6 x 1.575 x 20 x 0.05 x 20%) / 70
External dermal
exposure 50.4 mg/person
External dermal
exposure 2.52 mg/person
External dermal
exposure 0.72 mg/kg bw/d
External dermal
exposure 0.036 mg/kg bw/d
Systemic dermal
exposure 0.144 mg/kg bw/d
Systemic dermal
exposure 0.0072 mg/kg bw/d
Head Head
SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW
(0.06 x 1.575 x 20 x 20%) / 70 (0.06 x 1.575 x 20 x 1 x 20%) / 70
External dermal
exposure 1.89 mg/person
External dermal
exposure 1.89 mg/person
External dermal 0.027 mg/kg bw/d External dermal 0.027 mg/kg bw/d
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exposure exposure
Systemic dermal
exposure 0.0054 mg/kg bw/d
Systemic dermal
exposure 0.0054 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H)
+ SDEOA(B) + SDEOA(C)
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H)
+ SDEOA(B) + SDEOA(C)
Total external dermal
exposure 139.86 mg/person
Total external dermal
exposure 5.2857 mg/person
Total external dermal
exposure 1.998 mg/kg bw/d
Total external dermal
exposure 0.07551 mg/kg bw/d
Total systemic
dermal exposure 0.1944 mg/kg bw/d
Total systemic
dermal exposure 0.01305 mg/kg bw/d
Operators: Systemic inhalation exposure after application in sugar and fodder beets
Inhalation exposure during mixing/loading
SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW
(0.0006 x 1.575 x 20 x 100%) / 70 (0.0006 x 1.575 x 20 x 1 x 100%) / 70
External inhalation
exposure 0.0189 mg/person
External inhalation
exposure 0.0189 mg/person
External inhalation
exposure 0.00027 mg/kg bw/d
External inhalation
exposure 0.00027 mg/kg bw/d
Systemic inhalation
exposure 0.00027 mg/kg bw/d
Systemic inhalation
exposure 0.00027 mg/kg bw/d
Inhalation exposure during application
SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW
(0.001 x 1.575 x 20 x 100%) / 70 (0.001 x 1.575 x 20 x 1 x 100%) / 70
External inhalation
exposure 0.0315 mg/person
External inhalation
exposure 0.0315 mg/person
External inhalation
exposure 0.00045 mg/kg bw/d
External inhalation
exposure 0.00045 mg/kg bw/d
Systemic inhalation
exposure 0.00045 mg/kg bw/d
Systemic inhalation
exposure 0.00045 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA
Total external
inhalation exposure 0.0504 mg/person
Total external
inhalation exposure 0.0504 mg/person
Total external
inhalation exposure 0.00072 mg/kg bw/d
Total external
inhalation exposure 0.00072 mg/kg bw/d
Total systemic
inhalation exposure 0.00072 mg/kg bw/d
Total systemic
inhalation exposure 0.00072 mg/kg bw/d
Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO
Total systemic
exposure 13.6584 mg/person
Total systemic
exposure 0.9639 mg/person
Total systemic
exposure 0.19512 mg/kg bw/d
Total systemic
exposure 0.01377 mg/kg bw/d
% of AOEL 542.0 % % of AOEL 38.3 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.)
Table A 3: Estimation of operator exposure towards metamitron using the UK POEM
Without PPE
Active substance Metamitron
Product Goltix Titan (AG-QMM1-565 SC)
Formulation type water-based
Concentration of a.s. 525 mg/mL
Dose 3 L preparation/ha (1.575 kg a.s./ha)
Application volume 200 L/ha
Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Container 10 litres 63 mm closure
Work rate/day 50 ha
Duration of spraying 6 h
PPE during mix./loading None
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PPE during application None
Dermal absorption from product 1 %
Dermal absorption from spray 20 %
EXPOSURE DURING MIXING AND LOADING
Container size 10 Litres
Hand contamination/operation 0,05 mL
Application dose 3 Litres product/ha
Work rate 50 ha/day
Number of operations 15 /day
Hand contamination 0.75 mL/day
Protective clothing None
Transmission to skin 100 %
Dermal exposure to formulation 0.75 mL/day
DERMAL EXPOSURE DURING SPRAY APPLICATION
Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Application volume 200 spray/ha
Volume of surface contamination 10 mL/h
Distribution Hands Trunk Legs
65% 10% 25%
Clothing None Permeable Permeable
Penetration 100% 5% 15%
Dermal exposure 6.5 0.05 0.375 mL/h
Duration of exposure 6 h
Total dermal exposure to spray 41.55 mL/day
ABSORBED DERMAL DOSE
Mix/load
Application
Dermal exposure 0.75 mL/day 41.55 mL/day
Concen. of a.s. product or spray 525 mg/mL 7.875 mg/mL
Dermal exposure to a.s. 393.75 mg/day 327.20625 mg/day
Percent absorbed 1 % 20 %
Absorbed dose 3.9375 mg/day 65.44125 mg/day
INHALATION EXPOSURE DURING SPRAYING
Inhalation exposure 0.01 mL/h
Duration of exposure 6 h
Concentration of a.s. in spray 7.875 mg/mL
Inhalation exposure to a.s. 0.4725 mg/day
Percent absorbed 100 %
Absorbed dose 0.4725 mg/day
PREDICTED EXPOSURE
Total absorbed dose 69.85125 mg/day
Operator body weight 60 kg
Operator exposure 1.164188 mg/kg bw/day
Amount of AOEL 3233.9 %
With PPE
Active substance Metamitron
Product Goltix Titan (AG-QMM1-565 SC)
Formulation type water-based
Concentration of a.s. 525 mg/mL
Dose 3 L preparation/ha (1.575 kg a.s./ha)
Application volume 200 L/ha
Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Container 10 litres 63 mm closure
Work rate/day 50 ha
Duration of spraying 6 h
PPE during mix./loading Gloves
PPE during application Gloves
Dermal absorption from product 1 %
Dermal absorption from spray 20 %
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EXPOSURE DURING MIXING AND LOADING
Container size 10 Litres
Hand contamination/operation 0,05 mL
Application dose 3 Litres product/ha
Work rate 50 ha/day
Number of operations 15 /day
Hand contamination 0.75 mL/day
Protective clothing Gloves
Transmission to skin 5 %
Dermal exposure to formulation 0.0375 mL/day
DERMAL EXPOSURE DURING SPRAY APPLICATION
Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Application volume 200 spray/ha
Volume of surface contamination 10 mL/h
Distribution Hands Trunk Legs
65% 10% 25%
Clothing Gloves Permeable Permeable
Penetration 10% 5% 15%
Dermal exposure 0.65 0.05 0.375 mL/h
Duration of exposure 6 h
Total dermal exposure to spray 6.45 mL/day
ABSORBED DERMAL DOSE
Mix/load
Application
Dermal exposure 0.0375 mL/day 6.45 mL/day
Concen. of a.s. product or spray 525 mg/mL 7.875 mg/mL
Dermal exposure to a.s. 19.6875 mg/day 50.79375 mg/day
Percent absorbed 1 % 20 %
Absorbed dose 0.196875 mg/day 10.15875 mg/day
INHALATION EXPOSURE DURING SPRAYING
Inhalation exposure 0.01 mL/h
Duration of exposure 6 h
Concentration of a.s. in spray 7.875 mg/mL
Inhalation exposure to a.s. 0.4725 mg/day
Percent absorbed 100 %
Absorbed dose 0.4725 mg/day
PREDICTED EXPOSURE
Total absorbed dose 10.828125 mg/day
Operator body weight 60 kg
Operator exposure 0.180469 mg/kg bw/day
Amount of AOEL 501.3 %
A 1.1.2 Calculations for quinmerac
Table A 4: Input parameters considered for the estimation of operator exposure
Formulation type: SC Application technique:
Field Crop Tractor
Mounted (FCTM) Application rate (AR): 0.12 kg a.s./ha
Area treated per day (A): 20 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s.
Dermal absorption (DA): 75 % (concentr.) Dermal hands appl. (DA(H)): 0.38 mg/person/kg a.s.
75 % (dilution) Dermal body appl. (DA(B)): 1.6 mg/person/kg a.s.
Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 0.06 mg/person/kg a.s.
Body weight (BW): 70 kg/person Inhalation m/l (IM): 0.0006 mg/person/kg a.s.
AOEL 0.08 mg/kg bw/d Inhalation appl. (IA): 0.001 mg/person/kg a.s.
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Table A 5: Estimation of operator exposure towards quinmerac using the German model
Without PPE With PPE
Operators: Systemic dermal exposure after application in sugar and fodder beets
Dermal exposure during mixing/loading
Hands Hands
SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW
(2.4 x 0.12 x 20 x 75%) / 70 (2.4 x 0.12 x 20 x 0.01 x 75%) / 70
External dermal
exposure 5.76 mg/person
External dermal
exposure 0.0576 mg/person
External dermal
exposure 0.082286 mg/kg bw/d
External dermal
exposure 0.000823 mg/kg bw/d
Systemic dermal
exposure 0.061714 mg/kg bw/d
Systemic dermal
exposure 0.000617 mg/kg bw/d
Dermal exposure during application
Hands Hands
SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW
(0.38 x 0.12 x 20 x 75%) / 70 (0.38 x 0.12 x 20 x 0.01 x 75%) / 70
External dermal
exposure 0.912 mg/person
External dermal
exposure 0.00912 mg/person
External dermal
exposure 0.013029 mg/kg bw/d
External dermal
exposure 0.00013 mg/kg bw/d
Systemic dermal
exposure 0.009771 mg/kg bw/d
Systemic dermal
exposure 0.000098 mg/kg bw/d
Body Body
SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE 2) x DA) / BW
(1.6 x 0.12 x 20 x 75%) / 70 (1.6 x 0.12 x 20 x 0.05 x 75%) / 70
External dermal
exposure 3.84 mg/person
External dermal
exposure 0.192 mg/person
External dermal
exposure 0.054857 mg/kg bw/d
External dermal
exposure 0.002743 mg/kg bw/d
Systemic dermal
exposure 0.041143 mg/kg bw/d
Systemic dermal
exposure 0.002057 mg/kg bw/d
Head Head
SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW
(0.06 x 0.12 x 20 x 75%) / 70 (0.06 x 0.12 x 20 x 1 x 75%) / 70
External dermal
exposure 0.144 mg/person
External dermal
exposure 0.144 mg/person
External dermal
exposure 0.002057 mg/kg bw/d
External dermal
exposure 0.002057 mg/kg bw/d
Systemic dermal
exposure 0.001543 mg/kg bw/d
Systemic dermal
exposure 0.001543 mg/kg bw/d
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H)
+ SDEOA(B) + SDEOA(C)
Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H)
+ SDEOA(B) + SDEOA(C)
Total external dermal
exposure 10.656 mg/person
Total external dermal
exposure 0.40272 mg/person
Total external dermal
exposure 0.152229 mg/kg bw/d
Total external dermal
exposure 0.005753 mg/kg bw/d
Total systemic
dermal exposure 0.114171 mg/kg bw/d
Total systemic
dermal exposure 0.004315 mg/kg bw/d
Operators: Systemic inhalation exposure after application in Sugar and fodder beets
Inhalation exposure during mixing/loading
SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW
(0.0006 x 0.12 x 20 x 100%) / 70 (0.0006 x 0.12 x 20 x 1 x 100%) / 70
External inhalation
exposure 0.00144 mg/person
External inhalation
exposure 0.00144 mg/person
External inhalation
exposure 0.000021 mg/kg bw/d
External inhalation
exposure 0.000021 mg/kg bw/d
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Systemic inhalation
exposure 0.000021 mg/kg bw/d
Systemic inhalation
exposure 0.000021 mg/kg bw/d
Inhalation exposure during application
SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW
(0.001 x 0.12 x 20 x 100%) / 70 (0.001 x 0.12 x 20 x 1 x 100%) / 70
External inhalation
exposure 0.0024 mg/person
External inhalation
exposure 0.0024 mg/person
External inhalation
exposure 0.000034 mg/kg bw/d
External inhalation
exposure 0.000034 mg/kg bw/d
Systemic inhalation
exposure 0.000034 mg/kg bw/d
Systemic inhalation
exposure 0.000034 mg/kg bw/d
Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA
Total external
inhalation exposure 0.00384 mg/person
Total external
inhalation exposure 0.00384 mg/person
Total external
inhalation exposure 0.000055 mg/kg bw/d
Total external
inhalation exposure 0.000055 mg/kg bw/d
Total systemic
inhalation exposure 0.000055 mg/kg bw/d
Total systemic
inhalation exposure 0.000055 mg/kg bw/d
Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO
Total systemic
exposure 7.99584 mg/person
Total systemic
exposure 0.30588 mg/person
Total systemic
exposure 0.114226 mg/kg bw/d
Total systemic
exposure 0.00437 mg/kg bw/d
% of AOEL 142.8 % % of AOEL 5.5 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.)
Table A 6: Estimation of operator exposure towards quinmerac using the UK POEM
Without PPE
Active substance Quinmerac
Product Goltix Titan (AG-QMM1-565 SC)
Formulation type water-based
Concentration of a.s. 40 mg/mL
Dose 3 L preparation/ha (0.12 kg a.s./ha)
Application volume 200 L/ha
Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Container 10 litres 63 mm closure
Work rate/day 50 ha
Duration of spraying 6 h
PPE during mix./loading None
PPE during application None
Dermal absorption from product 75 %
Dermal absorption from spray 75 %
EXPOSURE DURING MIXING AND LOADING
Container size 10 Litres
Hand contamination/operation 0,05 mL
Application dose 3 Litres product/ha
Work rate 50 ha/day
Number of operations 15 /day
Hand contamination 0.75 mL/day
Protective clothing None
Transmission to skin 100 %
Dermal exposure to formulation 0.75 mL/day
DERMAL EXPOSURE DURING SPRAY APPLICATION
Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Application volume 200 spray/ha
Volume of surface contamination 10 mL/h
Distribution Hands Trunk Legs
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65% 10% 25%
Clothing None Permeable Permeable
Penetration 100% 5% 15%
Dermal exposure 6.5 0.05 0.375 mL/h
Duration of exposure 6 h
Total dermal exposure to spray 41.55 mL/day
ABSORBED DERMAL DOSE
Mix/load
Application
Dermal exposure 0.75 mL/day 41.55 mL/day
Concen. of a.s. product or spray 40 mg/mL 0.6 mg/mL
Dermal exposure to a.s. 30 mg/day 24.93 mg/day
Percent absorbed 75 % 75 %
Absorbed dose 22.5 mg/day 18.6975 mg/day
INHALATION EXPOSURE DURING SPRAYING
Inhalation exposure 0.01 mL/h
Duration of exposure 6 h
Concentration of a.s. in spray 0.6 mg/mL
Inhalation exposure to a.s. 0.036 mg/day
Percent absorbed 100 %
Absorbed dose 0.036 mg/day
PREDICTED EXPOSURE
Total absorbed dose 41.2335 mg/day
Operator body weight 60 kg
Operator exposure 0.687225 mg/kg bw/day
Amount of AOEL 859.0 %
With PPE
Active substance Quinmerac
Product Goltix Titan (AG-QMM1-565 SC)
Formulation type water-based
Concentration of a.s. 40 mg/mL
Dose 3 L preparation/ha (0.12 kg a.s./ha)
Application volume 200 L/ha
Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Container 10 litres 63 mm closure
Work rate/day 50 ha
Duration of spraying 6 h
PPE during mix./loading Gloves
PPE during application Gloves
Dermal absorption from product 75 %
Dermal absorption from spray 75 %
EXPOSURE DURING MIXING AND LOADING
Container size 10 Litres
Hand contamination/operation 0,05 mL
Application dose 3 Litres product/ha
Work rate 50 ha/day
Number of operations 15 /day
Hand contamination 0.75 mL/day
Protective clothing Gloves
Transmission to skin 5 %
Dermal exposure to formulation 0.0375 mL/day
DERMAL EXPOSURE DURING SPRAY APPLICATION
Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles
Application volume 200 spray/ha
Volume of surface contamination 10 mL/h
Distribution Hands Trunk Legs
65% 10% 25%
Clothing Gloves Permeable Permeable
Penetration 10% 5% 15%
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Dermal exposure 0.65 0.05 0.375 mL/h
Duration of exposure 6 h
Total dermal exposure to spray 6.45 mL/day
ABSORBED DERMAL DOSE
Mix/load
Application
Dermal exposure 0.0375 mL/day 6.45 mL/day
Concen. of a.s. product or spray 40 mg/mL 0.6 mg/mL
Dermal exposure to a.s. 1.5 mg/day 3.87 mg/day
Percent absorbed 75 % 75 %
Absorbed dose 1.125 mg/day 2.9025 mg/day
INHALATION EXPOSURE DURING SPRAYING
Inhalation exposure 0.01 mL/h
Duration of exposure 6 h
Concentration of a.s. in spray 0.6 mg/mL
Inhalation exposure to a.s. 0.036 mg/day
Percent absorbed 100 %
Absorbed dose 0.036 mg/day
PREDICTED EXPOSURE
Total absorbed dose 4.0635 mg/day
Operator body weight 60 kg
Operator exposure 0.067725 mg/kg bw/day
Amount of AOEL 84.7 %
A 1.2 Worker exposure calculations (IIIA1 7.5.1)
A 1.2.1 Calculations for metamitron
Table A 7: Input parameters considered for the estimation of worker exposure
Intended use(s): Sugar and fodder beets Dislodgeable foliar
residues (DFR): 1 µg/cm2/kg a.s.
Application rate (AR): 3.15 kg a.s./ha 1) Transfer coefficient (TC): 2500 cm2/person/h
Number of applications (NA): 1 see explanation below Work rate per day (WR): 2 h/d
Body weight (BW): 60 kg/person PPE 5 %
Dermal absorption (DA): 20 % ('worst case')
AOEL 0.036 mg/kg bw/d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’
Table A 8: Estimation of worker exposure towards metamitron using the German re-
entry model
Without PPE 1) With PPE 2)
Worker (re-entry): Systemic dermal exposure after application in sugar and fodder beets
SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW
(1 x 2500 x 2 x 3.15 x 1 x 20%) / 60 (1 x 2500 x 2 x 3.15 x 1 x 5% x 20%) / 60
External dermal exposure 15.75 mg/person External dermal exposure 0.7875 mg/person
External dermal exposure 0.2625 mg/kg bw/d External dermal exposure 0.013125 mg/kg bw/d
Total systemic exposure 3.15 mg/person Total systemic exposure 0.1575 mg/person
Total systemic exposure 0.0525 mg/kg bw/d Total systemic exposure 0.002625 mg/kg bw/d
% of AOEL 145.8 % % of AOEL 7.3 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 2) acceptable only with PPE: see 'Instructions for use'
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A 1.2.2 Calculations for quinmerac
Table A 9: Input parameters considered for the estimation of worker exposure
Intended use(s): Sugar and fodder beets Dislodgeable foliar
residues (DFR): 1 µg/cm2/kg a.s.
Application rate (AR): 0.24 kg a.s./ha 1) Transfer coefficient (TC): 2500 cm2/person/h
Number of applications (NA): 1 see explanation below Work rate per day (WR): 2 h/d
Body weight (BW): 60 kg/person PPE 5 %
Dermal absorption (DA): 75 % ('worst case')
AOEL 0.08 mg/kg bw/d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’
Table A 10: Estimation of worker exposure towards quinmerac using the German re-entry
model
Without PPE 1) With PPE 2)
Worker (re-entry): Systemic dermal exposure after application in sugar and fodder beets
SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW
(1 x 2500 x 2 x 0.24 x 1 x 75%) / 60 (1 x 2500 x 2 x 0.24 x 1 x 5% x 75%) / 60
External dermal exposure 1.2 mg/person External dermal exposure 0.06 mg/person
External dermal exposure 0.02 mg/kg bw/d External dermal exposure 0.001 mg/kg bw/d
Total systemic exposure 0.9 mg/person Total systemic exposure 0.045 mg/person
Total systemic exposure 0.015 mg/kg bw/d Total systemic exposure 0.00075 mg/kg bw/d
% of AOEL 18.8 % % of AOEL 0.9 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 2) acceptable only with PPE: see 'Instructions for use'
A 1.3 Bystander and resident exposure calculations (IIIA1 7.4.1)
A 1.3.1 Calculations for metamitron
Table A 11: Input parameters considered for the estimation of bystander exposure
Intended use(s): Sugar and fodder beets Drift (D): 2.77 % (FC, 1 m)
Application rate (AR): 1.575kg a.s./ha Exposed body surface area
(BSA):
1 m² (adults)
157.5mg/m2 0.21 m² (children)
Body weight (BW):
60kg/person (adults) Specific Inhalation
Exposure (I*A):
0.001 mg/kg a.s. (6 hours,
adults)
16.15kg/person (children) 0.000575 mg/kg a.s. (6 hours,
children)
Dermal absorption (DA): 20% ('worst case') Area Treated (A): 20
ha/d (based on
FCTM) Inhalation absorption (IA): 100%
AOEL: 0.036mg/kg bw/d Exposure duration (T): 5 min
Table A 12: Estimation of bystander exposure towards metamitron
Adults Children
Bystander: Systemic dermal exposure during/after application in (via spray drift)
SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW
(157.5 x 2.77% x 1 x 20%) / 60 (157.5 x 2.77% x 0.21 x 20%) / 16.15
External dermal
exposure 4.36275 mg/person
External dermal
exposure 0.916178 mg/person
External dermal
exposure 0.072713 mg/kg bw/d
External dermal
exposure 0.056729 mg/kg bw/d
Systemic dermal
exposure 0.014543 mg/kg bw/d
Systemic dermal
exposure 0.011346 mg/kg bw/d
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Bystander: Systemic inhalation exposure during/after application in Sugar and fodder beets (via spray drift)
SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW
(0.001 / 360 x 1.575 x 20 x 5 x 100%) / 60 (0.000575 / 360 x 1.575 x 20 x 5 x 100%) / 16.15
External inhalation
exposure 0.000438 mg/person
External inhalation
exposure 0.000251 mg/person
External inhalation
exposure 0.000007 mg/kg bw/d
External inhalation
exposure 0.000016 mg/kg bw/d
Systemic inhalation
exposure 0.000007 mg/kg bw/d
Systemic inhalation
exposure 0.000016 mg/kg bw/d
Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure: SEB = SDEB + SIEB
Total systemic
exposure 0.872988 mg/person
Total systemic
exposure 0.183487 mg/person
Total systemic
exposure 0.01455 mg/kg bw/d
Total systemic
exposure 0.011361 mg/kg bw/d
% of AOEL 40.4 % % of AOEL 31.6 %
Table A 13: Input parameters considered for the estimation of resident exposure
Intended use(s): Sugar and fodder beets Drift (D): 1.85 % (FC, 1 m, 4 appl.)
Application rate (AR): 3.15 kg a.s./ha 1) Transfer coefficient
(TC):
7300 cm2/h (adults)
0.0315 mg/cm2 2600 cm2/h (children)
Number of applications
(NA): 1 see explanation below
Turf Transferable
Residues (TTR): 5 %
Body weight (BW):
60 kg/person (adults) Exposure Duration (H): 2 h
16.15 kg/person (children) Airborne Concentration
of Vapour (ACV): 0
mg/m3
Dermal absorption (DA): 20 % ('worst case') Inhalation Rate (IR):
16.57 m3/d (adults)
Inhalation absorption (IA): 100 % 8.31 m3/d (children)
Oral absorption (OA): 100 % Saliva Extraction Factor
(SE): 50 %
AOEL: 0.036 mg/kg bw/d Surface Area of Hands
(SA): 20 cm2
Frequency of Hand to
Mouth (Freq): 20 events/h
Dislodgeable foliar
residues (DFR): 20 %
Ingestion Rate for
Mouthing of Grass/Day
(IgR):
25 cm2/d
1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’
Table A 14: Estimation of resident exposure towards metamitron
Adults Children
Residents: Systemic dermal exposure after application in sugar and fodder beets (via deposits caused by spray drift)
SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW
(0.0315 x 1 x 1.85% x 5% x 7300 x 2 x 20%) / 60 (0.0315 x 1 x 1.85% x 5% x 2600 x 2 x 20%) / 16.15
External dermal
exposure 0.425408 mg/person
External dermal
exposure 0.151515 mg/person
External dermal
exposure 0.00709 mg/kg bw/d
External dermal
exposure 0.009382 mg/kg bw/d
Systemic dermal
exposure 0.001418 mg/kg bw/d
Systemic dermal
exposure 0.001876 mg/kg bw/d
Residents: Systemic inhalation exposure after application in sugar and fodder beets (via vapour)
SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW
(0 x 16.57 x 100%) / 60 (0 x 8.31 x 100%) / 16.15
External inhalation
exposure none
External inhalation
exposure none
Systemic inhalation
exposure none
Systemic inhalation
exposure none
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Residents: Systemic oral exposure (hand-to-mouth
transfer)
SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x
OA) / BW
(0.0315 x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / 16.15
External oral
exposure 0.011655 mg/person
External oral
exposure 0.000722 mg/kg bw/d
Systemic oral
exposure 0.000722 mg/kg bw/d
Residents: Systemic oral exposure (object-to-mouth
transfer)
SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW
(0.0315 x 1 x % x 20% x 25 x 100%) / 16.15
External oral
exposure 0.002914 mg/person
External oral
exposure 0.00018 mg/kg bw/d
Systemic oral
exposure 0.00018 mg/kg bw/d
Total systemic exposure: SER = SDER + SIER Total systemic exposure: SER = SDER + SIER + SOER(H) +
SOER(O)
Total systemic
exposure 0.085082 mg/person
Total systemic
exposure 0.044872 mg/person
Total systemic
exposure 0.001418 mg/kg bw/d
Total systemic
exposure 0.002778 mg/kg bw/d
% of AOEL 3.9 % % of AOEL 7.7 %
A 1.3.2 Calculations for quinmerac
Table A 15: Input parameters considered for the estimation of bystander exposure
Intended use(s): Sugar and fodder beets Drift (D): 2.77 % (FC, 1 m)
Application rate (AR): 0.12 kg a.s./ha Exposed body surface
area (BSA):
1 m² (adults)
12 mg/m2 0.21 m² (children)
Body weight (BW):
60 kg/person (adults) Specific Inhalation
Exposure (I*A):
0.001 mg/kg a.s. (6
hours, adults)
16.15 kg/person
(children) 0.000575
mg/kg a.s. (6
hours, children)
Dermal absorption (DA): 75 % ('worst case') Area Treated (A): 20
ha/d (based on
FCTM) Inhalation absorption (IA): 100 %
AOEL: 0.08 mg/kg bw/d Exposure duration (T): 5 min
Table A 16: Estimation of bystander exposure towards quinmerac
Adults Children
Bystander: Systemic dermal exposure during/after application in sugar and fodder beets (via spray drift)
SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW
(12 x 2.77% x 1 x 75%) / 60 (12 x 2.77% x 0.21 x 75%) / 16.15
External dermal
exposure 0.3324 mg/person External dermal exposure 0.069804 mg/person
External dermal
exposure 0.00554 mg/kg bw/d External dermal exposure 0.004322 mg/kg bw/d
Systemic dermal
exposure 0.004155 mg/kg bw/d
Systemic dermal
exposure 0.003242 mg/kg bw/d
Bystander: Systemic inhalation exposure during/after application in sugar and fodder beets (via spray drift)
SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW
(0.001 / 360 x 0.12 x 20 x 5 x 100%) / 60 (0.000575 / 360 x 0.12 x 20 x 5 x 100%) / 16.15
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External inhalation
exposure 0.000033 mg/person
External inhalation
exposure 0.000019 mg/person
External inhalation
exposure 0.000001 mg/kg bw/d
External inhalation
exposure 0.000001 mg/kg bw/d
Systemic inhalation
exposure 0.000001 mg/kg bw/d
Systemic inhalation
exposure 0.000001 mg/kg bw/d
Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure: SEB = SDEB + SIEB
Total systemic
exposure 0.249333 mg/person Total systemic exposure 0.052372 mg/person
Total systemic
exposure 0.004156 mg/kg bw/d Total systemic exposure 0.003243 mg/kg bw/d
% of AOEL 5.2 % % of AOEL 4.1 %
Table A 17: Input parameters considered for the estimation of resident exposure
Intended use(s): Sugar and fodder beets Drift (D): 1.85 % (FC, 1 m, 4 appl.)
Application rate (AR): 0.24 kg a.s./ha 1) Transfer coefficient
(TC):
7300 cm2/h (adults)
0.0024 mg/cm2 2600 cm2/h (children)
Number of applications
(NA): 1 see explanation below
Turf Transferable
Residues (TTR): 5 %
Body weight (BW):
60 kg/person (adults) Exposure Duration (H): 2 h
16.15 kg/person (children) Airborne Concentration
of Vapour (ACV): 0
mg/m3
Dermal absorption (DA): 75 % ('worst case') Inhalation Rate (IR):
16.57 m3/d (adults)
Inhalation absorption (IA): 100 % 8.31 m3/d (children)
Oral absorption (OA): 100 % Saliva Extraction Factor
(SE): 50 %
AOEL: 0.08 mg/kg bw/d Surface Area of Hands
(SA): 20 cm2
Frequency of Hand to
Mouth (Freq): 20 events/h
Dislodgeable foliar
residues (DFR): 20 %
Ingestion Rate for
Mouthing of Grass/Day
(IgR):
25 cm2/d
1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), ‘worst case’
Table A 18: Estimation of resident exposure towards quinmerac
Adults Children
Residents: Systemic dermal exposure after application in sugar and fodder beets (via deposits caused by spray drift)
SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW
(0.0024 x 1 x 1.85% x 5% x 7300 x 2 x 75%) / 60 (0.0024 x 1 x 1.85% x 5% x 2600 x 2 x 75%) / 16.15
External dermal
exposure 0.032412 mg/person External dermal exposure 0.011544 mg/person
External dermal
exposure 0.00054 mg/kg bw/d External dermal exposure 0.000715 mg/kg bw/d
Systemic dermal
exposure 0.000405 mg/kg bw/d
Systemic dermal
exposure 0.000536 mg/kg bw/d
Residents: Systemic inhalation exposure after application in sugar and fodder beets (via vapour)
SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW
(0 x 16.57 x 100%) / 60 (0 x 8.31 x 100%) / 16.15
External inhalation
exposure none
External inhalation
exposure none
Systemic inhalation
exposure none
Systemic inhalation
exposure none
Residents: Systemic oral exposure (hand-to-mouth
transfer)
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SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x
OA) / BW
(0.0024 x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / 16.15
External oral exposure 0.000888 mg/person
External oral exposure 0.000055 mg/kg bw/d
Systemic oral exposure 0.000055 mg/kg bw/d
Residents: Systemic oral exposure (object-to-mouth
transfer)
SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW
(0.0024 x 1 x % x 20% x 25 x 100%) / 16.15
External oral exposure 0.000222 mg/person
External oral exposure 0.000014 mg/kg bw/d
Systemic oral exposure 0.000014 mg/kg bw/d
Total systemic exposure: SER = SDER + SIER Total systemic exposure: SER = SDER + SIER + SOER(H) +
SOER(O)
Total systemic
exposure 0.024309 mg/person Total systemic exposure 0.009768 mg/person
Total systemic
exposure 0.000405 mg/kg bw/d Total systemic exposure 0.000605 mg/kg bw/d
% of AOEL 0.5 % % of AOEL 0.8 %
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DRAFT REGISTRATION REPORT
Part B
Section 4: Metabolism and Residues
Detailed summary of the risk assessment
Product name: GOLTIX TITAN
Active Substance: Metamitron (525 g/L)
Quinmerac (40 g/L)
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: ADAMA Deutschland GmbH
Date: March 2015
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Table of Contents
4 METABOLISM AND RESIDUES DATA ................................................ 3
4.1 Evaluation of the active substances ............................................................... 3
4.2 Evaluation of the intended uses ..................................................................... 3
4.2.1 Selection of critical use and justification ....................................................... 3
4.2.2 Sugar/fodder beet ........................................................................................... 6
4.2.2.1 Residues in primary crops .............................................................................. 6
4.2.2.2 Distribution of the residue in peel/pulp ......................................................... 6
4.2.2.3 Residues in processed commodities............................................................... 7
4.2.2.4 Proposed pre-harvest intervals, withholding periods ..................................... 7
4.3 Consumer intake and risk assessment ............................................................ 7
4.3.1 Metamitron ..................................................................................................... 7
4.3.2 Quinmerac ...................................................................................................... 7
4.4 Proposed maximum residue levels (MRLs) ................................................... 8
4.5 Conclusion ..................................................................................................... 8
Appendix 1 Reference list ................................................................................................ 9
Appendix 2 Detailed evaluation of the additional studies relied upon ...................... 10
A 2.1 Storage stability ........................................................................................... 10
A 2.1.1 Storage stability of residues in plant products ............................................. 10
A 2.1.2 Storage stability of residues in animal products .......................................... 12
A 2.2 Residues in primary crops ............................................................................ 12
A 2.2.1 Nature of residues ........................................................................................ 12
A 2.2.2 Magnitude of residues in sugar beets ........................................................... 13
A 2.3 Residues in processed commodities............................................................. 23
A 2.4 Residues in rotational crops ......................................................................... 23
A 2.5 Residues in livestock.................................................................................... 23
A 2.6 Other studies/information ............................................................................ 23
Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) ...................................... 24
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4 METABOLISM AND RESIDUES DATA
4.1 Evaluation of the active substances
It is referred to the main application procedure of Goltix Titan®.
4.2 Evaluation of the intended uses
4.2.1 Selection of critical use and justification
The critical GAPs used for consumer intake and risk assessment are presented in Table 4.2-1.
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Table 4.2-1: Critical Uses (worst case) used for consumer intake and risk assessment
1 2 3 4 5 6 7 8 9 10 11 12 13
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
(a)
F
G
or
I
(b)
Pests or Group of
pests controlled
(additionally:
developmental
stages of the pest or
pest group)
(c)
Application Application rate PHI
(days)
(i)
Remarks:
e.g. safener/synergist
per ha
e.g. recommended or
mandatory tank
mixtures
(j)
Method /
Kind
(d-f)
Timing / Growth
stage of crop &
season
(g)
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
(h)
L product / ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
kg as/ha
a) max. rate per appl.
b) max. total rate per
crop/season
Water
L/ha
min /
max
1 DE Sugar beet, Fodder
beet
F Annual
monocotyledonous
weeds, Annual
dicotyledonous weeds
Spraying Spring,
BBCH 00-19
before emergence
(1st treatment),
after emergence
(2nd to 4th treatment)
a) 4
b) 4
2nd to 4th
treatment at
intervals of 5 to
10 days
a) timing 1: 3
timing 2: 1
timing 3: 1
timing 4: 1
b) 6
a) timing 1:
Metamitron: 1.58
Quinmerac: 0.12
timings 2-4:
Metamitron: 0.53
Quinmerac: 0.04
b) Metamitron: 3.15
Quinmerac: 0.24
200-400 F Total 6.0 L product/ha
2 NL, BE Sugar beet, Fodder
beet
F Annual
dicotyledonous weeds
Spraying BBCH 10-19 a) 1-3 (5 days)
b) 3
a) 2
b) 6
a) Metamitron: 1.05
Quinmerac: 0.08
b) Metamitron: 3.15
Quinmerac: 0.24
200-400 F Total 6.0 L product/ha
3 NL, BE Sugar beet, Fodder
beet
F Annual
dicotyledonous weeds
Spraying BBCH 00-09 a) 1
b) 1
a) 3
b) 3
a) Metamitron: 1.58
Quinmerac: 0.12
b) Metamitron: 1.58
Quinmerac: 0.12
200-400 F Total 6.0 L product/ha
(max. once per 3 years on
the same field)
BBCH 10-19 a) 1-3 (5 days)
b) 3
a) 1
b) 3
a) Metamitron: 0.53
Quinmerac: 0.04
b) Metamitron: 1.58
Quinmerac: 0.12
200-400 F
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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant,
the use situation should be described (e.g. fumigation of a structure)
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
(d) All abbreviations used must be explained
(e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting,
drench
(f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the
plants - type of equipment used must be indicated
(g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season
at time of application
(h) The minimum and maximum number of application possible under practical
conditions of use must be provided
(i) PHI - minimum pre-harvest interval
(j) Remarks may include: Extent of use/economic importance/restrictions
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4.2.2 Sugar/fodder beet
4.2.2.1 Residues in primary crops
The following tables are summarizing the results of the supervised residue trials selected for the
assessment of metamitron in sugar beet. For more details on those residue trials used in evaluating the
GAP, it is referred to Appendix 2.
Table 4.2-2: Overview of the selected supervised residue trials for metamitron
Commodity Region (a) Outdoor/
Indoor
Individual trial results (mg/kg) STMR
(mg/kg) (b)
HR
(mg/kg) (c)
Existing
MRL
(mg/kg)
Median
CF (d) Enforcement
(metamitron)
Risk assessment
(metamitron)
beet root NEU Outdoor 3 x <0.010; 4 x <0.050 3 x <0.010; 4 x <0.050 0.050 0.050 0.2 1
beet leaves
and tops
NEU Outdoor 3 x <0.010; 4 x <0.050 3 x <0.010; 4 x <0.050 0.050 0.050 0.2 1
(a): NEU, SEU, EU or Import (country code).
(b): Median value of the individual trial results according to the risk assessment residue definition.
(c): Highest value of the individual trial results according to the risk assessment residue definition.
(d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors
for each residues trial.
Table 4.2-3: Overview of the selected supervised residue trials for quinmerac
Commodity Region (a) Outdoor/
Indoor
Individual trial results (mg/kg)
STMR
(mg/kg) (b)
HR
(mg/kg) (c)
Existing
MRL
(mg/kg)
Median
CF (d)
Enforcement
(quinmerac)
Risk assessment
(quinmerac + BH 518-
2 + BH 518-4,
expressed as quinmerac)
beet root NEU Outdoor 3 x <0.05; 4 x <0.01 3 x <0.14; 4 x <0.10 0.10 0.14 0.5 n.a.
beet leaves
and tops
NEU Outdoor 3 x <0.05; 4 x <0.01 3 x <0.14; 4 x <0.10 0.10 0.14 0.5 n.a.
(a): NEU, SEU, EU or Import (country code)..
(b): Median value of the individual trial results according to the risk assessment residue definition.
(c): Highest value of the individual trial results according to the risk assessment residue definition.
(d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors
for each residues trial.
(§) molecular masses of BH 518-2 and BH 518-4 are 251.6 and 237.6 g/mol respectively (conversion factors 0.88, 0.93)
It is emphasized that in four of the trials the samples were stored frozen for periods considerably longer
than 12 months prior to extraction.
Storage stability of residues of parent quinmerac and its metabolites BH 518-2 and BH 518-4 was
reported in the DAR for at least 24 months in sugar beet roots and leaves.
Storage stability of residues of parent quinmerac and its metabolites BH 518-2 and BH 518-4 in watery
matrices (wheat green matter) was demonstrated in a study of the applicant for only 12 months
(ASB2011-9249). It is unclear if the applicant has access to a study cited in the DAR (ASB2010-13949)
demonstrating sufficient stability in/on sugar beet items over at least 24 months. If there would be no such
right of use the number of trials in support of the no-residue situation would be insufficient (i.e. < n=4)
for sugar beets, which is a major crop in northern Europe.
4.2.2.2 Distribution of the residue in peel/pulp
Not relevant.
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4.2.2.3 Residues in processed commodities
Not relevant. Due to low residues at harvest, no processing studies are required.
4.2.2.4 Proposed pre-harvest intervals, withholding periods
The proposed pre-harvest interval (PHI)/withholding period is deemed appropriate, due to application at
early growth stage of the crop.
4.3 Consumer intake and risk assessment
4.3.1 Metamitron
The consumer intake and risk assessment is based on the input values given in Table IIIA 4.3-1 and the
toxicological reference values stated in Table IIIA 4.3-2. For the detailed calculation results it is referred
to Appendix 3.
Table IIIA 4.3-1: Residue input values for the consumer risk assessment
Commodity
Chronic risk assessment Acute risk assessment
Input value
(mg/kg)
Comment Input value
(mg/kg)
Comment
Sugar beet 0.05 STMR 0.05 STMR
All other commodities of
Annex I to Reg (EC) No
396/2005
variable
MRLs
as laid down in Reg.
(EC) No 149/2008
not calculated
Table IIIA 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
ADI 0.03 mg/kg bw
TMDI (% ADI) according to EFSA PRIMo 26.5 % (based on UK toddlers diet).
NTMDI (% ADI) according to German NVS II-
model
17.1 % (based on DE children, aged 2-4 years, individual
consumption/body mass ratio)
IEDI (EFSA PRIMo) (% ADI) not required
NEDI (German NVS II-model) (% ADI) not required
Factors included in IEDI and NEDI none
ARfD 0.1 mg/kg bw
IESTI (EFSA PRIMo) (% ARfD) Sugar beet: 3 % (based on UK children 4-6 years)
NESTI (German NVS II-model) (% ARfD) Sugar beet: <1 % (based on DE children 2-4 years)
Factors included in IESTI and NESTI none
4.3.2 Quinmerac
The consumer intake and risk assessment is based on the input values given in Table IIIA 4.3-1 and the
toxicological reference values stated in Table IIIA 4.3-2. For the detailed calculation results it is referred
to Appendix 3.
In the absence of conversion factors for the vast majority of plant commodities and information on the
GAPs underlying the MRLs the dietary intake is based on the MRLs. Although this approach will
GOLTIX TITAN – ZV1 007529-00/01
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underestimate consumer intake it is nevertheless anticipated with a view to the TMDI (based almost
completely on LOQs for important commodities) that long-term dietary intake of EU consumers will not
exceed the ADI of quinmerac.
Table IIIA 4.3-3: Residue input values for the consumer risk assessment
Commodity
Chronic risk assessment Acute risk assessment
Input value
(mg/kg)
Comment Input value
(mg/kg)
Comment
Sugar beet 0.10 STMR 0.10 STMR
All other commodities
variable
MRLs
as laid down in Reg.
(EC) No 149/2008
not calculated
Table IIIA 4.3-4: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)
ADI 0.08 mg/kg bw
TMDI (% ADI) according to EFSA PRIMo 18.4 % (based on UK toddlers diet)
NTMDI (% ADI) according to German NVS II-
model
6.6 % (based on DE children aged 2-4 years, individual
consumption/body mass ratio)
IEDI (EFSA PRIMo) (% ADI) not required
NEDI (German NVS II-model) (% ADI) not required
Factors included in IEDI and NEDI none
ARfD 0.3 mg/kg bw
IESTI (EFSA PRIMo) (% ARfD) Sugar beet: 3 % (based on UK children 4-6 years)
NESTI (German NVS II-model) (% ARfD) Sugar beet: <1 % (based on DE children 2-4 years)
Factors included in IESTI and NESTI none
4.4 Proposed maximum residue levels (MRLs)
No new MRL is required.
4.5 Conclusion
Regarding aspects of seasonal application rates the cGAP of application 007529-00/01 is comparable to
that of the basic application of the product on sugar/fodder beets (007529-00/00). Hence, the statement
basically apply also for application 007529-00/01.
The available residue data is sufficient for dietary risk assessment, provided that there is access of the
applicant to a storage stability study showing storage stability of quinmerac and its relevant metabolites in
watery matrices for up to 17 months (such storage stability was reported up to 24 months in the DAR, but
access is unclear for the application under consideration). If there is no such right of use, the number of
independent trials is too small (n=3) to support a no-residue situation in sugar/fodder beets for quinmerac.
Residues of quinmerac and its metabolites were continuously seen below the respective LOQ. Hence, no
meaningful statement can be made for converting residues of quinmerac in compliance with the existing
residue definition for enforcement to that of risk assessment.
An exceedance of the current MRL of 0.2 mg/kg for metamitron and 0.5 mg/kg for quinmerac in sugar
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beet roots as laid down in EU residue legislation (Reg. (EC) No 14972009) is not expected.
A no-residue situation is indicated from the supervised residue trials for both actives and regarding both
roots and leaves with tops. It is therefore not anticipated that the intended uses impact residues in
commodities of animal origin.
The long-term and the short-term intake of residues of metamitron and quinmerac residues is unlikely to
present a public health concern.
With respect to consumer health protection issues, BfR/Germany agrees with the authorization of the
intended uses on sugar and fodder beet.
Appendix 1 Reference list
Table A 1: Reference list
Annex
point/
reference
No
Author(s) Year Title
Report-No.
Authority registration No
Data
protection
claimed
Owner How
considered in
dRR *
OECD KIIA
6.1.1
Mackenroth, C.;
Krotzky, A.
