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Biocides Submission Manual Application instructions:
Technical equivalence and chemical similarity
MANUAL
2 Biocides Submission Manual Version 4.0
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Version Changes Date
Version 1.0 First version August 2013
Version 2.0 Second release to include the new ECHA service of chemical similarity check
February 2014
Version 2.1 Updated to reflect a change in submission message following the release of R4BP version 3.1. (Chapter 8, step 5) and inclusion a new sub-chapter 8.2 ‘Submitting an authority requested task’.
April 2014
Version 2.2 Updated to reflect changes in R4BP 3.1.2 in section 8.1 which include
the removal of the ‘access level’ in the upload steps of the application ‘wizard’ and relevant screenshots.
June 2014
Version 3.0 Release of R4BP version 3.2 changes include the following:
Change to the manual title in line with the BSM series Deletion of Summary sheets and Glossary Updated instructions on launching the application wizards Reference to resubmission tasks in section 2.5.3
Addition of the IUCLID checklist
December 2014
Version 4.0 ANNEX entirely revised. Following chapter added: Chapter 5: Withdrawing a case from R4BP 3 Changes in the following chapter:
Requesting an extension for a resubmission task in section 4.3
June 2017
BSM Application instructions: Technical equivalence and chemical similarity
Reference: ECHA-14-B-02-EN
Catalogue number: ED-01-14-624-EN-N
ISBN: 978-92-9244-663-5
DOI: 10.2823/34449
Publ. date: June 2017
Language: EN
© European Chemicals Agency, 2017
Cover page © European Chemicals Agency
Legal notice:
Neither the European Chemicals Agency nor any person acting on behalf of the European
Chemicals Agency is responsible for the use which might be made of the following information.
A wealth of additional information on the European Chemicals Agency is available on the
Internet. It can be accessed through the ECHA website (http://echa.europa.eu).
If you have questions or comments in relation to this document please send them (quote the
reference and issue date) using the information request form. The information request form is
accessible from the Contact ECHA page at: http://echa.europa.eu/contact
European Chemicals Agency
Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland
Visiting address: Annankatu 10, Helsinki, Finland
Application instructions: Technical equivalence & chemical similarity June 2017 3
Table of Contents
1. Objective ................................................................................................................ 5
1.1 Biocides Submission Manuals – application instructions ................................................................ 5
1.2 Additional assistance ............................................................................................................... 5
2. General submission information ............................................................................. 7
2.1 R4BP Industry actors ............................................................................................................... 7
2.1.1 Case owner ......................................................................................................................... 7
2.1.2 Asset owner ......................................................................................................................... 7
2.2 Application types and ECHA fees and service charges .................................................................. 7
2.3 Application requirements .......................................................................................................... 8
2.3.1 IUCLID dossier ..................................................................................................................... 8
2.3.2 Supporting documents .......................................................................................................... 8
3. Submitting an application in R4BP 3 ..................................................................... 10
4. Post submission obligations ................................................................................. 11
4.1 Verify your submission ........................................................................................................... 11
4.2 Monitor your case (case owner) .............................................................................................. 11
4.3 Resubmission tasks ............................................................................................................... 11
5. Withdrawing a case from R4BP 3 ......................................................................... 12
6. Technical equivalence vs chemical similarity ........................................................ 13
7. Applications for technical equivalence assessment .............................................. 15
7.1 Launching the TE-APP application wizard .................................................................................. 15
7.2 Application requirements for TE-APP ........................................................................................ 16
8. Applications for Chemical similarity check ............................................................ 18
8.1 Types of chemical similarity checks ......................................................................................... 18
8.2 CSC Service charges and target processing times ...................................................................... 18
8.2.1 Individual applications ........................................................................................................ 19
8.2.2 Joint applications ................................................................................................................ 20
8.3 Launching the CS-APP application wizard ................................................................................. 20
8.4 Application requirements for CS-APP ....................................................................................... 21
ANNEX: How to prepare your IUCLID dossier ........................................................... 23
Preparing a dataset for an active substance ................................................................................... 23
Step 1: Create a ‘Substance’ dataset ............................................................................................. 23
Step 2: Select the dataset template .............................................................................................. 23
Step 3: Enter the ‘Applicant’ details .............................................................................................. 25
Step 4: Identify the active substance ............................................................................................ 25
Step 5: For technical equivalence Tier II assessments ..................................................................... 32
Finalise the dataset ..................................................................................................................... 32
Step 1: Create a ‘Mixture/Product’ dataset ..................................................................................... 33
Step 2: Link the two datasets together .......................................................................................... 33
How to create a dossier ............................................................................................................... 35
4 Biocides Submission Manual Version 4.0
Table of Figures Figure 1: Withdrawing a case from R4BP ................................................................................. 12
Figure 2: Launching the application ‘wizard’ for TE-APP .......................................................... 15
Figure 3: Launching the application ‘wizard’ for CS-APP .......................................................... 21
Figure 4: Creating a 'Substance' dataset .................................................................................. 23
Figure 5: Active substance dataset .......................................................................................... 24
Figure 6: 'BPR Active substance information' template............................................................ 24
Figure 7: Specify the active substance supplier ....................................................................... 25
Figure 8: Enter the manufacturing plant location ..................................................................... 25
Figure 9: IUCLID section 2.1 .................................................................................................... 26
Figure 10: Entering information on the manufacturing process ............................................... 27
Figure 11: Creating a composition block .................................................................................. 28
Figure 12: Entering the degree of purity .................................................................................. 28
Figure 13: Adding the constituents .......................................................................................... 29
Figure 14: A complete substance composition. ........................................................................ 30
Figure 15: Including absorption spectra data .......................................................................... 31
Figure 16: Creating a new endpoint study record .................................................................... 31
Figure 17: Attaching a supporting document in Section 13 of your IUCLID 5 dataset .............. 32
Figure 18: Creating a ‘Mixture/Product’ dataset ...................................................................... 33
Figure 19: Selecting the correct template ................................................................................ 33
Figure 20: Naming the endpoint that links the two datasets .................................................... 34
Figure 21: Completing the link between the two datasets ....................................................... 34
Figure 22: Query box ............................................................................................................... 35
Figure 23: Launching the dossier creation wizard .................................................................... 36
Figure 24: Selecting the dossier template ................................................................................ 37
Figure 25: Export your dossier ................................................................................................. 38
List of Tables Table 1: Technical equivalence and chemical similarity check applications ............................... 7
Table 2: Differences between TE assessment and CSC performed by ECHA ............................. 13
Table 3: Scale of charges for individual CSC applications ......................................................... 19
Table 4: Scale of charges for joint applications ........................................................................ 20
Application instructions: Technical equivalence & chemical similarity June 2017 5
1. Objective
This manual gives instructions on how to submit applications concerning biocidal product
authorisations that assist the making available on the market and use of biocidal products
through the Register for Biocidal Products (R4BP 3) according to the Biocidal Products
Regulation1 (BPR). This manual covers applications for technical equivalence (TE) and chemical
similarity checks (CSC).
