Delegated regulation 2014/1062 - Work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation 528/2012 - Main contents

EN

Official Journal of the European Union

L 294/1

Commission Regulation (EC) No 1451/2007 (2) lays down the detailed rules for the programme of review of existing biocidal active substances (the ‘review programme’) commenced in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3). Since that Directive has been repealed and replaced by Regulation (EU) No 528/2012, the detailed rules for the continuation of the review programme should be adapted to the provisions of that Regulation.

It is important to identify the active substance/product-type combinations that may be made available on the market and used, subject to national rules, by virtue of the transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012. Such should be the case for active substance/product-type combinations that are under evaluation in the review programme.

Where a product has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007, but is not covered by the exemption for food and feed laid down in Article 2(5)(a) of Regulation (EU) No 528/2012, the active substances it contains should be evaluated in the review programme for the relevant product-type. Subject to national rules, it should be allowed to be made available on the market and used until the end of that evaluation. A system of prior declaration should define which products benefit from this provision. The same should apply where the failure to notify an active substance/product-type combination is due to the new definition of product-types in Regulation (EU) No 528/2012 compared with that in Directive 98/8/EC, or is well justified based on a Commission decision taken in accordance with Article 3(3) of Regulation (EU) No 528/2012, on the case law, such as case C-420/10 (4), or on authoritative guidance from the Commission or Member States' competent authorities, which is subsequently reviewed.

Where a biocidal product contains, consists of or generates an active substance which is no longer included in the review programme but the use of that biocidal product is essential in a Member State, that use and the making available on the market for that use should be allowed in that Member State, under the responsibility of the Member State, subject to certain conditions and for a limited period of time.

With a view to ensure consistency and simplification, the procedure for evaluation of active substances in the review programme should, in all relevant parts, be identical with that for applications submitted pursuant to Article 7 of Regulation (EU) No 528/2012 or pursuant to Commission Implementing Regulation (EU) No 88/2014 (5).

For substances meeting the exclusion or substitution criteria, the evaluating Competent Authority should submit to the Agency a proposal for harmonised classification and labelling pursuant to Article 37(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (6) for the endpoints of concern, while preserving the right of the Member State to submit a proposal on other or...