Questions and Answers

Biocidal Products Regulation

Active substance suppliers

[899] If a company obtains a Letter of Access (LoA) to a dossier and submits the LoA to ECHA for inclusion in the list of relevant substances and suppliers under Article 95 of the BPR, does it have to pay a fee to ECHA? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
Active substance suppliers
Version: 1.1
Latest update: 04/06/2015

Given the Agency's work required to analyse submissions for inclusion in the list of relevant substances and suppliers referred to in Article 95 of the BPR, it is appropriate to levy a fee for these types of submissions. The applicable fees are laid down in the Commission Implementing Regulation (EU) No. 564/2013 of 18 June 2013 on the fees and charges payable to ECHA pursuant to Regulation (EU) No 528/2012.

The amount of work required for such a submission will vary significantly depending on whether the person submits a letter of access or a new dossier, since, in the latter case, ECHA will have to check that the dossier complies with Annex II to the BPR or, where appropriate, Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive.

Annex III of the aforementioned Commission Implementing Regulation (EU) No 564/2013 sets the applicable fees depending on the type of the submission under Article 95 of the BPR:

  • 2 000 EUR per submission of a letter of access to a dossier already found complete by the Agency or an evaluating competent authority;
  • 20 000 EUR per submission of a letter of access to part of a dossier already found complete by the Agency or an evaluating competent authority, together with complementary data;
  • 40 000 EUR per submission of a new dossier.

The text of the Commission Implementing Regulation (EU) No 564/2013 is available at:
http://echa.europa.eu/regulations/biocidal-products-regulation/legislation

BPR General

[900] When will the Union list of approved active substances be made publicly available? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
BPR General
Version: 1.1
Latest update: 04/06/2015

The Union list of approved active substances mentioned in Article 9(2) of the BPR is publicly available on the website of DG Environment of the European Commission:
http://ec.europa.eu/environment/chemicals/biocides/active-substances/approved-substances_en.htm

ECHA maintains a similar list on its website:
http://echa.europa.eu/web/guest/information-on-chemicals/biocidal-active-substances

Pursuant to Article 67(1) of the BPR, as amended by Regulation (EU) No 334/2014, approved active substances are added on this list from the date on which the Commission adopts an implementing Regulation providing that an actice substance is approved.

[906] Should I register an active substance under the REACH Regulation? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
BPR General
Version: 1.0
Latest update: 04/06/2015

Active substances which are on the Union list of approved active substances under the BPR (which includes those active substances included in Annex I to Directive 98/8/EC), or which are under evaluation in the Review Programme (Regulation (EC) No 1451/2007) are “regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product” (see Article 15(2) of the REACH Regulation). This only applies to approved active substances and “existing” active substances in the Review Programme, not to on-going evaluations of “new” active substances, or where the evaluation led to a non-approval decision, or to new active substances not yet submitted for approval. 
 
The exemption from REACH registration provided by Article 15(2) of REACH is extended by Article 57 of the BPR to also cover active substances manufactured or imported for use in biocidal products authorised in accordance with the BPR, Article 27 (simplified authorisation); Article 55 (by particular derogation) or Article 56 (research and development).
 
Accordingly, if an active substance is manufactured or imported without an intended and/or demonstrated claim of use in biocidal products, the registration obligations under REACH apply. If, on the other hand, the active substance is imported solely with the intended use and/or demonstrated claim for use as a biocidal product or to be incorporated in another biocidal product, the requirements of the BPR apply. This also includes the appropriate classification, labelling and packaging of the biocidal product in accordance with Article 69 of the BPR. 
 
[908] Is a safety data sheet required for active substances and biocidal products according to the BPR? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
BPR General
Version: 1.0
Latest update: 04/06/2015

The requirement to prepare a safety data sheet (SDS) for substances and mixtures according to Article 31 of the REACH Regulation applies for active substances and biocidal products. This is confirmed by Article 70 of the BPR. 
 
Note that an exposure scenario to be attached to the SDS would not be required for substances considered as registered, i.e. active substances which are included in the Union list of approved active substances (which includes those active substances included in Annex I to Directive 98/8/EC) or are under evaluation in the Review Programme (Regulation (EC) No 1451/2007) to the extent they are manufactured or imported for use in biocidal products only (see Article 15(2) of the REACH Regulation). For such substances no chemical safety report (CSR) is required according to REACH Article 14 and therefore an exposure scenario would not be required to be attached to the SDS.
 
Active substances which are not manufactured or imported only for use in biocidal products may require registration under the REACH Regulation. Where a CSR would be required according to Article 14 of REACH, an exposure scenario for all identified uses not covered by Article 15 (REACH) would be required to be attached in the SDS.
[909] Do I need to submit a renewal of national authorisation in R4BP 3 if an application for national authorisation submitted via R4BP2 is under evaluation? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
BPR General
Version: 1.0
Latest update: 04/06/2015

No. A renewal of national authorisation can only be granted for an existing authorisation. 
For an existing national authorisation, an application for renewal shall be submitted to the relevant Member State authority via R4BP 3.
 
For biocidal products that contain an active substance for which the approval will expire within 550 days and for which the national authorisation has not yet been granted, the applicant might have difficulties to submit an application for renewal in accordance with Article 31 of the BPR that states that applications have to be submitted at least 550 days before the authorisation expires. Since the applicant may have been prevented from applying for renewal for a reason that is not under its control, the applicant should contact the relevant MSCA to inquire if the application may still be accepted after the renewal deadline has passed.
 
Data Sharing

[905] What are the data sharing requirements under the BPR? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
Data Sharing
Version: 1.1
Latest update: 04/06/2015

Under the BPR, new studies involving vertebrate animals can be conducted only as a last resort and, therefore, mandatory data sharing applies.