1995 Investigation of the storage stability in sugar beet
95/10753 ! 3996 ! DE-H-LST/Z-91
GLP: Yes
Published: No
BVL-1989467,
ASB2010-13949
Yes BAS Add
OECD KIIA
6.1.1
Meyer, M. 2011 Determination of the storage stability of Quinmerac
and metabolites in plant matrices
IF-09/01173993
GLP: Yes
Published: No
BVL-2123934, BVL-2125702, BVL-2203833,
ASB2011-9249
Yes FSG Add**
OECD KIIA
6.3.1
Fuchsbichler, G. 1996 Determination of the residues of metamitron and
desamino-metamitron in sugar beets
2 (3) ! HVA 8/95 ! GER 94400/1
ASB2008-4378
Yes Add
OECD KIIA
6.3.1
Fuchsbichler, G. 1996 Determination of the residues of Metamitron and
Desomino-metamitron in sugar beets (4 trials in 1994)
HVA 8/95 ! GER 94400/1 ! 14185 ! 14186 ! 14187 !
14188
GLP: Yes Published: No
BVL-2206952,
ASB2011-14416
Yes FSG Add**
OECD KIIA
6.3.1
Hauck, E. J.;
Schulz, H.
2011 Study on the magnitude of residue of Metamitron and
its metabolite and Quimmerac and its metabolites in
sugar beets after one application of Goltix WG 70
formulation or three applications of Quinmerac and
Metamitron in Northern Europe 2010
RA-2131/01 ! IF-10/1539609
GLP: Yes Published: No
BVL-2203849,
ASB2011-14418
Yes FSG Add**
OECD KIIA
6.3.1
Hoenzelaers, R.;
Schulz, J.
1995 Final report about testing the residual behaviour of
AGH 211 (MAC 93 001 H) in sugar beet under field
conditions
AGR/RP-H 94/MAC 93 001 H
GLP: Yes Published: No
BVL-2206951,
ASB2011-14415
Yes FSG Add**
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Annex
point/
reference
No
Author(s) Year Title
Report-No.
Authority registration No
Data
protection
claimed
Owner How
considered in
dRR *
KIIA 6.3 Simek, I. 2009 Determination of Quinmerac and Metamitron residues
in Sugar Beet (RAC) following treatment with the
formulated product MAF0617 under field conditions
in Northern France in 2007
R A7091 ! FR-qut-07-1
GLP: Yes Published: No
BVL-2757382, ASB2015-1088
Yes ADAMA Y
* Y: Yes, relied on
N: No, not relied on
Add: Relied on, study not submitted by applicant but necessary for evaluation
** Studies provided by the applicant for the main application procedure of GOLTIX TITAN (ZV1 007529-00/00)
Appendix 2 Detailed evaluation of the additional studies relied upon
A 2.1 Storage stability
A 2.1.1 Storage stability of residues in plant products
A new study was submitted by the applicant on storage stability of Quinmerac and its metabolites in
various wheat matrices.
Reference: KIIIA 8.1.1/01
Report Meyer, M. (2011) Determination of the Storage Stability of Quinmerac and
Metabolites in Plant Matrices; ASB2011-9249
Guideline(s): YES
Chemikaliengesetz der Bundesrepublik Deutschland (ChemG) §19, sowie der
Anhänge 1 und 2 in the valid form; OECD document OECD-DOC.
ENV/MC/CHEM(98)17, Paris 1998; Storage stability of Residue Samples, EC doc.
7032/VI/95-rev.5, dated 22/7/97
Deviations: No
GLP: Yes
Acceptability: Yes
Materials and methods
Untreated samples of wheat green matter, wheat grain, wheat straw, and carrot roots were fortified with
either Quinmerac or BH 518-2 and BH 518-4 at a fortification level of 0.5 mg/kg and stored deep-frozen
at ≤-18°C protected from light over a period of 12 months. Samples were analysed after immediately after
specimen preparation (day 0), 3 months, 11 months, and 12 months. On each day of analysis 1 control
specimen, 1 freshly prepared Quinmerac fortified specimen, 1 freshly prepared BH 518-2 and BH 518-4
fortified specimen, 2 storage stability specimens fortified with Quinmerac, and 2 storage stability
specimens fortified with BH 518-2 and BH 518-4 were analysed per matrix.
Samples were analysed using the method “Determination of Residues of Quinmerac and its metabolites
BH 518-2 and BH 518-4 in Plant Matrices” which was validated by M. Meyer, SGS Institut Fresenius
under the Project No. IF-09/01249451 in April 2010. Samples were extracted with methanol/0.4 M
hydrochloric acid (70/30; v/v) and partitioned with Extrelut comprising a washing step with cyclohexane
and elution with ethyl acetate/formic acid (99/1; v/v). The eluate was evaporated to dryness under
nitrogen. Residues were reconstituted in acetonitrile/water (4/6; v/v + 0.1% formic acid). Final
determination was performed with LC-MS/MS. The limit of quantification was 0.05 mg/kg for all
matrices.
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Results and discussions
The recovery values in percentage of quinmerac and its metabolites BH 518-2 and BH 518-4 over the
whole storage time period and for all matrices are given in the table below. They were not corrected by
the mean recovery values of the simultaneously analysed freshly fortified specimens
Table A 2: Summary of storage stability of quinmerac and its metabolites BH 518-2 and BH
518-4 in wheat green matter, wheat grain, wheat straw, and carrot roots at ≤-18°C
Time [months]
0 3 11 12 Wheat green matter, recovery values [%]
Quinmerac
mean 91; 94 88; 89 86; 118 82; 82
93 89 102 82
BH 518-2
mean 100; 102 92; 92 96; 94 102; 104
101 92 95 103
BH 518-4
mean 96; 98 79; 79 81; 80 83; 83
97 79 81 83
Wheat grain, recovery values [%] Quinmerac
mean 107; 93 89; 91 90; 88 92; 92
100 90 89 92
BH 518-2
mean 101; 99 95; 94 103; 95 98; 99
100 95 99 99
BH 518-4
mean 96; 93 77; 75 78; 79 78; 80
95 76 79 79
Wheat straw, recovery values [%] Quinmerac
mean 91; 93 86; 86 90; 87 90; 91
92 86 89 91
BH 518-2
mean 101; 99 93; 92 94; 98 94; 93
100 93 96 94
BH 518-4
mean 94; 94 77; 81 77; 86 77; 75
94 79 82 76
Carrot roots, recovery values [%] Quinmerac
mean 90; 88 88; 89 85; 87 87; 90
89 89 86 89
BH 518-2
mean 88; 93 90; 90 98; 102 100; 104
91 90 100 102
BH 518-4
mean 82; 85 77; 77 80; 83 88; 89
84 77 82 89
The accuracy of the analytical method was by simultaneous analysis of one freshly prepared fortified
specimen from each matrix on each date of analysis (same level as for storage stability specimens). The
results are shown in the following table.
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Table A 3: Summary of concurrent recoveries of quinmerac and its metabolites BH 518-2
and BH 518-4 from various wheat matrices and carrot roots
No. of fortified
specimens
Mean recovery
rates [%]
Standard deviation Relative standard
deviation [%]
Wheat green matter
Quinmerac 4 92 1.7 1.9
BH 518-2 4 98 2.5 2.6
BH 518-4 4 91 8.3 9.1
Wheat grain
Quinmerac 4 96 3.9 4.0
BH 518-2 4 102 3.9 3.8
BH 518-4 4 90 8.4 9.3
Wheat straw
Quinmerac 4 92 6.9 7.5
BH 518-2 4 102 3.7 3.6
BH 518-4 4 92 7.8 8.5
Carrot roots
Quinmerac 4 92 6.9 7.5
BH 518-2 4 102 3.7 3.6
BH 518-4 4 92 7.8 8.5
Conclusion
Quinmerac and its metabolites BH 518-2 and BH 518-4 were found to be stable for at least 12 months
under deep freeze storage conditions in wheat green matter, wheat grain, wheat straw, and carrot roots.
Comments of zRMS: The study is acceptable to demonstrate stability of residues of quinmerac and its
metabolites over 12 months under deep freeze conditions in matrices of high water
content.
A 2.1.2 Storage stability of residues in animal products
No new studies were submitted on the storage stability of residues in animal products.
A 2.2 Residues in primary crops
A 2.2.1 Nature of residues
No further study was submitted on the nature of residues.
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A 2.2.2 Magnitude of residues in sugar beets
Reference: OECD KIIA 6.3
Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list)
Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box
Deviations: no relevant deviations unless stated otherwise in the commenting box
GLP: see reference list
Acceptability: acceptable unless stated otherwise in the commenting box
Table A 4: Residues of metamitron in sugar beets
RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Metamitron
(Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet
Federal Institute for Risk Assessment, Berlin
Federal Republic of Germany Submission date : 2011-12-08
Content of a.i. (g/kg or g/l) : 710 g/kg Indoors / outdoors : Outdoors (European North)
Formulation (e.g. WP) : WG Other a.i. in formulation
Commercial product (name) : submitted to AG-QMM1-565 SC 007529-00
treated with MAC 93 001 H, WDG (710 g/kg Metamitron)
(content and common name) :
Applicant : Feinchemie Schwebda GmbH Residues calculated as : 8.1 Metamitron
8.2 Desaminometamitron
1 2 3 4 5 6 7 8.1 8.2 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
AGR / RP-H 94 / MAC 93
001 H, GER 94 400/R,
trial MAK 12, 14185
Germany
47574 Goch
1994-01-31
sugar beet /
Sophie
1) 1994-04-04
2)
3) 1994-10-09
1.5
3.2
310
268
0.48
1.2
1994-05-19
1994-05-29
BBCH 19 plant
leaf
leaf
leaf
root
root
root
107
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
1.2
0.070
<0.050
<0.050
<0.050
<0.050
<0.050
0
16
30
120
16
30
120
(c) sprayings
analytical method: GC-NPD and GC-MSD
LOQ: 0.05 mg/kg,
max. sample storage: 16 months,
ASB2011-14415 (field part),
ASB2008-4378 (analytical part)
ASB2011-14416
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1 2 3 4 5 6 7 8.1 8.2 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
AGR / RP-H 94 / MAC 93
001 H, GER 94 400/R,
trial MAK 13, 14186
Germany
49685 Bühren
1994-01-31
sugar beet /
Meta
1) 1994-04-20
2)
3) 1994-10-06
1.4
3.7
287
315
0.47
1.2
1994-05-18
1994-05-28
BBCH 19
plant
leaf
leaf
leaf
root
root
root
278
0.050
0.090
<0.050
<0.050
<0.050
<0.050
4.9
0.13
<0.050
<0.050
<0.050
<0.050
<0.050
0
16
32
123
16
32
123
(c) sprayings
analytical method: GC-NPD and GC-MSD
LOQ: 0.05 mg/kg,
max. sample storage: 16 months,
ASB2011-14415 (field part),
ASB2008-4378 (analytical part)
ASB2011-14416
AGR / RP-H 94 / MAC 93
001 H, GER 94 400/R,
trial MAK 14, 14188
Germany
16278 Angermünde
1994-01-31
sugar beet /
Meta
1) 1994-04-24
2)
3) 1994-10-20
1.4
3.6
202
201
0.71
1.8
1994-05-26
1994-06-06
BBCH 19
plant
leaf
leaf
leaf
root
root
root
183
<0.050
<0.050
<0.050
0.0900
<0.050
<0.050
2.6
0.050
<0.050
<0.050
<0.050
<0.050
<0.050
0
16
32
135
16
32
135
(c) sprayings
analytical method: GC-NPD and GC-MSD
LOQ: 0.05 mg/kg,
max. sample storage: 16 months,
ASB2011-14415 (field part),
ASB2008-4378 (analytical part)
ASB2011-14416
AGR / RP-H 94 / MAC 93
001 H, GER 94 400/R,
trial MAK 15, 14187
Germany
67150 Niederkirchen
1994-01-31
sugar beet /
Kawe-Tuka
1) 1994-04-10
2)
3) 1994-10-18
1.5
3.6
206
200
0.71
1.8
1994-05-14
1994-05-24
BBCH 19
plant
leaf
leaf
leaf
root
root
root
2.6
0.10
<0.050
<0.050
<0.050
<0.050
<0.050
0.31
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
0
14
29
131
14
29
131
(c) sprayings
analytical method: GC-NPD and GC-MSD
LOQ: 0.05 mg/kg,
max. sample storage: 16 months,
ASB2011-14415 (field part),
ASB2008-4378 (analytical part)
ASB2011-14416
Remarks: (a) According to CODEX Classification / Guide
(b) Only if relevant
(c) Year must be indicated
(d) Days after last application (Label pre-harvest interval, PHI, underline)
(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Note: All entries to be filled in as appropriate
Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet.
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Table A 5: Residues of metamitron in sugar beets
RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Metamitron
(Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet
Federal Institute for Risk Assessment, Berlin
Federal Republic of Germany Submission date : 2011-12-08
Content of a.i. (g/kg or g/l) : 525 g/l / 700 g/kg Indoors / outdoors : Outdoors (European North)
Formulation (e.g. WP) : SC / WG Other a.i. in formulation
Commercial product (name) : AG-QMM1-565 SC / Goltix WG 700 (content and common name) : 40 g/l Quinmerac
Applicant : Feinchemie Schwebda GmbH Residues calculated as : 8.1 Metamitron
8.2 Desaminometamitron
1 2 3 4 5 6 7 8.1 8.2 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
IF-10/01539609,
90012787,
trial 10-DE-001, plot 3
Germany
64584 Biebersheim
2011-02-24
sugar beet /
Pauletta
1) 2010-03-17
2)
3) 2010-09-27
1.1
1.1
1.1
204
208
216
0.51
0.53
0.53
2010-04-16
2010-04-29
2010-05-27
BBCH 19
plant
leaf with top
beet root
0.012
<0.010
<0.010
0.023
<0.010
<0.010
14
123
123
(c) spraying s
AG-QMM1-565 SC , 525 g/L
analytical methods: IF-10/01618813
(HPLC-MS/MS), LOQ 0.01 mg/kg,
max. sample storage: 8 months
ASB2011-14418
IF-10/01539609,
90012787,
trial 10-DE-001, plot 2
Germany
64584 Biebersheim
2011-02-24
sugar beet /
Pauletta
1) 2010-03-17
2)
3) 2010-09-27
2.8 200 1.4 2010-06-10 BBCH 37 plant
leaf, with top
beet root
46.0
<0.010
<0.010
0.57
<0.010
<0.010
0
109
109
(c) spraying
Goltix WG 700 g/kg
analytical method: IF-10/01618813
(HPLC-MS/MS), LOQ 0.01 mg/kg,
max. sample storage: 8 months
ASB2011-14418
IF-10/01539609,
90012787,
trial 10-DE-002, plot 2
Germany
68649 Groß-Rohrheim
2011-02-24
sugar beet /
Theresa
1) 2010-03-15
2)
3) 2010-10-30
1.0
1.0
1.0
193
193
190
0.53
0.53
0.53
2010-04-16
2010-04-29
2010-05-27
BBCH 19
plant
plant
plant
leaf with top
leaf with top
root
root
17.9
<0.010
<0.010
<0.010
<0.010
<0.010
<0.010
0.38
<0.010
<0.010
<0.010
<0.010
<0.010
<0.010
0
29
60
90
123
90
123
(c) spraying s
AG-QMM1-565 SC , 525 g/L
analytical methods: IF-10/01618813
(HPLC-MS/MS), LOQ 0.01 mg/kg,
max. sample storage: 8.5 months
ASB2011-14418
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1 2 3 4 5 6 7 8.1 8.2 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
IF-10/01539609,
90012787,
trial 10-DE-003, plot 3
Germany
49685 Emstek
2011-02-24
sugar beet /
Ricada (KWS)
1) 2010-04-20
2)
3) 2010-11-20
0.99
1.1
0.98
284
300
280
0.35
0.35
0.35
2010-05-14
2010-05-27
2010-06-15
BBCH 19
plant
leaf with top
beet root
35.9
<0.010
<0.010
0.59
<0.010
<0.010
0
132
132
(c) spraying s
AG-QMM1-565 SC , 525 g/L
analytical methods: IF-10/01618813
(HPLC-MS/MS), LOQ 0.01 mg/kg,
max. sample storage: 7.5 months
ASB2011-14418
IF-10/01539609,
90012787,
trial 10-DE-004, plot 2
Germany
49685 Emstek
2011-02-24
sugar beet /
Ricada (KWS)
1) 2010-04-20
2)
3) 2010-11-20
1.1
1.0
1.0
322
288
286
0.35
0.35
0.35
2010-05-14
2010-05-27
2010-06-15
BBCH 19
plant
plant
plant
leaf with top
leaf with top
root
root
31.4
0.27
<0.010
<0.010
<0.010
<0.010
<0.010
0.47
0.28
<0.010
<0.010
<0.010
<0.010
<0.010
0
29
59
91
132
91
132
s(c) spraying s
AG-QMM1-565 SC , 525 g/L
analytical methods: IF-10/01618813
(HPLC-MS/MS), LOQ 0.01 mg/kg,
max. sample storage: 7.5 months
ASB2011-14418
IF-10/01539609,
90012787,
trial 10-DE-003, plot 2
Germany
49685 Emstek
2011-02-24
sugar beet /
Ricada (KWS)
1) 2010-04-20
2)
3) 2010-11-20
2.7 292 0.93 2010-06-28 BBCH 37 plant
leaf, with top
beet root
33.6
<0.010
<0.010
0.11
<0.010
<0.010
0
119
119
(c) spraying
Goltix WG 700 g/kg
analytical method: IF-10/01618813
(HPLC-MS/MS), LOQ 0.01 mg/kg,
max. sample storage: 7.5 months
ASB2011-14418
Remarks: (a) According to CODEX Classification / Guide
(b) Only if relevant
(c) Year must be indicated
(d) Days after last application (Label pre-harvest interval, PHI, underline)
(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. It is noted however that plot 2 and plot 3 of trial 10-
DE-001 as well as plot 2 and plot 3 of trial 10-DE-003 including plot 2 of trial trial 10-DE-003were not sufficiently independend from one another
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 17 / 24
Table A 6: Residues of metamitron in sugar beets
RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : metamitron
(Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet
Crop Code : BEAVA
Federal Institute for Risk Assessment, Berlin
Federal Republic of Germany Submission date : 2015-01-27
Content of a.i. (g/kg or g/l) : 500 g/L Indoors / Outdoors : Outdoors (European North)
Formulation (e.g. WP) : SC Other a.i. in formulation
Commercial product (name) : MAF06017 (content and common name) : 150 g/L quinmerac
Applicant : ADAMA Deutschland GmbH Residues calculated as : metamitron
1 2 3 4 5 6 7 8 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1)Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage
at last
treatment
Portion
analysed
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
study R A7091 trial
AN1,
France (north)
67160 Seebach
2009-03-11
sugar beet /
Nordika
1) 2007-04-11
2)
3) 2007-09-26
1.7 190 0.88 2007-05-03 BBCH 12 whole plant
leaf with top
root body
<0.050
<0.050
<0.050
92
146
146
(c) spraying
analytical method: Bayer 39/1986 (GC-MS)
LOQ: 0.05 mg/kg
max. sample storage 16 months
ASB2015-1088
study R A7091
trial BP1,
France (north)
45300 Engenville
2009-03-11
sugar beet /
Radar
1) 2007-03-16
2)
3) 2007-10-08
1.7 190 0.88 2007-05-21 BBCH 31 whole plant
leaf with top
root body
<0.050
<0.050
<0.050
91
140
140
(c) spraying
analytical method: Bayer 39/1986 (GC-MS)
LOQ: 0.05 mg/kg
max. sample storage 16 months
ASB2015-1088
study R A7091
trial BM1,
France (north)
72800 Thoree les Pins
2009-03-11
sugar beet /
Ardan
1) 2007-05-15
2)
3) 2007-10-09
1.9 220 0.87 2007-06-01 BBCH 11 whole plant
leaf with top
root body
<0.050
<0.050
<0.050
90
130
130
(c) spraying
analytical method: Bayer 39/1986 (GC-MS)
LOQ: 0.05 mg/kg
max. sample storage 15 months
ASB2015-1088
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 18 / 24
1 2 3 4 5 6 7 8 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1)Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage
at last
treatment
Portion
analysed
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
study R A7091
trial OB1,
France (north)
29830 Ploudalmezeau
2009-03-11
sugar beet /
Radar
1) 2007-04-20
2)
3) 2007-11-13
1.8 210 0.87 2007-05-17 BBCH 12 whole plant
leaf with top
root body
<0.050
<0.050
<0.050
103
180
180
(c) spraying
analytical method: Bayer 39/1986 (GC-MS)
LOQ: 0.05 mg/kg
max. sample storage 16 months
ASB2015-1088
Remarks: (a) According to CODEX Classification / Guide
(b) Only if relevant
(c) Year must be indicated
(d) Days after last application (Label pre-harvest interval, PHI, underline)
(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Comments of zRMS: Not acceptable. The trials cannot be used to suport the intended use of the product on sugar/fodder beet for reasons of not addressing the critical GAP
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 19 / 24
Table A 7: Residues of quinmerac in sugar beets
RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Quinmerac
(Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet
Federal Institute for Risk Assessment, Berlin
Federal Republic of Germany Submission date : 2011-12-08
Content of a.i. (g/kg or g/l) : 40 g/l Indoors / outdoors : Outdoors (European North)
Formulation (e.g. WP) : SC Other a.i. in formulation
Commercial product (name) : AG-QMM1-565 SC 007529-00 (content and common name) : 525 g/l Metamitron
Applicant : Feinchemie Schwebda GmbH All residues were calculated
as quinmerac equivalents
: 8.1 Quinmerac
8.2 BH 518-4 (7-chloro-3-hydroxymethyl-quinoline-8-carboxylic acid)
8.3 BH 518-2 (7-chloroquinoline-3,8-dicarboxylic acid)
1 2 3 4 5 6 7 8.1 8.2 8.3 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at
last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
IF-10/01539609,
90012787,
trial 10-DE-001, plot 3
Germany
64584 Biebersheim
2011-02-24
sugar beet /
Pauletta
1) 2010-03-17
2)
3) 2010-09-27
0.080
0.084
0.086
204
208
216
0.039
0.040
0.040
2010-04-16
2010-04-29
2010-05-27
BBCH 11
BBCH 14
BBCH 19
plant
leaf with top
beet root
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
14
123
123
(c) sprayings
analytical method: IF-09/01249451
(HPLC-MS/MS), LOQ 0.05 mg/kg
max. sample storage: 8 months
ASB2011-14418
IF-10/01539609,
90012787,
trial 10-DE-002, plot 2
Germany
68649 Groß-Rohrheim
2011-02-24
sugar beet /
Theresa
1) 2010-03-15
2)
3) 2010-10-30
0.077
0.077
0.076
193
193
190
0.040
0.040
0.040
2010-04-16
2010-04-29
2010-05-27
BBCH 10
BBCH 14
1BCH 19
plant
plant
plant
leaf, with top
leaf with top
root
root
1.7
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
0.089
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
0
29
60
90
123
90
123
(c) sprayings
analytical method: IF-09/01249451
(HPLC-MS/MS), LOQ 0.05 mg/kg
max. sample storage: 8.5 months
ASB2011-14418
IF-10/01539609,
90012787,
trial 10-DE-003, plot 3
Germany
49685 Emstek
2011-02-24
sugar beet /
Ricada (KWS)
1) 2010-04-20
2)
3) 2010-11-20
0.076
0.080
0.075
284
300
280
0.027
0.027
0.027
2010-05-14
2010-05-27
2010-06-15
BBCH 10
BBCH 14
BBCH 19
plant
leaf with top
beet root
3.0
<0.050
<0.050
0.084
<0.050
<0.050
<0.050
<0.050
<0.050
0
132
132
(c) sprayings
analytical method: IF-09/01249451
(HPLC-MS/MS), LOQ 0.05 mg/kg
max. sample storage: 7.5 months
ASB2011-14418
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 20 / 24
1 2 3 4 5 6 7 8.1 8.2 8.3 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at
last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
F-10/01539609,
90012787,
trial 10-DE-004, plot 2
Germany
49685 Emstek
2011-02-24
sugar beet /
Ricada (KWS)
1) 2010-04-20
2)
3) 2010-11-20
0.086
0.077
0.076
322
288
286
0.027
0.027
0.027
2010-05-14
2010-05-27
2010-06-15
BBCH 10
BBCH 14
BBCH 19
plant
plant
plant
leaf with top
leaf with top
root
root
2.7
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
0.075
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
0
29
59
91
132
91
132
spraying
analytical method: F-09/01249451
(HPLC-MS/MS), LOQ 0.05 mg/kg
max. sample storage: 7.5 months
ASB2011-14418
Remarks: (a) According to CODEX Classification / Guide
(b) Only if relevant
(c) Year must be indicated
(d) Days after last application (Label pre-harvest interval, PHI, underline)
(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. However, two of the trials are not sufficiently
independent to present separate residue level figures (trial 10-DE-003 and 10-DE-004).
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 21 / 24
Table A 8: Residues of quinmerac in sugar beets
RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS
(SUMMARY)
Active ingredient : quinmerac
(Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet
Crop Code : BEAVA
Federal Institute for Risk Assessment, Berlin
Federal Republic of Germany Submission date : 2015-01-27
Content of a.i. (g/kg or g/l) : 150 g/L Indoors / Outdoors : Outdoors (European North)
Formulation (e.g. WP) : SC Other a.i. in formulation
Commercial product (name) : MAF06017 (content and common name) : 500 g/L metamitron
Applicant : ADAMA Deutschland GmbH Residues calculated as : 8.1 Quinmerac
8.2 BH 518-4 (7-chloro-3-hydroxymethyl-quinoline-8-carboxylic acid)
8.3 BH 518-2 (7-chloroquinoline-3,8-dicarboxylic acid)
1 2 3 4 5 6 7 8.1 8.2 8.3 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
study R A7091,
trial AN1,
France (north)
67160 Seebach
2009-03-11
sugar beet /
Nordika
1) 2007-04-11
2)
3) 2007-09-26
0.50 190 0.26 2007-05-03 BBCH 12 whole plant
leaf with top
root
<0.010
<0.010
<0.010
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
92
146
146
(c) spraying
analytical method: CEN/TC 275
WG 4 (LC-MS/MS),
LOQ:
8.1: 0.01 mg/kg
8.2: 0.05 mg/kg
8.3: 0.05 mg/kg
max. sample storage 17 months
ASB2015-1088
study R A7091,
trial BP1,
France (north)
45300
Engenville
2009-03-11
sugar beet /
Radar
1) 2007-03-16
2)
3) 2007-10-08
0.50 190 0.26 2007-05-21 BBCH 31 whole plant
leaf with top
root body
<0.010
<0.010
<0.010
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
91
140
140
(c) spraying
analytical method: CEN/TC 275
WG 4 (LC-MS/MS),
LOQ:
8.1: 0.01 mg/kg
8.2: 0.05 mg/kg
8.3: 0.05 mg/kg
max. sample storage 17 months
ASB2015-1088
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 22 / 24
1 2 3 4 5 6 7 8.1 8.2 8.3 9 10
Report-No.
Location
incl. postal code
and date
Commodity/
Variety
Date of
1) Sowing
2) Flowering
3) Harvest
Application
rate per treatment
Dates of
treatments
Growth
stage at last
treatment
Portion
analysed
Residues
(mg/kg)
Residues
(mg/kg)
Residues
(mg/kg)
PHI
(days)
Remarks
kg
a.i./ha
Water
l/ha
kg
a.i./hl
(a) (b) (c) (a) (d) (e)
study R A7091,
trial BM1,
harvest trial
France (north)
72800 Thoree les
Pins
2009-03-11
sugar beet /
Ardan
1) 2007-05-15
2)
3) 2007-10-09
0.56 220 0.26 2007-06-01 BBCH 11 whole plant
leaf with top
root body
<0.010
<0.010
<0.010
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
90
130
130
(c) spraying
analytical method: CEN/TC 275
WG 4 (LC-MS/MS),
LOQ:
8.1: 0.01 mg/kg
8.2: 0.05 mg/kg
8.3: 0.05 mg/kg
max. sample storage 16 months
ASB2015-1088
study R A7091,
trial OB1,
France (north)
29830
Ploudalmezeau
2009-03-11
sugar beet /
Radar
1) 2007-04-20
2)
3) 2007-11-13
0.54 210 0.26 2007-05-17 BBCH 12 whole plant
leaf with top
root body
<0.010
<0.010
<0.010
<0.050
<0.050
<0.050
<0.050
<0.050
<0.050
103
180
180
(c) spraying
analytical method: CEN/TC 275
WG 4 (LC-MS/MS),
LOQ:
8.1: 0.01 mg/kg
8.2: 0.05 mg/kg
8.3: 0.05 mg/kg
max. sample storage 17 months
ASB2015-1088
Remarks: (a) According to CODEX Classification / Guide
(b) Only if relevant
(c) Year must be indicated
(d) Days after last application (Label pre-harvest interval, PHI, underline)
(e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included
Comments of zRMS: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. Event though conducted considerably overdosed the
results clearly show a nil-residue situation.
It is however unclear, if the applicant has access to the storage stability study on sugar bee tmatrices (ASB2010-13949) demonstrating integrity of samples
over periods of at least 24 months. In its own study on wheat matrices stability was demonstrated for only 12 months.
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 23 / 24
A 2.3 Residues in processed commodities
No new study on residues in processed commodities has been submitted and none is needed due to low
residues at harvest.
A 2.4 Residues in rotational crops
No new study on residues in rotational crops has been submitted.
A 2.5 Residues in livestock
No new study on residues in livestock has been submitted.
A 2.6 Other studies/information
None
GOLTIX TITAN – ZV1 007529-00/01
Part B – Section 4 - Core Assessment
zRMS version
Page 24 / 24
Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2)
Result of chronic risk assessment (EFSA PRIMo rev.2), based on input data as outlined in table 4.3-1
Result of chronic risk assessment (EFSA PRIMo rev.2), based on input data as outlined in table 4.3-3
Part B – Section 5
Core Assessment
GOLTIX TITAN
Registration Report
Central Zone
Page 1 of 36
ADAMA Deutschland GmbH Evaluator: Germany
Date: Feb 2016
REGISTRATION REPORT
Part B
Section 5 Environmental Fate
Detailed summary of the risk assessment
Product code: GOLTIX TITAN
(AG-QMM1-565 SC)
Active Substance(s): metamitron 525 g/L
quinmerac 40 g/L
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: ADAMA Deutschland GmbH
Date: Feb 2016
Part B – Section 5
Core Assessment
GOLTIX TITAN
Registration Report
Central Zone
Page 2 of 36
ADAMA Deutschland GmbH Evaluator: Germany
Date: Feb 2016
Table of Contents TABLE OF CONTENTS ....................................................................................................................................... 2
FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) .................................................................... 3
5.1 GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3 5.2 PROPOSED USE PATTERN ........................................................................................................................ 3 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ........................................................................................... 4 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 4 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (PECSOIL) (KIIIA1 9.4) ......................................................... 5 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (PECSW/PECSED) (KIIIA1 9.7)
6 141/ 156 .......................................................................................................................................................... 8 75 .................................................................................................................................................................... 8
5.7 RISK ASSESSMENT GROUND WATER (KIIIA1 9.6) ................................................................................. 10 5.7.1 Predicted environmental concentration in groundwater (PECGW) calculation for active substances
and metabolites (Tier 1 and 2) ...................................................................................................................... 10 5.7.2 Higher tier leaching assessment ...................................................................................................... 14 5.7.3 Summary of risk assessment for ground water ................................................................................ 14
5.8 POTENTIAL OF ACTIVE SUBSTANCE FOR AERIAL TRANSPORT ................................................................ 15
APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION .......................... 17
APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON .............................................. 19
KIIIA 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT ..................................................................................... 19
APPENDIX 3 TABLE OF INTENDED USES JUSTIFICATION AND GAP TABLES ........................... 35
Part B – Section 5
Core Assessment
GOLTIX TITAN
Registration Report
Central Zone
Page 3 of 36
ADAMA Deutschland GmbH Evaluator: Germany
Date: Feb 2016
FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9)
The product GOLTIX TITAN was already authorized in Germany (reg. No. 007529-00), Belgium
(reg. No. 1038P/B1) and the Netherlands (reg. No. 14298N) following a first original submission for
the use in beets (use no. 1 in the GAP table, see Appendix 3). This document comprises the risk
assessment for groundwater and the exposure assessment of surface water and soil for the plant
protection product GOLTIX TITAN for a label extension (use no. 2 in the GAP table, see
Appendix 3).
Within this document, the first Registration Report is cited in several chapters to avoid replication.
National Addenda are included containing country specific assessments for some annex points.
5.1 General Information on the formulation
Table 5.1-1: General information on the formulation GOLTIX TITAN
Code AG-QMM1-565 SC
Plant protection product GOLTIX TITAN
Applicant ADAMA Deutschland GmbH
Date of application 30.01.2014
Formulation type
(WP, EC, SC, …; density)
SC
Active substance (s) metamitron quinmerac
Concentration of as (g/L) 525 40
5.2 Proposed use pattern
The GAP used for exposure assessment is presented in Table 5.2-1. Further details on the intended use
within the zone is given in Appendix 3.
Table 5.2-1: Critical use pattern of GOLTIX TITAN
Use Crop/growth
stage
Application
method /
Drift scenario
Number of applications,
Minimum application
interval, interception,
application time
(season)
Application rate,
cumulative
(g as/ha)
Soil effective
application rate
(g as/ha)
2 beets (sugar and
fodder) /
BBCH 0-19
Spraying /
arable crops
4 x, 5 d,
1. 0 %
2.-4. 20 %,
spring
metamitron
1 x 1575
3 x 525
quinmerac
1 x 120
3 x 40
metamitron
1 x 1575
3 x 420
quinmerac
1 x 84
3 x 32
1 Could not be checked by zRMS, might be different
Part B – Section 5
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5.3 Information on the active substances
Please refer to the first Registration Report for GOLTIX TITAN that led to authorizations in Germany,
Belgium and the Netherlands.
As additional information, the RMS UK concluded in the draft addendum on confirmatory data in
2014 that the metamitron metabolite M3 was an experimental artifact. Therefore, the metabolite M3
has not to be considered in the groundwater assessment.
5.4 Summary on input parameters for environmental exposure assessment
Please refer to the first Registration Report for GOLTIX TITAN that led to authorizations in Germany,
Belgium and the Netherlands.
As additional information, the RMS UK concluded in the draft addendum on confirmatory data in
2014 that the metamitron metabolite M3 was an experimental artifact. Therefore, the metabolite M3
has not to be considered in the groundwater assessment.
Part B – Section 5
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5.5 Estimation of concentrations in soil (PECsoil) (KIIIA1 9.4)
PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation
kinetics. A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 20 cm (arable
crop)/5 cm (permanent crops) were assumed. The PECsoil calculations were performed with
ESCAPE 2.0 based on the input parameters as presented in tables below.
According to section 6 of the first Registration Report for GOLTIX TITAN the TER values in soil for
quinmerac and its soil metabolites were above the respective TER values for metamitron and far above
the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil
metabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation.
Table 5.5-1: Application related input parameters for PECSoil calculations
Plant protection product GOLTIX TITAN
Use No.: 2
Crop: beets (sugar and fodder)
Application rate: 6 L product/ha ( 3/ 1/ 1/ 1)
Number of applications/interval: 4x/ 5d
Crop interception: 0/ 20/ 20/ 20 %
Table 5.5-2: Substance related input parameters for PECsoil calculation
Active substance DT50
metamitron 22 d (Maximum Field studies, 1st
order)
metabolite Desamino-metamitron 39.7 d (Maximum Field studies, 1st
order)
Due to the fast degradation of metamitron in soil (DT90 <365 d, field data) the accumulation potential
of metamitron does not need to be considered. Besides PECact values also PECtwa, 21 d values are
required for risk assessment. PECtwa, 21 d values are also presented in Table 5.5-3.
Table 5.5-3: Results of PECsoil calculation for application of GOLTIX TITAN in beets (sugar
and fodder) (soil bulk density 1.5 g/cm-3, soil depth 5 cm)
active substance/
preparation
soil relevant
application rate
(g/ha)
PECact
(mg/kg)
PECtwa
21 d
(mg/kg)
tillage
depth
(cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
GOLTIX TITAN 5400 (cummulative,
no degradation)
7.2000 - - - -
metamitron
molecular weight:
202.2 g/mol
1x 1575, 3x 420 2.7561
occurring
on day 15
1.422 - - -
metabolite Desamino-
metamitron
molecular weight:
187.2 g/mol
Formation fraction:
0.5
0.8395
occurring
on day 47
0.7683 20 0.0000 0.8403
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5.6 Estimation of concentrations in surface water and sediment
(PECsw/PECsed) (KIIIA1 9.7)
PECsw and PECsed calculations are provided according to the recommendations of the FOCUS working
group on surface water scenarios in a stepwise approach considering the pathways drainage and
runoff.
The relevant input parameters used for PEC calculation are summarized in the tables below.
Table 5.6-1: Input parameters for metamitron for PECsw/sed calculations
Parameter Endpoint used for
PECsw/sed calculation
Values in
accordance to
EU endpoint in
LoEP
Remarks
Active substance metamitron
Molecular weight (g/mol) 202.2 yes
Saturated vapour
pressure (Pa)
3.01x 10-7
yes
Water solubility (mg/L) 1680 yes
Kf,oc (mL g-1) 86.4 yes Arithmetic mean
Freundlich Exponent
1/n
0.78 Arithmetic mean
DT50,soil (d) 19.1
yes in Addendum 5 (August 2008) a
DT50 of 19 days was used (Q10 of
2.2 instead of Q10 of 2.58)
DT50,water (d) 1000 yes Default value
DT50,sed (d) 11.41 yes
DT50,whole system (d) 11.41
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Table 5.6-2: Input parameters for quinmerac for PECsw/sed calculations
Parameter Endpoint used for
PECsw/sed calculation
Values in
accordance to
EU endpoint in
LoEP
Remarks
Active substance quinmerac - -
Molecular weight (g/mol) 221.64 yes -
Water solubility (mg/L) 107000 (pH 7) yes -
Kf,oc (mL g-1) 35.1 yes Deviating from first Registration
Report, in accordance with LoEP
DT50,soil (d) 17.4 yes (degradation
in soil)
Geometric mean, normalised
(20 ºC, pF2), laboratory studies.
Deviating from first Registration
Report, in accordance with LoEP.
DT50,water (d) Step 1/2:
179.4
yes Geomean of whole system (SFO,
20°C)
DT50,sed (d) Step 1/2:
179.4
yes Geomean of whole system (SFO,
20°C)
DT50,whole system (d) 179.4
yes Geomean of whole system (SFO,
20°C)
As in STEPS 1-2 in FOCUS model there is no possibility to calculate PECs resulting from combined
different application rates, use No.2 was calculated separately for the 1st application and then for the
next three applications. Resulting concentrations in surface water and sediment resulting from use
No.2 are then considered as sum of both parts of the calculations as a conservative approach.
Table 5.6-3: Input parameters related to application for PECsw/sed calculations
Plant protection product GOLTIX TITAN
Use No.
2
Crop: Sugar beet
Application rate: Metamitron: 1x 1575 g/ha, 3x 525 g/ha
Quinmerac: 1 x 120 g/ha, 3 x 40 g/ha
Number of applications/interval: 4 / 5 d
Season of application (step 2): Mar.-may
Crop interception (step 2): 1st: no interception, 2.-4.: minimal crop cover
Application method (step 3): ground spray
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Table 5.6-4: FOCUS Step 3 Scenario related input parameters for PECSW/sed calculations for
the application of GOLTIX TITAN
Crop / Use No Scenario Start of application
window
End of application
window
Single application/ 4
applications
Date of
applications*
Sugar beets/ No.2 D3 111 141/ 156
20.4./ 4.5./ 14.5./
19.5
D4 120 150/ 165
14.5./ 19.5./ 27.5/
4.6.
R1 102 132/ 147 26.4./ 1.5./ 8.5./ 15.5.
R3 75 105/ 120
28.3./ 4.4./ 11.4./
16.4
*determined by the Pesticide Application Timer (PAT) of FOCUS SW
Table 5.6-5: Maximum FOCUS Step 1 and Step 2 PECsw and PECsed of metamitron for the
application of GOLTIX TITAN in beets (sugar and fodder)
Metamitron 1x 1575 g/ha
no interception
FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)
485.25 406.74
FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg)
Europe North 94.78 77.53
Europe South 176.12 147.89
Metamitron
3x 525g/ha, 5d
interval
Minimal crop
cover
FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)
485.25 406.74
FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg)
Europe North 64.42 52.60
Europe South 119.36 100.06
Metamitron
Sum of 1575
g/ha and 3x
525 g/ha
FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)
970.5 813.48
FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg)
Europe North 159.2 224.81
Europe South 295.48 247.95
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Table 5.6-6: Maximum FOCUS Step 1 and Step 2 PECsw and PECsed of quinmerac for the
application of GOLTIX TITAN in beets (sugar and fodder) according to use No 2
Quinmerac
1x 120 g/ha
No
interception
FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)
39.32 13.69
FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg)
Europe North 7.55 2.63
Europe South 14.04 4.89
Quinmerac
3x 40 g/ha
5d interval
Minimal crop
cover
FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)
39.32 13.69
FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg)
Europe North 5.05 1.76
Europe South 9.35 3.26
Quinmerac
Sum
(conservative
approach)
FOCUS Step 1 PECsw (µg/L) PECsed (µg/kg)
78.64 27.38
FOCUS Step 2 PECsw (µg/L) PECsed (µg/kg)
Europe North 12.60 4.39
Europe South 23.39 8.15
Table 5.6-7: Global maximum FOCUS Step 3 PECsw and PECsed values for metamitron for
the application of GOLTIX TITAN in beets (sugar and fodder) according to use
No 2
FOCUS STEP 3
Scenario,
Single application 1.575 kg/ha
Water
Body
PECsw
global max (µg/L)
PECSED global max
(µg/kg)
D3 ditch 8.253 2.252
D4 pond 0.375 0.720
D4 stream 6.852 0.395
R1 pond 0.43 0.871
R1 stream 9.401 1.893
R3 stream 9.541 3.057
FOCUS STEP 3
Scenario,
1x 1575 g/ha, 3x 525g/ha, 5d interval
Water
Body
PECsw
global max (µg/L)
PECSED global max
(µg/kg)
D3 ditch 5.544 1.576
D4 pond 0.502 1.505
D4 stream 4.640 0.617
R1 pond 1.495 2.357
R1 stream 24.089 5.431
R3 stream 53.013 14.535
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5.7 Risk assessment ground water (KIIIA1 9.6)
5.7.1 Predicted environmental concentration in groundwater (PECGW)
calculation for active substances and metabolites (Tier 1 and 2)
Groundwater contamination by direct leaching of the active substance and its metabolites, degradation
or reaction products through soil is generally assessed by groundwater model calculations. The
applicant provided a calculation with PELMO 4.4.3 and PEARL 4.4.4 according to Stangelj (2011).
This study and its results are described in Appendix 2. The zRMS did not agree with all the input
parameters used and therefore did own calculations using FOCUS PELMO 5.5.3.
The study results of Stangelj (2011) show lower PECs compared to the calculations performed by the
zRMS. The main reason might be the different parametrisation of the plant uptake factor (Stangelj
(2011): 0.5, zRMS: 0).
In the following, the calculations of the zRMS are described, the calculation of Stangelj (2011) is
found in Appendix 2.
Table 5.7-1: Application related input parameters for PECGW modelling
Plant protection product GOLTIX TITAN
Use No. 2
Application rate (kg as/ha) metamitron: 1.575/ 0.42/ 0.42/ 0.42 (interception considered)
quinmerac: 0.12 / 0.032 / 0.032 / 0.032 (interception considered)
Application mode yearly (no crop rotation considered)
Crop (crop rotation) sugar beets
Relative application date(s) 4d before, 1d after, 6d after, 11d after emergence
Interception (%) 0%/ 20% / 20%/ 20%
Soil moisture 100 % FC
Q10-factor 2.58
Moisture exponent 0.7
Simulation period (years) 26
Metamitron
The PEC of metamitron and its metabolites in ground water have been assessed with standard FOCUS
scenarios to obtain outputs from the FOCUS PELMO.
