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14507 N
Solofol, 20146224 ZWTG
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1. BESLUIT
Op 23 december 2014 is van
Belchim Crop Protection N.V./S.A.
Technologielaan 7
B-1840 LONDERZEEL
Belgium
Aanvraag tot wijziging van gewasbeschermingsmiddeltoelating met Nederland als zonaal rapporteur
ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening)
voor het gewasbeschermingsmiddel
Solofol
op basis van de werkzame stof folpet.
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel
van dit besluit.
1.1 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.2 Gebruik
Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en
zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.
1.3 Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende
aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden
vermeld:
� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder
“verpakkingsinformatie” in bijlage I.
� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel
A van het registratierapport, Appendix I.
� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
14507 N
Solofol, 20146224 ZWTG
� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de
voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2
van deel A van het registratierapport.
1.4 Aflever- en opgebruiktermijn (respijtperiode)
Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op
de verpakking te worden aangebracht. De te hanteren w-coderingen en aflever- en
opgebruiktermijnen voor oude verpakkingen staan vermeld onder “toelatingsinformatie” in bijlage I.
2. WETTELIJKE GRONDSLAG
Besluit artikel 28 Verordening (EG) Nr. 1107/2009
Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009
Gebruikt toetsingskader Conform Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual
Zonaal 2.0.
3. BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en
ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn
bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het
middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar
geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die
vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd
gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het
werkzaam is.
Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het
registration report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel
bekendmaken delen A en B van het Registration Report.
14507 N
Solofol, 20146224 ZWTG
Bezwaarmogelijkheid
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de
Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes
weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College
voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.
Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift
opengesteld.
Ede, 1 juni 2018
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw
Voorzitter
14507 N
Solofol, 20146224 ZWTG
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraaginformatie
Aanvraagnummer: 20146224 ZWTG
Type aanvraag: Aanvraag tot wijziging van
gewasbeschermingsmiddeltoelating met Nederland als
zonaal rapporteur
Middelnaam: Solofol
Verzenddatum aanvraag: 18 december 2014
Formele registratiedatum: * 7 januari 2015
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2.2 Stofinformatie
Werkzame stof Gehalte
folpet 80 %
• De stof is per 1 oktober 2007 geplaatst op Annex I van Richtlijn 91/414/EEG ((2007/5/EC d.d.
7 februari 2007)) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011
goedgekeurd) De goedkeuring van deze werkzame stof expireert op 31-07-2018.
2.3 Toelatingsinformatie
Toelatingsnummer: 14507 N
Expiratiedatum: 1 augustus 2024
Afgeleide parallel of origineel: Wijziging Middel
Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel
Gebruikers: Professioneel
W-coderingen en aflever- en opgebruiktermijnen:
� W-codering professioneel gebruik: W2
� Vorige w-codering professioneel gebruik: W1
� Aflevertermijn professioneel gebruik: nvt
� Opgebruiktermijn professioneel gebruik: nvt
2.4 Verpakkingsinformatie
Aard van het preparaat:
Water dispergeerbaar granulaat
14507 N
Solofol, 20146224 ZWTG
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Solofol
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
folpet
methylnaftaleensulfonaat \ formaldehyde condensaat, natriumzout
Pictogram GHS05
GHS07
GHS08
GHS09
Signaalwoord Gevaar
Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken.
H318 Veroorzaakt ernstig oogletsel
H332 Schadelijk bij inademing.
H351 Verdacht van het veroorzaken van kanker.
H410 Zeer giftig voor in het water levende organismen, met langdurige
gevolgen.
Voorzorgsmaatregelen SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water
verontreinigt.
P201 Alvorens te gebruiken de speciale aanwijzingen raadplegen.
P273 Voorkom lozing in het milieu.
P280 Beschermende handschoenen/beschermende
kleding/oogbescherming/gelaatsbescherming dragen.
P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen
met water gedurende een aantal minuten; contactlenzen verwijderen,
indien mogelijk. Blijven spoelen.
P308 + P313 Na (mogelijke) blootstelling: een arts raadplegen.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
Aanvullende
etiketelementen
EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke
gezondheid en het milieu te voorkomen.
Kinderveilige sluiting verplicht Nee
Voelbare gevaarsaanduiding verplicht Nee
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 6 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018
REGISTRATION REPORT
Part A
Risk Management
Product code: Solofol (BCP324F)
Active Substance: 800 g/kg
COUNTRY: The Netherlands
Central Zone
Zonal Rapporteur Member State: The Netherlands
NATIONAL ASSESSMENT
Applicant: Belchim Crop Protection NV/SA
Date: May 2018
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 7 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Table of Contents
PART A – Risk Management 9
1 Details of the application 9
1.1 Application background 9
1.2 Annex I inclusion 10
1.3 Regulatory approach 10
1.4 Data protection claims 10
1.5 Letters of Access 11
2 Details of the authorisation 11
2.1 Product identity 11
2.2 Classification and labelling 11
2.2.1 Classification and labelling under Regulation (EC) No. 1272/2008 11
2.2.3 Other phrases for Regulation (EC) 1272/2008 12
2.3 Product uses 13
3 Risk management 16
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles 16
3.1.1 Physical and chemical properties 16
3.1.2 Methods of analysis 17
3.1.2.1 Analytical method for the formulation 17
3.1.2.2 Analytical methods for residues 17
3.1.3 Mammalian Toxicology 17
3.1.3.1 Acute Toxicity 18
3.1.3.2 Operator Exposure 18
3.1.3.3 Bystander Exposure 19
3.1.3.4 Worker Exposure 19
3.1.4 Residues and Consumer Exposure 19
3.1.4.1 Residues 19
3.1.4.2 Consumer exposure 19
3.1.5 Environmental fate and behaviour 20
3.1.6 Ecotoxicology 24
3.1.6.1 Effects on Terrestrial Vertebrates 24
3.1.6.2 Effects on Aquatic Species 26
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 8 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
3.1.6.3 Effects on Bees and Other Arthropod Species 27
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms 27
3.1.6.5 Effects on organic matter breakdown 28
3.1.6.6 Effects on Soil Non-target Micro-organisms 28
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)
28
3.2 Conclusions 31
3.2 Additional information 31
Appendix 1 – Copy of the product authorisation 32
Appendix 2 – Copy of the product label 33
Wettelijk Gebruiksvoorschrift 33
Appendix 3 – Letter of Access 35
Appendix 4: List of data submitted in support of the evaluation 36
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 9 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018
PART A – Risk Management
1 Details of the application
This document describes the specific conditions of use and labelling required for the registration of the
plant protection product Solofol containing the active substance folpet which was included into Annex I
of Directive 91/414 (Commission Directive 2007/5/EC of 07 February 2007) and under Regulation
1107/2009/EC (Commission Regulation n° 540/2011 of 25 May 2011).
Where appropriate this document refers to the conclusions of the EU review of the active substance
folpet. This will be where:
• the active substance data is 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.
Ctgb from The Netherlands received application for Solofol (BCP324F) on 24 December 2010. After
evaluation of the application the product was approved on 1 August 2014 with Approval nr.: 14507 N.
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 The
Netherlands. The information, data and assessments provided in Registration Report, Parts B includes
assessment of further data or information as required at national re-registration/registration by the EU
review. It also includes assessment of data and information relating to Solofol where that data has not
been considered in the EU review.
Appendix 1 of this document provides a copy of the final product authorisation The Netherlands.
Appendix 2 of this document is a copy of the approved product label for The Netherlands.
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.
Table 2.3 of this document is the table of intended uses for Solofol.
1.1 Application background
This application was submitted by Belchim Crop Protection nv/sa on December 2014.
The application was for approval of Solofol, a WG containing 800 g/kg folpet for use as a fungicide for
use on vines and on flower bulbs.
Company: Belchim Crop Protection N.V./S.A.
Address: Technologielaan 7
B-1840 Londerzeel
Belgium
Telephone: +32 52 30 09 06
Fax: +32 52 30 11 35
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 10 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
1.2 Annex I inclusion
Folpet was included into Annex I of Directive 91/414 (Commission Directive 2007/5/EC of 07 February
2007) and under Regulation 1107/2009/EC (Commission Regulation n° 540/2011 of 25 May 2011).
The Annex I Inclusion Directive for folpet (2007/5/EC) 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
1.3 Regulatory approach
To obtain re-approval/approval the product Solofol 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.
Ctgb from the Netherlands received application for Solofol (BCP324F) on 24 December 2010. After
evaluation of the application the product was approved on 1 August 2014 with Approval nr.: 14507 N.
The SANCO report for folpet (SANCO/10032/2006 – rev. 5 of 11 July 2008) is considered to provide the
relevant review information or a reference to where such information can be found. The following table
provides the EU endpoints to be used in the evaluation.
EU End-points
End-Point Active Substance
EU agreed endpoints
(SANCO/10032/2006 – rev. 5)
Endpoints used a
Purity of active substance Minimum 940 g/kg Minimum 960 g/kg
Identity of relevant
impurities in the active
substance as manufactured
Perchloromethyl mercaptan: max. 3.5 g/kg
Carbon tetrachloride max. 4 g/kg
< 1 g/kg
< 1 g/kg a Data based on new manufacturing sources for technical folpet of the applicant. Details on the composition including
confirmation of the technical equivalence by the designated member state France are provided in Part C.
This application was submitted in order to allow the registration of the product in The Netherlands in
accordance with the above.
1.4 Data protection claims
Where protection for data is being claimed for information supporting the registration of Solofol
(BCP324F), it is indicated in the reference lists in Appendix 1 of the Registration report, Part B, Sections
1-8 and Part C.
