The Biocidal Products Regulation (BPR; Regulation (EU) 528/2012), which repeals and replaces the Biocidal Products Directive (BPD, 98/8/EC), entered into force on September 1, 2013. The BPR retains the legal framework established by the BPD, including the two-tier approval system for biocidal substances, but also introduces a number of new provisions, such as those relating to treated articles and food contact materials containing biocides.
In order to prepare applicants for the new changes, ECHA recently published priority guidance on applying information requirements for biocidal active substances (Annex II) and biocidal products (Annex III). The head of ECHA’s biocides unit, Hugues Kenigswald, says that there are a number of further documents in development that will complement it. However, applicants can begin submitting biocidal and technical equivalence dossiers immediately.
Unless they are included in ECHA’s list of approved active substance suppliers, all manufacturers or importers of active substances contained in biocidal products must submit a dossier before placing products on the market. Applicants can prepare a dossier by using the first versions of BPR submission tools, the Iuclid report generator software and the R4BP3 register for biocidal products. The ECHA has published guidance for using these tools on their website.
Some in the industry worry that the submission process, particularly the Iuclid software, will be too complex for companies. Yet overall, industry is expected to benefit from the Regulation, which will allow industry to request an EU-wide authorization for biocidal products, thereby removing national barriers to trade. This simplified and more efficient product authorization, along with data sharing and information requirements, is estimated to save industry € 2.7 billion over a period of 10 years. However, Mr. Kenigswald did express concern as to whether member states will have enough resources to provide the support needed to make the BPR an effective Regulation.