Table 5.7-2: Input parameters related to metamitron for PECGW modelling
Parent Metamitron Remarks/Reference
Molecular weight (g/mol) 202.2
DT50 in soil (d) 19.1 38.2 -> Desaminometamitron, 38.2 -> M3
Kfoc 86.4 (median LoEP)
1/n 0.78
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Table 5.7-3: Input parameters related to metabolites of metamitron for PECGW modelling
Metabolite A1 Desamino-
metamitron
Remarks/Reference
Molecular weight (g/mol) 187.2
Formation fraction 0.5 DAR
DT50 in soil (d) 30.5
Kfoc 102.5
1/n 0.78
Table 5.7-4: PECGW at 1 m soil depth for metamitron and its metabolites for the application of
GOLTIX TITAN in beets (sugar and fodder)
(based on geom. mean for DT50 value and arithm. mean for Kfoc)
Use No /crop Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1)
groundwater model: FOCUS PELMO 5.5.3
Metamitron Metabolite
Desamino-metamitron
2 /sugar beets Châteaudun < 0.001 0.010
Hamburg 0.001 0.054
Jokioinen <0.001 <0.001
Kremsmünster <0.001 0.022
Okehampton 0.001 0.070
Piacenza 0.005 0.203
Porto <0.001 0.042
Sevilla <0.001 < 0.001
Thiva <0.001 <0.001
The PECGW values for Metamitron (80th percentile at 1.0 m depth) following consecutive yearly use
(for 26 years) were significantly below the acceptable concentration limit of 0.1 µg/L in all respective
scenarios and all crops using FOCUS PELMO 5.5.3. The PECGW values for the Metamitron metabolite
Desamino-metamitron was calculated to be below 0.1 µg/L in 8 of the 9 scenarios.
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Quinmerac
The PEC of quinmerac and its metabolites in ground water have been assessed with standard FOCUS
scenarios to obtain outputs from the FOCUS PELMO 5.5.3.
Table 5.7-5: Input parameters related to quinmerac for PECGW modelling
Parameter Endpoint used for
PECGW calculation
Remarks/Reference
Molecular weight (g/mol) 221.64 -
DT50 in soil (d) 17.4 Deviating from first Registration Report, in accordance with
LoEP (EFSA, 2010)
Geometric mean normalised lab studies.*
Kfoc 35.1 Deviating from first Registration Report, in accordance with
LoEP
1/n 0.86 Arithmetic mean soils with pH ≥ 6.5 Deviating from first Registration Report, in accordance with
LoEP
plant uptake factor 0 -
* Field studies were conducted by another study sponsor and can’t be used for this application.
Table 5.7-6: Input parameters related to metabolites of quinmerac for PECGW modelling
Parameter Endpoint used for
PECGW calculation
Remarks/Reference
Metabolite 1 BH 518-2
Molecular weight (g/mol) 251.63 -
Formation fraction 0.490 (from parent) Arithmetic mean of formation fractions from laboratory
studies with Quinmerac, LoEP
DT50 in soil (d) 29.7 Deviating from first Registration Report, in accordance with
LoEP
Kfoc 28 Kfoc of the soil with lowest pH (worst case scenario), LoEP
1/n 0.88 1/n value of the soil with lowest pH (worst case scenario),
LoEP
plant uptake factor 0
Metabolite 2 BH 518-5
Molecular weight (g/mol) 237.64 -
Formation fraction 0.234 (from parent) Arithmetic mean of formation fractions from laboratory
studies with Quinmerac, LoEP
DT50 in soil (d) 601.5 Deviating from first Registration Report,
in accordance with LoEP
geometric mean, normalised (20ºC, pF2), laboratory studies
Kfoc 73.5 Arithmetic mean, LoEP
1/n 0.80 Arithmetic mean (without 1/n values < 0.7), LoEP
plant uptake factor 0 -
Part B – Section 5
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Table 5.7-7: PECGW at 1 m soil depth for quinmerac and its metabolites for the application of
GOLTIX TITAN in beets (sugar and fodder)
(based on geom. mean for DT50 value and arithm. mean for Kfoc)
Crop/ use No. Szenario 80th percentile PECGW at 1 m soil depth (µg L-1)
groundwater model: FOCUS PELMO 5.5.3
quinmerac metabolite
BH 518-2
metabolite
BH 518-5
sugar beets / 2 Châteaudun 0.062 2.036 14.269
Hamburg 0.050 2.304 11.598
Jokioinen 0.022 1.665 8.939
Kremsmünster 0.049 1.784 10.02
Okehampton 0.145 2.38 7.878
Piacenza 0.103 1.743 10.075
Porto 0.117 1.449 6.023
Sevilla 0.043 1.016 13.588
Thiva 0.003 0.634 18.476
According to the PECGW modelling with FOCUS PELMO a groundwater contamination of the active
substance quinmerac at a concentration of ≥ 0.1 µg/L is not expected for all of the FOCUS
groundwater scenarios.
For the metabolite BH 518-2 a groundwater concentration of ≥ 0.1 µg/L cannot be excluded in all of
the FOCUS groundwater scenarios exept Jokioinen.
For the metabolite BH 518-5 groundwater concentrations of ≥ 0.1 µg/L cannot be excluded in all of
the FOCUS groundwater scenarios.
In addition to the tier 1 PECGW modelling a higher tier leaching assessment using experimental data
from lysimeter studies/field leaching studies for the active substance quinmerac is performed.
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5.7.2 Higher tier leaching assessment
Two lysimeter studies with quinmerac were submitted for Annex I inclusion (see DAR, 2007 and
LoEP, 2010) as higher tier studies. Results of the lysimeter study in Jülich, Germany (Mittelstaedt and
Fuehr, 1993, study no. 1993/11386) with an application in spring of 224.6 g a.s./ha and sugar beets as
treated crops are considered relevant for this assessment. The study revealed no leaching water
concentrations of quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. However, the
yearly annual concentration of metabolite BH 518-2 was 6.32 µg/L.
Results of the lysimeter study in Schmallenberg, Germany with an application in autumn of 240 g
a.s./ha and oilseed rape are considered is as of limited relevance with respect to the critical use. The
maximum yearly annual concentration in the leachate were 0.06 µg/L (quinmerac), 2.35 µg/L (BH
518-2) and 0.74 µg/L (BH 518-5).
One field leaching study (Krotzky and Hesse, 1992, study no. 1992/11923) with Quinmerac has been
submitted for Annex 1 inclusion (DAR, 2007) as higher tier study. This study is of limited relevance
with respect to the critical use pattern provided in Chapter 5.2, since Quinmerac was applied with a
greater application rate of 500 g a.s./ha. The field leaching study indicated no risk of a groundwater
contamination with quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. Once again,
groundwater contamination with the metabolite BH 518-2 in concentrations > 0.1µg/L could not be
excluded.
5.7.3 Summary of risk assessment for ground water
Results of modelling show that the active substance metamitron is not expected to penetrate into
groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in all of the scenarios.
For the metabolite Desamino-metamitron concentrations of ≥ 0.1 µg/L in groundwater cannot be
excluded in one out of nine FOCUS groundwater scenarios in the intended uses.
As assessment of metabolite regarding their relevance for groundwater is necessary (see Section 8).
Results of modelling show that the active substance quinmerac is not expected to penetrate into
groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites
BH 518-2 and BH 518-5 concentrations of ≥ 0.1 µg/L in groundwater cannot be excluded in all of the
FOCUS groundwater scenarios in the intended use.
Higher tier leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a
lower leaching potential of metabolite BH 518-5 than expected from the lower tier modelling. It has to
be considererd that the degradation rate used for modeling of metabolite BH 518-5 of DT50 = 601.5 d
is a geomean that includes several default values of 1000 d.
Furthermore, according to usual crop rotation scemes yearly applications are not expected. In the
original DAR, calculations were performed for the use every three years. However, the active
ingredient is now registered not only for the use in rape on a national level, but also for beets, for
example. This would allow a crop rotation with for example two treatment years in four years.
As assessment of metabolites regarding their relevance for groundwater is necessary (see Section 8).
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5.8 Potential of active substance for aerial transport
The vapour pressure at 20 °C of the active substance metamitron is < 10-5 Pa. Hence the active
substance metamitron is regarded as non-volatile.
The vapour pressure at 20 °C of the active substance quinmerac is < 10-5 Pa. Hence the active
substance quinmerac is regarded as non-volatile.
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Appendix 1 List of data submitted in support of the evaluation
Table A 1: List of data submitted in support of the evaluation
Annex
point/referenc
e No
Author(s) Year Title
Source (where different from
company)
Report-No.
GLP or GEP status (where
relevant),
Published or not
Authority registration No
Data
protection
claimed
Owner How considered
in dRR
Study-
Status/Usage*
KIIIA 9.6.1/01
Barrada,
M.
2014a CALCULATION OF
PREDICTED
ENVIRONMENTAL
CONCENTRATIONS IN
GROUNDWATER (PECGW)
FOR METAMITRON AND
ITS SOIL METABOLITE
DESAMINO-METAMITRON
AND FOR QUINMERAC
AND ITS SOIL
METABOLITES BH 518-2
AND BH 518-5 USING THE
MODEL SOFTWARE
FOCUS PELMO 5.5.3 AND
FOCUS PEARL 4.4.4
GAB Consulting Agrociencias
S.L.U
Quena Plant Protection N.V.
Report-no. 501833-A3-
090601-03
GLP/GEP: no
Published: no
yes QUE 3) (own
calculation by
evaluator)
OECD:
KIIIA1
9.6.1/02
Stangelj, A 2011 Calculation of predicted
environmental concentrationin
groundwater (PECGW) for
Metamitron and its soil
metabolite Desamino-
Metamitron and for Quinmerac
and its soil metabolites BH
518-2 and BH 518-5 using the
model software Pelmo 4.4.3
and Pearl 4.4.4
Y FSG 4) (but
submitted in
dossier for other
GOLTIX
TITAN use)
KIIIA 9.7.1/01
Barrada,
M.
2014b CALCULATION OF
PREDICTED
ENVIRONMENTAL
CONCENTRATIONS IN
SURFACE WATER (PECSW)
AND SEDIMENT (PECSED)
yes QUE 3) (own
calculation by
evaluator)
Part B – Section 5
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Date: Feb 2016
*
1) accepted (study valid and considered for evaluation)
2) not accepted (study not valid and not considered for evaluation)
3) not considered (study not relevant for evaluation)
4) not submitted but necessary (study not submitted by applicant but necessary for evaluation)
5) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)
FOR THE ACTIVE
SUBSTANCES
METAMITRON AND
QUINMERAC AND MAJOR
METABOLITES USING
FOCUS SW MODELLING
SOFTWARE AND
SCENARIOS
GAB Consulting Agrociencias
S.L.U.
Quena Plant Protection N.V.
Report-no. 501833-A3-
090701-03
GLP/GEP: no
Published: no
Part B – Section 5
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Date: Feb 2016
Appendix 2 Detailed evaluation of studies relied upon
KIIIA 9 Fate and Behaviour in the Environment
KIIIA 9.6 Stangelj (2011)
Reference: KIIIA1 9.6
Report Calculation of predicted environmental concentration in groundwater (PECGW) for
Metamitron and its soil metabolite Desamino-Metamitron and for Quinmerac and
its soil metabolites BH 518-2 and BH 518-5 using the model software Pelmo 4.4.3
and Pearl 4.4.4, Stangelj, A.
Guideline(s): FOCUS GW
Generic Guidance for Tier 1, FOCUS Ground Water Assessments Version 2.0,
January 2011
Deviations: -
GLP: -
Summary
The Predicted Environmental Concentrations in ground water (PECGW) of Metamitron and Quinmerac
and the major soil metabolites, after the application of the product in sugar or fodder beet were
determined using the model software FOCUS PELMO 5.5.3 and FOCUS PEARL 4.4.4.
The PEC values of Metamitron and Quinmerac, as well as major metabolites in groundwater (PECGW)
have been assessed with the endpoints established in the EU review. Furthermore, additional calculations
were performed for Quinmerac and metabolites with adsorption endpoints established in the EU review
along with new data submitted.
Metamitron
Table 9.6-1: Agreed EU End-points used in the Evaluation for Metamitron and metabolite
(EFSA Scientific Report (2008) 185, 1-95)
End-Point Metamitron Desamino-metamitron
Molecular mass
[g/mol]
202.2 187.2
Solubility in water (at 20°C)
[mg/L]
1680 n.r.
Vapour pressure (at 20°C)
[Pa]
3.01 × 10-7 n.r.
KOC
[L/kg]
86.4
(median, n = 15)
102.5
(arithmetic mean, n = 4)
KOM
[L/kg]
50.1
(KOC/1.724)
59.5
(KOC/1.724)
1/n, arithmetic mean 0.78
(median, n = 15)
0.7805
(arithmetic mean, n = 4)
DT50 lab
[days] normalised to 20°C and
pF2
19
(geometric mean, n = 27)
30.5
(geometric mean, n = 9)
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Formation fraction
[%] Not applicable
0.5
(highest calculated from lab aerobic
soil metabolism study)
Plant uptake 0.5
(Brigg calculation)
0.5
(Brigg calculation)
n.r. not reported
Quinmerac
Table 9.6-2: Agreed EU End-points used in the Evaluation for Quinmerac and metabolites
(EFSA Journal 2010, 8(3):1532)
End-Point Quinmerac BH 518-2 BH 518-5
Molecular mass
[g/mol]
221.64 251.63 237.64
Solubility in water (at
pH7, 20°C) [mg/L]
107,000 n.r. n.r.
Vapour pressure (at
20°C) [Pa]
1.0 × 10-10 0
(conservative default)
0
(conservative default)
KOC
[L/kg]
35.1
(arithmetic mean, n =
8, soil pH ≥ 6.5)
28
(worst case, n = 4)
73.5
(arithmetic mean, n =
4)
KOM
[L/kg]
20.4
(KOC/1.724)
16.2
(KOC/1.724)
42.6
(KOC/1.724)
1/n, arithmetic mean
0.86
(arithmetic mean, n =
8, soil pH ≥ 6.5)
0.88
(worst case)
0.81
(mean)
DT50 soil
[days] normalised to
20°C and pF2
10.4
(normalised field,
median, n = 8)
29.7
(normalised laboratory,
geometric mean, n = 4)
601.5
(normalised
laboratory, geometric
mean, n = 4)
Formation fraction
[%] Not applicable 0.49 0.234
Plant uptake 0.5
(default)
0.5
(default)
0.5
(default)
n.r. not reported
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Metamitron
Table 9.6-3: Summary of input parameters for Metamitron for the leaching simulation models
FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
Physical-Chemical parameters
Molecular weight [g mol-1] 202.2 LoE
Phys.-chem. properties
Water solubility [mg L-1] 1680
(20°C)
LoE
Phys.-chem. properties
Molar enthalpy of dissolution [kJ mol-1] 27 FOCUS recommendation
Vapour pressure [Pa] 3.01 × 10-7
(20°C)
LoE
Phys.-chem. properties
Molar enthalpy of vaporization [kJ mol-1] 95 FOCUS recommendation
Diffusion coefficient in water [m² d-1] 4.3 × 10-5 (20 °C)
(PEARL) FOCUS recommendation
Diffusion coefficient in gas [m² d-1] 0.43 (20 °C) FOCUS recommendation
Degradation in soil
Desamino-metamitron
formation fraction [ - ] 0.5
LoE
Worst case
DT50 soil [d] 19
LoE
geometric mean of laboratory studies
(n=27 , normalised to 20°C and pF2)
Temperature correction function
Reference temperature [°C]
PEARL: [kJ mol-1]
PELMO: Q10 [-]
20
65.4
2.58
FOCUS recommendation
EFSA recommendation
EFSA recommendation
Moisture correction function
Reference moisture [-]
PEARL / PELMO: moisture exponent [-]
pF 2
0.7
FOCUS recommendation
Sorption to soil
Kf,oc [mL g-1] 86.4 LoE
median (n = 15)
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Table 9.6-3: Summary of input parameters for Metamitron for the leaching simulation models
FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
Kf,om [mL g-1] 50.1 calculated from Koc values
(Koc = Kom × 1.7242)
Freundlich exponent 1/n [-] 0.78 LoE
median (n = 15)
Method of sorption subroutine
description pH independent
Crop/ Management related parameters
Crop uptake factor [-] 0.5 Brigg calculation
LoE list of endpoints / EFSA report3
Metamitron major metabolite – Desamino-metamitron
Table 9.6-4: Summary of input parameters for Desamino-metamitron for the leaching
simulation models FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
Physical-Chemical parameters
Molecular weight [g mol-1] 187.2 LoE
Water solubility [mg L-1] n.r. -
Molar enthalpy of dissolution [kJ mol-1] 27 FOCUS recommendation
Vapour pressure [Pa] n.r. -
Molar enthalpy of vaporization [kJ mol-1] 95 FOCUS recommendation
Diffusion coefficient in water [m² d-1] 4.3 × 10-5 (20 °C)
(PEARL) FOCUS recommendation
Diffusion coefficient in gas [m² d-1] 0.43 (20 °C) FOCUS recommendation
Degradation in soil
DT50 soil [d] 30.5
LoE
Geometric mean of laboratory studies
(n= 9 , normalised at 20°C, pF2)
Temperature correction function
Reference temperature [°C]
20
FOCUS recommendation
EFSA recommendation
2 SANCO/321/2000 rev.2, 202 pp, 2000. FOCUS groundwater scenarios in the EU review of active substances”, EC Document
Reference SANCO/321/2000 rev.2, 202 pp, 2000. 3 EFSA Scientific Report (2008) 185, 1-95; Conclusions on the peer review of metamitron
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Table 9.6-4: Summary of input parameters for Desamino-metamitron for the leaching
simulation models FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
PEARL: [kJ mol-1]
PELMO: Q10 [-]
65.4
2.58
EFSA recommendation
Moisture correction function
Reference moisture [-]
PEARL / PELMO: moisture exponent [-]
pF 2
0.7
FOCUS recommendation
Sorption to soil
Kf,oc [mL g-1] 102.5 LoE
arithmetic mean (n = 4)
Kf,om [mL g-1] 59.5 calculated from Koc values
(KOC = KOM × 1.7244)
Freundlich exponent 1/n [-] 0.78 LoE
arithmetic mean (n = 4)
Method of sorption subroutine
description pH independent
Crop/ Management related parameters
Crop uptake factor [-] 0.5 Brigg Calculation
LoE list of endpoints / EFSA report5
n.r. not relevant
Quinmerac
Table 9.6-5: Summary of input parameters for Quinmerac for the leaching simulation models
FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
Physical-Chemical parameters
Molecular weight [g mol-1] 221.64 LoE
Phys.-chem. properties
Water solubility [mg L-1] 107,000 (20°C) LoE
Phys.-chem. properties
Molar enthalpy of dissolution [kJ mol-1] 27 FOCUS recommendation
Vapour pressure [Pa] 1.0 × 10-10 (20°C) LoE
4 SANCO/321/2000 rev.2, 202 pp, 2000. FOCUS groundwater scenarios in the EU review of active substances”, EC Document
Reference SANCO/321/2000 rev.2, 202 pp, 2000. 5 EFSA Scientific Report (2008) 185, 1-95; Conclusions on the peer review of metamitron
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Table 9.6-5: Summary of input parameters for Quinmerac for the leaching simulation models
FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
Phys.-chem. properties
Molar enthalpy of vaporization [kJ mol-1] 95 FOCUS recommendation
Diffusion coefficient in water [m² d-1] 4.3× 10-5 (20°C)
(PEARL) FOCUS recommendation
Diffusion coefficient in gas [m² d-1] 0.43 (20°C) FOCUS recommendation
Degradation in soil
518-2
formation fraction [ - ]
518-5
formation fraction [ - ]
0.490
0.234
LoE
DT50 soil [d] 10.4 median of field studies
(n= 8, normalised to 20°C and pF2)
Temperature correction function
Reference temperature [°C]
PEARL: [kJ mol-1]
PELMO: Q10 [-]
20
65.4
2.58
FOCUS recommendation
EFSA recommendation
EFSA recommendation
Moisture correction function
Reference moisture [-]
PEARL / PELMO: moisture exponent [-]
pF 2
0.7
FOCUS recommendation
Sorption to soil
Kf,oc [mL g-1]
35.1 LoE
arithmetic mean, n = 8 (soil pH ≥ 6.5)
30.9
additional calculations LoE + new
studies
arithmetic mean, n=11 (soil pH ≥ 6.5)
Kf,om [mL g-1] 20.4 calculated from Koc values
(KOC = KOM × 1.7246) 17.9
Freundlich exponent 1/n [-]
0.86 LoE
arithmetic mean, n = 8 (pH ≥ 6.5)
0.82
additional calculations LoE + new
studies
arithmetic mean, n=11 (soil pH ≥ 6.5)
6 SANCO/321/2000 rev.2, 202 pp, 2000. FOCUS groundwater scenarios in the EU review of active substances”, EC Document
Reference SANCO/321/2000 rev.2, 202 pp, 2000.
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Table 9.6-5: Summary of input parameters for Quinmerac for the leaching simulation models
FOCUS PEARL 4.4.4 and FOCUS PELMO 4.4.3 or 5.5.3
Parameter Value Remarks
Method of sorption subroutine
description pH dependent LoE
Crop/ Management related parameters
Crop uptake factor [-] 0.5 FOCUS recommendations a
LoE list of endpoints / EFSA report7 a FOCUS recommendation: default value for
systemic substances
Quinmerac major metabolites – BH 518-2 and BH 518-5
Table 9.6-6: Summary of input parameters for metabolites BH 518-2 and BH 518-5 for the
leaching simulation models FOCUS PELMO 4.4.3 or 5.5.3 and FOCUS PEARL 4.4.4
Parameter BH 518-2 Remarks BH 518-5 Remarks
Physical-Chemical parameters
Molecular weight [g mol-1] 251.63 LoE 237.64 LoE
Water solubility [mg L-1] 1000 * LoE 1000 * LoE
Molar enthalpy of dissolution [kJ
mol-1] 27
FOCUS
recommendation 27
FOCUS
recommendation
Vapour pressure [Pa] 1.0 × 10-10
** DAR
1.0 × 10-10
** DAR
Molar enthalpy of vaporization [kJ
mol-1] 95
FOCUS
recommendation 95
FOCUS
recommendation
Diffusion coefficient in water [m²
d-1]
4.3 × 10-5
(20 °C)
FOCUS
recommendation
4.3 × 10-5
(20 °C)
FOCUS
recommendation
Diffusion coefficient in gas [m² d-
1] 0.43 (20°C)
FOCUS
recommendation 0.43 (20°C)
FOCUS
recommendation
Degradation in soil
DT50 soil [d] 29.7
Normalised
geomean from lab
studies, n=4; 20°C
601.5
Normalised
geomean from lab
studies, n=4
Formation fraction [ - ] 0.49 a LoE 0.234 a LoE
Temperature correction function
Reference temperature [°C]
PEARL: [kJ mol-1]
20 #
0.095 +
FOCUS
recommendation #
EFSA
recommendation +
20 #
0.095 +
FOCUS
recommendation #
EFSA
recommendation +
7 EFSA Journal 2010; 8(3): 1523; Conclusion on pesticide peer review – Conclusion on peer review of the pesticide risk
assessment of the active substance quinmerac
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PELMO: Q10 [-] 2.58 + 2.58 +
Moisture correction function
Reference moisture [-]
PEARL / PELMO: moisture
exponent [-]
pF 2
0.7
FOCUS
recommendation
pF 2
0.7
FOCUS
recommendation
Sorption to soil
Kf,oc [mL g-1] 28 LoE
(lowest value) 73.5
LoE
(arithmetic mean,
n=4)
Kf,om [mL g-1] 16.2 b - 42.6 b -
Freundlich exponent 1/n [-] 0.88 LoE
(lowest Koc value) 0.81
LoE
(arithmetic mean,
n=4)
Method of sorption subroutine
description
pH
dependent LoE
pH
independent -
Crop/ Management related parameters
Crop uptake factor [-] 0.5 default 0.5 Default)
LoE list of endpoints / EFSA report11
a maximum occurrence in soil – BH 518-2 = 42.4% and BH 518-5 = 34.7%
b calculated from KOC values (KOC= KOM × 1.7248)
* no measured value available, worst case for leaching considered
** no measured value available, default value used
8 SANCO/321/2000 rev.2, 202 pp, 2000. FOCUS groundwater scenarios in the EU review of active substances”, EC Document
Reference SANCO/321/2000 rev.2, 202 pp, 2000.
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The application rate and frequency correspond to the maximum recommended application rate and
number per year. The key application data used for the modelling are summarised in the following.
Table 9.6-7: Key application data used in the FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4
calculations
FOCUS
Scenario
FOCUS
Crop / no.
of
applications
/ scheme
Interval
between
applications
Mode of
application
/ plant
uptake
Plant
interception
Application
timing
(both
models)
Application
rate
PELMO 4.4.3
& PEARL
4.4.4
Châteaudun
Hamburg
Jokioinen
Kremsmünster
Okehampton
Piacenza
Porto
Sevilla
Thiva
Sugar beet /
4 /
application
scheme B
5
Downward
spraying
overall,
every year /
0.5
1st appl.: 0%
2-4th appl.: 20%
1st appl.
four days
before
emergence
1st appl.:
3.0 L/ha
product
Metamitron:
1.575
Quinmerac:
0.120
2nd to 4th appl.:
1.0 L/ha
product
Metamitron:
0.525
Quinmerac:
0.040
A summary of calculation results is presented below in the following tables. Additionally PECGW for
Quinmerac and metabolites was calculated considering KOC and 1/n endpoints established in the EU
review along with new data submitted.
Furthermore, sugar beet will be rotated with other crops and is typically grown every third year, therefore,
the PECGW calculations for metabolites were performed assuming application onto the same area every
third year for the scenarios where the PECGW is exceeding the limit of 0.1 µg/L.
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Metamitron
Table 9.6-8: Predicted concentrations of Metamitron in groundwater (PECGW) following
application scheme B (one pre-emergence & three post-emergence applications of 3.0 or 1.0 L AG-
QMM1-565 SC, equivalent to 1.575 or 0.525 kg Metamitron/ha) per growing season every year for
26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4 (sugar beet)
FOCUS Scenario Application dates PECGW [µg a.s./L] (80th percentile at 1 m depth)
FOCUS PELMO 4.4.3 FOCUS PEARL 4.4.4
Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr < 0.001 < 0.001
Hamburg 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001
Jokioinen 21-May/26-May/31-May/05-
Jun < 0.001 < 0.001
Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001
Okehampton 21-Apr/26-Apr/01-May/06-
May < 0.001 < 0.001
Piacenza 16-Mar/21-Mar/26-Mar/31-
Mar 0.002 < 0.001
Porto 11-Mar/16-Mar/21-Mar/26-
Mar < 0.001 < 0.001
Sevilla 6-Nov/11-Nov/16-Nov/21-Nov < 0.001 < 0.001
Thiva 27-Apr/02-May/07-May/12-
May < 0.001 < 0.001
Metamitron metabolite – Desamino-metamitron
Table 9.6-9: Predicted concentrations of Desamino-metamitron in groundwater (PECGW)
following application scheme B (one pre-emergence & three post-emergence applications of 3.0 or
1.0 L AG-QMM1-565 SC, equivalent to 1.575 or 0.525 kg Metamitron/ha) per growing season every
year for 26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4
(sugar beet)
FOCUS Scenario Application dates
PECGW [µg/L] (80th percentile at 1 m depth)
FOCUS PELMO
4.4.3 FOCUS PEARL 4.4.4
Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr 0.004 0.109
Hamburg 11-Apr/16-Apr/21-Apr/26-Apr 0.017 0.050
Jokioinen 21-May/26-May/31-May/05-
Jun < 0.001 < 0.001
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Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr 0.011 0.013
Okehampton 21-Apr/26-Apr/01-May/06-May 0.034 0.034
Piacenza 16-Mar/21-Mar/26-Mar/31-Mar 0.100 0.034
Porto 11-Mar/16-Mar/21-Mar/26-Mar 0.023 0.001
Sevilla 6-Nov/11-Nov/16-Nov/21-Nov < 0.001 < 0.001
Thiva 27-Apr/02-May/07-May/12-
May < 0.001 < 0.001
Quinmerac
Table 9.6-10: Predicted concentrations of Quinmerac in groundwater (PECGW) following
application scheme B (one pre-emergence & three post-emergence applications of 3.0 or 1.0 L AG-
QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every year for
26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4 (sugar beets)
FOCUS Scenario Application dates
PECGW [µg a.s./L] (80th percentile at 1 m
depth)
FOCUS PELMO 4.4.3 FOCUS PEARL 4.4.4
Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr 0.001 0.002
Hamburg 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 0.001
Jokioinen 21-May/26-May/31-May/05-
Jun < 0.001 < 0.001
Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr 0.001 < 0.001
Okehampton 21-Apr/26-Apr/01-May/06-
May 0.003 0.001
Piacenza 16-Mar/21-Mar/26-Mar/31-Mar 0.003 0.001
Porto 11-Mar/16-Mar/21-Mar/26-Mar 0.003 < 0.001
Sevilla 6-Nov/11-Nov/16-Nov/21-Nov 0.003 < 0.001
Thiva 27-Apr/02-May/07-May/12-
May < 0.001 < 0.001
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Quinmerac metabolites – BH 518-2 and BH 518-5
Table 9.6-11: Predicted concentrations of BH 518-2 and BH 518-5 in groundwater (PECGW)
following application scheme B (one pre-emergence & three post-emergence applications of 3.0 or
1.0 L AG-QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every
year for 26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4
(sugar beets)
FOCUS
Scenario Application dates
PECGW [µg/L] (80th percentile at 1 m depth)
BH 518-2 BH 518-5
FOCUS
PELMO
4.4.3
FOCUS
PEARL
4.4.4
FOCUS
PELMO
4.4.3
FOCUS
PEARL
4.4.4
Châteaudun 12-Apr/17-Apr/22-Apr/27-
Apr 0.876
1.620 6.309
6.794
Hamburg 11-Apr/16-Apr/21-Apr/26-
Apr 0.790
1.445 5.608
8.057
Jokioinen 21-May/26-May/31-
May/05-Jun 0.867
0.977 5.736
6.925
Kremsmünster 11-Apr/16-Apr/21-Apr/26-
Apr 0.822
1.011 5.147
6.465
Okehampton 21-Apr/26-Apr/01-May/06-
May 1.128
1.182 4.750
5.882
Piacenza 16-Mar/21-Mar/26-Mar/31-
Mar 0.710
0.583 4.889
6.298
Porto 11-Mar/16-Mar/21-Mar/26-
Mar 0.733
0.435 3.922
4.408
Sevilla 6-Nov/11-Nov/16-Nov/21-
Nov 0.660
0.391 5.812
5.088
Thiva 27-Apr/02-May/07-May/12-
May 0.154
0.287 5.878
8.053
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Additional calculations for Quinmerac and metabolites (new Koc and 1/n-endpoints)
Table 9.6-12: Predicted concentrations of Quinmerac in groundwater (PECGW) following
application scheme B (one pre-emergence & three post-emergence applications of 3.0 or 1.0 L AG-
QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every year for
26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4 (sugar beets)
FOCUS Scenario Application dates
PECGW [µg a.s./L] (80th percentile at 1 m
depth)
FOCUS PELMO 4.4.3 FOCUS PEARL 4.4.4
Châteaudun 12-Apr/17-Apr/22-Apr/27-Apr < 0.001 < 0.001
Hamburg 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001
Jokioinen 21-May/26-May/31-May/05-
Jun < 0.001 < 0.001
Kremsmünster 11-Apr/16-Apr/21-Apr/26-Apr < 0.001 < 0.001
Okehampton 21-Apr/26-Apr/01-May/06-
May 0.001 < 0.001
Piacenza 16-Mar/21-Mar/26-Mar/31-Mar 0.001 < 0.001
Porto 11-Mar/16-Mar/21-Mar/26-Mar 0.001 < 0.001
Sevilla 6-Nov/11-Nov/16-Nov/21-Nov < 0.001 < 0.001
Thiva 27-Apr/02-May/07-May/12-
May < 0.001 < 0.001
Table 9.6-13: Predicted concentrations of BH 518-2 and BH 518-5 in groundwater (PECGW)
following application scheme B (one pre-emergence & three post-emergence applications of 3.0 or
1.0 L AG-QMM1-565 SC, equivalent to 0.120 or 0.040 kg Quinmerac/ha) per growing season every
year for 26 years. Calculations according to FOCUS PELMO 4.4.3 and FOCUS PEARL 4.4.4
(sugar beets)
FOCUS
Scenario Application dates
PECGW [µg/L] (80th percentile at 1 m depth)
BH 518-2 BH 518-5
FOCUS
PELMO
4.4.3
FOCUS
PEARL
4.4.4
FOCUS
PELMO
4.4.3
FOCUS
PEARL
4.4.4
Châteaudun 12-Apr/17-Apr/22-Apr/27-
Apr 0.866 1.608 6.292 6.783
Hamburg 11-Apr/16-Apr/21-Apr/26-
Apr 0.783 1.436 5.574 8.051
Jokioinen 21-May/26-May/31-
May/05-Jun 0.857 0.967 5.726 6.912
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Kremsmünster 11-Apr/16-Apr/21-Apr/26-
Apr 0.816 1.004 5.134 6.460
Okehampton 21-Apr/26-Apr/01-May/06-
May 1.113 1.174 4.744 5.876
Piacenza 16-Mar/21-Mar/26-Mar/31-
Mar 0.703 0.582 4.881 6.298
Porto 11-Mar/16-Mar/21-Mar/26-
Mar 0.722 0.433 3.919 4.407
Sevilla 6-Nov/11-Nov/16-Nov/21-
Nov 0.648 0.383 5.766 5.053
Thiva 27-Apr/02-May/07-May/12-
May 0.152 0.283 5.854 8.028
Table 9.6-14: Summary of predicted maximum 80th percentile PECGW values for metabolites
resulting from applications every third year to beets and for scenarios exceeding the trigger value
of 0.1 µg/L –result from application scheme B
Substance Maximum 80th percentile concentrations (µg/L) of all crop relevant scenarios
FOCUS PELMO 4.4.3 FOCUS PEARL 4.4.4
Desamino-
metamitron 0.024 a 0.015 b
BH 518-2 ≤ 0.429 / ≤ 0.423* ≤ 0.591 / ≤ 0.586*
BH 518-5 ≤ 1.945 / ≤ 1.937* ≤ 2.566 / ≤ 2.556*
a only Piacenza scenario
b only Châteaudun scenario
* additional calculations with new endpoint for Quinmerac
The PECGW values for Metamitron and Quinmerac (80th percentile at 1.0 m depth) following consecutive
yearly use (for 26 years) were significantly below the acceptable concentration limit of 0.1 µg/L in all
respective scenarios and all crops using FOCUS PELMO and FOCUS PEARL models. The PECGW
values for the Metamitron metabolite – Desamino-metamitron was calculated to be below 0.1 µg/L in 8
out of 9 scenarios. In one scenario (Châteaudun) the PECGW was calculated to be slightly above the limit.
However, assuming application onto the same area every third year the resulting PECGW for the
metabolite is below the trigger for this scenario.
The PECGW values for BH 518-2 and BH 518-5 are clearly above the groundwater trigger value of 0.1
µg/L or 0.75 µg/L. Assuming application onto the same area every third year the resulting PECGW for the
metabolites BH 518-2 and BH 518-5 are considerably lower. However, the concentrations are still above
the groundwater trigger value of 0.1 µg/L or 0.75 µg/L.
Part B – Section 5
Core Assessment
GOLTIX TITAN
Registration Report
Central Zone
Page 33 of 36
ADAMA Deutschland GmbH Evaluator: Germany
Date: Feb 2016
zRMS:
IIIA 9.6.1/01
The above summary was prepared by the applicant. Values reported were compared with
the original study corrected, were necessary.
The study results show lower PECs compared to the calculations performed by the zRMS
(see chapter 5.7), even mainly the same input parameters were used. The zRMS, however,
does not use a default value of 0.5 for the plant uptake factor, and uses a value of 0. This
might be the main reason for the differences.
A second application sceme (calles application sceme A) was modelled in the study. This is
not relevant for this assessment and was deleted in the summary in order to facilitate the
overview.
As PEARL-results form Kremsmünster are of special interest for NL but were not reported
in the above summary in Table 9.6-14 for the application every third year, these values are
summarized in the following.
Predicted maximum 80th percentile PECGW values for metabolites resulting from
applications every third year to beets and for scenarios calculated with application
scheme B and FOCUS PEARL 4.4.4 :
Desamino-metamitron: <0.001 µg/L
BH 518-2: 0.311 µg/L (LoEP), 0.275 µg/L (new endpoint)
BH 518-5: 2.052 µg/L (LoEP), 1.785 µg/L (new endpoint)
Part B – Section 5
Core Assessment
GOLTIX TITAN
Registration Report
Central Zone
Page 35 of 36
ADAMA Deutschland GmbH Evaluator: Germany
Date: Feb 2016
Appendix 3 Table of Intended Uses justification and GAP tables
GAP-Table of intended uses for all cMS (without Germany), not verified by zRMS
PPP (product name/code) AG-QMM1-565 SC
active substance 1 Metamitron
active substance 2 Quinmerac
active substance
safener -
synergist -
Formulation type: SC (suspension concentrate)
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Conc. of as:
Conc. of safener: -
Conc. of synergist: -
Applicant: company
Zone(s): northern/central/southern/EU
professional use
non professional use
Verified by MS: no
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days) Remarks:
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
Method /
Kind Timing /
Growth stage of
crop & season
Max. number (min.
interval between
applications)
a) per use
b) per crop/ season
kg, L product / ha
a) max. rate per appl.
b) max. total rate per
crop/season
g as/ha
a) max. rate per
appl.
b) max. total rate
per crop/season
Water L/ha
min / max
1 NL, BE
Beets (sugar and
fodder) Use already
authorised
F
GALAP and other
annual
dicotyledonous weed
species
spraying BBCH 10-19 a) 1-3 (5)
b) 3
a) 2
b) 6
a) Metamitron:
1050
Quinmerac: 80
b) Metamitron:
3150
Quinmerac: 240
200 / 400 F
Max. 2.0 L product/ha per treatment
Total 6.0 L product/ha
Max. once per three years on same
field
Part B – Section 5
Core Assessment
GOLTIX TITAN
Registration Report
Central Zone
Page 36 of 36
ADAMA Deutschland GmbH Evaluator: Germany
Date: Feb 2016
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days) Remarks:
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
Method /
Kind Timing /
Growth stage of
crop & season
Max. number (min.
interval between
applications)
a) per use
b) per crop/ season
kg, L product / ha
a) max. rate per appl.
b) max. total rate per
crop/season
g as/ha
a) max. rate per
appl.
b) max. total rate
per crop/season
Water L/ha
min / max
2 NL, BE Beets (sugar and
fodder) F
POAAN, GALAP
and other annual
dicotyledonous weed
species
spraying
BBCH 00-09 a) 1
b) 1
a) 3
b) 3
a) Metamitron:
1575
Quinmerac: 120
b) Metamitron:
1575
Quinmerac: 120
200 / 400 F
Total 6.0 L product/ha
Max. once per three years on same
field
BBCH 10-19 a) 1-3 (5)
b) 3
a) 1
b) 3
a) Metamitron:
525 Quinmerac:
40
b) Metamitron:
1575
Quinmerac: 120
200 / 400 F
Use No. 1 is already authorized.
Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
(f) All abbreviations used must be explained
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(i) g/kg or g/l
(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(k) The minimum and maximum number of application possible under practical conditions of use
must be provided
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use/economic importance/restrictions
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 1 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
REGISTRATION REPORT
Part B
Section 5 Environmental Fate
Detailed summary of the risk assessment
Product code: GOLTIX TITAN
(AG-QMM1-565 SC)
Active Substance(s): metamitron 525 g/L
quinmerac 40 g/L
Central Zone
Zonal Rapporteur Member State: Germany
NATIONAL ADDENDUM – Germany
Applicant: ADAMA Deutschland GmbH
Date: Feb 2016
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 2 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Table of Contents TABLE OF CONTENTS ....................................................................................................................................... 2
SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ........................................ 3
5.1 GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3 5.2 PROPOSED USE PATTERN ........................................................................................................................ 4 5.3 INFORMATION ON THE ACTIVE SUBSTANCES ........................................................................................... 5 5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 5 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ........................................................................ 6 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ............................ 8
5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition .......................... 8 5.6.2 PECSW after exposure by surface run-off and drainage ..................................................................... 9
5.7 RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6) ........................................................................... 10 5.7.1 Direct leaching into groundwater .................................................................................................... 11 5.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and
drainage ........................................................................................................................................................ 15
APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION .......................... 17
APPENDIX 2 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 2014-04-14) ... 19
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 3 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT
(KIIIA 9)
The exposure assessment of the plant protection product GOLTIX TITAN in its intended uses in beets
(sugar and fodder) is documented in detail in the core assessment of the plant protection product
GOLTIX TITAN dated from Feb 2016 performed by Germany.
This document comprises the risk assessment for groundwater and the exposure assessment of surface
water and soil for authorization of the plant protection product GOLTIX TITAN in Germany
according to uses listed in Appendix 2.
Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document.
PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary
(see National addendum Germany, part B, section 6 and part A).
The plant protection product GOLTIX TITAN has already been authorized in Germany in beets (sugar
and fodder) (Reg No. 007529-00-00). Therefore the exposure assessment of the intended use of
GOLTIX TITAN in beets (sugar and fodder) according to use No. 1 refers also to the German national
addendum dated from June 2012. This application is an application for label extension.
5.1 General Information on the formulation
Table 5.1-1: General information on the formulation GOLTIX TITAN
Code AG-QMM1-565 SC
Plant protection product GOLTIX TITAN
Applicant ADAMA Deutschland GmbH
Date of application 30.01.2014
Formulation type
(WP, EC, SC, …; density)
SC
Active substances (as) metamitron quinmerac -
Concentration of as (g/L) 525 40 -
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 4 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.2 Proposed use pattern
The intended uses in Germany classified according the soil effective application rate (cumulative,
disregarding degradation in soil) is presented in Table 5.2-1. Full details of the proposed uses that will
be assessed is included in Appendix 2.
The intended uses in Germany (use No. 1) are covered by the core assessment performed by Germany.
Table 5.2-1: Classification of intended uses in Germany for GOLTIX TITAN
Use No* Crop/growth
stage
Application
method
Drift scenario
Number of applications,
Minimum application
interval, application
time, interception
Application rate,
cumulative
(g as/ha)
Soil effective
application rate
(g as/ha)
00-001 beets (sugar and
fodder) /
BBCH 0-19
Spraying /
arable crops
4 x, 5 d, 11.04, 16.04,
21.04, 26.04
1. 0 %
2.-4. 20 %
metamitron
1 x 1575
3 x 525
quinmerac
1 x 120
3 x 40
metamitron
1 x 1575
3 x 420
quinmerac
1 x 120
3 x 32
* For administrative purposes, each intended use of a plant protection product in Germany is assigned with an
individual use number from the German Federal Office of Consumer Protection and Food Safety (BVL). A
complete list of the individual GAPs in Germany together with their assigned use numbers is given in Appendix
2 of this Addendum.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 5 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.3 Information on the active substances
Please refer to the German national addendum of GOLTIX TITAN (Reg No. 007529-00-00) dated
from June 2012.
As additional information, the RMS UK concluded in the draft addendum on confirmatory data in
2014 that the metamitron metabolite M3 was an experimental artifact. Therefore, the metabolite M3
has not to be considered in the groundwater assessment.
5.4 Summary on input parameters for environmental exposure assessment
Please refer to the German national addendum of GOLTIX TITAN (Reg No. 007529-00-00) dated
from June 2012.
As additional information, the RMS UK concluded in the draft addendum on confirmatory data in
2014 that the metamitron metabolite M3 was an experimental artifact. Therefore, the metabolite M3
has not to be considered in the groundwater assessment.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 6 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.5 Estimation of concentrations in soil (KIIIA1 9.4)
Results of PECsoil calculation for GOLTIX TITAN according to EU assessment considering 5 cm soil
depth are given in the core assessment, part B, section 5, chapter 5.5.
According to section 6 of the first Registration Report for GOLTIX TITAN the TER values in soil for
quinmerac and its soil metabolites were above the respective TER values for metamitron and far above
the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil
metabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation.
For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler,
Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittel-
wirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben
FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of
2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As
soil bulk density 1.5 g cm-3 is assumed.
Due to the fast degradation of the active substance metamitron in soil (DT90 < 365 d) the accumulation
potential of Metamitron does not need to be considered.
The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented
in Table 5.5-1.
Table 5.5-1: Input parameters for GOLTIX TITAN for PECsoil calculation
Active substance DT50
metamitron 22 d (Maximum Field studies, 1st order)
Metabolite Desamino-
metamitron
39.7 d (Maximum Field studies, 1st order)
Additional PECsoil,act was calculated for the formulation GOLTIX TITAN for a soil depth of 2.5 cm.
No short-term and long-term PECsoil were calculated for the formulation since PECsoil,act is considered
sufficient for German risk assessment.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 7 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
The calculated PECsoil used for German risk assessment for metamitron and quinmerac as well as for
the formulation GOLTIX TITAN are summarized in Table 5.5-2.
