The EU Commission releases a regulation for biocides renewals

On 14 May 2014, the EU Commission delegated regulation 492/2014, which supplements the Biocidal Products Regulation 528/2012 (''BPR'').

EU Regulatory Bulletin contents

• The EU Commission releases a regulation for biocides renewals
• The EU Commission releases a final draft of a regulation on the review programme under the BPR
• BPR challenged before the Court of Justice
• Review of MRLs under Regulation 396/2005
• New penalties under the EU Pesticides Regulations in Italy
• Member State Committee reviews the first application of the prioritisation approach for SVHCs

 

On 14 May 2014, the EU Commission delegated regulation 492/2014, which supplements the Biocidal Products Regulation 528/2012 (''BPR'') as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition, was published in the EU Official Journal (OJ 2014 L 139/1).

Originally, biocidal product approvals were authorised under the mutual recognition system. Although provisions for renewing product approvals granted by one Member State are covered by the BPR, there is still a need for supplementary rules with regards to authorizations subject to mutual recognition in more than one EU country. Under the new system, once a product has received its first Member State approval, applicants may ask other national authorities to recognize the same authorization without the need for more assessments. The main prerequisite for the application of the new rules is that they will apply to approvals having (with limited exceptions) the same terms and conditions in the relevant Member States.

The new procedure can be summarized as follows:

• The renewal should be managed by one reference national authority, which can be chosen by the applicant.

• The renewal should be submitted at least 550 days before the approval's expiry date, and will be accordingly sent to the reference Member State and to all the other Member States where renewal is sought.

• The reference national authority will then have 180 days to provide its assessment report, and one year in case a full evaluation is needed.

• Next, all the designated Member States will have 90 days for an agreement, and 30 days to renew the approvals.

• Finally, if not consensus is reached, each national authority which accepts the assessment continues individually with the renewals.

The draft regulation is in the form of a '''delegated act'', meaning that the Commission did not need to consult the EU Parliament or the Council on this dossier.