The new Biocidal Products Regulation (BPR) (PE-CONS 3/12, available online here), was adopted on May 10, 2012, and entered into force on September 1, 2013. The BPR will repeal and replace the current Biocidal Products Directive (Directive 98/8/EC) and will make some significant changes to the way biocidal products - or non agricultural pesticides - are regulated in the European Union (EU), as well as how so-called treated articles and food contact materials containing biocides are regulated.
Generally speaking the new BPR retains and consolidates the legal framework established under the current BPD. Biocidal products will, for example, continue to be subject to the two tier approval system established under the BPD involving, firstly, approval of an active biocidal substance for use in a particular field of application (so-called Product Type) and, secondly, authorization of a specific biocidal product containing the approved active. However, the new BPR also will contain a number of new provisions, such as those relating to treated articles. For the first time all treated articles will fall within the scope of the new BPR rather than merely those containing actives with external effect.
Broadly speaking the new provisions in the BPR have one of two fundamental objectives. On the one hand there are those provisions which aim to improve the European single market regarding products containing biocidal active substances. On the other, there are those provisions which aim to improve protection to human health and the environment from the risks posed by these products.
As the New BPR will strengthen the European single market for products containing biocidal active substances by, amongst other things, removing national barriers to trade - industry will likely benefit from new commercial opportunities and reduced red tape. To benefit from this, however, industry will need to fully understand, among other things: how and when to take advantage of Union Authorisation to obtain pan-EU product authorisation, how and when to use the new fast track simplified product authorisation procedure to gain quick access to the EU market, how the new procedures regarding mutual recognition will operate in practice, how to take advantage of the reduced data requirements, etc.
At the same time, the new BPR will introduce a number of new requirements intended to bolster and improve protection to risks posed by products containing biocidal active substances. Therefore, industry will also need to fully understand a number of new provisions, including: how the new provisions on substitution work in practice, the likelihood of of certain substances gaining Annex I inclusion given the exclusion criteria, the new provisions regulating treated articles and in-situ generated biocidal products, the provisions regarding nanomaterials and the broadened scope of the new BPR and its impact on, for example, food contact materials. Keller and Heckman is able to assist on all these issues.