Table 5.5-2: Results of PECsoil calculation for the intended use in beets used for German risk
assessment
plant protection product: GOLTIX TITAN
use: 01-001
Number of applications/intervall 4x, interval 5d
application rate: 6L product/ha ( 3/ 1/ 1/ 1)
crop interception: 0% / 20/ 20/ 20 %
active substance/
formulation
soil relevant
application rate
(g/ha)
soil depthact
(cm)
PECact
(mg/kg)
tillage
depth (cm)
PECbkgd
(mg/kg)
PECaccu =
PECact +
PECbkgd
(mg/kg)
GOLTIX TITAN 5400
(cummulative, no
degradation)
2.5 14.4000 - - -
Metamitron 1x 1575, 3x 420 2.5 5.5123 on
d 15
- - -
Metabolit Desamino-
metamitron
Formation
fraction: 0.5
2.5 1.6790
occurring
on day 47
20 0.0007 1.6798
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 8 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.6 Estimation of concentrations in surface water and sediment (KIIIA1 9.7)
Results of PECsw calculation of metamitron and quinmerac for the intended uses of GOLTIX TITAN
in beets (sugar and fodder) using FOCUS Surface Water are given in the core assessment, part B,
section 5, chapter 5.6.
For authorization in Germany, exposure assessment of surface water considers the two routes of entry
(i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in
order to allow risk mitigation measures separately for each entry route.
Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with
the model EVA 2.1. Surface water exposure via surface run-off and drainage is estimated using the
model EXPOSIT 3.0.
The aquiatic toxicity of the formulated product GOLTIX TITAN (AG-QMM1-565 SC) is mainly
driven by the active substance metamitron, as an evaluation of the toxicity per fraction under
consideration of the respective endpoints for quinmerac and metamitron show (please refer to the core
assessement of the first application (Reg No. 007529-00-00), Sect. 6, point 6.16.1). Therfore, no
aquatic PEC values for quinmerac were calculated.
The German surface water exposure assessment is outlined in the following chapters.
5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent
deposition
The calculation of concentrations in surface water is based on spray drift data by Rautmann and
Ganzelmeier. The vapour pressure at 20 °C of the active substance metamitron is < 10-5 Pa. Hence the
active substance metamitron is regarded as non-volatile. Therefore exposure of surface water by the
active substance metamitron due to deposition following volatilization does not need to be considered.
The calculation of PECsw after exposure via spray drift and volatilization with subsequent deposition
is performed using the model EVA 3. For a single application, the exposure assessment via spray drift
is based on the application rate in conjunction with the 90th percentile of the drift values. For multiple
applications, lower percentiles of the drift values for each application are applied, resulting in an
overall 90th percentile of drift probabilities. Only one volatilization event following the last use of
pesticide is generally considered.
The endpoints used for modelling of surface water exposure via spray drift and volatilization with
subsequent deposition with EVA 3 are summarized below.
Table 5.6-1: Endpoints of metamitron used for the PECSW calculations with EVA 3
Parameter Metamitron Reference
vapour pressure (Pa) not required since no v/d See core assessment,
Solubility in (mg/L) not required since no v/d
DissT50 water (d) 11.55 SFO (worst case) see CA 7529
DegT50 water/sediment study,
total system (d)
only water phase is considered
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 9 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
The calculated PECsw values after exposure via spray drift for metamitron for the intended use of
GOLTIX TITAN in beets (sugar and fodder) according to use No 001 are presented in the National
addendum Germany, part B, section 6, chapter 6.5 considering the following input parameters related
to the application.
Table 5.6-2: Input parameters for GOLTIX TITAN used for PECSW calculations with EVA 3
Use No.: 001
Number of applications/ interval 4 x/ 5d
Application rate
Metamitron: 1575 g/ha/ 525 g/ha/ 525 g/ha/ 525 g/ha
Drift scenario Arable crops
5.6.2 PECSW after exposure by surface run-off and drainage
The concentration of the active substance metamitron in adjacent ditch due to surface runoff and
drainage is calculated using the model EXPOSIT 3.01.
The substance specific input parameters used for modelling surface water exposure via run-off and
drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in chapter 5.7.2 of this document.
The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance
metamitron for the intended use of GOLTIX TITAN in beets (sugar and fodder) according to use No.
1 are presented in the National addendum Germany, part B, section 6, chapter 6.5 considering the
following input parameters related to the application.
Table 5.6-3: Input parameters related to the application for PECsw calculations with Exposit
3.01
Use No.: 001
Number of applications/ interval: 4, interval of 5d
Application rate
(g a.s./ha)
Metamitron: 1x 1575 g/ha, 3x 525g/ha
Crop interception: 0%/ 20% /20% /20%
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 10 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.7 Risk assessment for groundwater (KIIIA1 9.6)
Results of the PECgw calculation of metamitron and quinmerac for the intended uses of GOLTIX
TITAN in beets (sugar and fodder) according to EU assessment using FOCUS PELMO are given in
the core assessment, part B, section 5, chapter 5.7.
For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct
leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and
drainage of the active substance into an adjacent ditch with subsequent bank filtration into the
groundwater.
Direct leaching after soil passage is assessed following the recommendations of the publication of
Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental
concentrations of active substances of plant protection products and their metabolites in groundwater
(PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011)
for tier 1 and tier 2 risk assessment. According to Hold et al, 2011, endpoints for groundwater
modelling are derived with the program INPUT DECISION 3.1 and subsequent simulations are
performed for the groundwater scenarios “Hamburg” or with the scenarios “Hamburg” and
“Kremsmünster” of FOCUS PELMO.
In tier 3 risk assessment, results of experimental studies (lysimeter studies and/or field leaching
studies) can also be considered in German groundwater risk assessment.
Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the
groundwater are estimated using the model EXPOSIT 3.
The German risk assessment for groundwater is given in the following chapters.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 11 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.7.1 Direct leaching into groundwater
5.7.1.1 PECGW modelling
The worst case scenario used for PECgw modelling is summarized in Fehler! Verweisquelle konnte
nicht gefunden werden. following table. It covers the intended uses of GOLTIX TITAN in beets
according to Table 5.2-1 (see also Appendix 2).
Table 5.7-1: Input parameters related to application for PECGW modelling with FOCUS
PELMO 5.5.3
use evaluated 00-001
application rate (kg as/ha) Metamitron: 1x 1.575 , 3x 0.42 ( interception considered)
crop (crop rotation) Sugar beet
date of application 11.4./ 16.4./ 21.4./ 26.4
interception (%) 0/ 20/20/20 %
soil moisture 100 % FC
Q10-factor 2.58
moisture exponent 0.7
plant uptake Quinmerac: 0*,
Metamitron: 0.5 and for the metabolites : 0**
simulation period (years) 26
* The plant uptake factor for Quinmerac and its soil metabolites BH 518-2 and BH 518-5 was set to 0 in
order to simulate a worst case scenario in tier 1 modelling as proposed in Holdt et al. (2011). In tier 2
modelling the PECgw can be refined by experimental determination of the substance specific plant
uptake factor (FOCUS 2009). This approach should be developed in close collaboration between the
notifier and the responsible authority (Holdt et al., 2011).
** The use of the plant uptake factor 0 for the metabolites deviates from the input parameters in
the core assessment where a plant uptake factor of 0.5 was used.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 12 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Metamitron
The endpoints used for groundwater modelling for Metamitron and its metabolites Desamino-
metamitron and M3 according to INPUT DECISION 3.1 are summarized in the following table.
Table 5.7-2: Input parameters related to Metamitron for PECGW modelling
Parent Metamitron Remarks/Reference to Part B, Section 5,
Core assessment
molecular mass 202.2
DT50 in soil (d) 19.1
Kfoc Kf: 1.45/ 1.45/ 1.45/ 0 /0
/0
Deviation from the input parameters in the
core assessment: Use of horizon specific
Kf-values for Metamitron according to
Input_Decision_3_2 instead of the median
KOC value 86.4 used in the LoEP.
1/n 0.77
Metabolite Desamino-metamitron A1 in metabolism schema
molecular mass 187.2
Formation fraction 0.5
DT50 in soil (d) 30.5
Kfoc 102.5
1/n 0.78
The results of the groundwater simulation are presented in Table 5.7-3.
Table 5.7-3: PECGW at 1 m soil depth of Metamitron and its metabolites Desamino-
metamitron considered relevant for German exposure assessment
Use No. Szenario
80th Percentile PECGW at 1 m Soil Depth (µg L-1) modeled by FOCUS
PELMO 5.5.3
Metamitron Metabolite Desamino-metamitron
001 Hamburg <0.001 0.032
According to the results of the groundwater simulation with FOCUS-PELMO 5.5.3, a groundwater
contamination of the active substance Metamitron in concentrations of ≥ 0.1 µg/L is not expected for
the intended use in sugar beet.
For the metabolite Desamino-metamitron a groundwater concentration of ≥ 0.1 µg/L can be excluded
for the application in sugar beet according to the results of the groundwater simulation with FOCUS-
PELMO 5.5.3.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 13 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Quinmerac
The endpoints used for groundwater modelling for quinmerac and its metabolites in the core
assessment are regarded as worst case endpoints, that would be also used for national assessment.
Therefore no additional calculation with national endpoints is considererd necessary.
The results of the groundwater simulation are presented in Table 5.7-4. As a pH-dependency was
stated for the sortion behavior, the scenario Kremsmünster is relevant additionally to Hamburg.
Table 5.7-4: PECGW at 1 m soil depth of quinmerac and its metabolites considered relevant for
German exposure assessment (yearly application assumed for modelling)
Use No. Szenario
80th Percentile PECGW at 1 m soil depth (µg L-1) modeled by FOCUS
PELMO 5.5.3
quinmerac Metabolite BH 518-2 Metabolite BH 518-5
001 Hamburg 0.050 2.304 11.598
Kremsmünster 0.049 1.784 10.02
In addition to the PECgw modelling experimental data from lysimeter studies/ field leaching studies
are used to assess the leaching behaviour of the active substance quinmerac.
5.7.1.2 Experimental data to the leaching behaviour
Quinmerac
Two lysimeter studies with quinmerac were submitted for Annex I inclusion (see DAR, 2007 and
LoEP, 2010) as higher tier studies. Results of the lysimeter study in Jülich, Germany (Mittelstaedt and
Fuehr, 1993, study no. 1993/11386) with an application in spring of 224.6 g a.s./ha and sugar beets as
treated crops are considered relevant for this assessment. The study revealed no leaching water
concentrations of quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. However, the
yearly annual concentration of metabolite BH 518-2 was 6.32 µg/L.
Results of the lysimeter study in Schmallenberg, Germany with an application in autumn of 240 g
a.s./ha and oilseed rape are considered is as of limited relevance with respect to the critical use. The
maximum yearly annual concentration in the leachate were 0.06 µg/L (quinmerac), 2.35 µg/L (BH
518-2) and 0.74 µg/L (BH 518-5).
One field leaching study (Krotzky and Hesse, 1992, study no. 1992/11923) with Quinmerac has been
submitted for Annex 1 inclusion (DAR, 2007) as higher tier study. This study is of limited relevance
with respect to the critical use pattern provided in Chapter 5.2, since Quinmerac was applied with a
greater application rate of 500 g a.s./ha. The field leaching study indicated no risk of a groundwater
contamination with quinmerac and the metabolite BH 518-5 in concentrations > 0.1 µg/L. Once again,
groundwater contamination with the metabolite BH 518-2 in concentrations > 0.1µg/L could not be
excluded.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 14 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.7.1.3 Summary on risk assessment for groundwater after direct leaching
Results of modelling show that the active substance metamitron is not expected to penetrate into
groundwater at concentrations of ≥ 0.1µg/L is not expected to penetrate into groundwater at
concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolite Desamino-metamitron
concentrations of ≥ 0.1µg/L in groundwater can be excluded.
Results of modelling show that the active substance quinmerac is not expected to penetrate into
groundwater at concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites
BH 518-2 and BH 518-5 concentrations of ≥ 0.1 µg/L in groundwater cannot be excluded in all of the
FOCUS groundwater scenarios in the intended use.
Higher tier leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a
lower leaching potential of metabolite BH 518-5 than expected from the lower tier modeling. It has to
be considererd that the degradation rate used for modeling of metabolite BH 518-5 of DT50 = 601.5 d
is a geomean that includes several default values of 1000 d.
Furthermore, according to usual crop rotation scemes yearly applications (as assumed in modeling) are
not expected. In the original DAR, calculations were performed for the use every three years.
However, the active ingredient is now registered not only for the use in rape on a national level, but
also for beets, for example. This would allow a crop rotation with for example two treatment years in
four years.
As a result, the active substance quinmerac is not expected to penetrate into groundwater at
concentrations of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites BH 518-2 and
BH 518-5 concentrations of ≥ 0.1 µg/L cannot be excluded, but it is expected that concentrations
remain below 10 µg/L.
Consequences for authorization:
none
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 15 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
5.7.2 Ground water contamination by bank filtration due to surface water
exposure via run-off and drainage
Metamitron
The input parameters for metamitron used for modelling surface water exposure via run-off and
drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.0
are summarized in Table 5.7-5.
Table 5.7-5: Input parameters for Metamitron used for PECGW calculations with EXPOSIT
3.01
Parameter Metamitron
K foc, Runoff 122
Kfoc, mobility class 37
DT50 soil (d) 22
Solubility in water (mg/L) 1680
Mobility class 3
Reduction by bank filtration 90%
The calculated PECgw for Metamitron after surface run-off and drainage with subsequent bank
filtration are summarized in Table 5.7-6.
Table 5.7-6: PECgw for Metamitron after surface run-off and drainage with subsequent bank
filtration (modelled with EXPOSIT 3.01 )
Active substance Metamitron
Use No. application
rate
interception
PECgw due to
run-off drainage
vegetated buffer
strip
(m)
bank filtrate
(µg/L)
Time of
application
bank filtrate
(µg/L)
001 1x 1575, 3x
525g/ha with
an interval of
5d,
interception:
0/ 20/20/20%
0 0.144 autumn/winter/
early spring Not relevant
5 0.124
10 0.107 spring/summer 0.047
20 0.075
required labelling yes
According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L
by the active substance Metamitron due to surface run-off and drainage into the adjacent ditch with
subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of
20 m) are applied
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 16 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Quinmerac
It can be concluded from the original Registration Report (reg. no. 007529-00-00) that the calculated
PECs of quinmerac and its metabolites are far below the trigger of 0.1 µg/L in a comparable use.
Therefore, a calculation for this use is not necessary.
Consequences for authorization:
The authorization of the plant protection product GOLTIX TITAN is linked with following labeling:
Use No. 001 NG 404
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Registration Report
Central Zone
zRMS: Germany
Page 17 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Appendix 1 List of data submitted in support of the evaluation
No additional data for national assessment submitted.
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Tstst Registration Report
Central Zone
zRMS: Germany
Page 19 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
Appendix 2 Table of Intended Uses in Germany (according to BVL 2014-04-14)
PPP (product name/code) Goltix Titan
active substance 1 Metamitron
active substance 2 Quinmerac
Formulation type: SC
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Applicant: ADAMA Deutschland GmbH
Zone(s): central/EU
professional use X
non professional use
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days) Remarks:
e.g. safener/synergist per ha
e.g. recommended or
mandatory tank mixtures
Method /
Kind Timing / Growth
stage of crop &
season
Max. number
(min. interval
between
applications)
a) per use
b) per crop/
season
kg, L product /
ha
a) max. rate per
appl.
b) max. total rate
per crop/season
g, kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water L/ha
min / max
001 DE Sugar beet
BEAVA
fodder beet
BEAVC
F TTTMS
TTTDS
Spraying
splitting 4
applications
Spring
BBCH 00 – 19
1st treatment before-
emergence
2nd to 4th treatment
after emergence
a) 4
b) 4
the 2nd to 4th
treatment with
an interval of 5
to 10 days
a)
timing 1:
3 L/ha
timing 2-4:
1 L/ha
a)
timing 1:
Metamitron
1575 g as/ha
Quinmerac
120 g as/ha
timing 2-4:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
200 - 400 *XF
Part B – Section 5
National Addendum– Germany
GOLTIX TITAN Tstst Registration Report
Central Zone
zRMS: Germany
Page 20 of 20
ADAMA Deutschland GmbH Evaluator: Germany (UBA)
Feb 2016
b) 6 L/ha
maximum
application rate
for the intented
crop per year
b)
Metamitron
3150 g as/ha
Quinmerac
240 g as/ha
maximum
application rate
for the intented
crop per year
*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in
days is not required resp.
Remarks: (1) Numeration of uses in accordance with the application/as verified by MS
(2) Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(8) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g. g or kg / ha)
(12) The range (min/max) of water volume under practical conditions of use must be given
(L/ha)
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
Part B – Section 6
Core Assessment
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Applicant: ADAMA Evaluator: zRMS DE
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REGISTRATION REPORT
Part B
Section 6: Ecotoxicological studies
Detailed summary of the risk assessment
Product code: GOLTIX TITAN
(AG-QMM1-565 SC)
Active Substances: Metamitron 525 g/L
Quinmerac 40 g/L
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: ADAMA
Date: May 2015
Part B – Section 6
Core Assessment
GOLTIX TITAN Draft Registration Report
Central Zone
Page 2 of 55
Applicant: ADAMA Evaluator: zRMS DE
Date May 2015
Table of Contents SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)............................................................ 5
6.1 GAP AND OVERALL CONCLUSIONS .................................................................................................. 6
6.1.1 Table of intended uses ............................................................................................................ 6
6.1.2 Grouping of intended uses for risk assessment ...................................................................... 7
6.1.3 Consideration of metabolites .................................................................................................. 8
6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ................................................................. 9
6.2.1 Justification for new endpoints ............................................................................................ 10
6.2.2 Risk assessment (MIIIA 10.1.1, MIIIA 10.1.2) for spray applications ................................ 10
6.2.3 Biomagnification in terrestrial food chains .......................................................................... 18
6.2.4 Risk assessment (MIIIA 10.1.3, MIIIA 10.1.4, MIIIA 10.1.5) for baits, pellets, granules,
prills or treated seed ............................................................................................................. 18
6.2.5 Overall conclusions .............................................................................................................. 18
6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC
10.1.2) .................................................................................................................................................... 18
6.3.1 Justification for new endpoints ............................................................................................ 19
6.3.2 Risk assessment (MIIIA 10.3.1) for spray applications ....................................................... 19
6.3.3 Biomagnification in terrestrial food chains .......................................................................... 28
6.3.4 Risk assessment (MIIIA 10.3.1) for baits, pellets, granules, prills or treated seed .............. 28
6.3.5 Overall conclusions .............................................................................................................. 28
6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC
10.1.3) .................................................................................................................................................... 28
6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ...................................... 29
6.5.1 Justification for new endpoints ............................................................................................ 32
6.5.2 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ........................................... 33
6.5.3 Overall conclusions .............................................................................................................. 37
6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) .................................................................................. 38
6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ..................................... 38
6.7.1 Justification for new endpoints ............................................................................................ 38
6.7.2 Risk assessment .................................................................................................................... 38
6.7.3 Overall conclusions .............................................................................................................. 43
6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1,
KPC 10.4.2) ............................................................................................................................................ 44
6.8.1 Justification for new endpoints ............................................................................................ 46
6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and
TERLT (MIIIA 10.6.1) .......................................................................................................... 46
6.8.3 Higher tier risk assessment ................................................................................................... 47
6.8.4 Overall conclusions .............................................................................................................. 47
6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) .................................................. 47
6.9.1 Justification for new endpoints ............................................................................................ 49
6.9.2 Risk assessment .................................................................................................................... 49
6.9.3 Overall conclusions .............................................................................................................. 50
6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) .......................................................... 50
6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ........................................................ 50
6.10.2 Justification for new endpoints ............................................................................................ 51
6.11 EFFECTS ON OTHER TERRESTRIAL ORGANISMS (FLORA AND FAUNA) (KPC 10.7) ......................... 53
6.12 MONITORING DATA (KPC 10.8) ..................................................................................................... 53
6.13 AVAILABLE PRELIMINARY DATA (IIIA 10.9) .................................................................................. 53
6.14 OTHER/SPECIAL STUDIES (IIIA 10.10) ............................................................................................ 53
APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ................. 54
APPENDIX 2 DETAILED EVALUATION OF THE NEW STUDIES .............................................. 55
Part B – Section 6
Core Assessment
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Applicant: ADAMA Evaluator: zRMS DE
Date May 2015
Part B – Section 6
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Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)
This document reviews the ecotoxicological studies for the product GOLTIX TITAN containing the active
substances Quinmerac and Metamitron, which is currently approved under Reg. (EC) No 1107/2009
(repealing Directive 91/414/EEC) and fulfils the criteria according to commission implementing regulation
(EU) No 546/2011, Annex, Part I C , 2.
GOLTIX TITAN (AG-QMM1-565 SC) was not the representative formulation considered in the EU review
process as part of Annex I inclusion. The studies with the relevant endpoints for each non-target organism
group were agreed during EU review process and are used for the risk assessment. Reference is made to
the following documents, if not otherwise labelled with an asterisk:
Quinmerac: EFSA Conclusion: EFSA Journal 2010; 8(3):1523
Metamitron: EFSA Conclusion: EFSA Scientific Report (2008) 185, 1-95
Full details of toxicity studies are provided in the respective EU DAR. The applicant provides further
studies with the formulation GOLTIX TITAN and for the active substances Quinmerac, Metamitron and
its major metabolites. This Registration Report 007529-00-01 is a label extension to Registration Report
007529-00-00. Detailed study summaries for the studies performed with the formulated product GOLTIX
TITAN and for other new studies are presented in Registration Report 007529-00-00 GOLTIX TITAN.
Part B – Section 6
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GOLTIX TITAN
Draft Registration Report
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Date April 2015
6.1 GAP and overall conclusions
6.1.1 Table of intended uses
Table 6.1-1: GAP and overall conclusions
Intended
use F/G
Timing
(months,
BBCH)
Max number
appl. (interval
in days)
Application per treatment Overall conclusions
kg a.s./ha
max
Rate/season
[kg a.s./ha]
max
Birds Aquatic
organisms Mammals Bees
Non-target
arthropods
Soil
organisms
Non-target
plants
2 (sugar- and
fodder beets) F
BBCH 0-
19 4
Metamitron:
3150
Quinmerac
240
6.0 L prod./ha,
max. once per
three years on
same field
X X X1
Please refer
to the risk
assessemnt
outcome as
provided by
JKI
X X X
F: Field use; G: Glasshouse use
Remarks:
Safe use identified
Further refinement and/or risk mitigation measures are needed
No safe use identified and considered possible
Explanations:
The colours in the Table 6-1 are intended to reflect the outcome of the assessments including the available and valid refinement steps and risk mitigations measures.
Remarks “X1”: acceptability criteria TER>5 is not total reached for focal species “woodmouse” Apodemus sylvaticus, further refinement on national level is
necessary
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6.1.2 Grouping of intended uses for risk assessment
The following table lists the grouping of the intended uses in order to perform a risk envelope approach.
Please not: provided Registration Report 00759-00-01 is a label extension of product GOLTIX TITAN
007529-00-00.
Table 6.1-2: Critical use pattern of GOLTIX TITAN (label extension)
Use Crop/growth
stage
Application
method /
Drift scenario
Number of applications,
Minimum application
interval, interception,
application time
(season)
Application rate,
cumulative
(g as/ha)
Soil effective
application rate
(g as/ha)
2 beets (sugar and
fodder) /
BBCH 0-19
Spraying /
arable crops
4 x, 5 d,
1. 0 %
2.-4. 20 %,
Spring,
1x 3L prod./ha +
3x 1L prod./ha
metamitron
1 x 1575
3 x 525
quinmerac
1 x 120
3 x 40
metamitron
1 x 1575
3 x 420
quinmerac
1 x 120
3 x 32
Table 6.1-3: Critical use pattern of GOLTIX TITAN grouped according to soil relevance, drift scenario and crop scenario
Groups – Soil relevance
Group Intended uses Application rate (Interception) Soil relevant effective appl. rate, cumulative
[g/ha] [g/ha]
B01 2 Metamitron: 1 x 1575
3 x 525
Quinmerac: 1 x 120
3 x 40
Application:
4 x, 5 d,
1. 0 %
2.-4. 20 %,
spring
Metamitron: 1 x 1575
3 x 420
Quinmerac: 1 x 120
3 x 32
Groups – Drift szenario
Group Intended uses Application rate Drift scenario
[g/ha]
D01 2 Metamitron: 1 x 1575
3 x 525
Quinmerac: 1 x 120
3 x 40
74th percentile
Groups – Birds and mammals
Group Intended uses Application rate Crop scenario [g/ha]
V01S01 2 Metamitron: 1 x 1575 Bare soil,
Part B – Section 6
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3 x 525
Quinmerac: 1 x 120
3 x 40
Root and stem vegetables
6.1.3 Consideration of metabolites
The metabolites which require an ecotoxicological assessment according to the endpoint list are given
below.
Copy the following tables from section 5.
Table 6.1-4: Metabolites of active substance Metamitron potentially relevant for exposure
assessment (> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of a.s. and maximum of formation not yet reached at the end of the study)
Metabolite Structural formula/Molecular
formula
occurrence in compartments (Max. at day/
Status of Relevance (EFSA Conclusion: EFSA
Scientific Report (2008) 185,
1-95)
Metamitron
Desamino-
metamitron
C10H9N3O
Soil: max. 17.1% on day 30
Surface water: max. 54% on
day 58
Sediment: max. 27.5% on day
58
No
M3, not
identified
Soil: Transient, 2x>5% No information available,
assessment of confirmatory
data pending
1) According to Guidance Document on the assessment of the relevance of metabolites in groundwater of substances regulated
under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)
Table 6.1-5: Metabolites of active Quinmerac potentially relevant for exposure assessment
(> 10 % of as or > 5 % of as in 2 sequential measurements or > 5 % of a.s. and maximum of formation not yet reached at the end of the study)
Metabolite Structural
formula/Molecular
formula
occurrence in compartments
(Max. at day/
Status of Relevance
(EFSA Conclusion: EFSA
Journal 2010; 8(3):1523)
N
NH
N
O
Me
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BH 518-2
N
COOH
Cl
O OH
C11H6ClNO4
Soil:
Aerobic degradation:
Max. 29.1 % TAR after 30 d
(at 20 °C and 40 % MWHC)
Max. 42.2 % TAR after 224 d
(at 5 °C and 60 % FC)
Anaerobic degradation:
Max. 18.12 % TAR after 92 d
Field studies:
73.1 % max. TAR after 98 d
Surface water:
Max. 9.5 % TAR after 100 d
(at the end of the study)
Risk to soil and aquatic
organisms assessed as low.
BH 518-5
NCl
O OH
OH
C11H8ClNO3
Soil:
Aerobic degradation:
Max. 30.17 % TAR after 120 d
(20 °C and 50 % MWHC)
Max. 34.7 % TAR after 91 d
(10 °C and 60 %FC)
Anaerobic degradation:
Max. 7.78 % TAR after 92 d
(at the end of study)
Field studies:
76.4 % TAR max. after 30 d
EFSA conclusion:
Acute risk to soil organisms
assessed as low
Long-term risk to earthworms
needs to be adressed further .
Risk to aquatic organisms
assessed as low.
1) According to Guidance Document on the assessment of the relevance of metabolites in groundwater of substances
regulated under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)
6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)
Table 6.2-1: Endpoints used for risk assessment for birds
Species Substance Exposure
System
Results Reference Internal
code
Colinus virgianus Quinmerac Acute LD50 > 2000 mg
a.s./kg bw/d
XXX
1987
Project
No.11W0100/8633
28982
Coturnix coturnix
japonica
Quinmerac Long-term NOEL = 173 mg
a.s./kg bw/d
XXX
1999
147-180
49934
Coturnix coturnix
japonica
Quinmerac Long-term LOAEL = 11 mg
a.s./kg bw/d*
(=100 ppm)
XXX
2010
25301
76731
Coturnix coturnix
japonica
Metamitron acute LD50 = 1302 mg/kg
bw/d (female)
XXX
07.02.1992
90 10 42 250
29712
Colinus
virginianus
Metamitron Long-term NOAEL = 81.5
mg/kg bw/day
XXX
28.02.1992
VB-015
38429
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Applicant: ADAMA Evaluator: zRMS DE
Date May 2015
* New study submitted by applicant in core assessment of GOLTIX titan and already evaluated by RMS. Please refer to the
Registration Report for Goltix titan, part B, Section 6 of the core assessment for Central Zone Dec. 2012.
6.2.1 Justification for new endpoints
A new long term study with Coturnix coturnix japonica using Quinmerac (XXX 2010) was submitted by
applicant in core assessment of GOLTIX titan and already evaluated by RMS. Please refer to the
Registration Report for Goltix titan, part B, Section 6 of the core assessment for Central Zone Dec. 2012.
6.2.2 Risk assessment (MIIIA 10.1.1, MIIIA 10.1.2) for spray applications
The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for
Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438).
Exposure to standard generic focal species was estimated according to the Guidance Document on Risk
Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438)
∑
∑
×××=
××××
=
i
i
i
totali
PTARRUDbw
FIR
PTARRUDbw
FIRPDDDD
where:
DDD = Daily dietary dose (mg/kg bw/day)
PDi = composition of diet obtained from treated area
FIRi = Food intake rate of indicator species i (g fresh weight/d)
bw = Body weight (g)
RUD = Residue per unit dose, bases on an application rate of 1 kg a.s./ha and assuming
broadcast seedling
AR = Application rate (kg/ha)
PT = Proportion of diet obtained in the treated area (0…1)
In a first approach, it is assumed that birds do not avoid contaminated food items, that they feed exclusively
in the treated area and on a single food type. Factors PT and PD are therefore equal to 1.
The risk assessment procedure follows a stepwise approach. A first screening step involves standard
scenarios and default values for the exposure estimate, representing a “reasonable worst case”. If a risk is
indicated in the screening step, then one or several refinement steps (Tier 1, Tier2) may follow. According
to the Guidance Document, no further assessment is required if all uses are safe in the screening step.
Mixture toxicity
According to Appendix B to the Guidance Document on the Risk assessment for birds and mammals
(EFSA, 1438/2009), the basic concept of the risk assessment is that animals are exposed to residues of the
active substances in the environment. Thus, the assessment for GOLTIX TITAN does not evaluate the
formulation toxicity as such, but the effects of an exposure to a mixture of active substances in the
environment, resulting from the use of the formulation. Toxicity studies for birds with formulated products
are typically not available. For the assessment of acute effects, a surrogate LD50 is calculated. Sublethal
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Date May 2015
effects and effects on reproduction are assessed on a case-by-case basis. A model often used to estimate the
toxicity of mixtures is the assumption of dose/concentration additivity of toxicity (Finney approach of
concentration additivity of toxicity; Finney 1948 and 1971).
The following formula is used to derive a surrogate LD50 for the mixture of active substances with known
toxicity assuming dose additivity:
( )( )
( )
1
50
50..
..−
= ∑
i i
i
saLC
saXmixLD
where:
X(a.s. i) = fraction of active substance (i) in the mixture expressed as:
X(Metamitron) = 525 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0,93
X(Quinmerac) = 40 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0,07
LD50(a.s. i) = acute toxicity value for active substance (i)
Because of the direct proportionality of the calculated TER to the LD50, it is possible to calculate a
TER(mix) with the following formula:
1
)TER(a.s.
1TER(mix)
−
= ∑
i i
where:
TER(a.s.i)= calculated TER for the active substance i
6.2.2.1 Screening assessment
In the screening step, the risk to indicator bird species from an exposure to GOLTIX TITAN is assessed.
These indicators are considered to have highest exposure in a specific crop at a particular time due to their
size and feeding habits and represent a worst case scenario.
To estimate the daily dietary doses, following equations were used:
Daily dietary dose (DDD):
DDDsingle application = application rate [kg a.s./ha] × shortcut value1
1 see section 4.1 of EFSA/2009/1438
In case of multiple applications, the daily dietary dose for a single application is multiplied with an
appropriate multiple application factor for 90th percentile residue data (MAF90; see Table 7 of
EFSA/2009/1438 ).A specific MAF90 may be calculated according to Appendix H of EFSA/2009/1438 for
non-standard application intervals.
DDDmultiple application = DDDsingle application × MAF901
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Date May 2015
Toxicity exposure ratio (acute):
bw/day) (mg/kg DDD Acute
bw/day) mg/kg(LD=TER 50
A
The results of the acute and reproductive screening risk assessments are summarized in the following tables.
Table 6.1.2.1-1: Acute screening assessment for birds
Intended use Indicator species Endpoint SV MAF90 DDD TER
[g/ha] [mg/kg bw] (GD)
Combined toxicity, TER mix
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha
and 1 x 120 g
Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Bare soil
Small granivorous
bird
17.7
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha
and 1 x 120 g
Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Sugar beet
Small omnivorous
bird
2.7
Metamitron
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Bare soil
Small granivorous
bird
1302 24.7 1.8 70.025 18.6
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Sugar beet
Small omnivorous
bird
1302 158.8 1.8 450.198 2.9
Quinmerac
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Bare soil
Small granivorous
bird
>2000 24.7 1.8 5.335 375
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Sugar beet
Small omnivorous
bird
>2000 158.8 1.8 34.301 58
SV: shortcut value; MAF90: multiple application factor (90th percentile); DDD: daily dietary dose; TER: toxicity to exposure
ratio. TER values shown in bold fall below the relevant trigger.
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Date May 2015
Table 6.2-2: Reproductive screening assessment for birds
Intended use Indicator species Endpoint SV MAFm DDD TER
[g/ha] [mg/kg bw/d]
Combined toxicity, TER mix
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha
and 1 x 120 g
Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Bare soil
Small granivorous
bird
2.5
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha
and 1 x 120 g
Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Sugar beet
Small omnivorous
bird
0.4
Metamitron
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Bare soil
Small granivorous
bird
81.5 11.4 2.2x0.53 20.936 3.9
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Sugar beet
Small omnivorous
bird
81.5 64.8 2.2x0.53 119.0 0.7
Quinmerac
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Bare soil
Small granivorous
bird
11 11.4 2.2x0.53 1.595 6.9
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Sugar beet
Small omnivorous
bird
11 64.8 2.2x0.53 9.067 1.2
SV: shortcut value; MAF90: multiple application factor (90th percentile); DDD: daily dietary dose; TER: toxicity to exposure
ratio. TER values shown in bold fall below the relevant trigger.
According to EFSA/2009/1438, the calculation of a combined toxicity is not applicable to the risk
assessment of reproductive effects. Due to differences in evaluated endpoints and the dependency of the
derived NOEL of the test design, any calculated TERmix value can only be used for illustrating purposes.
Hence, in the case of an unacceptable TERmix, it has to be discussed if the results of the toxicity studies
present any evidence for a possible concentration additivity of the effects and risks.
6.2.2.2 Tier 1 risk assessment
In the Tier 1 risk assessment step, the defined daily dietary doses and TER values were calculated for so-
called generic focal species (see EFSA 1438/2009, Annex I). As for the indicator species, the generic focal
Part B – Section 6
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Date May 2015
species are considered to be representative for all species potentially at risk. In the Tier 1 assessment, a
mixed diet approach is followed when appropriate and interception of the spray by the crop is taken into
account for the calculation of residue levels for different food types.
If more than one generic focal species is relevant for the crop, the one that is relevant in terms of time of
application or growth stage should be selected. If more than one generic focal species is relevant in terms
of application time and growth stage, then the risk should be assessed for all relevant generic focal species.
If the same generic focal species is relevant for several application times according to the BBCH growth
stages, the risk assessment for this generic focal species is conducted once using the highest mean short-
cut value, since this mirrors a realistic worst case scenario.
For Metamitron, the TERA was below the trigger of 10 in the screening step for the intended uses in sugar
beets. Therefore, a Tier 1 risk assessment step will be performed for these uses.
The results of the acute and reproductive Tier 1 risk assessments are summarized in the following tables.
For acute risk assessment in “bare soil” screening step was sufficient for assessement. Higher tier
assessment is needed for “sugar beet” growth stage.
Table 6.2-3: Acute tier 1 risk assessment for birds for the GOLTIX TITAN/Combined risk, Metamitron and Quinmerac
Intended use Generic focal
species
Generic diet
composition
Endpoint SV MAF90 DDDA TER
[mg/kg bw/d] [mg/kg bw/d]
Intended use 2 Combined toxicity (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitro./ha and 1 x 120 g
Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet
Early spring
BBCH 10 - 19
Small
omnivorous
bird “lark”
18.2
BBCH 10 - 19 Small
omnivorous
bird “wagtail”
40.1
Intended use 2 (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitron/ha), sugar beet
Early spring
BBCH 10 - 19
Small
omnivorous
bird “lark”
1302 10.9 1.8 68.040 19.1
BBCH 10 - 19 Small
omnivorous
bird “wagtail”
1302 5.9 1.8 30.902 42.1
Intended use 2 (1 x 120 g Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet
Early spring
BBCH 10 - 19
Small
omnivorous
bird “lark”
2000 24 1.8 5.184 385.8
BBCH 10 - 19 Small
omnivorous
bird “wagtail”
2000 10.9 1.8 2.354 849.5
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Date May 2015
SV: shortcut value; MAF90: multiple application factor (90th percentile); DDD: daily dietary dose; TER: toxicity to exposure
ratio. TER values shown in bold fall below the relevant trigger.
For reproductive risk assessment refinement is needed for “bare soil” and “sugar beet” stage.
Table 6.2-4: Reproductive Tier-1 risk assessment for birds for Metamitron
Intended use Generic focal
species
Generic diet
composition
Endpoint SV MAFx
twa
DDDA TER
[mg/kg bw/d] [mg/kg bw/d]
Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha), bare soil and sugar beet
Bare soil
BBCH <10
Sugar beet
BBCH 10 19
Small
granivorous
bird “lark”
81.5 Worst
case
10.9
2.2x0.53 20.017 4.1
Bare soil
BBCH 10- 19
Sugar beet
BBCH 10- 19
Small
insectivorous
bird “wagtail”
81.5 5.9
5.9
2.2x0.53 10.835 7.5
Bare soil
BBCH <10
Small
granivorous
bird “finch”
81.5 11.4 Worst
case
2.2x0.53
21.007 3.9
SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
shown in bold fall below the relevant trigger.
Refinement needed for Metamirton for small granivorous bird “lark”on bare soil and in sugar beet and for
small granivorous bird “finch” in bare soil.
Table 6.2-5: Reproductive Tier-1 risk assessment for birds for Quinmerac
Intended use Generic focal
species
Generic diet
composition
Endpoint SV MAFx
twa
DDDA TER
[mg/kg bw/d] [mg/kg bw/d]
Intended use 2 (1 x 120 g Quinmerac/ha + 3 x 40 g Quinmerac/ha), bare soil and sugar beet)
Bare soil
BBCH <10
Sugar beet
BBCH 10 19
Small
granivorous
bird “lark”
11.0 Worst
case
10.9
2.2x0.53 1.530 7.2
Bare soil
BBCH 10- 19
Sugar beet
BBCH 10- 19
Small
insectivorous
bird “wagtail”
11.0 5.9
5.9
2.2x0.53 0.828 13.3
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Bare soil
BBCH <10
Small
granivorous
bird “finch”
81.5 11.4 Worst
case
2.2x0.53
0.725 15.2
SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
shown in bold fall below the relevant trigger.
6.2.2.3 Higher tier risk assessment for Metamitron in agriculture
Table 6.2-6: Refinement of reproductive risk assessment for lark exposed to Metamitron according to EFSA Journal (2009) in intended use 2. For details see text
Intended use Generic focal species
Generic diet composition
Endpoint SV MAFx twa
DDDA TER
[mg/kg bw/d] [mg/kg bw/d]
Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha), bare soil and sugar beet
Bare soil
BBCH <10
Sugar beet
BBCH 10 19
Small
granivorous
bird “lark”
81.5 Worst
case
10.9
2.2x0.53 20.017 4.1
Refinement: more realistic application scenario: lark is focal species for bare soil stages BBCH <10 and
for sugar beet scenarios BBCH 10- 19 1x 1575 g Metamitron./ha in bare soil BBCH <10, SV “lark”= 8.2,
and 3x 525 g Metamitron/ha on sugar beet BBCH 10-19, SV “lark” = 10.9.
For each application date a DDD will be calculated without residue dynamic. Residue dynamic is
considered in twa calculation DT50 (default)= 10d, twa-intervall: 21 d
Bare soil
BBCH <10
Sugar beet
BBCH 10 19
Small
granivorous
bird “lark”
81.5 8.2
10.9
Overall DDD
12.915
6.33
Table 6.2-7: Refinement of reproductive risk assessment for finch exposed to Metamitron
according to EFSA Journal (2009) in intended use 2. For details see text
Intended use Generic focal
species
Generic diet
composition
Endpoint SV MAFx
twa
DDDA TER
[mg/kg bw/d] [mg/kg bw/d]
Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha), bare soil and sugar beet
Part B – Section 6
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Date May 2015
Bare soil
BBCH <10
Small
granivorous
bird “finch”
81.5 11.4 Worst
case
applica-
tion
2.2x0.53
21.007 3.9
Refinement: finch is focal species for bare soil stages BBCH < 10 but not for sugar beet scenarios BBCH 10- 19,
no MAF will be used for application design, more realistic application rate: 1x 1575 g Metamitron/ha
Bare soil
BBCH <10
Small
granivorous
bird “finch”
81.5 11.4 1x0.53 9.516 8.6
6.2.2.4 Drinking water exposure
Due to the characteristics of the exposure scenario in connection with the standard assumptions for water
uptake by animals (see below), no specific calculations of exposure and TER are necessary when the ratio
of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case
of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500
L/kg). The puddle scenario has been taken into account to calculate the exposure concentration of GOLTIX
TITAN (AG-QMM1-565 SC) formed on a field after rainfall. The ratios do not exceed the value of 50 for
Metamitron (Koc = 122.3 L/kg) and Quinmerac (Koc = 35.1 L/kg), thus it is not necessary to conduct a
drinking water risk assessment for birds.
A comparison of the relevant endpoints with the effective application rates for Metamitron and Quinmerac
is presented below.
Table 6.2-8: Application rate to endpoint ratios for birds exposed to Metamitron and Quinmerac
Intended
use
Exposure
Scenario
Effective
application rate*
Koc LD50/NOEL Ratio
Application Rate :
endpoint
[g a.s./ha]* [L/kg] [mg a.s./kg bw]
Metamitron
Intended
use 2
Acute Total:
3150
122.3 1302 <50
Long-term 81.5 <50
Quinmerac
Intended
use 2
Acute Total:
240
35.1 >2000 <50
Long-term 11 <50
* effective application rate = application rate multiplied by mean MAF
6.2.2.5 Effects of secondary poisoning (MIIIA 10.1.9)
The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a
log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6
Part B – Section 6
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"Bioaccumulation and food chain behaviour"). ). Since the log Kow values of Quinmerac. and Metamitron
are 1.41 (pH=7) and 0.85 respectively, these active substances are deemed to have a negligible potential to
bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required.
6.2.3 Biomagnification in terrestrial food chains
Not relevant.
6.2.4 Risk assessment (MIIIA 10.1.3, MIIIA 10.1.4, MIIIA 10.1.5) for baits, pellets,
granules, prills or treated seed
Not relevant.
6.2.5 Overall conclusions
Dietary risk assessment
Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from
an exposure of birds to Metamitron and Quinmerac (oral exposure and exposure via drinking water and
secondary poisoning) according to the GAP of the formulation GOLTIX TITAN achieve the acceptability
criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No 546/2011,
Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. The results of the assessment indicate
an acceptable acute and long-term risk for birds due to the intended use of GOLTIX TITAN in agriculture
according to the label.
Risk assessment for exposure via drinking water
Based on the calculation of the risk arising from the uptake of Metamitron and Quinmerac via drinking
water , the calculated TER values for birds exposed to the active substances Metamitron and Quinmerac
according to the GAP of the formulation GOLTIX TITAN achieve the acceptability criteria TER ≥ 5,
according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific
principles, point 2.5.2. for long-term effects.
Risk assessment for exposure via secondary poisoning
Since the log Kow values of Quinmerac. and Metamitron are 1.41 (pH=7) and 0.85 respectively, these active
substances are deemed to have a negligible potential to bioaccumulate in animal tissues. No formal risk
assessment from secondary poisoning is therefore required.
