Biocidal products are regulated to ensure they are used safely and effectively, and to minimize their risks to human health, animal health, and the environment. If you are looking for services to help you comply with the Biocidal Products Regulation (BPR), it is important to understand that the BPR (EU) 528/2012 is a regulatory framework that controls the placing on the market and use of biocidal products, which are used to protect humans, animals, materials, or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. The BPR regulation came into force from 1 September 2013, repealing the previous Directive 98/8/EC. The regulation of biocidal products involves several key services, including:
1. Product Authorization: Before a biocidal product can be placed on the market, it must be authorized. This involves a thorough assessment of the product's efficacy, safety, and potential risks. The authorization process may vary depending on the region-for example, in Great Britain, products are regulated under the GB Biocidal Products Regulation (GB BPR), while in Northern Ireland, the EU Biocidal Products Regulation (EU BPR) applies. We are supporting on how to apply for authorization of biocidal products under the BPR, including the preparation and submission of dossiers.
2. Evaluation of Active Substances: Active substances contained in biocidal products must be evaluated and approved. This evaluation assesses the risks and benefits of the substance when used in biocidal products. We support in the application process for the approval of active substances used in biocidal products.
3. Risk Assessment: Support in conducting risk assessments for human health and the environment as part of the authorization process. Help with the preparation of chemical safety reports and exposure scenarios.
4. Efficacy Assessment: Assistance in generating and evaluating efficacy data to demonstrate that the biocidal product is sufficiently effective as required by the BPR.
5. Dossier Preparation and Submission: Assisting with the preparation, submission, and follow-up of dossiers to the relevant authorities.
6. Labeling compliance: Ensuring that the labeling of biocidal products meet the requirements set out in the BPR.
7. Safety Data Sheet (SDS) preparation: We support in CLP compliant SDS preparation.
8. Letter of access and Data Protection: We can support in preparing letter of access and guide on how to comply with data protection requirements under the BPR.
9. Supply Chain Compliance: Ensuring that active substances are sourced from suppliers listed in Article 95 of the BPR.
10. Mutual Recognition & National Regulations: Assistance with the mutual recognition process in the EU for biocidal products. Guidance on how to comply with national regulations that apply to biocidal products in specific EU Member States or regions, such as Great Britain or Northern Ireland post-Brexit.
These services are part of a comprehensive regulatory framework designed to ensure that biocidal products are used safely and responsibly, while also facilitating their availability on the market. It is crucial to work with a service provider that has expertise in the field of biocidal products and is up-to-date with the latest regulatory requirements and guidance documents. Compliance with the BPR is essential not only for legal reasons but also to ensure the safety of users and the environment.