Information on the detailed composition of Solofol can be found in the confidential dossier of this
submission (Registration Report - Part C).
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 11 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
1.5 Letters of Access
Letter of access by ADAMA Makhteshim Ltd. for studies IIIA 8.3.1/03 (R-27558) and IIIA 8.3.1/04 (R
27930) on magnitude of residue of folpet and its metabolite phthalimide in table grapes.
2 Details of the authorisation
2.1 Product identity
Product Name Code name: BCP324F /Folpet 80WG - Marketing name : Solofol
Authorization Number (for re-
registration)
To be assigned
Function Fungicide
Applicant Belchim Crop Protection N.V./S.A.
Composition 800 g/kg folpet
Formulation type Water dispersible granules [Code: WG]
Packaging Bags comprising of PET/LDPE: 125 g.
Bag comprising of three layers of film (triplex), formed by an external
layer of polyamide bi-oriented, a middle layer of aluminum and an
internal layer of polyethylene: 1 kg and 5 kg
Bags comprising of brown kraft 70 + LDPE 15 + ALU FOIL 19-7 My +
LDPE 35: 10 kg
2.2 Classification and labelling
2.2.1 Classification and labelling under Regulation (EC) No. 1272/2008
Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the
co-formulants, the method of application and the risk assessment for the operator, as mentioned above,
the following labeling of the preparation is proposed:
The identity of all substances in the mixture that contribute to the classification of the mixture *:
Folpet, condensation of product of sodium methyl naphthalene and formaldehyde
Pictogram: GHS05 Signal word: danger
GHS07
GHS08
GHS09
H-statements: H317 May cause an allergic skin reaction
H318 Causes serious eye damage.
H332 Harmful if inhaled.
H351 Suspected of causing cancer.
H410 Very toxic to aquatic life with long lasting effects.
P-statements: P201 Obtain special instructions before use.
Part A National Assessment Country – The Netherlands
Solofol
Registration Report – Central Zone Page 12 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye
protection/face protection.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for
several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
P308+P313 IF exposed or concerned: Get medical
advice/attention.
P391 Collect spillage.
P501 Dispose of contents/container to…
Supplemental Hazard
information:
EUH401 To avoid risks to human health and the
environment, comply with the instructions for use.
SP-statement: SP1 Do not contaminate water with the product or its
container
Child-resistant fastening obligatory? n.a.
Tactile warning of danger obligatory? n.a.
Explanation:
Pictogram: -
H-statements: H317 and H351 are assigned based on the classification of
folpet. H318 and H332 are assigned based on calculation rules.
P-statements: P280 is assigned based on H317, H318, and H351
classification. P305+P351+P338 is assigned based on H318
classification. Other P-statements were proposed by the
applicant and accepted.
Other: -
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
2.2.3 Other phrases for Regulation (EC) 1272/2008
-
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 13 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018
2.3 Product uses
PPP (product name/code) Solofol/BCP 324 F
Active substance 1 folpet
Active substance 2 n.a.
Safener /
Synergist /
Formulation type: WG
Conc. of as 1: 800 g/kg
Conc. of as 2: n.a.
Conc. of safener: /
Conc. of synergist: /
Applicant: Belchim Crop Protection NV/SA
Zone(s): Central Zone
professional use
non professional use
Verified by MS:
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 season
kg product / ha
a) max. rate
per appl.
b) max. total
rate per season
kg as/ha
a) max. rate per
appl.
b) max. total rate
per crop/season
Water
L/ha
min /
max
Existing use in NL, not evaluated in this dossier
1 NL Wine grape
(VITVI,
Vitis
vinifera)
F Downy
mildew
(PLASVI,
Plasmopara
viticola)
Airblast
sprayer;
foliar
application
BBCH 12 –
BBCH 83
(spring –
summer)
(April –
September)
a) 10
(7 days)
b) 10
(7 days)
a) 1.8 kg/ha
b) 18.0kg/ha
a) 1.44 kg
b) 14.4 kg
1000 /
1200
28
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 14 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
New uses
9 NL Flower
bulbs and
flower
corms
(GLASS,
Gladiolus
spp.)
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 1.8 kg/ha
b) 1.8 kg/ha
a) 1.44 kg
b) 1.44 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
360 L/ha
10 NL Flower
bulbs and
flower
corms
(CROSS,
Crocussus
spp.)
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 2.43 kg/ha
b) 2.43 kg/ha
a) 1.944 kg
b) 1.944 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
487.5 L/ha
11 NL Flower
bulbs and
flower
corms
(IRISS, Iris
spp.)
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 2.45 kg/ha
b) 2.45 kg/ha
a) 1.96 kg
b) 1.96 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
490 L/ha
12 NL Flower
bulbs and
flower
corms
(TULSS,
Tulipa
spp.)
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 3.25 kg/ha
b) 3.25 kg/ha
a) 2.6 kg
b) 2.6 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
650 L/ha
13 NL Flower
bulbs and
flower
corms
(NARSS,
Narcissus
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 3.25 kg/ha
b) 3.25 kg/ha
a) 2.6 kg
b) 2.6 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
650 L/ha for miniature
bubs
(m.u.v. grofbollige narcis)
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 15 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
spp.)
14 NL Flower
bulbs and
flower
corms
(LILSS,
Lilium
spp.)
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 3.5 kg/ha
b) 3.5 kg/ha
a) 2.8 kg
b) 2.8 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
700 L/ha
15 NL Flower
bulbs and
flower
corms
(HYASS,
Hyacinthus
spp.)
I/F FUSASP,
Fusarium spp.
bulb dip BBCH 00
(Before
planting)
(January –
December)
a) 1
(n.a.)
a) 3.575 kg/ha
b) 3.575 kg/ha
a) 2.86 kg
b) 2.86 kg
- - Dose rate of 0.5% product.
Bulb dip water uptake
715 L/ha
16 NL Flower
bulbs and
flower
corms
(NNNZJ,
all species)
F BOTRSP,
Botrytis spp.
foliar
spray
BBCH
12-39 91
(March-
September)
a) 2 10#
(7 days)
b) 2 10#
(7 days)
a) 1.0 kg/ha
1.5
b) 2.0 kg/ha
10-15
a) 0.80 kg
1.2
b) 1.60 kg
8-12
150 /
400
- # Before BBCH 40, only
2applications with the
lowest dose are allowed.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 16 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018
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 The product Solofol is a water dispersible granular formulation (WG). The in–use concentrations are
0.10 - 1.0 %. All studies have been performed in accordance with the current requirements, the critical
GAP and the results are deemed to be acceptable. The appearance of the product is that of brown
granules, with no characteristic odour. It is not explosive and has no oxidising properties. It has a self
ignition temperature of > 400°C. In a 1% aqueous dilution, it has a pH value of around 8.8 to 9.8. The
stability data indicate a shelf life of at least 2 years at ambient temperature. Its technical characteristics
are acceptable for a WG formulation.
Implications for labelling: There are not clear implications for labelling
Compliance with FAO specifications:
Yes, the product Solofol complies with FAO specifications.
Compatibility of mixtures:
Not applicable. No specific tank mixtures or mixing recommendations are proposed on the label.
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. Solofol is intended
to be commercialised in five commercial packs: 1 kg bags, a case containing 10 of the 1 kg bags, a 1 kg
box, a 5 kg 3-ply bag and a 10 kg multi layer bag.
Nature and characteristics of the protective clothing and equipment:
Information regarding the required protective clothing and equipment for the safe handling of Solofol has
been provided and is considered to be acceptable (IIIA 4.2.1).
Implications for labelling:
Hazard Pictogram:
GHS07, GHS08, GHS09
Signal word: Warning
Part A National Assessment Country – The Netherlands
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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
3.1.2 Methods of analysis
Folpet is determined in formulated Solofol via HPLC with UV detection. The method was fully validated
with respect to specificity, linearity, repeatability and accuracy. A CIPAC method is not available for
folpet formulated as a water dispersible granule. However, CIPAC methods exist for folpet technical,
dustable powders and wettable powders and during the EU review were considered to be applicable for
WG formulations.
3.1.2.1 Analytical method for the formulation
There are no impurities within the preparation that are of toxicological, ecotoxicological or environmental
concern. The toxicological relevant impurities in technical folpet of the reference specification (i.e.
carbon tetrachloride and perchloromethyl mercaptan) are well below 0.1% in the material from the
manufacturing sources for Solofol and are significantly below the limit values (0.35% for
perchloromethyl mercaptan and 0.4% for carbon tetrachloride) set for the inclusion of folpet in Annex I of
Council Directive 91/414/EEC (for details on the composition of the technical active substance in Solofol
please refer to the confidential part C of this dossier). Since these impurities cannot be formed upon
storage of the technical active substance or the manufacturing and storage of the formulated product, no
analytical method is needed for their determination in Solofol.
Analytical methods for determination of folpet, impurities and relevance of CIPAC methods in Solofol
were not evaluated as part of the EU review of folpet. Therefore all relevant data are provided and are
considered adequate.
A CIPAC method is not available for folpet formulated as a water dispersible granule. However, the
existing CIPAC methods for folpet technical (CIPAC 1B, 75/TC/M), dustable powders (CIPAC 1B,
75/DP/M) and wettable powders (CIPAC 1B, 75/WP/M) are considered to be applicable (EU endpoint
list).
3.1.2.2 Analytical methods for residues
The applicant supports the use of Solofol in vines and flower bulbs. The EU Annex II dossier contains
several crop residue methods in these segments. However, the majority of crop residue methods did not
consider the quantification of phthalimide which, at the time of Annex I decision, was considered a
relevant degradation product in plants.
