On 25 February 2014 the European Parliament adopted the long awaited legislation to amend the Biocidal Products Regulation (BPR). The changes were agreed in a plenary session with an overwhelming majority of 658 MEPs in favour as opposed to 14 against. The text voted upon by MEPs was agreed in an informal trialogue between the European Commission, Council of the EU and the European Parliament on 2 December 2013.
The European Commission's initial proposal to amend the BPR was first submitted in May 2013. The Parliament proposed some changes to the Commission text, in particular, regarding biocidal product families, treated articles and the list of approved suppliers provided by Article 95.
Regarding the notion of product families, industry had expressed concern about the lack of clarity in the Regulation and the large obstacles in the way of defining how different products should fit into families. In the original text, each product was required to have the same classification, hazard and precautionary statements in order to be a member of the same biocidal product family. The Parliament's amendments allow biocidal products with less severe classifications to be part of a family based on higher risk formulations provided that they have similar composition, exposure levels, and proven efficacy.
Concerning the list of approved suppliers, the current version of the BPR only allows manufacturers and importers to make an application in order to be included on the list of 'relevant persons' provided by Article 95 BPR. The amendment includes the option under Article 95 for formulators using an active substance ('product suppliers') to apply to be listed themselves. The scope of mandatory data sharing has also been extended to data on environmental fate and behaviour (in addition to toxicological and ecotoxicological data). Additionally, the list will now also include reference to the relevant product type. It should also be noted that the revised BPR includes an important change whereby, following renewal of the approval of an active substance, authorised suppliers can only remain on the Article 95 list if they submit the relevant data or a letter of access to the data within 12 months from the renewal.
The other major aspects of the revised BPR are as follows:
- clarification of an unintended market freeze for treated articles which contain active substances that have not been part of the review programme;
- the inclusion of data protection periods relevant for data submitted for products under the simplified authorisation;
- extension of the Forum for Exchange of Information on Enforcement (Forum), which provides for a network between national authorities responsible for REACH enforcement, to the BPR. From Parliament's point of view, this initiative ''is required to facilitate the coordination of the enforcement of the BPR at national level''.
The text of the Parliament BPR Resolution (page 274) can be found here.
Since a consensus on the amendments was reached by the Parliament, the Council and the Commission during the informal trialogue on 2 December 2013, the vote on 25 February 2014 is the final stage in the adoption of the revised BPR. The consolidated version of the text and its publication in the EU Official Journal is expected in approximately one month.
