Navigating the BPR Authorization Process: A Comprehensive Guide
Embarking on the BPR authorization process (Regulation (EU) no. 528/2012) can feel overwhelming, but with careful planning and the right information, you can successfully navigate this complex process. Here’s a step-by-step guide to help you understand the requirements:
1. Initial Assessment of the Active Substance:
Before you begin, your active substance must undergo a rigorous evaluation. Competent authorities will determine if it meets the safety standards outlined in the Biocidal Products Regulation (BPR) for your intended biocidal uses.
2. Continuous Monitoring:
Once the evaluation process is underway, it’s crucial to stay updated on the opinions of the Biocidal Products Committee (BPC). A positive opinion on your active substance is a green light to start developing your authorization strategy.
3. Tailored Strategy:
Developing a robust strategy is essential before submitting your formal application. Consider factors such as the specific requirements of your product, technical and economic feasibility, and the resources needed. Anticipating potential hurdles will help you be better prepared.
4. Active Substance Approval:
Once the European Commission approves your active substance, you’ll have a specific timeframe to submit your authorization application. Don’t miss this crucial deadline.
5. Application Preparation:
Preparing your application is a complex task that requires extensive documentation. You’ll need to conduct thorough tests, assess the safety of your product, and compile a detailed technical dossier.
- Testing: Tests will be conducted to evaluate your product’s efficacy and its physicochemical properties.
- Risk Assessment: The risks to human health, animal health, and the environment will be assessed.
- Technical Dossier: This document compiles all relevant information about your product, including test results and safety assessments (IUCLID, SPC and PAR).
6. Submission:
Once you’ve completed all the necessary documentation, you can submit your application to the competent authority of a Member State. Clearly indicate the countries where you intend to market your product.
7. Date of approval
When the deadline for the approval of the active substance arrives, our authorization application must already have been submitted. Failure to submit the application and/or lack of prior national authorization for our products will prevent us from continuing to market them.
8. Transitional period:
During the transitional period, we can continue marketing our products provided they meet the criteria established by submitting the BPR application on time and holding the corresponding national authorization (Directive 98/8/CE). Otherwise, we have a 6-month grace period for continued marketing followed by an additional 6 months to ensure the complete withdrawal of our products from the market.
9. Authorization of our biocidal products
Following the evaluation of our BPR application and our response to the competent authority’s requirements, we will receive authorization to market our products. This authorization is typically granted within four to five years of the initial application
10. Renewal of the authorization
Remember that BPR authorizations are valid for 10 years and must be renewed periodically.
Need Assistance?
If you find yourself navigating this process and require expert guidance, don’t hesitate to contact us. Our team can assess the feasibility of your project and guide you through the entire BPR authorization process.
Why Choose Us?
- Experience: We have years of experience in handling BPR applications.
- Technical Expertise: Our team is highly qualified and up-to-date on the latest regulatory requirements.
- Personalized Service: We tailor our services to meet the specific needs of each client.
More links: BPR Regulation
