Practical guide on biocidal products regulation.
Date: 2015-05-08
Institutions: European Chemicals Agency
Subjects: chemical element, chemical industry, chemical product, dangerous substance, directive (EU), environmental risk prevention, regulation (EU), research and development, toxic substance, user guide

Practical Guide   
on Biocidal Products Regulation

ABC

Practical guide on Biocidal Products Regulation

ECHA-14-B-19-EN 

Reference:  
Cat. number:   ED-01-14-753-EN-N 
978-92-9244-764-9 
ISBN:  
10.2823/54053 
DOI:  
September 2014 
Date:  
English
Language: 

© European Chemicals Agency, 2014

If you have questions or comments in relation to this document please send them (quoting the reference and 
issue date) using the information request form. The form can be accessed via 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 18, Helsinki, Finland

 
 
 
 
Table of Contents

APPROVAL OF ACTIVE SUBSTANCE 

RENEWAL OF AN APPROVAL OF ACTIVE SUBSTANCE

REVIEW OF AN APPROVAL OF ACTIVE SUBSTANCE

ARTICLE 95: LIST OF ACTIVE SUBSTANCES AND SUPPLIERS

TECHNICAL EQUIVALENCE

NATIONAL AUTHORISATION

MUTUAL RECOGNITION

RENEWAL OF NATIONAL AUTHORISATION AND AUTHORISATIONS SUBJECT TO MUTUAL RECOGNITION

UNION AUTHORISATION

SIMPLIFIED AUTHORISATION

CHANGES OF BIOCIDAL PRODUCTS

DATA SHARING

RESEARCH AND DEVELOPMENT

APPEALS

PRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Approval of active substance

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 
(BPR)) is that a biocidal product (BP) must be authorised before it can 
be made available on the market or used in the European Union (EU)/
European Economic Area (EEA).1 This takes place in two consecutive 
steps. As the first step, the active substance is evaluated and, provided 
the criteria are fulfilled, is then approved in a specified product-type (PT). 
The second step is the authorisation of each BP consisting of, containing 
or generating the approved active substance(s). This document concerns 
the first step, approval of active substances. 2

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

Any person may apply for the approval of an active substance. Normally, 
the application is expected to be made by a person who is placing the 
active substance on the market within the EU. 

The applicant may have a person/entity handling the practical issues 
related to the application on behalf of the applicant (e.g. a consultant).

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

An application for approval of a new active substance3 can be submitted 
at any time.

An application for active substance approval may also need to be 
submitted within a specified timeframe where active substances are 
eligible for inclusion into the Review Programme.4 

1  Ref: Article 17(1) of the BPR.
2  Ref: Chapter II of the BPR.
3  A “new active substance” is a substance which was not on the market on 14 May 2000, 
as an active substance of a BP for purposes other than scientific or product and process-
orientated research and development (Article 3(1)(e) of the BPR).
4  The Review Programme is a Commission work programme for reviewing all existing 
biocidal active substances. The programme was set up under the Biocidal Products Directive 
and continues under the BPR. (Note that the new Review Programme Regulation is likely to 
be published in autumn 2014.)

For active substances contained in certain products not covered by 
Directive 98/8/EC but falling under the BPR5 available on the market 
before 1 September 2013, there is a deadline of 1 September 2016 for 
the submission of the applications for the relevant AS in those products. 
Where such an application is not made by the deadline, the product must 
be removed from the market by 1 September 2017.

BPs that contain only existing active substances6 that are included in the 
Review Programme may be permitted to be made available on the market 
or used before the approval date of the active substance, subject to 
national laws of the relevant Member State (MS). 

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Article 6 of the BPR lists the requirements for an application for active 
substance approval. Biocides Submission Manual 3a: Active substances 
Part A, Initial submissions, available on the European Chemicals Agency’s 
(ECHA) website, explains what types of information files should be 
prepared and included in the application for active substance approval.

ECHA provides more advice on information requirements as given by 
Annexes II and III to the BPR and the assessment of the information in 
the Guidance on information requirements for Biocides, available on 
ECHA’s website.

Issues to consider:
•  To avoid duplication of testing on vertebrates, owners of existing 

data and prospective applicants must share data involving tests on 
vertebrates for biocidal active substances and products already 
submitted to ECHA or the MSCAs under the BPR or Directive 98/8/
EC. First, the prospective applicants should enquire from ECHA about 
the contact details of the data submitters. While sharing of vertebrate 
data is mandatory, the prospective applicant may also request to 
share non-vertebrate data. Where an enquiry has been made, and 
then negotiations fail in spite of every effort of the applicant, ECHA 
can grant permission to the applicant to refer to the data. For more 
information see Practical Guide chapter on data sharing.

If the applicant is a small or medium-sized enterprise (SME), it may be 
entitled to a reduced fee. Note that ECHA needs to recognise the SME 
status of the applicant, before submitting an application for active 
substance approval. For more information on the recognition of an SME 
status and on how to submit relevant documentation see ECHA’s website.7

5  Ref: Article 93 of the BPR.
6  An “existing active substance” is a substance which was on the market on 14 May 2000 
as an active substance of a BP for purposes other than scientific or product and process-
orientated research and development (Article 3(1)(d) of the BPR).
7  http://echa.europa.eu/support/small-and-medium-sized-enterprises-smes/smes-fees-
under-bpr

Practical guide on Biocidal Products Regulation  Approval of active substanceHOW

 PROCEDURE TO FOLLOW 

Creation of a IUCLID 5 dossier:
The applicant seeking an approval of an active substance needs to submit 
the data using a IUCLID 5 format. 

The following documents describe how to create and complete a IUCLID 
dossier:
•  BPR dossier creation/IUCLID Quick Guide, available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID, 

available in ECHA’s YouTube channel;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications, 

available on ECHA’s website; 

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications, 

available on ECHA’s website.

Submission and processing of an application using R4BP 3:
The application for active substance approval should be submitted using 
R4BP 3. Following confirmation that the submission has passed the 
initial checks by ECHA, the application will be forwarded to the relevant 
evaluating competent authority (eCA) for validation and evaluation. 
Evaluation (365 days unless additional information is requested) is 
followed by a peer review (270 days) performed by ECHA through the 
Biocidal Products Committee (BPC) which issues an opinion. During 
the evaluation, if active substances are identified as candidates for 
substitution8, a public consultation will be launched in parallel with the 
peer review. On the basis of the BPC opinion, the Commission takes a 
decision on the approval of the active substance.9 The total time from 
submitting an application to having a formal active substance approval 
decision is approximately two and a half years as a minimum. The approval 
process will take longer if the data package needs to be complemented 
during the evaluation.

Applicants need to monitor the status of their submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails 
to meet a deadline, e.g. for payment of fees, or, at a later stage, request 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline. Details on the applicants’ input during the 
peer review are given below.

Applicants will find the relevant information and instructions for 
submitting and following up their application through R4BP 3 in the 
submission manuals on ECHA’s website:
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications;
•  Biocides Submission Manual 3a: Active substances Part A, Initial 

submission.

8  Ref: Article 10 of the BPR.
9  Ref: Articles 7-9 of the BPR.

Practical guide on Biocidal Products Regulation Approval of active substanceMore information related to invoicing and R4PB 3 can be found in the 
Biocides Submission Manual 5: Invoicing in R4BP 3.

Applicants input to the peer review 
The peer review process entails a scientific and technical review by 
the BPC working groups (WGs) before eventual adoption of the opinion 
by the BPC.  During the peer review, ECHA permits the participation 
of applicants to clarify any discussion items and to make sure that all 
aspects are properly addressed and understood when the BPC and the 
BPC WGs consider their application.   

The role and responsibilities of applicants participating in the peer 
review phase is explained in the ECHA Code of conduct for applicants 
participating in the Biocidal Products Committee and its Working Groups10 
available on ECHA’s website. The Code of conduct sets out general rules 
and responsibilities for applicants, explains the mechanism by which 
applicants may participate in meetings and explains their obligations 
regarding confidentiality and the rules regarding documentation from 
applicants.  

To participate in the BPC or BPC WG meetings, after the draft agenda 
for the meeting has been published on ECHA’s website, applicants need 
to contact the BPC or BPC WG Secretariat no later than 14 days before 
the meeting. Accredited stakeholder organisations (ASO) can be present 
at WG meetings, but do not have access to confidential substance 
documents.

Applicants are given the opportunity to participate in the process also 
at other stages of the process as described in the Working Procedure11 
available on ECHA’s website. The document describes the process 
and timelines in detail. In accordance with the working procedure, the 
applicant:
•  Should review, where a public consultation is required, the text 

proposal for the public consultation to make sure that no confidential 
information is placed in the public domain;

•  May provide comments on the Competent Authority Report (CAR) 
during the commenting period by which the peer review stage is 
launched. Where the applicant makes comments it should discuss 
these with the eCA with the aim of reaching an agreement that will 
then be recorded in the commenting table. The applicant may discuss 
any remaining open points trilaterally with the eCA and ECHA;
•  May review the updated commenting table, once the results of all 

trilateral discussions are included by the eCA, to make sure that all points 
have been addressed correctly. If there is disagreement, the applicant can 
request re-opening a point for a discussion in the BPC or WG meeting;
•  Should monitor ECHA’s website to find out when their application is 
scheduled to be discussed in the WG or BPC meeting. The applicant 

10  http://echa.europa.eu/documents/10162/4221979/bpc_conduct_code_applicants_
en.pdf
11  Biocidal active substance approval: working procedure for the BPC,  http://echa.europa.
eu/documents/10162/4221979/bpc_working_procedure_active_substance_en.pdf

Practical guide on Biocidal Products Regulation  Approval of active substancemay register and attend the discussions on their application if they 
have previously registered;

•  Should review the discussion table to be discussed at the relevant WG 
meeting. If the applicant wishes to discuss an issue that is not in the 
discussion table, they should immediately contact the Secretariat. 
ECHA will include such additional issues in the discussion table before 
the WG meeting only when they are critical for the approval and/or for 
fulfilling the exclusion or substitution criteria; 

•  Where an agreement is not reached during the WG meeting, the WG 

convenes an ad hoc follow-up group coordinated by ECHA. The intention 
is to reach an agreement for all remaining open points from the WG 
meeting. The applicant may be invited to participate as an observer; 
•  Can review and send comments on the minutes of the WG meeting to 

the Secretariat; 

•  Receives the draft BPC opinion and updated assessment report 

before the BPC meeting. After the meeting, the eCA together with the 
applicant, will prepare a non-confidential version of the assessment 
report and the study summaries for the active substance (doc IIIA).

RESULT

OUTCOME OF THE OBLIGATION/PROCESS

The European Commission (COM) takes a decision on the AS approval 
through an implementing regulation or non-approval through an 
implementing decision, which will be published in the Official Journal 
of the European Union. The COM implementing regulation will include 
the approval and expiry date. The approved active substances will be 
included in a Union list of approved active substances12 available on 
ECHA’s website. The approval of an active substance will concern only 
the product types applied for. The approval of the active substance is not 
specific to any company (unlike in the case of the BP authorisation which 
is specific to the company which is responsible for placing the product on 
the market).

Approval for an active substance can be granted for a maximum period of 
10 years (renewable).

Approval for an active substance that meets the substitution criteria (see 
below) can be granted for a maximum period of seven years (renewable). 

Approval for an active substance that meets the exclusion criteria will 
not be granted unless the substance meets the derogation conditions of 
Article 5(2) of the BPR (see below). In such cases, approval may be granted 
for a maximum period of five years (renewable).

The applicant will be included also in the list of active substances and 
suppliers (Article 95 list) after the validation of the application by the 
evaluating CA. In the case of an eventual non-approval decision, the entry 
will be taken off the list. For more information see Practical Guide chapter 
on Article 95: List of active substances and suppliers.

12  http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances

Practical guide on Biocidal Products Regulation Approval of active substanceTO NOTE

EXCEPTIONS AND PARTICULAR CASES

Exclusion criteria
In the course of evaluation of applications for active substance approval, 
active substances will be assessed against the exclusion criteria13:
•  carcinogens, mutagens and reprotoxic substances category 1A or 1B 

according to the CLP Regulation14;

•  endocrine disruptors;
•  persistent, bioaccumulative and toxic (PBT) substances;
•  very persistent and very bioaccumulative (vPvB) substances.

Such active substances shall not be approved unless conditions set out 
under Article 5(2) are met: if exposure to them is negligible, they are 
essential in controlling a serious danger, or where the consequences of 
not using them are disproportional to the risk avoided.

Substitution criteria
Active substances meeting the substitution criteria are considered as 
potential candidates for substitution and they will undergo a public 
consultation during the approval process15. The criteria are based on the 
intrinsic hazardous properties in combination with the use and potential 
exposure and include:
•  meeting at least one of the exclusion criteria;
•  classification as a respiratory sensitiser;
• 

toxicological reference values significantly lower than those of the 
majority of approved active substances for the same PT and use;

•  meeting two of the criteria to be considered as PBT;
•  causing concerns for human or animal health and for the environment 

even with very restrictive risk management measures;

•  containing a significant proportion of non-active isomers or impurities.

During the evaluation of a BP containing active substances considered as 
candidates for substitution, a comparative assessment will be performed 
to assess whether less harmful products are available for the same use16.

Annex I to the BPR
It is also possible to apply for the active substance to be included in Annex 
I to the BPR. This annex lists active substances which do not give rise 
to concern. The process is set out in Regulation (EU) No 88/201417, and 
largely follows that for active substance approval.  

13  Ref: Article 5(1) of the BPR.
14  Regulation (EC) no 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation 
(EC) No 1907/2006.
15  Ref: Article 10 of the BPR.
16  Ref: Article 23 of the BPR.
17  Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying 
a procedure for the amendment of Annex I 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.

Practical guide on Biocidal Products Regulation  Approval of active substanceBPs containing one or more active substance(s) included on Annex I to 
the BPR are eligible for a simplified authorisation procedure (where 
certain conditions are met), as well as the regular product authorisation 
procedure. More details on the former can be found in the Practical Guide 
chapter on simplified authorisation. 

Applicants seeking to include an active substance in categories 1, 2, 3, 4 or 5 
of Annex I to the BPR must submit an application through R4BP 3 in line with 
the data requirements listed in Regulation (EU) No 88/2014.  Where there is 
no conclusive evidence of a robust consensus of expert opinion regarding one 
or more endpoints, an application must contain all additional data necessary 
to show that the substance does not give rise to the concern.

Applicants seeking to include an active substance in category 6 of Annex 
I to the BPR must submit a dossier containing a data package through 
R4BP 3, equivalent to those submitted for active substance approvals, 
allowing a full risk assessment for the intended use.

For the time being, the COM has not specified the information 
requirements and procedure to amend category 7 of Annex I to the BPR.

More information and instructions for submitting the application for the 
inclusion on Annex I are given in the Biocides Submission Manual 3a: Active 
substances Part A, Initial submissions, available on ECHA’s website. ECHA’s 
website also gives further details on the proces

Implications for approval of active substances used in  treated articles
The BPR introduces the principle that a treated article cannot be placed 
on the market unless the active substance contained in the BPs that it is 
treated with or incorporates is approved for the relevant product types or 
is included in Annex I.18

To prevent a market freeze, there are transitional provisions in place.19

If the active substance is either under examination in the Review 
Programme on 1 September 2016 or if an application for the active 
substance approval is received by that date and/or there is a combination 
of those active substances plus already approved active substances, 
then the treated article can stay on the market until the date of approval 
of the last active substance. If (one of) the active substances is/are not 
approved (decision adopted) after 1 September 2016, then the active 
substance must be off the market within 180 days of that decision.

Where the active substance is not under evaluation on 1 September 2016 
(Review Programme or new application) or is the subject of a non-approval 
decision before 1 September 2016, then the treated article can stay on 
the market until 1 March 2017 (phase-out period).

18  Ref: Article 58 of the BPR.
19  Ref: Article 94 of the BPR.

Practical guide on Biocidal Products Regulation Approval of active substanceTherefore, where a treated article contains an active substance which 
is not already approved, or for which an application for approval has not 
already been made (in the Review Programme or Article 7 of Directive 
98/8/EC or Article 11 of the BPR) in order to continue placing it on the 
market after 1 September 2016, the company will need to submit a 
complete application dossier on the active substance by 1 September 
2016. The active substance dossier must include data on the relevant PT.

If the active substance is not approved (decision adopted after 1 
September 2016) for the relevant PT, treated articles which were treated 
with or incorporated a BP containing this active substance should no 
longer be placed on the market as from 180 days from the decision of 
non-approval on the active substance. 

If the active substance is not approved (decision adopted before 1 
September 2016) for the relevant PT, the relevant treated articles should 
no longer be placed on the market as from 1 March 2017. 

Precursors of in situ generated substances 
Precursors placed on the market with the intention to generate active 
substances in situ will be covered by the definition of a BP. The in situ 
generated active substance will require to be approved and product 
authorisation granted before they can be made available on the market.

The COM and MSs are considering how to deal with precursors and the in situ 
generated active substances as part of the Review Programme. This will be 
addressed in the new Review Programme Regulation expected to be adopted 
by the end of 2014. This practical guide will be updated accordingly.

Furthermore, for precursors and the in situ generated active substances 
which are not part of the Review Programme, and where the BP did not fall 
within the scope of Directive 98/8/EC, there are transitional provisions 
in place20. The BP may be made available on the market or used, subject 
to national laws of the MSs, where an application for the relevant active 
substance/product type combination is made by 1 September 2016. If 
such an application is not made by that date, the BP should be removed 
from the market by 1 September 2017 (phase out date). 

