The Biocidal Products Regulation (BPR, Reg. (EU) n. 528/2012) aims to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
Furthermore, the BPR Regulation ensures an equal treatment of persons placing active substances on the market.
We assist our clients in fulfilling their obligations, providing high-quality assistance for the entire authorisation process. Our team of experts is up to date on the latest developments of the Regulation in order to assist the client with the best strategy for the achievement of a successful authorisation.
SERVICES
- Approval of active substances
- Authorisation of biocidal products
- Article 95 submission
- Goal(s) definition and priority setting for an efficient strategy
- Managing and monitoring of laboratory tests
- IUCLID/R4BP
- Data gap analysis
- QSAR modeling and read-across approach
- Dossier preparation, submission and pre-/post-submission assistance
- Human health and environmental risk assessment
- Communication with Regulatory Authorities
- Endocrine Disruptor Testing strategy and Assessment
- PMC (Presidi Medico Chirurgici) Authorisation according to National regulation DPR 392/98
- Regulatory compliance on BPR after Brexit