Additional data on methods/validation in crops, soil, sediment, water, air, body fluid & tissues for folpet
have been provided for the original application for Solofol and considered adequate.
All analytical methods are active substance data and were provided in the EU review of the active
substance folpet and were considered adequate.
The analytical method for the determination of residues in surface water meets the Dutch national
requirement (LOQ<0.1 µg/L)
3.1.3 Mammalian Toxicology
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 18 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
3.1.3.1 Acute Toxicity
The following tests were performed on Solofol: acute LD50 oral (rat), acute LD50 dermal (rat), skin
irritation (rabbit) and eye irritation (rabbit). An inhalation toxicity study was not performed. The
calculation method has been used instead. A skin sensitisation test was not performed as the active
substance is already classified for its sensitising effects. The eye irritation test did not comply with OECD
405 and has therefore not been used for the classification of Solofol. The calculation method has been
used instead.
Table 3.1.3-1: Summary of Acute toxicological data of Solofol
Parameter
[Reference]
Species Result
mg/kg or mg/m3 or effect
Classification according
to CLP Reg (EC) No
1272/2008
Acute oral toxicity
Rat
LD50 > 2000 unclassified
Acute dermal
toxicity
Rat
LD50 > 2000 unclassified
Acute inhalation
toxicity Based on the calculation method, H332 is required. H332 (“Harmful if inhaled)
Skin irritation
Rabbit
Not irritating unclassified
Eye irritation
Based on the calculation method, H318 is required.
H318 (“Causes serious eye
damage”)
Skin sensitization n.a. Sensitizer1 H317 “May cause an
allergic skin reaction” 1 Classification based on data of the active substance
Solofol containing 800 g/kg folpet, has a low toxicity in respect to acute oral and dermal toxicity and in
not irritating to the rabbit skin. It has been found to be a skin sensitizer, based on skin sensitising
properties of the active substance. Based on the calculation method, H318 (Causes serious eye damage)
and H332 (Harmful if inhaled) is required for classification and labelling of the product.
Acute toxicity studies for Solofol were not evaluated as part of the EU review of the active substance
folpet. Therefore, all relevant data are provided here and are considered adequate.
3.1.3.2 Operator Exposure
The model estimations were based on the following data:
Endpoint Folpet
Endpoints used in risk assessment
Dermal penetration Concentrate: 0.3%
Spray dilution (3.2 g/L): 2%
Spray dilution (1.5 g/L): 4%
AOEL 0.1 mg/kg bw/day
In the Netherlands, only flower bulb dipping and foliar spray in flower bulbs (field) has been applied for.
According to the model calculations, it can be concluded that the risk for the operator using Solofol for
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 19 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
mechanical outdoor spraying on flower bulbs and for automated indoor dipping of flower bulbs is
acceptable without the use of PPE (23% and 29% of the AOEL, respectively).
Given the eye irritating and sensitising potential of Solofol impermeable gloves and eye/face protection
should be worn when handling the concentrate.
3.1.3.3 Bystander Exposure
It is concluded that there is no undue risk to any, work related bystander, non-work related bystander or
resident (adult or child) after exposure to Solofol. The exposure is estimated to be less than 3.1% of the
AOEL for all relevant NL-GAP uses.
3.1.3.4 Worker Exposure
Based on the Dutch national assessment for re-entry activities in flower bulbs after foliar application and
in flower bulb planting (for putting the treated bulbs manually upright), the worker exposure does not
exceed the EU-AOEL without the use of PPE. The exposure is estimated to be 41% of the AOEL for the
foliar application in flower bulbs and 98% of the AOEL for flower bulb planting.
3.1.4 Residues and Consumer Exposure
3.1.4.1 Residues
The metabolism and residue data of folpet have been evaluated by EFSA during the peer review (EFSA
Scientific Report (2009) 297, 1-80) and review of the existing MRLs of folpet (EFSA Journal 2014;
12(5):3700). In the peer review and MRL review residue definition for monitoring and risk assessment is
defined as sum of folpet and phthalimide.
Additional supervised residue trials with folpet in pasture, grapes and grape’s processed commodities,
nature of folpet resides in hydrolytic conditions have been submitted for this application. The studies have
been evaluated by Ctgb and also summary of the studies is available in this application.
Eight trials in wine grapes in Northern Europe are available. Four trials have been evaluated in the DAR
and four trials are evaluated in this application. Total residues of folpet (sum of folpet and phthalimide,
expressed as folpet) were 0.43-3.5 mg/kg. The intended use in wine grapes is covered by the current EU-
MRL (20 mg/kg).
Six residue trials with folpet in table grapes in Northern Europe are provided, that have been previously
evaluated in EFSA Journal 2013;11(9):3384. Total residues of folpet (sum of folpet and phthalimide,
expressed as folpet) were 0.19 – 0.73 mg/kg. Table grapes are minor crop in Northern Europe, hence six
trials is considered acceptable. The intended use in table grapes is covered by the current EU-MRL of 6
mg/kg.
Based on the submitted study on nature of folpet residues in processing simulation, it was concluded that
folpet is hydrotically unstable. Depending on hydrolysis conditions degradation via phthalimide to
phthalamic acid, phthalic acid and 2-cyanobenzoic acid was observed. One balance and three follow up
studies in grapes have been submitted for this application. Transfer factors for processing into wine, juice
and dry raisins have been calculated.
3.1.4.2 Consumer exposure
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev.
2.0, containing all available Member State diets. This calculation was updated with the median residue
values (STMR) derived from the residue trials conducted on the crops under consideration in this
Part A National Assessment Country – The Netherlands
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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
application. This calculation covers the requested use in wine grapes and table grapes. No long term risk
for the consumers has been identified (highest TMDI was 7.4% of the ADI for FR general population).
A calculation of the International Estimated Short Term Intake (IESTI) was carried out using EFSA
PRIMo rev. 2.0, including uses requested within this application. The percentage of the IESTI is 13.6 %
of the ARfD for wine grapes for UK infant and 23.9 % of the ARfD for table grapes for German child.
The risk assessments show that folpet residues from the intended uses in wine grapes and table grapes do
not represent an acute risk to consumers.
Based on the different calculations made to estimate the risk for consumers through diet and other means
it can be concluded that the use of product Solofol does not lead to an unacceptable risk for consumers for
the requested use in wine grapes and table grapes.
3.1.5 Environmental fate and behaviour
The calculations of predicted environmental concentrations in soil, groundwater, surface water, sediment
and air presented in the core assessment were performed in consideration of the risk envelope GAP use
covering all other intended GAP uses for which authorisation is sought in the EU central zone.
A comparison of the GAP uses supported in with the envelope uses of the core assessment is provided in
the Table 3.1.5-01.
Table 3.1.5-01
Critical use patterns of Folpet for each crop supported in the C-EU (flower bulbs only intended for The Netherlands)
Use given in GAP sheet Supported risk envelope for the
C-EU
GAP
use
no.*
Crop Application
method
App. rate per
treatment (g
a.s./ha)
No.
of
app.
Interval
(days)
App. rate per
treatment (g
a.s./ha)
No.
of
app.
Interval
(days)
1 Vine (VITVI,
Vitisvinifera)
Airblast
sprayer; foliar
application
1500 10 7
1500 10 7 4 1500 5 7
6
Flower bulbs
(GLASS,
Gladiolus
spp.)
Bulb dip
1440
1 - 2860 1 -
7 Flower bulbs
(CROSS,
Crocussus
spp.)
1944
8 1960
9
Flower bulbs
(TULSS,
Tulipa spp.)
2600
10
Flower bulbs
(NARSS,
Narcissus
spp.)
2600
11
Flower bulbs
(LILSS,
Lilium spp.)
2800
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 21 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Table 3.1.5-01
Critical use patterns of Folpet for each crop supported in the C-EU (flower bulbs only intended for The Netherlands)
Use given in GAP sheet Supported risk envelope for the
C-EU
GAP
use
no.*
Crop Application
method
App. rate per
treatment (g
a.s./ha)
No.
of
app.
Interval
(days)
App. rate per
treatment (g
a.s./ha)
No.
of
app.
Interval
(days)
12
Flower bulbs
(HYASS,
Hyacinthus
spp.)
2860
13
Flower bulbs
(NNNZJ, all
species)
foliar spray
800+800+1200
+1200+1200
+1200+1200
+1200+1200
+1200
10 7
800+800+1200
+1200+1200
+1200+1200
+1200+1200
+1200
10 7
*: Please refer to GAP table listed in core assessment for the detailed GAP table.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil)
All PEC calculations in the core dossier have been performed assuming a soil bulk density of 1.5 g/cm³
and an equal distribution of the product in the top 5 cm (spray application) or 10 cm (planting after
dipping). The bulbs are almost completely and equally distributed over the topsoil and they are covered
with 5 cm soil. Therefore a soil layer of 10 cm (5 cm cover soil + 5 cm soil below) is used for PECsoil
calculations. It was assumed that the degradation of the active substance in soil follows a simple first
order kinetic with a worst-case DT50 value of 10 days. In vines grapes (use no. 1) interception rates of
50% for 1st and 2nd application, 60% for 3rd to 10th application were used. No interception needs to be
taken account for calculating PECs for flower bulb in use no. 6 to 12 as method of application was bulb
dip. In use no. 13, interception of 10% for first two applications, and 40% for 3rd to 10th application were
used.
Active Substance
Initial and time weighted PECs values of folpet for application to vines, and flower bulb are provided in
the core dossier. Initial PECs values of 1.324, 1.907, 1.419 and 1.907 mg/kg were obtained for vines,
flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar
application), respectively.
