The Biocidal Products Regulation (BPR) and nanomaterials
The Biocidal Products Regulation (BPR) has specific provisions for nanomaterials. The provisions apply to products and substances that meet the criteria defined in the BPR. These definitions are based on the Commission recommendation on the definition of nanomaterials.
These provisions apply for active and non-active substances with the following characteristics:
- 50 % or more of the particles have a size of 1-100 nm in at least one external dimension.
- Particles are in an unbound state or as an aggregate or agglomerate.
According to the BPR, the approval of the active substance does not cover the nanoform of the active substance 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 the nanoform of the active and non-active substances are used in a biocidal product. The label of the biocidal products must show the name of each nanomaterial followed by the word "nano" in brackets. Products containing nanomaterials are excluded from the simplified authorisation procedure.