1.1 Biocides Submission Manuals – application instructions
This manual is part of the Biocides Submission Manual (BSM) series concerning application
instructions. It should be used with the following technical guides and process manuals.
Technical guides:
BSM – Technical guide: Using IUCLID, which describes how to prepare a general IUCLID
dossier, giving you details on the different functionalities in IUCLID, as well as explaining the
different sections contained within a dossier.
BSM – Technical guide: Using R4BP 3, which describes how to create a valid legal entity in
IUCLID, create user accounts in R4BP 3 through ECHA Accounts and gives a detailed description
of the generic steps in an application wizard2.
BSM – Technical guide: Using the SPC Editor, which describes how to prepare a summary
of the product characteristics (SPC) required for certain application types.
Process manuals:
BSM – Process of invoicing in R4BP 3, which describes the general information related to
invoices and credit notes issued by ECHA following the submission of an application.
BSM – Process of confidentiality requests for biocide applications, which describes how
to make confidentiality claims in IUCLID and which dossier information can be claimed
confidential.
A link to all of the Biocides Submission Manuals, including the technical guides,
application instructions and related processes can be found from ECHA’s
website.
1.2 Additional assistance
In addition to the Biocides Submission Manuals, you can find more information concerning the
regulatory context of biocide applications and an overview of the evaluation process from:
Practical guides, which give a more detailed look at the procedures and
obligations of certain process under the BPR.
1 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning
the making available on the market and use of biocidal products. 2 The R4BP 3 application ‘wizard’ guides you through the various steps of an application form,
prompting you to include necessary files such as a dossier and supporting documents.
6 Biocides Submission Manual Version 4.0
Guidance documents, which help to implement the BPR by describing good
practice on how to fulfil the obligations.
Regulatory web pages, which offer a general introduction to some of the
processes under the BPR.
Q&As on R4BP 3 (e.g. account management, invoicing, submissions) and the
Biocidal Products Regulation (e.g. active substance suppliers, data sharing,
treated articles).
The ECHA Helpdesk, which is available for specific and general advice on the
BPR, particular submissions, as well as the IT tools IUCLID, R4BP 3, and the
SPC Editor.
For all the latest news, subscribe to the weekly e-News and bimonthly
Newsletter
Application instructions: Technical equivalence & chemical similarity June 2017 7
2. General submission information
This chapter gives a general overview of the different application types concerning the technical
equivalence and chemical similarity applications. Detailed submission information on each
application type is provided in its own specific chapter. Summarised submission information
(preparing, submitting, and monitoring an application) for each application can also be found
from the ECHA Support pages. From here, you will also find links to video tutorials and webinars.
2.1 R4BP Industry actors
The R4BP 3 industry interface is dedicated to industry users, allowing the secure submission of
applications and exchange of information with authority users. There are two main actors dealing
with technical equivalences applications in R4BP: the case owner and the asset owner.
2.1.1 Case owner
The case owner is the legal entity who is submitting an application, notification, inquiry or
request, and monitoring the progress of a case3, for example, providing any additional
information requested by authorities or commenting on any draft evaluation reports or opinions,
etc.
2.1.2 Asset owner
The asset owner is the legal entity who will be the ‘owner’ of the asset4 once it has been created.
The case owner may also be the asset owner, but this is not always the case, for example, the
case owner may be a consultant or another party appointed by an asset owner.
2.2 Application types and ECHA fees and service charges
Table 1 outlines the case abbreviations used in R4BP 3 for the application types covered in this manual and whether there is an associated ECHA fee/service charge (€).
ECHA informs the case owner of the fees payable and will reject the application
if the fee is not paid within 30 days. For more general information regarding
ECHA fees and invoicing, please consult the R4BP 3 Q&A on invoicing.
Table 1: Technical equivalence and chemical similarity check applications
Case
abbreviation
Application
TE-APP Assessment of technical equivalence €
CS-APP Chemical similarity check € (refer to section 5.2 for the charges payable).
3 Once you submit an application in R4BP 3, a corresponding ‘case’ with a unique case number is created. 4 An asset is a regulatory decision on an application which has a unique asset number.
8 Biocides Submission Manual Version 4.0
The ECHA fee for technical equivalence is based on the assessment type you are
applying for i.e. Tier I or Tier II. Additional information about the possible application
types for technical equivalence and the associated fees are outlined in the Guidance
on applications for technical equivalence and Q&A on technical equivalence.