Relevant Metabolites
Phthalimide, phthalic acid and phthalamic acid are major soil metabolites of folpet. These soil metabolites
of folpet appear shortly after application.
Initial and time weighted PECs values of metabolites for application to vines, and flower bulb are
provided in the core dossier.
Initial PECs values of 1.367, 0.615, 1.607 and 1.717 mg/kg were obtained for phthalimide for vines,
flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar
application), respectively.
Initial PECs values of 0.124, 0.179, 0.131 and 0.179 mg/kg were obtained for phthalic acid for vines,
flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar
application) respectively.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 22 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Initial PECs values of 0.092, 0.175, 0.088 and 0.175 mg/kg were obtained for phthalamic acid for vines,
flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar
application) respectively.
Results can be used for the ecotoxicological assessment.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECgw)
PECgw for the active substance folpet and its metabolites were presented in the core assessment (points
IIIA 9.6 to 9.6.1) in consideration of the worst case GAP use that cover all intended uses in the zone.
A conservative transformation scheme, i.e. complete sequential conversion from folpet to Phthalimide to
Phthalamic acid to Phthalic acid and finally to CO2 and non-extractable residues was used for the
leaching assessment.
The FOCUS PEARL Kremsmünster scenario, which is relevant to the conditions in the Netherlands,
shows acceptable PECgw of <0.001 µg/L for all assessed crop simulations (use 1 for vines, use 15 and 16
-separately and combined- for dip and foliar treatment of flower bulbs respectively). .
Thus, use of Solofol is not likely to cause a risk for leaching to groundwater.
Monitoring data groundwater
There are no data available regarding the presence of the active substance folpet in groundwater.
Regarding the presence of metabolites no monitoring data are available.
3.1.5.3 Predicted Environmental Concentration in Surface Water (PECsw)
An assessment was carried out to estimate the PECsw after application of Solofol (800 g/kg folpet) to
vines and flower bulbs. The PEC of folpet in surface water (PECsw and PECsed) has been assessed with the
Dutch TOXSWA 1.2 model and Dutch specific drift figures and the DT50 water/sediment values
established in the EU review.
The GAP uses supported in the Netherlands with the envelope uses of the core assessment is provided in
Table 3.5.1. As the Dutch surface water model only accounts for emission via spray drift, no assessment
is done for the flower bulb dip treatment.
The applicant proposed mitigation measures to reduce the level of spray drift for both the use in vines as well as the foliar use in flower bulbs.
The maximum PECsw of 2.568 µg/L and a maximum PECsed of 0.0016 mg/kg were obtained for folpet
after application in vines in the standard spring scenario, thereby assuming a mitigation of Venturi nozzle
(90 % drift reduction) + one sided spraying last three row and reduced air fan setting.
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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
The maximum PECsw of 2.854 µg/L and a maximum PECsed of 0.0019 mg/kg were obtained for folpet
after application in flower bulbs in the standard spring scenario, thereby assuming a 75% drift reducing
mitigation.
Results can be used for the ecotoxicological assessment.
Monitoring data surface water
Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold
and environmental quality standards.
The active substance folpet was observed in the surface water (most recent data from 2014). Several
locations show an exceedance of the ad hoc MPC threshold. Therefore it is assessed whether there is a
correlation between the observed exceedances and land use types. The correlation analysis as included in
the Pesticide Atlas uses a progressive three-year period to assess whether there is a relation. The last three
available years, in this case 2012-2014 are used to establish the relation.
The observed exceedance of the water quality standard ad hoc MPC threshold is not significantly
correlated to any proposed use.
Therefore, no consequences can be drawn from the observed exceedance.
The surface water metabolite phtalimide (NL translation ftalimide) was observed in the surface water
(most recent data from 2014). As there is no exceedance of thresholds, the monitoring data have no
consequences for the proposed uses of the product.
Drinking water criterion
Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or
existing substances on the Dutch market (authorised for more than 3 years).
For new substances, a pre-registration calculation is performed.
For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board).
If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows
this VEWIN assessment.
If for an existing substance based on monitoring data a potential problem is identified by VEWIN, Ctgb
assesses whether the 90th percentile of the monitoring data meet the drinking water criterion at each
individual drinking water abstraction point.
Folpet has been on the Dutch market for > 3 years (authorised since 12-05-1993). This period is
sufficiently large to consider the market share to be established. From the general scientific knowledge
collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this
case no concrete indications for concern about the consequences of this product for surface water from
which drinking water is produced, when used in compliance with the directions for use. The Ctgb does
under this approach expect no exceeding of the drinking water criterion. The standards for surface water
destined for the production of drinking water are met.
Part A National Assessment Country – The Netherlands
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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
3.1.5.4 Predicted Environmental Concentration in Air (PECAir)
The behaviour of the active substance and its metabolites in air has been considered in the EFSA
conclusion. It was concluded that volatilisation from freshly treated soils is not a relevant factor for the
transport into the air.
Concentrations of folpet in the air are expected to be negligible, due to its low volatility and short
persistence in the atmosphere.
3.1.6 Ecotoxicology
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the
active substance folpet, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 29.09.2006 (Standing Committee took note of the
change of the ARfD on 11 July 2008) shall be taken into account. In this overall assessment Member
States must pay particular attention to the:
- the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should
include risk mitigation measures
These concerns have been addressed within the current submission.
The ecotoxicological properties and risk assessment of the active substance folpet and its main
metabolites were evaluated in this document. The risk assessments were based on exposure values
estimated for the active substance, its metabolites or the formulated product.
The following chapters summarise specific risk assessment for non-target organisms and hence risk
mitigation measures for the authorisation of BCP324F (Solofol, folpet 800WG) according to its intended
use in vines and flower bulbs (only The Netherlands).
Where specific national requirements were not considered or covered in the core assessment and a
national assessment is needed, calculations were done on the basis of the worst-case application scenario
for Solofol in the Netherlands. This concerns the following point(s):
- Effects on aquatic organisms:
The risk assessment for aquatic and sediment-dwelling organisms was performed on the basis of
member state specific PECsw calculations using the modelling program TOXSWA 1.2
- Effects on arthropods other than bees:
The risk assessment for terrestrial non-target arthropods was performed on the basis of member
state specific PERoff-field calculations using national spray drift scenarios
3.1.6.1 Effects on Terrestrial Vertebrates
Effects on birds:
Folpet is of low toxicity to birds in acute and reproduction studies. The main metabolites of folpet in
plants are phthalic acid, phthalamic acid and phthalimide. The risk assessment on folpet is also valid for
these metabolites.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 25 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
The acute toxicity exposure values based on the screening data are above 10, thus indicating a low acute
risk to birds from the proposed uses (since February 2018) of SOLOFOL in Flower bulbs and flower
corms and grape vines.
The risk of birds to be exposed to contaminated drinking water through residual spray liquid from pools
in leaf whorls is considered negligible for the uses in question. However, birds may drink water from
puddles formed on the soil surface after a rainfall event or irrigation follows the application to a crop or
bare soil, and the risk from this exposure must be investigated. The risk assessment shows that the worst
case TER value for the use of SOLOFOL exceeds the trigger level of 10, thus indicating a negligible
acute risk for birds drinking from field puddles formed after the application of SOLOFOL in vineyards
and Flower bulbs and flower corms. The corresponding reproductive TER value exceeds the trigger value
of 5. It is therefore concluded that the reproductive risk is negligible for birds drinking from field puddles.
For the birds a low long-term risk from the use of SOLOFOL in Flower bulbs and flower corms was
found in Tier one. For the use of SOLOFOL in vineyards, a low risk is predicted in tier 1 for small
granivorous and omnivorous birds. The TER value for small insectivorous birds is below 5 and should
require a refined risk assessment. However if rounded to one digit it will be already five and because it is
in the first Tier only a small refinement will be needed and therefore won’t be taken into account but is
reckoned to be save.
Given the low potential for bioaccumulation of folpet in fish in combination with the fast degradation in
the environment, and the very low potential for accumulation in the pharmacokinetic studies in mammals
(EU endpoint list), the risk of secondary poisoning at multiple levels in the terrestrial vertebrate food
chain is very low and further studies are not required.
Effects on Terrestrial Vertebrates Other Than Birds:
Folpet is of low toxicity in acute, short-term and reproduction studies. The main metabolites of folpet in
plants are phthalic acid, phthalamic acid and phthalimide. These metabolites were also found in
metabolism studies in rats and show no risk to accumulate in animal tissues. Hence, the risk assessment
on folpet also takes into account the presence of these metabolites.
The acute toxicity exposure ratio values based on the screening data are below 10, thus triggering the
first-tier risk assessment. Under the first-tier assumptions, the acute TER-values were all above the trigger
value of 10, indicating a low acute risk to mammals from the proposed uses of SOLOFOL in Flower
bulbs and flower corms and grape vines.
The TERLT value based on the screening data is less than five, therefore the first-tier risk assessment was
conducted for long term as well. The TER values for long-term exposure in the first-tier risk assessment
are above the trigger level of five for mammals in the Flower bulbs and flower corms and in the vineyard
scenario except for small herbivorous mammal (BBCH >40)
At the next tier a refinement is applied on DT50, a DT50 of 4.3 in grasses is applied instead of default of
10. As a result the TER value for long-term exposure in the Step 2 risk assessment is above the trigger
level of five indicating acceptable long-term risk to small herbivorous mammals.
The acute and reproductive exposure risk from contaminated drinking water can be limited to scenarios
with field puddles. The worst case TER value for the use of SOLOFOL exceeds the trigger level of 10.
