The Commission envisions significant amendments to the recently adopted text of Regulation 528/2012
As stated in our previous alert, Regulation 528/2012 concerning the making available on the market and use of biocidal products (the "Biocidal Products Regulation" or "BPR") was published in the Official Journal on 27 June 2012. It came into force on 17 July 2012 and will apply as of 1 September 2013. Notwithstanding these developments, the Commission and Member States are still discussing possible changes to the text of the BPR.
Within this context, new wording was recently discussed during last week's CA meeting for, amongst other provisions, Article 95 of the BPR. It will be recalled that according to that provision, as of 1 September 2013, any person wishing to place active substances on the EU market (being an EU manufacturer or an importer who is not part of the review programme of Directive 98/8) will have to submit to the European Chemicals Agency ("ECHA") either: (i) an active substance dossier, (ii) a letter of access ("LoA") to an active substance dossier, or (iii) a reference to a dossier for which all data protection periods have expired, in order to be included in the list of "relevant persons" (or "list of authorized sources") published by ECHA.
As part of this inclusion process, mandatory data sharing is provided for. Currently, mandatory data sharing under Article 95 of the BPR is limited to all toxicological and ecotoxicological studies including non vertebrate studies. However, following from last week's CA meeting, the intention is now to extend this to environmental fate and behaviour studies.
Although this is still not a done deal (the proposed wording will need to be adopted into law), there is a strong possibility that it will become the norm.