Biocides Regulation
Comprehensive solutions for authorisation and commercialisation of biocidal products in the European Union.
Biocides Regulatory Services
Experts in regulation for chemical products designed to protect human and animal health
In the EU, biocidal products may only be placed on the market once approved by the competent authorities of the Member States in which they are to be distributed.
Since September 2013, the placing on the market and use of biocidal products has been regulated by the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012), which repeals the Biocidal Products Directive (Directive 98/8/EC) with a transitional period for certain provisions.
REACH Monitor offers specialised assistance to navigate this complex regulatory landscape, ensuring your products meet all applicable requirements and can access the market efficiently.
Two-Stage Authorisation Process
Under the BPR, obtaining authorisation for placing a product on the market follows two fundamental stages
Active Substance Approval
Evaluation and approval of the active substance and product type combination at European Union level, including its inclusion in Annex I where applicable.
Biocidal Product Authorisation
Obtaining authorisation for the specific biocidal product, either at EU level (Union authorisation) or at Member State level (national authorisation).
Biocidal products containing active substances under the review programme remain subject to national laws during the transitional period. They may be placed on the market and used (if they comply with national laws) pending the final decision on active substance approval and until the specified deadline.
Our Regulatory Services
Complete solutions for every stage of the biocides authorisation process
Authorisation Strategy
We design the optimal strategy for marketing your products in the European market, maximising the chances of success and minimising costs and approval times.
- Analysis of specific requirements for your product
- Selection of the most appropriate authorisation route
- Timeline planning for the complete process
- Estimation of regulatory costs
Deadline Management
We ensure your applications are submitted within established deadlines, actively monitoring regulatory timelines and anticipating regulatory changes.
- Monitoring of review programme deadlines
- Control of applicable transitional periods
- Alerts on critical regulatory deadlines
- Early preparation of required documentation
Transitional Period
We help you navigate the complex requirements of the transitional period while the review programme for existing active substances is completed.
- Assessment of specific national requirements
- Preparation and submission of national notifications
- Management of registrations and renewals during the transition
- Adaptation to new requirements when substances are approved
Active Substance Approval Process
Notifications and Consultations
We manage all initial communications with authorities, including notifications and pre-submissions to determine the specific requirements applicable to your active substance.
Approval Applications
We prepare and submit complete applications for the approval of active substances, including all technical and scientific documentation needed to demonstrate their safety and efficacy.
Technical Equivalence
We evaluate and document the technical equivalence of your substances with reference substances, facilitating the approval process and minimising additional testing requirements.
Inclusion in Annex I or Article 95
We assist in the process of including your company or substance in Annex I or the Article 95 list, essential elements for placing biocidal products on the EU market.
Review Programme Assessment
We analyse the status of your substances in the EU review programme and establish strategies to optimise the process and outcomes.
Chemical Similarity
We evaluate and document the chemical similarity of your substances, allowing you to access existing data and significantly reduce testing costs.
Renewals
We manage the renewal process for active substance approvals, ensuring continued market access for your products.
Once the active substance is approved, biocidal products containing it require specific authorisation to be placed on the market. REACH Monitor offers complete support for all types of product authorisation:
Union Authorisation
We prepare and manage applications for the Union authorisation, allowing your products to be marketed throughout the EU through a single application process.
- Eligibility assessment for Union authorisation
- Preparation of the complete dossier in R4BP3 format
- Communication with ECHA and evaluating authorities
- Follow-up throughout the evaluation process
National Authorisations
We prepare specific applications for each country where you wish to market your products, adapting to the particular requirements of each national authority.
- Authorisation of individual products
- Authorisation of biocidal product families
- Parallel or sequential mutual recognitions
- Simplified authorisations where applicable
Change Management and Trade
We manage all post-authorisation aspects, including modifications, updates and ongoing compliance.
- Minor and major changes to authorised products
- Authorisations for identical biocidal products
- Parallel trade permits
- Combinations of biocidal products
The preparation of a complete and robust technical dossier is fundamental to a successful authorisation process. Our team of experts in toxicology, ecotoxicology and chemistry manages all technical aspects:
Data Collection and Evaluation
We comprehensively collect and evaluate all available data, including literature research, to reduce the need for new tests.
Intelligent Testing Strategies
We develop Intelligent Testing Strategies (ITS) to minimise unnecessary testing, reduce costs and approval times.
- Laboratory contracting and monitoring
- Scientific justifications for data waivers
- QSAR model development
- Read-across approaches
Risk Assessment
We perform comprehensive risk assessments for users, the general public and the environment, demonstrating the safety of your product under normal conditions of use.
Technical Documentation
We prepare all required technical documentation according to specific BPR formats and standards.
- Fully documented IUCLID dossiers
- Draft Assessment Reports (PAR)
- Summary Product Characteristics (SPC)
- Submissions via R4BP3
We offer continuous assistance after submission, managing all communications with regulatory authorities and responding to requests for additional information.
Product Portfolio Assessment
We analyse your complete biocidal product portfolio to identify opportunities, regulatory risks and establish action priorities.
- Analysis of current regulatory status
- Identification of critical dates and deadlines
- Regulatory compliance assessment
- Identification of data and documentation gaps
Regulatory and Legal Advice
We provide expert advice on all regulatory and legal aspects related to biocidal products.
- Interpretation of regulations and guidelines
- Analysis of authority decisions and precedents
- Evaluation of regulatory alternatives
- Long-term compliance strategies
Compliance Audits
We carry out comprehensive audits to verify compliance with all BPR requirements and related regulations.
- Labelling and SDS audit
- Review of notifications and registrations
- Verification of composition conformity
- Regulatory risk analysis
Management, Research and Development Services
Advanced solutions to optimise processes and develop innovative strategies
Management Services
- Consortium Management for cost sharing and resource optimisation
- Coordination and management of multidisciplinary work teams
- Data sharing negotiations between multiple parties
- Specific solutions for the post-Brexit market
R&D Services
- Development of specific protocols to adapt legal requirements to particular technical properties
- Design and coordination of efficacy tests under semi-field/field conditions
- Collection and analysis of real data under market conditions
- Research into alternatives to problematic substances