COST

RELATED FEES

Both ECHA and national fees are applicable for this process. 

ECHA fees related to this process are described in the Annex I to 
Commission Implementing Regulation (EU) No 564/2013. Additional fees 
may be applicable for additional product types and if the substance is a 
candidate for substitution.

20  Ref: Article 93 of the BPR.

Practical guide on Biocidal Products Regulation  Approval of active substanceNote that small or medium-sized enterprise (SME) may be entitled to a 
reduced fee, see ECHA’s website.21 

National fees related to the application for active substance approval may 
vary between CAs and are established in national legal acts of each MS. 
The applicant is responsible for checking and paying the specified amount 
of fees to the chosen eCA.

For more information about the CA fees, the applicant should contact the 
designated national CA or its helpdesk.

HELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCA’s contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Approval of active substances
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

approval-of-active-substances 

Annex I amendment
 » http://www.echa.europa.eu/regulations/biocidal-products-regulation/

annex-i-amendment

The Biocidal Products Committee 
 » http://echa.europa.eu/about-us/who-we-are/biocidal-products-

committee

Treated articles 
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

treated-articles

21  http://www.echa.europa.eu/support/small-and-medium-sized-enterprises-smes/sme-
fees-under-bpr

Practical guide on Biocidal Products Regulation Approval of active substanceRelevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Active substance approval
 » http://www.echa.europa.eu/support/dossier-submission-tools/

r4bp/active-substance-approval

Approval of an active substance in an additional product type 
 » http://www.echa.europa.eu/support/dossier-submission-tools/
r4bp/approval-active-substance-additional-product-type

Annex I amendment
 » http://www.echa.europa.eu/support/dossier-submission-tools/

r4bp/annex-i-amendment

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 3a: Active substances Part A, Initial 
submissions
 » http://www.echa.europa.eu/documents/10162/14938692/

bsm_03a_active_subst_init_subm_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3 
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

Practical guide on Biocidal Products Regulation  Approval of active substanceBPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation Approval of active substancePRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Article 95: List of active substances  
and suppliers

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

Article 95 of the Biocidal Products Regulation ((EU) No 528/2012 (BPR)) 
aims to ensure equal treatment of persons placing active substances on 
the market (on their own or in biocidal products (BPs)). The supplier of the 
active substance or the product is required to hold a dossier or have a letter 
of access (LoA) to a dossier, for each of the active substances used in the 
relevant BP.1 The European Chemicals Agency (ECHA) verifies whether the 
dossier, or the LoA, is adequate.2 In other words, the aim is to make sure that 
all players contribute to the costs of the active substance approval process 
during the period when they place the active substance on the market. The 
equal treatment objective of Article 95 is fulfilled through ECHA’s publication 
of a list of active substances and suppliers (the Article 95 list).3 

From 1 September 2015, a BP cannot be placed on the EU market if the 
substance supplier or product supplier is not included in the Article 95 list 
for the product-type (PT) to which the product belongs.

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

Article 95 creates an obligation on persons making available BPs on the 
market to make sure that either the “substance supplier” or “product 
supplier” is included in the list published by ECHA under Article 95 (for the 
PT to which the product belongs).

The entities to be listed can be classified into two groups:

•  Those who are placed automatically on the list and will thus not have to 

make a submission to ECHA under Article 95, namely:

 • participants in the Review Programme4;
 •

supporters of new active substances (those who have 
submitted a dossier under Article 11 of Directive 98/8/EC 
(BPD) or under Article 7 of the BPR;

1  Ref: Recital (8) and Article 95 of the BPR.
2 
In accordance with Article 95(1) of the BPR, a dossier is deemed “complete” when it 
fulfils the information requirements set out in Annex II to the BPR or with Annex IIA or IVA to 
Directive 98/8/EC and , where relevant, Annex IIIA to that Directive. 
3  http://echa.europa.eu/information-on-chemicals/active-substance-suppliers
4  Review Programme is the term used for the work programme established by the 
Commission under Article 16(2) of the BPD for the assessment of existing active substances 
established, which is continued under Article 89(1) of the BPR. 

 •

submitters of third party dossiers (alternative active 
substance dossiers submitted as part of a product 
authorisation application).

•  Alternative suppliers who must make a submission to ECHA under Article 

95 to be included on the list. Such entities would normally include:

 • manufacturers of active substances in the Review 

 •

Programme who were not participants in the Review 
Programme; 
importers of active substances (on their own or in BPs) in the 
Review Programme who were not participants in the Review 
Programme; 

 • manufacturers of new active substances who did not support 

 •

the approval of the active substance;
importers of new active substances (on their own or 
in BPs) who did not support the approval of the active 
substance;

 • manufacturers of BPs, if the supplier of the active 

substance(s) used in their products is not on the list;
 • entities which make BPs available on the market if the 

supplier of the active substance(s) used in their products is 
not on the list.

The Article 95 list is structured per active substance. Apart from the 
names of the entities, the list shows the role of the entities as “substance 
supplier” and/or “product supplier”, the relevant PT, and the date of 
inclusion of the entity in the list. 

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

The concerned companies (alternative suppliers) need to make a 
submission that is compliant with Article 95 to ECHA in time to be 
included on the list before 1 September 2015. From 1 September 2015, a 
BP cannot be placed on the EU market if the substance supplier or product 
supplier is not included in the list for the PT to which the product belongs.

For new active substances, a submission can be made as soon as the 
original new active substance dossier is considered to be complete by the 
evaluating competent authority.

Practical guide on Biocidal Products Regulation  Article 95: List of active substances and suppliersWHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Companies can submit a full dossier, a LoA, a combination of a dossier and 
an LoA or a reference to an existing dossier for which all data protection 
periods have expired. 

Biocides Submission Manual 3a: Active substances Part A, Initial 
submissions explains what types of information files should be prepared 
and included in the application for inclusion on the Article 95 list. 
For further information on information requirements companies are 
recommended to consult the Guidance on active substance suppliers5 
as well as Annex II to the BPR and the Guidance for information 
requirements for Biocides, available on ECHA’s website.

Issues to consider:
The duplication of tests on vertebrates for the purposes of the BPR is 
prohibited. Any person intending to perform such tests should make an 
inquiry to ECHA to find out if the tests have already been submitted to 
ECHA or the MSCAs under the BPD or the BPR. If the relevant studies 
have already been submitted, ECHA will give the inquiring company the 
contact details of the data submitter.

Owners of existing data and prospective applicants are obliged to share 
data involving tests on vertebrates. Furthermore, for the submissions 
under Article 95 relating to substances listed in the Review Programme6, 
the respective parties are also obliged to share all toxicological, 
ecotoxicological and environmental fate and behaviour studies (including 
those not on vertebrates).

For more information see: Practical Guide chapter on data sharing.

HOW

 PROCEDURE TO FOLLOW 

Creation of a IUCLID 5 dossier:
The entity seeking inclusion on the Article 95 list is required to submit the 
required information using a IUCLID 5 format. 

The following documents describe how to create and complete a 
IUCLID dossier:

•  BPR dossier creation/IUCLID Quick Guide, available on the IUCLID website;
•  Video tutorial Creation of a biocidal product dossier with IUCLID, 

available in ECHA’s YouTube channel;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications, 

available on ECHA’s website; 

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications, 

available on ECHA’s website.

5  Under revision (September 2014).
6  Ref: Annex II to Regulation (EC) No 1451/2007.

Practical guide on Biocidal Products Regulation Article 95: List of active substances and suppliersFor a submission based on an LoA to a complete substance dossier, no 
IUCLID dossier is required.

Submission and processing of an application using R4BP 3:
The application for inclusion on the Article 95 list should be submitted 
through R4BP 3. Following confirmation that the submission has passed 
the initial checks by ECHA, the application will be evaluated by the 
Agency. ECHA will send a draft decision to the applicant for comments, 
and at this time it is also possible for the applicant to submit missing 
information. ECHA then takes a decision on the inclusion of the supplier in 
the Article 95 list.

Applicants need to monitor the status of their submission and receive/
react to requests from ECHA in R4BP 3. If the applicant fails to meet a 
deadline, e.g. for payment of fees or to comment or submit additional 
information further to a draft decision, the application may be rejected. 
Only one update of the dossier is permitted. Updates of the dossier on the 
initiative of the applicant are not possible.

Applicants will find the relevant information and instructions for 
submitting and following-up their application through R4BP 3 in the 
submission manuals on ECHA’s website:
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications;
•  Biocides Submission Manual 3a: Active substances Part A, Initial 

submission.

More information related to invoicing and R4PB 3 can be found in the 
Biocides Submission Manual 5: Invoicing in R4BP 3.

RESULT

OUTCOME OF THE OBLIGATION/PROCESS

If a positive decision is made to include a company in the Article 95 list, 
it will be included on the Article 95 list as a substance and/or product 
supplier (as appropriate) for the relevant active substance and PT.  The 
related entry is published by ECHA in its regular update of the Article 95 
list.

If a negative decision is made, the company will not be included on the list, 
and may consider submitting a new application.

From 1 September 2015, a BP cannot be placed on the EU market if the 
substance supplier or product supplier is not included in the list for the PT 
to which the product belongs.

Practical guide on Biocidal Products Regulation  Article 95: List of active substances and suppliersTO NOTE

EXCEPTIONS AND PARTICULAR CASES

Relation with the technical equivalence process
The assessment of technical equivalence for Article 95 purposes is not 
mandatory under the BPR and inclusion of a supplier in the Article 95 list 
does not automatically indicate the technical equivalence of their active 
substance.

Nevertheless, a company can request a technical equivalence assessment 
under Article 54 of the BPR (or a chemical similarity check, if a decision 
to approve the active substance has not yet been adopted) from ECHA 
before applying to be listed in the Article 95 list to make sure that the 
data they are about to obtain from an already listed company are relevant 
for its active substance.

For more information see the Practical Guide chapter on technical 
equivalence.

Annex I to the BPR
Except for the substances listed in category 6, all other active substances 
listed in Annex I are not within the scope of Article 95. As a consequence, 
BPs containing such active substances can be made available on the 
market after 1 September 2015, provided they are authorised.

For substances listed in category 6 of Annex I, companies responsible 
for placing BPs containing such substances will have to comply with the 
provisions of Article 95. Therefore, the same rules apply as for other 
active substances.

Treated articles
Producers or importers of treated articles are not subject to the 
requirements of Article 95. 

COST

RELATED FEES

Fees related to this process are described in the fifth entry of Annex III to 
Commission Implementing Regulation (EU) No 564/2013.

Practical guide on Biocidal Products Regulation Article 95: List of active substances and suppliersHELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Active substances and suppliers
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

approved-suppliers 

Guidance on biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Inclusion on the list of active substances and suppliers (Article 95)
 » http://echa.europa.eu/web/guest/support/dossier-submission-

tools/r4bp/inclusion-list-of-active-substance-suppliers

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 3a: Active substances Part A, Initial
submissions 
 » http://echa.europa.eu/documents/10162/14938692/bsm_03a_

active_subst_init_subm_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

Practical guide on Biocidal Products Regulation  Article 95: List of active substances and suppliers•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Questions and Answers on Active substances and suppliers

Practical guide on Biocidal Products Regulation Article 95: List of active substances and suppliersPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Technical equivalence

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The intention of the provision of Article 54 of the Biocidal Products 
Regulation ((EU) No 528/2012 (BPR)) is to enable the European Chemicals 
Agency (ECHA) to determine the similarity of the chemical composition 
and hazard profile of active substances that may differ from the one that 
was evaluated for the purpose of approval (reference source).

The assessment of technical equivalence (TE) is required when the 
active substance to be used in a biocidal product (BP) differs from the 
reference source of the approved active substance by having a different 
manufacturing process, a different manufacturing location or a different 
manufacturer. 

A positive decision on the TE of the active substance issued by ECHA is a 
required element in the application for a BP authorisation (Commission 
Delegated Regulation (EU) No 837/2013 amending Annex III to the BPR). 

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

Manufacturers or suppliers of alternative sources of active substances 
(including the Review Programme1 participants and supporters of new 
active substances following a change in the reference source) who wish 
to sell their actives to product formulators. Formulators may also apply 
for TE in particular when the manufacturers or suppliers of their active 
substance do not have an interest to apply for TE.

The applicant may have a person/entity handling the practical issues 
related to the application on its behalf (e.g. a consultant).

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

Companies may request the assessment of the TE of their active 
substance once the decision on the approval of the active substance 
has been adopted. Since ECHA’s decision on TE has to be included in 

1  The Review Programme is a Commission work programme for reviewing all existing 
biocidal active substances. The programme was set up under the Biocidal Products 
Directive and continues under the Biocidal Products Regulation. (Note that the new Review 
Programme Regulation is likely to be published in autumn 2014.)

an application for a BP authorisation, the deadlines relevant for BP 
authorisation applications (where applicable) need to be taken into 
account when submitting an application for TE.

For BPs containing existing active substances, and already on the market 
under national laws, the BP authorisation application must be made by 
the date of approval of the active substance, as explained in the Practical 
Guide chapters on national authorisation and Union authorisation, 
otherwise the products must be removed from the market within 180 
days of the active substance approval date. (A product authorisation 
application can also be made at a later date but until it is granted the 
products must be removed from the market). 

For BPs containing new active substances, and therefore not already 
available on the market, there is no deadline for the product authorisation 
application. 

In all cases, however, TE applications should be made well ahead of the foreseen 
submission date of the respective product authorisation application to 
accommodate for the time needed for the processing of the TE applications. 

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Biocides Submission Manual 3b: Active substances Part B, Technical 
equivalence and Chemical similarity, available on ECHA’s website, 
explains what types of information files should be prepared and included 
in an application for TE.

Section 3.3 in the Guidance on applications for technical equivalence, 
available on ECHA’s website, provides more advice on information 
requirements of the TE application and provides suggestions for further 
reading. For further details on the relevant information requirements, 
applicants should refer to Annex II to the BPR and the Guidance for 
information requirements for Biocides, available on ECHA’s website.

Applicants should be aware when compiling their dossiers that the 
information requirements differ if they choose to apply for Tier I or Tier 
II TE assessment. Tier I assessment focuses on the substance identity 
and the impurity profile. In addition to these requirements, for Tier II 
toxicological and ecotoxicological data are also evaluated. 

It should be noted that a five-batch analysis is always requested and that 
the spectral data is used to confirm the identity of the active substance. 
The methods of analysis should also be validated.

Issues to consider:
The fee for the application for assessment of the TE will be based on the 
type of the application, Tier I or Tier II. It is in the responsibility of the 
applicants to assess which tier is appropriate for their case.  

Practical guide on Biocidal Products Regulation  Technical equivalenceWhen applying for a Tier II assessment, a self-assessment of TE with the 
relevant toxicological and ecotoxicological data needs to be included in 
the application. The list of endpoints for the approved reference active 
substances is available from the CA Biocides CIRCABC website.2

The applicants should be aware that each dossier can only refer to one 
alternative source. If several alternative sources need assessment, for 
example, if the company obtains their active substance from more than 
one source which differ in the manufacturing process, the company needs 
to submit separate applications for each alternative source of the active 
substance.

HOW

 PROCEDURE TO FOLLOW 

Creation of a IUCLID 5 dossier:
The applicant seeking assessment of TE is required to submit the data 
using a IUCLID 5 format.

For more detailed instructions, see section 2.5 of the Biocides Submission 
Manual 3b: Active substances Part B, Technical equivalence on how to 
include all required information in an IUCLID 5 dataset. 

The following documents describe in further detail how to create and 
complete a IUCLID dossier:
•  BPR dossier creation/IUCLID Quick Guide available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID 

available in ECHA’s YouTube channel;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications 

available on ECHA’s website;

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications, 

available on ECHA’s website.

Submission and processing of an application using R4BP 3:
The application for TE should be submitted through R4BP 3. Following 
confirmation that the submission has passed the initial checks by ECHA, 
the application will be evaluated by ECHA (90 days unless additional 
information requested). ECHA takes a decision on the TE.

Applicants need to monitor the status of their submission and receive/
react to requests from ECHA in R4BP 3. If the applicant fails to meet a 
deadline, e.g. for payment of fees, or, at a later stage, request for any 
additional information, the application may be rejected or the evaluation 
may be completed disregarding the information that has been provided 
after the deadline. Only one update of the dossier is permitted in relation 
to a particular request. Updates of the dossier on the initiative of the 
applicant are not possible. 

2  https://circabc.europa.eu/w/browse/c8291b94-5b48-440b-ba6d-f03fa3777109

Practical guide on Biocidal Products Regulation Technical equivalenceApplicants will find the relevant information and instructions for 
submitting and following up the application for TE through R4BP 3 in the 
following submission manuals available on ECHA’s website: 
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications.
•  Biocides Submission Manual 3b: Active substances Part B, Technical 

equivalence and Chemical similarity.

ECHA’s website provides further details on the processing of the 
applications.

RESULTS

OUTCOME OF THE OBLIGATION/PROCESS

On the basis of the assessment made by ECHA, applicants will receive a 
decision through R4BP 3 that: 
1)  For Tier I: either the TE cannot be concluded upon and the applicant 
should proceed to Tier II OR that the alternative and reference sources 
are equivalent. 
2)  For Tier II: the alternative and reference sources are/are not 
equivalent.