For full details of the fees and charges payable, please refer to Annex II and III of
the BPR Fee Regulation5
2.3 Application requirements
Depending on the application type and your individual circumstances, you may need to include
a IUCLID dossier, an SPC, and/or other additional supporting documents. You can find specific
instructions on what is required for your application and where to include it in the relevant
sub-chapter of this manual.
For detailed information on how and what you can claim confidential under
Article 67(3) of the BPR, please consult BSM ‘Process of confidentiality requests
for biocide applications’.
2.3.1 IUCLID dossier
A IUCLID dossier (.i6z format) may be required as part of your application. We recommend that
you use the designated IUCLID fields wherever possible to store your data.
Note: Please aim to keep your dossier size below 400 MB; otherwise, you
may face additional problems when submitting your application. If your
dossier size is more than 400 MB, you can try to reduce the size by uploading
supporting documents directly in the R4BP 3 wizard.
As a guide to help you understand the principles of dossier preparation, you
may wish to first consult the summary sheets 'Understanding IUCLID
datasets' and 'Creating a dataset and dossier in IUCLID' at the end of this
manual.
For full technical assistance on how to enter data into various sections of a
IUCLID dataset and prepare a dossier and, please refer to the BSM ‘Technical
guide: How to prepare a biocides dossier’.
2.3.2 Supporting documents
Under the BPR, you often need to submit supporting documents as part of your application.
Depending on the type of application you are submitting, the required supporting documents will
need to be attached either in your IUCLID dossier or uploaded directly in the R4BP 3 application
‘wizard’. You can find direct instructions on where to include individual supporting documents
relevant to your application type in the applicable chapter of this manual.
5 Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges
payable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products
Application instructions: Technical equivalence & chemical similarity June 2017 9
Additional ECHA supporting documents: For many application types, ECHA
requires additional supporting documents to enable the correct handling and
processing of your application. Consult the relevant chapter for your application
for specific details or visit the ‘Supporting documents’ page from ECHA’s
website for the full list.
10 Biocides Submission Manual Version 4.0
3. Submitting an application in R4BP 3
Make sure that you have fulfilled all of the application requirements in IUCLID and have all the
necessary documents ready in your dossier or ready for uploading before you begin the
submission process in R4BP 3.
When you launch an application in R4BP 3, the application wizard automatically prompts you in
a step-wise fashion to upload the files such as a dossier and other supporting documents required
for each application. Specific help texts and tool tips in R4BP 3 will further help you during the
application procedure.
You can find additional guidance on working in R4BP 3 in ‘BSM Technical
guide: using R4BP 3’.
Application instructions: Technical equivalence & chemical similarity June 2017 11
4. Post submission obligations
As a case owner and/or asset owner, you are required to monitor your case(s) and take the
necessary actions.
4.1 Verify your submission
After submitting your application, an on-screen message will be visible to you containing a
submission number, i.e. the unique number identifying your case. Read and pay attention to this
on-screen message as it may contain instructions outlining further actions that you may need to
do.
If you do not receive a post-submission message, your application has not been
submitted correctly and you will have to start the application process again.
4.2 Monitor your case (case owner)
It is the case owner’s responsibility to monitor individual cases on a regular basis. Through the
‘Case details’ sub tab, you can manage and view the progress of any of your submitted
applications. In addition, email alerts can also be set to inform you of the case status – this is
particularly helpful if you need to react to authority requests where a deadline has been set.
You can find more detailed information on how to monitor your case in:
‘BSM Technical guide: using R4BP 3’.
4.3 Resubmission tasks
To make sure that an application can be processed correctly, a case owner may need to complete
task items assigned by authority users (e.g. a ‘Resubmit information’ task). You are obliged to
monitor your task items and complete them within the defined time. You can access the task
items by selecting the ‘TASKS’ tab on the toolbar (Please refer to BSM Technical guide: using
R4BP 3 for full details).
Only one reply to a ‘request information’ task is permitted in R4BP 3. Please make
sure that you include all the information requested in the task item. If you need
more time to complete a resubmission task, you are allowed to contact the
relevant authority to request an extension.
12 Biocides Submission Manual Version 4.0
5. Withdrawing a case from R4BP 3
If you don’t want to proceed with one of your application, you can withdraw it via the Case
details page. Click on ‘withdraw case’ and confirm the case withdrawal (Figure 1).
Figure 1: Withdrawing a case from R4BP
Once you have withdrawn your case, any open task items will be closed immediately, any
pending delegations or case transfers will be cancelled and an appropriate event will be recorded.
Note that if you choose to withdraw a reference case while the concerned cases
have not yet reached the Business rules step, the system will automatically set them
as ‘closed’. If the concerned cases have reached the Business rules check step, then
the authority will have to withdraw all concerned cases.
Note that this action will also affect delegated cases to other companies.
Application instructions: Technical equivalence & chemical similarity June 2017 13
6. Technical equivalence vs chemical similarity
The main difference between TE assessments and CSCs are summarised in Table 2.
TE assessment is only relevant for active substances for which a final decision
on approval has been adopted by the Commission. The CSC service is intended
for active substances for which there is no final decision on approval adopted
by the Commission and therefore TE assessment under Article 54 of the BPR
cannot be applied.
Table 2: Differences between TE assessment and CSC performed by ECHA
Technical equivalence assessment Chemical similarity check
Basis Article 54 of the BPR ECHA Management Board Decision 31/20136, and Article 15 of the BPR Fee Regulation
Legal requirement Mandatory to include a positive decision
of TE assessment for biocidal product authorisation applications in cases when the active substance is considered a substance from a source different from the reference source.
Voluntary
Intended for Active substances for which there is a Commission decision on approval
Active substances for which there is no Commission decision on approval
Purpose The purpose of a TE assessment is to:
determine the similarity of a substance,
with regards to the chemical composition and hazard profile, which is produced from i) a source7 different to the reference source8, or, ii) the reference source but following a change to the manufacturing process and/or manufacturing location, when
compared to the substance of the reference source.