The corresponding reproductive TER value exceeds the trigger value of 5. It is therefore concluded that
the acute and reproductive risk is negligible for mammals drinking from field puddles formed after the
application of SOLOFOL in vineyards and flower bulb fields.
Part A National Assessment Country – The Netherlands
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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Given the low toxicity to mammals and the low potential for bioaccumulation of folpet in fish and
earthworms in combination with the fast degradation in the environment, and the very low potential for
accumulation in the pharmacokinetic studies in mammals (EU endpoint list), the risk of secondary
poisoning at multiple levels in the terrestrial vertebrate food chain is very low and further studies are not
required.
3.1.6.2 Effects on Aquatic Species
No acceptable risk is indicated for all GAP uses supported in the Netherlands. The long-term TER for
aquatic invertebrates is considerably below the trigger value of 10, even with drift reduction measures.
Hence, a further refinement of the long-term risk to aquatic invertebrates is required.
Toxicity data on fish, Daphnia and algae indicate that the metabolites which were considered potentially
of concern in aquatic systems show less toxicity compared to the parent folpet. Concurrently, relevant
PECsw values for these metabolites do not exceed the predicted concentrations calculated for the parent
folpet. Thus, either way (from both the toxicity and exposure point of view), it is reasonably concluded
that the risk for aquatic organisms arising from these metabolites is covered by the parent folpet and
consequently, separate TER calculations for this metabolite are not considered to be required.
Core assessment:
For the exposure and risk assessment based on FOCUS SWASH PECsw calculations, the risk envelope
GAP use in vineyards was considered as worst-case application scenario.
An acceptable acute risk for fish is indicated using a species sensitivity distribution refinement. An
acceptable acute risk for fish is indicated at Step-3 for R1 Pond scenario, at Step-4 considering a no spray
zone of 10-m for D6 Ditch, and at Step-4 considering a vegetated filter strip and no spray zone of 10-m
forR3 Stream scenario. For R1, R2 and R4 stream scenario an acceptable acute risk for fish is indicated at
Step-4 considering a vegetated filter strip and no spray zone of 20-m.
An acceptable chronic risk for fish is indicated at Step-3 for R1 Pond scenario, at Step-4 considering a no
spray zone of 10-m for D6 Ditch, and at Step-4 considering a vegetated filter strip of 20-m for R3 Stream,
at Step-4 considering a no spray zone of 20-m for R2 stream scenarios.
For R1 and R4 stream scenario an acceptable acute risk for fish is indicated considering a 2-d PECsw,twa
value at Step-4/20-m vegetated filter strip and no spray zone.
On this account the acute risk for fish is considered acceptable with a 20 m no spray zone for drainage
scenarios and 20 m vegetated filter strip and no spray zone in runoff scenarios at this zonal level
evaluation.
An acceptable acute risk for daphnia is indicated at Step-3 for R1 Pond scenario, at Step-4 considering a
no spray zone of 10-m for D6 Ditch and considering a vegetated filter strip and no spray zone of 10-m R3
Stream scenario and at Step-4 considering a vegetated filter strip and no spray zone of 20-m for R1 and
R2, Stream scenarios.
For R4 stream scenario an unacceptable acute risk for daphnia is indicated at Step-4 considering a
vegetated filter strip and no spray zone of 20-m. However the R4 stream scenario is only relevant for
Hungary and Ireland, while the maximum proposed application rate of BCP324F used in current
assessment is recommended for the Netherlands, Slovenia, Romania, and Slovakia, only. On this account
the acute risk for daphnia is considered acceptable with a 20 m no spray zone for drainage scenarios and
20 m vegetated filter strip and no spray zone in runoff scenarios at this zonal level evaluation.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 27 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Based on an NOEC of 320 µg a.s./L, an acceptable chronic risk for Daphnia is indicated at Step-3, except
for R4 stream with flower bulps. However, it should be noted that the use in flower bulbs is specific for
The Netherlands and only presented here for completeness.
Based on a EC of > 10000 µg a.s./L, an acceptable risk for algae is indicated at Step-1 without the need of
any risk mitigation measures.
NL assessment:
The entry route spray drift was considered to be of potential relevance for loading of surface water and
sediment following spray application of BCP324F. For this route of exposure, the predicted
environmental concentrations in surface water and sediment were calculated using the modelling program
TOXSWA 1.2.
Considering the Tier-1 TER calculations an acceptable risk is indicated for all GAP uses supported in the
Netherlands provided the following restrictions:
• “Om in het water levende organismen te beschermen is de toepassing van het middel in de teelt van
bloembollen en bloemknollen op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
indien gebruik wordt gemaakt van minimaal 75% drift reducerende spuitdoppen.”
In February 2018, the GAB was revised for the use in Wine grapes (not relevant for NL) as was the use in
flower bulbs (field spray). These revised uses represent a less conservative use pattern compared to the
use pattern assessed in the Fate assessment. Therefore, the fate risk assessment is considered appropriate
for the proposed uses and not altered. In some cases, this revised GAP may lead to less strict mitigation
measures compared to those proposed in the fate core assessment. However in the common practice in the
Netherlands a restriction that is needed is already provided through the activities decree.
Further, the risk arising from bioaccumulation of the active substance folpet is considered to be low.
3.1.6.3 Effects on Bees and Other Arthropod Species
The acute risks to honeybees for the formulated product, expressed as the active substance, were assessed
using the maximum single field use rate and the LD50 values to calculate hazard quotients. All hazard
quotients (HQ) are considerably less than 50, indicating that folpet and Solofol applied at the maximum
use rate in vines poses low risk to bees. As folpet does not pose an unacceptable risk to honey-bees,
further tests were not necessary for larval toxicity, long residual effects, disorienting effects, tunnels tests
were not necessary.
Other Arthropods:
The first level of risk assessment is based on Hazard Quotients (HQ) for two standard species, Aphidius
rhopalosiphi and Typhlodromus pyri. These species are generally the most sensitive tested in laboratory
studies and assessment of risk to these species therefore covers assessment of risk to other species. The
HQ values are all below the trigger value of 2, as recommended by ESCORT 2, indicating no risk to non-
target arthropods within the field.
Further higher tier test data was available and a risk assessment was performed by using a trigger value of
50% effect on lethal or sub-lethal endpoints in extended laboratory studies. For the Tier-2 data available
for non-target arthropods, the endpoints on reproduction were compared to the in-field PER values.
Results were all below the trigger value of 50% indicating no unacceptable effects on reproduction.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms
Effects on earthworms:
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 28 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
The worst-case TERA values are all above the relevant trigger value of 10 indicating an acceptable acute
risk for earthworms. The TERLT values for flower bulbs (bulb dipping) is below the relevant trigger value
of 5 when using the NOEC derived from study conducted on folpet technical. However, the TERLT values
was above the trigger of 5 when toxicity endpoint (NOAEC = 15.34 mg as/kg soil) is taken from the
study conducted with the formulated product Solofol, indicating an acceptable chronic risk for
earthworms. Therefore, it can be concluded that when folpet is used in the preparation BCP 324 F there
will be low risk to earthworms following the recommended uses of BCP 324 F.
The toxicity of the major soil metabolites phthalimide, phthalic acid and phthalamic acid was not tested
with earthworms but since they are formed rapidly by hydrolysis it is assumed that the metabolites were
present in the tests with folpet and hence the risk is covered by the risk assessment for folpet (EFSA,
2009a).
Effects on other non-target soil macro-organisms:
The DT90 values of folpet under field conditions are far below 365 days (DT50 = 4.3 days). Furthermore,
as there are no unacceptable risks associated with the use of the active substance or the formulated
product to soil macrofauna, non-target arthropods and soil microflora, additional tests on other soil
macro-organisms have not been conducted and no studies are deemed necessary.
3.1.6.5 Effects on organic matter breakdown
The active substance is rapidly dissipated in soil and therefore is not expected to have any significant
effects on organic matter breakdown. Therefore no studies have been conducted and no studies are
deemed necessary.
3.1.6.6 Effects on Soil Non-target Micro-organisms
For the acute toxicity study on soil microflora, reference is made to the non-protected report from 1995
cited in the European dossier under IIA 8.5/01.
The effects of folpet, and its quickly formed main soil metabolites, on the activity of soil-microflora
(nitrogen transformation / soil nitrification /; carbon mineralization / soil respiration, dehydrogenase
activity) were investigated in laboratory studies measuring short-term respiration and nitrification. Since
the formulated product does not contain any co-formulants which give raise to adverse effects on soil
microorganisms, a study with the formulated product is not considered necessary.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna)
Toxicity tests on non-target plants have been carried out with Solofol on seven different species: Zea
mays, Lolium perenne, Triticum aestivum, Cucumis sativus, Beta vulgaris, Lycopersicon esculentum, and
Brassica napus. No significant inhibitory effects (exceeding 50 %) on shoot height and biomass
production of overall 7 species could be observed. In consideration of these results, the ER50 of this test
system is determinable at 1600 g a.s./ha that covers the maximum single application rate of 1500 g a.s./ha
intended for the use in vineyard.
The effects of Solofol, a.s. content 78.0%, to vegetative vigour of 3 monocotyledon and 4 dicotyledon
terrestrial plant species were determined in glass house conditions over 21 days. ER50 values have been
calculated using final foliar fresh weight data for each species. No symptoms of visual injury or plant
mortality were recorded in any treatment of any species. ER50 values based on final fresh weights for all
species are greater than the highest rate tested of 3.2 kg a.s./ha.
