Comprehensive Advocacy and Regulatory Compliance for Biocides

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Biocides

In the highly regulated biocides sector, EU Focus Group provides specialized advocacy and support to ensure that active substances meet the strict requirements for approval across the European Union.

We offer end-to-end assistance, from dossier reviews to strategic advocacy, helping our clients secure and maintain approvals in a rapidly evolving regulatory landscape.

Our Biocides Services

 

  • Active Substance Approvals: EU Focus Group assists clients in securing approvals for active substances by conducting detailed dossier reviews, ensuring regulatory compliance, and addressing scientific concerns effectively. Our team prepares robust advocacy materials tailored to meet EU and Member State standards.
  • Article 5 Derogations and Policy Advocacy: We support clients in obtaining Article 5 derogations, where necessary, by structuring position papers and drafting regulatory analyses that justify the need for exceptions. Our advocacy extends to both EU institutions and Member States, reinforcing the critical role of biocidal products in various industries.
  • Scientific and Legal Integration: Working with our scientific partners and legal partner Fieldfisher, EU Focus Group ensures a multidisciplinary approach to regulatory compliance. Our services include integrating scientific evidence into regulatory submissions and addressing legal challenges in biocide approvals and renewals.
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Key Regulations in the Biocides Sector

  1. Biocidal Products Regulation (BPR) (EU No 528/2012) – Sets strict standards for the approval and market authorization of biocidal products to protect human health and the environment.
  2. REACH Regulation (EC No 1907/2006) – Requires registration, evaluation, and authorization of chemicals, including those used in biocidal products, to ensure their safety.
  3. New CLP Regulation Amendments (2023) – Adds new hazard classifications relevant to biocidal products, impacting labeling and safety requirements.
  4. Endocrine Disruptors Strategy (2020 Update) – Aims to reduce the use of chemicals with endocrine-disrupting properties, affecting biocidal approvals and formulations.

Regulations Biocides

  1. Biocidal Products Regulation (BPR) (EU No 528/2012) – Regulates biocidal products to ensure they are safe for human health and the environment.
  2. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation (EC No 1907/2006) – Requires safety data and risk assessment for substances, including those used in biocides.
  3. New CLP Regulation Amendments (2023) – Introduces new hazard classifications relevant to biocidal products.
  4. Endocrine Disruptors Strategy (2020 Update) – Targets biocides that may have endocrine-disrupting properties, potentially impacting approvals.

Why Choose EU Focus Group for Biocides Compliance?

Navigating the regulatory requirements for biocidal products demands a deep understanding of both science and policy. EU Focus Group combines these insights to support our clients with strategic advocacy and regulatory compliance solutions. From securing Article 5 derogations to integrating scientific data in regulatory filings, we ensure that our clients meet the high standards of the EU biocides regulatory framework. Let EU Focus Group be your partner in achieving compliance and safeguarding your products in the European market.