The Regulation on Biocidal Pproducts (Regulation (EU) No. 528/2012) aims to protect humans, animals, materials and / or articles against harmful organisms like pests or bacteria, through the action of active substances contained in the product.
The regulation ensures fair treatment of all stakeholders involved in the process of placing active substances on the market.
We assist our clients in fulfilling their obligations, providing high quality assistance and supporting them throughout the registration process. Our team of experts is constantly updated on the latest legislative developments, in order to offer the client the best possible strategy.
- Approval of active substances
- Authorization of biocidal products
- Article 95 submission
- Goal(s) definition and priority setting for an efficient strategy
- Managing and monitoring of laboratory tests
- 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
- Biocide Approval in other Eu member states, according to national legislation in transitional period of active substance in evaluation
- Mutual recognition in other Eu member states
- Request of inclusion in Article 95 uk
- Request of Authorization for biocidal products in UK