The purpose of the CSC is to establish
the similarity between specifications of
the same active substance (AS) obtained from different sources, with regards to the substance identity and chemical composition.
Application types Tier I applications
Tier II applications
Individual application: comparison of one source of an active substance to an active substance which has been submitted for evaluation under the BPR
6 Decision of the management board on the service charge for CSC performed for biocidal active
substances; for the purposes of facilitating the implementation of Regulation (EU) No 528/2012, in
particular submissions under Article 95 of that Regulation.
7 Source refers to the specific manufacturing location of a substance. It refers to a specific manufacturing plant for which the manufacturing process has been outlined and the specifications of the starting materials are provided.
8 The reference source is established based on the sources on which the risk assessment was carried out and for which a decision has been taken by the Commission to approve the AS for inclusion in the Union
list.
14 Biocides Submission Manual Version 4.0
Technical equivalence assessment Chemical similarity check
or the Biocidal Products Directive9 (BPD)
Joint applications: comparison of several sources of the same AS
Scope of assessment Substance composition and hazard profile:
Tier I: Substance identity and chemical composition (including analytical information)
Tier II: Substance identity and chemical
composition (including analytical
information) and the (eco)toxicological profile
Substance identity and chemical composition (including analytical information)
Information requirements
Depicted in the ‘Guidance on applications for technical equivalence’, for both Tier I and Tier II
Same as for TE Tier I, depicted in the ‘Guidance on applications for technical equivalence’
The assessment of chemical similarity carried out by ECHA will be without
prejudice to the official reference source and reference specifications of the AS
established when the AS is approved by a Commission decision under Article 9(1)
of the BPR. That is to say, the reference source and specifications used for the
CSC may be different from the final approved reference source and specifications.
Furthermore, the CSC cannot pre-empt or replace an assessment of TE under
Article 54 of the BPR. This means that when the AS is approved, there will need
to be a separate application made to have the TE of the alternative source of that
AS established under Article 54 of the BPR before product authorisation can be
applied for (even where that alternative source has been assessed under CSC).
9 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the
placing of biocidal products on the market
Application instructions: Technical equivalence & chemical similarity June 2017 15
7. Applications for technical equivalence assessment
Applications for the assessment of technical equivalence can only be made for active substances
for which there is a Commission decision on approval. More information can be found from the
Guidance and Practical Guides.
The principles and processes behind technical equivalent assessment are
described in the Practical Guide ‘chapter on technical equivalence’ available from
ECHA’s website.
Guidance on applications for technical equivalence - providing an overview of the
process of technical equivalence, how ECHA handles an application, and important
additional information for an industry user.
Guidance Document on Information Requirements – a general guidance
document concerning information requirements for active substances and biocidal
products.
The Agency has 90 days to take a decision on technical equivalence. During the assessment, the
Agency can ask for additional information (‘Resubmit information’ task, section 2.5.3) from the
applicant and will ask the applicant to submit the additional information within a specified time
limit10. The evaluation continues on the date when the updated dossier file is received.
The 90-day period within which ECHA takes the decision is suspended from the
date of issue of the request, until the information is received.
7.1 Launching the TE-APP application wizard
The R4BP 3 application wizard for TE-APP is launched as a ‘NEW APPLICATION’. You can launch
the application wizard as a new application, click on the ‘NEW APPLICATION’ tab on the R4BP 3
toolbar to see the full list of application types available in alphabetical order. Then, select
‘TE-APP - Assessment of technical equivalence’ from the list of processes (Figure 2).
Figure 2: Launching the application ‘wizard’ for TE-APP
10 This time limit may not exceed 180 days except where justified.
16 Biocides Submission Manual Version 4.0
Please note that each application must refer to only one source. If you wish ECHA
to assess several sources, please submit separate applications for each source. If
you wish ECHA to assess several product types, please indicate in the supporting
document which product types you wish ECHA to assess. ECHA will check whether
the assessment of the indicated product types is possible within one case and
may contact you if necessary.
Please refer to the guidance for a description of the application types for technical
equivalence before you start your application.
7.2 Application requirements for TE-APP
This sub-chapter describes the application requirements necessary for each step of the TE-APP
application wizard. Additional instructions and guidance are available in R4BP 3 at each wizard
step to help you with the application procedure.
Application instructions: Technical equivalence & chemical similarity June 2017 17
Upload dossier(.i6z) and select the language
In all applications (Tier I and Tier II), the IUCLID dossier must contain Information on:
manufacturer of the active substance and the manufacturing plant location
the substance identity, chemical composition, analytical profile of five
representative batches, description of the analytical method used for the
determination of the substance, absorption spectra.
Additionally, for Tier II applications:
information on the hazard profile (toxicological & ecotoxicological data)
a self assessment of TE is to be attached in section 13 of the IUCLID
file
Set submission details
Enter the details of the proposed ’asset owner’ and indicate the payment details.
Case owner details A contact person for the case must be specified.
Supporting information details
Indicate the correct assessment type you are applying for to ensure ECHA can issue the correct fee. Tier I: where the difference between the active substance sources is limited to a change in the manufacturing location OR goes beyond a change in manufacturing
location.
Tier II: where the previous conditions are not met and the application is based on the analytical data and hazard profile.
Upload other files
In all cases: upload the ECHA ‘Supporting document for technical equivalence’ and any other files you wish to support you application at this step.
Confirm application
If the data in the confirmation screen is correct enter the security check text and submit your application.
18 Biocides Submission Manual Version 4.0
8. Applications for Chemical similarity check
The service is offered by ECHA for the purposes of facilitating the implementation of the BPR and
may be useful for example for:
i) Alternative suppliers of active substances before they invest in a letter of access to
the dossier of an active substance in order to be included in the list of approved
suppliers under Article 95 of the BPR;
ii) Prospective applicants seeking confirmation that different sources of the same active
could be assessed jointly before they submit the application for approval of the active
substance.