The decision must be attached to the application for product 
authorisation or where relevant to the application for an administrative 
change to an existing authorisation to be submitted under Implementing 
Regulation (EU) No 354/2013.

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

Chemical similarity check
If the active substance is not yet approved, companies can request ECHA 
to check the chemical similarity of the relevant sources of the active 
substances. Two types of applications can be submitted: individual 
applications and joint applications. The chemical similarity check does 
not replace the TE assessment obligation when the active substance is 
eventually approved.

The principles that apply for the chemical similarity check service are 
similar to those applied for TE. 

More information about the chemical similarity check service and the 
different application types can be found on ECHA’s website and in the 
Biocides Submission Manual 3b: Active substances Part B, Technical 
equivalence and Chemical similarity.

Relation with Article 95
It should be noted that the assessment of TE is not required for Article 95 
purposes. The listing in the active substances and suppliers list (Article 95 
list) does not automatically imply the TE to an active substance. For more 
information on inclusion on the Article 95 list see Practical Guide chapter 
Article 95: List of active substances and suppliers.

Practical guide on Biocidal Products Regulation  Technical equivalenceNevertheless, a company may benefit from requesting a TE assessment 
from ECHA before applying to be listed in the Article 95 list. This is 
relevant where the company intends to acquire rights to data used to 
establish the reference source during the active substance approval 
for the purposes of inclusion on the Article 95 list. It will provide some 
assurances to the company that the data they are about to acquire rights 
to are relevant for their active substance.

Where the active substance is not yet approved, applying for the chemical 
similarity check by an alternative supplier before applying for inclusion 
on the Article 95 list may provide similar benefits. The fact that, in this 
case, the reference source is temporary and the active substance may not 
eventually be approved brings its own risks.

COST

RELATED FEES

Fees related to this process are described in the first entry of Annex III to 
Commission Implementing Regulation (EU) No 564/2013.

HELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Technical equivalence
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

technical-equivalence

Chemical similarity check service
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

chemical-similarity-check-service

Practical guide on Biocidal Products Regulation Technical equivalenceGuidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Assessment of technical equivalence
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

assessment-of-technical-equivalence

Chemical similarity check service
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

chemical-similarity-check-service

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 3b: Active substances Part B, 
Technical equivalence and Chemical similarity
 » http://echa.europa.eu/documents/10162/14938692/bsm_03b_

active_subst_techn_equiv_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3 
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide

 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation  Technical equivalencePRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

National authorisation

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 
(BPR)) is that a biocidal product (BP) must be authorised before it can 
be made available on the market or used in the European Union (EU)/
European Economic Area (EEA).1 This takes place in two consecutive 
steps. As the first step, the active substance is evaluated and, provided 
the criteria are fulfilled, is then approved in a specified product-type (PT). 
The second step is the authorisation of each BP consisting of, containing 
or generating the approved active substance(s). This document concerns 
the second step, the authorisation of a BP2.  

The national authorisation (NA) of a BP is granted by the competent 
authority of the Member State (MSCA) where the BP will be made 
available on the market (receiving MS) and is only valid for the approved 
terms and conditions stated therein. To avoid duplication of the evaluation 
procedure, the product authorisation granted in one MS can be recognised 
in other MS through the mutual recognition procedure3. For more details 
on mutual recognition see Practical Guide chapter on Mutual recognition.

The same rules as for a single BP apply also for a biocidal product family 
(BPF)4.

Certain BPs may be authorised at Union level, without the need to obtain 
single NAs. For more information see the Practical Guide chapter on Union 
authorisation.

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

An application for NA can be made by, or on behalf of, the prospective 
authorisation holder (AH). Accordingly, the prospective AH may have a 
person/entity handling the practical issues related to the application on 
its behalf (e.g. a consultant).

1  Ref: Article 17(1) of the BPR.
2  Ref: Chapter IV of the BPR.
3  Ref: Articles 33 and 34 of the BPR.
4 
‘Biocidal product family’ means a group of BPs with similar uses, the same active 
substances, similar composition with specified variations and similar levels of risk and 
efficacy (ref. Article 3(s) of the BPR).
 Ref: Article 3(1)(p) of the BPR.

The AH is the person/entity established within the EU/EEA who is 
responsible for the placing on the market of a BP in a particular MS5.

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

The application for NA can, in general, be made at any time after the 
decision to approve the active substance has been adopted.

Specific transitional rules apply to the timing of the application for NA 
with regards to existing BPs6:

•  The BP authorisation application must be made by the date of approval 
of the active substance; otherwise the products must be removed from 
the market within 180 days of the active substance approval date.7 The 
use of existing stocks of that BP may continue until 365 days after the 
approval date. A product authorisation application can also be made at 
a later date but until it is granted the products must be removed from 
the market.

•  Where that BP contains more than one active substance for the same 
PT, the application for NA must be submitted no later than the date 
of approval of the last active substance for that PT. If the BP belongs 
to several PTs it is only necessary to apply for NA when the active 
substance(s) contained in it has/have been approved for all relevant 
PTs before the deadline of the last approved.
See the Union list of approved active substances8, available on the 
European Chemicals Agency’s (ECHA) website.
In practice, there is around a two-year time period to submit an 
application for NA for an existing BP from the date on which the 
decision was taken to approve the product’s active substances. 
The approval date is included in the Annex to the approval decision 
(Commission Regulation).

• 

•  For an existing BP already on the market in more than one MS in 

accordance with national laws, to enable closer cooperation between 
MSs in the evaluation of this BP, it is necessary to apply for mutual 
recognition in parallel at the same time in all the MSs where the 
product is intended to be authorised. One of those MSs should act as 
reference MS. 

It is recommended that NA applications are made well ahead of the 
deadline to accommodate for possible rejection due to submission or 
payment failures before the applications are accepted for processing.

“Existing BPs” refers in the context of this Practical Guide, to those products which have 

5  Ref: Article 3(1)(p) of the BPR.
6 
already been placed on the market of the relevant MS (as opposed to the EU market as a 
whole) at the date of approval of the active substance. This concerns BPs containing only 
active substances included in the Review Programme (Article 89(2) of the BPR).
7  Ref: Article 89(3) of the BPR.
8  http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances

Practical guide on Biocidal Products Regulation  National authorisationPhasing-out periods also apply when the application for NA is rejected 
or the receiving MSCA decides not to grant the authorisation9. Existing 
products must be removed from the market within 180 days of the date 
of such rejection or decision. The use of existing stocks of that BP may 
continue until 365 days after the date of the rejection or decision.

The application for NA of a new BP10 can be submitted at any time after 
the decision on the approval of the (last) active substance contained 
therein is adopted. Such a new BP can be placed on the market of the 
relevant MS for the first time only when the NA has been granted.

If a BP contains only existing active substances which have not been 
approved yet, an application for authorisation can be submitted according 
to the national rules of the MS in which authorisation is sought.

Products not covered by Directive 98/8/EC (BPD), but as BPs now falling 
within the scope of the BPR
The BPR includes transitional measures to facilitate the transition from 
the BPD system to the new provisions of the BPR. There are products 
which, since 1 September 2013, fall within the scope of the BPR11.

If such BPs were available on the market before 1 September 2013, 
then the legal provisions cited above contain timelines and deadlines (1 
September 2016) for the submission of the applications for the relevant AS 
in those products. Where such an application is not made by the deadline, 
the product must be removed from the market by 1 September 2017.

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Article 20(1)(a) and (2) of the BPR lists the requirements for an 
application for NA of a BP. Biocides Submission Manual 4a: Biocidal 
products Part A, Initial submissions, chapter 3 available on ECHA’s 
website explains what types of information files should be prepared and 
included in an application for NA.

ECHA provides more advice on information requirements as given by 
Annexes II and III to the BPR and assessment of the information in the 
Guidance on information requirements for Biocides, available on ECHA’s 
website.

Issues to consider:
The applicant has to consider a number of important elements before 
preparing an application for NA:
• 

If the applicant is not the data owner of the dossier(s) of the approved 
active substance(s) contained in the BP, then the applicant needs to 

9  Ref: Article 89(4) of the BPR.
10  “New BPs” refers in the context of this Practical Guide, to those products which have not 
already been placed on the market of any MS at the date of the approval of the (last) active 
substance contained therein.
11  Ref: Article 93 of the BPR or the Regulation (EU) No 613/2013.

Practical guide on Biocidal Products Regulation National authorisationprovide information to demonstrate access to the relevant data of 
each of the active substance to fulfil the requirements set out in Annex 
II to the BPR. This may be achieved by:

 • providing evidence of access to the information submitted 
for the purposes of the BPD or the BPR through a Letter of 
Access (LoA)12; or

 • declaring that the relevant data protection period for the 

information on the active substance has expired. The right to 
refer to that data by the subsequent applicant is subject to an 
agreement of the receiving competent authority (CA) in so far 
as the applicant can provide evidence that the active substance 
is technically equivalent to the reference source13; or 
 • waiving of information requirements14 by providing 

justifications why specific data of a complete dossier are not 
relevant to the uses which are claimed to be supported; or

 • providing alternative and equivalent studies, including 

published studies, instead of those protected15. Note that 
some data is mandatory to share. For more information see 
Practical Guide chapter on data sharing.

• 

• 

If the active substance(s) contained in the BP has/have a different 
source (e.g. a different manufacturer or the same manufacturer, but 
manufactured by a different process) than the reference source(s) 
used for approval of the active substance(s), the applicant needs to 
provide a proof of technical equivalence with the application for NA. 
See the Practical Guide chapter on technical equivalence. 
If the applicant is the owner of the data on the active substance 
contained in the dossier used to support the approval of the active 
substance, but the data was not originally submitted in IUCLID format, 
the applicant may submit a complete IUCLID file or submit a reference 
to its own active substance(s) dossier(s).   

•  The applicant can also refer to data related to BPs where the data 

protection period relevant to them has expired. The use of the data by 
the subsequent applicant is subject to an agreement of the receiving 
CA. In such a case, the subsequent applicant has to provide evidence 
that the BP is the same as the one already authorised or an explanation 
that the differences between them are not significant in relation to the 
risk assessment and the active substance(s) contained in the BP are 
technically equivalent to those in the BP already authorised.16

•  An NA for a BP may cover various PTs. The applicant should make sure 
that the PT(s) is/are relevant to the use purpose and pattern of the BP. 
If there are any doubts as to whether a product is falling within the 
scope of the BPR or not, or to which PT(s) it belongs, the applicants are 
invited to contact the future receiving CA.17

• 

•  Special attention should be given to the use instructions (e.g. use 
patterns, application rates, categories of users, risk mitigation 

12  Ref. Article 20(a)(a)(iii) and Article 59(1)(a) of the BPR.
13  Ref. Article 64(1), first subparagraph, and Article 59(1)(b) of the BPR.
14  Ref: Article 21(1) and (2) of the BPR.
15  Ref: Article 20(1)(a)(iii) of the BPR.
16  Ref: Article 64(1), subparagraph 2, of the BPR.
17  Ref: Article 3(3) of the BPR.

Practical guide on Biocidal Products Regulation  National authorisationmeasures if applicable) and label claims as they are also used for the 
purpose of the risk and efficacy assessment.

•  For any uses not evaluated earlier during the active substance 

approval, a risk assessment has to be conducted and included in the 
product authorisation application. 

•  The efficacy data requirements are more elaborate at the product 

authorisation stage than for the active substance approval. 

•  Careful consideration needs to be given to the design of the summary 
of the product characteristics (SPC) as it is also critical for the BP 
label information.18  

HOW

 PROCEDURE TO FOLLOW 

Creation of a IUCLID 5 dossier:
The applicant seeking to obtain NA needs to submit the data using a 
IUCLID 5 format. 

The following documents describe how to create and complete a IUCLID 
dossier:
•  BPR dossier creation/IUCLID Quick Guide available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID 

available on the IUCLID website;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications 

available on ECHA’s website;

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications 

available on ECHA’s website.

Submission and processing of an application:
The application for NA should be submitted through R4BP 3. Following 
confirmation that the submission has passed the initial checks by 
ECHA, the application will be forwarded to the relevant receiving CA 
for validation and evaluation. During the evaluation (365 days unless 
additional information is requested) of a BP containing active substances 
that are considered as candidates for substitution, a comparative 
assessment will be performed. This will assess whether less harmful 
alternative products are available for the same use. The receiving CA 
takes a decision on the authorisation19.

Applicants need to monitor the status of their submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails 
to meet a deadline, e.g. for payment of fees, or, at a later stage, request 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline. 

To facilitate the evaluation of the application, it would be preferable that 
the applicant submits the application for NA to the CA in that MS, which 

18  CA-May14-Doc.5.6 – Final
19  Ref: Articles 29-30 of the BPR.

Practical guide on Biocidal Products Regulation National authorisationevaluated the dossier of the active substance contained in the product, if the 
BP is already placed or is intended to be placed on the market of that MS.

Applicants are however free to choose the CA where they want to 
apply for the initial NA; subsequently, they can apply either for mutual 
recognition in sequence or in parallel of this BP in other MSs.

Applicants will find the relevant information and instructions for 
submitting and following up the application for NA through R4BP 3 in the 
following submission manuals available on ECHA’s website: 
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications
•  Biocides Submission Manual 4a: Biocidal products Part A, Initial 

submissions, Chapter 3. 

ECHA’s website provides further details on the processing of the 
applications.

RESULTS

OUTCOME OF THE OBLIGATION/PROCESS

After finalising the assessment, the MSCA will update all necessary 
information related to the BP (assessment report and SPC) in R4BP 3 and 
either grant, or not grant, an NA. To grant the authorisation, the conditions 
summarised in Article 19 of the BPR have to be met. NA for a BP can be 
granted for a maximum period of 10 years, which is renewable.

For BPs containing an active substance that is a candidate for 
substitution, NA may be granted for a period not exceeding five years. The 
authorisation cannot be granted for longer than the approval period of the 
active substance(s) contained therein.

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

Authorisation of same biocidal products20
Where applications for NA for two or more BPs with the same properties 
are submitted by the applicant to the same receiving MSCA, the NAs may 
be granted based on one single product evaluation. 

It is also possible to submit an application for NA of the same BP on 
the basis of a BP which is already authorised to the MSCA where the 
authorisation for the first BP was granted. 

The terms and conditions for authorisation will be based on the evaluation 
made on the reference BP. 

20  Ref: Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying 
a procedure for the authorisation of same biocidal products in accordance with Regulation 
(EU) No 528/2012 of the European Parliament and of the Council.

Practical guide on Biocidal Products Regulation  National authorisationIn both cases, the proposed differences between the same product and 
the reference product may concern only information which can be the 
subject of an administrative change21.

Authorisation of the same product will have a different authorisation 
number and may be changed or cancelled independently of authorisation 
related to the reference product.

More information and instructions for submitting the application for a 
same BP through R4BP 3 are given in the Biocides Submission Manual 4a: 
Biocidal products Part A, Initial submissions, chapter 7.

National authorisation granted for a BPF
If an NA is granted for a BPF, a notification through R4BP 3 is required 
for each BP within this family before placing it on that MS market, except 
where a particular BP is explicitly identified in the authorisation or the 
variation in composition concerns only pigments, perfumes and dyes.22 

More information and instructions for submitting the notification through 
R4BP 3 are given in the Biocides Submission Manual 7, Notifications and 
permits, chapter 5. 

National authorisation of BPs containing only active substance(s) from 
Annex I of the BPR
Normally when an active substance is on Annex I to the BPR, the simplified 
authorisation is appropriate. However, if that is not available because the 
BP does not fulfil Article 25(b), (c) or (e) of the BPR it remains a possibility 
to apply for NA.23

Permit for parallel trade
BPs can be also made available on the market using a parallel trade 
permit24. A parallel trade permit is relevant when a company is interested 
in purchasing an authorised BP in a specific MS (MS of origin) and making 
it available on the market in another MS (MS of introduction-MSI), where 
an identical product has already been authorised. The applicant does not 
need to be the BP authorisation holder.

The applicant for a parallel trade permit does not need to submit data to 
show that the BP it wishes to make available on the market in the MSI is 
safe and efficacious, only that it is identical to the BP already authorised 
in the MS of introduction (the reference BP)25. Additional information 
such as example labels are also required as part of the application26. If the 
application is successful, the MSI shall grant the permit within 60 days 

21  Ref: Commission Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal 
products authorised in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council.
22  Ref: Article 17(6) of the BPR.
23  Ref: Article 19(1) of the BPR.
24  Ref: Article 53 of the BPR.
25  Ref: Article 53(3) of the BPR.
26  Ref: Article 53(4) of the BPR.

Practical guide on Biocidal Products Regulation National authorisationof receipt of the applicable fees from the applicant (this may take longer 
where additional information is required from the MS of origin). 

A parallel trade permit should be granted under the same terms and 
conditions as the authorisation for the reference BP. Furthermore, 
its expiry date is the same as the expiry date of authorisation of the 
reference BP. 

A parallel trade permit may be cancelled independently of the 
authorisation related to the reference BP. At the same time, cancellation 
of authorisation of the reference BP on request of the AH does not 
affect the parallel trade permit, if the requirements of Article 19 are still 
fulfilled. However, the MSCA in the MSI may withdraw the parallel trade 
permit if the authorisation of the introduced product is withdrawn in the 
MS of origin due to safety or efficacy reasons.

