BPR Published in Official Journal
We have been carefully monitoring the progress of the Biocidal Products Regulation ("BPR") into EU law. We reported to you that on 10 May 2012, the Council of the European Union adopted the Regulation at second reading (see our previous alert) and that the European Parliament had earlier adopted the Regulation at second reading on 19 January 2012 (see our January 2012 EU Regulatory Bulletin).
We can now report that on 27 June 2012, Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products was published in the Official Journal. It will enter into force on the 20th day following that of its publication in the Official Journal. It's date of application remains 1 September 2013.
Key Changes
The BPR changes the current regulation of biocidal products in Europe. Our earlier bulletin in January 2012 set out in full the key changes manufacturers, importers and formulators should be aware of. These included:
- mandatory data sharing (and compensation) for vertebrate animal studies and certain non-vertebrate toxicological and ecotoxicological studies;
- an EU-wide authorization scheme for some biocidal product types;
- specific provisions for the regulation of articles treated with biocidal products;
- hazard-based “exclusion criteria” designating active substances which will be considered as candidates for substitution; and
- specific provisions addressing the use of nanomaterials in active substances and biocidal products.
Regulation (EU) 528/2012 repeals Directive 98/8/EC with effect from 1 September 2013, as we previously reported.
