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The EU Commission releases a final draft of a regulation on the review programme under the BPR



The EU Commission has published a draft Regulation,on the work programme for the systematic examination of all existing active substances contained in biocidal products.
EU Regulatory Bulletin contents


On 2 May 2014, the EU Commission published a draft Regulation, in the form of a delegated act, on the work programme for the systematic examination of all existing active substances contained in biocidal products (''the review programme'') referred to in the Biocidal Products Regulation 528/2012 (''BPR'').

The rules for the review programme were commenced in accordance with Article 16(2) of the Biocidal Products Directive 98/8/EC (''BPD''). However, as the BPR repealed and replaced the BPD, it is appropriate to adapt the review programme rules accordingly. The rules define the rights and obligations of the competent authorities and of participants in the work programme. 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.

In the Commission's view, attention should be drawn to part 1 of Annex II and to the listing of the three nanomaterials supported under the review programme (entries 1017, 1018 and 1019). The description of the substances is based on: 

  • The decision on which the SCBP was consulted regarding entry (1018).

  •  A communication from the applicant regarding entry (1019).

  • The opinion from ECHA regarding entry (1017).

Apart from the question of the description of these substances, which will need to be confirmed at the time of their possible approvals for entries 1017 and 1919, what is important is that no other nanomaterial than these three is currently supported under the review programme.

The entry into force of this Regulation, once adopted, will trigger a period of 12 months for interested persons to take over the role of participant for nanomaterial forms of substances listed in part 2 of Annex II (i.e. nanomatorial forms of substances currently supported under the review programme except entries 1017, 1018 and 1919, as well as nanomaterial forms of substances already approved).

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