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Biocidal Products Regulation

BPR General

When will the Union list of approved active substances be made publicly available?

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/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.

Should I register an active substance under the REACH Regulation?
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. 
 
Is a safety data sheet required for active substances and biocidal products according to the BPR?
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.
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?
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.
 
Which active substances ('ASs') in a biocidal product containing more than one AS have to be approved before the product can be authorised under the BPR?
According to Article 19(1)(a) of the BPR, a biocidal product can only be authorised if all the ASs are approved for the relevant product-type ('PT'). 
 
However, a distinction is made between ASs contributing to the biocidal function(s) of the product and ASs which have no intended biocidal function outside of the product. The latter category are commonly called ‘silent ASs'; typically in-can or film preservatives aimed at preserving the biocidal product itself from bacterial deterioration. A biocidal product containing a so-called silent AS can be authorised under the BPR even before the silent AS has been approved. This is because the approval requirement under Article 19(1)(a) of the BPR should be read with the function of the product in mind. Given that silent ASs do not make any significant contribution to any of the biocidal functions of the product, similarly to non-active substances, their previous approval is not required. However, such ASs must be under evaluation at the moment of the application for product authorisation.
Do ecotoxicological and toxicological tests have to comply with the principles of good laboratory practice (GLP)?
According to point 6 of Annexes II and III to the BPR, ecotoxicological and toxicological tests should be performed in compliance with the principles of good laboratory practice or other international standards recognised as being equivalent by the Commission or ECHA. Note that for the time being, no 'other international test methods' within the meaning of point 6 of Annexes II and III to the BPR have been recognised by the Commission or by ECHA.
 
Further information can be found in the Guidance on information requirements for Biocides.
Is an annual fee payable to ECHA also for a Union Authorisation granted through the Same Biocidal Product regulation?

Yes, an annual fee is payable to ECHA also for a Union Authorisation granted through the Same Biocidal Product Regulation (Commission Implementing Regulation (EU) No 414/2013). 

What is the fee for Union authorisation of a same biocidal product application?

Fee payable to ECHA (ref. (EU) No 564/2013 – Biocides Fee Regulation):

A fee for “Union authorisation of a same biocidal product” is specified in Annex II, Table 1 of the Biocides Fee Regulation. Whether the application is for a product or for a whole family, the fee is the same.

In addition, there is an annual fee for all authorised biocidal products (single product and family) specified in Annex III of the Biocides Fee Regulation. It is applicable also to biocidal products authorised via the same biocidal product application.

A fee for “notification to the Agency of an additional product within a biocidal product family” is specified in Annex II, Table 1 and it is applicable also to families authorised via the same biocidal product application.

Fee payable to eCA:

Please note that the fees related to UA applications payable to the evaluating Competent Authority (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. The contact information for national helpdesks is available at: https://echa.europa.eu/support/helpdesks

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