The principles and processes behind chemical similarity checks are described in the
Practical Guide ‘chapter on technical equivalence’ available from ECHA’s website.
Additional information concerning the application and assessment procedure of
chemical similarity can be found from the Biocides regulatory webpages on the
ECHA website.
8.1 Types of chemical similarity checks
This sub-chapter describes the two types of CSCs i) for individual applications and ii) joint
applications.
i) Individual applications: the comparison of one source of an active substance to a
biocidal active substance which has been submitted for assessment under the BPD or
BPR but for which no final decision on the approval has yet been adopted,
ii) Joint applications: the comparison of two or more sources of the same active
substance in view of a prospective joint application for active substance approval
under the BPR. To apply for a joint application you need to a request ‘joint application
number’ from ECHA that needs to be included in each individual application of the
joint application.
Before a joint application is made, one representative applicant of the group
must first inform ECHA about the upcoming application by submitting a request via
the ECHA Helpdesk contact form (topic ‘Regulatory advice’) and include:
“Subject of your question”field: “Request for joint application number for joint CSC
application”.
“Question” field: Description of the upcoming joint application, name and numerical
identifiers of the active substance (e.g. EC/CAS name/number), number of
applications (i.e. number of sources to be compared), and the names of the
prospective applicants.
8.2 CSC Service charges and target processing times
The service charges and the target processing times for individual and joint CSC applications
are included in Tables 3 and 4 as defined in the ECHA Management Board Decision 31/2013.
ECHA will start the check upon receipt of the service charge per application and will make every
effort to process it within the target processing time. The target processing time will start running
Application instructions: Technical equivalence & chemical similarity June 2017 19
only when all the necessary information has been received either from the applicant or if
relevant, from the relevant authorities.
After all the applications related to a specific joint application have been received,
and the dossiers have passed the initial format check, ECHA will issue separate
invoices to each applicant11. The service charge per application depends on the
number of applications submitted for comparison by the joint applicants.
8.2.1 Individual applications
For individual applications, ECHA will need to consult the MSCA responsible for the evaluation of
the active substance in the Review Programme or under the new AS approval approval to clarify
the status of the active substance evaluation. This is due to the fact that the work required for
checking the application depends on the status of the reference source (Table 3). Thus, the
charge will be based on this consultation.
Table 3: Scale of charges for individual CSC applications
Description Service charge (EUR)
Target processing
time
Temporary reference source exists.
4.200 EUR 25 calendar days
Temporary reference source does not exist and only one participant has submitted a
dossier under the Review Programme for
existing active substances or under the new active substance approval (Article 7 of the BPR or under Article 11 of BPD).
9.400 EUR 35 calendar days
Temporary reference source does not exist
and more than one participant has submitted a dossier under the Review Programme for existing active substances or under new active substance approval (Article 7 of the BPR or under Article 11 of BPD).
Basic charge: 11.200 EUR for two dossiers used
for establishing the temporary reference source. Where additional dossiers have been submitted: 1.500 EUR each.
45 calendar days
Example: A company submits an individual application for an active substance that is under evaluation
in the Review Programme, and there is no temporary reference source, and four participants have
submitted a dossier to the Review Programme.
Therefore, the service charge of the CSC assessment will be 11.200 EUR+21500 EUR =14.200 EUR.
11 The invoice will sent to the applicant’s (i.e. case owner) ‘Message list’ in R4BP 3.
20 Biocides Submission Manual Version 4.0
8.2.2 Joint applications
For joint applications, the service charge is dependent on the number of data sets12
(i.e. applications) submitted for comparison (Table 4). Note that each applicant within the joint
application will receive their own invoice. In case one, or more, applicants in the joint application
fails to pay the service charge, the other applicants may receive additional invoices in line with
the reduced number of applications submitted for comparison.
Table 4: Scale of charges for joint applications
Description Service charge (EUR)
Target processing
time
Two data sets submitted for comparison
9.400 EUR 35 calendar days
Three or more data sets submitted for
comparison
Basic charge:
11.500 EUR for three data sets Additional data sets: 1.900 EUR each
45 calendar days
Example: A joint application consisting of five data sets send their applications for chemical similarity check in view of a joint application for active substance approval. They submit 5 different data sets*.
The total service charge for the joint application check will be 11.500 EUR+21.900 EUR =15.300 EUR.
Therefore, each applicant will receive an invoice for 15.300 EUR /5=3060 EUR.
8.3 Launching the CS-APP application wizard
The R4BP 3 application wizard for CS-APP is launched as a ‘NEW APPLICATION’. You can launch
the application wizard as a new application, click on the ‘NEW APPLICATION’ tab on the R4BP 3
toolbar to see the full list of application types available in alphabetical order. Then, select ‘CS-
APP – Application for chemical similarity’ from the list of processes (Figure 3).
Each applicant in the joint application will need to submit its own application
through R4BP 3, including a IUCLID dossier and an additional supporting document.
If a specific applicant wishes to have several sources checked, they will need to
submit a separate application for each source.
ECHA will assess the information in the application following, in principle, the same
criteria that apply for the Tier I assessment for technical equivalence. The criteria
is described in detail in the ‘Guidance on applications for technical equivalence’ and
the procedure is outlined on the biocides regulatory webpages.
12 Not to be confused with the IUCLID term ‘dataset’, which is used to create a non-editable ‘dossier’.
Application instructions: Technical equivalence & chemical similarity June 2017 21
Figure 3: Launching the application ‘wizard’ for CS-APP
8.4 Application requirements for CS-APP
This sub-chapter describes the application requirements necessary for each step of the CS-APP
application wizard. Additional instructions and guidance are available in R4BP 3 at each wizard
step to help you with the application procedure.