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6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1,
KPC 10.1.2)
Table 6.3-1: EU agreed endpoints and new endpoints
Species Substance Exposure
System
Results Reference Internal
code
Rat Quinmerac Acute oral
toxicity
LD50 >5000 mg
a.i./kg bw/d
XXX
1987
1987/040
76812
Mouse Metamitron Acute oral
toxicity
LD50 = 644 mg
a.i./kg bw/d
XXX
30.10.1996
25596 /T
8060723
77874
Rabbit Quinmerac Long-term
toxicity and
reproduction
NOAEL = 30
mg/kg a.s./kg bw /d
LOAEL = 100
mg/kg a.s./kg bw/d
XXX
1987
BASF RegDoc
1988/0506
76867
Rat Metamitron Long-term
toxicity and
reproduction
NOAEL = 36.4 mg
a.s/kg bw/d (male)
NOAEL = 53.8 mg
a.s/kg bw/d (female)
XXX
08.11.1993
TOXI.ES-991-
RP-G2
76422
Rat GOLTIX TITAN
(AG-QMM1-565)
Acute oral
toxicity
LD50 > 2000 mg
prod./ kg bw/day
XXX
02.07.2010
25392
77820
6.3.1 Justification for new endpoints
Not necessary.
6.3.2 Risk assessment (MIIIA 10.3.1) for spray applications
The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for
Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438). Please see 6.2.2 for detailed
information on the estimation of daily intake rates and the assessment of mixture toxicity.
6.3.2.1 Screening assessment
For the estimation of Daily dietary doses (DDD) and the calculation of TER values, please see 6.2.2.1.
The results of the acute and reproductive screening risk assessments are summarized in the following tables.
Table 6.3-2: Acute screening assessment for mammals
Intended use Indicator species Endpoint SV MAF90 DDD TER
[mg/kg bw/d] [mg/kg bw/d]
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Combined toxicity, TER mix
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha
and 1 x 120 g
Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Bare soil
Small granivorous
mammal
15.64
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha
and 1 x 120 g
Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Sugar beet
Small herbivorous
mammal
1.89
Metamitron
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Bare soil
Small granivorous
mammal
644 14.4 1.8 18.711 15.8
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Sugar beet
Small herbivorous
mammal
644 118.4 1.8 335.664 1.9
Quinmerac
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Bare soil
Small granivorous
mammal
>5000 14.4 1.8 3.110 1607
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Sugar beet
Small herbivorous
mammal
>5000 118.4 1.8 25.574 965.5
SV: shortcut value; MAF90: multiple application factor (90th percentile); DDD: daily dietary dose; TER: toxicity to exposure
ratio. TER values shown in bold fall below the relevant trigger.
Table 6.3-3: Reproductive screening assessment for mammals
Intended use Indicator species Endpoint SV MAFm DDD TER
[g/ha] [mg/kg bw/d] [mg/kg
bw/d]
Combined toxicity, TER mix
Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha and
1 x 120 g Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Bare soil
Small granivorous
mammal
2.92
Part B – Section 6
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Intended use 2 (1 x 1575 g
Metamitron./ha +
3 x 525 g Metamitro./ha and
1 x 120 g Quinmerac/ha +
3 x 40 g Quinmerac/ha)
Sugar beet
Small herbivorous
mammal
0.39
Metamitron
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Bare soil
Small granivorous
mammal
36.4 6.6 2.2x0.53 12.121 3.0
Intended use 2 (1 x 1575 g
a.s./ha +
3 x 525 g a.s./ha)
Sugar beet
Small herbivorous
mammal
36.4 48.3 2.2x0.53 88.701 0.4
Quinmerac
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Bare soil
Small granivorous
mammal
100 6.6 2.2x0.53 0.923 108.3
Intended use 2 (1 x 120 g
a.s./ha +
3 x 40 g a.s./ha)
Sugar beet
Small herbivorous
mammal
100 48.3 2.2x0.53 6.758 14.8
SV: shortcut value; MAFm: multiple application factor (mean); DDD: daily dietary dose; TER: toxicity to exposure ratio. TER
values shown in bold fall below the relevant trigger.
According to EFSA/2009/1438, the calculation of a combined toxicity is not applicable to the risk
assessment for reproductive effect. Due to differences in evaluated endpoints and the dependency of the
derived NOEL of the test design, any calculated TERmix value can only be used for illustrating purposes.
Hence, in the case of an unacceptable TERmix, it has to be discussed if the results of the toxicity studies
present any evidence for a possible concentration additivity of the effects and risks.
6.3.2.2 Tier-1 risk assessment
For the estimation of Daily dietary doses (DDD) and the calculation of TER values, please see 6.2.2.2.
The results of the acute and reproductive Tier 1 risk assessments are summarized in the following tables.
Table 6.3-4: Acute tier 1 risk assessment for birds for the GOLTIX TITAN/Combined risk,
Metamitron and Quinmerac
Intended use Generic focal
species
Generic diet
composition
Endpoint SV MAF90 DDDA TER
[mg/kg
bw/d]
[mg/kg
bw/d]
Intended use 2 Combined toxicity (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitro./ha and 1 x 120 g
Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet
BBCH 10 - 19 Small
insectivorous
mammal “shrew”
29.61
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BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
6.43
BBCH 10- 39 Small omnivorous
mammal “mouse”
13.07
Intended use 2 (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitron/ha), sugar beet
BBCH 10 - 19 Small
insectivorous
mammal “shrew”
644 7.6 1.8 21.546 29.9
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
644 35.1 1.8 99.509 6.5
BBCH 10- 39 Small omnivorous
mammal “mouse”
644 17.2 1.8 48.762 13.2
Intended use 2 (1 x 120 g Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet
BBCH 10 - 19 Small
insectivorous
mammal “shrew”
>5000 7.6 1.8 1.642 3045.
8
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
>5000 35.1 1.8 7.582 659.5
BBCH 10- 39 Small omnivorous
mammal “mouse”
>5000 17.2 1.8 3.715 1345.
8
SV: shortcut value; MAF90: multiple application factor (90th percentile); DDD: daily dietary dose; TER: toxicity to exposure
ratio. TER values shown in bold fall below the relevant trigger.
Further refinement for acute risk assessment for product GOLTIX TITAN and active substance Metamitron
for large herbivorous mammal “lagomorphs” is needed.
Table 6.3-5: Reproductive Tier-1 risk assessment for terrestrial vertebrates other than birds for Metamitron
Intended use Generic focal
species
Generic diet
composition
Endpoint SV MAF DDDLT TER
[g/ha] [mg/kg
bw/d]
Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha), bare soil and sugar beet
Bare Soil
BBCH 10 - 19 Small
omnivorous
mammal
“mouse”
Small omnivorous
mammal “mouse”
36.4 5.7 2.2x0.5
3
10.504 3.5
Sugar beet
BBCH 10 – 39
Small
insectivorous
mammal “shrew”
36.4 4.2 2.2x0.
53
7.740 4.7
BBCH 10- 39 Large
herbivorous
36.4 14.3 2.2x0.
53
26.351 1.4
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mammal
“lagomorph”
BBCH 10- 39 Small
omnivorous
mammal
“mouse”
36.4 7.8 2.2x0.
53
14.373 2.5
SV: shortcut value; MAF: multiple application factor. DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
shown in bold fall below the relevant trigger.
Further refinement for reproductive risk assessment for active substance Metamitron for small omnivorous
mammal “mouse” in bare soil is needed and for small insectivorous mammal “shrew”, large herbivorous
mammal “lagomorphs” and small omnivorous mammal “mouse” in sugar beet.
6.3.2.3 Higher tier risk assessment for GOLTIX TITAN/ combined risk and for
Metamitron in sugar beets (KPC 10.1.2.2)
Table 6.3-6: Refinement of acute risk assessment for large herbivorous mammals “lagomorphs” exposed to Metamitron according to EFSA Journal (2009) in sugar beets. For details see text
Intended use Generic focal species
Generic diet composition
Endpoint SV MAF90 DDDA TER
[mg/kg
bw/d]
[mg/kg
bw/d]
Intended use 2 Combined toxicity (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitro./ha and 1 x 120 g
Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
6.43
Using refined values for Metamitron for focal species “Lagomorph”( Refinement: lagomorph is focal species for
sugar beet stages BBCH 10-39 but not for bare soil scenarios BBCH <10, MAF for 3x application = 1.6,
application rate: 3x 525 g Metamitron/ha)
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
Metamitron:
644
Quinmerac:
>5000
35.1
35.1
1.6
1.8
29.484
7.582
21.8
659.5
Combi
ned
Tox.
Result
=
21.1
Intended use 2 (1 x 1575 g Metamitron./ha + 3 x 525 g Metamitron/ha), sugar beet
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
644 35.1 1.8 99.509 6.5
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Refinement: lagomorph is focal species for sugar beet stages BBCH 10-39 but not for bare soil scenarios BBCH
<10, MAF for 3x application = 1.6, application rate: 3x 525 g Metamitron/ha
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
644 35.1 1.6 29.484 21.8
Intended use 2 (1 x 120 g Quinmerac/ha + 3 x 40 g Quinmerac/ha), sugar beet
BBCH 10 – 39 Large herbivorous
mammal
“lagomorph””
>5000 35.1 1.8 7.582 659.5
No further refinement for acute risk assessment for product GOLTIX TITAN and active substances
Metamitron ans Quinmerac for mammals is needed.
Further refinement for reproductive risk assessment for active substance Metamitron for small
omnivorous mammal “mouse” in bare soil is needed and for small insectivorous mammal “shrew, large
herbivorous mammal “lagomorphs” and small omnivorous mammal in sugar beet.
Table 6.3-7: Refinement of reproductive risk assessment for small omnivorous mammals “mouse”, small insectivorous mammal “shrew” and large herbivorous mammals
“lagomorphs” exposed to Metamitron according to EFSA Journal (2009) in sugar beets. For details see text
Intended use
Species/BBCH stage
Diet composition
MAFx twa
FIR/ bw
PD RUD PT DDD Endpoint TER
[mg/kg
bw/d]
[mg/kg
bw/d]
Wood mouse, Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha),
02 Sugar beet
BBCH 10-
39
Apodemus
sylvaticus
25% non-
grass herbs
2.2x0.
53
0.07 1 28.7 1 3.518 36.4
2.6
25% ground
arthropods
(with
interception)
2.2x0.
53
0.07 1 3.5 1 0.429
50%weed
seeds 2.2x0.
53
0.13 1 40.2 1 9.854
Wood mouse
Early stages of beet fields do not provide sufficient plant cover for small mammals. Studies estimating the reaction
of wood mice to fields with sparse vegetation will help to estimate the exposure more realistically.
In the study conducted by Todd et al. (2000)1 23 wood mice were radio tracked in winter and spring (November –
March) and 56 in summer (June – August) in arable habitat. The preferred macrohabitat of the wood mouse in arable
land were hedgerows. In the study conducted by Tew et al. (2000)2 48 wood mice were radio tracked and
1 Todd I.A., Tew T.E. and Macdonald D.W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 1.
MacrohabitatJ.Zoo., Lond. 250, 299-303 2 Tew, T. E., Todd, I. A. & Macdonald, D. W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 2. Microhabitat.
Journal of Zoology (London), 250, 305-311.
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microhabitats were recorded. In their study they found that wood mice avoided foraging in areas with a high
abundance of bare earth. On such fields, predatory risk to feeding mice is high. This finding is also confirmed by
Green (1979)3, who showed that fields with bare soil surface are not attractive feeding areas for mammals.
The predominant feeding habitats of a wood mouse are thick grass, woodland, arable land, heather and sand dunes
(Mammals Bible4). They need cover protection for themselves and their offspring such as stone walls, hedgerows,
gardens and even buildings if unoccupied. Beet fields at early BBCH stages do not provide such cover. Due to the
absence of cover protections, it is unlikely that wood mouse will exclusively forage in beet fields in early BBCH
stages. Thus a reduced PT value of 0.8 is much more realistic and will be considered in a refined risk assessment.
02
Sugar beet
BBCH 10-
39
Apodemus
sylvaticus
25% non-
grass herbs
2.2x0.
13*
(refer
to
refine
ment
of
rabbit)
0.07 1 28.7 0.8 0.690 4.1
25% ground
arthropods
(with
interception)
2.2x0.
53
0.07 1 3.5 0.8 0.343
50%weed
seeds 2.2x0.
53
0.13 1 40.2 0.8 7.883
Rabbit
02
Sugar beet
BBCH 10-
39
Rabbit
Oryctolagus
cuniculus
100% non-
grass herbs
2.2x0.
53
0.50 1 28.7 1 26.327 36.4 1.4
3 Green, R. 1979. The ecology of Wood mice (Apodemus sylvaticus) on arable farmland. Journal of Zoology, 188: 357–377. 4 Gurney, J. E., Perett, J., Crocker, D. R. & Pascual, J. A. (1998): Mammal bible. Mammals and farming: information for risk
assessment. Contract PN0910/PN0919. pp. 2-223. York: Central Science Laboratory; Project No. M37
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Refinement for rabbit:
Refinement of ftwa: The use of the same time window (21 days), and a DT50 value from the residue studies (please
refer to EFSA Report (2008)) resulted in a refined ftwa for Metamitron. For a refined exposure assessment, initial
residue levels on beets and their time-dependent decrease were calculated by use of measured residue levels
determined in residue studies with Metamitron. A twa-value of 0.13 was considered in the following risk
assessment which was calculated using a DT50 value of 1.9 days (based on residue decline studies; please refer to
EFSA Report (2008) List of Endpoints) for foliar residues. According to EFSA Report (2008) of Metamitron the
apparent short foliar half-life of Metamitron is also supported by the results of four German residue field studies in
which, following spray applications of formulated Metamitron, the high initial measured residues of Metamitron
were found to be reduced to non-significant level. The evidence is considered sufficient to support use of a DT50 of
1.9 days for foliar residues in the refined risk assessment.
02
Sugar beet
BBCH 10-
39
Rabbit
Oryctolagus
cuniculus
100% non-
grass herbs
2.2x0.
13
0.50 1 28.7 1 6.457 36.4 5.6
Shrew: no further refinement was provided by applicant. There is still a light undercut of acceptability criteria
TER >5 for focal species “common shrew”. No refined assessment was done until that point. A light
refinement of PD (composition of diet obtained from treated area) or PT (proportion of an animal´s diet
obtained in habitat treated with pesticide) would reach TER >5. As presented in CRD Mammals Bible
(2007) feeding habitat for Sorex araneus is wher low vegetation provides cover, particularly in thick
grass and scrub, hedgerows and deciduous woodland. Thus the shrew will not stay total searching for
food on treated area. Also as presented in Mammal bible food of Sorex araneus do not consist of 100%
ground arthropods, but particulary also on earthworms and snails. In total the risk for common shrew
should be acceptable, also with a light undercut of acceptability criteria.
02
Sugar beet
BBCH 10-
19
Common
shrew
Sorex
araneus
100%
ground
arthropods
without
interception
2.2x0.
53
0.55 1 7.5 1 7.623 36.4 4.8
SV: shortcut value; MAF: multiple application factor. DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
shown in bold fall below the relevant trigger.
There is still a very light undercut of acceptability criteria TER >5 for focal species common shrew caused
by active substance Metamitron. As shown in refinement there are different possibilities in further
refinement options (for instance according to information in frequency of feeding habitat use and food
consumption).
There is still a light undercut of acceptability criteria TER >5 for focal species woodmouse Apodemus
sylvaticus caused by active substance Metiram. On the ZONAL HARMONISATION WORKSHOP
HIGHER TIER BIRDS AND MAMMALS in Wageningen, June 2014 there were a discussion about
changing trigger values for vole and mouse, but majority of MS were not willing to change trigger values
of vole and mouse.
In higher tier assessment approaches, member states might check refinement options considering their
national environmental conditions and agricultural sceneries to reach a save use for wood mouse too.
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6.3.2.4 Drinking water exposure
Due to the characteristics of the exposure scenario in connection with the standard assumptions for water
uptake by animals (see below), no specific calculations of exposure and TER are necessary when the ratio
of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case
of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500
L/kg). The puddle scenario has been taken into account to calculate the exposure concentration of GOLTIX
TITAN (AG-QMM1-565 SC) formed on a field after rainfall. The ratios do not exceed the value of 50 for
Metamitron (Koc = 122.3 L/kg) and Quinmerac (Koc = 35.1 L/kg), thus it is not necessary to conduct a
drinking water risk assessment for birds.
A comparison of the relevant endpoints with the effective application rates for Metamitron and Quinmerac
is presented below.
Table 6.3-8: Application rate to endpoint ratios for mammals exposed to Metamitron and Quinmerac
Intended
use
Exposure
Scenario
Effective
application rate*
Koc LD50/NOEL Ratio
Application Rate :
endpoint
[g a.s./ha]* [L/kg] [mg a.s./kg bw]
Metamitron
Intended
use 2
Acute Total:
3150
122.3 644 <50
Long-term 36.4 >50 refinement needed
(puddle scenario)
Quinmerac
Intended
use 2
Acute Total:
240
35.1 >5000 <50
Long-term 100 <50
* effective application rate = application rate multiplied by mean MAF
Puddle scenario
Table 6.3-9: Exposure of mammals to the active substance Metamitron via contaminated drinking water in puddles and calculated toxicity exposure ratio
Substance Crop Time
scale
Indicator
species
Endpoint
Concentration
in runoff/
puddles
KFOC
PEC
puddle
TER
[mg a.s./kg bw/d]
[mg/L] [ml/g] [mg/L]
Metamitron
acute Apodemus
sylvaticus
644
787.5 122.3 0.77
3466.2
long-
term 36.4 195.9
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6.3.2.5 Effects of secondary poisoning (MIIIA 10.3.2.3)
The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a
log Kow ≥ 3 is used to indicate that there might be a potential for bioaccumulation (see chapter 5.6
"Bioaccumulation and food chain behaviour"). ). Since the log Kow values of Quinmerac. and Metamitron
are 1.41 (pH=7) and 0.85 respectively, these active substances are deemed to have a negligible potential to
bioaccumulate in animal tissues. No formal risk assessment from secondary poisoning is therefore required.
6.3.3 Biomagnification in terrestrial food chains
Not relevant.
6.3.4 Risk assessment (MIIIA 10.3.1) for baits, pellets, granules, prills or treated seed
Not relevant.
6.3.5 Overall conclusions
Dietary risk assessment
Based on higher tier assessment step, the calculated TER values for the acute and long-term risk resulting
from an exposure of mammals to Quinmerac and Metamitron (oral exposure and exposure via drinking
water and secondary poisoning) according to the GAP of the formulation GOLTIX TITAN achieve the
acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No
546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. The results of the assessment
indicate an acceptable acute and long-term risk for mammals due to the intended use of GOLTIX TITAN
in beets according to the label. Further refinement for long-term risk for woodmouse Apodemus sylvaticus
may be needed on national level.
Risk assessment for exposure via drinking water
Based on the calculation of the risk arising from the uptake of Quinmerac and Metamitron via drinking
water , the calculated TER values for mammals exposed to the active substances Quinmerac and
Metamitron according to the GAP of the formulation GOLTIX TITAN achieve the acceptability criteria
TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific
principles, point 2.5.2. for long-term effects.
6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC
10.1.3)
Not yet considered.
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6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)
Table 6.5-1: Endpoints used for risk assessment for aquatic organisms for Quinmerac and its relevant metabolites
Species Substance Exposure
System
Results Reference Internal
code
[mg a.s./L]
Oncorhynchus
mykiss
Quinmerac 96 h LC50 = 86.8 mg
a.s./L
XXX
1987
Report No.12F100/86
28978
Oncorhynchus
mykiss
Quinmerac 28 d NOEC = 3.16 mg
a.s./L
XXX
1990
Project
No.42F0100/865133
28979
Daphnia magna Quinmerac 48 h EC50 > 100 mg
a.s./L
Jatzek, H.-J.
2000
99/0703/50/1
49764
Daphnia magna Quinmerac 48 h EC50 > 100 mg
a.s./L
Kuhl, R., Deierling, T.
2009
49684220
76753
Daphnia magna Quinmerac 21 d NOEC ≥ 100 mg
a.s./L
Jatzek H.-J.
2003
02/0103/51/1
49770
Daphnia magna Quinmerac 21 d NOEC = 10 mg
a.s./L
Kuhl, R., Wydra, V.
2010
49686221
76763
Anabaena flos-
aquae
Quinmerac 72 h EbC50 > 100 mg
a.s./L
ErC50 > 100 mg
a.s./L
Kubitza, J.
2000
58020
49765
Anabaena flos-
aquae
Quinmerac 72 h EbC50 > 100 mg
a.s./L
ErC50 > 100 mg
a.s./L
Kuhl, R., Deierling, T.
2010
49682210
76765
Lemna gibba Quinmerac 7 d EbC50 = 96 mg
a.s./L
ErC50 > 100 mg
a.s./L
Dohmen, G.P.
1996
36449
49769
Lemna gibba Quinmerac 7 d EbC50 = 16 mg
a.s./L
ErC50 > 32 mg
a.s./L
Kuhl, R. Deierling, T.
2009
49685240
76772
Metabolites of Quinmerac
Oncorhynchus
mykiss
BH 518-2 96 d LC50 (96h) >
100 mg/L
XXX
1992
Report
No.12F0516/915092
28990
Oncorhynchus
mykiss
BH 518-5 96 h LC50 (96h) >
100 mg/L
XXX
2000
49781
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12F0305/995040
Oncorhynchus
mykiss
BH 518-5 96 d LC50 (96h) > 100
mg/L
XXX
2010
49704230
76752
Oncorhynchus
mykiss
BH 518-2 28 d NOEC = 0.32
mg/L (no study,
assumption: 10
times higher
toxicity of parent)
- -
Oncorhynchus
mykiss
BH 518-5 28 d NOEC (28d) = 5
mg/L
XXX
1993
42F0514/915142//93/1
0798
28997
Daphnia magna BH 518-2 48 h EC50 > 100 mg/L Dohmen, G.P.
1992
P92-E015 3425
28987
Daphnia magna BH 518-5 48 h EC50 > 100 mg/L Dohmen, G.P.
1992
P92-E016 3427
64695
Daphnia
magna
BH 518-2 21 d NOEC = 25
mg/L
Jatzek, H.-J.
1993
93/1051/51/1
28989
Daphnia
magna
BH 518-5 21 d NOEC = 25
mg/L
Jatzek, H.-J.
1993
93/1052/51/1
28995
P. subcapitata BH 518-2 72 h EbC50 = 700
mg/L
Dohmen, G.P.
1992
P92-E018, 3431
28986
P. subcapitata BH 518-5 72 h EbC50 = 160
mg/L
Dohmen, G.P.
1992
P92-E017, 3432
28993
Lemna gibba BH 518-2 7 d EbC50 > 100
mg/L
ErC50 > 100
mg/L
Dohmen, G.P.
1996
36452
49773
Lemna gibba BH 518-2 7 d EbC50 > 100
mg/L
ErC50 > 100
mg/L
Kuhl, R. Deierling, T.
2010
49691240
76771
Lemna gibba BH 518-5 7 d EbC50 > 100
mg/L
ErC50 > 100
mg/L
Dohmen, G.P.
1996
36453
49782
Lemna gibba BH 518-5 7 d EbC50 > 100
mg/L
ErC50 > 100
mg/L
Kuhl, R. Deierling, T.
2010
49702240
76770
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Table 6.5-2: Endpoints used for risk assessment for aquatic organisms for Metamitron and its
relevant metabolites
Species Substance Exposure
System
Results Reference Internal
code
[mg a.s./L]
Oncorhynchus
mykiss
Metamitron 96 h, static EC50 > 190 mg
a.s./L
XXX
1991
80-91-0131-03-91
27758
Oncorhynchus
mykiss
Metamitron 21 d semi-static NOEC (growth) =
7.0 mg a.s./L
XXX
1991
80-91-0131-04-91
27759
Daphnia magna Metamitron 48 h static EC50
(immobility) =
5.7 mg/L
Bell, G.
1995
AGM 13(b)/941205
68002
Daphnia magna Metamitron 21 d semi-static NOEC
(reproduction) =
10 mg a.s./L
Peither, A.
1999
732688
68005
Pseudo-
kirchneriella
subcapitata
Metamitron 72 h static
EbC50 = 0.4 mg
a.s./L
ErC50 = 1.8 mg
a.s./L
Anderson, J.P.E.
1993
AJO/110193
38233
Lemna gibba Metamitron 7 d semi-static
EbC50 = 0.4 mg
a.s./L
ErC50 = 0.8 mg
a.s./L
Dengler, G.
1998
98063/01-AALg
38534
Lemna gibba Metamitron 14 d semi-static
EbC50 = 0.38 mg
a.s./L
EC50 = 0.45 mg
a.s./L
Scheerbaum, D.
1998
980219FC
39029
Metabolites of Metamitron
Oncorhynchus
mykiss Desamino-
Metamitron
96 h, static EC50 > 1000 mg
a.s./L
XXX
1994
FAR42441
31364
Daphnia magna Desamino-
Metamitron
48 h static EC50 (mortality)
= 745 mg a.s./L
Noack, M.
1994
DAI42441
31363
Chironomus
riparius
Desamino-
Metamitron
28 d static NOEC > 100 mg
a.s./L
Heimbach, F.
1999
E 416 1705-4
68010
Pseudo-
kirchneriella
subcapitata
Desamino-
Metamitron
72 h static
EbC50 = 25.1 mg
a.s./L
ErC50 = 73.5 mg
a.s./L
Dorgerloh, M.
1999
DOM 99085
43659
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Table 6.5-3: Endpoints used for risk assessment for aquatic organismsfor GOLTIX TITAN
Species Substance Exposure
System
Results Reference Internal
code
[mg a.s./L]
Oncorhynchus
mykiss
GOLTIX TITAN
(AG-QMM1-565
SC)
96 h, static EC50 > 100 mg/L XXX
2010
S10-00592
77803
Daphnia magna GOLTIX TITAN
(AG-QMM1-565
SC)
48 h static EC50 (mortality)
> 100 mg/L
Borrmann, K.
2010
S10-00593
77801
Pseudokirchneri
ella subcapitata GOLTIX TITAN
(AG- QMM1-565
SC)
72 h, static EbC50 = 2,09
mg/L
EyC50 = 1,99
mg/L
ErC50 = 3,77
mg/L
von Seydlitz-
Kurzbach, J.
2010
S10-00594
77794
Lemna gibba GOLTIX TITAN
(AG- QMM1-565
SC)
7 d semi-static
EbC50 = 0.86
mg/L (frond area)
EyC50 = 1.50
mg/L (frond
yield)
EbC50 = 1.55
mg/L (frond No.)
ErC50 = 3.66
mg/L (growth
rate)
Borrmann, K.
2010
S10-00593
77795
Higher tier tests
Goltix SC 700 Phyto-plankton,
Zooplank-ton and
macrophyte
communi-ties
NOEAEC = 1.12
mg a.s./L
(Assessment
factor: 3)
Heimbach, F. et
al.
1999
HBF/Mt 07
43664 Goltix
SC 700
6.5.1 Justification for new endpoints
EU Peer review on mesocosms data:
After a single application of ‘Goltix SC 700’ (containing 700 g/L Metamitron) to outdoor mesocosm
enclosures containing phytoplankton, zooplankton and macrophyte communities, significant treatment
related effects were observed at the 2 highest test concentrations (i.e. 1120 and 4480 µg a.s./L), but only
for physical-chemical endpoints related to the community metabolism (pH and dissolved oxygen
concentration), with these effects at 1120 µg a.s./L being slight and transient (day 2 reductions of 0.5 in pH
& of 30% in oxygen levels, with no effects when next assessed on day 5). No consistent treatment related
effects on structural endpoints of phytoplankton (species composition, densities, chlorophyll-a level),
periphyton (chlorophyll-a level) and macrophytes (% cover, final biomass, growth of Myriophyllum
spicatum in in situ bioassays) were obtained at up to the highest test concentration. In addition, densities of
the major zooplankton groups appeared to be unaffected.
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Only the more pronounced effects on oxygen and pH levels at 4480 µg a.s./L (i.e. reductions on day 2
compared with day 0 in oxygen levels by 80% and a pH drop from 9.2. to 7.5, with recovery by day 15) are
considered to be ecologically relevant, and on this basis the study NOAEC is 1120 µg a.s./L or 1.12 mg
a.s./L (nominal value).
Given the low level and rapid reversibility of effects at the NOAEC, the effects of Metamitron exposure at
or below this concentration are considered to be unlikely to increase significantly by repeated exposure.
Although effects on a wide range of aquatic invertebrates and algae species were assessed in the study,
effects on only three species of higher aquatic plants were assessed – which may not be fully representative
of the range of sensitivity of higher aquatic plants to Metamitron. To take account of the uncertainty
involved in extrapolating the results of the mesocosm study to the field situation, an uncertainty factor of 3
has been proposed by the RMS to the study NOAEC during Annex I inclusion of Metamitron to regulation
91/414/EEC.
The regulatory endpoint derived from the mesocosm study on the solo formulation Goltix SC 700
containing 700 g Metamitron/L is also applicable for risk assessments for the preparation GOLTIX TITAN
(AG-QMM1-565 SC) because Metamitron is by a factor of > 1000 more toxic to aquatic organisms than
the other active substance (Quinmerac) in the product (see also the comparison of toxicity per fraction
below). The contribution of Quinmerac to the aquatic toxicity of the product in an aquatic environment is
therefore considered as negligible. This is confirmed by the laboratory study endpoints for the most
sensitive aquatic species showing a comparable toxicity for the mixture formulation as for the active
ingredient Metamitron. For more detailed explanations see below.
6.5.2 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1)
The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with
the recommendations of the “Guidance Document on Aquatic Ecotoxicology”, as provided by the
Commission Services (SANCO/3268/2001 rev.4 (final), 17 October 2002).
Mixture Toxicity
According to EFSA conclusion report on the active substance Quinmerac, the active substance MEtamitron
in the formulation GOLTIX TITAN can be considered to drive the toxicity of the formulation for aquatic
organisms. A model often used to estimate the toxicity of mixtures is the assumption of dose/concentration
additivity of toxicity (Finney approach of concentration additivity of toxicity; Finney, D.J., 1948 and 1971).
Toxicity studies on acute and chronic effects of the active substances and GOLTIX TITAN to aquatic
organisms are available. For a more detailed assessment of mixture toxicity, a surrogate LC50 or EC50 can
be calculated. However, reliable results can only be expected for combinations of ECX values for the same
biological endpoint. Moreover, the use of NOEC values, which are strongly depending on dose-spacing,
would introduce additional bias in the calculations.
The following formula is used to derive a surrogate LC50 or EC50 for the mixture of active substances with
known toxicity assuming concentration additivity:
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( )( )
( )
1
50
50
−
= ∑
i i
i
.s.aLC
.s.aXmixLC
where:
X(a.s.i) = fraction of active substance (i) in the mixture expressed as:
X(Metamitron) = 525 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0.93
X(Quinmerac) = 40 g a.s./kg / (525 g Metamitron /kg + 40 g Quinmerac/kg) = 0.07
LC50(a.s .i) = toxicity value for active substance (i)
Because of the direct proportionality of the calculated TER to the LC50, it is possible to calculate a
TER(mix) with the following formula:
1
)TER(a.s.
1TER(mix)
−
= ∑
i i
where:
TER(a.s.i)= calculated TER for the active substance i
The relevant global maximum FOCUS Step 1, 2 and 3 PECSW for risk assessments covering the proposed
use pattern and the resulting TER values are presented in the following table.
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6.5.2.1 Toxicity to exposure ratio for the active substances
In the following table the TER values for each FOCUS scenario for each organisms group are given.
Table 6.5-4: Aquatic organisms: PECsw for Metamitron and relevant ecotoxicological endpoints for each organism’ group.
Scenario PECSW
global
max
Fish
acute
Fish
prolonged
Invertebrates
acute
Invertebrates
prolonged
Algae Aquatic
plant
Mesocosm
O. mykiss O. mykiss D. magna D. magna P.
subcapitata
L. gibba Invertebrates
FOCUS LC50 NOEC EC50 NOEC EbC50 NOEC NOEC
190000 70000 5700 10000 400 380 1120
[µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L] [µg/L]
Focus Step 1
970.5 195.8 7.2 5.9 10.3 0.4 0.4 1.2
Focus Step 2
N.Europe 159.2 1193.5 44 35.8 62.8 2.5 2.4 7
S.Europe 295.48 643 23.7 19.3 33.8 1.4 1.3 3.8
Focus Step 3
D3/ditch 5.544 34271.3 1262.6 1028.1 1803.8 72.2 68.5 202
D4/pond 0.502 378486.1 13944.2 11354.6 19920.3 796.8 757 2231.1
D4/stream 4.64 40948.3 1508.6 1228.4 2155.2 86.2 81.9 241.4
R1/pond 1.495 127090.3 468.,3 3812.7 6689 267.6 254.2 749.2
R1/stream 24.089 7887.4 290.6 236.6 415.1 16.6 15.8 46.5
R3/stream 53.013 3584 132 107.5 188.6 7.5 7.2 21.1
TER
criterion
100 10 100 10 10 10 3
TER values shown in bold fall below the relevant trigger.
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Table 6.5-5: Aquatic organisms: PECsw for Quinmerac and it´s metabolites and relevant ecotoxicological endpoints for long time effects in fish with Pecsw values for
Quinmerac (worst case value).
Substance Endpoint
(µg/L)
Focus Scenario Pecsw global
max (µg/L)
TER TER
criterion
Quinmerac
Oncorhynchus mykiss NOEC = 3160 Step 1 - 78.64 40.2 10
BH 518-2
Oncorhynchus mykiss NOEC = 320 Step 1 - 78.64 4.07 10
Step
2
Europe North 12.60 25.4
Step 2 Europe South 23.39 13.7
BH 518-5
Oncorhynchus mykiss NOEC = 5000 Step1 - 78.64 63.6 10
The TER values for all scenarios for acive substance Metamitron and Quinmerac are above the Annex VI
trigger value of 100 or 10, except of the TERLT value for the R3 Stream scenario of Metamitron, which is
below the Annex VI trigger value of 10. Thus, a further risk refinement is required for Metamitron, R3
Stream scenario for algae and aquatic plants.
Refined risk assessment for Metamitron
As written in beginning of that chapter a mesocosm study was performed with Goltix SC 700, a formulation
containing 700 g/L Metamitron. The results of this field mesocosm study indicate an NOAEC of 1120 µg
a.s./L. The NOAEC of 1120 µg a.s./L has been used for further refinement of the risk assessment of
Metamitron. A comparison of this NOAEC with the FOCUS Step 3 PECsw values (worst-case) for the
relevant scenario has been performed in table obove.
Based on the mesocosm study and on the FOCUS Step 3 PECsw, the TERLT value for Metamitron for the
R3 Stream scenario is above the trigger value of 3 for algae and aquatic plants. This indicates that the active
substances Metamitron and Quinmerac contained in GOLTIX TITAN pose a low long-term risk to algae
and aquatic plants following application of GOLTIX TITAN at the proposed application rates.
6.5.2.2 Consideration of Metabolites
Metamitron forms one major metabolite in surface water: Desamino-Metamitron (54 % after 58 d). This
metabolite is also formed in sediment (27.5 % after 58 d). Moreover Desamino-Metamitron is a major
metabolite in soil (17.1 % after 30 d). Contamination of surface waters via run-off and drainage can not be
excluded. Ecotoxicological studies on the metabolite Desamino-Metamitron are available with fish (acute),
daphnids (acute) and algae.
The comparison of the study results for the metabolite Desamino-Metamitron with the study results of the
parent compound Metamitron show a higher sensitivity of aquatic organisms towards the active ingredient
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Metamitron. Since risk assessment gives indication that the use of Metamitron as intended in GOLTIX
TITAN poses low risks to aquatic organisms, also the environmental risk arising from the metabolite
Desamino-Metamitron is considered to be low.
Metamitron forms the unidentified major metabolite M3 in soil. The metabolite M3 was found in amounts
of > 5% AR on two consecutive sample points (day 1 and day 2) in one soil. Therefore, contamination of
surface waters via run-off and drainage can not be excluded. As no ecotoxicological studies are available
for the metabolite M3, an environmental risk assessment can not be performed quantitatively. The Inclusion
Directive for Metamitron lists as confirmatory data to be delivered to the Commission till August 2011
requirements for further studies with the metabolite M3. However, subject to the provisions of the results
of the confirmatory data evaluation, the risk for organisms exposed via run-off and drainage is expected to
be low. It is not expected that the metabolite M3 reaches surface waters before it is degradaded (transient
metabolite detected in one soil only at day 1 and 2).
Quinmerac forms one major metabolite in surface water: BH 518-2 (9.5 % after 100 d). In soil the
metabolites BH 518-2 and BH 518-5 are formed (BH 518-2 = 29.1 % after 30 d and 42.2 % after 224 d;
and BH 518-5 = 34.7 % after 91 d and 30.1 % after 120 d). Contamination of surface waters via run-off and
drainage can not be excluded. Ecotoxicological studies for the metabolites BH 518-2 and BH 518-5 are
available with fish, daphnids, algae and aquatic plants.
The comparison of the studies for the metabolites BH 518-2 and BH 518-5 with the studies of Quinmerac
show that the sensitivity of aquatic organisms towards the active ingredient Quinmerac and the metabolites
are comparable, with the exception of long-term toxicity for fish for BH 518-2. As no long-term study with
BH 518-2 was conducted the EC50 of Quinmerac is assumed as surrogate for the aquatic risk assessment.
Therefore a TERLT for fish was calculated for BH 518-2 but for the other groups of aquatic organisms the
risk assessment of the metabolites is covered by that of the active substance Quinmerac.
6.5.2.3 Accumulation in aquatic non-target organisms
Bioaccumulation of any of the active substances under natural conditions is not expected to occur and a
study is not necessary to determine bioaccumulation in aquatic non-target organisms.
6.5.3 Overall conclusions
Based on the calculated concentrations of active substances Metamitron and Quinmerac in surface water
(PECSW FOCUS Step 3), the calculated TER values for the acute and long-term risk resulting from an
exposure of aquatic organisms to active substance Metamitron and Quinmerac according to the GAP of the
formulation GOLTIX TITAN achieve the acceptability criteria TER ≥ 100, TER ≥ 10 and TER ≥ 3,
according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific
principles, point 2.5.2. for long-term effects. The results of the assessment indicate an acceptable risk for
aquatic organisms due to the intended use of GOLTIX TITAN in beets according to the label.
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6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)
In the the honey bee risk assessment for the main application it was concluded that the risk to bees is
acceptable when GOLTIX TITAN (AG-QMM1-565 SC) is used up to 6 L product/ha in pre-emergence
or early post-emergence fodder and sugar beet fields. Since the recommended application rate does not
exceed this rate no further risk assessment is required.
Labelling phrase NB6641 shall be applied.
6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)
Table 6.7-1: Toxicity of the product GOLTIX TITAN (AG-QMM1-565 SC) to non-target arthropods
Species Substance Exposure
System
Results
Reference Internal
code
Aphidius
rhopalosiphi
FSG 02122 H
(40g/L Quinmerac
+ 525g/L
Metamitron
nominal
2 d,
Extended
Laboratory study
3D: barley
plants, mortality
and reproduction
capability
LR50 >
6000 mL
Prod../ha
Stevens, J.
27.04.2010
FSG-10-1
77797
Typhlodromus pyri FSG 02122 H (40
G/L Quinmerac +
525 g/L Metamitron
nominal)
7 d
Extended
laboratory study,
2D: bean leaves,
mortality and
reproduction
capability
LR50 >
6000 mL
Prod./ha
Fallowfield, L.
27.04.2010
FSG-10-2
77798
* Endpoint differing from LoEP / New study submitted
6.7.1 Justification for new endpoints
Not necessary.
6.7.2 Risk assessment
The evaluation of the risk for non-target arthropods was performed in accordance with the
recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the
Commission Services (SANCO/10329/2002 rev.2 (final), October 17, 2002), and in consideration of the
recommendations of the guidance document ESCORT 2.
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6.7.2.1 Risk assessment for in-field exposure
Exposure
The in-field exposure, given as predicted environmental rates, PER, for non-target arthropods resulting
from the intended uses of GOLTIX TITAN is calculated according to published agreement after ESCORT
2 workshop (Candolfi et al. 20015 -hereafter referred to as ‘Guidance Document’) using the following
equation:
Application rate (g a.s./ha) MAFin field
PER−
= ×
where:
MAF = generic multiple application factor used to take into account the potential build-up of
applied substances between applications. This factor integrates number of applications,
application interval and degradation kinetics of the active substance
Default MAF values for given numbers of applications are listed in the Guidance Document.
Application scheme in use 02: 1x 3.0 L prod./ha + 3x 1 L prod./ha (equivalent to total 6.0 L prod./ha
per season). Maximum application rate of 6.0 L prod./ha is used (without MAF) as a worst case
application rate in PER calculation.
Table 6.7-2: Predicted in-field environmental rates (PER) (worst case)
Intended use Exposure Max. appl. rate MAF PERin-field
[L Prod./ha] (worst
case)
[L Prod/ha]
02 In-field 6 - 6
02 refinement In-field 1x 3.0 L prod./ha + 3x 1
L prod./ha
2.3 5.3
MAF: Multiple application factor; fdrift: Drift factor; fveg: Vegetation distribution factor; PER: Predicted environmental rates
Tier 1 risk assessment for in-field exposure
The risk for non-target arthropods exposed in-field to GOLTIX TITAN was assessed by calculating the
hazard quotient (HQ = exposure/toxicity) as the ratio of the predicted environmental rate (PER) and the
lowest lethal rate (LR50) estimated in standard toxicity tests with non-target arthropods according to the
formula:
5 Candolfi, M.P.; Barrett, K.L.; Campbell, P.; Forster, R.; Grandy, N.; Huet, M.C.; Lewis. G.; Oomen, P.A.; Schmuck, R.; Vogt,
H. (2001): Guidance document on regulatory testing and risk assessment procedures for plant protection products with
non-target arthropods. ESCORT2 Workshop European Standard Characteristics of Non-Target Arthropod Regulatory
Testing. Wageningen, The Netherlands, 46 pp.
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50LR
PER field-InHQ fieldIn =
The resulting HQ in-field values for the standard species are presented in the following table.
It is noted that the tier 1 HQ trigger criterion has been calibrated using laboratory LR50s from glass plate
studies on the standard tier 1 indicator species. However, according to the ESCORT II report, “for products
where effects on reproduction are expected, sub-lethal parameters (e.g. oviposition) should also be
evaluated” in tier 1. Effects on reproduction should be assessed if detected in tier 1 studies. Considering the
worst-case character of the exposure conditions in standard tier 1 studies it is considered appropriate to set
the tier 1 acceptability criterion for reproductive effects for T. pyri and A. rhopalosiphi at an HQ of 2 in
line with the mortality assessment. Therefore, the tier 1 risk assessment uses the ER50 for the most sensitive
parameter (mortality or reproduction) in HQ calculations.
Table 6.7-3: HQ values for non-target arthropods (Tier-1) for in-field exposure
Intended use Species L/ER50 Exposure PER HQ
[L prod./ha] [L prod./ha]]
Use 02 A. rhopalosiphi >6 in-field 6 1
T. pyri >6 in-field 6 1
PER: Predicted environmental rates ; HQ: Hazard quotient
Higher tier risk assessment for in-field exposure
The risk for non-target arthropods exposed in-field to GOLTIX TITAN was assessed by comparing the
environmental rate (PERin-field) to the lowest lethal rate (LR50) estimated in toxicity tests with non-target
arthropods. With regard to extended laboratory tests and semi-field tests, lethal and sublethal effects of less
than 50 % are considered acceptable, provided that the tests covered the appropriate field rate.
Table 6.7-4: Predicted in-field environmental rates (PER) – Higher tier
Intended use Exposure Single appl. rate MAF PERin-field
[L prod./ha] [L prod./ha]
Use 02 In-field 6 - 6
MAF: Multiple application factor; fveg: Vegetation distribution factor; PER: Predicted environmental rates
The results of the risk assessment are summarised in the following table.
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Table 6.7-5: Risk assessment for non-target arthropods (Higher tier) for in-field exposure
Intended use LR50/ER50 PER Risk acceptable
[g a.s./ha] [g a.s./ha] [yes/no]
Use 02 >6 6 yes
PER: Predicted environmental rates
6.7.2.2 Risk assessment for off-field exposure
Exposure
Exposure of non-target arthropods living in non-target off-field areas to GOLTIX TITAN will mainly be
due to spray drift from field applications. Off-field predicted environmental rates (PER-values) were
calculated from in-field PERs in conjunction with drift values published by the BBA (20006) as shown in
the following equation:
)(
100
vdffactorondistributivegetation
percentiledriftxPERfieldinMaximum
PERfieldOff
−
=−
where:
vdf = vegetation distribution factor used in combination with test results derived from 2-dimensional
exposure set-ups
To account for interception and dilution by three-dimensional vegetation in off-crop areas, a vegetation
distribution or dilution factor (vdf, see above) is incorporated into the equation when calculating off-field
exposure in conjunction with toxicity endpoints derived from two-dimensional studies (e.g. glass plate or
leaf discs). A vdf of 10 is recommended in the ESCORT 2 report when the off-field risk assessment is based
on toxicity endpoints obtained in a test design with two-dimensional exposure but has been questioned.