On this account, an acceptable risk for terrestrial non-target plants exposed to applications of BCP 324 F
is indicated.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 29 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
3.1.7 Efficacy (Part B, Section 7, Point 8):
BCP324F (Solofol) is currently registered in NL for the control of Plasmopara viticola in wine grape. It
concerns a new application in this crop in other member states. For the Netherlands authorisation is now
also sought for table grape (unprotected), and for flower bulbs and flower corms, either by dipping
(Fusarium spp.) or by spraying in the field (Botrytis spp.).
Grape Plasmopara viticola
For the Netherlands, the current use in wine grape against Plasmopara viticola can be reregistered, as it
remains unchanged from the current authorization, and because there have been no relevant resistance
issues. As the use is limited to a spray volume of 1000-1200 liter water per ha, the following sentence is
written on the label:
In de teelt van wijndruif het middel toepassen in 1000 tot 1200 liter water per ha.
The use in table grapes is a new use. For determination of efficacy of Solofol in table grapes in the
Maritime EPPO Zone only 4 trials are available. In the trials disease pressure was sufficient for reliable
assessments. Use of Solofol against Plasmopara viticola in wine grape is currently authorized in the
Netherlands at a dose rate of 1.8 kg/ha.
Unprotected cultivation of table grapes in the Netherlands does not occur according to available
information; cultivars for table grapes are grown under protected conditions in our climate. Therefore the
applicant decided to withdrawn this use for The Netherlands
Flower bulbs and corms, Fusarium spp.
For control of Fusarium spp in flower bulbs, Solofol is claimed as a dip application at a dose rate of
0.5%. For dose justification Solofol was tested in 8 tulip and 3 gladiolus trials at 0.25, 0.5, 1 and 2%. A
clear dose response was not found in most trials. In one gladiolus trial and two tulip trials with a medium
to high infection pressure, a dose response is found. A dose of 1% seems to be the optimum dose rate. But
as the efficacy results between the 0.5% and 1% do not differ that much, a dose 0.5% can be seen as the
minimum effective dose.
For efficacy, based on the results of 9 tulip trials and 3 in gladiolus trials it can be concluded that,
compared to the untreated, bulb treatment with Solofol results in a significant effective control of
Fusarium oxysporum. Level of control is generally comparable to the reference products based on
prochloraz or captan. Extrapolation is possible to Fusarium spp. in all flower bulbs (field grown).
Flower bulbs and corms, Botrytis
For control of Botrytis in flower bulbs and corms, Solofol is claimed as a spray application at a dose rate
of 1.5 kg/ha. However, due to risk to birds at early application (before BBCH 40); Solofol can only be
applied 2 times at a maximum dose rate of 1.0 kg/ha before BBCH 40. After BBCH 40, the proposed
label rate for Solofol is 1.5 kg/ha.
In a total of 9 relevant efficacy trials against Botrytis sp., BCP 324F was tested at dose rates of 1, 1.5 and
2 kg/ha. The trials were conducted in tulip (2), lily (5) and gladiolus (2). Though generally no clear dose
related effect was observed, a tendency towards higher and more prolonged control of Botrytis was
observed in tulip and lily for higher dose rates of Solofol. In these crops the higher rate of 1.5 kg/ha
achieved a more effective control of Botrytis sp. as compared to the rate of 1.0 kg/ha. Higher
effectiveness was observed at a dose rate of 2 kg/ha as compared to the dose rate of 1.5 kg/ha in 2 trials in
lily. The dose rate is found to be sufficiently justified.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 30 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Compared to the reference product, at the claimed dose rate BCF324 performed significantly better than
the mancozeb based product in lily and tulip, but under high disease pressure in gladiolus, somewhat
worse. Overall it compared favourably to the reference.
According to the extrapolation document “Possibilities for extrapolation of efficacy and crop safety of
crop protection products” (CTGB, 2013) extrapolation is possible from Botrytis tulipae in tulip, Botrytis
elliptica in lily and Botrytis gladiolorum in gladiolus to Botrytis spp. in all flower bulbs.
The amount of data presented is low, however efficacy in the trials was good and consistent, only in one
trial (out of four) in tulip efficacy was low. Folpet based products have been on the market for several
decades, also for applications in flower bulbs, based on expert judgement the small data package is found
to be acceptable.
It is concluded the product Solofol sufficiently controls Botrytis sp. in flower bulbs when applied in the
original intended GAP (up to 10 applications of 1.0 to 1.5 kg/ha applied between BBCH 12 and 91).
However, the applicant provided an adjusted GAP during the commenting phase to comply with the risk
envelope for birds and mammals. Compared to the initial GAP, the adjusted GAP is restricted by
reducing the maximum number of applications from 10 to 2 in flower bulbs and flower corn as well as by
restricting the maximal dose rate to 1.0 kg/ha as well as by shortening the application timing period
(which was initial from BBCH 12 to 91 and is now proposed from BBCH 12 to 39).
The proposed restrictions were re-evaluated regarding the efficacy on Botrytis spp. in flower bulbs and
flower corns which led to the conclusion that (single) applications of 1.0 kg/ha BCP324F do give a
sufficient contribution to the control of Botrytis spp. in flower bulbs and flower corns.
However, considering that BCP324 F has a preventative mode of action and that trials were set up to
demonstrate the efficacy of BCP324 F over the complete course of a growing season, it is strongly
assumed that efficacy on Botrytis spp. significantly decreases when BCP324F is applied with the
proposed restrictions. This assumption appears to be a logic consequence due to the fact that no
applications are allowed anymore towards the end of the growth season (after BBCH 39) and due to the
reduced dose rate and number of applications in a single growth season.
As subsequence of the assumed lower efficacy due to the restrictions in the adjusted GAP the following
sentence will be placed on the Dutch label to ensure complete control of Botrytis spp. over the course of a
season.
Yield
Yield was assessed in a total of 28 relevant trials in flower bulbs conducted in the Netherlands in the
period between 2008 and 2013. No adverse effect on the bulb grading was found.
Phytotoxicity
With the exception of some minor phytotoxic symptoms in lily after foliar application, no negative effects
to the crop were observed after application with Solofol. Based on the presented data and the wide
experience with the use of products containing folpet in flower bulbs, it is concluded that Solofol does not
cause unacceptable effects to the crop of flower bulbs and flower corms.
In de teelt van bloembollen en bloemknollen is het maximale aantal toepassingen 2. Dit kan onvoldoende zijn voor een volledige bestrijding van Grauwe schimmel. Het wordt daarom aangeraden het middel af te wisselen met toegelaten middelen op basis van andere actieve stoffen.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 31 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Other adverse effects
The product did not cause significant phytotoxicity. In addition, products based on folpet have already
been authorized for usage in flower bulbs and grapevine for a considerable time all over Europe.
Experience shows that adverse effects on parts of plants used for propagating purposes, succeeding crops
and adjacent crops are not expected.
Resistance management
Folpet is classified by the Fungicide Resistance Action Committee (FRAC) in ‘multi-site contact activity’
mode of action with FRAC code M4 and it belongs therefore to low risk group without any signs of
resistance developing to the fungicides. Some of the claimed pathogens have a high risk for development
of resistance but based on the mode of action of the product, it is concluded that the resistance risk for this
product is found to be acceptable.
3.2 Conclusions
The product Solofol, is a WG solo formulation containing folpet as the active substance at 800 g/kg. Its
planned uses are for vines by foliar spray and for flower bulbs by bulb dipping and foliar spray in The
Netherlands.
For the Netherlands: Based on the data provided an authorization can be granted for flower bulbs by bulb
dipping and for the use in flower bulbs by foliar spray in The Netherlands. The specific risk management
measures outlined should be applied.
3.2 Additional information
None.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 32 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Appendix 1 – Copy of the product authorisation
Product authorization will be inserted after finalization of the RR
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 33 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018
Appendix 2 – Copy of the product label
Wettelijk Gebruiksvoorschrift
Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden.
Toepassingsgebied Type toepassing Te bestrijden organisme
Dosering (middel) per toepassing
Maximaal aantal toepassingen per teeltcyclus
Minimum interval tussen toepassingen in dagen
Veiligheidstermijn in dagen
Wijndruif (onbedekte teelt)
Gewasbehandeling Valse meeldauw1
1,8 kg/ha 10 7 28
Gladiool (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Krokus (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Iris (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Tulp (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Narcis m.u.v. grofbollige narcis (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Lelie (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Hyacint (onbedekte teelt)
Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)
1 - -
Bloembollen en bloemknollen
Gewasbehandeling Grauwe schimmel3
1,0 kg/ha 2 7 -
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 34 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Toepassingsgebied Type toepassing Te bestrijden organisme
Dosering (middel) per toepassing
Maximaal aantal toepassingen per teeltcyclus
Minimum interval tussen toepassingen in dagen
Veiligheidstermijn in dagen
(onbedekte teelt) 1 Valse meeldauw (Plasmopara viticola) 2 Fusarium (Fusarium spp.) 3 Grauwe schimmel (Botrytis spp.) Toepassingsvoorwaarden In de teelt van wijndruif het middel toepassen in 1000 tot 1200 liter water per ha. Om in het water levende organismen te beschermen is toepassing in de teelt van druiven op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop met ventilatorstand laag, waarbij de laatste gewasrij éénzijdig in de richting van het perceel bespoten dient te worden, in combinatie met een teeltvrije zone van 4,5 meter (gemeten vanaf het midden van de laatste gewasrij tot aan de insteek van de sloot). Om de zoogdieren te beschermen is toepassing in de teelt van bloembollen en bloemknollen uitsluitend toegestaan voordat een bodembedekking van maximaal 25% is bereikt. In de teelt van bloembollen en bloemknollen is het maximale aantal toepassingen 2. Dit kan onvoldoende zijn voor een volledige bestrijding van Grauwe schimmel. Het wordt daarom aangeraden het middel af te wisselen met toegelaten middelen op basis van andere actieve stoffen.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 35 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Appendix 3 – Letter of Access
• Applicant has provided the ZRMS a letter of access to the protected data / third party data that
was needed for evaluation of the formulation.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 36 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Appendix 4: List of data submitted in support of the evaluation
Annex
point
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Data
protection
claimed
Y/N
Studie
relied
on
Y/N
Dataprotection
granted
Y/N
Owner
IIIA,
2.8/01
2014 Physical and Chemical
Properties of BCP324F:
Accelerated Storage Stability
up to 2 weeks at 54°C. Report
nr. OZ/14/001/2
GLP: Y
Unpublished
Y Y Y Belchim
Human Toxicology
No new studies submitted.