More information and instructions for submitting the application for 
parallel trade permit through R4BP 3 are given in the Biocides Submission 
Manual 7 Notifications and permits, chapter 6.

Derogations from the requirements
Under certain conditions, derogations from authorisation requirements 
are possible, namely:
•  Provisional authorisation

For a BP containing a new active substance not yet approved, a 
provisional authorisation can be granted by the MSCA for a period 
not exceeding three years, renewable for one year27. 
Such a provisional authorisation may be granted only after the 
MSCA, which evaluated the new active substance has submitted 
a recommendation for approval of this substance and the MSCAs 
which received the application for the provisional authorisation 
consider that the BP complies with the provisions laid down in 
Article 19(1) points (b), (c) and (d) taking into account the factors 
set out in Article 19(2) of the BPR.
More information and instructions for submitting the application 
for provisional national authorisation through R4BP 3 are given 
in the Biocides Submission Manual 4a: Biocidal products Part A, 
Initial submissions, Chapter 3.

•  Permission for a limited and controlled use

An MSCA can permit the making available on the market or use 
of a BP, which is not authorised if there is an unforeseen danger 
to public or animal health or the environment which cannot be 
contained by other means28. Such BPs can be placed on the market 
for a limited and controlled use only and under the supervision 
of that MSCA for a period not exceeding 180 days. Only with a 
justified request of the MSCA, can the European Commission (COM) 
extend that period by no more than 550 days.

27  Ref: Article 55(2) of the BPR.
28  Ref: Article 55(1) of the BPR.

Practical guide on Biocidal Products Regulation  National authorisation•  Authorisation given to protect the cultural heritage

A BP, which contains a non-approved active substance can be 
authorised by the MSCA if this active substance is essential for 
the protection of cultural heritage and there are no appropriate 
alternatives on the market. An application29 containing due 
justification shall be submitted by the MSCA to the COM and the 
authorisation can be given only with the consent of the COM.

Applications for NA submitted under the BPD
Where an application for NA was submitted under the BPD and the 
evaluation was not completed by 1 September 2013, the relevant CA 
continues the evaluation in accordance with that directive. However, if 
the risk assessment on the active substance indicates that one or more 
of the exclusion criteria is met30, the BP shall be authorised in accordance 
with Articles 19 and 23 of the BPR. If the risk assessment of the active 
substance shows that one or more of the substitution criteria31 is met 
but not any of the exclusion criteria, the conditions for authorisations are 
those laid down in Article 5 of the BPD and Article 23 of the BPR (and the 
principles of Annex VI to the BPD should be taken into account to evaluate 
the product). If neither the exclusion or substitution criteria are met, the 
conditions for authorisations are those laid down in Article 5 of the BPD 
(and the principles of Annex VI to the BPD should be taken into account 
to evaluate the product). Nevertheless, the legal basis for the product 
authorisation will be Article 19 and 91 of the BPR. Where the evaluation 
identifies concerns arising from the application of provisions of the 
BPR which were not included in the BPD, the applicant shall be given the 
opportunity to provide additional information.

COST

RELATED FEES

The national fees related to the application for NA may vary between 
the MSCAs and are established in national legal acts of each MS. The 
applicant is responsible for checking and paying the specified amount of 
fees to the MSCA.

For more information about the MSCAs’ fees, the applicant should contact 
the designated national MSCA or its helpdesk.

There is no fee charged by ECHA for an NA, but if together with an 
application for NA also applications for MRP are submitted to one or 
more concerned MS, the Mutual Recognition Submission Fee for them 
should be paid to ECHA in accordance with the third entry of Annex III to 
Commission Implementing Regulation (EU) No 564/2013. 

29  Ref: Article 55(3) of the BPR.
30  Ref: Article 5(1) of the BPR.
31  Ref: Article 10 of the BPR.

Practical guide on Biocidal Products Regulation National authorisationHELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCAs contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Authorisation of biocidal products 
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

authorisation-of-biocidal-products

Relevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

CA-Feb13-Doc.5.1.b.a – Final: Summary of the biocidal product 
characteristics for a biocidal product and biocidal product family;

CA-Sept13-Doc.5.1.g – Final.Rev.1: Application of BPR procedures 
to applications for product authorisation submitted under the BPD 
regime and on which a decision has not been taken by 1 September 
2013;

CA-Sept13-Doc.6.2.a – Final.Rev.1: Authorisation of skin sensitiser 
biocidal products requiring PPE for non-professional users;

CA-Sept13-Doc.6.2.b Rev.1: Authorisation under the Biocidal 
Products Regulation of products containing more than one existing 
active substance or belonging to more than one product-type;

CA-March14-Doc.5.1: Transition between national schemes and 
BPR-authorisations following active substance approvals;

CA-March14-Doc.5.4- Final: Comparative assessment of biocidal 
products;

CA-May14-Doc.5.6 – Final: Discussion paper on the content of label 

Practical guide on Biocidal Products Regulation  National authorisationof biocidal products with regard to the authorised uses in the SPC;

CA-Sept14-Doc.5.7: Harmonised approach to the consideration 
of the expiry dates of new product authorisations linked to other 
authorisations through certain authorisation procedures;

CA-Sept14-Doc.5.9: Provisional authorisations granted or to be 
granted in accordance with Article 55(2) of the BPR and conversion 
to definitive authorisations;

CA-xxxxxx-Doc.x.x: Implementing the new concept of biocidal 
product families (likely to be published on Circa in November 2014).

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

National authorisation of biocidal products
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

national-authorisation-biocidal-products

National authorisation of a same biocidal product  (authorised and 
pending)
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

national-authorisation-same-biocidal-product

Parallel trade
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

parallel-trade

Notification for a product in a product family for national 
authorisation
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/
notification-product-in-product-family-national-authorisation

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Practical guide on Biocidal Products Regulation National authorisationBiocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions 
 » http://echa.europa.eu/documents/10162/14938692/bsm_04a_

bproducts_initial_submissions_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation  National authorisationPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Mutual recognition

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The authorisation of a biocidal product (BP) can be recognised in other 
Member States (MSs) in accordance with the mutual recognition 
(MR) procedures to avoid duplication of the evaluation. There are two 
procedures: mutual recognition in sequence (MRS) which is relevant where 
there is an existing authorisation1, and mutual recognition in parallel (MRP) 
which is relevant where the initial application for national authorisation 
(NA) and the applications for MR are submitted at the same time2.

Authorisation according to MRS/MRP should be granted under the same 
terms and conditions as the (initial) NA; however, in certain cases3, the 
MSs concerned may propose to refuse to grant the authorisation or to 
adjust its terms and conditions.

The same rules as for a single BP also apply for a biocidal product family 
(BPF)4.

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

For MRS, the application can be made by, or on behalf of, the authorisation 
holder (AH) in the reference MS. Accordingly, the applicants may have a 
person/entity handling the practical issues related to the application on 
their behalf (e.g. a consultant). The AH is the person established within the 
European Union (EU)/European Economic Area (EEA) who is responsible 
for the placing on the market of the BP in the reference/concerned MSs.5

If the prospective AH in the concerned MS is a separate person/entity 
than the AH of the reference NA, they can also make the application, 
provided they obtain the necessary rights to the required data. 

For MRP, the application for the initial NA must be made by, or on behalf 
of, the prospective AH. If the prospective AH in the concerned MSs is a 
separate person/entity than the AH of the initial NA, they can also make 

1  Ref: Article 33 of the BPR.
2  Ref: Article 34 of the BPR.
3  Ref: 35(2) and 37(1) of the BPR.
4 
‘Biocidal product family’ means a group of BPs having similar uses, the same active 
substances, similar composition with specified variations, and similar levels of risk and 
efficacy (ref. Article 3(s) of the BPR).
 Ref: Article 3(1)(p) of the BPR.
5  Ref: Article 3(1)(p) of the BPR

the application, if they obtain the necessary rights to the required data on 
the active substance and BP.

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

An application for MR, just like in the case of NA, can be made only after 
the decision to approve the active substance is adopted.

An application for MRP is made after the decision to approve the active 
substance is adopted and at the same time as the initial NA application. 
An application for MRS can be made at any point after the NA is granted in 
the reference MS, on the condition that it is still valid.

Specific transitional rules apply to the timing of the application for MRP 
in regards to existing BPs6:
•  The application(s) for MRP in the MSs concerned together with an 

application in the reference MS for an initial NA must be made by the 
date of approval of the active substance; otherwise the products must 
be removed from the market within 180 days of the active substance 
approval date7. The use of existing stocks of that BP may continue until 
365 days after the approval date. A product authorisation application 
can also be made at a later date but, until it is granted, the products 
must be removed from the market.

•  Where that BP contains more than one active substance for the same 
product-type (PT), the applications must be submitted no later than 
the date of approval of the last active substance for that PT. If the BP 
belongs to several PTs, it is only necessary to apply when the active 
substance(s) contained in it has/have been approved for all relevant 
PTs before the deadline of the last approved.
The Union list of approved active substances8 is available on the 
European Chemicals Agency’s (ECHA) website.
In practice, there is around a two-year time period to submit an 
application for MRP from the date on which the decision was taken 
to include all of the product’s active substances. The approval date is 
included in the Annex to the approval decision (Commission Regulation).

• 

The application for MRP of a new BP9 can be submitted at any time after 
the decision on the approval of the (last) active substance is adopted. 
Such a new BP can be placed on the market of the relevant MS for the first 
time only when the NA from that MS has been granted.

6 
“Existing biocidal products” refers in the context of this Practical Guide, to those 
products which have already been placed on the market of the relevant MS (as opposed to 
the EU market as a whole) at the date of approval of the active substance. This concerns BPs 
containing only active substances included in the Review Programme (Article 89(2) of the 
BPR).
7  Ref: Article 89(3) of the BPR.
8  http://echa.europa.eu/information-on-chemicals/biocidal-active-substances
“New biocidal products” refers in the context of this Practical Guide, to those products 
9 
which have not already been placed on the market of any MS at the date of the approval of 
the (last) active substance.

Practical guide on Biocidal Products Regulation  Mutual recognitionIt is recommended that MRP applications are made well ahead of the 
deadline to accommodate for possible rejection due to submission or 
payment failures before the applications are accepted for processing.

Phasing-out periods apply when the application for MRP is rejected or the 
reference MS decides not to grant the authorisation10. Existing products 
must be removed from the market within 180 days of the date of the 
rejection or decision. The use of existing stocks of that BP may continue 
until 365 days after the date of rejection or decision.

For MRS, the BP can only be placed on the market in the concerned MS 
once the authorisation is granted by this MS.

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions, Chapter 5 available on ECHA’s website outlines the different 
types of information files that should be prepared and included in an 
application for MRP or MRS.

HOW

 PROCEDURE TO FOLLOW 

For an application for MRS and for MRP in the MSs concerned, a IUCLID 
5 dossier is not required. Nevertheless, a IUCLID 5 dossier must be 
submitted with the initial NA application to the reference MS as explained 
in the Practical Guide chapter on national authorisation.

Submission and processing of an application:
The application for MRP/MRS should be submitted through R4BP 3. 
Following confirmation that the submission has passed the initial checks 
by ECHA, the application will be forwarded to the relevant MSCA for 
validation and evaluation: 
• 
• 

for MRS, to the MSs concerned;  
for MRP, to the reference MSCA (the initial application) and at the 
same time to all MSs concerned (MRP). 

The respective MSCA takes a decision on the authorisation. NA will be 
granted in the concerned MSs within 30 days of agreement being reached 
on the summary of the product characteristics (SPC). In the case of 
MRP, this takes place only after the reference MSCA has evaluated the 
application (365 days). In some cases, granting the authorisation through 
an MRS/MRP procedure requires a decision by the European Commission 
(COM) or an agreement by the Coordination Group (CG) (see below).

10  Ref: Article 89(4) of the BPR.

Practical guide on Biocidal Products Regulation Mutual recognitionApplicants need to monitor the status of their submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails 
to meet a deadline, e.g. for payment of fees, or, at a later stage, request 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline.

Applicants will find the relevant information and instructions for 
submitting and following up of the application for NA through R4BP 3 in 
the following submission manuals available on ECHA’s website: 
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications
•  Biocides Submission Manual 4a: Biocidal products Part A, Initial 

submissions, Chapter 5. 

ECHA’s website provides further details on the processing of the 
applications.

More information related to invoicing and R4PB 3 can be found in the 
Biocides Submission Manual 5: Invoicing in R4BP 3 available on ECHA’s 
website.

the protection of the environment; 

Derogations 
By way of derogation from authorising a BP under the same terms and 
conditions through an MRS/MRP procedure, any of the concerned MSs 
may propose to refuse to grant a NA through MRS/MRP or to adjust its 
terms and conditions based on the following grounds11:
• 
•  public policy or public security; 
• 

the protection of health and life of humans, particularly of vulnerable 
groups, or of animals or plants; 
the protection of national treasures possessing artistic, historic or 
archaeological value;  
the target organisms not being present in harmful quantities; or

• 
•  an active substance is a candidate for substitution.

• 

In each case, a detailed justification is required to be communicated from 
the MS concerned to the applicant. The MS concerned seeks to reach 
agreement with the applicant on the proposed derogation.

If an agreement between the two is not reached, the MS concerned 
informs COM who takes a final decision on the derogation. COM may 
ask ECHA for an opinion on scientific and technical issues (through the 
Biocidal Products Committee (BPC)) in order to conclude on its decision.12 

Besides the reasons for derogations listed above, authorisations of BPs 
of PTs 15, 17 and 20 may be refused from MRP/MRS by an MSCA on the 
grounds of animal welfare13. Such a refusal must be justified and the other 
MSs and COM informed.

11  Ref: Article 37(1) of the BPR.
12  Ref: Article 37(2) and (3) of the BPR.
13  Ref: Article 37(4) of the BPR.

Practical guide on Biocidal Products Regulation  Mutual recognitionThis procedure can also apply when additional/different restrictions are 
proposed by the MS concerned which, in the case of the BP containing 
an active substance that is a candidate for substitution, has made a 
supplementary comparative assessment to the comparative assessment 
carried out by the reference MS. 

Settlement of disagreements 
When any of the MSs concerned disagree with the conclusions of the 
product assessment report or with the SPC, it must send a detailed 
explanation of the reasons for such a position to the reference MS, all 
other MSs concerned and the applicant. The points of disagreement must 
be referred to the CG14 without delay by the reference MS where the 
MSs use their best endeavours to reach an agreement. The applicant is 
allowed to present its point of view. When an agreement is not reached by 
the CG within 60 days, the reference MS informs COM which takes a final 
decision by means of an implementing act. COM may either ask ECHA for 
an opinion on scientific and technical issues (through the BPC) or give an 
opportunity to the applicant to comment (30 days) in order to conclude on 
its decision. 

RESULT

OUTCOME OF THE OBLIGATION/PROCESS 

After finalising the evaluation and reaching an agreement between 
the reference MS and MS(s) concerned, each of the MSCAs update the 
information in R4BP 3 relating to this BP and grant an NA of the BP.

Authorisation according to MRP should be granted for the same 
number of years in all MSs (e.g. up to 10 years). For MRS, the validity 
of the product authorisation should also be the same as for the initial 
authorisation granted by the reference MS, unless the active substance is 
a candidate for substitution (i.e. maximum of four or five years).

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

Application for MR made by official or scientific bodies 
If there is a general interest in the use of a BP, which is not on that MS’s 
market, official or scientific bodies involved in pest control activities or 
the protection of public health may apply for MRS of the same BP with the 
same use and the same conditions of use as in the MS already authorised 
provided that15: 
•  no application for authorisation has been submitted to that MSCA for 

such a BP already authorised in the other MS, and
the AH of this BP has agreed to such an application. 

• 

When the authorisation is given by that MSCA, the body that made the 
application has the same rights and obligations as other AHs.

14  Ref: Article 35(1) of the BPR.
15  Ref: Article 39 of the BPR.

Practical guide on Biocidal Products Regulation Mutual recognitionCOST

RELATED FEES

The national fees related to an application for MRS/MRP may vary 
between MSs and are established in national legal acts of each MS. The 
applicant is responsible for checking and paying the specified amount of 
fees to the MSCA.

For more information about the MSs fees, the applicant should contact 
the designated national competent authorities or helpdesk.

An MR Submission Fee will be charged by ECHA in relation to applications 
for NA of a BP through MRS/MRP in accordance with the third entry of 
Annex III to Commission Implementing Regulation ((EU) No 564/2013).

HELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCAs contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

authorisation-of-biocidal-products 

Relevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

CA-Feb13-Doc.5.1.b.a - Final: Summary of the biocidal product 
characteristics for a biocidal product and biocidal product family;

CA-Sept13-Doc.5.1.g – Final.Rev.1: Application of BPR procedures 
to applications for product authorisation submitted under the BPD 
regime and on which a decision has not been taken by 1 September 
2013;

Practical guide on Biocidal Products Regulation  Mutual recognitionCA-Sept13-Doc.6.2.a - Final.Rev.1: Authorisation of skin sensitiser 
biocidal products requiring PPE for non-professional users;

CA-Sept13-Doc.6.2.b Rev.1: Authorisation under the Biocidal 
Products Regulation of products containing more than one existing 
active substance or belonging to more than one product-type;

CA-Sept13-Doc.6.2.d – Final: Submission in EN of the proposed 
SPC in applications for mutual recognition in parallel and other 
regulatory procedures;

CA-March14-Doc.5.1: Transition between national schemes and 
BPR-authorisations following active substance approvals;

CA-March14-Doc.5.4 - Final: Comparative assessment of biocidal 
products

CA-Sept14-Doc.5.7: Harmonised approach to the consideration 
of the expiry dates of new product authorisations linked to other 
authorisations through certain authorisation procedures;

CA-xxxxxx-Doc.x.x: Implementing the new concept of biocidal 
product families (likely to be published on Circa in November 2014).