Germany considers a vdf of five as a more reliable value to extrapolate from a two dimensional exposure
situation to the exposure situation in the field. The exposure estimation was based mainly on the ‘Retention
Area Index’ (RAI) characterizing the total retention area of sprayed plant protection products in a canopy
per base area. As a ‘realistic worst case scenario, meadow canopies < 20 cm height was chosen (Koch and
Weisser, 20047; German Federal Environment Agency UBA, 20068). The derived vdf of 5 agrees well with
6 BBA (Biologische Bundesanstalt für Land- und Forstwirtschaft) (2000): Abdrifteckwerte für Flächen- und Raumkulturen sowie
für den gewerblichen Gemüse-, Zierpflanzen- und Beerenobstanbau. Bundesanzeiger 100, 26. Mai 2000, Köln, pp.
9879.
7 Koch H and Weisser P, 2004. Die Gesamtoberflaeche in Saumstrukturen als potentielle Retentionsflaeche fuer Driftpartikel,
Retention Area Index (RAI). Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 56, 65-69.
8 German Federal Environment Agency (UBA), 2006. Exposure calculation for arthropods in field border structures - selection
of an appropriate ‘vegetation distribution factor’. Parma.
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field data by Koch et al. (2003)9, who compared measured residues of plant protection products on two
dimensional surfaces with the measured residues on meadows next to a treated area (factor of 4.4 to 6.5
between median spray residues on leaves when a standard nozzle was used for spray application). For
endpoints resulting from 3-dimensional studies, i.e. where spray treatment is applied onto whole plants, the
vdf is not used.
Active substances Metamitron and Quinmerac have a vapour pressure of < 10-5 Pa and is therefore classified
as non-volatile. Hence, deposition following volatilization has not to be considered.
Maximum application rate of 6.0 L prod./ha is used (without MAF) as a worst case application rate
in PER calculation.
The drift rate at 1 m distance is 2.77% of the application rate (90th percentile drift). It has to be noted that
this value is a worst case assumption.
The resulting PERoff-field value is shown in the following table:
Table 6.7-6: Predicted off-field environmental rates (PER) for GOLTIX TITAN
Intended use Exposure Single appl.
rate
MAF Drift
scenario
fdrift vdf PERoff-field
[L prod./ha] [L
prod./ha]
Use 02 Off-field 6 - 90th 2.77 1 (3D) 0.1662
Use 02 Off-field 6 - 90th 2.77 5 (2D) 0.0332
Use 02 refinement Off-field 5.3 2.3 74th 1.85 1 (3D) 0.0981
Use 02 refinement Off-field 5.3 2.3 74th 1.85 5 (2D) 0.0196
MAF: Multiple application factor; fdrift: Drift factor; vdf: Vegetation distribution factor; PER: Predicted environmental rates
Higher tier risk assessment for off-field exposure
For the results of study with T. pyri exposed to GOLTIX TITAN (AG-QMM1-565 SC), a vegetation
distribution factor has to be considered (study conducted in 2D environment). Regarding the results of the
study with A. rhopalosiphi exposed to GOLTIX TITAN (AG-QMM1-565 SC), the vegetation distribution
factor does not have to be considered since it was conducted in 3D environment.
According to ESCORT II , lethal and sublethal effects less than 50 % at the calculated deposition rates
including the correction factor are considered acceptable. The correction factor can be lowered to 5 if higher
9 Koch H, Weisser P and Landfried M, 2003. Effect of drift potential on drift exposure in terrestrial habitats. Nachrichtenblatt des
Deutschen Pflanzenschutzdienstes, 55, 181-188.
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tier tests with the more sensitive of the species affected in tier I and ‘two additional species with different
biology’ were submitted (please refer to European Commission 2002)10
Additionally the assessment of the risk to non-target arthropods due to an exposure to GOLTIX TITAN
was performed on basis of the calculation of toxicity-exposure ratios (TER values) according the following
formula:
)/(
)/(50)(
haproductLPERfieldOff
haproductLRELTER
−=
The risk is considered acceptable if the values obtained are TER off-field > 10 when the ecotoxicological
data resulted from tier 1 tests on glass plates or TER off-field > 5 if higher tier tests with the more sensitive
of the species affected in tier I and ‘two additional species with different biology’ were submitted (please
refer to European Commission, 2002)11.
The results of the risk assessment are summarized in the following table.
Table 6.7-7: Risk assessment for non-target arthropods (Tier 2) for off-field exposure
Intended
use
Species Test type LR50/ER50 PERoff-field TER Risk acceptable
[L
prod./ha]
[L prod./ha] [yes/no]
02 Aphidius
rhopalosiphi
Lab. 3D >6 0.1662 >36.1 Yes
02 Typhlodromus
pyri
Lab. 2D >6 0.0332 >180.7 Yes
PER: Predicted environmental rates; TER: Toxicity to ecposure ratio. TER values shown in bold fall below the relevant trigger.
6.7.2.3 Risk mitigation measures
No risk mitigation needed.
6.7.3 Overall conclusions
In-field
Based on the calculated rates of GOLTIX TITAN in in-field areas, the calculated HQ and TER values
describing the risk resulting from an exposure of non-target arthropods to GOLTIX TITAN with active
10 European Commission (2002): Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC:
Directorate E - Food Safety: plant health, animal health and welfare, international questions; E1 - Plant health.
11 European Commission. 2002. Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC:
Directorate E - Food Safety: plant health, animal health and welfare, international questions; E1 - Plant health.
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Date May 2015
substances Metamitron and Quinmerac according to the GAP of the formulation GOLTIX TITAN achieves
the acceptability criteria HQ ≤ 2 (Tier 1) of TER ≥ 10 (Tier 1) resp. 5 (Higher tier), according to commission
implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results
of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of GOLTIX
TITAN in agriculture according to the label.
Off-field
Based on the calculated rates of formulation GOLTIX TITAN in off-field areas the calculated HQ and TER
values describing the risk resulting from an exposure of non-target arthropods to active substances
Metamitron and Quinmerac in the formulation GOLTIX TITAN according to the GAP of the formulation
GOLTIX TITAN achieve the acceptability criteria HQ ≤ 2 (Tier 1) and of TER ≥ 10 (Tier 1) resp. 5 (Higher
tier), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific
principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods
due to the intended use of GOLTIX TITAN in beets according to the label.
6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC
10.4.1, KPC 10.4.2)
Table 6.8-1: EU agreed endpoints and new endpoints for earthworms and other soil macro- and
mesofauna
Species Substance Exposure
System
Results Reference Internal
code
Eisenia
fetida
Quinmerac
BAS 518 H
14 d
akut
LC50 >1000
mg/kg
Mortality
Lührs, U.
24.08.2001
10481021
49849
Eisenia
foetida
Quinmerac
Metabolit
Dicarbonsäuremetabolit
BH518-2
14 d
akut
LC50 >1000
mg/kg TS
Dohmen, G.P.
1992
P92-E008 // 3438
28984
Eisenia
foetida
Quinmerac
Metabolit
BH518-5
14 d
akut
LC50 >1000
mg/kg TS
Mortality
Dohmen, G.P.
1992
P92-E009 // 3439
28991
Eisenia
foetida
Quinmerac
Metabolit
BH518-5
chronic NOEC = 0.775
mg a.s./kg soil
Luehrs 2003 LOEP
Eisenia
foetida
Quinmerac
Metabolit
BH518-5
chronic
56 d
NOEC = 20 mg
a.s./kg soil**
Witte, B.
21.01.2010
49703022
76783
Folsomia
candida
Quinmerac
Metabolit
BH518-5
Chronic
56 d
NOEC = 1000 mg
a.s./kg soil
Witte, B.
20.01.2010
49705016
76784
Eisenia
foetida
Metamitron 14 d
akut
LC50 = 914 mg
a.s./kg dw soil
Heimbach, F.
06.07.1999
HBF/Rg 307
68019
Part B – Section 6
Core Assessment
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Date May 2015
Eisenia
foetida
Metamitron
Metabolit
Desamino-Metamitron
14 d
akut
LC50 > 1000 mg
a.s./kg dw soil
LC50 corr > 500
mg a.s./kg dw soil
Meisner, P.
28.05.2001
MPE/Rg 372/01
68020
Eisenia
foetida
Metamitron chronic NOER = 21 kg
a.s./ha
NOEC = 28 mg
a.s./kg soil*
= NOEC = 28.36
mg ai/kg -
Calculated
considering a soil
depth of 5 cm and
a density of 1.5
g/cm3 (aus LoEP)
Winkelmann, G.
16.03.2007
RRR112401
68022
Folsomia
candida
Metamitron
Metabolit
Desamino-Metamitron
chronic NOEC = 100 mg
a.s./kg soil
EFSA 2008 -
Eisenia
foetida
GOLTIX TITAN (AG-
QMM1-565 SC)
acut
14 d
NOEC = 1000 mg
product/kg
(at 10% peat
content)
Krome, K.**
20.05.2010
OFC00018409
77827
Eisenia
foetida
GOLTIX TITAN (AG-
QMM1-565 SC)
chronic
56 d
NOEC = 100 mg
product/kg
(at 10% peat
content)
Krome, K.**
08.06.2010
RRA13609
77826
* endpoint considering a soil depth of 5 cm
**New studies, submitted by the applicant in application report 007529-00-00 (GOLTIX TITAN), detailed
information about study can be found in Appendix 3 of first GOLTIX TITAN application (007529-00-00).
According to EFSA Journal 2010; 8(3):1523 no chronic study required for Quinmerac or BH 518-2 – DT50 >
100 and < 365 days, one application proposed.
Metabolite studies of the applicant used for risk assessments:
The results of the chronic earthworm study on the major soil metabolite of Quinmerac, BH 518-5 (Luehrs
2003), were equivocal. Some statistically significant effect on adult mortality was observed at the highest
test concentration of 1.25 mg/kg. However, as there was no clear dose-response, the rapporteur considered
this effect not treatment-related and proposed 1.25 mg/kg, i.e. the highest concentration tested as endpoint.
The effects seen in the chronic worm study only concerned adult survival with no impairment on
reproductive parameters. Nevertheless, EFSA did not agree to this proposal resulting in the lower endpoint
of 0.775 mg/kg as the relevant figure included in the list of endpoints. However, in agreement with the
original interpretation of the rapporteur, that effects in the study by Luehrs were not treatment-related, a
NOEC of 20 mg BH 518-5/kg (again the highest concentration tested) in a new study of the applicant
(Witte 2010c) indicates a low chronic toxicity of this metabolite towards earthworms. For these reasons, in
the risk assessment it is referred to the endpoint of the new study of the applicant (Witte 2010c).
Part B – Section 6
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GOLTIX TITAN Draft Registration Report
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Date May 2015
6.8.1 Justification for new endpoints
Justification of new studies on Quinmerac metabolites were done in application report 007529-00-00
(GOLTIX TITAN), detailed information about study can be found there in Appendix 3.
6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna,
TERA and TERLT (MIIIA 10.6.1)
The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance
with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the
Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).
For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the
environmental fate section (Part B, Section 5) of this submission.
The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure
to GOLTIX TITAN and active substances Metamitron and Quinmerac as well as the major soil degradation
products of Metamitron and Quinmerac was assessed by comparing the maximum PECSOIL with the 14-day
LC50 value to generate acute TER values. The TERA was calculated as follows:
The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breakdown
resulting from an exposure to GOLTIX TITAN and active substances Metamitron and Quinmerac as well
as the major soil degradation product of Quinmerac BH 518-5 was assessed by comparing the maximum
PECSOIL with the NOEC value to generate chronic TER values. The TERLT was calculated as follows:
The results of the risk assessment are summarized in the following table.
As written in Sec. 5 core assessment chapter 5.5 no Pec Soil calcualton s for Quinmerac were carried out.
Explanation: according to section 6 of the first Registration Report for GOLTIX TITAN the TER values in
soil for quinmerac and its soil metabolites were above the respective TER values for metamitron and far
above the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil
metabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation. Results
from first Registration Report for GOLTIX TITAN for Quinmaerc and its metabolites for use 01 are
presented for information.
Table 6.8-2: TER values for earthworms and other soil macro- and mesofauna (Tier-1), use 02, application rate: 1 x 1575 g Metamitron/ha +3 x 420 Metamitron/ha and 1x 120 g
Quinmerac/ha + 3 x 32 g Quinmerac/ha, 5 d interval
Species Test item Time scale Endpoint Max. PECact
worst case
TER
[mg/kg soil dw] [mg/kg soil dw]
(mg/kg) PEC
(mg/kg) LC=TER
soil
50
A
(mg/kg) PEC
(mg/kg) NOEC=TER
soil
LT
Part B – Section 6
Core Assessment
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Date May 2015
Eisenia fetida Metamitron Acute 914 2.7561 331.6
Chronic 28 2.7561 10.2
Desamino-
Metamitron
Acute >500 corr. 0.8395 595.6
GOLTIX TITAN Acute 1000 7.200 138.8
Chronic 100 7.200 13.8
Folsomia
candida
Desamino-
Metamitron
Chronic 100 0.8395 119.1
TER values for earthworm for Quinmerac and its metabolites for use 01 of GOLTIX TITAN for information
Folsomia
candida
Quinmerac Acute 1000 0.2414 4143
BH 518-2 Acute 1000 0.1215 8230
BH 518-5 Acute 1000 0.0939 10649
TER values shown in bold fall below the relevant trigger.
6.8.3 Higher tier risk assessment
Not relevant.
6.8.4 Overall conclusions
Based on the predicted concentrations of Metamitron and Quinmerac and their metabolites in soils, the TER
values describing the acute and long-term risk for earthworms and other non-target soil organisms following
exposure to active substances Metamitron, Quinmerac and formulation GOLTIX TITAN according to the
GAP of the formulation GOLTIX TITAN achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5
according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific
principles, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to
the intended use of GOLTIX TITAN in beetsaccording to the label.
6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)
Effects on soil micro-organisms for GOLTIX TITAN (AG-QMM1-565 SC) were not evaluated as part of
the EU review of either Quinmerac or Metamitron. Therefore, all relevant data and assessments are
provided here and are considered adequate.
Table 6.9-1: EU agreed endpoints and new endpoints for soil microorganisms
Test design Substance Results Source Internal code
Part B – Section 6
Core Assessment
GOLTIX TITAN Draft Registration Report
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Date May 2015
CO2-Development Quinmerac 30 d
aerob
Effect < 25 %
1 kg ai/ha (3.3
mg ai/kg dw)
Effect <25 %
5 kg ai/ha (16.5
mg ai/kg dw)
Hamm, R.T.
1987
2417
70752
Nitrate-turnover Quinmerac 28 d
aearob
Effect : 11 %
at 3.3 mg ai/kg
dw
Effect : 12 %
at 16.5 mg ai/kg
dw
Hamm, R.T.
1987
P86-E021
70753
Nitrate-turnover BH 518-2 28 d
Effect : < 10
%
0.625 kg ai/ha
(0.83 mg ai/kg
dw Effect : <
10 %
0.125 kg ai/ha
(0.17 mg ai/kg
dw)
Gerhardt, R.
1992
P92-E003
70913
CO2-Development
BH 518-2 28 d
aerob
Effect : < 25
difference to
control
0.83 mg ai/kg
dw + 0.17 mg
ai/kg dw
Gerhardt, R.
1992
P92-E002
70916
Nitrate-turnover
BH 518-5 28 d
aerob
Effect <10 %
At 0.3125 kg
ai/ha (0.42 mg
ai/kg dw)
Effect <10 % at
0.0625 kg ai/ha
(0.083 mg ai/kg
dw)
Gerhardt, R.
1992
P92-E005
70912
CO2-Development
BH 518-5 28 d
aerob
Effect < 10 %
At 0.3125 kg
ai/ha (0.42 mg
ai/kg dw) and at
0.0625 kg ai/ha
(0.083 mg ai/kg
dw)
Gerhardt, R.
1992
P92-E004
70914
CO2-Development GOLTIX SC 700
containing 690 g/L
Metamitron
28 d
aerob
Effects at 19.5
mg a.s./kg d.w.
soil throughout
the study <
±25% of the
control
Schulz, L.
03.05.2007
07 10 48 008 C
76445
Nitrate-turnover GOLTIX SC 700
containing 690 g/L
Metamitron
28 d
aerob
Effects by day
28 at 19.5 mg
a.s./kg d.w.
Schulz, L.
03.05.2007
07 10 48 008 N
68111
Part B – Section 6
Core Assessment
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Date May 2015
soil < ±25% of
the control
Nitrate-turnover Desamino-
Metamitron
42 d Effects by day
42 at 21.73 mg
/kg d.w.
soil < ±25% of
the control
Anderson, J.P.E.
05.07.2001
AJO/220701
68112
CO2-Development GOLTIX TITAN
(AG-QMM1-565
SC)
*
At 20.0 L
product/ha
(31.04 mg/kg
soil dry
weight): no
adverse effects
on carbon
turnover in soil,
no difference to
control < 25 %.
Schulz, L.
22.09.2010
101048022 C7N*
77819
Nitrate-turnover GOLTIX TITAN
(AG-QMM1-565
SC)
*
At 20.0 L
product/ha
(31.04 mg/kg
soil dry
weight): no
adverse effects
on nitrogen
turnover in soil,
no difference to
control < 25 %.
Schulz, L.
22.09.2010
101048022 C7N*
77819
* New study submitted by applicant
However, as the actual preparation contains two active substances, the data on the formulated product are
most relevant for the risk assessments.
6.9.1 Justification for new endpoints
Summaries of new submitted studies by applicant were evaluated in main application proposal GOLTIX
TITAN (007529-00-00).
6.9.2 Risk assessment
The evaluation of the risk for earthworms was performed in accordance with the recommendations of the
“Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services
(SANCO/10329/2002 rev 2 (final), October 17, 2002).
Please refer to above for the predicted environmental concentrations in soil (PECSOIL) of Metamitron,
Quinmerac and GOLTIX TITAN.
The results of the risk assessment are summarized in the following table.
Part B – Section 6
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Table 6.9-2: Risk assessment for effects on soil micro-organisms
Test substance Test concentration
(adverse effects < 25%)
PECSOIL Risk acceptable
[mg /kg] [mg/kg] [yes/no]
GOLTIX TITAN (AG-
QMM1-565 SC)
31.04 mg prep./kg soil = 20 L
prod./ha
7.2 Yes
Quinmerac 16.5 mg a.s./kg soil 0.2414* Yes
Metamitron 19.5 mg a.s./kg soil 2.7561 Yes
BH 518-2 0.83 mg a.s./kg soil 0.1215* Yes
BH 518-5 0.42 mg a.s./kg soil 0.0939* Yes
Desamino-Metamitron 21.73 mg a.s./kg soil 0.8395 Yes
*Pecsoil values for Quinmerac and its metabolites from main application proposal GOLTIX TITAN
(007529-00-00) Core assessment
6.9.3 Overall conclusions
Based on the predicted concentrations of Metamitron, Quinmerac and GOLTIX TITAN in soils, the risk to
soil microbial processes following exposure to Metamitron, Quinmerac according to the GAP of the
formulation GOLTIX TITANis considered to be acceptable according to commission implementing
regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.
6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)
6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1)
Table 6.10-1: EU-agreed endpoints and new endpoints for non-target terrestrial plants
Species Substance Exposure
System
Results
Reference Internal
code
Rape (Brassica
napus), Sunflower
(Helianthus annuus),
Flax (Linum
usitatissimum),
Tomato (Solanum
lycopersicum), Soya
bean (Glycine max),
Carrot (Daucus
carota), Onion
(Allium cepa), Oats
(Avena sativa), Rye
gras (Lolium
AG-QMM1- 565
SC (40 g/L
Quinmerac + 525
g/L Metamitron)
Seedling
emergence
ER50 >
1116 mL
Präp./ha
oilseed
rape, flax,
tomato,
carrot
Minarski, A.,
Marquardt, J.
04.08.2010
AS150
77821
Part B – Section 6
Core Assessment
GOLTIX TITAN Draft Registration Report
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Date May 2015
mulltiflorum), Corn
(Zea mays)
Rape (Brassica
napus), Sunflower
(Helanthus annuus),
Flax (Linum
usitisimum), Tomato
(Solanum
lycopersicum), Soya
bean (Glycine max),
Carrot (Daucus
carota), Onion
(Allium capa), Oats
(Avena sativa), Rye
grass (Lolium
multiflorum), Corn
(Zea mays)
AG-QMM1- 565
SC (40 g/L
Quinmerac + 525
g/L Metamitron)
Vegetative
vigour
ER50 >
1116 mL
Präp./ha
flax, tomato
Minarski, A.,
Marquardt, J.
30.07.2010
AS151
77822
6.10.2 Justification for new endpoints
Summaries of new submitted studies by applicant were evaluated in main application proposal GOLTIX
TITAN (007529-00-00).
6.10.2.1 Risk assessment
The risk assessment is based on the “Guidance Document on Terrestrial Ecotoxicology”,
(SANCO/10329/2002 rev.2 final, 2002). It is restricted to off-field situations, as non-target plants are non-
crop plants located outside the treated area. Spray drift from the treated areas may lead to residues of a
product in off-crop areas.
Exposure
Effects on non-target plants are of concern in the off-field environment, where they may be exposed to
spray drift. The amount of spray drift reaching off-crop habitats is calculated using the 90th percentile
estimates derived by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann (2000).
Any dilution over the 3-dimensional vegetation surface is accounted for in the study design. Therefore, in
contrast to the assessment of risks to arthropods from standard laboratory tests, no vegetation distribution
factor is considered here.
PERoff-field= Maximum PERin-field (including MAF) x %drift
Active substances Metamitron and Quinmerac have a vapour pressure of < 10-5 Pa and is therefore classified
as non-volatile. Hence, deposition following volatilization has not to be considered.
For calculation of PERin-field, please refer to 6.7.2.1.
Part B – Section 6
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Table 6.10-2: Predicted off-field environmental rates (PER) for GOLTIX TITAN, use 02, 74th drift percentile, MAF: 2.3
Intended use Exposure Single appl. rate MAF Drift scenario fdrift PERoff-field
[L prod./ha] [L prod./ha]
Use 02 Off-field 1x 3.0 L
prod./ha+ 3x 1.0
L prod./ha
= 5.30 L prod./ha
2.3 74 1.85 0.098
MAF: Multiple application factor; fdrift: Drift factor; PER: Predicted environmental rates
Screening assessment
The risk is considered acceptable if at the intended application rate no significant effects occur.
Tier 1 assessment
The assessment of the risk to non-target arthropods due to an exposure to GOLTIX TITAN is performed
on basis of the calculation of toxicity-exposure ratios (TER values) according the following formula:
)/(
)/(50
haproductLPERfieldOff
haproductLERTER
−=
The results of the risk assessment are summarized in the following table.
Table 6.10-3: Risk assessment for non-target terrestrial plants exposed to GOLTIX TITAN
for intended use 2
Intended use ER50 PER TER
[L prod./ha] [g/ha]
Use 2 > 1.116 0.098 >11.39
Risk mitigation measures
No risk mitigation needed.
6.10.2.2 Higher tier risk assessment (quantitative risk assessment)
Not relevant.
Part B – Section 6
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6.10.2.3 Overall conclusions
Based on the predicted rates of GOLTIX TITAN with active substances Quinmerac and Metamitron in off-
field areas, the TER values describing the risk for non-target plants following exposure to Quinmaerac and
Metamitron according to the GAP of the formulation GOLTIX TITAN achieve the acceptability criteria
TER ≥ 10 resp. ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C
, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target
terrestrial plants due to the intended use of GOLTIX TITAN in beets according to the label.
6.11 Effects on other terrestrial organisms (flora and fauna) (KPC 10.7)
6.12 Monitoring data (KPC 10.8)
6.13 Available preliminary data (IIIA 10.9)
6.14 Other/special studies (IIIA 10.10)
Part B – Section 6
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Appendix 1 List of data submitted in support of the evaluation
Please refer to main application proposal GOLTIX TITAN (007529-00-00).
Part B – Section 6
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Appendix 2 Detailed evaluation of the new studies
Summaries of new submitted studies by applicant were evaluated in main application proposal GOLTIX
TITAN (007529-00-00).
Part B – Section 6
National Addendum – DE
GOLTIX TITAN
Draft Registration Report
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REGISTRATION REPORT
Part B
Section 6: Ecotoxicological studies
Detailed summary of the risk assessment
Product code: GOLTIX TITAN
(AG-QMM1-565 SC)
Active Substance: Metamitron g/L
Quinmerac 40 g/L
Central Zone
Zonal Rapporteur Member State: Germany
NATIONAL ADDENDUM
Applicant: ADAMA
Date: May 2015
Part B – Section 6
National Addendum – DE
GOLTIX TITAN
Draft Registration Report
Central Zone
Page 2 of 17
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Date May 2015
Table of Contents
SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)............................................................ 3
6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES .............................................................. 4
6.1.1 Grouping of intended uses for risk assessment ...................................................................... 4
6.1.2 Consideration of metabolites .................................................................................................. 5
6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ................................................................. 6
6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC
10.1.2) ...................................................................................................................................................... 6
6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC
10.1.3) ...................................................................................................................................................... 7
6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ........................................ 8
6.5.1 Overview ................................................................................................................................ 8
6.5.2 Toxicity .................................................................................................................................. 8
6.5.3 Justification for new endpoints .............................................................................................. 8
6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ............................................. 8
6.5.5 Overall conclusions .............................................................................................................. 11
6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) .................................................................................. 12
6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ..................................... 12
6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1,
KPC 10.4.2) ............................................................................................................................................ 12
6.8.1 Justification for new endpoints ............................................................................................ 12
6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and
TERLT (MIIIA 10.6.1) .......................................................................................................... 12
6.8.3 Higher tier risk assessment ................................................................................................... 14
6.8.4 Overall conclusions .............................................................................................................. 14
6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) .................................................. 14
6.9.1 Justification for new endpoints ............................................................................................ 14
6.9.2 Risk assessment .................................................................................................................... 14
6.9.3 Overall conclusions .............................................................................................................. 15
6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) .......................................................... 15
6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) ........................................................ 15
APPENDIX 1 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 2014-04-
14) 16
Part B – Section 6
National Addendum – DE
GOLTIX TITAN
Draft Registration Report
Central Zone
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Date May 2015
Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)
A full risk assessment according to Uniform Principles for the plant protection product GOLTIX TITAN
in its intended uses in beets is documented in detail in the core assessment of the plant protection product
GOLTIX TITAN dated from May 2015 performed by zRMS Germany.
This document comprises specific risk assessment for some annex points for authorization of the plant
protection product GOLTIX TITAN in Germany according to the uses listed in Appendix 2.
General information on the formulation GOLTIX TITAN can be found in Table 5.1-1of Section 5 of the
National addendum Germany (May 2015).
Part B – Section 6
National Addendum – DE
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Draft Registration Report
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6.1 Proposed use pattern and considered metabolites
6.1.1 Grouping of intended uses for risk assessment
Full details of the proposed use pattern of the formulation GOLTIX TITAN that will be assessed are pre-
sented in Appendix 1 and summarized in the table below. The intended uses in Germany are covered by
the core assessment performed by zRMS Germany.
The following table lists the grouping of the intended uses in order to perform a risk envelope approach.
Table 6.1-1: Critical use pattern of GOLTIX TITAN
Use No* Crop/growth
stage
Application
method
Drift scenario
Number of applications,
Minimum application
interval, application
time, interception
Application rate,
cumulative
(g as/ha)
Soil effective
application rate
(g as/ha)
00-001 beets (sugar and
fodder) /
BBCH 0-19
Spraying /
arable crops
4 x, 5 d, 11.04, 16.04,
21.04, 26.04
1. 0 %
2.-4. 20 %
metamitron
1 x 1575
3 x 525
quinmerac
1 x 120
3 x 40
metamitron
1 x 1575
3 x 420
quinmerac
1 x 120
3 x 32
* For administrative purposes, each intended use of a plant protection product in Germany is assigned with an indi-
vidual use number from the German Federal Office of Consumer Protection and Food Safety (BVL). A complete list
of the individual GAPs in Germany together with their assigned use numbers is given in Appendix 2 of this Addendum.
Table 6.1-2: Critical use pattern of GOLTIX TITAN grouped according to soil relevance, drift
scenario and crop scenario
Groups – Soil relevance
Group Intended uses Application rate (Interception) Soil relevant effective appl.
rate, cumulative
[g/ha] [g/ha]
B01 1 Metamitron: 1 x 1575
3 x 525
Quinmerac: 1 x 120
3 x 40
Application:
4 x, 5 d,
1. 0 %
2.-4. 20 %,
spring
Metamitron: 1 x 1575
3 x 420
Quinmerac: 1 x 120
3 x 32
Groups – Drift szenario
Group Intended uses Application rate Drift scenario
[g/ha]
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D01 2 Metamitron: 1 x 1575
3 x 525
Quinmerac: 1 x 120
3 x 40
Groups – Birds and mammals
Group Intended uses Application rate Crop scenario
[g/ha]
V01S01 2 Metamitron: 1 x 1575
3 x 525
Quinmerac: 1 x 120
3 x 40
Bare soil,
Root and stem vegetables
6.1.2 Consideration of metabolites
Please refer to the core assessment.
Part B – Section 6
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6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)
Please refer to the core assessment.
Consequences for authorization:
none
6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1,
KPC 10.1.2)
For all other focal species please refer to the core assessment. For refinement of woodmouse Apodemus
sylvaticus please refer to table beneath.
Table 6.3-1: Refinement of reproductive risk assessment for small omnivorous mammals
“mouse”, small insectivorous mammal “shrew” and large herbivorous mammals
“lagomorphs” exposed to Metamitron according to EFSA Journal (2009) in sugar
beets. For details see text
Intended
use
Species/BB
CH stage
Diet
composition
MAF
x twa
FIR/
bw
PD RUD PT DDD Endpoint TER
[mg/kg
bw/d]
[mg/kg
bw/d]
Wood mouse, Intended use 2 (1 x 1575 g a.s./ha + 3 x 525 g a.s./ha),
01 Sugar beet
BBCH 10-
39
Apodemus
sylvaticus
25% non-
grass herbs
2.2x0.
53
0.07 1 28.7 1 3.518 36.4
2.6
25% ground
arthropods
(with
interception)
2.2x0.
53
0.07 1 3.5 1 0.429
50%weed
seeds 2.2x0.
53
0.13 1 40.2 1 9.854
Wood mouse
Early stages of beet fields do not provide sufficient plant cover for small mammals. Studies estimating the reaction
of wood mice to fields with sparse vegetation will help to estimate the exposure more realistically.
In the study conducted by Todd et al. (2000)1 23 wood mice were radio tracked in winter and spring (November –
March) and 56 in summer (June – August) in arable habitat. The preferred macrohabitat of the wood mouse in arable
land were hedgerows. In the study conducted by Tew et al. (2000)2 48 wood mice were radio tracked and microhab-
itats were recorded. In their study they found that wood mice avoided foraging in areas with a high abundance of
bare earth. On such fields, predatory risk to feeding mice is high. This finding is also confirmed by Green (1979)3,
who showed that fields with bare soil surface are not attractive feeding areas for mammals.
1 Todd I.A., Tew T.E. and Macdonald D.W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 1. Macrohabi-
tatJ.Zoo., Lond. 250, 299-303 2 Tew, T. E., Todd, I. A. & Macdonald, D. W. (2000): Arable habitat use by wood mice (Apodemus sylvaticus). 2. Microhabitat.
Journal of Zoology (London), 250, 305-311. 3 Green, R. 1979. The ecology of Wood mice (Apodemus sylvaticus) on arable farmland. Journal of Zoology, 188: 357–377.
Part B – Section 6
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The predominant feeding habitats of a wood mouse are thick grass, woodland, arable land, heather and sand dunes
(Mammals Bible4). They need cover protection for themselves and their offspring such as stone walls, hedgerows,
gardens and even buildings if unoccupied. Beet fields at early BBCH stages do not provide such cover. Due to the
absence of cover protections, it is unlikely that wood mouse will exclusively forage in beet fields in early BBCH
stages. Thus a reduced PT value of 0.8 is much more realistic and will be considered in a refined risk assessment.
01
Sugar beet
BBCH 10-
39
Apodemus
sylvaticus
25% non-
grass herbs
2.2x0.
13*
(refert
to
refine
ment
of
rabbit)
0.07 1 28.7 0.8 0.690 4.1
25% ground
arthropods
(with
interception)
2.2x0.
53
0.07 1 3.5 0.8 0.343
50%weed
seeds 2.2x0.
53
0.13 1 40.2 0.8 7.883
In cases where the relevant model species for assessment of the risk from the intended uses of Metamitron
is a mouse (e.g. Apodemus sylvaticus) or a vole, the TER acceptability criterion may be modified. In terms
of size and potential exposure, mice and voles already represent the ‘worst case’ for agricultural areas in
Europes' central zone. Furthermore, the toxicological endpoints and effect values for the assessment are
determined on phylogenetically closely related species. Hence, a TER ≥ 5 in the acute exposure scenario
and a TER ≥ 2 in the long-term exposure scenario may be accepted as sufficient. It should additionally be
noted that there are currently no indications for a significant impact of pesticides on the population dynam-
ics of mice or voles in the agricultural landscape, which are apparently determined by other biological
factors (e.g. periodical increases in vole populations creating the necessity for control measures).
The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the in-
tended use of GOLTIX TITAN in beets according to the label.
Consequences for authorization:
none
6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC
10.1.3)
Please refer to the core assessment.
4 Gurney, J. E., Perett, J., Crocker, D. R. & Pascual, J. A. (1998): Mammal bible. Mammals and farming: information for risk
assessment. Contract PN0910/PN0919. pp. 2-223. York: Central Science Laboratory; Project No. M37
Part B – Section 6
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Consequences for authorization:
none
6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)
6.5.1 Overview
Results of aquatic risk assessment for the intended for uses of GOLTIX TITAN in beets based on FOCUS
Surface Water PEC values is presented in the Core assessment, Part B, Section 6, chapter 6.5
For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i)
spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to
allow risk mitigation measures separately for each entry route. Hence, aquatic risk assessment differs from
those in the core assessment.
The risk assessment for aquatic organism for authorization of GOLTIX TITAN is outlined in the following
chapters.
6.5.2 Toxicity
Please refer to the core assessment.
6.5.3 Justification for new endpoints
Please refer to the core assessment.
6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1)
The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with
the recommendations of the “Guidance Document on Aquatic Ecotoxicology”, as provided by the Com-
mission Services (SANCO/3268/2001 rev.4 (final), 17 October 2002).
Mixture Toxicity
According to EFSA conclusion report on the active substance Quinmerac, the active substance Metamitron
in the formulation GOLTIX TITAN can be considered to drive the toxicity of the formulation for aquatic
organisms. A model often used to estimate the toxicity of mixtures is the assumption of dose/concentration
additivity of toxicity (Finney approach of concentration additivity of toxicity; Finney, D.J., 1948 and 1971).
Toxicity studies on acute and chronic effects of the active substances and GOLTIX TITAN to aquatic or-
ganisms are available. For a more detailed assessment of mixture toxicity, a surrogate LC50 or EC50 can be
calculated. However, reliable results can only be expected for combinations of ECX values for the same
biological endpoint. Moreover, the use of NOEC values, which are strongly depending on dose-spacing,
would introduce additional bias in the calculations.
The following formula is used to derive a surrogate LC50 or EC50 for the mixture of active substances with
known toxicity assuming concentration additivity:
Part B – Section 6
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( )( )
( )
1
50
50
−
= ∑
i i
i
.s.aLC
.s.aXmixLC
where:
X(a.s. i) = fraction of active substance (i) in the mixture expressed as:
X(Metamitron) = 525 g a.s./kg / (525 g Metamitron/kg + 40 g Quinmerac/kg) = 0.93
X(Quinmerac) = 40 g a.s./kg / (525 g Metamitron /kg + 40 g Quinmerac/kg) = 0.07
LC50(a.s. i) = acute toxicity value for active substance (i)
Because of the direct proportionality of the calculated TER to the LC50, it is possible to calculate a
TER(mix) with the following formula:
1
)TER(a.s.
1TER(mix)
−
= ∑
i i
where:
TER(a.s.i)= calculated TER for the active substance i
6.5.4.1 TER values for the entry into surface water via spraydrift and deposition
following volatilization
The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel-
meier. Active substance Metamitron and Quinmerac have a vapour pressure of < 10-5 Pa and are therefore
classified as non-volatile. Hence, deposition following volatilization has not been considered. The input
parameters for Metamitron and Quinmerac are given in Section 5.5.6
Several ecotoxicological endpoints are available to assess the risk of the active substances Metamitron,
Quinmerac and the formulation GOLTIX TITAN (see chapter 6.5.2). The choice of the relevant scenario
is based on the ratio of endpoint to the highest PEC for each active substance and the formulation, related
to the relevant trigger TER value.
Table 6.5-1: Decision making of the relevant scenario for risk assessment of aquatic organisms
based on the lowest ratio of TER to safety factor
Substance Max.
application rate
Drift factor Max. PEC
(act)
Endpoint,
Species, safety
factor
TER TER/SF
[g/ha] % [µg/L] [µg/L]
Quinmerac 1 x 120 +
3 x 40
74th 1.470 3160
Oncorhynchus
mykiss
SF= 10
2150 215
Metamitron 1 x 1575 +
3 x 525
74th 19.291 1.12
Mesocosm
58.1 19.4
Part B – Section 6
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SF=3
PEC: predicted environmenral concentration; TER: Toxicity exposure ratio; SF: Safety factor
Based on the table above, endpoint from Mesocosm study provides for Metamitron the lowest TER/SF ratio
and is therefore the relevant scenario for risk assessment.
Table 6.5-2: Risk assessment for Metamitron for aquatic organisms for the entry route via spray-
drift and deposition following volatilization under the implementation of different
risk mitigation measures
Compound: Metamitron
Crop/Application rate: 1 x 1575 +3 x 525 g a.i./ha
Growth stage and season 0-19 BBCH
Intended use group: 1
DT50 water (SFO): 1000 (default)
PEC-selection: actual
Drift-Percentile: 74th
Buffer
zone
Entry via
spraydrift
Entry via
deposition
following
volatilization
PECsw; conventional and drift reducing technique
0% conv. 50% red. 75% red. 90% red.
[m] [%] [µg/ha] [%] [µg/L] [µg /L]
1 1.85 1.470 1.470 0.735 0.367 0.147
5 0.38 0.302 0.302 0.151 0.075 0.030
10 0.19 0.151 0.151 0.075 0.038 0.015
15 0.13 0.103 0.103 0.052 0.026 0.010
20 0.10 0.079 0.079 0.040 0.020 0.008
Relevant toxicity endpoint: NOEAEC = 1.12 mg a.s./L, multispecies mesocosm
Relevant TER: 3
Buffer zone [m] TER
1 2150.0 4299.9 8599.9 21499,7
Risk mitigation measures none
PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
6.5.4.2 TER values for the entry into surface water via run-off and drainage
The concentration of the active substance Metamitron in adjacent ditch due to surface runoff and drainage
is calculated using the model EXPOSIT 3.01. The input parameters for Metamitron for exposure modelling
with EXPOSIT 3.01 are given in the German National Addendum Section 5, chapter 5.6.2.
Table 6.5-3: Risk assessment for Metamitron for aquatic organisms for the entry route via run-
off and drainage under the implementation of different risk mitigation measures
Compound: Metamitron
Part B – Section 6
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Application rate: 1 x 1575 +3 x 525 g a.i./ha
Intended use 1
Relevant toxicity endpoint: NOEAEC = 1.12 mg a.s./L, multispecies mesocosm
Relevant TER: 3
Run-off
Buffer zone
[m]
PEC
[µg/L]
TER
0 17.94 62.4
5 15.55 72.0
10 13.33 84.1
20 9.33 120.1
Drainage
Time of application PEC TER
[µg/L]
Autumn/winter/early spring 18.08 61.94
Spring/summer 5.88 190.6
Risk mitigation measures -none
PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.
6.5.4.3 Consideration of Metabolites
Please refer to the core assessment.
6.5.5 Overall conclusions
Based on the calculated concentrations of Metamitron and Quinmerac in surface water (EVA 2.1, EXPOSIT
3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic
organisms to Metamitron according to the GAP of the formulation GOLTIX TITAN achieve the accepta-
bility criteria TER ≥ 3 (multispecies mesocosm), according to commission implementing regulation (EU)
No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. for long-term effects. The results of the
assessment indicate an acceptable risk for aquatic organisms due to the intended use of GOLTIX TITAN
in beets according to the label.
Consequences for authorization:
For the authorization of the plant protection product GOLTIX TITAN following labeling and conditions
of use are mandatory:
Required Labelling
NW 262 EbC50Metamitron = 0.4 mg/L (P. subcapitata; EC50Goltix Titan = 2.0 mg/L (P.
subcapitata)
Part B – Section 6
National Addendum – DE
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Central Zone
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Date May 2015
NW 263 LC50Metamitron = 5.7 mg/L (D. magna)
NW 265
EbC50Metamitron = 0.4 mg/L (L. gibba); ErC50Goltix Titan = 3.66 mg/L (L.
gibba)
Conditions for use
GOLTIX TITAN NW 468
use No. 2 NW 642
6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)
Please refer to the core assessment and the risk assessment outcome as provided by JKI.
Consequences for authorization:
none
6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)
Please refer to the core assessment.
Consequences for authorization:
None
6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC
10.4.1, KPC 10.4.2)
Please refer to the core assessment.
6.8.1 Justification for new endpoints
Please refer to the core assessment.
6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna,
TERA and TERLT (MIIIA 10.6.1)
The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance
with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the
Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).
For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the
environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values
Part B – Section 6
National Addendum – DE
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for the active substances Metamitron and the major soil degradation products are presented in the table
below.
As written in Sec. 5 core assessment chapter 5.5 no Pec Soil calcualton s for Quinmerac were carried out.
Explanation: according to section 6 of the first Registration Report for GOLTIX TITAN the TER values in
soil for quinmerac and its soil metabolites were above the respective TER values for metamitron and far
above the trigger. Therefore it was concluded that no calculation of PECsoil for quinmerac and its soil me-
tabolites is necessary, as the risk is covered by the assessment of metamitron and the formulation.
For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Ku-
biak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirk-
stoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ
360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is
applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density
1.5 g cm-3is assumed.
The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure
to Metamitron as well as the major soil degradation products of Metamitron was assessed by comparing
the maximum PECSOIL with the 14-day LC50 value to generate acute TER values. The TERA was calculated
as follows:
The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breack-
down resulting from an exposure to GOLTIX TITAN and Metamitron as well as the major soil degradation
products of Metamitron was assessed by comparing the maximum PECSOIL with the NOEC value to gener-
ate chronic TER values. The TERLT was calculated as follows:
The results of the risk assessment are summarized in the following table.
Table 6.8-1: TER values for earthworms and other soil macro- and mesofauna (Tier-1) for Met-
amitron for the use in beets
TER values shown in bold fall below the relevant trigger.
Species Test item Time scale Endpoint Max. PECact
worst case
TER
[mg/kg soil dw] [mg/kg soil dw]
Eisenia fetida Metamitron Acute 914 5.5123 165.8
Chronic 28 5.5123 5.1
Desamino-
Metamitron
Acute >500 corr. 1.6790 297.8
(mg/kg) PEC
(mg/kg) LC=TER
soil
50
A
(mg/kg) PEC
(mg/kg) NOEC=TER
soil
LT
Part B – Section 6
National Addendum – DE
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GOLTIX TITAN Acute 1000 14.400 69.4
Chronic 100 14.400 6.94
Folsomia
candida
Desamino-
Metamitron
Chronic 100 1.6790 59.8
6.8.3 Higher tier risk assessment
Not relevant.
6.8.4 Overall conclusions
Based on the predicted concentrations of Metamitron/ GOLTIX TITAN in soils, the TER values describing
the acute and longterm risk for earthworms and other non-target soil organisms following exposure to Met-
amitron/ GOLTIX TITAN according to the GAP of the formulation GOLTIX TITAN achieves the accept-
ability criteria TER ≥ 10 resp. TER ≥ 5 according to commission implementing regulation (EU) No
546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an
acceptable risk for soil organisms due to the intended use of GOLTIX TITAN in beets according to the
label.
Consequences for authorization:
none
6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)
Please refer to the core assessment.
6.9.1 Justification for new endpoints
Please refer to the core assessment.
6.9.2 Risk assessment
The evaluation of the risk for earthworms was performed in accordance with the recommendations of the
“Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services
(SANCO/10329/2002 rev 2 (final), October 17, 2002).
Please refer to above for the predicted environmental concentrations in soil (PECSOIL) of Metamitron, Quin-
merac and GOLTIX TITAN.