Before you apply for a joint application: the ‘joint application number’ received
from the ECHA helpdesk and the number of applicants (i.e. datasets) submitted for
comparison by the joint application is required.
After carrying out the check, ECHA will make available to you a draft outcome for
the applicant to comment on (through R4BP 3). For joint applications, each
applicant will receive its own draft outcome and all comments will be considered.
The final outcome document will include the result of the check.
22 Biocides Submission Manual Version 4.0
Upload dossier (.i5z) and select the language
the IUCLID dossier must contain information on:
manufacturer of the active substance and the manufacturing plant location
the substance identity
chemical composition
analytical profile of five representative batches
description of the analytical method used for the determination of the
substance
absorption spectra.
Upload other files
The following additional supporting document ‘Application for the assessment of chemical similarity’ available from ECHA’s website is required to be uploaded at this step. For joint applications, a ‘joint application number’ needs to be included in this supporting document for each individual application. Please upload any other files you wish to support you application at this step.
Confirm application
If the data in the confirmation screen is correct enter the security check text and
submit your application. If any information is incorrect, you can update the specific fields by clicking the ‘Previous’ button to return to the application form.
Case owner details Contact person for the case must be specified.
Set submission details
Enter the details of the proposed ’asset owner’ and indicate the payment details.
Application instructions: Technical equivalence & chemical similarity June 2017 23
ANNEX: How to prepare your IUCLID dossier
The subsequent sections of this chapter detail how to fill in the specific IUCLID fields relevant
for technical equivalence assessment and CSC applications. Furthermore, there are instructions
on how to create a dossier from a dataset. For a more comprehensive illustration of how to
prepare a dataset and generate a dossier using IUCLID 6, please see the BSM Technical guide:
using IUCLID .
Preparing a dataset for an active substance
This chapter outlines how to prepare a ‘Substance’ dataset using the dataset template ‘BPR
Active substance application’, containing information about the active substance. This BSM
should be used in conjunction with the other manuals in the BSM series, as well as the Guidance
documents.
Step 1: Create a ‘Substance’ dataset
In the ‘Tasks’ pane of the IUCLID 6 homepage , create a ‘Substance’ dataset by right clicking
on the Substance icon icon (Figure 4). Alternatively, if you have already created a ‘Substance’
dataset and you wish to update information within it at any stage, click on the substance icon
and search for it in the navigation panel.
Figure 4: Creating a 'Substance' dataset
Step 2: Select the dataset template
Once you have gained access to the Active Substance dataset homepage, enter basic information
regarding the substance name and the reference substance (Figure 5). The reference substance
identifies the active substance for which the dataset has been created. In order to identify your
reference substance, click on the icon next to the ‘reference substance’ box.
24 Biocides Submission Manual Version 4.0
Figure 5: Active substance dataset
Confirm your entries by saving your work . This will enable you to access the TOC tab and
therefore to enter more detailed information regarding your active substance. To be able to enter
these information, choose the template “BPR Active substance information” from the pick list
(Figure 6).
Figure 6: 'BPR Active substance information' template
Application instructions: Technical equivalence & chemical similarity June 2017 25
Step 3: Enter the ‘Applicant’ details
IUCLID section 1.3 ‘Active substance manufacturer’ name and manufacturing plant location
IUCLID section 1.3 contains the identity of the active substance manufacturer, which must be
included. This information is used to identify the source of the AS. To indicate the name of the
manufacturer, start by creating a block (Figure 7). Enter some search criteria (e.g. Legal
entity name) in the appearing ‘Query’ window and then click ‘Search’ (Figure 8). It may be the
case that the manufacturer has not been entered into your database. In this case, click the ‘New’
button in the ‘Query’ window (Figure 8), to launch the Legal Entity assistant. Enter all related
information, and click on the ‘Sites’ tab to include the manufacturing plant location.
Further details are given in ‘Step 3: Enter the ‘Applicant details’ of the BSM Technical guide:
Using IUCLID.
Figure 7: Specify the active substance supplier
Figure 8: Enter the manufacturing plant location
Step 4: Identify the active substance
IUCLID section 2.1 - Common name and synonyms
Identify the substance that you wish the TE assessment or CSC to be done on by linking the
26 Biocides Submission Manual Version 4.0
dataset to a reference substance13 with the specifications of the active substance composition
provided.
Ensure that at least a IUPAC name and a structural formula are indicated in the relevant fields
of the reference substance. Furthermore, a common name proposed or accepted by ISO, any
synonyms (usual name, trade name, abbreviation), CAS number and CAS name, EC, INDEX and
CIPAC numbers (if allocated), molecular formula, SMILES notation and molar mass should all
be included when available (Figure 9).
Step by step instructions on how to create a reference substance are given in ‘Step 4: Identify
the active substance’ of BSM Technical guide: using IUCLID.
Figure 9: IUCLID section 2.1
IUCLID section 2.9 – Specification on purity of the active substance as manufacturer
Right click on section 2.9 and select ‘New record’. Enter information on the technological
processes involved in the manufacture of the active substance into the ‘Description of
composition’ free text field, and/or by adding an attachment in the ‘Attachments’ tab (Figure
10).
13 The ’reference substance’ is a term used in IUCLID 5 identifying the AS to be assessed and should not
be confused with the ‘reference source’ used in the BPR. Source refers to the specific manufacturing location of a substance for which the manufacturing process has been outlined and the specifications of the starting material are provided.
Application instructions: Technical equivalence & chemical similarity June 2017 27
Figure 10: Entering information on the manufacturing process
IUCLID section 2.9 - Specification of purity
Provide the full composition specifications of the substance (including any constituents,
impurities and additives) together with an explanation of how these specifications were derived
and the results of the five-batch analysis.