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Mutual recognition in sequence

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

mutual-recognition-in-sequence

Mutual recognition in parallel

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

mutual-recognition-in-parallel

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions 
 » http://echa.europa.eu/documents/10162/14938692/bsm_04a_

bproducts_initial_submissions_en.pdf

Practical guide on Biocidal Products Regulation Mutual recognitionBiocides Submission Manual 5: Invoicing in R4BP 3
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation  Mutual recognitionPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Renewal of national authorisation and 

authorisations subject to mutual recognition

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The Biocidal Products Regulation ((EU) No 528/2012 (BPR)) states that 
an authorisation of a biocidal product (BP) can be granted for a maximum 
period of 10 years1. Article 31 of the BPR sets out the procedure for 
the renewal of a national authorisation granted by the Member State 
competent authority (MSCA). 

Supplementary rules for the renewal of authorisations subject to mutual 
recognition (MR) procedures and having the same terms and conditions 
with limited exceptions2, in all the Member States (MSs) where renewal 
is sought, are laid down in the MR Renewal Regulation (Commission 
Delegated Regulation (EU) No 492/2014).

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

An application for the renewal of national authorisation (NA) can be 
made by, or on behalf of, the authorisation holder(s) (AH) of the original 
authorisation(s). Accordingly, the applicant may have a person/entity 
handling the practical issues related to the application and renewal 
procedure on behalf of the AH.

The AH is the person/entity established within the European Union (EU)/
European Economic Area (EEA), who is responsible for placing the BP on 
the market in a particular MS3.

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

An application for the renewal of NA including those subject to MR shall 
be submitted at least 550 days before the expiry date of the NA. In the 
case of the applications for renewal of NA, subject to or granted through 
MR, the applications need to be made to the reference MS and the MSs 
concerned at the same time.

Phasing-out period for BPs
If an application for renewal has not been submitted, or is rejected, or 

1  Ref: Article 17(4) of the BPR.
2  Ref: Article 1(3) of the MR Renewal Regulation.
3  Ref: Article 3(1)(p) of the BPR.

additional information on the request of the MS has not been submitted 
by the applicant, the BPs shall be taken off the market within 180 days 
after the expiry date of the initial authorisation. An additional maximum 
period of 180 days can be granted for the use of existing stocks4. 

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions, Chapter 4, available on the European Chemical Agency’s 
(ECHA) website, outlines the different types of information files that 
should be prepared and included in an application for renewal.

ECHA provides more advice on information requirements as given by Annexes 
II and III to the BPR and assessment of the information in the Guidance on 
information requirements for Biocides, available on ECHA’s website.

HOW

 PROCEDURE TO FOLLOW 

Creation of a IUCLID 5 dossier:
An application must always include a IUCLID dossier with, at minimum, 
the information on the product composition. Where relevant, the technical 
and scientific data also have to be included in the IUCLID 5 file.

The following documents describe how to create and complete a IUCLID 
dossier:
•  BPR dossier creation/IUCLID Quick Guide; available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID, 

available in ECHA’s YouTube channel;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications, 

available on ECHA’s website;

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications, 

available on ECHA’s website.

Submission and processing of an application:
The application for renewal of NA should be submitted through R4BP 3: 
• 
• 

for renewal of a single NA, to the receiving MS;  
for renewal of NA, subject to or granted through mutual MR, to the 
reference MS and all MS(s) concerned. 

Following confirmation that the submission has passed the initial checks 
by ECHA, the application will be forwarded to the relevant MS(s) for 
validation and evaluation. At a very early stage, the receiving/reference 
MSCA decides whether a full evaluation of the application for renewal is 
necessary or not. Full evaluation takes 365 days. If a full evaluation is not 
necessary, the evaluation has to be completed in 180 days. The receiving/
reference MSCA may request the applicant to submit additional data.

4  Ref: Article 52 of the BPR.

Practical guide on Biocidal Products Regulation  Renewal of national authorisation and authorisations subject to mutual recognitionThe respective competent authority(s) (CA) take(s) a decision on 
the renewal of an authorisation. In the context of renewal, subject 
to or granted through MR, in some cases granting the renewal of an 
authorisation requires a decision by the European Commission (COM) or 
an agreement by the Coordination Group (CG) (see below).

Applicants need to monitor the status of their submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails 
to meet a deadline, e.g. for payment of fees, or, at a later stage, request 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline. 

Applicants will find the relevant information and instructions for 
submitting and following up the application for renewal through R4BP 3 
in the Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions, Chapter 4, available on ECHA’s website. 

ECHA’s website gives details on the assessment procedure in relation to 
this process.

the protection of the environment; 

Derogations 
For renewal, subject to or granted through MR, any of the MSs concerned 
may propose to refuse to renew an authorisation or to adjust its terms 
and conditions based on the following grounds5:
• 
•  public policy or public security; 
• 

the protection of health and life of humans, particularly of vulnerable 
groups, or of animals or plants; 
the protection of national treasures possessing artistic, historic or 
archaeological value; 
the target organisms not being present in harmful quantities; or

• 
•  an active substance is a candidate for substitution.

• 

In each case, a detailed justification is required to be communicated from 
the MS concerned to the applicant. The MS concerned seeks to reach 
agreement with the applicant on the proposed derogation. 

If an agreement between the two is not reached, the MS concerned 
informs COM who takes a final decision on the derogation. COM may ask 
the ECHA for an opinion on scientific and technical issues (through the 
Biocidal Products Committee (BPC)) in order to conclude on its decision6.

This procedure can also apply when additional/different restrictions 
are proposed by the MS concerned, which for BPs containing an 
active substance which is a candidate for substitution, has made a 
supplementary comparative assessment to the comparative assessment 
carried out by the reference MS.

 Ref: Article 37(1) of the BPR.

5 
6  Ref: Article 37(2) and (3) of the BPR.

Practical guide on Biocidal Products Regulation Renewal of national authorisation and authorisations subject to mutual recognitionSettlement of disagreements 
In the case of renewal subject to, or granted through MR, when any of the 
MSs concerned disagrees with the conclusions of the product assessment 
report or with the summary of the product characteristics (SPC) it must 
send a  detailed explanation of the reasons for such a position to the 
reference MS, all other MSs concerned and the applicant. The points of 
disagreement must be referred to the CG7 without delay by the reference 
MS where the MSs use their best endeavours to reach an agreement. The 
applicant is allowed to present its point of view. 

When an agreement is not reached by the CG within 60 days, the 
reference MS informs COM, which takes a final decision by means of an 
implementing act. COM may either ask ECHA for an opinion on scientific 
and technical issues (through the BPC) or give an opportunity to the 
applicant to comment in order to conclude on its decision.

RESULT

OUTCOME OF THE OBLIGATION/PROCESS

TO NOTE

After finalising the evaluation and, in the case of MR, after reaching an 
agreement between reference MS and MS(s) concerned, the authorisation 
shall be renewed for a maximum period of 10 years, unless the active 
substance is a candidate for substitution (i.e. maximum of five years).

For authorisations granted through MR, the maximum validity of the 
renewed authorisations should be the same in all the MSs where the 
product is renewed.

For reasons beyond the control of the AH where no decision is taken on the 
renewal before the expiry date of the initial authorisation, the relevant MSCA 
must grant a renewal for the period necessary to complete the evaluation.

EXCEPTIONS AND PARTICULAR CASES

Renewals of authorisations of anticoagulant rodenticides
For already authorised BPs containing anticoagulant rodenticides8, which 
are candidates for substitution, a comparative assessment has to be done 
before their authorisations will be renewed. Applications for renewal of 
such products have to be submitted within the usual 550-day deadline but 
then the assessment will be put on hold by the MSs until decisions on the 
renewal of the relevant active substance approvals are taken. 

So far, the applicants have been requested to submit only an application 
form for renewal of product authorisation generated from R4BP 3. 
Provided that an application for renewal of BP authorisation has been 
submitted, MSs should grant a renewal of the existing authorisation for a 
period necessary to complete the evaluation. 

7  Ref: Article 35(1) of the BPR.
8  Difenacoum, difethialone,  chlorophacinone, bromadiolone, coumatetralyl, flocoumafen, 
brodifacoum, warfarin and warfarin sodium.

Practical guide on Biocidal Products Regulation  Renewal of national authorisation and authorisations subject to mutual recognitionWhen the approval of the active substance is renewed, the applicants 
will have to submit all data generated since the initial authorisation was 
granted and potentially other information. 

COST

RELATED FEES

The national fees related to the application for renewals of NA may vary 
between MSCAs and are established in national legal acts of each MS. The 
applicant is responsible for checking and paying the specified amount of 
fees to the MSCA.

For more information about the MSs fees, the applicant should contact 
the designated national CA or its helpdesk.

There is no fee charged by ECHA for a renewal of NA or authorisations 
subject to or granted through MR.

HELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCAs contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Renewal of National authorisation and authorisations subject to Mutual 
recognition
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

authorisation-of-biocidal-products

Practical guide on Biocidal Products Regulation Renewal of national authorisation and authorisations subject to mutual recognitionRelevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

CA-Feb13-Doc.5.1.b.a – Final: Summary of the biocidal product 
characteristics for a biocidal product and biocidal product family;

CA-Feb13-Doc.5.2.b – Final: Substance approval and product 
authorisation renewals of the anticoagulant rodenticides

CA-July13-Doc.11.3 – Final: Application of Art. 23(4) of the BPR to 
anticoagulant rodenticides for which the authorisation decision will 
be taken after 1st September 2013

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Renewal of national authorisation
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

renewal-national-authorisation

Renewal of authorisations subject to mutual recognition
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/
renewal-of-authorisations-subject-to-mutual-recognition

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions 
 » http://echa.europa.eu/documents/10162/14938692/bsm_04a_

bproducts_initial_submissions_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

Practical guide on Biocidal Products Regulation  Renewal of national authorisation and authorisations subject to mutual recognitionBPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation Renewal of national authorisation and authorisations subject to mutual recognitionPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Union authorisation

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 
(BPR)) is that a biocidal product (BP) must be authorised before it can 
be made available on the market or used in the European Union (EU)/
European Economic Area (EEA).1 This takes place in two consecutive 
steps. As the first step, the active substance is evaluated and, provided 
the criteria are fulfilled, is then approved in a specified product-type. The 
second step is the authorisation of each BP consisting of, containing or 
generating the approved active substance(s). This document concerns the 
second step, the authorisation of a BP.

The BPR introduces the possibility to have certain BPs authorised at the 
Union level. UA allows companies to place their BPs on the market throughout 
the entire EU/EEA, without the need to obtain single national authorisations. 
The Union authorisation (UA) will give the same rights and obligations in all 
the Members States (MSs) as those provided by national authorisations. 

UA can be granted for products with similar conditions of use across the 
EU. Some BPs are precluded from UA, namely: BPs that contain active 
substances that meet the exclusion criteria (Article 5 of the BPR) and BPs 
of product-types (PTs) 14, 15, 17, 20 and 212. It is possible to apply for UA 
of both BPs and biocidal product families (BPFs)3. The relevant provisions 
regarding UA are set out in Chapter VIII of the BPR.

UA may be viewed as an alternative to applying for national authorisation 
followed by mutual recognition(s) provided that the products belong to 
eligible PTs. See the Practical Guide chapter on national authorisation and 
Practical Guide chapter on mutual recognition. 

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

An application for UA shall be made by or on behalf of the prospective 
authorisation holder (AH). Accordingly, the applicants may have a person/
entity handling the practical issues related to the application on their 
behalf (e.g. a consultant).

1  Ref: Article 17(1) of the BPR.
2  Ref: Article 42(1) of the BPR.
‘Biocidal product family’ means a group of BPs with similar uses, the same active 
3 
substances, similar composition with specified variations and similar levels of risk and 
efficacy (ref. Article 3(s) of the BPR).

The AH is the person/entity established within the EU/EEA, who is 
responsible for the placing on the market of a BP in a particular MS.4

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

For the categories of BPs eligible for UA, a pre-defined schedule has 
been identified which depends on whether the product contains new5 or 
existing6 active substances.

A product of a PT eligible for UA containing new active substances, also 
in combination with existing active substances, may be authorised by UA 
from 1 September 2013.

For BPs containing only existing active substances, UA can be granted in 
three different stages, depending on the PT of the product:
from 1 September 2013 for PTs 1, 3, 4, 5, 18 and 19; 
• 
from 1 January 2017 for PTs 2, 6 and 13; 
• 
from 1 January 2020 onwards for the remaining PTs 7, 8, 9, 10, 11, 12, 
• 
16 and 22.

Specific transitional rules apply to the timing of the application for UA as 
regards existing BPs7: 
•  The UA application must be made by the date of approval of the 

active substance; otherwise, the products must be removed from the 
market within 180 days of the active substance approval date. The use 
of existing stocks of that BP may continue until 365 days after the 
approval date8. A product authorisation application can also be made 
at a later date but until it is granted the products must be removed 
from the market.

•  Where that BP contains more than one active substance for the same 
PT, the application for UA must be submitted no later than the date 
of approval of the last active substance for that PT. If the BP belongs 
to several PTs it is only necessary to apply for UA when the active 
substance(s) contained in it has/have been approved for all relevant 
PTs before the deadline of the last approved.
See the Union list of approved active substances9 available on ECHA’s 
website.

4  Ref: Article 3(1)(p) of the BPR.
5  A “new active substance” is a substance which was not on the market on 14 May 2000, 
as an active substance of a BP for purposes other than scientific or product and process-
orientated research and development (Article 3(1)(e) of the BPR).
6  An “existing active substance” is a substance which was on the market on 14 May 2000 
as an active substance of a BP for purposes other than scientific or product and process-
orientated research and development (Article 3(1)(d) of the BPR).
7 
already been placed on the market of the relevant Member State (as opposed to the EU 
market as a whole) at the date of approval of the active substance. This concerns biocidal 
products containing only active substances included in the Review Programme (Article 89(2) 
of the BPR).
8  Ref: Article 89(3) of the BPR.
9  http://echa.europa.eu/information-on-chemicals/biocidal-active-substances

“Existing BPs” refers in the context of this Practical Guide, to those products which have 

Practical guide on Biocidal Products Regulation  Union authorisation• 

In practice, there is around a two-year time period to submit an 
application for UA for an existing BP from the date on which the 
decision was taken to approve the last of the product’s active 
substances. The approval date is included in the Annex to the approval 
decision (Commission Regulation). 

It is recommended that UA applications are made well ahead of the 
deadline to accommodate for possible rejection due to submission or 
payment failures before the applications are accepted for processing.

Phasing-out periods apply also when the application for UA is rejected or 
the Commission (COM) decides not to grant the authorisation10. Existing 
products must be removed from the market within 180 days of the date 
of such rejection or decision. The use of existing stocks of that BP may 
continue until 365 days after the date of rejection or decision.

The applications for UA of new BPs11 are not subject to any deadlines 
and the application can be made at any point after the decision on the 
approval of the (last) active substance is adopted. Making available on the 
market and use of such a new BP can start after the UA is granted.

Products not covered by the Directive 98/8/EC (BPD), but as BPs now 
falling within the scope of the BPR
The BPR includes transitional measures to facilitate the transition from 
the BPD system to the new provisions of the BPR. There are products 
which fall, only since 1 September 2013, as BPs within the scope of the 
BPR12.

If such BPs were made available on the market before 1 September 2013, 
then the legal provisions cited above contain timelines and deadlines (1 
September 2016) for the submission of the applications for the relevant 
active substance in those products including those for UA apply. Where 
such an application is not made by the deadline, the product must be 
removed from the market by 1 September 2017.

Make pre-submission six months in advance
A prospective applicant for UA should make a pre-submission to ECHA 
as soon as possible and at the latest six months before the intended date 
of submission of a UA application. The pre-submission serves to confirm 
whether:
• 
• 
• 

the product falls within the scope of BPR;
the product has similar conditions of use across the EU; and
that the appropriate PT has been identified.

10  Ref: Article 89(4) of the BPR.
11  “New BPs” refers in the context of this Practical Guide, to those products which have not 
already been placed on the market of any Member State at the date of the approval of the 
(last) active substance therein.
12  Ref: Article 93 or 94 of the BPR or the Regulation (EU) No 613/2013.

Practical guide on Biocidal Products Regulation Union authorisationWHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions, Chapter 8 outlines the different types of information files 
that should be prepared and included for the purposes of pre-submission 
and in an application for UA.

ECHA provides more advice on information requirements as given by 
Annexes II and III to the BPR and assessment of the information in the 
Guidance on information requirements for Biocides, available on ECHA 
website.