The results of the risk assessment are summarized in the following table.
Part B – Section 6
National Addendum – DE
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Table 6.9-1: Risk assessment for effects on soil micro-organisms
Test substance Test concentration
(adverse effects < 25%)
PECSOIL Risk acceptable
GOLTIX TITAN (AG-
QMM1-565 SC) 31.04 mg prep./kg soil
14.40 Yes
Quinmerac 16.5 mg a.s./kg soil 0.4829* Yes
Metamitron 19.5 mg a.s./kg soil 5.5123 Yes
BH 518-2 0.83 mg a.s./kg soil 0.2319* Yes
BH 518-5 0.42 mg a.s./kg soil 0.1851* Yes
Desamino-Metamitron 21.73 mg a.s./kg soil 1.6790 Yes
*Pecsoil values for Quinmerac and its metabolites from main application proposal GOLTIX TITAN
(007529-00-00) National assessment
6.9.3 Overall conclusions
Based on the predicted concentrations of Metamitron, Quinmerac and GOLTIX TITAN in soils, the risk to
soil microbial processes following exposure to Metamitron, Quinmerac and GOLTIX TITAN according to
the GAP of the formulation GOLTIX TITAN is considered to be acceptable/ not acceptable according to
commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point
2.5.2.
Consequences for authorization:
none
6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)
6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1)
Please refer to the core assessment.
Consequences for authorization:
None
Part B – Section 6
National Addendum – DE
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Draft Registration Report
Central Zone
Page 16 of 17
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Date April 2015
Appendix 1 Table of Intended Uses in Germany (according to BVL 2014-04-14)
PPP (product name/code) Goltix Titan
active substance 1 Metamitron
active substance 2 Quinmerac
Formulation type: SC
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Applicant: ADAMA
Zone(s): central/EU
professional use X
non professional use
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination / pur-
pose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally: developmen-
tal stages of the pest or
pest group)
Application Application rate PHI
(days)
Remarks:
e.g. safener/synergist per ha
e.g. recommended or manda-
tory tank mixtures
Method /
Kind
Timing / Growth
stage of crop & sea-
son
Max. number
(min. interval
between appli-
cations)
a) per use
b) per crop/
season
kg, L product /
ha
a) max. rate per
appl.
b) max. total rate
per crop/season
g, kg as/ha
a) max. rate
per appl.
b) max. total
rate per
crop/season
Water L/ha
min / max
001 DE Sugar beet
BEAVA
fodder beet
BEAVC
F TTTMS
TTTDS
Spraying
splitting 4
applications
Spring
BBCH 00 – 19
1st treatment before-
emergence
2nd to 4th treatment
after emergence
a) 4
b) 4
the 2nd to 4th
treatment with
an interval of 5
to 10 days
a)
timing 1:
3 L/ha
timing 2-4:
1 L/ha
a)
timing 1:
Metamitron
1575 g as/ha
Quinmerac
120 g as/ha
timing 2-4:
Metamitron
525 g as/ha
200 - 400 *XF
Part B – Section 6
National Addendum – DE
GOLTIX TITAN
Draft Registration Report
Central Zone
Page 17 of 17
Applicant: ADAMA Evaluator: zRMS DE
Date April 2015
b) 6 L/ha
maximum appli-
cation rate for
the intented crop
per year
Quinmerac
40 g as/ha
b)
Metamitron
3150 g as/ha
Quinmerac
240 g as/ha
maximum ap-
plication rate
for the intented
crop per year
*The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in
days is not required resp.
Remarks: (1) Numeration of uses in accordance with the application/as verified by MS
(2) Member State(s) or zone for which use is applied for
(3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use sit-
uation should be described (e.g. fumigation of a structure)
(4) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages
(6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Black-
well, ISBN 3-8263-3152-4), including where relevant, information on season at time of applica-
tion
(8) The maximum number of applications possible under practical conditions of use for each single
application and per year (permanent crops) or crop (annual crops) must be provided
(8) Min. interval between applications (days) were relevant
(10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season
must be given in metric units (e.g. kg or L product / ha)
(11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per
crop/season must be given in metric units (e.g. g or kg / ha)
(12) The range (min/max) of water volume under practical conditions of use must be given
(L/ha)
(13) PHI - minimum pre-harvest interval
(14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc.
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REGISTRATION REPORT
Part B
Section 7: Efficacy Data and Information
Detailed Summary
Product Code: Goltix Titan / AG-QMM1-565 SC
Reg. No.: 007529-00/01
Active Substance: metamitron 525 g/L +
quinmerac 40 g/L
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT
Applicant: Applicant: ADAMA Deutschland GmbH
Date: January 2014 (Label Extension)
Evaluator: Julius Kühn-Institut
Date: 2015-02-06
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Table of Contents
IIIA1 6 Efficacy Data and Information on the Plant Protection Product ............................ 3
General information ............................................................................................. 3
Recent registration situation/history of the PPP ................................................... 3
Information on the active ingredients (Uptake and mode of action) ..................... 3
Information on crops and pests ........................................................................... 4
Information on the intended uses for Germany .................................................... 4
IIIA1 6.1 Efficacy data........................................................................................................ 5
IIIA1 6.1.1 Preliminary range-finding tests ............................................................................ 5
IIIA1 6.1.2 Minimum effective dose tests .............................................................................. 5
IIIA1 6.1.3 Efficacy tests ....................................................................................................... 6
IIIA1 6.1.4 Effects on yield and quality .................................................................................. 8
IIIA1 6.1.4.1 Impact on the quality of plants and plant products ............................................... 8
IIIA1 6.1.4.2 Effects on the processing procedure ................................................................... 9
IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...................................... 9
IIIA1 6.2 Adverse effects ................................................................................................... 9
IIIA1 6.2.1 Phytotoxicity to host crop..................................................................................... 9
IIIA1 6.2.2 Adverse effects on health of host animals ......................................................... 10
IIIA1 6.2.3 Adverse effects on site of application ................................................................ 10
IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) ................................ 10
IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...................... 11
IIIA1 6.2.6 Impact on succeeding crops .............................................................................. 11
IIIA1 6.2.7 Impact on other plants including adjacent crops ................................................ 12
IIIA1 6.2.8 Possible development of resistance or cross-resistance ................................... 12
IIIA1 6.3 Economics ........................................................................................................ 14
IIIA1 6.4 Benefits ............................................................................................................. 14
IIIA1 6.4.1 Survey of alternative pest control measures ...................................................... 14
IIIA1 6.4.2 Compatibility with current management practices including IPM........................ 14
IIIA1 6.4.3 Contribution to risk reduction ............................................................................. 15
IIIA1 6.5 Other/special studies ......................................................................................... 15
IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...................... 15
IIIA1 6.7 List of test facilities including the corresponding certificates .............................. 16
Appendix 1: List of data submitted in support of the evaluation ............................................. 17
Appendix 2: GAP Table ........................................................................................................ 27
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IIIA1 6 Efficacy Data and Information on the Plant Protection Product
General information
This document summarises the information related to the efficacy data for a label extension of the plant protection product AG-QMM1-565 SC (in Germany: Goltix Titan). AG-QMM1-565 SC is a herbicide for the control of annual weeds in fodder- and sugar beet. It contains the active ingre-dients metamitron and quinmerac. AG-QMM1-565 SC (Goltix Titan) was authorised in Germany on December 20th, 2012 for the post-emergence control of annual dicotyledonous weeds in fod-der- and sugar beets (Registration N°: 007529-00). Further authorisations for this indication cur-rently exist in Belgium (GOLTIX QUEEN: Registration N° 10238P/B) and the Netherlands (GOLTIX QUEEN: Registration N° 14298 authorised on Dec. 6th, 2013). Metamitron was added to the list of approved active substances contained in Commission Imple-menting Regulation (EU) No 540/2011 (date of approval 01/09/2009). The inclusion expires on 31/08/2019. Rapporteur Member State is Great Britain. Quinmerac was added to the list of approved active substances contained in Commission Imple-menting Regulation (EU) No 540/2011 (date of approval 01/05/2011). The inclusion expires on 30/04/2021. Rapporteur Member State is UK. According to the EPPO standard PP1/241 (zones of comparable climate in the EPPO region) Germany, Belgium and the Netherlands are part of the maritime EPPO zone.
Zonal rapporteur member state (zRMS) and concerned member states (cMS).
zRMS Germany DE
cMS Belgium, Netherlands BE, NL
Recent registration situation/history of the PPP
Both active substances are registered in Germany and in countries of zone B in different herbicidal products. Metamitron is presently registered as a component of several other herbicides for the control of annual weeds in sugar- and fodder beet. Examples from Germany are: Reg.-No.: 006470-00 [Goltix Gold], 024081-00 [Tornado], 005338-00 [Beetix SC], 024169-00 [Completto], 005428-00 [Betanal Quattro]. The active ingredient Quinmerac is presently authorised for weed control in sugar beet as a com-ponent of the herbicide Rebell (Reg.-No.: 024105-00 [Germany]). The test product AG-QMM1-565 SC is not registered in any country of the EU yet.
Information on the active ingredients (Uptake and mode of action)
Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used in fodder- and sugar beets for the control of mono- and dicotyledonous weeds. Primarily it is taken up by plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron transport at the photosystem II receptor site (Hill-reaction). Plant uptake is influenced by many factors: temperature, humidity, soil moisture and sorption properties of the soil. Selectivity of weeds is based on different metabolisation. Susceptible weed seedlings be-come chlorotic, exhibit yellowed and cleared discolouration and finally get withered. Metamitron is highly selective in fodder and sugar beets. Metamitron is readily degraded by aqueous photol-ysis. The major metabolite in sugar beet is deaminated metamitron. The further degradation takes
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place by opening of the heterocyclic ring. A main metabolite in sugar beet is 3-methyl-6-phenyl-1,2,4-triazin-5(4H)-on. Site of action (HRAC-group): C1 Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake by roots and the onset of activity. Uptake by leaves depends on the concen-tration of the active ingredient and time. Light increases the uptake rate. In contrast dependence on temperature is slight. Its mode of action has been proposed as root growth inhibition which exhibits auxin type effects (similar to phenoxycarboxylic acids). Based on the auxin effects quin-merac stimulates the formation of the phytohormone ethylene in sensitive plants, leading to epi-nasty, altered uptake and other effects. In the biosynthesis the enzymatic activity of 1-aminocy-clopropane-1-carboxylic-acid synthase will be induced. As a result an accumulation of abscisic acid (ABA) in the plant tissue occurs. The consequences are: deformation of plants, occlusion of stomata, inhibition of transpiration, CO2-assimilation and growth as well as the death of plant cells. The selective effect is based on plant tissue/target location selectivity in crop plants. In sugar beet the tolerance is supported by a faster degradation. Uptake and translocation has no great signif-icance for herbicide efficacy. Plant metabolism studies showed that hydroxylation of the quinoline ring and hydroxylation/car-boxylation of the 3-methyl-quinoline moiety and subsequent carbohydrate conjugation are the primary metabolic pathways of quinmerac. Major metabolites identified were 7-chloro-3-hy-droxymethyl quinoline-8.carboxylic acid and 7-chloro-quinoline-3,8-dicarboxylic acid. Site of ac-tion (HRAC-group): O
Information on crops and pests
According to the importance (occurrence, cultivation) in the member states (MS) the intended target/crop can be classified in Germany as follows: Table 6.0-1: Importance of intended target/crop in Germany
target/crop EPPO Country Classification
target
annual dicotyledonous weeds
TTTDD Germany major
annual monocotyledonous weeds
TTTMS Germany major
Crop
Sugar beet BEAVA Germany major
Fodder beet BEAVC Germany minor
Information on the importance of crops and pests for Belgium and the Netherlands is not reported sufficiently by the applicant.
Information on the intended uses for Germany
2014-06-24 Goltix Titan Use No. 007529-00/01-001 Field of use Agriculture (field crops) Crop(s)/object(s) fodder beet (BEAVC), sugar beet (BEAVA) Crop stage(s) (BBCH) 00 to 19
Formatiert: Links
Formatiert: Links
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Pest(s)/target(s) annual monocotyledonous weeds (TTTMS)*, annual dicotyle-donous weeds (TTTDS)
Area of application Outdoors Timing of application Spring, before emergence (1st treatment), after emergence (2nd to
4th treatment) Notes on time of treat-ment
the 2nd to 4th treatment with an interval of 5 to 10 days
Max. number of treat-ments for the use
4
Max. number of treat-ments per crop or sea-son
4
Application method/kind of treat-ment
spraying
Remarks on application method
splitting (4 applications)
Application rate(s) timing 1: 3 L/ha in 200 to 400 L water/ha timing 2: 1 L/ha in 200 to 400 L water/ha timing 3: 1 L/ha in 200 to 400 L water/ha timing 4: 1 L/ha in 200 to 400 L water/ha
Notes on application rate
maximum application rate for the intended crop per year 6 L/ha
*withdrawn by letter of applicant from 2015-01-13. The new indication No. 002 (label extension) in the GAP list in App. 2 for AG-QMM1-565 SC is intended for Belgium and the Netherlands.
IIIA1 6.1 Efficacy data
IIIA1 6.1.1 Preliminary range-finding tests
The applicant indicates that the active substances of AG-QMM1-565 SC, metamitron and quin-
merac, are authorised and widely used for weed control in many countries inside and outside of
Europe. It is therefore not deemed necessary to provide results from preliminary range finding
tests.
IIIA1 6.1.2 Minimum effective dose tests
An overview of trials presented for the purpose ‘minimum effective dose’ is given in Table 6.1.2-1. Table 6.1.2-1: Overview and distribution of field trials carried out to determine the minimum effec-tive dose EU zone EPPO zone Country Year: 2012 Central Maritime BE 2 DE 4 NL 4 Sum 10
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In 10 trials carried out in 2012 AG-QMM1-565 SC was tested to determine the minimum effective dose. The reduced tested rates of AG-QMM1-565 SC were 2.4+3x0.8 L/ha and 1.5+3x0.5 L/ha. The rate range reflects 60%, 80% and 100% of the full recommended application rate of AG-QMM1-565 SC, in accordance with the EPPO standard PP1/225(1) “Minimum effective dose”. Efficacy is tested under a range of environmental conditions to fully challenge the product. The trials were carried out in Germany, Belgium and the Netherlands (all EC Central zone; maritime EPPO zone). They were of a randomised block design with four replicates and a minimum plot size of 17.5 m2. Reference products were Goltix Gold (Goltix SC) either as single product splitting applications or as pre-emergence applications followed by common spraying sequences at au-thorised rates. The dose response results against some target weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is increased, if rates lower than 3+3x1 L/ha of AG-QMM1-565 SC are applied (table 6.1.2-2). Table 6.1.2-2: Efficacy (% control) of different rates of AG-QMM1-565 SC against target weed species in 2012
EPPO code
Scientific Name
n
1.5+3x0.5 L/ha (50%)
2.4+3x0.8 L/ha (80%) 3+3x1 L/ha (100%)
Ø Med Min Max Ø Med Min Max Ø Med Min Max
POAAN Poa annua 2 100 100 100 100 100 100 100 100 100
CHEAL Chenopodium album
5 68 69 29 96 79 87 53 99 91 95 79 100
POLPE Polygonum persicaria
4 94 96 85 99 96 96 93 100 92 97 74 99
VIOAR Viola arvensis 4 80 88 54 91 87 92 64 99 94 94 90 99
AETCY Aethusa cynapium
3 85 99 55 100 97 99 91 100 100 100 99 100
CAPBP Capsella bursa-pastoris
3 100 100 99 100 100 100 99 100 100 100 100 100
FUMOF Fumaria offici-nalis
3 36 18 0 91 65 93 10 93 72 91 26 98
GALAP Galium apa-rine
3 80 75 66 100 84 76 75 100 89 91 75 100
STEME Stellaria media 3 95 99 85 100 94 99 84 100 93 100 78 100
Conclusion The dose response results against some target weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is in-creased, if rates lower than 3+3x1 L/ha of AG-QMM1-565 SC are applied.
IIIA1 6.1.3 Efficacy tests
A total of 17 trials were carried out in 2010, 2011, and 2012 to evaluate the efficacy of AG-QMM1-565 SC for the control of the target weed species in fodder- and sugar beet. All of them were conducted to GEP and followed the appropriate EPPO standards (PP1/52 “Weeds in sugar and fodder beet”, PP1/152 “Design and Analysis of Efficacy Evaluation Trials”, PP1/181 “Conduct and Reporting of Efficacy Evaluation Trials”). The field trials were of a random-ized complete block design with four replicates and a minimum plot size of 17.5 m2. Trials included
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a range of locations to determine efficacy against the target weed species on a number of com-mercially grown varieties of the target crops under a range of conditions. All the trials were placed within regions where fodder- and sugar beets are commonly grown. The trials presented in this dossier for the European Central regulatory zone have been carried out in Belgium, Germany and the Netherlands in the maritime EPPO zone (according to EPPO standard PP1/241(1) “Guidance on comparable climates”. Table 6.1.3-1 presents the distribution of the trials over years and countries. Table 6.1.3-1: Overview and distribution of field trials carried out to determine the efficacy of AG-QMM1-565 SC on target weeds species in fodder- and sugar beet
EU zone EPPO zone Country Year
Sum 2010 2011 2012
Central Maritime BE 2 2 DE 4 4 NL 4 3 4 11 Sum 4 3 10 17
The applied application rate of AG-QMM1-565 SC was 3 L/ha pre-emergence followed by up to 3 post-emergence splitting applications of 1 L/ha each. Reference products were Goltix Gold, Goltix 700 SC and application sequences consisting of different products used in practice com-monly. In all GEP compliant efficacy trials weed control was assessed according to EPPO standards, with a series of visual assessments of % control in relation to an untreated plot. Either weed cover was recorded as plants/m2 or populations were recorded using a % ground cover score. Across the trials visual weed assessments were done up to 4 times. A summary of the results from tests carried out in 2010, 2011, and 2012 is presented in Table 6.1.3-2. Table 6.1.3-2: Efficacy (% control) of AG-QMM1-565 SC against target weed species
Weed Species n
AG-QMM1-565 SC Reference Product(s)
EPPO Code
Scientific Name Ø Med Min Max Ø Med Min Max
POAAN Poa annua 2 100 100 100 100 100 100
ECHCG Echinochloa crus-galli 2 28 0 56 99 98 100
CHEAL Chenopodium album 8 85 85 71 100 97 98.5 88 100
VIOAR Viola arvensis 5 92 92 86 99 95 94 89 100
POLPE Polygonum persicaria 5 87 97 68 99 94 99 76 100
STEME Stellaria media 5 86 78 29 100 96 100 86 100
AETCY Aethusa cynapium 3 100 100 99 100 79 93 43 100
CAPBP Capsella bursa-pastoris 3 100 100 100 100 100 100 100 100
LAMPU Lamium purpureum 3 98 100 94 100 98 100 95 100
GALAP Galium aparine 3 89 91 75 100 88 91 75 97
FUMOF Fumaria officinalis 3 72 90.8 26 98 70 100 11 100
POLCO Fallopia convolvulus 3 71 67 50 96 65 78 17 100
POLAV Polygonum aviculare 3 59 60 43 75 82 81 65 100
MATCH Matricaria chamomilla 2 100 100 100 100 99 100
VERSS Veronica 2 100 100 100 97 94 100
LAMAM Lamium amplexicaule 2 89 83 95 99 98 100
SOLNI Solanum nigrum 2 74 71 77 100 100 100
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Weed Species n
AG-QMM1-565 SC Reference Product(s)
EPPO Code
Scientific Name Ø Med Min Max Ø Med Min Max
MERAN Mercurialis annua 2 58 18 99 96 93 100
MATSS Matricaria 1 100 100
AMARE Amaranthus retroflexus 1 100 100
SENVU Senecio vulgaris 1 100 100
SSYOF Sisymbrium officinale 1 100 100
GASPA Galinsoga parviflora 1 98 100
URTUR Urtica urens 1 98 100
ATXPA Atriplex patula 1 90 100
POLTO Polygonum tomentosum 1 50 81
SINAR Sinapis arvensis 1 43 95
Conclusion Based on the results it can be concluded AG-QMM1-565 SC provides sufficient control of a num-ber of annual dicotyledonous weed species in fodder and sugar beets. POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous species didn´t occur in the efficacy trials. So a final evaluation for annual monocotyledonous species is not possible. Member States should consider the levels of control achieved according to National conventions.
IIIA1 6.1.4 Effects on yield and quality
To evaluate the effects of AG-QMM1-565 SC on yield and quality it is focused on the specific weed free yield trials.
IIIA1 6.1.4.1 Impact on the quality of plants and plant products
Quality parameters being determined in the tests are the sugar content and the components so-dium, potassium and amino-N. The adjusted sugar content is presented in this report as the result of these parameters. The sugar content and the components sodium, potassium and α-amino-N were determined in 8 selectivity trials. The adjusted sugar content was calculated by the author using the 'Braunschwei-ger formula'. The results are presented in Table 6.1.4-1. They demonstrate that there is no influ-ence on the sugar content or the adjusted sugar content of beets by AG-QMM1-565 SC, even if the product is applied at double rate. Table 6.1.4-1: Influence of AG-QMM1-565 SC applied at target rate (3 L/ha pre- + 3x1 L/ha post-emergence) and double rates on the sugar content of sugar beets
No.
Sugar content [%] Adjusted sugar content [%]
Con- trol
AG-QMM1-565 SC
Ref. Prod. Con- trol
AG-QMM1-565 SC
Ref. Prod.
3+3x 1 L/ha
6+3x 2 L/ha
X-rate 2X-rate 3+3x
1 L/ha 6+3x
2 L/ha X-rate 2X-rate
1 18.14 17.76 18.08 18.52 16.10 15.75 16.00 16.20 2 18.52 19.12 19.22 19.06 16.72 17.29 17.39 17.18 3 16.57 16.68 17.15 16.73 14.82 14.94 15.38 14.96 4 14.21 14.17 14.16 14.14 12.12 12.06 12.07 12.01 5 15.36 15.10 15.81 15.33 13.63 13.37 14.05 13.59 6 15.32 15.69 15.40 15.39 15.68 13.20 13.53 13.27 13.27 13.50
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7 16.19 16.16 16.21 16.18 16.36 13.94 13.92 13.92 13.94 14.10 8 15.30 15.29 15.00 14.91 15.25 13.46 13.46 13.15 13.07 13.40 Ø 16.20 16.24 16.38 16.28 15.76 14.25 14.29 14.40 14.28 13.67
Conclusion: Based on the results of 8 trials carried out in sugar beets in Germany and the Netherlands during the cropping season 2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant products in sugar or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rates there is no substantial risk for an impact on plant or plant products.
IIIA1 6.1.4.2 Effects on the processing procedure
Since the market introduction of the active ingredients metamitron and quinmerac no cases of negative influences on parameters influencing the processing procedure of sugar- or fodder beets were reported, neither from practical use nor from trial experience. Thus, no special trials were carried out for the assessment of this criterion.
IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products
Yield was taken in 8 selectivity trials carried out under almost weed free conditions. The results are presented in Table 6.1.4.3-1. Table 6.1.4.3-1: Influence of AG-QMM1-565 SC on yield quantity (relative to control) of sugar beets
No. Cultivar Control
AG-QMM1-565 SC Reference product(s) 3-3x1 L/ha 6+3x2 L/ha X-rate 2X-rate
t/ha t/ha rel t/ha rel t/ha rel t/ha rel
1 Sporta 52.3 52.4 100 52.2 100 52.4 100 2 Emilia 55.4 55.6 101 55.6 100 55.4 100
3 Schubert 99.5 98.2 99 99.6 100 96.3 97 4 Hella 61.7 62.2 101 62.3 101 62.0 100
5 Christarina 74.6 70.1 94 80.6 108 74.6 100 6 Isabella 115.1 115.7 101 112.9 98 114.5 100 111.2 97 7 Isabella 94.9 94.6 100 88.3 93 91.6 97 94.1 99
8 Fernanda 95.0 92.9 98 88.9 94 84.2 89 91.4 96 Ø 81.1 80.2 99 80.0 99 78.9 97 98.9 97
Conclusion The results demonstrate that there are no indications for a negative impact on quantity of yield in sugar- or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rate there is no substantial risk for an impact on yield quantity.
IIIA1 6.2 Adverse effects
IIIA1 6.2.1 Phytotoxicity to host crop
The effects AG-QMM1-565 SC applied in splitting applications (3 L/ha pre-emergence + 3x1 L/ha post-emergence) on the target crop were rated in a total of 25 trials (17 efficacy trials and 8 se-lectivity trials). In Table 6.2.1-1 the frequency and the magnitude of observations of phytotoxic symptoms are presented.
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Table 6.2.1-1: Crop tolerance (Phyto*[%]) of AG-QMM1-565 SC applied POST emergence at the target rates in sugar beets
AG-QMM1-565 SC / 3+3x1 L/ha Reference product(s)
Eff. trials Sel. trials All trials Eff. trials Sel. trials All trials
across the whole test pe-riod
Mean** 0.22 0 0.15 1.5 0 0.82
Maximum 3.75 0 3.75 10 0 10
N° of tests: 0% 16 8 24 14 8 22
N° of tests: >0-5% 1 0 1 1 0 1
N° of tests: >5-15% 0 0 0 2 0 2
N° of tests: >15% 0 0 0 0 0 0
N° of tests 17 8 25 17 8 25 *) phyto = general phytotoxicity or maximum value of symptoms **) averaged maximum crop injury values within the evaluation period
Conclusion The results show that AG-QMM1-565 SC is tolerated well by sugar beets. For this indication only one year results are available from trials carried out with the double rate included under almost weed free conditions (2013). So Therefore a label warning (Damage is possible to the crop.) should be considered.
IIIA1 6.2.2 Adverse effects on health of host animals
This is not an EC data requirement.
IIIA1 6.2.3 Adverse effects on site of application
This is not an EC data requirement.
IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees)
The herbicide Goltix Titan has been proposed for split applications in sugar and fodder beets with a total application rate of 6 L/ha. Taking into account the potential dissipation of the active ingre-dients between applications, the worst case application rate can be calculated to be approximately 5.4 L/ha.
The evaluation of adverse effects of the proposed use of the test product on beneficial organisms (other than bees) is covered by the assessment in the main application (007529-00/00). Conclusion At the proposed application rate of 6 L/ha and year, Goltix Titan was harmless for Aphidius rhopalosiphi and Typhlodromus pyri with effects < 25%. The two indicator species are no relevant antagonists for the proposed crops, hence no classification is proposed for them. The results for the sensitive indicator species Typhlodromus pyri and the results for spiders of the genus Pardosa with metamitron indicate that the test product will not be harmful for other, relevant predatory mites and spiders. Besides the two indicator species, only the rove beetle Aleochara bilineata was tested with SC-formulations of the both active ingredients of the test product, metamitron and quinmerac. Met-amitron was shown to be slightly harmful with an effect between 30 – 80% under worst case conditions. No effects occurred in a laboratory study with the combination product AG-QM2-500 SC and in an extended laboratory study with metamitron, but the latter test did not fulfil the validity
Formatiert: Deutsch (Deutschland)
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criteria. Thus it could not be excluded, that the test product can be slightly harmful for Aleochara bilineata. On the basis of the results of an extended laboratory study with Metamitron, the test product has to be considered as slightly harmful for the ladybird beetle Coccinella septempunctata. Classification according to IOBC: Laboratory tests on artificial substrates
< 30% = not harmful 30 – 79% = slightly harmful ≥ 80% = harmful
Extended laboratory tests on natural substrates < 25% = not harmful 25 - 50% = slightly harmful > 50% = harmful
IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes
Neither from the agricultural use of metamitron or quinmerac during the past years, nor from field trials there is any information that the application of products containing these active ingredients has any influence on the propagation behaviour of sugar beet.
IIIA1 6.2.6 Impact on succeeding crops
EC10-values of AG-QMM1-565 SC are determined. The results are demonstrated in Table 6.2-6.-1. Table 6.2.6-1: EC10-values of AG-QMM1-565 SC for the parameter fresh weight (AG-QMM1-565 SC mg/kg dry soil)
Crops
BRSNN BEAVA PIBSA TRFPR HORVS ZEAMX
EC10-value (mg/kg) 0.129 1.752 3.158 0.077 3.158 1.225
The TER-values are calculated as a quotient of the EC10-values and PECsoil. TER-values >1 indi-cate no unacceptable risk for the following crop. The results show that there is no indication by the TER-values for an unacceptable risk for all succeeding crops in common crop rotations. Out of the tested crops, red clover is the most sensitive crop to AG-QMM1-565 SC available in soil. It is followed by oil seed rape. Maize is moderately sensitive and barley, peas and sugar beets showed to be tolerant even at the highest rates tested. Table 6.2.6-2: TER- values of AG-QMM1-565 SC (3x2030 g AI/ha) for different crops at different DAAs
Days After Application (DAA)
0 10 30 60 90 120 150 240 360 Mixing Depth in soil: 5 cm
PECsoil MMN 2.739 1.999 1.064 0.414 0.161 0.062 0.024 0.001 0.000 PECsoil QMC 0.236 0.209 0.165 0.115 0.081 0.056 0.039 0.013 0.003 PECsoil Total 2.975 2.208 1.229 0.529 0.241 0.119 0.064 0.015 0.003
HORVS 1.06 1.43 2.57 6.0 13 26 49 212 978 PIBSA 1.06 1.43 2.57 6.0 13 26 49 212 978 BEAVA 0.59 0.79 1.43 3.31 7.2 14 27 118 542 ZEAMX 0.41 0.55 1.00 2.32 5.1 10 19 82 379 BRSNN 0.04 0.06 0.10 0.24 0.53 1.1 2.03 8.7 39
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TRFPR 0.03 0.03 0.06 0.15 0.32 0.65 1.21 5.2 23
Conclusion Potential impacts on succeeding crops have to be analysed on the basis of the EPPO standard PP1/207. The results show that there is no unacceptable risk for all succeeding crops in common crop rotations.
IIIA1 6.2.7 Impact on other plants including adjacent crops
The risk assessment for higher plants came to the conclusion, that the risk for all 10 species investigated following an application of AG-QMM1-565 SC is low (table 6.2.7-1). Table 6.2.7-1: Initial predicted environmental concentrations (PECini) in L/ha for the evaluation of the risk to non-target plants (use 001)
L/ha Distance
(m)
Drift values [90th percen-
tile] (%)
PECini (L/ha) Conventional
nozzles Drift reducing nozzles
50% 75% 90%
3 1 2.77 0.0831 0.04155 0.020775 0.00831 5 0.57 0.0171 0.00855 0.004275 0.00171
To assess the risk to emerged and non emerged adjacent crops, the phytotoxicity of AG-QMM1-565 SC was determined for 10 terrestrial plant species. Table 6.2.7-2: ED50-values (L/ha) of crops based on plant fresh weight
AVESA ZEAMX LOLPE ALLCE BRSNN HELAN LINUS LYCES DAUCA GLXMA
non-emer-ged plants
>2.009 >3.616 >2.009 >2.009 >1.116 >2.009 >1.116 >1.116 >1.116 >2.009
Emer-ged plants
>2.009 >3.616 >2.009 >2.009 >2.009 >3.616 >1.116 >1.116 >2.009 >3.616
Conclusion The comparison indicates that there is no risk of spray drift damage for the tested crops. Following the principles of good agriculture practice during the application, no effects on adjacent crops are expected.
IIIA1 6.2.8 Possible development of resistance or cross-resistance
Mechanism of resistance The herbicide Goltix Titan contains the active substances metamitron and quinmerac. Metamitron inhibits the photosynthesis by the inhibition of the electron transport in photosystem II. Due to this primary target site and the chemical subgroup, metamitron is classified as a HRAC group C1 herbicide (inhibition of photosynthesis at photo-system II). The other chemical groups in HRAC group C1 are: triazines, triazolinones, uracils, pyridazi-nones and phenyl-carbamates. The major reason for the reduced sensitivity of resistant weed biotypes against HRAC group C1 herbicides is a changed receptor protein psbA caused by a single SNP (Ser264Gly). The mecha-nism of resistance inherited maternal is well characterised with respect to physiological, biochem-ical and molecular processes. In addition, as it has been found in Amaranthus tuberculatus re-cently a second, nuclear inherited mechanism of resistance to triazines might exist in exceptional cases. However, plants being resistant to triazines by this mechanism are not cross resistant to
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triazinones (in this case metribuzin). Recently a new mutation has been described (Leu218Val) in Chenopodium album inducing resistance to metamitron, metribuzin and chloridazone, but not to triazines. Quinmerac belongs to the chemical group of the quinolinecarboxylic acids. Due to its primary target site and its chemical family, in the HRAC mode of action classification quinmerac is classi-fied as group O. Although the mechanism of resistance of group O herbicides has not been determined, resistance may be due to an insensitive target site.
Evidence of resistance and cross resistance HRAC group C1 herbicides are used for weed control in agricultural crops for about 50 years. Since the first observations of weeds becoming resistant to this group of herbicides in the early 1970s, worldwide further reports followed continuously until today with a peak during the 1980s and the early 1990s. In the global database of Ian Heap, 72 weed species with resistance to at least one active substance of the HRAC group C1 are listed (www.weedscience.org, accessed July 2014). In the predominant majority the cases are based on the development of weeds being resistant to triazines, but recently also some cases of metamitron resistant Chenopodium album biotypes were reported from Belgium and Germany and in Germany it was shown that Matricaria species collected from areas treated with metamitron for several years were less susceptible to this substance than species from areas that have never been treated with metamitron. Based on the HRAC resistance classification, cross resistance should be expected to be likely between metamitron (triazinones) and the other HRAC group C1 herbicides and was approved recently for metamitron, lenacil (uracil) and chloridazone (pyridazinone), all of them being HRAC Group C1 herbicides that inhibit photosynthesis at PS II. The metamitron-resistant C. album pop-ulations examined showed negative cross-resistance to S-metolachlor (HRAC Group K3: inhibi-tion of cell division), prosulfocarb (Group N: lipid synthesis, not ACCase, inhibition), aclonifen and clomazone (both Group F3: inhibition of carotenoid biosynthesis). Based on the HRAC database no case of cross resistance to herbicides belonging to different HRAC groups is reported. Cases of multiple resistance including HRAC group C1 herbicides are reported for biotypes of Amaran-thus species (mainly at oversea locations, 1 case in Germany 1980), Bidens subalternans, Kochia species, Portulaca oleracea (all on oversea locations) and Alopecurus myosuroides (Belgium 1996). In the global database of Ian Heap, 31 weed species with resistance to at least one active sub-stance of the HRAC group O are listed (www.weedscience.org, accessed July 2014). There are no known cases of resistance to quinmerac. However, based on HRAC resistance classification, cross resistance should be expected to be likely between quinmerac and other HRAC group O herbicides. In Europe cases of multiple resistance including HRAC group O herbicides are re-ported for biotypes of Papaver rhoeas. Analysis of the inherent risk Major weed species concerned by the intended indication for Goltix Titan are Poa annua, Cheno-podium album, Stellaria media, Polygonum species, Capsella bursa pastoris, Galinsoga parvi-flora, Matricaria species, Mercurialis annua, Viola species, Veronica species, Thlaspi arvensis, Lamium species and Solanum nigrum. Based on the reported cases of resistance the inherent risk to develop resistance against metamitron in Europe is considered high for Poa annua, Ama-ranthus retroflexus, Chenopodium album, Senecio vulgaris and Solanum nigrum. These weeds show the highest frequency of resistance development. Due to a presently increasing number of reported resistances and the generally high inherent risk, Matricaria species are considered as high risk weed species as well. With respect to quinmerac in general the frequency of the occur-rence of resistance against HRAC group O herbicides is very low, especially when only the Eu-ropean observations are taken into consideration. The applicant has not provided baseline sensitivity data but has reported on a monitoring study conducted on Chenopodium album in Germany during 2007 to 2009 to determine the actual sen-sitivity status of Chenopodium album to this active substance. 25 Chenopodium album sources from 25 German locations (sugar beet production areas) were compared to a known resistant
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Belgium source (Outgaarden). 24 sources showed to be sensitive to metamitron with ED50 - val-ues ranging from 0.16 to 0.76 L/ha of Goltix Gold, while Chenopodium album from 1 location (near Hannover) was resistant (ED50: 2.4 L/ha; resistant standard Outgaarden: ED50 = 1.93 L/ha). Based on the averaged sensitivity of the sensitive Chenopodium album sources the resistance factor (diversity factor) of this resistant source is calculated to be 4.52 (resistant standard Outgaarden: 3.98). Analysis of the agronomic risk The herbicide Goltix Titan is aimed at being applied for control of annual monocotyledonous weeds, GALAP and other annual dicotyledonous weeds in sugar and fodder beets. Sugar beets are planted exclusively in crop rotations with an interval of at least 3 years and it is not common practice to plant sugar beets in crop rotation with maize. They are typically rotated with cereals and in Germany and Benelux almost all available cereal herbicides have modes of action (A, B, C2, C3, E, F1, K1, K3, N, O) different from metamitron. Under many situations, the herbicide will be applied in tank mixtures or sequences with other active substances or MoA. Some of the target species of Goltix Titan may therefore also be con-trolled by other substances so that the selection pressure and resistance risk is slightly reduced. The herbicide contains two active ingredients providing different modes of action. The design of the respective crop rotations and the associated frequency of application of Goltix Titan may differ in the various Member States in the EU and a national-specific assessment of the agronomic risk is therefore recommended. Summary and conclusion The applicant claims that the risk for the development of resistant weed biotypes in major sugar beet production areas is considered medium because of the fact that despite many years of in-tensive use of metamitron only very occasional proven problems with weed resistance are re-ported in Europe, and that no proven problems of quinmerac with this active ingredient are re-ported. This conclusion cannot be fully followed. As the number of metamitron resistance cases reported for Chenopodium album has substantially increased in the last years, the resistance risk for metamitron has to be rated as high especially for Germany and Belgium. As the spectrum of weed species controlled by metamitron on and quinmerac is not overlapping and because the above mentioned high risk weed species (especially Chenopodium album) are nor controlled by quinmerac, the resistance risk of the herbicide has to be rated a medium to high. Management strategy Due to the medium to high resistance risk, management strategies are required. The applicant claims that basic recommendations for resistance risk management will be clearly recommended on the label.
IIIA1 6.3 Economics
This is not an EC data requirement.
IIIA1 6.4 Benefits
IIIA1 6.4.1 Survey of alternative pest control measures
This is not an EC data requirement.
IIIA1 6.4.2 Compatibility with current management practices including IPM
This is not an EC data requirement.
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IIIA1 6.4.3 Contribution to risk reduction
This is not an EC data requirement.
IIIA1 6.5 Other/special studies
None.
IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5
AG-QMM1-565 SC is a herbicide for the control of annual weeds in fodder- and sugar beet. It contains the active ingredients metamitron and quinmerac. The dose response results against some target weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is in-creased, if rates lower than 3+3x1 L/ha of AG-QMM1-565 SC are applied. Based on the efficacy results it can be concluded AG-QMM1-565 SC provides sufficient control of a number of annual dicotyledonous weed species in fodder and sugar beets. POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous species didn´t occur in the efficacy trials. So a final evaluation for annual monocotyledonous species is not possible. Member States should consider the levels of control achieved according to National conventions. Based on the results of 8 trials carried out in sugar beets in Germany and the Netherlands during the cropping season 2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant products in sugar or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rates there is no substantial risk for an impact on plant or plant products. The yield results demonstrate that there are no indications for a negative impact on quantity of yield in sugar- or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rate there is no substantial risk for an impact on yield quantity. The crop tolerance results show that AG-QMM1-565 SC is tolerated well by sugar beets. For this indication only one year results are available from trials carried out with the double rate included under almost weed free conditions (2013). So Therefore a label warning (Damage is possible to the crop.) should be considered. The test product is classified as not harmful for populations of relevant predatory mites and spi-ders. The test product can be slightly harmful for populations of the species Coccinella sep-tempunctata (seven-spotted ladybird) and Aleochara bilineata (rove beetle). Potential impacts on succeeding crops have to be analysed on the basis of the EPPO standard PP1/207. The results show that there is no unacceptable risk for all succeeding crops in common crop rotations. There is no risk of spray drift damage for the tested crops. Following the principles of good agri-culture practice during the application, no effects on adjacent crops are expected. Due to the medium to high resistance risk, management strategies are required. The applicant claims that basic recommendations for resistance risk management will be clearly recommended on the label.
