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Transitional measures

Transitional law is a legal framework that governs the transition from previous regulatory frameworks to new ones. The Biocidal Products Directive (BPD) 98/8/EC, adopted in 1998, standardized the EU market for biocidal products, prioritizing environmental protection and human and animal health. In 2013, Regulation No. 528/2012 replaced the BPD, governing biocidal product availability and use. Transitional law aims to minimize market disruptions while maintaining high standards of environmental and human health protection. 

BPR/EU Regulation

Under EU/BPR Regulation registration or authorization for biocide active substances and biocidal products in the EU/EEA, three distinct regulations must be considered: BPR (Biocidal Products Regulation), CLP (Classification, Labelling, and Packaging), and REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals). The major legislation is BPR, which is regulated by the European Chemicals Agency (ECHA) in partnership with individual member state competent authorities (e CAs).

Our diverse team of scientists and registration professionals can evaluate your biocidal products and treated articles to identify their present status and future compliance needs.

Type of BPR Registration

•  National authorization with option to apply for mutual recognition in other Member States
•  Union authorization
•  Simplified authorization
•  Authorization for same product

Key services

• Strategic advice and guidance

 Auxilife by leveraging their expertise helps navigate the complex world of regulatory compliance. By compiling comprehensive dossiers, conducting scientific and risk assessments, and liaising with regulatory authorities, we gain product  approvals. The team of experts monitor regulatory updates and changes to ensure safety, efficacy, and environmental concerns are addressed.

• Risk assessment

  Conducting a thorough risk assessment is a crucial step in evaluating the efficacy and safety of your product. Auxilife specializes in risk assessment procedures that ensure compliance with both EU and national regulations, implementing strategic mitigations where necessary. Our assessment covers several critical areas, including:

  • 1. Dietary risk assessment
  • 2. Non- Dietary risk assessment
  • 3. Environmental Risk Assessment (EUSES Model)
• Data gap analysis, waiving strategy, and bridging arguments

  This service is structured to optimize the utilization of existing data requirements by addressing data gaps, preparing data waivers, and formulating bridging arguments, ultimately minimizing testing expenses.

• Technical documentation support
  Auxilife offers technical documentation support encompassing various facets such as physical-chemical properties, efficacy, toxicology, ecotoxicology, and the fate and behaviour of substances in the environment.
• Regulatory submissions and Dossier preparation
  Auxilife provides comprehensive support and compliance with regulatory frameworks like BPR and National transitional rules.
  • 1. Preparation, submission, and post-submission management of dossiers.
  • 2. IUCLID dossier preparation for both new active substance(s) or Article 95 application
  • 3. Classification and labelling support in compliance with CLP
  • 4. Dossier preparation (IUCLID) and submission (R4BP3)
• Project management

  Auxilife offers a procedural model to help navigate regulatory strategies, starting with understanding goals and product. We craft customized strategies, evaluate factors affecting registration, provide advice, and assess factors. A designated point of contact assists with submission and technical support.

  General Services offered by Auxilife include:

  •  Study monitoring – study design, protocol and report reviews.
  •  Management of data generation and Preliminary Risk assessment
  •  Active substance approval / Renewal Application
  •  Regulatory compliance with Article 95 requirements
  •  Tier I and II technical equivalence applications
  •  Literature search and ED assessment for active and co-formulants
  •  Study placement, monitoring, and design (both in-house and through partner laboratories)
  • Auxilife can assist you with the Biocidal Product Regulation by assembling and submitting active ingredient or product authorization dossier, applying for Article 95 inclusion, and managing consortiums. Regarding the interpretation of the BPR, our expertise are up to date.

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