Issues to consider: 
The applicant has to consider a number of important elements before 
preparing an application for UA:
•  BPs should have similar conditions of use across the EU13. Applicants 

• 

are invited to contact ECHA to confirm these through a pre-submission 
consultation (see below).
If the applicant is not the data owner of the dossier(s) of the approved 
active substance(s) contained in the BP, then they will need to provide 
information to demonstrate access to the relevant data of each of the 
active substances to fulfil the requirements set out in Annex II to the 
BPR. This may be achieved by:

 • providing evidence of access to the information submitted 
for the purposes of the BPD or the BPR through a Letter of 
Access (LoA)14 ; or

 • declaring that the relevant data protection period for the 

information on the active substance has expired. The right to 
refer to that data by the subsequent applicant is subject to 
an  agreement of ECHA in so far as the applicant can provide 
evidence that the active substance is technically equivalent 
to the reference source15; or  

 • waiving of information requirements16 by providing 

justifications why specific data of a complete dossier are not 
relevant to the uses which are claimed to be supported; or

 • providing alternative and equivalent studies, including 

published studies, instead of those protected17. Note that 
some data is mandatory to share. For more information see 
Practical Guide chapter on data sharing.

• 

If the active substance(s) contained in the BP has/have a different 
source (e.g. a different manufacturer or the same manufacturer, but 
manufactured by a different process) than the reference source(s) 
used for approval of the active substance(s), the applicant needs to 
provide a proof of technical equivalence with the application for UA. 
See the Practical Guide chapter on technical equivalence.

13  CA-Feb13-Doc.5.1.e – Final.
14  Ref: Article 20(a)(a)(iii) and Article 59(1)(a) of the BPR.
15  Ref: Article 64(1), first subparagraph, and Article 59(1)(b) of the BPR.
16  Ref: Article 21(1) and (2) of the BPR.
17  Ref: Article 20(1)(a)(iii) of the BPR.

Practical guide on Biocidal Products Regulation  Union authorisation• 

If the applicant is the owner of the data on the active substance 
contained in the dossier used to support the approval of the active 
substance, but the data was not originally submitted in IUCLID format, 
the applicant may submit a complete IUCLID file or submit a reference 
to its own active substance(s) dossier(s). 

•  The applicant can also refer to data related to BPs where the data 

protection period relevant to them has expired. The use of the data 
by the subsequent applicant is subject to an agreement of ECHA. In 
such a case, the subsequent applicant has to provide evidence that the 
BP is the same as the one already authorised or an explanation that 
the differences between them are not significant in relation to the 
risk assessment and the active substance(s) contained in the BP are 
technically equivalent to those in the BP already authorised.18

•  A UA for a BP may cover various PTs. The applicant should make sure 

that the PT(s) is/are relevant to the use purpose and pattern of the BP. 

•  Special attention should be given to the use instructions (e.g. use 
patterns, application rates, categories of users, risk mitigation 
measures if applicable) and label claims as they are also used for the 
purpose of the risk and efficacy assessment.

•  For any uses not evaluated earlier during the active substance 

approval,  a risk assessment has to be conducted and included in the 
product authorisation application. 

•  The efficacy data requirements are more elaborate at the product 

authorisation stage than for the active substance approval.

• 

•  Careful consideration needs to be given to the design of the summary 
of the product characteristics (SPC) as it is also critical for the BP 
label information19.  
If the applicant is a small or medium-sized enterprise (SME), it may be 
entitled to a reduced fee. Note that ECHA needs to recognise the SME 
status of the applicant, before submitting an application for UA. For 
more information on the recognition of an SME status and on how to 
submit relevant documentation see ECHA’s website.20

HOW

 PROCEDURE TO FOLLOW 

Pre-submission phase

To make a pre-submission for UA, the applicant should contact the ECHA 
Helpdesk. The ECHA Helpdesk will provide the applicant with a supporting 
document for the pre-submission phase. This should be submitted to ECHA 
through the appropriate functional mailbox (ua-pre-submission@echa.europa.
eu) together with a draft of the Summary of Product Characteristics (SPC).

On the basis of the pre-submission information, ECHA will launch a 
consultation of MSs and COM. ECHA will inform the prospective applicant 
of the outcome of the pre-submission consultation.

18  Ref: Article 64(1), subparagraph 2, of the BPR.
19  CA-May14-Doc.5.6 – Final
20  http://www.echa.europa.eu/support/small-and-medium-sized-enterprises-smes/sme-
fees-under-bpr

Practical guide on Biocidal Products Regulation Union authorisationApplicants will find the relevant information and instructions in Biocides 
Submission Manual 4a: Biocidal products Part A, Initial submissions.

Applications for Union authorisation

Creation of a IUCLID 5 dossier:
The applicant seeking to obtain UA needs to submit the data using a 
IUCLID 5 format. 

The following documents describe how to create and complete a IUCLID 
dossier:
•  BPR dossier creation/IUCLID Quick Guide available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID 

available on ECHA’s YouTube channel;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications 

available on ECHA’s website;

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications 

available on ECHA’s website.

Submission and processing of an application:
The application for UA should be submitted through R4BP 3. Following 
confirmation that the submission has passed the initial checks by ECHA, the 
application will be forwarded to the relevant evaluating CA (eCA) for validation 
and evaluation. During the evaluation (365 days unless additional information 
is requested) of a BP containing active substances that are considered as 
candidates for substitution, a comparative assessment will be performed. 
This will assess whether less harmful products are available for the same use. 
Evaluation is followed by a peer review (180 days) performed by ECHA through 
the Biocidal Products Committee (BPC) which issues an opinion. On the basis of 
the BPC opinion, COM takes a decision on the authorisation.21 

Within 30 days after the BPC opinion is sent to COM, the applicant has to 
submit the SPC in all official languages of the EU. 

Applicants need to monitor the status of their submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails 
to meet a deadline, e.g. for payment of fees, or, at a later stage, request 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline. 

To facilitate the evaluation of the application, it would be preferable that 
the applicant submits the application for UA to the CA which was eCA for 
the approval of the active substance contained in the product. Applicants 
are however free to choose their eCA.

Applicants will find the relevant information and instructions for 
submitting and following up the application for UA through R4BP 3 in the 
following submission manual available on ECHA’s website: 

21  Ref: Articles 43-44 of the BPR.

Practical guide on Biocidal Products Regulation  Union authorisationBiocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions, Chapter 8.  

More information related to invoicing and R4PB 3 can be found in the 
Biocides Submission Manual 5: Invoicing in R4BP 3. 

ECHA’s website provides further details on the processing of the 
applications.

Applicants input to the peer review 
The peer review process entails a scientific and technical review by 
the BPC working groups (WGs) before eventual adoption of the opinion 
by the BPC.  During the peer review, ECHA permits the participation 
of applicants to clarify any discussion items and to make sure that all 
aspects are properly addressed and understood when the BPC and the 
BPC WGs consider their application.   

The role and responsibilities of applicants participating in the peer 
review phase is explained in the ECHA Code of conduct for applicants 
participating in the Biocidal Products Committee and its Working 
Groups22 available on ECHA’s website. The Code of conduct sets 
out general rules and responsibilities of applicants, explains the 
mechanism by which applicants may participate in meetings and explains 
their obligations regarding confidentiality and the rules regarding 
documentation from applicants.  

To participate in BPC or BPC WG meetings, after the draft agenda 
for the meeting has been published on ECHA’s website, applicants 
need to contact the BPC or BPC WG Secretariat no later than 14 days 
before the meeting. Accredited stakeholder organisations (ASO) can 
be present at WG meetings, but do not have access to confidential 
substance documents.

Applicants are also given an opportunity to participate at other stages 
of the process as described in the Working Procedure23 available on 
ECHA’s website. The document describes the process and timelines in 
detail.

RESULT

OUTCOME OF THE OBLIGATION/PROCESS 

To grant the authorisation, the conditions summarised in Article 19 of 
the BPR have to be met. If there is a positive decision, COM will adopt 
an Implementing Regulation including the conditions for the validity 
of authorisation, which will be published in the Official Journal of the 
European Union. UA for a BP can be granted for a maximum period of 10 
years.

22  http://echa.europa.eu/documents/10162/4221979/bpc_conduct_code_applicants_
en.pdf 
23  Union authorisation applications: working procedure for the BPC, http://echa.europa.eu/
documents/10162/4221979/bpc_working_procedure_union_authorisation_en.pdf

Practical guide on Biocidal Products Regulation Union authorisationFor BPs containing an active substance that is a candidate for 
substitution, UA may be granted for a period not exceeding five years. The 
authorisation cannot be granted for longer than the approval period of the 
active substance(s) contained therein. 

The list of BPs with UA will be published on ECHA’s website.

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

Authorisation of same biocidal products24
Where applications for UA for two or more BPs with the same properties 
are submitted by the applicant to ECHA, the UAs may be granted based on 
one single product evaluation. 

It is also possible to submit an application for UA of the same BP on the 
basis of a BP which is already authorised through UA. The terms and 
conditions for authorisation will be based on the evaluation made on the 
reference BP. 

In both cases, the proposed differences between the same product 
and the related product may concern only information which can be the 
subject of an administrative change.25

Authorisation of the same product will have a different authorisation 
number and may be changed or cancelled independently of authorisation 
related to the reference product.

Union authorisation granted for a BPF
If a UA is granted for a BPF, the AH shall notify ECHA and COM through 
R4BP 3 for each BP within this family before placing it on the EU market, 
except where a particular BP is explicitly identified in the authorisation or 
the variation in composition concerns only pigments, perfumes and dyes.26 

Union authorisation of BPs containing only active substance(s) from 
Annex I to the BPR
Normally, when an active substance is on Annex I to the BPR, the 
simplified authorisation is appropriate. However, if that is not available 
because the BP does not fulfil Article 25(b), (c) or (e) of the BPR, it 
remains a possibility to apply for UA.27

Provisional authorisation
For a BP containing a new active substance not yet approved, a provisional 
authorisation can be granted by COM for a period not exceeding three 

24  Ref: Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying 
a procedure for the authorisation of same biocidal products in accordance with Regulation 
(EU) No 528/2012 of the European Parliament and of the Council.
25  Ref: Commission Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal 
products authorised in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council.
26  Ref: Article 17(6) of the BPR.
27  Ref: Article 19(1) of the BPR.

Practical guide on Biocidal Products Regulation  Union authorisationyears, renewable for one year.28 

Such a provisional authorisation may be granted only after the 
MSCA, which evaluated the new active substance has submitted a 
recommendation for approval of this substance and ECHA which received 
the application for the provisional authorisation consider that the BP 
complies with the provisions laid down in Article 19(1) points (b), (c) and 
(d) taking into account the factors set out in Article 19(2) of the BPR.

More information and instructions for submitting the application for 
provisional Union authorisation through R4BP 3 are given in Biocides 
Submission Manual 4a: Biocidal products Part A, Initial submissions, 
Chapter 8, available on ECHA’s website.

COST

RELATED FEES

The fees related to UA applications payable to ECHA are described in 
Annex II to Commission Implementing Regulation (EU) No 564/2013.

Note that SMEs may be entitled to a reduced fee, see ECHA’s website.29

The fees related to UA applications payable to the eCA may vary between 
the CAs and are established in the national legal acts of each MS. The 
applicant is responsible for checking and paying the specified amount of 
fees to the chosen eCA.

For more information about the CA fees, the applicant should contact the 
CA or its helpdesk.

HELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCAs contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

28  Ref: Article 55(2) of the BPR.
29  http://www.echa.europa.eu/support/small-and-medium-sized-enterprises-smes/sme-
fees-under-bpr

Practical guide on Biocidal Products Regulation Union authorisationMORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Union authorisation 
 » http://echa.europa.eu/web/guest/regulations/biocidal-products-
regulation/authorisation-of-biocidal-products/union-authorisation

Relevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

CA-Feb13-Doc.5.1.b.a – Final: Summary of the biocidal product 
characteristics for a biocidal product and biocidal product family;

CA-Feb13-Doc.5.1.e – Final:  Note for Guidance on the Definition of 
Similar Conditions of Use across the Union

CA-Sept13-Doc.5.1.g – Final.Rev1: Application of BPR procedures to 
applications for product authorisation submitted under the BPD regime 
and on which a decision has not been taken by 1 September 2013

CA-Sept13-Doc.6.2.a – Final.Rev.1: Authorisation of skin sensitiser 
biocidal products requiring PPE for non-professional users;

CA-Sept13-Doc.6.2.b Rev.1: Authorisation under the Biocidal 
Products Regulation of products containing more than one existing 
active substance or belonging to more than one product-type.

CA-March14-Doc.5.4- Final: Comparative assessment of biocidal 
products

CA-May14-Doc.5.6 – Final: Discussion paper on the content of label 
of biocidal products with regard to the authorised uses in the SPC

CA-May14-Doc.5.6 – Final: Discussion paper on the content of label 
of biocidal products with regard to the authorised uses in the SPC

CA-Sept14-Doc.5.9: Provisional authorisations granted or to be 
granted in accordance with Article 55(2) of the BPR and conversion 
to definitive authorisations

CA-xxxxxx-Doc.x.x: Implementing the new concept of biocidal 
product families (likely to be published on Circa in November 2014)

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Practical guide on Biocidal Products Regulation  Union authorisationSubmission 
•  Submission instructions

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

union-authorisation

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions 
 » http://echa.europa.eu/documents/10162/14938692/bsm_04a_

bproducts_initial_submissions_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation Union authorisationPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Simplified authorisation

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The simplified authorisation (SA) procedure aims to encourage the use 
of biocidal products (BPs) that have a more favourable environmental or 
human and animal health profile.

The application procedure for SA of a BP is similar to the procedure 
for national authorisation except that there are fewer information 
requirements.

To apply for the SA procedure, the BP must be eligible according to Article 
25 of the Biocidal Products Regulation ((EU) No 528/2012 (BPR)):
•  all the active substances contained in the BP appear in Annex I to the 

• 
• 
• 
• 

BPR and comply with the specified restrictions;
the BP does not contain any substance of concern;
the BP does not contain any nanomaterials; 
the BP is sufficiently effective;
the handling of the BP and its intended use do not require personal 
protective equipment.

The SA of a BP is granted by the competent authority (CA) of the 
evaluating Member State (MS) and is only valid for the approved terms 
and conditions stated therein. 

Mutual recognition by other MSs is not needed for an SA. A notification to 
the relevant MS(s) before actually placing the product on its territory is 
sufficient (derogations may apply)1.

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

An application for SA (and notification for placing on the market) 
can be made by, or on behalf of, the prospective authorisation holder 
(AH). Accordingly, the applicants may have a person/entity handling 
the practical issues related to the application on their behalf (e.g. a 
consultant).

The AH is the person/entity established within the European Union (EU)/
European Economic Area (EEA) who is responsible for the placing a BP on 
the market in a particular MS.

1  Ref: Article 27 of the BPR.

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

An application for SA can be submitted at any time where all the 
conditions in Article 25 of the BPR are met. The BP can only be made 
available on the market in a given MS when the SA is granted by the 
relevant eCA.2

To place the BP on the market of another MS after the initial SA is 
granted, a notification must be made to the MS in whose territory the BP 
will be made available no later than 30 days before placing the BP on the 
market in the territory of that MS. This may be done only once the SA has 
been granted by the eCA.

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements and sources
Article 20(1)(b) of the BPR lists the requirements for an application for 
an SA of a BP. Biocides Submission Manual 4a: Biocidal products Part 
A, Initial submissions, Chapter 6 available on ECHA’s website explains 
what types of information files should be prepared and included in an 
application for simplified authorisation. Biocides Submission Manual 7: 
Notifications and permits available on the European Chemicals Agency’s 
(ECHA) website lists the information requirements for the notification for 
placing on the market.

ECHA provides more advice on information requirements as given by 
Annexes II and III to the BPR and assessment of the information in the 
Guidance on information requirements for Biocides, available on ECHA 
website.

Issues to consider:
•  As for the requirement to provide efficacy data3, the information 
requirements in section 6 on efficacy in Annex III to the BPR are 
relevant in full for this type of application. This data requirement can 
be fulfilled by providing the relevant studies, a letter of access (LoA) 
to such studies, or declaring that the relevant data protection period 
has expired (upon agreement of the receiving competent authority).4 
It may also be possible to waive certain information requirements5 
by providing justifications why specific data are not relevant to the 
uses which are claimed to be supported, why it is not scientifically 
necessary to supply the data or why it is not technically possible to 
generate the data. 

•  Technical equivalence is only a requirement for active substances in 

category 6 of Annex I (also regarded as “approved”). Therefore, where 

If the active substance is included in the Review Programme, the BP it contains may 

2 
be made available on the market and used without an authorisation under the BPR, as per 
Article 89 of the BPR.
3  Ref: Article 20(1)(b)(ii) of the BPR.
4  Ref: Article 60(3) of the BPR, as amended by Regulation (EU) No 334/2014.
5  Ref: Article 21(1) and (2) of the BPR.

Practical guide on Biocidal Products Regulation  Simplified authorisationthe BP contains an AS in category 6 of Annex I, proof of technical 
equivalence should be submitted with the application for SA. See the 
Practical Guide chapter on technical equivalence. For substances listed 
in categories 1 to 5, and 7, the establishment of  technical equivalence 
is not relevant since no reference source has been established. 
•  For all substances listed so far in Annex I (except category 6), no 

limitation is indicated regarding product-type (PT). Accordingly, BPs 
that contain them and that are eligible for the SA procedure can be 
placed on the market within any PT.
If there are any doubts as to whether a product falls within the scope 
of the BPR or not, or to which PT it belongs, the applicants are invited 
to contact the future receiving competent authority6.