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IIIA1 6.7 List of test facilities including the corresponding certificates
ID Trial Unit Countr Address Phone GE
ATT Agrartest GmbH DE Palmbachstraße 37 65326 Aarbergen-Panrod
XXX Y
AGA Agricola DE Ruselweg 6b 94330 Salching
XXX Y
BCA BioChem Agrar Labor für biologische und chemische Analytik GmbH
DE Kupferstraße 6 04827 Machern
XXX Y
DBR De Bredelaar B.V. Research Company for Plant Protection
NL Breedlerdestraat 7 6662 NP Elst
XXX Y
FRS Field Research Support DE Potts Kamp 8 31515 Wunstorf
XXX Y
AH Hetterich Fieldworks Ingenieurbüro für landwirtschaftliche Feldversuche
DE Bambergerstraße 50 97359 Schwarzach
XXX Y
GO Landwirtschaftskammer Nordrhein-Westfalen Pflanzenschutzamt
DE Siebengebirgsstr. 200 53229 Bonn
XXX Y
RDB Redebel s.a. - n.v. BE Rue de Chassart 4 6221 Saint-Amand
XXX Y
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Appendix 1: List of data submitted in support of the evaluation
Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
MIIIA1 Sec 6
Feinchemie Schwebda GmbH
2014 dRR - B6 - core assess. - DE - 007529-00/01 - Goltix Titan O/O N 2574121/349275
O FSG Y
MIIIA1 Sec 6
Feinchemie Schwebda GmbH
2014 dRR - B6 - core assess. - DE - 007529-00/01 - Goltix Titan O/O N 2574123/349277
O FSG Y
MIIIA1 Sec 7
Feinchemie Schwebda GmbH
2014 dRR - B7 - core assess. - DE - 007529-00/01 - Goltix Titan O/O N 2574125/349279
O FSG Y
MIIIA1 Sec 7
Feinchemie Schwebda GmbH
2014 dRR - B7 - core assess. - DE - 007529-00/01 - Goltix Titan O/O N 2574127/349281
O FSG Y
MIIIA1 Sec 6
Feinchemie Schwebda GmbH
2014 dRR - B6 - nat. add. - DE - 007529-00/01 - Goltix Titan O/O N 2574184/349290
O FSG Y
MIIIA1 Sec 6
Feinchemie Schwebda GmbH
2014 dRR - B6 - nat. add. - DE - 007529-00/01 - Goltix Titan O/O N 2574185/349291
O FSG Y
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Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6
Feinchemie Schwebda GmbH
2014 dRR (BAD) - B7 - core assess. - DE - 007529-00/01 - Goltix Titan (vertraulich) O/O N 2574409/349297
O FSG Y
KIIIA1 6
Feinchemie Schwebda GmbH
2014 dRR (BAD) - B7 - core assess. - DE - 007529-00/01 - Goltix Titan (vertraulich) O/O N 2574417/349299
O FSG Y
KIIIA1 6.1.1
Minarski, A. 2010 AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) standardized bioassay for the determination of EC10-(NOEC) and EC50-values for herbicides and selected following crops in soil AG-QMM1-565SC N/J N 2594007/349305
J FSG Y
KIIIA1 6.1.2
van de Ven, W. 2013 Evaluate the efficacy of AG-QMM1-565 SC for the control of dicotyledonous weeds and Poa annua in sugar beet 11200612 N/J N 2594008/349307
J FSG Y
KIIIA1 6.1.2
Rohr, J. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E01 N/J N 2594009/349309
J FSG Y
KIIIA1 6.1.2
Dissemond 2012 ACETY, GALAP, LAMPU-Z.-Rüben VA, NA 2012 FCS12-1621-E03 N/J N 2594010/349311
J FSG Y
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
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Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.1.2
Labusch, U. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E04 N/J N 2594098/349314
J FSG Y
KIIIA1 6.1.2
Wolf, P. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E05 N/J N 2594100/349317
J FSG Y
KIIIA1 6.1.2
Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R090-12H N/J N 2594104/349320
J FSG Y
KIIIA1 6.1.2
Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R091-12H N/J N 2594105/349322
J FSG Y
KIIIA1 6.1.3
van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Goltix of 2010-the Netherlands H-10-2105 N/J N 2594108/349325
J FSG Y
KIIIA1 6.1.3
van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Fiesta new of 2011-the Netherlands H-11-2101 N/J N 2594114/349328
J FSG Y
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Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.1.3
van de Ven, W. 2013 Evaluate the efficacy of AG-QMM1-565 SC for the control of dicotyledonous weeds and Poa annua in sugar beet 11200612 N/J N 2594134/349332
J FSG Y
KIIIA1 6.1.3
Rohr, J. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E01 N/J N 2594137/349335
J FSG Y
KIIIA1 6.1.3
Dissemond 2012 ACETY, GALAP, LAMPU-Z.-Rüben VA, NA 2012 FCS12-1621-E03 N/J N 2594138/349337
J FSG Y
KIIIA1 6.1.3
Labusch, U. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E04 N/J N 2594140/349340
J FSG Y
KIIIA1 6.1.3
Wolf, P. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E05 N/J N 2594150/349343
J FSG Y
KIIIA1 6.1.3
Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R090-12H N/J N 2594155/349346
J FSG Y
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
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Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.1.3
Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R091-12H N/J N 2594160/349349
J FSG Y
KIIIA1 6.1.4
Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550B N/J N 2594162/349352
J FSG Y
KIIIA1 6.1.4
Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550A N/J N 2594164/349355
J FSG Y
KIIIA1 6.1.4
Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550C N/J N 2594166/349358
J FSG Y
KIIIA1 6.1.4
Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550D N/J N 2594167/349360
J FSG Y
KIIIA1 6.1.4
Franke, K. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550E N/J N 2594168/349363
J FSG Y
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Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.1.4
van de Ven, W. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in 2013 NL13HSBEAVA001 N/J N 2594169/349366
J FSG Y
KIIIA1 6.2.1
van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Goltix of 2010-the Netherlands H-10-2105 N/J N 2594173/349368
J FSG Y
KIIIA1 6.2.1
van de Ven, W. 2011 Crop safety and control of dicotyledonous weeds in sugar beet by AG-QMM1-565 SC and Fiesta new of 2011-the Netherlands H-11-2101 N/J N 2594174/349371
J FSG Y
KIIIA1 6.2.1
van de Ven, W. 2013 Evaluate the efficacy of AG-QMM1-565 SC for the control of dicotyledonous weeds and Poa annua in sugar beet 11200612 N/J N 2594176/349373
J FSG Y
KIIIA1 6.2.1
Rohr, J. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E01 N/J N 2594177/349376
J FSG Y
KIIIA1 6.2.1
Dissemond 2012 ACETY, GALAP, LAMPU-Z.-Rüben VA, NA 2012 FCS12-1621-E03 N/J N 2594178/349379
J FSG Y Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Feldfunktion geändert
Formatiert: Deutsch (Deutschland)
Formatiert: Deutsch (Deutschland)
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Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.2.1
Labusch, U. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E04 N/J N 2594180/349382
J FSG Y
KIIIA1 6.2.1
Wolf, P. 2012 An evaluation of the efficacy of AG-QMM1-565 SC against ACETY, GALAP and dicotyle weeds after splitting application in sugar beets FCS12-1621-E05 N/J N 2594181/349385
J FSG Y
KIIIA1 6.2.1
Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R090-12H N/J N 2594183/349389
J FSG Y
KIIIA1 6.2.1
Reynens, P. 2013 Sugarbeet-Efficacy of AG-QMM1-565 SC R091-12H N/J N 2594184/349392
J FSG Y
KIIIA1 6.2.1
Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550B N/J N 2594185/349394
J FSG Y
KIIIA1 6.2.1
Zickart, U. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550A N/J N 2594186/349397
J FSG Y
Part B – Section 7 Core Assessment
Goltix Titan / AG-QMM1-565 SC 007529-00/01
Registration Report Central Zone
Page 24 of 31
Julius Kühn-Institut 2015-02-06
Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.2.1
Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550C N/J N 2594187/349399
J FSG Y
KIIIA1 6.2.1
Hetterich, A. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550D N/J N 2594189/349402
J FSG Y
KIIIA1 6.2.1
Franke, K. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in Germany 2013 DE13HSBEAVA550E N/J N 2594192/349404
J FSG Y
KIIIA1 6.2.1
van de Ven, W. 2013 An evaluation of the selectivity of AG-QMM1-565 SC in sugar beet (pre- and post emergence) in 2013 NL13HSBEAVA001 N/J N 2594193/349407
J FSG Y
KIIIA1 6.2.6
Minarski, A. 2010 AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) standardized bioassay for the determination of EC10-(NOEC) and EC50-values for herbicides and selected following crops in soil AG-QMM1-565SC N/J N 2594198/349410
J FSG Y
KIIIA1 6.2.7
Minarski, A. 2010 Effect of AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) on vegetative vigour of terrestrial plants AS150 N/J N 2594199/349413
J FSG Y
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Part B – Section 7 Core Assessment
Goltix Titan / AG-QMM1-565 SC 007529-00/01
Registration Report Central Zone
Page 25 of 31
Julius Kühn-Institut 2015-02-06
Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.2.7
Minarski, A. 2010 Effect of AG-QMM1-565SC (40g/L Quinmerac+525 g/L Metamitron) on vegetative vigour of terrestrial plants AS151 N/J N 2594202/349416
J FSG Y
KIIIA1 6.2.8
Heimbach, U., Kral, G., Niemann, P.
2000 Implementation of resistance risk analysis of plant protection products in the German authorisation procedure Proceedings of the Brighton Crop Protection- Pests and Diseases N/N J 2594204/349419
N LIT Y
KIIIA1 6.2.8
Petersen, J. 2003 Sensitivität verschiedener herkünfte von Matricaria inodora und Matricaria chamomilla gegenüber Metamitron Gesunde Pflanzen N/N J 2594205/349421
N LIT Y
KIIIA1 6.2.8
William, L., Patzoldt, Bradley, S., Dixon, Patrick, J., Tranel
2003 Abstract of: Triazine resistance in Amaranthus tuberculatus (Moq) Sauer that is not site-of-action mediated Pest Management Science N/N J 2594207/349424
N LIT Y
KIIIA1 6.2.8
Mechant, E., Bulcke, R.
2006 Cross-resistance profile of Metamitron-resistant Chenopodium album L. biotypes from sugar beet Zeitschrift für Pflanzenkrankheiten und Pflanzenschutz N/N J 2594212/349427
N LIT Y
KIIIA1 6.2.8
Petersen, J. 2010 Ein neuer Gänsefuß-Biotyp mit resistenz gegenüber Metribuzin und Metamitron Fachhochschule Bingen, Institut für Zuckerrübenforschung N/N J 2594215/349430
N LIT Y
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Part B – Section 7 Core Assessment
Goltix Titan / AG-QMM1-565 SC 007529-00/01
Registration Report Central Zone
Page 26 of 31
Julius Kühn-Institut 2015-02-06
Annex Point
Author
Year Title Source Report-No. GLP/GEP Published Authority registration No./JKI-No.
Data pro-tection claimed (J=Yes O=Open N=No)
Owner How consid-ered in
dRR Study-Status / Usage
KIIIA1 6.2.8
Petersen, J. 2010 Sensitivitätsanalyse verschiedener Chenopodium album-Herkünfte gegen Metamitron (Goltix Gold) ITB GmbH an der Fachhochschule Bingen N/N J 2594216/349432
N LIT Y
KIIIA1 6.2.8
Thiel, H., Varrelmann, M.
2012 Identification of a new PSII target site psbA mutation leading to D1 amino acid Leu 218Val exchange in the Chenopodium album D1 protein and comparison to cross-resistance profiles of known modifications at positions 251 and 264 Society of Chemical Industry N/N J 2594225/349435
N LIT Y
KIIIA1 3.9
Anonymous 2014 Gebrauchsanleitung N/N N 2594255/349438
J FSG Y
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Part B – Section 7 Core Assessment
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Julius Kühn-Institut 2015-02-06
Appendix 2: GAP Table
GAP- Table of intended uses for Germany GAP rev. (No), date: 2014-04-14
PPP (product name/code) Goltix Titan active substance 1 Metamitron active substance 2 Quinmerac
Formulation type: SC Conc. of as 1: 525 g/L Conc. of as 2: 40 g/L
Applicant: Feinchemie Schwebda GmbH Zone(s): central/EU
professional use X non professional use
Verified by MS: yes
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-No.
Mem-ber state(s)
Crop and/ or situation (crop destination / purpose of crop)
F G or I
Pests or Group of pests controlled (additionally: devel-opmental stages of the pest or pest group)
Application Application rate PHI (days)
Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mix-tures
Method / Kind
Timing / Growth stage of crop & season
Max. num-ber (min. in-terval be-tween appli-cations)
a) per use
b) per crop/ season
kg, L product / ha
a) max. rate per appl.
b) max. total rate per crop/season
g, kg as/ha
a) max. rate per appl.
b) max. total rate per crop/season
Water L/ha min / max
001 DE Sugar beet
BEAVA
fodder beet
BEAVC
F annual monocotyle-donous weeds (TTTMS)*, annual di-cotyledonous weeds (TTTDS)
Spraying
splitting 4 applica-tions
Spring
BBCH 00 – 19
1st treatment before-emer-gence
2nd to 4th treat-ment after emergence
a) 4
b) 4
the 2nd to 4th treatment with an inter-val of 5 to 10 days
a)
timing 1: 3 L/ha
timing 2: 1 L/ha
timing 3: 1 L/ha
timing 4: 1 L/ha
a)
timing 1:
Metamitron
1575 g as/ha
Quinmerac
120 g as/ha
timing 2:
Metamitron
200 - 400 **XF
Part B – Section 7 Core Assessment
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Page 28 of 31
Julius Kühn-Institut 2015-02-06
b) 6 L/ha
maximum ap-plication rate for the in-tentedin-tended crop per year
525 g as/ha
Quinmerac
40 g as/ha
timing 3:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
timing 4:
Metamitron
525 g as/ha
Quinmerac
40 g as/ha
b)
Metamitron
3150 g as/ha
Quinmerac
240 g as/ha
maximum application rate for the intentedin-tended crop per year
*withdrawn by letter of applicant from 2015-01-13 **The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp.
Part B – Section 7 Core Assessment
Goltix Titan / AG-QMM1-565 SC 007529-00/01
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Page 29 of 31
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GAP- Table of intended uses for all cMS (without Germany), not verified by zRMS PPP (product name/code) AG-QMM1-565 SC active substance 1 Metamitron active substance 2 Quinmerac active substance safener - synergist -
Formulation type: SC (suspension concentrate) Conc. of as 1: 525 g/L Conc. of as 2: 40 g/L Conc. of as: Conc. of safener: - Conc. of synergist: -
Applicant: Feinchemie Schwebda GmbH Zone(s): central/EU
professional use non professional use
Verified by MS: no
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-No.
Mem-ber state(s)
Crop and/ or situation (crop destina-tion / purpose of crop)
F G or I
Pests or Group of pests con-trolled (additionally: de-velopmental stages of the pest or pest group)
Application Application rate PHI (days)
Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures
Method / Kind
Timing / Growth stage of crop & sea-son
Max. number (min. interval be-tween applica-tions)
a) per use
b) per crop/ sea-son
kg, L product / ha
a) max. rate per appl.
b) max. total rate per crop/season
g as/ha
a) max. rate per appl.
b) max. total rate per crop/season
Water L/ha min / max
1 NL, BE
Beets (sugar and fodder) Use already au-thorised
F
GALAP and other annual dicotyle-donous weed species
spraying BBCH 10-19
a) 1-3 (5)
b) 3
a) 2
b) 6
a) Metamitron: 1050 Quin-merac: 80
b) Metamitron: 3150 Quin-merac: 240
200 / 400
F
Max. 2.0 L product/ha per treatment
Total 6.0 L product/ha
Max. once per three years on same field
2 NL, BE Beets (sugar and fodder)
F
Poa annua POAAN, Galium aparine GALAP ,
spraying BBCH 00-09
a) 1
b) 1
a) 3
b) 3
a) Metamitron: 1575 Quin-merac: 120
b) Metamitron: 1575 Quin-merac: 120
200 / 400
F
Total 6.0 L product/ha
Max. once per three years on same field
Part B – Section 7 Core Assessment
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Page 30 of 31
Julius Kühn-Institut 2015-02-06
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-No.
Mem-ber state(s)
Crop and/ or situation (crop destina-tion / purpose of crop)
F G or I
Pests or Group of pests con-trolled (additionally: de-velopmental stages of the pest or pest group)
Application Application rate PHI (days)
Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures
Method / Kind
Timing / Growth stage of crop & sea-son
Max. number (min. interval be-tween applica-tions)
a) per use
b) per crop/ sea-son
kg, L product / ha
a) max. rate per appl.
b) max. total rate per crop/season
g as/ha
a) max. rate per appl.
b) max. total rate per crop/season
Water L/ha min / max
annual dicotyle-donous weeds (TTTDS) BBCH 10-
19
a) 1-3 (5)
b) 3
a) 1
b) 3
a) Metamitron: 525 Quin-merac: 40
b) Metamitron: 1575 Quin-merac: 120
200 / 400
F
3 NL, BE
Beets (sugar and fodder) withdrawn by applicant on 14 February 2014
F
POAAN, GALAP and other annual dicotyledonous weed species
spraying
BBCH 00-09
a) 1
b) 1
a) 3
b) 3
a) Metamitron: 1575 Quin-merac: 120
b) Metamitron: 1575 Quin-merac: 120
200 / 400
F
Pre-emergence: 1 × 3.0 L fp/ha
Post-emergence: Max. individual applica-
tion rate: 3.0 L fp/ha,
E.g. 1× 3.0 L;
1 × 1.25 L + 1 × 1.0 L + 1 × 1.0 L;
1 × 1.5 L + 1 x 1.75 L fp/ha;
or combinations of other uses with 0.75 L/ha min).
Max. total post-emer-gence applied of 3.25 L
fp/ha
Max use rate of 250 g/ha Quinmerac is restricted
BBCH 10-19
a) 1-4 (5)
b) 4
a) 1,25
b) 3,25
a) Metamitron: 656 Quin-merac: 50
b) Metamitron: 1706 Quin-merac: 130
200 / 400
F
BBCH 10-19
a) Metamitron: 525 Quin-merac: 40
b) Metamitron: 1575 Quin-merac: 120
200 / 400
F
Part B – Section 7 Core Assessment
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Page 31 of 31
Julius Kühn-Institut 2015-02-06
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-No.
Mem-ber state(s)
Crop and/ or situation (crop destina-tion / purpose of crop)
F G or I
Pests or Group of pests con-trolled (additionally: de-velopmental stages of the pest or pest group)
Application Application rate PHI (days)
Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures
Method / Kind
Timing / Growth stage of crop & sea-son
Max. number (min. interval be-tween applica-tions)
a) per use
b) per crop/ sea-son
kg, L product / ha
a) max. rate per appl.
b) max. total rate per crop/season
g as/ha
a) max. rate per appl.
b) max. total rate per crop/season
Water L/ha min / max
on the same field per year.
withdrawn by applicant on 14 February 2014
4 NL, BE
Beets (sugar and fodder) withdrawn by applicant on 14 February 2014
F
POAAN, GALAP and other annual dicotyledonous weed species
spraying BBCH 10-19
a) 1 (5)
b) 6
a) 0,75
b) 1,25
a) Metamitron: 394 Quin-merac: 30
b Metamitron: 656 Quin-merac: 50
200 / 400
F
Max. individual applica-tion rate: 1.25 L fp/ha,
e.g. 5 × 1.25 L fp/ha or uses in
between
Max use rate of 250 g/ha Quinmerac is restricted on the same field per year.
withdrawn by applicant on 14 February 2014
Indication 1 is already authorised
Indication 3 and 4 only as national addendum – withdrawn by applicant on 14 February 2014
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Part B – Section 8
Core Assessment /
Natioanl Addendum
GOLTIX TITAN
Draft Registration Report –
Central Zone
Page 1 of 16
Feinchemie Schwebda GmbH Evaluator: zRMS Germany
May 2015
Draft REGISTRATION REPORT
Part B
Section 8 Assessment of the relevance of
metabolites in groundwater
Detailed summary of the risk assessment
Product code: GOLTIX TITAN
Active Substance: Metamitron 525 g/L
Quinmerac 40 g/L
Central Zone
Zonal Rapporteur Member State: Germany
CORE ASSESSMENT / NATIONAL
ADDENDUM GERMANY
Applicant: Feinchemie Schwebda GmbH
Date: May 2015
Part B – Section 8
Core Assessment /
Natioanl Addendum
GOLTIX TITAN
Draft Registration Report –
Central Zone
Page 2 of 16
Feinchemie Schwebda GmbH Evaluator: zRMS Germany
May 2015
Table of Contents TABLE OF CONTENTS ....................................................................................................................................... 2
SEC 8 ASSESSMENT OF THE RELEVANCE OF METABOLITES IN GROUNDWATER ..... 3
8.1 EXCLUSION OF DEGRADATION PRODUCTS OF NO CONCERN .......................................................................... 3
8.2 QUANTIFICATION OF POTENTIAL GROUNDWATER CONTAMINATION ............................................................. 4
8.2.1 Metamitron .............................................................................................................................................. 4
8.2.2 Quinmerac ............................................................................................................................................... 5
8.3 HAZARD ASSESSMENT: IDENTIFICATION OF RELEVANT METABOLITES ......................................................... 7
8.3.1 Screening for biological activity ............................................................................................................. 7
8.3.2 Screening for genotoxicity ...................................................................................................................... 7
8.3.3 Screening for toxicity .............................................................................................................................. 7
8.4 EXPOSURE ASSESSMENT – THRESHOLD OF CONCERN APPROACH .................................................................. 7
8.5 REFINED RISK ASSESSMENT FOR NON-RELEVANT METABOLITES .................................................................. 8
8.5.1 Refined toxicological risk assessment for non-relevant metabolites ....................................................... 8
8.5.2 Refined ecotoxicological risk assessment for non-relevant metabolites ............................................... 11
APPENDIX 1 GAP TABLE ............................................................................................................................ 12
APPENDIX II REFERENCE LIST ........................................................................................................................... 14
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Sec 8 ASSESSMENT OF THE RELEVANCE OF METABOLITES IN
GROUNDWATER
Metamitron
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance Metamitron, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
In the Inclusion Directive of Metamitron (2008/125/EC resp. regulation 540/2011) under Part B it is stated
that the concerned Member States shall request the submission of further data, in particular information as
regards the impact of soil metabolite M3 on groundwater, information as regards residues in rotational
crops and information to further address the long term risk to insectivorous birds, and the specific risk to
birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the
applicant provides such confirmatory data and information to the Commission by 31 August 2011.
The RMS UK concluded in the draft addendum on confirmatory data in 2014 that the metamitron metabolite
M3 was an experimental artifact. Therefore, the metabolite M3 has not to be considered in the groundwater
assessment.
Quinmerac
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance Quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
In the Inclusion Directive of Quinmerac (2010/89/EC resp. regulation 540/2011) under Part B it is stated
that the Member States concerned shall request the submission of information as regards to the potential of
plant metabolism to result in an opening of the quinolone ring and the residues in rotational crops and the
long term risk for earthworms due to the metabolite BH 518-5. They shall ensure that the applicant provides
such confirmatory data and information to the Commission by 30 April 2013.
8.1 Exclusion of degradation products of no concern
None.
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8.2 Quantification of potential groundwater contamination
8.2.1 Metamitron
8.2.1.1 Exposure assessment for the Central Zone
PECGW calculations after leaching from soil for the active substance Metamitron and its metabolites were
performed using the simulation model FOCUS PELMO 5.5.3 (see Section 5).
The results of the simulations for the scenarios "sugar beet" are as follows.
Table 8.2-1: PECGW at 1 m soil depth for Metamitron and its metabolites
Use No /crop Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1)
groundwater model: FOCUS PELMO 5.5.3.
Metamitron Metabolite
Desamino-metamitron
2 /sugar beets Châteaudun < 0.001 0.010
Hamburg 0.001 0.054
Jokioinen <0.001 <0.001
Kremsmünster <0.001 0.022
Okehampton 0.001 0.070
Piacenza 0.005 0.203
Porto <0.001 0.042
Sevilla <0.001 < 0.001
Thiva <0.001 <0.001
Concentrations >0.1 µg/L are printed bold.
The PECGW values for the Metamitron metabolite Desamino-metamitron wer calculated to be below
0.1 µg/L except for the scenario Piacenza. A relevance assessment for the metabolite is triggered only in
case Piacenza is regarded as a relevant scenario by the respective MS for the national assessment (not the
case for DE).
The relevance of the groundwater metabolite Desamino-metamitron has already been assessed at EU level
(EFSA Scientific Report (2008) 185, 1-95. The metabolite is reagarded as of no toxicological relevance
up to 10 µg/L.
8.2.1.2 Exposure assessment for Germany
The PECGW values for the metabolite Desamino-metamitron were calculated to be below 0.1 µg/L in the
national assessment for Germany.
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8.2.2 Quinmerac
8.2.2.1 Exposure assessment for the Central Zone
PECGW calculations after leaching from soil for the active substance Quinmerac and its metabolites were
performed using the simulation model FOCUS PELMO 5.5.3 (see Section 5).
The results of the simulations for the scenarios "sugar beet" are as follows.
Table 8.2-2: PECGW at 1 m soil depth for Quinmerac and its metabolites
Use-No. Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1)
groundwater model: FOCUS PELMO 4.4.3
Quinmerac Metabolite
BH 518-2
Metabolite
BH 518-5
2 Châteaudun 0.062 2.036 14.269
Hamburg 0.050 2.304 11.598
Jokioinen 0.022 1.665 8.939
Kremsmünster 0.049 1.784 10.02
Okehampton 0.145 2.38 7.878
Piacenza 0.103 1.743 10.075
Porto 0.117 1.449 6.023
Sevilla 0.043 1.016 13.588
Thiva 0.003 0.634 18.476
Yearly applications were assumed as worst case.
For the metabolites BH 518-2 and BH 518-5, a groundwater concentration of ≥ 0.1 µg/L cannot be excluded
regarding all applicable model scenarios.
In addition to the Tier 1 PECGW modeling, a higher tier leaching assessment using experimental data from
lysimeter studies and a field leaching study for the active substance Quinmerac is performed. Higher tier
leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a lower leaching
potential of metabolite BH 518-5 than expected from the lower tier modelling.
Furthermore, according to usual crop rotation scemes yearly applications are not expected. In the original
DAR, calculations were performed for the use every three years. However, the active ingredient is now
registered not only for the use in rape on a national level, but also for beets, for example. This would allow
a crop rotation with for example two treatment years in four years.
An assessment of the relevance of the metabolites BH 518-2 and BH 518-5 for groundwater is necessary.
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8.2.2.2 Exposure assessment for Germany
PECgw calculations after leaching from soil for the active substance Quinmerac and metabolites were
perfoGWrmed using the simulation model FOCUS PELMO 5.5.3 (see Section 5).
The results of the simulations for the scenarios "sugar beet" are as follows.
Table 8.2-3: PECGW at 1 m soil depth of Quinmerac and its metabolites BH 518-2 and BH 518-5
considered relevant for German exposure assessment, Concentrations >0.1 µg/L are
printed bold.
Use No. Scenario 80th Percentile PECGW at 1 m Soil Depth (µg L-1) modelled by FOCUS
PELMO 4.4.3
Quinmerac Metabolite BH 518-2 Metabolite BH 518-5
00-001 Hamburg 0.050 2.304 11.598
Kremsmünster 0.049 1.784 10.02
For the metabolites BH 518-2 and BH 518-5, a groundwater concentration of ≥ 0.1 µg/L cannot be
excluded.
In addition to the Tier 1 PECGW modeling, a higher tier leaching assessment using experimental data from
lysimeter studies and a field leaching study for the active substance Quinmerac is performed. Higher tier
leaching studies indicate a slightly higher leaching potential of metabolite BH 518-2 and a lower leaching
potential of metabolite BH 518-5 than expected from the lower tier modelling.
Furthermore, according to usual crop rotation scemes yearly applications (as assumed in modeling) are not
expected. In the original DAR, calculations were performed for the use every three years. However, the
active ingredient is now registered not only for the use in rape on a national level, but also for beets, for
example. This would allow a crop rotation with for example two treatment years in four years.
As a result, the active substance quinmerac is not expected to penetrate into groundwater at concentrations
of ≥ 0.1 µg/L in the intended uses in beets. For the metabolites BH 518-2 and
BH 518-5 concentrations of ≥ 0.1 µg/L cannot be excluded, but it is expected that concentrations remain
below 10 µg/L.
An assessment of the relevance of the metabolites BH 518-2 and BH 518-5 for groundwater is necessary.
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8.3 Hazard Assessment: Identification of relevant metabolites
8.3.1 Screening for biological activity
8.3.1.1 Metamitron-Metabolite
A relevance assessment for the metabolite desamino-metamitron is triggered only in case Piacenza is
regarded as a relevant scenario by the respective MS for the national assessment (not the case for DE). The
metabolite desamino-metamitron was found to have no biological activity as compared to the parent
compound in the EU assessment (EFSA Scientific Report (2008) 185).
8.3.1.2 Quinmerac-Metabolites
The metabolites BH 518-2 and BH 518-5 have been evaluated in the peer review in view of the Annex I
inclusion of Quinmerac. The metabolites BH 518-2 and BH 518-5 have no biological activity as compared
to the parent compound (EFSA Conclusion Quinmerac EFSA Journal 2010: 8(3), 1523).
8.3.2 Screening for genotoxicity
8.3.2.1 Metamitron-Metabolite
A relevance assessment for the metabolite desamino-metamitron is triggered only in case Piacenza is
regarded as a relevant scenario by the respective MS for the national assessment (not the case for DE).
The metabolite desamino-metamitron was found to be not toxicologically relevant in the EU assessment
(EFSA Scientific Report (2008) 185, 1-95).
8.3.2.2 Quinmerac-Metabolites
The metabolites BH 518-2 and BH 518-5 have been evaluated in the peer review in view of the Annex I
inclusion of Quinmerac (EFSA Conclusion Quinmerac EFSA Journal 2010: 8(3), 1523). Please refer 8.5.1.
8.3.3 Screening for toxicity
8.3.3.1 Metamitron-Metabolite
A relevance assessment for the metabolite desamino-metamitron is triggered only in case Piacenza is
regarded as a relevant scenario by the respective MS for the national assessment (not the case for DE). The
metabolite desamino-metamitron was found to be not toxicologically relevant in the EU assessment (EFSA
Scientific Report (2008) 185, 1-95).
8.3.3.2 Quinmerac-Metabolites
The metabolites BH 518-2 and BH 518-5 have been evaluated in the peer review in view of the Annex I
inclusion of Quinmerac (EFSA Conclusion Quinmerac EFSA Journal 2010: 8(3), 1523). Please refer to
8.5.1.
8.4 Exposure assessment – threshold of concern approach
Please refer to 8.5.1.
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8.5 Refined risk assessment for non-relevant metabolites
8.5.1 Refined toxicological risk assessment for non-relevant metabolites
The quinmerac-metabolites BH518-02 and BH518-05 are predicted to occur in groundwater at
concentrations above 0.1 µg/L. An assessment of the relevance of these metabolites according to the
stepwise procedure of the EC guidance document SANCO/221/2000 –rev.10 is therefore required.
8.5.1.1 Relevance assessment of BH518-02
A summary of the relevance assessment is given in Table 8.5.1-4.
Table 8.5.1-4 Summary of the relevance assessment for BH518-02
Assessment step Result of assessment
STEP 1 Metabolite of no concern? no
Qu
an
ti
fica
tio
n o
f
gro
un STEP 2
Max PECgw See above
Based on
Ha
zard
ass
essm
ent
STEP 3 Stage 1 Biological activity comparable
to the parent?
no
Stage 2 Genotoxic properties of
metabolite
pass
Stage 3 Toxic properties of metabolite;
Classification of parent pass
Classification of metabolite pass
Co
nsu
mer
hea
lth
ris
k
ass
essm
ent
STEP 4 Estimated consumer exposure
via drinking water and other
sources; threshold of concern
approach
Exposure > TTC
STEP 5 Refined risk assessment pass
Predicted exposure Exposure < ADI
Summary concerning the toxicological relevance:
The relevance of the groundwater metabolite BH518-02 has already been assessed and accepted at EU
level (EFSA Journal 2010; 8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]).
Metabolite BH518-2 was evaluated as part of the EU peer-review. Available studies are summarised in
Table 8.5.1-5. According to the background documents to the EU procedure (e.g., EFSA Journal 2010;
8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]) this metabolite passed stage 2 and stage 3 of step 3.
However, PECgw is above 0.75 µg/l. Hence, a refined risk assessment is needed.
Taking into account, the default exposure assumptions (2 L/day, 60 kg bw), predicted exposure through
drinking water (0.058 µg/kg bw per day) is below the ADI for quinmerac (0.08 mg/kg bw) which was
considered applicable to BH518-2 during the EU peer review (EFSA Journal 2010; 8(3):1523, 1-68
(2010-02-26) [ASB2012-3439]).
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Table 8.5.1-5 Summary of the results of toxicity studies with BH518-2
Type of test Result Reference*
Ames test negative with S-9 mix,
positive in TA 100, TA
1537 and TA 98 in the
pre-incubation test
(without metabolic
activation)
ASB2007-809,
ASB2007-810*
Ames test negative ASB2011-9361
In vitro HPRT Inconclusive ASB2007-811,
ASB2007-812*
In vitro MLA negative ASB2009-10949,
ASB2009-10950,
ASB2009-10951*
In vitro MLA negative (several positive
control cultures show no
dose-response)
ASB2011-9362,
ASB2011-9371
In vitro CA negative ASB2007-813,
ASB2007-814*
In vitro CA negative ASB2011-9363
In vivo MN negative (no signs of
toxicity, no indication
that bone marrow was
exposed)
ASB2007-815*
*indicates that a study was reviewed at EU level; considering that the additional studies submitted for this application corroborate
the results of the studies submitted for the EU peer-review procedure, no detailed evaluations are prepared (SANCO/10328/2004
– rev. 8, 2012-01-24).
8.5.1.2 Relevance assessment of BH518-05
A summary of the relevance assessment is given in Table 8.5.1-3.
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Table 8.5.1-6 Summary of the relevance assessment forBH518-5
Assessment step Result of assessment
STEP 1 Metabolite of no concern? no
Qu
an
ti
fica
tio
n o
f
gro
un STEP 2
Max PECgw See above
Based on
Ha
zard
ass
essm
ent
STEP 3 Stage 1 Biological activity comparable
to the parent?
no
Stage 2 Genotoxic properties of
metabolite
pass
Stage 3 Toxic properties of metabolite;
Classification of parent pass
Classification of metabolite pass
Co
nsu
mer
hea
lth
ris
k
ass
essm
ent
STEP 4 Estimated consumer exposure
via drinking water and other
sources; threshold of concern
approach
Exposure > TTC
STEP 5 Refined risk assessment pass
Predicted exposure Exposure < ADI
Summary concerning the toxicological relevance:
The relevance of the groundwater metabolite BH518-05 has already been assessed and accepted at EU
level (EFSA Journal 2010; 8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]).
Metabolite BH518-5 was evaluated as part of the EU peer-review. Available studies are summarised in
Table 8.5.1-7. According to the background documents to the EU procedure (e.g., EFSA Journal 2010;
8(3):1523, 1-68 (2010-02-26) [ASB2012-3439]) this metabolite passed stage 2 and stage 3 of step 3.
However, PECgw is above 0.75 µg/l. Hence, a refined risk assessment is needed.
Taking into account, the default exposure assumptions (2 L/day, 60 kg bw), predicted exposure through
drinking water (0.379 µg/kg bw per day) is below the ADI for quinmerac (0.08 mg/kg bw) which was
considered applicable to BH518-5 during the EU peer review (EFSA Journal 2010; 8(3):1523, 1-68
(2010-02-26) [ASB2012-3439]). It is noted, that GD SANCO/221/2000 does not allow metabolite
concentrations above 10 µg/L groundwater.
Table 8.5.1-7 Summary of the results of toxicity studies with BH518-5
Type of test Result Reference*
Rat LD50 oral > 2200 mg/kg bw TOX2003-1899*
Ames test negative TOX2003-1901*
In vitro HPRT inconclusive TOX2003-1904*
In vivo MN negative TOX2003-1903*
90-d, rat water consumption ↑;
urea levels ↑; kidney
(histopathological
changes)
TOX9300119*
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NOAEL: 216 mg/kg
bw/d (3000 ppm)
dev tox,rat feed consumption ↓, bw
and bw gain ↓ (early
phase of test substance
administration)
NOAEL(mat): < 1000
mg/kg bw/d
NOAEL(dev): 1000
mg/kg bw/d
TOX2003-1905,
ASB2009-11228*
*indicates that a study was reviewed at EU level
8.5.2 Refined ecotoxicological risk assessment for non-relevant metabolites
Not applicable.
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Section 8 Date May 2015
Appendix 1 GAP table
GAP-Table of intended uses for all cMS (without Germany), not verified by zRMS
PPP (product name/code) AG-QMM1-565 SC
active substance 1 Metamitron
active substance 2 Quinmerac
active substance
safener -
synergist -
Formulation type: SC (suspension concentrate)
Conc. of as 1: 525 g/L
Conc. of as 2: 40 g/L
Conc. of as:
Conc. of safener: -
Conc. of synergist: -
Applicant: company
Zone(s): northern/central/southern/EU
professional use
non professional use
Verified by MS: no
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days)
Remarks:
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
Method /
Kind
Timing /
Growth stage of
crop & season
Max. number (min.
interval between
applications)
a) per use
b) per crop/ season
kg, L product / ha
a) max. rate per appl.
b) max. total rate per
crop/season
g as/ha
a) max. rate per
appl.
b) max. total rate
per crop/season
Water L/ha
min / max
1 NL, BE
Beets (sugar and
fodder)
Use already
authorised
F
GALAP and other
annual
dicotyledonous weed
species
spraying BBCH 10-19 a) 1-3 (5)
b) 3
a) 2
b) 6
a) Metamitron:
1050
Quinmerac: 80
b) Metamitron:
3150
Quinmerac: 240
200 / 400 F
Max. 2.0 L product/ha per treatment
Total 6.0 L product/ha
Max. once per three years on same
field
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1 2 3 4 5 6 7 8 10 11 12 13 14
Use-
No.
Member
state(s)
Crop and/
or situation
(crop destination /
purpose of crop)
F
G
or
I
Pests or Group of pests
controlled
(additionally:
developmental stages of
the pest or pest group)
Application Application rate PHI
(days)
Remarks:
e.g. safener/synergist per ha
e.g. recommended or mandatory tank
mixtures
Method /
Kind
Timing /
Growth stage of
crop & season
Max. number (min.
interval between
applications)
a) per use
b) per crop/ season
kg, L product / ha
a) max. rate per appl.
b) max. total rate per
crop/season
g as/ha
a) max. rate per
appl.
b) max. total rate
per crop/season
Water L/ha
min / max
2 NL, BE Beets (sugar and
fodder) F
POAAN, GALAP
and other annual
dicotyledonous weed
species
spraying
BBCH 00-09 a) 1
b) 1
a) 3
b) 3
a) Metamitron:
1575
Quinmerac: 120
b) Metamitron:
1575
Quinmerac: 120
200 / 400 F
Total 6.0 L product/ha
Max. once per three years on same
field
BBCH 10-19 a) 1-3 (5)
b) 3
a) 1
b) 3
a) Metamitron:
525 Quinmerac:
40
b) Metamitron:
1575
Quinmerac: 120
200 / 400 F
Use No. 1 is already authorized.
Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use
situation should be described (e.g. fumigation of a structure)
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds
(d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989
(f) All abbreviations used must be explained
(g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench
(h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of
equipment used must be indicated
(i) g/kg or g/l
(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of
application
(k) The minimum and maximum number of application possible under practical conditions of use
must be provided
(l) PHI - minimum pre-harvest interval
(m) Remarks may include: Extent of use/economic importance/restrictions
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Appendix II Reference list
Annex point/
reference No
Author(s) Year Title
Report-No.
Authority registration No
Data
protection
claimed
Owner How
considered in
dRR #
KIIA 5.4.1.3,
KIIA 5.8.1.
Brosius, S. 2006 Quinmerac (BAS 518 H): Response to
questions raised by the rapporteur
member state UK on January 26, 2006
2006/1009969
ASB2009-11228
Open BASF Add*
KIIA 5.8. Engelhardt, G. 2004 Amendment No. 1 to the report: In vitro
chromosome aberration assay with Reg.
No. 176326 (metabolite of BAS 518 H,
Quinmerac) in V79 cells
2004/1010810 ! 32M0150/034019
GLP: Yes Published: No
BVL-1007257, BVL-1850068, BVL-
1946278, BVL-1984452, BVL-
2033007, ASB2007-814
Yes BAS N*
KIIA 5.8. Engelhardt, G. 2004 Amendment No. 1 to the report: In vitro
gene mutation test with Reg. No.
176326 (metabolite of BAS 518 H,
Quinmerac) in CHO cells (HPRT locus
assay)
2004/1010811 ! 50M0150/034018
GLP: Yes Published: No
BVL-1007312, BVL-1850088, BVL-
1946298, BVL-1984482, BVL-
2033027, ASB2007-812
Yes BAS N*
KIIA 5.8. Engelhardt, G. 2004 Amendment No. 1 to the report:
Salmonella typhimurium / Escherichia
coli reverse mutation assay (standard
plate test and preincubation test) with
Reg. No. 176326 (Metabolite of BAS
518 H, Quinmerac)
2004/1010812 ! 40M0150/034014
GLP: Yes Published: No
BVL-1007310, BVL-1850086, BVL-
1946296, BVL-1984480, BVL-
2033025, ASB2007-810
Yes BAS N*
KIIA 5.8 Engelhardt, G.; Leibold, E. 2003 Salmonella typhimurium / Escherichia
coli reverse mutation assay (standard
plate test and preincubation test) with
Reg. No. 176326 (Metabolite of BAS
518 H, Quinmerac)
2003/1014012 ! 40M0150/034014
GLP: Yes Published: No
BVL-1007309, BVL-1850085, BVL-
1946295, BVL-1984479, BVL-
2033024, ASB2007-809
Yes BAS N*
KIIA 5.8 Engelhardt, G.; Leibold, E. 2003 In vitro chromosome aberration assay
with Reg. No. 176326 (metabolite of
BAS 518 H, Quinmerac) in V79 cells
2003/1018219 ! 32M0150/034019
GLP: Yes Published: No
BVL-1007313, BVL-1850089, BVL-
1946299, BVL-1984483, BVL-
2033028, ASB2007-813
Yes BAS N*
KIIA 5.8 Engelhardt, G.; Leibold, E. 2004 In vitro gene mutation test with Reg.
No. 176326 (metabolite of BAS 518 H,
Quinmerac) in CHO cells (HPRT locus
assay)
2004/1004526 ! 50M0150/034018
GLP: Yes Published: No
BVL-1007311, BVL-1850087, BVL-
1946297, BVL-1984481, BVL-
2033026, ASB2007-811
Yes BAS N*
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Annex point/
reference No
Author(s) Year Title
Report-No.
Authority registration No
Data
protection
claimed
Owner How
considered in
dRR #
KIIA 5.8 XXXXX. 2004 Cytogenetic study in vivo with Reg. No.
176326 (metabolite of BAS 518 H,
Quinmerac) in the mouse micronucleus
test after two oral administrations
2004/1009125 ! 26M0150/034112
GLP: Yes Published: No
BVL-1007258, BVL-1850069, BVL-
1946279, BVL-1984453, BVL-
2033008, ASB2007-815
Yes BAS N*
KIIA 5.8 Wollny, H.-E. 2000 Gene mutation assay in Chinese hamster
V79 cells in vitro (V79 / HPRT) with
Reg.-No. 230 089
2000/1000183 ! 50M0305/999038 !
647603
GLP: Yes Published: No
BVL-1007307, BVL-1850083, BVL-
1946293, BVL-1984477, BVL-
2033022, TOX2003-1904
Yes BAS Add*
KIIA 5.8 Wollny, H.-E. 2007 Cell mutation assay at the thymidine
kinase locus (TK+/-) in mouse
lymphoma L5178Y cells with Reg. No.
176326 (Metabolite of BAS 518 H,
Quinmerac)
2007/1020127 ! 1082802 !
52M0150/039024
GLP: Yes Published: No
BVL-1852342, BVL-1946325, BVL-
1995257, BVL-2033054, ASB2009-
10949
Yes BAS N*
KIIA 5.8 Wollny, H.-E. 2007 Cell mutation assay at the thymidine
kinase locus (TK+/-) in mouse
lymphoma L5178Y cells with Reg. No.
176326 (Metabolite of BAS 518 H,
Quinmerac) - First amendment
2007/1048088 ! 1082802 !
52M0150/039024
GLP: Yes Published: No
BVL-1852348, BVL-1946326, BVL-
1995258, BVL-2033055, ASB2009-
10950
Yes BAS N*
KIIA 5.8 Wollny, H.-E. 2007 Cell mutation assay at the thymidine
kinase locus (TK+/-) in mouse
lymphoma L5178Y cells with Reg. No.
176326 (Metabolite of BAS 518 H,
Quinmerac) - Second amendment
2007/1049350 ! 1082802 !
52M0150/039024
GLP: Yes Published: No
BVL-1852354, BVL-1946327, BVL-
1995259, BVL-2033056, ASB2009-
10951
Yes BAS N*
KIIA 5.10 Flügge, C. 2010 Mutagenicity study of BH 518-2 in the
mouse lymphoma forward mutation
assay - in vitro
24050
GLP: Yes Published: No
BVL-2200800, ASB2011-9371
Yes FSG Y
KIIA 5.10, KIIA
5.8, KIIIA1 7.11
Flügge C. 2010 In vitro assessment of the clastogenic
activity of BH 518-2 in cultured human
peripheral lymphocytes
LPT 25223
GLP: Yes Published: No
BVL-2200799, BVL-2200807, BVL-
2203829, ASB2011-9363
Yes FSG Y
Part B – Section 8
Core Assessment /
National Addendum – DE
GOLTIX TITAN
Registration Report –
Central Zone
Page 16 of 16
Annex point/
reference No
Author(s) Year Title
Report-No.
Authority registration No
Data
protection
claimed
Owner How
considered in
dRR #
KIIA 5.10, KIIA
5.8, KIIIA1 7.11
Flügge, C. 2010 Mutagenicity study of BH 518-2 in the
salmonella typhimurium reverse
mutation Assay (in vitro)
LPT 24049
GLP: Yes Published: No
BVL-2200797, BVL-2200805, BVL-
2203827, ASB2011-9361
Yes FSG Y
KIIA 5.10, KIIA
5.8, KIIIA1 7.11
Flügge, C. 2010 Mutagenicity study of BH 518-2 in the
mouse lymphoma forward mutation
assay - in vitro - Amendment No. 1
LPT 24050
GLP: Yes Published: No
BVL-2200798, BVL-2200806, BVL-
2203828, ASB2011-9362
Yes FSG Y
KIIA 5.8 Engelhardt, G.; Hoffmann,
H. D.
1988 Report on the study of Reg.No. 230
089/02 in the AMES test (standard plate
test and preincubation test with
Salmonella typhimurium)
88/0507 ! 40M0220/884057
GLP: Yes Published: No
BVL-2200819, TOX2003-1901
No BAS Y
KIIA 5.8 XXXXX. 1988 Report on the study of acute oral
toxicity on the rat based on OECD and
EPA (FIFRA) of Reg.No. 230 089/02
88/0397 ! 10A0220/881064
GLP: Yes Published: No
BVL-2200817, TOX2003-1899
No BAS Y
KIIA 5.8 XXXXX. 1990 Report on the study of the prenatal
toxicity of Reg.No. 230 089/02 in rats
after oral administration (gavage),
LIMIT-test, based on OECD Guideline
90/0028 ! 34R0220/88024
GLP: Yes Published: No
BVL-2200821, TOX2003-1905
No BAS Y
KIIA 5.8 XXXXX. 1990 Report on the study to evaluate the
potential of Reg.No. 230 089 to induce
micronuclei in the polychromatic
erythrocytes of CD-1 mice, based on
OECD and JMAFF Guidelines
90/0074 ! 31MREBLG.003 ! BLG
3/MNT ! 26M0220/889020
GLP: Yes Published: No
BVL-2200820, TOX2003-1903
No BAS Y
KIIA 5.8 XXXXX. 1993 Report on the study of the oral toxicity
with Reg. No. 230 089 in Wistar rats -
Administration in the diet over 3 months
93/10972 ! 31S0514/91069
GLP: Yes Published: No
BVL-2200818, TOX9300119
No BAS Y
# Y: Yes, relied on
N*: Studies from EU peer-review were included here in terms of completeness, transparency and consistency, c.f., SANCO/10328/2004
– rev. 8 (2012-01-24)
Add*: Studies from EU peer-review were included here in terms of completeness, transparency and consistency, c.f., SANCO/10328/2004
– rev. 8 (2012-01-24), study not submitted by applicant but necessary for evaluation