Residu
Annex
point
Year
Title
Source (where different
from company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Data
protection
claimed
Y/N
Studie
relied
on
Y/N
Data protection
granted
Y/N
Owner
IIIA
8.1.1/02 2007a
Frozen Storage Stability of
Residues of folpet in Grapes
RAC and Processing
Fractions
Anadiag, France,
Report No. A7067
GLP
Unpublished
Y Y N
Belchim
Crop
Protection
N.V.
IIIA
8.3.1/01
(& IIIA
8.5.3/01)
2007b
Determination of folpet and
phthalimide residues in
grapes (RAC and processed
fractions) following
treatments with Solofol
under field conditions in
Europe
Anadiag, France
Report No. A7008
GLP
Unpublished
Y Y N
Belchim
Crop
Protection
N.V.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 37 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
point
Year
Title
Source (where different
from company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Data
protection
claimed
Y/N
Studie
relied
on
Y/N
Data protection
granted
Y/N
Owner
IIIA
8.3.1/02 2009
Determination of folpet and
phthalimide residues in
grapes following treatments
with Solofol under field
conditions in Europe in
2009
Anadiag, France
Report No. A9078
GLP
Unpublished
Y Y N
Belchim
Crop
Protection
N.V.
IIIA
8.3.1/03 2011
Magnitude of residue of
folpet and its metabolite
phthalimide in table grape
raw agricultural commodity
after four applications of
Folpan 80 WDG – 4 decline
curve trials – Germany –
2010. Biotek Agriculture.
Study no.: BPL 10/321/VI
(sponsor no.: R-27558)
Y Y N
ADAMA
Makhteshim
Ltd.
IIIA
8.3.1/04 2012
Magnitude of residue of
folpet and its metabolite
phthalimide in table grape
Raw Agricultural
Commodity after four
applications of FOLPAN 80
WDG – 4 trials (4 HS) –
Northern Europe (Hungary)
- 2011. Biotek Agriculture.
Study no.: BPL 11/334/VI
(sponsor no.: R-27930)
Y Y N
ADAMA
Makhteshim
Ltd.
IIIA
8.5.1/01 2007
[14C]-Folpet: Investigation
of the nature of the potential
residue in the product of
industrial processing or
household preparation
Battelle, UK
Report No. OZ/07/007
GLP
Unpublished
Y Y N
Belchim
Crop
Protection
N.V.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 38 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
point
Year
Title
Source (where different
from company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Data
protection
claimed
Y/N
Studie
relied
on
Y/N
Data protection
granted
Y/N
Owner
IIIA
8.5.3/02 2010
Determination of folpet and
phthalimide residues in
RAC grapes and processed
fractions (must, young wine
and juice) following
treatments with Solofol in
Europe in 2009
Anadiag, France
Report No. A9139
GLP
Unpublished
Y Y N
Belchim
Crop
Protection
N.V.
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 39 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Fate and behaviour
Annex
point
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Data
protection
claimed
Y/N
Owner data
protection
granted
y/n’
studies
relied on
y/n’
IIIA
9.6/01
2015 Raw data to Predicted
environmental concentrations in
groundwater (PECgw) for folpet
and its metabolites Using FOCUS
PEARL 4.4.4 AND FOCUS
PELMO 5.5.3
related to the Draft Registration
Report Part B Section 5 of
BCP324F for the Central Zone
Report no. (ReSc-15-0007)
GVK Biosciences Private Limited
Not GLP, unpublished
Y BCP N Y
IIIA
9.7/01
2015 Raw data to Predicted
environmental concentrations in
surface water (PECsw) for folpet
and its metabolites Using FOCUS
models
related to the Draft Registration
Report Part B Section 5 of
BCP324F for the Central Zone
Report no. (ReSc-15-0008)
GVK Biosciences Private Limited
Not GLP, unpublished
Y BCP N Y
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 40 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Efficacy
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1.3
IIIA1
6.2.1
2012
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG), and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2011.
Martin
Feldversuc
hswesen
F11-
VITVI-03-
DE01
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.3
IIIA1
6.2.1
2012
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG), and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2011.
Martin
Feldversuc
hswesen
F11-
VITVI-03-
DE02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2012
Evaluation of the
efficacy of BCP324F
(Folpet, 800 g ai/kg,
WG), and BCP330F
(Cymoxanil+Folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2012.
Martin
Feldversuc
hswesen
F12-
VITVI-04-
DE01
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2013
Determination of the
efficacy of BCP324F
and BCP330F on
Plasmopara viticola
in European
grapevine, 1 Site in
Germany 2012
Eurofins
Agroscienc
e Services
GmbH
F12-
VITVI-04-
DE02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2014
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) on Plasmopara
viticola in European
grapevine (moving
moderl). Central zone
(Maritime EPPO
zone). 2013
Martin
Feldversuc
hswesen
F13-
VITVI-
06A-DE01
Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 41 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2014
Determination of the
efficacy of BCP324F
on Plasmopara
viticola in European
grapevine,
1 Site in Germany
2013
Eurofins
Agroscienc
e Services
GmbH
F13-
VITVI0-
6A-DE02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.3
IIIA1
6.2.1
2013
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG), and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2 trials in Czech
Republic, 2012
Eurofins
Agroscienc
e Services
F12-
VITVI-
04A-CZ01
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.3
IIIA1
6.2.1
2013
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG), and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2 trials in Czech
Republic, 2012
Eurofins
Agroscienc
e Services
F12-
VITVI-
04A-CZ02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.3
IIIA1
6.2.1
2014
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG) on Plasmopara
viticola in European
grapevine
ATC –
Agro Trial
Center
GmbH
F13-
VITVI-
06A-CZ01
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.2.1 2012
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG), and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2012
Governmen
t Office of
Baranya
County
F12-
VITVI-04-
A-HU01
Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 42 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2012
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg
WG), and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in European
grapevine. Central
zone. 2012
SynTech
Research
Hungary
F12-
VITVI-04-
A-HU02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2008
Efficacy of stand
alone Cymoxanil
dose rates against
downy mildew on
vines (artificial
contamination and
misting)
Field
Research
Support
FRS05208 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2009
Evaluation of the
efficacy and
selectivity of
BCP324F at different
dose rates on
Plasmopara viticola
in grapevines.
Martin
Feldversuc
hswesen
F09VITVI
04GE01 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2008
Efficacy of
Cymoxanil and
Folpet against downy
mildew on vines
ANADIAG
APA
EU08107A
L1 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2008
Efficacy of
Cymoxanil and
Folpet against downy
mildew on vines
ANADIAG
APA
EU08107.
SO8HGF.J
G65
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2013
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) on Plasmopara
viticola in European
grapevine (fixed
model). Central zone
(South-East EPPO
zone). 2013
Governmen
t Office of
county
Komárom-
Esztergom
F13-
VITVI-
19A-HU01
Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 43 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2013
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) on Plasmopara
viticola in European
grapevine (fixed
model). Central zone
(South-East EPPO
zone). 2013
SynTech
Research
Hungary
F13-
VITVI-
19A-HU02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2013
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) on Plasmopara
viticola in European
grapevine (fixed
model). Central zone
(South-East EPPO
zone). 2013
GEMERPR
ODUKT
VALICE
OVD
F13-
VITVI-
20A-SK01
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2014
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) on Plasmopara
viticola in European
grapevine (fixed
model). Central zone
(South-East EPPO
zone), 2013
Eurofins
Agroscienc
e Services
SRL
F13-
VITVI-
19A-RO01
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2014
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) on Plasmopara
viticola in European
grapevine (fixed
model). Central zone
(South-East EPPO
zone), 2013
Eurofins
Agroscienc
e Services
SRL
F13-
VITVI-
19A-RO02
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.3
IIIA1
6.2.1
2014
Registration.
Evaluation of the
efficacy of BCP324F
(folpet, 800 g/l, WP)
and BCP362FC
(folpet 250 g/l, PO3
375 g/l, SC) on
Plasmopara viticola
in European
grapevine. Moving
model based on leaf
wall area. Maritime
EPPO zone, 2014.
Belchim
Crop
Protection
NV
F14VITVI-
06A-DE01 Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 44 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1.3
IIIA1
6.2.1
2014
Registration.
Evaluation of the
efficacy of BCP324F
(folpet, 800 g/l, WP)
and BCP362FC
(folpet 250 g/l, PO3
375 g/l, SC) on
Plasmopara viticola
in European
grapevine. Moving
model based on leaf
wall area. Maritime
EPPO zone, 2014.
Eurofins
Agroscienc
e Services
GmbH
F14VITVI-
06A-DE02 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.2
IIIA1
6.1.3
IIIA1
6.2.1
2014
Registration.
