BPR

The Biocidal Products Regulation – Regulation (EU) No 528/2012

Regulation of biocidal products in the European Union

The Biocidal Products Regulation (BPR) lays down the rules and procedures for placing biocidal products on the market in the EU. Under the regulation, a biocidal product is defined as a substance or mixture containing one or more active substances intended to destroy or control harmful organisms.

There are 22 different biocidal product types covered by the regulation, grouped into four main categories:

  • Main Group 1: Disinfectants, e.g., hand sanitisers, surface disinfectants
  • Main Group 2: Preservatives, e.g., film and wood preservatives
  • Main Group 3: Pest control, e.g., rodenticides, insect repellents
  • Main Group 4: Other biocidal products, e.g., antifouling paints, embalming fluids

Biocidal products falling under the scope of BPR require an authorisation to be granted before they can be placed on the market. The regulation establishes a two-stage system for the registration of biocidal products, involving:

  • Active Substance Approval: any active substance contained in a biocidal product must first have been approved at an EU-wide level for use in the appropriate product type.
  • Biocidal Product Authorisation: when an active substance has been approved for the relevant product type, a biocidal product containing the active substance must receive an authorisation for use in the Member State where it will be placed on the market.

The registration processes involve rigorous assessment of both active substances and biocidal products by regulators to ensure adequate protection of human and animal health, and the environment. Products must also demonstrate to be sufficiently effective for their intended use and according to any label claims made. The process places obligations on applicants to supply comprehensive technical dossiers detailing information on the intrinsic properties, hazards, efficacy and intended use patterns of the biocidal product. Exposure and emission scenario assessments must also be performed to demonstrate that no unacceptable risk to human and animal health or the environment will result from the intended uses of the product.

Enviresearch’s regulatory specialists are experienced in assisting businesses, both large and small, with registration of individual biocidal products and product families including disinfectants, repellents and marine antifouling paints. With our flexible, customer-focused approach, we will work with you to build a bespoke support package that can assist you with each step on your path to gaining your product authorisations, including:

  • regulatory strategy development focused on achieving cost-effective approaches to gaining biocidal product authorisations across the EU
  • project management support for each stage of your regulatory strategy with emphasis on providing responsive, honest and clear communication to keep you informed
  • data gap analysis of active substance and product data packages, including assistance in devising and implementing strategies to address identified gaps
  • technical support in the analysis, interpretation and reporting of active substance and product data in the appropriate regulatory context and specific to the intended use patterns of the product
  • performing human health and environmental risk assessments required to support product authorisations
  • efficacy data assessment and advice to ensure product label claims are robustly supported
  • full dossier preparation and submission support for product authorisations via sequential or parallel mutual recognition procedures
  • Article 95 and technical equivalence application support
  • regulatory support and advice for bringing biocide-treated articles to market in compliance with the BPR
  • bringing to market biocidal products eligible for transitional measures under the BPR

EU Transitional Measures (pre-BPR product authorisation)

Certain biocidal products are eligible to be placed on the market without a BPR product authorisation in accordance with national transitional measures (Article 89) laid down in the BPR. The transitional measures may apply where at least one active substance in a product is part of the BPR Review Programme (for the relevant product type), and that active substance is still undergoing review for approval. In such cases, products may be placed on the market in EU countries according to each country’s national rules, until all Review Programme active substances in the product have been approved under the BPR. The national rules and requirements for placing such biocidal products on the market vary from country to country. Without prior knowledge and understanding of the regulatory systems in place, it can be complex to interpret which rules must be complied with in different countries.

Enviresearch has been assisting clients with product registrations according to national procedures in many EU countries since the BPR came into force in 2013. Our consultants can guide you on the differences between national procedures in EU countries and help devise time-efficient and cost-effective strategies for bringing your products to market in line with the correct national processes.

Regulation of biocidal products in Great Britain

Following the United Kingdom’s exit from the EU, an independent biocidal products regulatory framework has been in operation in Great Britain (GB) as of 1 January 2021. The GB BPR, as it is now commonly referred to, was established via a ‘lift and shift’ of Regulation (EU) No 528/2012 into UK law with amendments made where necessary to the text to make it operable in a GB-only context. Consequently, the GB regulatory framework broadly continues to mirror the rules and instruments laid down in the EU BPR.

However, the GB BPR is entirely independent of the equivalent EU regulation, meaning separate active substance approvals and biocidal product authorisations must be granted under the GB BPR before a product or product family can be placed on the GB market. To add further complexity, Northern Ireland (NI) remains subject to the EU law (and hence the EU BPR), owing to the NI Protocol that was agreed as part of the Brexit deal.

Since Brexit, Enviresearch has been working closely with clients to manage the transition to the new GB BPR and ensure continued market access in the region. Our consultants are proactively engaging with the adoption of the GB BPR in parallel with our continuing work to support our clients with gaining authorisations for their biocidal products under EU BPR. When you wish to bring your products to both the GB and EU/NI markets, Enviresearch can support you in developing and managing consolidated strategies that will provide a cost-efficient route to product registrations across each region.

Regulations

PPP
BPR
REACH
CLP
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