HOW

 PROCEDURE TO FOLLOW 

Application for simplified authorisation 

Creation of a IUCLID 5 dossier:
The applicant seeking to obtain SA is required to submit the data using a 
IUCLID 5 format. 

The following documents describe how to create and complete a IUCLID 
dossier:
•  BPR dossier creation/IUCLID Quick Guide available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID 

available in ECHA’s YouTube channel;

•  Biocides Submission Manual 1: Using IUCLID for biocide applications 

available on ECHA’s website;

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications 

available on ECHA’s website.

Submission and processing of an application:
Applicants seeking SA should submit their application through R4BP 3. 
Following confirmation that the submission has passed the initial checks 
by ECHA, the application will be forwarded to the relevant evaluating 
CA (eCA) for acceptance and evaluation (90 days unless additional 
information requested). The eCA takes a decision on the authorisation.7

The applicant needs to monitor the status of its submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails 
to meet a deadline, e.g. for payment of fees, or, at a later stage, request 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline. 

Applicants will find the relevant information and instructions for 
submitting and following up the application for SA through R4BP 3 in the 

6  Ref: Article 3(3) of the BPR.
7  Ref: Article 26 of the BPR.

Practical guide on Biocidal Products Regulation Simplified authorisationfollowing submission manuals available on ECHA’s website:
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications
•  Biocides Submission Manual 4A: Biocidal products Part A, Initial 

submission

ECHA’s website provides further details on the processing of the 
applications.

Notification for placing on the market

Submission and processing of an notification:
The applicant should submit a notification for placing on the market 
to each relevant MS through R4BP 3. Following confirmation that the 
submission has passed the initial checks by ECHA, the notification will be 
forwarded to the relevant CAs (30 days). In some cases, processing of the 
notification requires an agreement by the Coordination Group (CG) or a 
decision by the European Commission (COM) (see below).8 

The applicant needs to monitor the status of its submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails to 
meet a deadline, e.g. for payment of fees, or, at a later stage, request for 
comments, etc., the notification may be rejected or its processing may 
be completed disregarding the information that has been provided after 
the deadline. 

Applicants will find the relevant information and instructions for 
submitting and following up the notification for placing on the market 
through R4BP 3 in the Biocides Submission Manual 7: Notifications and 
permits available on ECHA’s website.

Settlement of disagreements through CG
When any of the MSs concerned disagree on whether the BP meets 
the criteria for SA or consider that it has not been notified or labelled 
correctly, the CG has to be addressed by that MS9. A detailed explanation 
of the reasons for such a position has to be made by the MS to the 
evaluating MS, all other MSs concerned and the applicant. The CG shall 
within 60 days reach an agreement and the applicant is allowed to present 
its point of view. When an agreement is not reached by the CG, COM takes 
a final decision by means of an implementing act. COM may either ask 
the Agency for an opinion on scientific and technical issues (through the 
Biocidal Products Committee) or give an opportunity to the applicant to 
comment (30 days) in order to conclude on its decision.

8  Ref: Article 27 of the BPR.
9  Ref. Article 27(2) of the BPR.

Practical guide on Biocidal Products Regulation  Simplified authorisationRESULT

OUTCOME OF THE OBLIGATION/PROCESS 

The eCA shall authorise the BP in SA procedure if satisfied that the product 
meets the conditions laid down in Article 25 of the BPR for a defined 
number of years, not exceeding 10. A BP placed on the market through the 
SA/notification procedure may be on the market as long as the SA of the BP 
granted by the eCA is valid.

In the context of the notification on the market, where the respective MS 
has valid reasons to consider that a BP authorised in SA procedure does 
not meet the criteria laid down in Article 25 and a decision by the CG has 
not yet been taken, that MS may provisionally restrict or prohibit the 
product being available on the market or used in its territory.

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

Authorisation under the BPD

Where the relevant low risk product registration has been made under 
Directive 98/8/EC (BPD (close to the concept of the SA procedure under 
the BPR)), it is valid under the BPR until expiry, but no notification for 
placing on the market can be made.

Please refer to the ‘CA Notes for Guidance’ regarding the placing on the 
market of a product not authorised according to Article 26 of the BPR but 
for which a biocidal product registration application was submitted and/
or granted according to the BPD10.

COST

RELATED FEES

National fees are applicable to the SAs.

The national fees related to an application for SA may vary between MSs 
and are established in national legal acts of each MS. The applicant is 
responsible for checking and paying the specified amount of fees to the 
chosen eCA.

The notification to the concerned MS(s) may be subject to fees. 

For more information about the MSs fees, the applicant should contact 
the designated national CA or its helpdesk.

10  The Notes for Guidance on ‘Handling of applications for product registration submitted 
under the BPD for which the evaluation has not been completed by 1st September 2013’ 
should be followed (CA-Sept13-Doc.6.2.e).

Practical guide on Biocidal Products Regulation Simplified authorisationHELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCAs contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Authorisation 
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

authorisation-of-biocidal-products 

Relevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

CA-Sept13-Doc.6.2.e – Final: Handling of applications for product 
registration submitted under the BPD for which the evaluation has 
not been completed by 1st September 2013

CA-May14-Doc.5.5 – Final: Consideration of storage stability, 
stability and shelf-life data in the context of applications for 
product authorisation under the simplified procedure

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Simplified authorisation of biocidal products
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

simplified-authorisation-biocidal-products

Notification for placing on the market - simplified authorisation
 » http://echa.europa.eu/web/guest/support/dossier-submission-
tools/r4bp/notification-placing-on-the-market-simplified-
authorisation

Practical guide on Biocidal Products Regulation  Simplified authorisation•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions 
 » http://echa.europa.eu/documents/10162/14938692/bsm_04a_

bproducts_initial_submissions_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

Biocides Submission Manual 7: Notifications and permits
 » http://echa.europa.eu/documents/10162/14938692/bsm_7_

notifications_and_permits_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation Simplified authorisationPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Changes of biocidal products

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

National authorisations (NAs) of biocidal products (BPs) issued by 
competent authorities of the Member States (MSCAs) or for Union 
authorisations (UAs) by the European Commission (COM) are only valid for 
the approved terms and conditions stated therein.

The relevant provisions on amendments of NAs and UAs on request of 
the authorisation holder (AH) can be found in Article 50 of the Biocidal 
Products Regulation ((EU) No 528/2012 (BPR)) and the detailed rules 
for notifications/applications and procedures for changes of these 
authorisations in the Commission Implementing Regulation ((EU) No 
354/2013) on changes of biocidal products authorised in accordance with 
the Changes Regulation (CR) ((EU) No 528/2012). 

Three types of changes can be distinguished1: 
•  administrative changes2;
•  minor changes, which should not affect the conclusion with regard to 

the fulfilment of the conditions for authorisation3; and 

•  major changes, when a need for reassessment of the risk and the 

efficacy can be expected to fulfil the conditions for authorisation4. 

The MSCAs for NA, or the European Chemicals Agency (ECHA) for 
UA, must be informed of all intended changes to an authorised BP. All 
amendments to the terms and conditions of an authorisation of a BP are 
handled only by the MSCAs for NA or by COM for UA.

The same rules as for a single BP apply also for a biocidal product family 
(BPF).

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

The AH or its representative (e.g. a consultant) may apply for amendments 
to any of the information included in the authorisation of a BP/BPF.

1  See the non-exhaustive list in the Annex to CR.
2  Ref: Article 3(1)(aa) of the BPR.
3  Ref: Article 3(1)(ab) of the BPR.
4  Ref: Article 3(1)(ac) of the BPR.

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

The applicant can apply for changes at any time. For certain administrative 
changes, the applicant may only be required to notify the relevant MSCA 
for NA or ECHA for UA within 12 months following the implementation of 
such a change5.

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
The information requirements are listed in Article 5 of the CR. Biocides 
Submission Manual 4, Part B: National authorisation changes on request 
explains what types of information files should be prepared and included 
in the application/notification. For the time-being the manual covers only 
the request for changes in relation to NA.

Issues to consider:

Classification of changes:
Taking into account the extent to which the change requires a 
reassessment of the risk and efficacy of the BP/BPF, changes to the 
authorisations are classified into three different categories6:
•  administrative change. Administrative changes are further divided into 

two types:

 •

 •

changes which have to be notified before implementation; 
and
changes which can be notified within 12 months 

•  after implementation;
•  minor changes; 
•  major changes.

The Annex to the CR helps to determine the category of the change sought.

An administrative change to the authorisation is sought by a notification 
procedure and a minor or major change by an application procedure.

Grouping of changes:
As a general rule, a separate notification/application shall be 
submitted for each change. Under certain conditions, the changes 
can be grouped. Some examples are given in the Biocides Submission 
Manual 4, Part B: National authorisation changes on request, available 
on ECHA’s website.

Even when changes are grouped, for NA, a notification/application has to 
be submitted simultaneously to each MS concerned.

5  Ref: Annex, title 1, section 2 to CR.
6  Ref: Article 3(1)(aa), (ab) and (ac) of the BPR.

Practical guide on Biocidal Products Regulation  Changes of biocidal productsHOW

 PROCEDURE TO FOLLOW 

Request ECHA to classify a change where relevant
If the applicant is unable to determine the category to which the intended 
change belongs (it is not listed in one of the tables in the Annex to the CR), 
the applicant may request ECHA to issue an opinion on the classification 
of the change. For this purpose, the applicant has to submit an application 
for classification of the change. A separate application for an opinion 
must be submitted for each change sought through R4BP 3. 

More details concerning information requirements and how to submit and 
application for classification of change are given in the Biocides Submission 
Manual 4b: Biocidal products Part B, National authorisation changes on 
request, Chapter VII, available in the support section of ECHA’s website.

More information related to invoicing and R4PB 3 can be found in the 
Biocides Submission Manual 5: Invoicing in R4BP 3. 

Submit a notification for administrative change/application for a 
minor/major change

Creation of a IUCLID 5 dossier:
Where relevant, the applicant should submit the data using a IUCLID 5 
format. The following documents describe how to create and complete a 
IUCLID dossier:
•  BPR dossier creation/IUCLID Quick Guide; available on the IUCLID 

website;

•  Video tutorial Creation of a biocidal product dossier with IUCLID, 

available in ECHA’s YouTube channel; 

•  Biocides Submission Manual 1: Using IUCLID for biocide applications, 

available on ECHA’s website;

•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications, 

available on ECHA’s website.

Submission and processing of a notification/application using 
R4BP 3: 

The applicant needs to submit a notification/application through R4BP 3:
to all MSs concerned, which have issued the authorisation and where 
• 
the change is intended – for NA, or
to ECHA – for UA.

• 

Where a change of BP (NA) has already been agreed in one or more MS, and 
the AH wants to apply for the same change in an additional MS concerned, a 
notification/application has to be submitted to the additional MS.

Following confirmation that the submission has passed the initial checks 
by ECHA, the notification/application will be forwarded to the relevant 
authority, i.e.:
• 

to all MSs concerned, which have issued the authorisation and where 
the change is intended – for NA, or

Practical guide on Biocidal Products Regulation Changes of biocidal products• 
• 

to ECHA – for administrative and minor changes to UA, or 
to the evaluating competent authority (eCA) – for major changes to UA.

Depending on the category of the intended change, different procedures 
apply7. 

The requests for minor and major changes to BPs authorised by NA are 
validated and evaluated by a reference MS. Requests for major changes 
to BPs authorised by UA are validated and evaluated by the eCA. The 
reference/evaluating CA should be the same that evaluated the initial 
NA/UA application. Only when the change of the BP authorised by NA/
UA is not sought in that MS, can the applicant choose another MS. ECHA 
validates and evaluates the requests for minor changes to BPs authorised 
through UA. 

The processing of the notifications/applications for changes in relation 
to BPs authorised through UA involves the opinion of ECHA (through the 
Biocidal Products Committee (BPC)).

The decision to agree or reject the change is taken by the MSCAs concerned 
for NA or by the COM for UA. The decision concerning NAs has to be taken 
in every MS individually. For some requests for a change concerning NA 
submitted to more than one MS, the decision by COM or an agreement by 
the Coordination Group (CG) may also be necessary (see below).

Applicants need to monitor the status of their submission and receive/
react to requests from the authorities in R4BP 3. If the applicant fails to 
meet a deadline, e.g. for the payment of fees, or, at a later stage, requests 
for any additional information, the application may be rejected or the 
evaluation may be completed disregarding the information that has been 
provided after the deadline.

The applicants will find more information and instructions for submitting 
and following up their notification/application through R4BP 3 in the 
submission manuals on ECHA’s website:
•  Biocides Submission Manual 2: Using R4BP 3 for biocide applications
•  Biocides Submission Manual 4b: Biocidal products Part B, National 

authorisation changes on request

More information related to invoicing and R4PB 3 can be found in the 
Biocides Submission Manual 5: Invoicing in R4BP 3 available on ECHA’s 
website. 

Derogations - NA
Any of the MSs concerned may disagree with the proposed change to 
a NA and propose to refuse to adjust the terms and conditions of the 
authorisation based on the following grounds8:

7  For the notification procedure for administrative changes of BP see Article 6 for NA 
or Article 11 for UA of the CR. For the application procedure for minor changes of BP see 
Article 7 for NA or Article 12 for UA of the CR. For the application procedure for major 
changes of BP see Article 8 for NA or Article 13 for UA of the CR.
8  Ref: Article 10(1) of the CR.

Practical guide on Biocidal Products Regulation  Changes of biocidal productsthe protection of the environment; 

• 
•  public policy or public security; 
• 

• 

the protection of health and life of humans, particularly of vulnerable 
groups, or of animals or plants; 
the protection of national treasures possessing artistic, historic or 
archaeological value; 
the target organisms not being present in harmful quantities; or 

• 
•  an active substance being a candidate for substitution9.

In each case, a detailed justification is required to be communicated from 
the MS concerned to the applicant. The MS concerned seeks to reach 
agreement with the applicant on the proposed derogation.

If an agreement between the two is not reached, the MS concerned 
informs COM who takes a final decision on the derogation. COM may ask 
ECHA for an opinion on scientific and technical issues (through the BPC) in 
order to conclude on its decision10. 

This procedure can also apply when additional/different restrictions are 
proposed by the MS concerned which, in the case of the BP containing 
an active substance that is a candidate for substitution, has made a 
supplementary comparative assessment to the comparative assessment 
carried out by the reference MS.

Settlement of disagreements - NA
When, for requests of a change, the MS concerned disagrees with the 
conclusions of the assessment report, with the summary of the product 
characteristics (SPC) or with the notified change, it must send a detailed 
explanation of the reasons for such a position to the reference MS, all 
other MSs concerned and the applicant. The points of disagreement must 
be referred to the CG11 without delay by the reference MS where the MSs 
use their best endeavours to reach an agreement. The applicant is allowed 
to present its point of view. When the agreement is not reached by the CG 
within 60 days, the reference MS informs COM which takes a final decision 
by means of an implementing act. COM may either ask ECHA for an opinion 
on scientific and technical issues (through the BPC) or give an opportunity 
to the applicant to comment in order to conclude on its decision. 

The settlement of disagreements through CG is not relevant for UA.

RESULT

OUTCOME OF THE OBLIGATION/PROCESS

Administrative changes for NA and UA, which can be notified within 12 
months after implementation12 may be implemented any time before 
completion of the procedures laid down in Articles 6 and 11 of the CR.

9  Ref: Article 37(1) of the BPR.
10  Ref: Article 37(2) and (3) of the BPR.
11  Ref: Article 35(1) of the BPR.
12  Section 2 of title 1 of the Annex to the CR.

Practical guide on Biocidal Products Regulation Changes of biocidal productsAdministrative changes, which have to be notified before implementation13 
may be implemented at the earliest on the date when the MSCA (for NA) or 
the COM (for UA) agree with the change, or 45 days following receipt of the 
notification by the MSCA (for NA) or  ECHA (for UA), whichever is first.

Minor changes concerning NA may be implemented any time after 
the reference MS has recorded the agreement on the conclusions of 
the assessment report, and the SPC where relevant, in R4BP 3, or for 
UA, any time after ECHA’s positive opinion has been made available in 
R4BP 3.

Major changes may only be implemented after the MSs concerned for NA 
or, COM for UA has agreed with the change and, where relevant, amended 
the decision granting the existing authorisation.

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

BP authorised through simplified authorisation procedure14
Where the authorisation has been granted in accordance with the 
simplified authorisation procedure15, the applicant is obliged to notify 
each MS through R4BP 3 on the territory of which this BP is made 
available, of each notification/application for the change(s) made to the 
reference MS (under implementation). Where a revised version of the SPC 
has been accepted by the reference MS, the applicant has to submit this 
revised version to each MSCA in the official language(s) of that MS.

COST

RELATED FEES

The national fees related to notification/application of changes may vary 
between MSs and are established in national legal acts of each MS.

For more information about the MS fees, the applicant should contact the 
designated MSs.

Fees related to notification/application for change(s) of UA as well 
as classification of changes payable to ECHA are listed in Annex II to 
Commission Implementing Regulation ((EU) No 564/2013). 

The fee applicable to the classification of a change applies to both NA and 
to UA. The fee is deducted from a subsequent notification/application for 
administrative or minor change in the context of UA.