Start by creating a new ‘Substance composition’ block using the ‘Add’ function (Figure 11). Enter
the name of the newly created composition block (e.g. Composition of…), and give a ‘Brief
description’ of how the composition of the substance has been derived. Then, indicate the degree
of purity of the substance, with units. This can be either as the minimum degree of purity (>,
≥) or as a concentration range (>, ≥; <, ≤) (Figure 12).
28 Biocides Submission Manual Version 4.0
Figure 11: Creating a composition block
Figure 12: Entering the degree of purity
Do not give the degree of purity as circa (ca.).
Create a block for each constituent of the active substance, and fill in relevant information.
Ensure you link a reference substance to each constituent block. The steps to follow when linking
a reference substance, are the same as those outlined in IUCLID section 2.1 ‘Common name
and synonyms’. Once the reference substance has been linked, specify the ‘Concentration range’
and the ‘Typical concentration’ range (Figure 13). If you have any impurities or additives, create
a block for each and fill in the block in a similar fashion to the constituents.
Application instructions: Technical equivalence & chemical similarity June 2017 29
Figure 13: Adding the constituents
Finally, attach the results of the five batch analysis in the ‘Attachments’ tab in the ‘Information’
box, as described in IUCLID section 2.9 ‘Specification on purity of the active substance as
manufacturer’ above. Thus, the ‘Substance composition’ block should include a name and brief
description, the degree of purity of the substance, all the constituents, impurities and additives,
as well as an attachment (Figure 14).
30 Biocides Submission Manual Version 4.0
Figure 14: A complete substance composition.
IUCLID section 3.6 - Absorption spectra data
Right click on section 3.6. to ‘create a new record’. Under the ‘Methods and results of analysis’,
include the absorption spectra, such as (UV/VIS, IR, NMR) and a mass spectrum, molar
extinction coefficient. To do this, add a new repeatable block for each analysis available by
clicking the ‘Add’ function. Information regarding the analysis type, the test substance, the
method used and any remark you consider relevant can be placed in the relevant free text fields
(Figure 15). In addition, ensure you attach the spectral data by clicking on the plus button
( )(Figure 15). The steps needed to add an attachment are further described in IUCLID section
2.9 above.
Application instructions: Technical equivalence & chemical similarity June 2017 31
Figure 15: Including absorption spectra data
IUCLID section 5 – Methods of detection and identification
Right click on section 5. And create a new endpoint summary. You are required to name your
new endpoint study record. It is recommended that you name the endpoints in a descriptive way
e.g. ‘Determination of active substance’, ‘Determination of Impurity 1’, ‘Determination of
Additive 1’, etc.
Include data on the analytical methods used for the determination of the active substance,
residues, isomers, impurities and additives (e.g. stabilisers) in this section. Create a new
endpoint study record for each analytical method used to determine the active substance,
residues, isomers, impurities and additives (e.g. stabilisers).
Information regarding the analytical method used, can be filled into the relevant fields of the
endpoint study record, or simply attached as a document in the ‘Attachments’ tab of the
‘Information’ box (Figure 16). The steps needed to add an attachment are further described in
IUCLID section 2.9 above. For your own convenience, you can navigate to the different sections
of the endpoint using the links at the top of your IUCLID 6 screen (Figure 16).
Figure 16: Creating a new endpoint study record
For a detailed explanation on how to fill in the different fields of this endpoint, please see “5 How
to complete IUCLID endpoint study records” of BSM Technical guide: Using IUCLID.
32 Biocides Submission Manual Version 4.0
Information on the analytical methods to be used for the determination of non-
relevant and relevant impurities can be found in the guidance on technical
equivalence and guidance on information requirements.
Step 5: For technical equivalence Tier II assessments
Include a hazard profile for the active substance
If you are submitting a Tier II application, you are required to include relevant information in
IUCLID 6 endpoint sections 8, 9 and 10. For further instructions on how to complete these
endpoint sections, please consult chapter 5 ‘How to complete IUCLID endpoint study records’ of
BSM Technical guide: Using IUCLID.
Include a self-assessment of technical equivalence
If you are submitting a Tier II application, you are required to prepare a self-assessment on TE.
The information submitted in this self-assessment should cover both human health and
environmental hazards, including the potential for bioaccumulation and persistence. You should
submit all the available information needed and include the self-assessment as an attachment
in IUCLID 5 section 13 ‘Summary and evaluation’ (Figure 17).
The template for the self-assessment can be found as an Annex to the ‘Guidance
Document on Applications for Technical Equivalence’.
To include the appropriate primary supporting documents, right-click on section 13 ‘Summary
and evaluation’ and select ‘New summary’. Attach the document in the ‘Summar and evaluation’
field. In the ‘Type of report’ field, select ‘other:’ using the drop-down menu and enter the type
of document you are attaching in the adjacent field, e.g. Tier II self-assessment.
Figure 17: Attaching a supporting document in Section 13 of your IUCLID 5 dataset
Finalise the dataset
To ensure ECHA can process your assessment of TE or CSC application correctly, you need to
first create a valid dossier. Creating a valid dossier can only be done by linking your ‘Substance’
dataset to a ‘Mixture/Product’ dataset. This ‘Mixture/Product’ dataset need only contain one
section (IUCLID section 2.3 ‘Product composition’) and must be used to create the dossier.
Please, follow the next steps to finalise your dataset and create a valid dossier.
Application instructions: Technical equivalence & chemical similarity June 2017 33
Step 1: Create a ‘Mixture/Product’ dataset
In the ‘Tasks’ pane of the IUCLID 5 homepage , create a ‘Mixture/Product’ dataset by right
clicking on ‘the ‘Mixture/Product’ icon (Figure 18)
Ensure the legal entity is the same as the one used in the ‘Substance’ dataset and
also the same as the one you will use to apply in R4BP 3.
