The new Regulation on Biocidal products (EU) No 528/2012 is applicable from 1 September 2013. The Biocidal Product Regulation (BPR) is the first piece of EU legislation to implement the Commission definition on nanomaterials.
The nanomaterial provisions apply both for active and non-active substances with the following characteristics:
- 50% or more of the particles have a size of 1-100 nanometres in at least one dimension
- Particles are in an unbound state, as an aggregate or as an agglomerate
According to the BPR, the approval of the active substance does not cover the nanomaterial form of it except where explicitly mentioned. A separate dossier with all data requirements must usually be prepared for nanoforms of active substances.
A dedicated risk assessment is needed when a nanomaterial form of an active or non-active substance is used in a biocidal product. Such biocidal products must also be labelled and indicate the name the nanomaterial followed by the word "nano" in brackets. However, the simplified procedure for authorisation introduced in the BPR is not applicable for nanomaterials.
Member States must report on the implementation of the BPR every five years. This reporting must include information on the use of nanomaterials in biocidal products.
All biocidal products must get authorisation before they can be made available on the market. Industry has to apply through ECHA for the approval of an active biocidal substance as well as authorisation for a biocidal product containing an approved one. The BPR requires that the active substances used in a biocidal product are technically equivalent to approved ones.
Under the new regulation, articles can only be treated with biocidal products containing approved active substances. Treated articles must be appropriately labelled according to the BPR and the regulation on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation). The new BPR repeals and replaces the former Directive (98/8/EC).
The European Chemicals Agency (ECHA) has a webpage for the BPR, and a dedicated webpage for nanomaterials under the BPR. Follow this link for ECHA's press release regarding the announcement of the BPR.