Customised Assessment
With our deep industry expertise and customised approach, we ensure your products meet all of the biocidal regulation requirements.
EU Biocide Support
Stay ahead of regulatory shifts and secure your business with our personalised biocides solutions
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Regulatory Expertise
We help determine if your product or use is covered by the EU biocides regulatory framework and assess its current and future requirements.
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Tailored Solutions
Our team provides guidance on achieving compliance with the EU Biocide Regulation and preparing for authority inspections.
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Comprehensive Support
We offer support with national obligations (EU 528 2012), including product notifications in your country.
EU Biocide Regulation Overview
Understand the complexities of EU BPR and ensure that your company is compliant with it’s various requirements
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EU BPR
- The EU Biocidal Products Regulation 528/2012 (BPR) governs the use of biocides, imposing obligations on manufacturers, suppliers, and users.
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Scope
- The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) covers active substances, biocidal product authorisations, and treated articles, requiring manufacturers to demonstrate efficacy while minimizing risks.
- The regulation applies to a wide range of biocidal products, including disinfectants, preservatives, pest control agents, and antifouling products.
- It aims to harmonise the market, enhance protection, and promote alternative, less harmful substances.
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Requirements
- All biocidal products and their active substances must be authorised and approved before entering the EU market.
Our Bespoke Biocide Solutions
Personalised Guidance
Our team provides tailored advice from initial compliance strategies to ongoing regulatory updates, ensuring you stay ahead in the constantly evolving landscape.
Continual Support
Choose H2 Compliance for a partnership that prioritises your unique challenges and delivers solutions that meet your specific biocidal needs.
Meet Our Biocide Expert
Dedicated professionals guiding your compliance journey.
Mary Kerley |B.SC, CAPM|
Consultant II
Dublin, Ireland
Frequently Asked Questions
There are two main steps to be considered for getting a biocidal product approved under the BPR
- Active Substance Approval: The active substance must be approved for use in the relevant product type
- Product Authorisation: The product must be authorised at either national, mutual recognition, or Union level.
If the product contains an active substance intended to destroy, deter, render harmless, or exert a controlling effect on any harmful organism, it likely requires BPR compliance.
The substance manufacturer must prepare a technical and scientific dossier. This dossier must be submitted to the evaluating Competent Authority (CA) or Rapporteur Member State (RMS) for that active substance. The RMS evaluates and prepares a draft Competent Authority Report (CAR) of the submitted data that also contains a proposal on the decision to approve or non-approve the active substance.
There are several different types of product authorisation under the BPR?
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- National Authorisation – For one EU country.
- Mutual Recognition – Extends authorisation to other EU countries.
- Union Authorisation – Single authorisation valid across the entire EU.
A product dossier must be submitted for the Product Type required. Such a dossier is typically composed of the following elements:
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- Active substance detail
- Product formulation
- Efficacy studies
- Human and environmental risk assessments
- Proposed labelling and instructions for use
Evaluation can take 2-4 years, depending on the complexity and completeness of the dossier.