Evaluation of the
efficacy of BCP324F
(folpet, 800 g ai/kg,
WG) and BCP330F
(cymoxanil+folpet,
40+334 g ai/kg, WG)
on Plasmopara
viticola in european
grapevine (fixed
model). South-East
EPPO zone. 2014.
Governmen
t Office of
Heves
County,
Plant
protection
and soil
conservatio
n
directorate
F14VITVI
09A-HU01 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.4.2 2008
Non intentional effect
on four Belchim
fungicides on wines
processing and
quality of wines
ANADIAG
APA
EU08109A
L1 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.4.2 2008
Non intentional effect
on four Belchim
fungicides on wines
processing and
quality of wines
ANADIAG
APA
EU08109D
R1 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.4.2 2013
Evaluation of efficacy
of different
formulations applied
at different timings on
wine making in
Grapevine. France
2012
SGS Agri
Min
12 REG F
BE AN
002
Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1.4.2 2013
Evaluation of efficacy
of different
formulations applied
at different timings on
wine making in
Grapevine in France
2012
SGS Agri
Min
12 WHG F
BE RS 003 Y Y Y
Belchim
Crop
Protectio
n NV
IIIA1
6.1
IIIA1
6.2
2008 Vuurbestrijdig tulp Innoventis 2008 I
Tulip Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 45 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1
IIIA1
6.2
2009 Vuurbestrijdig tulp Innoventis 2009 I
tulip Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010 Disinfection of flower
bulbs (tulip)
Proeftuin
Zwaagdijk 10024 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010 Disinfection of flower
bulbs (tulip)
Proeftuin
Zwaagdijk 10025 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010 Disinfection of flower
bulbs in gladiolus
Proeftuin
Zwaagdijk 10182 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010
Control of Botrytis
gladiolorum in
gladiolus
Proeftuin
Zwaagdijk 10200 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010
Control of Botrytis
gladiolorum in
gladiolus
Proeftuin
Zwaagdijk 10201 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010
Control of Botrytis
gladiolorum in
gladiolus
Proeftuin
Zwaagdijk 10180 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2010
Control of Botrytis
gladiolorum in
gladiolus
Proeftuin
Zwaagdijk 10181 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs (tulip)
Proeftuin
Zwaagdijk 11011 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs (tulip)
Proeftuin
Zwaagdijk 11012 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs (tulip)
Proeftuin
Zwaagdijk 11013 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs (tulip)
Proeftuin
Zwaagdijk 11014 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs (lilium)
Proeftuin
Zwaagdijk 11174 Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 46 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs (lilium)
Proeftuin
Zwaagdijk 11175 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs in gladiolus
Proeftuin
Zwaagdijk 11202 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Disinfection of flower
bulbs in gladiolus
Proeftuin
Zwaagdijk 11203 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Control of Botrytis
tulipae in tulip
Proeftuin
Zwaagdijk 11015 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Control of Botrytis
tulipae in tulip
Proeftuin
Zwaagdijk 11016 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Control of Botrytis
tulipae in tulip
Proeftuin
Zwaagdijk 11017 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Control of Botrytis
tulipae in tulip
Proeftuin
Zwaagdijk 11018 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Control of Botrytis
elliptica in Lilium
Proeftuin
Zwaagdijk 11176 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2011 Control of Botrytis
elliptica in Lilium
Proeftuin
Zwaagdijk 11177 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2012 Control of Botrytis
elliptica in Lilium
Proeftuin
Zwaagdijk 12168 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2013 Disinfection of flower
bulbs in Tulip
Proeftuin
Zwaagdijk 13052 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2013 Control of Botrytis
tulipae in Tulip
Proeftuin
Zwaagdijk 13061 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2013 Control of Botrytis
elliptica in Lilium
Proeftuin
Zwaagdijk 13168 Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 47 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
Point
Report
Date Title Source
Company
Report
No.
Studies
relied
on
Y/N
Data
protection
claimed
Y/N
Data
protection
granted
Y/N
Owner
IIIA1
6.1
IIIA1
6.2
2013 Control of Botrytis
elliptica in Lilium
Proeftuin
Zwaagdijk 13181 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2015
Efficacy of Solofol
and BCP345F in bulb
dipping tulip
Proeftuin
Zwaagdijk 150025 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2015
Efficacy of Solofol
and BCP345F in bulb
dipping tulip
Proeftuin
Zwaagdijk 150026 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2016
Efficacy of Solofol,
BCP345F, Monarch
and BCP352F in bulb
dipping tulip
Proeftuin
Zwaagdijk 160049 Y Y Y
Belchim
Crop
Protectio
n NV IIIA1
6.1
IIIA1
6.2
2016
Efficacy of Solofol,
BCP345F, Monarch
and BCP352F in bulb
dipping tulip
Proeftuin
Zwaagdijk 160050 Y Y Y
Belchim
Crop
Protectio
n NV
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 48 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Ecotox
Annex
point
Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
Protection
Claimed
Owner data
protection
granted
y/n
studies
relied on
y/n
IIIA
10.1.2 1989
Nahrungsökologie und Raumnutzung einer
subalpinen Population des Hänflings
(Carduelis cannabina) [Feeding ecology
and habitat use in a subalpine population
of linnets].
Der Ornithologische Beobachter 86, pp.
291-305.
GLP not relevant, published.
No Public n y
IIIA
10.1.2 2011
Landscape-moderated biodiversity effects
of agri-environmental management: a
meta-analysis
Proc Biol Sci. Jun 22, 2011; 278(1713):
1894–1902
GLP not relevant, published.
No Public n y
IIIA
10.2.2.1/01 2007a
Acute Toxicity of Folpet 80 WG to
Rainbow Trout (Oncorhynchus mykiss) in
a 96-hour semi-static Test
IBACON GmbH, Germany
Report No33891230, GLP, unpublished.
Yes Sapec
Belchim y y
IIIA
10.2.2.2/01 2007b
Acute toxicity of Folpet 80 WG to
Daphnia magna in a Semi-static 48-hour
Immobilization Test.
IBACON GmbH, Germany
Report No 33892220, GLP, unpublished.
Yes Sapec
Belchim y y
IIIA
10.3.3/01 2010
Small Mammal focal species in vineyards
in southern Europe.
RifCon, Germany
Report No RA-10023, GLP not relevant,
unpublished.
Yes Sapec
Belchim y y
IIIA
10.3.3/02 2011
Determination of initial residues and residue
decline of folpet after one application of Folpet
80 WG in pasture at 3 sites in Northern and Southern Europe 2011 ; Eurofins GmbH report
S11-01405 ; GLP, unpublished;
Yes Sapec
Belchim y y
IIIA
10.4.2/01 2007
Effects of Folpet 80 WG (Acute Contact
and Oral) on Honey Bees (Apis mellifera
L.) in the Laboratory.
IBACON GmbH, Germany
Report No33893035, GLP, unpublished.
Yes Sapec,
Belchim y y
IIIA
10.5.1/01 2007a
Effects of Folpet 80 WG on the Predatory
Mite Typhlodromus pyri in the Laboratory
- Dose Response
IBACON GmbH, Germany
Test. Report No33895063, GLP,
unpublished.
Yes Sapec,
Belchim y y
IIIA
10.5.2/01 2007b
Effects of Folpet 80 WG on the Parasitoid
Aphidius rhopalosiphi, Extended
Laboratory Study - Aged Residue Test.
IBACON GmbH, Germany
Report No 33899003, GLP, unpublished.
Yes Sapec,
Belchim y y
IIIA
10.5.2/02 2007c
Effects of Folpet 80 WG on the Lacewing
Chrysoperla carnea, Extended Laboratory
Study - Dose Response Test.
IBACON GmbH, Germany
Report No33898047, GLP, unpublished.
Yes Sapec,
Belchim y y
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 49 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018
Annex
point
Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
Protection
Claimed
Owner data
protection
granted
y/n
studies
relied on
y/n
IIIA
10.5.2/03 2007d
Effects of Folpet 80 WG on the Ladybird
Beetle Coccinella septempunctata,
Extended Laboratory Study - Dose
Response Test.
IBACON GmbH, Germany
Report No33897012, GLP, unpublished.
Yes Sapec,
Belchim y y
IIIA
10.6.2/01 2009
Acute Toxicity (14 days) of Folpet 80 WG
to the Earthworm Eisenia fetida in
Artificial Soil with 5% Peat.
IBACON GmbH, Germany
Report No51141021, GLP, unpublished.
Yes Sapec
Belchim y y
IIIA
10.6.3/01 2014
Effects of BCP324F on Reproduction and
Growth of Earthworms Eisenia fetida in
Artificial Soil with 5% Peat.
IBACON GmbH, Germany; unpublished
report
Yes Belchim y y
IIIA
10.8/01 2009a
Evaluation of the Phytotoxicity of Folpet
80% WG - Non Target Terrestrial Plant
Vegetative Vigor Test.
Agrochemex Ltd. UK
Report No ACE-08-260, GLP,
unpublished.
Yes Sapec
Belchim y y
IIIA
10.8/02 2009b
Evaluation of the Phytotoxicity of Folpet
80% WG - Non Target Terrestrial Plant
Seedling Emergence and Growth Test.
Agrochemex Ltd., UK
Report No ACE-08-259, GLP,
unpublished.
Yes Sapec
Belchim y y
IIIA
10.10.1/01 2007c
Influence of Folpet technical to Daphnia
magna in a Reproduction Test,
IBACON GmbH, Germany
Report No 33881221, GLP, unpublished
Yes Sapec
Belchim y y
Part A National Assessment Country – The Netherlands
BCP324F Registration Report – Central Zone Page 50 of 50
Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018