Figure 18: Creating a ‘Mixture/Product’ dataset
Step 2: Link the two datasets together
Once you have the dataset open, enter the mixture/Product name and save your work. Click on
the ‘TOC’ tab and select the template ‘BPR Biocidal product authorisation’ from the drop-down
menu using the black arrow under the ‘Section tree’ tab (Figure 19).
The only section that needs to be completed is IUCLID section 2.3 ‘biocidal product
composition’. Therefore, go straight to this section and create a new endpoint study record.
This is done by right-clicking on section 2.3 and then clicking ‘New record’ (Figures 20). Provide
a name for it (e.g. ‘Acrolein link’), the endpoint study record will open automatically.
Figure 19: Selecting the correct template
Ensure that the ‘BPR Biocidal product authorisation’ template is selected for the
‘Mixture/Product’ dataset.
34 Biocides Submission Manual Version 4.0
Figure 20: Naming the endpoint that links the two datasets
Within the endpoint study record, you only need to create a component block by clicking on the
‘plus’ function. The link to the ‘Substance’ dataset, containing all of the active substance data,
is made through this composition block.
To complete the link between the two datasets, in the ‘Function’ field, click the black pointer
and select ‘Active Substance’ (Figure 21). Then, next to the ‘Name’ field, click the link button
to open the ‘Query’ box (Figure 22).
Figure 21: Completing the link between the two datasets
Ensure ‘Substance’ is in the ‘Select query result type:’ (Figure 22). Specify the search criteria
and click ‘Search’ to find the relevant ‘Substance’ dataset you have created. Please note that the
‘Chemical name’ is the name you assigned to the ‘Substance’ dataset.
From the search results, select the correct ‘Substance’ dataset and ‘Assign’ the AS ‘Substance’
dataset to the ‘Mixture/Product’ dataset (e.g. active substance Acrolein).
Application instructions: Technical equivalence & chemical similarity June 2017 35
Figure 22: Query box
You can now make a valid dossier from this ‘Mixture/Product’ dataset.
If you do not have a ‘Substance’ dataset prepared, go to Preparing a dataset for
your active substance first.
How to create a dossier
Ensure all of the appropriate information is included in the ‘Substance’ dataset and it has been
linked to a ‘Mixture/Product’ dataset, before creating your dossier. To create a valid dossier go
to the IUCLID 5 homepage and double click on the ‘Mixture/Product’ icon.
Then, search for your ‘Mixture/Product’ dataset contained in the navigation panel tab and right
click on the mixture/product name to be able to ‘Create dossier’ (Figure 23). This will launch the
dossier creation wizard.
36 Biocides Submission Manual Version 4.0
Figure 23: Launching the dossier creation wizard
The dossier creation wizard will guide you through a set of steps in order to create the relevant
dossier type, i.e. ‘BPR Active substance application’. The steps below explain how to navigate
through the dossier creation wizard. When ready, click ‘Next>’ to move to the next step of the
wizard (Figure 24).
Step 1 Select the correct dossier type, i.e. ‘BPR Active substance application’.
Application instructions: Technical equivalence & chemical similarity June 2017 37
Figure 24: Selecting the dossier template
Step 2 Review the related entities.
Step 3 Filter the information to be included in the dossier. Most fields in a IUCLID dataset
can be flagged as confidential and/or specifically for the purpose of certain
regulatory programmes. To include all records in a dossier, no matter how their
confidentiality and/or regulatory purpose flags are set, click both ‘Select all’ buttons.
To exclude records that have a particular type of flag set, un-tick the box for that
flag type.
For most cases, ECHA recommends that you ‘Select all’ the checkboxes, making
sure that all of the required elements of the Substance or ‘Mixture/Product’ dataset
are included in the dossier to be submitted.
Step 4 Verify the selected sections for inclusion. There are default tabs displayed, one for
each of the ‘Substance’ dataset templates and the ‘Mixture/Product’ dataset
templates available in IUCLID. By default, all the components selected in
accordance with the template are included in the dossier. To exclude a component,
un-tick the pertinent box in the relevant dataset.
Step 5 Verify the selected endpoint summaries/study records. Deselect sections as
appropriate.
Step 6 Verify the sections of your dataset that will be included in the dossier.
Step 7 Verify the inclusion or exclusion of annotations.
Step 8 Specify the name of the dossier in the free text field and include any additional
remarks if relevant. Please record the dossier name as this can be used to view the
dossier later.
Step 9 Note that the dossier creation ‘wizard’ skips step 9 for the creation of biocides
dossiers as this step is only relevant to REACH-related dossiers.
Step 10 Copy-protect study records and click ‘Finish’. If you tick this box, the ownership of
the dossier data will be protected in such a way that copying the endpoint
study/summary records using the IUCLID clipboard manager will be prevented.
38 Biocides Submission Manual Version 4.0
Step 11 Export your dossier (Figure 25), after ensuring all of the information contained
within it is correct, and save it on your local IT environment.
This allows you to upload your IUCLID dossier as part of your application in R4BP 3.
Follow the steps in the Export assistant to i) select the appropriate option for
annotation export and click ‘Next’, then ii) click the ‘Save’ button to define where
you wish to save the dossier. Select your desired location from the ‘Look In’ field
and specify the name of the dossier in the ‘File Name’ field, then click ‘OK’.
Figure 25: Export your dossier
Clicking ‘View dossier’ in the prompt window will direct you to the ‘Dossier
header’ section of your newly created dossier.
Application instructions: Technical equivalence & chemical similarity June 2017 39
EUROPEAN CHEMICALS AGENCY
ANNANKATU 18, P.O. BOX 400,
FI-00121 HELSINKI, FINLAND ECHA.EUROPA.EU
