Following up on a draft from earlier this year, on 10 October 2014, the Regulation No 1062/2014 on the review programme for existing active substances under the 528/2012 Biocidal Products Regulation (BPR) was published in the EU Official Journal. The Regulation, in the form of a Commission delegated act, lists all substances and their product-types (PTs) that are currently supported for review and included in the review programme, as well as those that are not supported.
The rules for the review programme were commenced in accordance with Article 16(2) of the Biocidal Products Directive 98/8/EC (BPD) and provided in Regulation 1451/2007 (the so-called Second Review Regulation). However, as the BPR repealed and replaced the BPD, it is appropriate to adapt the review programme rules accordingly. The new Regulation defines the rights and obligations of the Member State competent authorities (CAs) and of participants in the work programme and repeals Regulation 1451/2007. There are no amendments in terms of substance; the main purpose of the revision is simplification and establishment of stricter deadlines which need to be met by the Rapporteur Member States.
The new Regulation provides for substance/PT combinations which are still eligible for inclusion in the review programme and allows companies to submit to the European Chemicals Agency (ECHA) or the European Commission a declaration of interest to notify such substances, within specific deadlines, in order to include them in the review programme. To that end, all notifications of non-supported active substances/PT combinations will have to be submitted through ECHA's R4BP system. Substance/PT combinations eligible for inclusion in the review programme include products falling under a different PT under the BPR as the one notified under the BPD and substances which benefitted from the food and feed derogation, but also cases where guidance or written advice was provided by the Commission or the CA and was then subsequently reviewed in a decision adopted pursuant to Article 3.3 of the BPR or in new authoritative guidance published by the Commission. In case of redefinition of the substance identity or withdrawal of all participants, ECHA will publish an open invitation to take over the role of participant.
It should also be noted that the new Regulation now also provides that the role of participant can be taken over or shared by mutual agreement between an existing and a prospective participant, provided that the prospective participant has the right to refer to all the data submitted or referred to by the existing participant.
The Regulation consists of 516 supported active substances/PT combinations, which means that in order to meet the 31 December 2024 deadline for finalizing the review programme, the CAs and the Biocidal Products Committee (BPC) will have to adopt an average of 50 opinions per year.
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