Following Brexit, Great Britain (GB) is no longer part of the EU scheme for regulating biocides. The GB Biocidal Products Regulation (GB BPR) was implemented on 31 December 2020 and operates similarly to the EU Biocidal Products Regulation.
Our skilled and experienced teams of regulatory experts, scientists, and toxicologists in the UK and EU can assess your biocidal products and determine both current and future obligations under the GB BPR. Eurolab provides extensive technical and regulatory support throughout all stages of a project.
Our range of GB/EU BPR services includes:
- Product development and strategic consulting.
- Regulatory support and advice:
- Determining compliance requirements under the BPR, including data requirements for active substances.
- Completing data gap analysis and preliminary risk assessments, including cost estimates for finalizing the data package.
- Identifying authorization requirements under the BPR.
- Outlining requirements for inclusion on the Article 95 Lists.
- Supporting classification and labeling in compliance with the Classification, Labeling, and Packaging (CLP) regulation.
- Regulatory submissions and study support:
- Writing, submitting, and monitoring regulatory dossiers.
- Preparing dossiers (IUCLID-format) and submissions (R4BP 3) according to the BPR.
- Handling national applications prior to the approval of the active substance.
- Post-submission monitoring and liaising with competent authorities.
- Technical documentation support:
- Establishing physical-chemical properties, efficacy, and toxicology.
- Preparing toxicological risk assessments.
- Conducting dietary risk assessments.
- Performing endocrine disruption assessments.
- Study placement, monitoring, and design, both in-house and through partner laboratories.
Additionally, Eurolab offers global support and customized solutions for clients seeking market authorization of biocides in Canada and the United States.
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