Biocides

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Expert guidance for BPR compliance: simplified authorization of biocidal products

Regolamento biocidi
Tutela uomo animali materiali

The Biocidal Products Regulation (Reg. (EU) No. 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 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.

Project management services
  • Goals definition and priority setting for an efficient strategy
  • Data Gap Analysis
  • Preliminary risk assessment
Monitoring of laboratory test
  • Definition of the study plan
  • Support to client in selecting laboratories and ensuring two-way communications
  • Managing and monitoring of laboratory tests
Elaboration of technical and administrative dossiers
  • Preparation and submission of dossiers for new active substances and biocidal products
  • Article 95 submission
  • IUCLID/R4BP
  • QSAR modeling and read-across approach
  • Human health and environmental risk assessment
  • Pre/post-submission assistance
Application for Mutual Recognition
Endocrine Disruptor Testing strategy and Assessment
PMC (Presidi Medico Chirurgici) Authorisation according to National regulation DPR 392/98
Regulatory compliance on BPR after Brexit
Authorisation and/or notification of biocidal products according to european or extra-European National regulations
Follow-up with the Authorities
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