Simplify Regulatory Compliance for Your Biocide Products
Tailored guidance from a dedicated team of experts to ensure full compliance for your biocide products.
Comprehensive Support at Every Stage of Biocide Compliance
Efficient authorization support for your Biocidal Products
Ensure compliance with transitional biocidal product regulations with our expertise.
- Identification of regulatory requirements
- Comprehensive assessment and updates of product documents (SDS, labels, etc.)
- Notifications and national transitional authorizations
- Anticipation and adaptation to BPR data requirements
Accelerate your product’s market entry with our full-spectrum MA solutions:
- National, EU, simplified, identical product & mutual recognition authorizations
- Development of tailored MA strategies
- Design of test plans
- Creation & submission of product or family dossiers
- Management of technical equivalence
- Post-submission regulatory support
- Dossier renewal services
- Exemption and substitution dossier management
Enhance compliance efficiency by joining a biocide consortium, optimizing costs and resource allocation.
- Joint submission of MA dossiers
- Cost-sharing benefits
- Streamlined resource management
- Reduced lead times
- Customized regulatory strategies
- Confidentiality and legal protection
- Ongoing substance approval monitoring
Regulatory Strategy Consulting
• Strategic diagnosis for a biocide product Marketing Authorization (MA)
• Marketing: regulatory cost, budget, timelines, and deadlines
• Compliance of approved suppliers
• Completion of data gaps in efficacy, physico-chemistry, toxicology, and ecotoxicology
• Review of active substances in your product portfolio (analysis of approval dates for SA/TP pairs, obligations of the market operator…)
Personalized Regulatory Consulting with EcoTeam
Project analysis and monitoring
On-demand expert consultation
Custom consulting packages
Why choose EcoTeam consulting for your chemicals?
In-house
With EcoMundo
Trusted by industry leaders
Frequently asked questions
What is the difference between transitional and authorization period for biocidal products?
- Transitional Regime: Applies to biocidal products containing active substances under evaluation. These products can still be marketed under national regulations until approval is granted.
- Authorization Period: Once all active substances in the product are approved, it must receive Biocidal Products Regulation (BPR) authorization (EU regulation No. 528/2012) before market entry.
What happens if a biocidal product (BP) contains two active substances (AS) or two product types (TP)?
In this case, compliance is determined by the latest approval date of any active substance present in the formulation.
What are the costs involved in submitting a Marketing Authorization Application (MA)?
The costs of registering a biocidal product/family include:
- Laboratory testing expenses for the necessary studies
- EcoMundo’s service fees for MA dossier preparation and submission
- Evaluation costs charged by national authorities (e.g., ANSES in France)
- Data purchase fees from active substance suppliers
Can I freely select an active substance (AS) supplier for my biocidal product?
No. Only suppliers listed under Article 95 of the Biocidal Products Regulation can be selected. This ensures that they have participated in the substance approval process.
What are the compliance requirements for articles processed in Europe?
1. Determine whether your product is classified as a biocide or a treated article.
2. Ensure that active substances used are approved or under approval.
3. Conduct necessary tests (standardized or non-standardized) to justify product claims.
4. Check that labeling meets EU regulatory requirements.
