EU BPR Compliance

Background of the EU BPR

In order to ensure the safety of biocidal products and to protect human health and the environment, the EU issued the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), which is a regulation on the marketing and management of biocide products. Under the BPR, the European Chemicals Agency (ECHA) is responsible for the approval of biocide active ingredients and assists in the authorization of biocide products at the EU level. The sale and use of all types of biocidal products in the EU must be authorized by the competent authority and the active substance contained in the biocidal product shall be approved.

The EU BPR regulation regulates biocidal active substances and biocidal products, as well as biocide-treated articles. The inclusion of biocide-treated articles in the BPR regulation has had a significant impact on many downstream companies of preservatives, disinfectants, etc.

About Us

Our company provides expert guidance and support to help you fulfill your current and future obligations under the EU BPR, thereby accelerating your biocidal products' entry into the EU market.

As a leading provider of regulatory compliance services for the EU chemical and biocide industries, we have established a team of qualified and experienced EU regulatory experts, toxicologists, and scientists. We evaluate your biocidal products and develop the most suitable compliance path and strategy for your business to overcome the EU BPR compliance barriers and expand your market. In addition, we provide ongoing attention and follow-up on EU BPR technical guidance documents to help relevant enterprises cope with the complex EU regulatory environment.

Our EU BPR Compliance Services

We provide extensive technical and regulatory support to our clients at all stages of the project. We help manufacturers, importers, or exporters of active substances, biocidal products, and treated articles clarify compliance requirements under the EU BPR and provide corresponding compliance strategies. Our services include but are not limited to:

• Only representative under EU-BPR
• Communication with ECHA and/or competent authorities
• EU-BPR regulatory consultation and monitoring of relevant regulatory developments
• Compliance strategy analysis report
• Data gap analysis
• Status verification of all active substances
• Preparation of new active substance approval dossier
• Application for active substance approval
• Preparation and submission of applications for inclusion in the article 95 active substance supplier list
• Preparation of biocidal product documents for national and union authorization
• Product authorization application
• Transitional member state registration of biocide products
• Submission of applications for authorization changes
• Post-submission support (addressing additional information queries/requests from ECHA and/or competent authorities)
• Technical equivalence (TE) application
• Lab screening and test supervision
• Safety data sheet and labeling generation for biocidal products
• Renewal of authorization applications

Our Advantages

• Regulatory expertise: Our biocide regulatory experts have rich experience in dealing with the complex regulatory environment of the EU BPR.
• Superior resources of authority and laboratory: We have established good relationships with GLP laboratories, ECHA, EU national authorities, and numerous associations/consortia/task forces.
• Ongoing support: We provide ongoing support and guidance throughout the project and beyond to help companies fully comply with EU BPR regulations.

If you need help or have a question, please feel free to contact us for more details.