Prospective applicants, intending to perform new tests on vertebrate animals, have an obligation to find out which tests and studies are already available, by submitting an inquiry through R4BP 3 to ECHA.

Prospective applicants may also inquire about tests and studies not involving tests on vertebrate animals. Accordingly, an inquiry is mandatory when the intention is to perform tests on vertebrate animals and is optional when the intention is to perform tests which do not involve vertebrate animals. An inquiry is also a pre-requisite before a data sharing dispute claim can be submitted to ECHA under Article 63(3) of the BPR (including in cases where the prospective applicant already knows the identity of the data owner).

Once a request for test data (on vertebrate animals or not) has been made to a data owner (or any data submitter that is entitled to negotiate on behalf of the data owner), the parties must make every effort to reach an agreement to ensure that the cost of sharing the information is determined in a fair, transparent and non-discriminatory way, in accordance with the provisions of Article 63(1) and (4) of the BPR. ECHA will provide the inquirer with the contact details of all previous data submitters, when tests or studies were already submitted to the competent authorities or ECHA in connection with an application under the former Directive 98/8/EC or the BPR. Where applicable, the data submitters are required to facilitate the contacts between prospective applicants and data owners.

Please consult the ECHA website on inquiry, available at: http://www.echa.europa.eu/ regulations/biocidal-products-regulation/data-sharing/inquiry and at:
http://echa.europa.eu/support/dossier-submission-tools/r4bp/submit-inquiry-share-data-active-substance

The data sharing obligation also applies to the inclusion in the list of relevant substances and suppliers under Article 95 of the BPR. Note that mandatory data sharing for the purpose of Article 95 extends to all toxicological, eco-toxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrate animals.

Please consult the ECHA website on data sharing (and the related documents), available at:
http://www.echa.europa.eu/regulations/biocidal-products-regulation/data-sharing
Simplified authorisation

[902] How can a company request an amendment of Annex I of the BPR? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
Simplified authorisation
Version: 1.1
Latest update: 04/06/2015

The European Commission has adopted an Implementing Regulation (Commission Implementing Regulation (EU) No 88/2014) specifying the procedure for amending Annex I of the BPR. It clarifies the procedure to be followed when an application is made to include a substance in Annex I.The regulation confirms that the application follows the procedure of Article 7 of the BPR.
 
The data requirements for the inclusion of an active substance are given in Annex I to Regulation (EU) No 528/2012.
 
You can find the Implementing Regulation at:
 
[903] How much are the fees for the simplified authorisation procedure according to the provisions of the BPR and how can a company apply for it? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
Simplified authorisation
Version: 1.0
Latest update: 04/06/2015

A simplified authorisation can be requested as of 1 September 2013 if the conditions in Article 25 are satisfied. The fees applicable for the dossier evaluation depend on the competent authorities selected by the applicant for the evaluation process as described in Article 26(2) of the BPR. 
 
Note that the Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 concerns only the fees and charges payable to ECHA pursuant to Regulation (EU) No. 528/2012. 
 
The format acceptable for the submission of a simplified authorisation is a IUCLID file submitted through R4BP 3. Applicants are requested to use the general template for product authorisation by filling in only the relevant parts described under Article 20(1)(b).
 
Treated articles

[898] How to comply with the BPR for placing on the market treated articles which have been treated with, or include, biocidal products containing active substances? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
Treated articles
Version: 1.1
Latest update: 04/06/2015

According to Article 58(2) of the BPR, only treated articles that have been treated with or include biocidal products containing active substances included in the list drawn up in accordance with Article 9(2) (Union list of approved active substances) for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met can be placed on the EU market. The active substances included in Annex I to Directive 98/8/EC have been transferred to the Union list of approved active substances as of 1 September 2013.
 
The BPR also requires that the person responsible for the placing on the market of such a treated article shall ensure that the treated article is labelled when: 
 
1. a claim that the treated article has biocidal properties is made
2. it is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article
 
The label shall provide the information referred to in Article 58(3) of the BPR and needs to be easily understandable and visible for consumers.
 
More information on treated articles can be found in the ‘Note for Guidance on Frequently asked questions on treated articles’ available on the ECHA website at:
 
Note that Article 94(1) of the BPR (amended by the Regulation (EU) No. 334/2014 of 11 March 2014) seeks to allow the placing on the market of articles treated with biocidal products containing active substances which, albeit not yet approved, are being evaluated, either in the context of the work programme referred to in Article 89(1) of the BPR or based on an application submitted by 1 September 2016 pursuant to Article 94(1). 
 
The text of the Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 (BPR) concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market, is available at:
[904] Is my product a treated article, a biocidal product or neither? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
Biocidal Products Regulation
Treated articles
Version: 1.0
Latest update: 04/06/2015

The decision on whether a product is a biocidal product, a treated article or neither will always have to be taken case-by-case, considering all properties and functions, as well as the intended use of an article. 
 
A claim, for instance that an article itself is protected by a biocidal treatment, is likely to be considered a claim about a biocidal property rather than indicating a biocidal function, and is unlikely to drive a decision that the article would be considered a biocidal product. 
 
Member States may request the European Commission, according to Article 3(3) of the BPR, to take a decision on whether a product is a biocidal product, a treated article or neither. 
 
More information on treated articles can be found in the Note for Guidance on Frequently asked questions on treated articles available on the ECHA website at:
 
The guidance includes a decision tree which may help deciding whether an object treated with or intentionally incorporating one or more biocidal products is a treated article, a biocidal product or neither.