13  Section 1 of title 1 of the Annex to the CR.
14  Ref: Article 9 of the CR.
15  Ref: Article 26 of the BPR.

Practical guide on Biocidal Products Regulation  Changes of biocidal productsHELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

MSCAs contact details
 » http://echa.europa.eu/contacts-of-the-member-state-competent-

authorities

National authorities providing support 
 » http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-

national-helpdesks

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Authorisation of biocidal products
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

authorisation-of-biocidal-products

The Biocidal Products Committee
 » http://echa.europa.eu/about-us/who-we-are/biocidal-products-

committee

Relevant Biocides competent authorities meetings documents
 » https://circabc.europa.eu/w/browse/85cf24d4-e4d3-4b34-b59d-

7a69394d0942

CA-Sept13-Doc.6.2.d – Final: Submission in EN of the proposed 
SPC in applications for mutual recognition in parallel and other 
regulatory procedures

Guidance on Biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Classification of a change to a product authorisation
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

classification-change-product-authorisation

National authorisation: administrative change on request
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

national-authorisation-administrative-change-request

Practical guide on Biocidal Products Regulation Changes of biocidal productsNational authorisation: minor change on request
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

national-authorisation-minor-change-request

National authorisation: major change on request
 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

national-authorisation-major-change-request

•  Biocides Submission Manuals 

 » http://echa.europa.eu/support/dossier-submission-tools/r4bp/

biocides-submission-manuals

Biocides Submission Manual 1: Using IUCLID for biocide 
applications
 » http://echa.europa.eu/documents/10162/14938692/bsm_01_

preparing_in_iuclid_en.pdf 

Biocides Submission Manual 2: Using R4BP 3 for biocide 
applications 
 » http://echa.europa.eu/documents/10162/14938692/bsm_02_

using_r4bp3_en.pdf

Biocides Submission Manual 4, Part B: National authorisation 
changes on request 
 » http://echa.europa.eu/documents/10162/14938692/bsm_04b_

bproducts_national_auth_changes_request_en.pdf

Biocides Submission Manual 5: Invoicing in R4BP 3 
 » http://echa.europa.eu/documents/10162/14938692/bsm_05_

invoicing_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Q&As
 » http://echa.europa.eu/support/qas-support

Practical guide on Biocidal Products Regulation  Changes of biocidal productsPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Data Sharing

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The Biocidal Products Regulation ((EU) No 528/2012 (BPR)) prohibits 
repeating tests on vertebrates for the purposes of the BPR.1

Owners of existing data and prospective applicants are obliged to share 
certain data from tests and studies on biocidal active substances and 
products submitted to relevant authorities under the BPR or the Biocidal 
Products Directive 98/8/EC.2 The aim of this is to avoid unnecessary 
animal testing and to share costs. 

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

Before performing any new tests on vertebrate animals, the prospective 
applicant is obliged to make an inquiry to the European Chemicals Agency 
(ECHA); an inquiry about other tests and studies is optional.3 The inquiry 
serves to inform the prospective applicant about the contact details of 
the data submitters.

Where an inquiry is made, and there are available vertebrate tests, the 
prospective applicant is obliged to request from the data owner to 
share the data. For non-vertebrate tests, the data-sharing request is 
optional. Where a request to share data is made, the data owner and 
the prospective applicant are required to make every effort to reach an 
agreement in a fair, transparent and non-discriminatory way.4

WHEN

TIMELINES, DEADLINES AND TRANSITIONAL PERIOD RELATED TO THE 
OBLIGATION/PROCESS

The prospective applicants are required to submit inquiries to share data: 

•  For vertebrate tests, as soon as the need for such a test has been 

identified and before any test is performed; 

•  For non-vertebrate tests, at any time.

1  Ref: Article 62(1) of the BPR.
2  Ref: Article 62 and 63 of the BPR.
3  Ref: Article 62(2) of the BPR.
4  Ref: Article 63 of the BPR.

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
To make an inquiry, you need to indicate during the submission:

• 

• 

the name of the active substance when the inquiry relates to studies on 
active substances, or
the relevant ‘reference number’ (asset number) of the biocidal product 
(BP) when the inquiry relates to studies on BPs.

More details on the information requirements:
Biocides Submission Manual 3a: Active substances Part A, Initial 
submissions, Chapter 5 and Biocides Submission Manual 4a: Biocidal 
products Part A, Initial submissions, Chapter 9.

It is also advised to consult the Guidance on data sharing available 
on ECHA’s website. This document was originally created for REACH; 
therefore, an explanatory note has been added to clarify chapters that 
are particularly relevant to the BPR. The guidance helps the users to 
identify their obligations, the purpose of the inquiry process, how to 
conduct negotiations so as to prevent disputes and how to determine cost 
allocations and compensations.

Issues to consider:
Prior to submitting an inquiry to share data, prospective applicants may 
benefit from checking the List of active substances and suppliers (Article 
95 list)5 on ECHA’s website to find out who manufactures or imports 
the same active substance or BP and contact the respective supplier to 
share these data. Note that the suppliers listed on the list are not always 
the data owners. The obligation to submit an inquiry discussed in this 
Practical Guide chapter are nevertheless not avoided by consulting the 
Article 95 list.

HOW

PROCEDURE TO FOLLOW 

Inquiry to share data 
The inquiry is submitted using R4BP 3. No IUCLID dossier is needed. 

Following confirmation that the submission has passed the initial checks 
by ECHA, the inquiry will be processed by ECHA. 

Applicants will find the relevant information and instructions for 
submitting and following-up their inquiry through R4BP 3 in the Biocides 
Submission Manual 3a: Active substances Part A, Initial submission 
and Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions, available on ECHA’s website.

5  http://echa.europa.eu/web/guest/information-on-chemicals/active-substance-
suppliers

Practical guide on Biocidal Products Regulation Data sharingRESULT

OUTCOME OF THE OBLIGATION/PROCESS

Following the inquiry to share data, ECHA provides the prospective 
applicants with the contact details of the data submitter to allow them to 
proceed with negotiations with the data owner on the sharing of the data. 
In parallel, ECHA informs the data submitter about an inquiry on their 
active substance or BP. 

TO NOTE

EXCEPTIONS AND PARTICULAR CASES

Article 95 obligation to share non-vertebrate data
For the purposes of making an application for inclusion on the Article 95 
list, data sharing is mandatory for all toxicological, ecotoxicological and 
environmental fate and behaviour studies relating to Review Programme6 
active substances, including any such studies not involving tests on 
vertebrates.7 For more information on the process of Inclusion on the 
Article 95 list, see Practical Guide chapter on Article 95: List of active 
substances and suppliers.

Data-sharing dispute claims
Where the parties fail to reach an agreement, the prospective applicant 
may, as a last resort, initiate a data-sharing dispute procedure before ECHA 
which may result in ECHA granting a permission to refer to the data.8 

The inquiry is a formal pre-requisite for a data-sharing dispute claim. The 
dispute claim can be made at the earliest one month after the inquiry has 
been answered by ECHA.

A prospective applicant submitting a data-sharing dispute claim needs 
to provide documentary evidence demonstrating the efforts made by all 
parties compelled to reach an agreement on sharing data. 

A data-sharing dispute claim must be submitted by the prospective 
applicant using the web form9, available on ECHA’s website. ECHA 
assesses the parties’ respective efforts to reach such an agreement 
and takes a decision to grant or not to grant permission to refer to the 
relevant studies. We urge to continue negotiations even when a dispute 
has been submitted.

A data-sharing dispute must be settled before the application concerning 
that data can be submitted.

6  The Review Programme is a Commission work programme for reviewing all existing 
biocidal active substances. The programme was set up under the Biocidal Products Directive 
and continues under the Biocidal Products Regulation. See Commission Regulation (EU) 
No 613/2013. Note that the new Review Programme regulation is likely to be adopted in 
Autumn 2014. 
7  Ref: Article 95(3) of the BPR.
8  Ref: Article 63(3) of the BPR.
9  https://comments.echa.europa.eu/comments_cms/Article633.aspx

Practical guide on Biocidal Products Regulation Data sharingECHA decisions on data-sharing disputes are published on ECHA’s 
website.10

Where the negotiations started before 1 September 2013
As under the previous legislation (Directive 98/8/EC) there was no 
mandatory data-sharing obligation per se, the new obligation under 
the BPR cannot have retroactive effect, and ECHA cannot take into 
consideration what was achieved or negotiated prior to 1 September 
2013 in a data-sharing dispute. 

Where negotiations started before the entry into application of the BPR, 
parties should identify the remaining points of disagreement and the 
points on which they have reached an agreement as of 1 September 2013. 
This can serve as a basis for the negotiations that must take place after 1 
September 2013. 

It remains mandatory for “any person intending to perform tests or 
studies on vertebrate animals” to submit an inquiry to ECHA and to 
negotiate for at least one month after receiving the relevant contact 
details, before being entitled to submit a data-sharing dispute claim. This 
applies equally to a claim for toxicological and ecotoxicological studies 
not involving tests on vertebrates under Article 95.

COST

RELATED FEES

No fees are applicable for these processes.

HELP

TO CONTACT FOR FURTHER INFORMATION

ECHA Helpdesk
 » http://echa.europa.eu/contact/helpdesk-contact-form

10  http://echa.europa.eu/regulations/biocidal-product-regulation/data-sharing/echa-
decisions-on-data-sharing-disputes-under-bpr

Practical guide on Biocidal Products Regulation Data sharingMORE

INFORMATION 

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

Regulatory aspects
Data sharing
 » http://echa.europa.eu/regulations/biocidal-products-regulation/data-

sharing

Guidance on biocides legislation
 » http://echa.europa.eu/guidance-documents/guidance-on-biocides-

legislation

Submission 
•  Submission instructions

Submit an inquiry to share data for active substance
 » http://echa.europa.eu/web/guest/support/dossier-submission-

tools/r4bp/submit-inquiry-share-data-active-substance

Submit an inquiry to share data for biocidal product
 » http://echa.europa.eu/web/guest/support/dossier-submission-

tools/r4bp/submit-inquiry-share-data-biocidal-product

•  Biocides Submission Manuals 

Biocides Submission Manual 3a: Active substances Part A, Initial 
submissions
 » http://echa.europa.eu/documents/10162/14938692/bsm_03a_

active_subst_init_subm_en.pdf

Biocides Submission Manual 4a: Biocidal products Part A, Initial 
submissions
 » http://echa.europa.eu/documents/10162/14938692/bsm_04a_

bproducts_initial_submissions_en.pdf

•  BPR specific IUCLID 5 Manuals

 » http://iuclid.eu/index.php?fuseaction=home.
documentation&type=public#bprmanual

BPR dossier creation / IUCLID Quick Guide
 » http://iuclid.eu/download/documents/usermanual/IUCLID_5.5_

BPR_dossier_creation_quick_guide_v1.0.pdf

Video tutorial Creation of a biocidal product dossier with IUCLID
 » http://www.youtube.com/watch?v=QQ9z4LacDnE

Practical guide on Biocidal Products Regulation Data sharingQ&As

 » http://echa.europa.eu/support/qas-support

Questions and Answers on Data sharing under BPR
 » http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/

biocidalproductsregulation/datasharing

Practical guide on Biocidal Products Regulation Data sharingPRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION

Appeals

WHY

PRINCIPLES BEHIND THE OBLIGATION/PROCESS

The Biocidal Products Regulation ((EU) No 528/2012 (BPR)) foresees the 
possibility to appeal certain decisions taken by the European Chemicals 
Agency before the ECHA Board of Appeal (BoA).1 Appeals are possible 
against the following types of decisions:

Decisions to reject the application due to non-payment of the ECHA fee:
•  approval of active substance; 
•  amending Annex I to the BPR;
• 
renewal of approval of active substance; 
•  Union authorisation of biocidal product; 
• 
• 

renewal of Union authorisation of biocidal products; 
technical equivalence. 

Decisions on substance:
•  Technical equivalence:

 • Rejection of application because additional information has 

not been provided;

 • Decision on technical equivalence.

•  permission to refer to tests or studies; 
•  permission to refer to data for which the data protection period is 

deemed to have expired.

It is also possible to appeal against some of ECHA’s decisions taken under 
certain related Commission regulations. These Agency decisions concern:

•  Applications for recognition of SME status (see Commission 

Implementing Regulation (EU) No 354/2013);

•  Notifications or applications for changes of authorised products (see 

Commission Implementing Regulation (EU) No 564/2013):

 •

 •

rejection of notification of administrative, or application 
for minor or major change because of non-payment of 
ECHA fee;
rejection of application for minor change because of failure 
to provide additional information.

•  Notifications of additional active substance/product-type combination 
to be examined in the Review Programme (see Commission Regulation 
(EU) No 613/20132):

 •

rejection of notification because of non-payment of ECHA fee;

1  Ref: Article 77 of the BPR.
2  Note that new Review Programme regulation is likely to be adopted in Autumn 2014.

 •

rejection of notification because of failure to provide 
additional information.

The BoA set up within ECHA is responsible for processing appeals against 
the relevant decisions adopted by the Agency under the BPR and related 
Commission regulations.

The main rules for bringing an appeal against an Agency decision are the 
same as for appeals under the REACH Regulation3. They are further detailed 
in the Rules of organisation and procedure of the BoA4. 

WHO

WHO IS CONCERNED BY THIS OBLIGATION/PROCESS?

Any natural or legal person may appeal against any of the above decisions 
addressed to that person. Any natural or legal person may also appeal 
against a decision that is of direct and individual concern to them, even 
though the decision is addressed to another person. 

WHEN

TIMELINES AND DEADLINES RELATED TO THE OBLIGATION/PROCESS

If the appeal is brought by the addressee of the decision, an appeal has 
to be lodged within three months of the notification of the decision 
to the person concerned. If the appellant (i.e. the person making the 
appeal) is not the addressee of the decision, the appeal must be lodged 
within three months of the day on which the decision became known to 
the appellant. 

For the types of ECHA decisions set out above which are appealable to 
ECHA’s BoA, an appeal must be brought to the BoA before an action can be 
brought to the Court of Justice of the European Union.

WHAT 

INFORMATION REQUIREMENTS AND SOURCES

Information requirements:
Forms, a supporting check list as well as Practice Directions are available 
on the BoA’s section of ECHA’s website. Practice Directions give further 
advice on the information to be submitted by the appellants.

3  Ref: Article 77 of the BPR as well as Article 92(1) and Articles 93 and 94 of the REACH 
Regulation.
4  Ref: Commission Regulation (EC) No 771/2008.

Practical guide on Biocidal Products Regulation  AppealsHOW

PROCEDURE TO FOLLOW 

All procedural documents, as well as any other correspondence must be 
sent by post, telefax or email to and lodged at the Registry of the Board. 
Documents may also be lodged directly at ECHA’s reception.

An appeal will be considered to be received only once the applicable fee 
has been received.

If, after consultation with the Chairman of the BoA, the Executive Director of 
ECHA considers the appeal to be admissible and well founded, he may rectify 
the decision within 30 days of the appeal being filed. 

ECHA has the opportunity to lodge the defence within two months after 
being notified of the notice of appeal.

Each appeal lodged before the BoA is announced on ECHA’s website5. 
Within two weeks of the publication of the announcement, any persons 
who consider that they have sufficient interest may apply to intervene in 
the proceedings by submitting an application for leave to intervene. 

Parties to appeal proceedings may request an oral hearing no later than 
two weeks from the date of notification of the closure of the written part 
of the proceedings. Alternatively, a hearing may also be organised at the 
request of the BoA. Hearings6 are normally held in public. Following the oral 
procedure, the BoA takes a decision on appeals.7

Appellants will find the relevant rules and further information on appeal 
proceedings in Rules of Procedure8 and in the Practice directions, 
available on ECHA’s website.

RESULT

OUTCOME OF THE OBLIGATION/PROCESS

The BoA may exercise any power which lies within the competence of 
ECHA or remit the case to the competent body of the Agency for further 
action.

An appeal has suspensive effect on the contested decision until the 
decision of the Board of Appeal is taken.

An action, contesting a decision taken by the BoA, may be brought before 
the Court of Justice of the European Union.9

5  http://echa.europa.eu/about-us/who-we-are/board-of-appeal/announcements
6  http://echa.europa.eu/about-us/who-we-are/board-of-appeal/hearings
7  Ref: Article 77 of the BPR, Article 92(1) and (2) and Articles 93 and 94 of the Regulation 
(EC) No 1907/2006.
8  Ref: Commission Regulation (EC) No 771/2008.
9  Ref: Article 263 of the Treaty on the Functioning of the European Union and Article 94 of 
the Regulation..

Practical guide on Biocidal Products Regulation Article 95: List of active substances and suppliersTO NOTE

EXCEPTIONS AND PARTICULAR CASES

An action concerning an ECHA decision where no right of appeal lies 
before its BoA may be brought before the Court of Justice of the 
European Union, in accordance with Article 263 of the Treaty on the 
Functioning of the European Union.

COST

RELATED FEES

ECHA fee is applicable for this process. It is given in Annex III to 
Commission Implementing Regulation (EU) No 564/2013.

HELP

TO CONTACT FOR FURTHER INFORMATION

Board of Appeal
 » http://www.echa.europa.eu/about-us/who-we-are/board-of-appeal/

contact/enquiry-form

MORE

INFORMATION

Legislation relevant to biocides
 » http://echa.europa.eu/regulations/biocidal-products-regulation/

legislation

ECHA’s Board of Appeal 
 » http://www.echa.europa.eu/regulations/appeals

Practical guide on Biocidal Products Regulation  Appeals