The Biocidal Products Regulation 528/2012/EU (“BRP”) came into force on 1 September 2013. It continues the two stage process for authorisation established under the Biocidal Products Directive. First an EU level authorisation of the active substance(s) used in the relevant biocidal product against one of 22 product types and second approval for the biocidal product itself (either at EU or individual Member State level).
The BPR also saw the introduction of an approved list of EU suppliers. From 1 September 2015 a biocidal product cannot be placed on the market if the manufacturer/importer of that active substance or where that entity is not established within the EU the importer of the biocidal product is not on the approved list.
Additional requirements were also introduced for so called “treated articles”.
The undoubted complexity of the legislation itself was not helped by some provisions which appeared to have unintended consequences. Accordingly the EU has recently amended the BPR, through Regulation 334/2014, and some of these difficult issues have now been clarified.
Of particular interest are:
- Article 94(1) has been amended so that it is clear it is not intended to act as a derogation from the labelling and information requirements applicable to treated articles. Treated articles can continue to be placed on the market whilst the active substance, contained in the biocidal product with which they have been treated remains in the review programme. However, they must be appropriately labelled.
- Article 94(1), as originally drafted appeared to allow treated articles that were already on the EU market to remain, but to prevent the introduction of any new treated article until the active substances within the biocidal product with which they had been treated had been approved. Article 94(1) has been amended to make clear transitional provisions apply to all treated articles.
- Article 95 extends the mandatory data sharing requirements for active substances subject to the EU Review Programme from studies in respect of vertebrates to all studies required for a human health and environmental risk assessment. The new amendment goes further extending this to studies on environmental fate and behaviour.
Complexities still remain however. Particular areas of challenge for business is the labelling requirements relating to complex treated articles, and the distinction between treated articles with a primary biocidal function (which are considered to be biocidal products) and a treated article whose primary function is not biocidal (which are considered to be treated articles).
As we move towards 2015 and the reality that the only biocidal products which can be made available on the market are those whose active substance supplier, or the importer of the biocidal product, is on the EU approved list we anticipate further requests for data sharing to come forward. Those involved with REACH will already appreciate some of the practical difficulties around data sharing. This issue in the context of biocides looks, if anything, to be even more challenging.
Anybody involved with biocidal products is urged to look at these changes now.