Biocides
From active substance approval to product authorisations… We offer the strategic and regulatory insights and scientific knowledge required to support the implementation of your Biocidal Product Regulation (BPR) obligations.
Apeiron-Team is your partner for your BRP obligations on national and European level.
Data Gathering
Data
Analysis
Report Generation
Report Submission
Biocides
Together with Apeiron, your actual needs can be determined and a sound, future-proof, biocidal product strategy can be developed. The best-suited strategy will be established and put into practice.
A plan is drafted by evaluating your product composition, the regulatory status of the active substances present in your product, your full product portfolio, the intended uses and a wish list of the Member States where you want to place your products on the market.
WITHIN SUCH A PLAN THE FOLLOWING IS PRESENTED:
- The impact of active substances status on the applicable process,
- An insight in what your future biocidal product portfolio could look like,
- A proposal on the most appropriate application type, Union vs National authorisation, with or without mutual recognition,
- Data gap analysis,
- The impact of hazardous substances present in your products: SoCs? EDs?
- All you need in function of decision making.
Contact our expert
The regulatory landscape for biocides is complex and sometimes overwhelming, let us help you.
Tine Vandenbrouck
Contact Our Expert.
Biocidal products for which the active substance(s) are not yet approved but still under evaluation within the Review Program can be placed on the market when compliant to transitional (national) rules.
The advantage of this situation is that once the substance is approved and a new BPR dossier has been submitted, you may remain on the market during the evaluation phase of your new BPR dossier. However, the diversity of requirements, timelines and costs associated with the different processes in the different Member States under the transitional regime is enormous.
Is the active substance present in your biocidal product about to be approved? Or do you wish to market a biocidal product with an active substance that’s already approved? Together we can build your biocidal product authorisation dossier following the BPR requirements.
NATIONAL OR UNION DOSSIER BUILDING
Apeiron-Team holds all the expertise to build both single product dossiers as biocidal product family (BPF) dossiers, from A to Z. This includes:
- Think through the set-up of your BPF and metaSPCs,
- Data gap analysis,
- Study monitoring,
- IUCLID dossier building, incl. waiver generation,
- Exposure and risk assessment: human health & environment,
- Determination of SoC & evaluation of endocrine disrupting properties,
- Generation of draft PAR,
- Discussions with authorities throughout the process.
Start well and ensure the active substance used in your biocidal product is Art. 95 listed.
Are you interested in becoming an active substance supplier or biocidal product producer? We can help you to become Art. 95 listed.
THIS MEANS WE TAKE ON THE FOLLOWING TASKS FOR YOU:
- Contact data holders for verification of the Letter of Access Terms,
- Evaluate the substance identity profile of the approved Active Substance compared to your substance composition,
- When required, perform a technical equivalence assessment.
Contact our expert
To get your substance Art.95 listed in the right way.
Tine Vandenbrouck
Contact Our Expert.
Name it and we provide you with the support needed!
- Generation of a new active substance dossier,
- Support during the evaluation of your active substance dossier,
- Support in function of the renewal of your current active substance dossier,
- Or anything in between!
Contact our expert
To let us help you update specific sections of your dossier, generate additional exposure or risk assessments, monitor studies, …
Tine Vandenbrouck
Contact Our Expert.
Is your biocidal product authorisation about to expire or is your active substance up for renewal?
APEIRON-TEAM CAN SUPPORT YOU TO:
- Generate the newly required information,
- Update your dossier to the latest requirements,
- Check the status of your dossier in the function of ED (endocrine disrupting properties),
- Generate risk assessments for new uses.
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For any questions you may have on renewal of biocidal product authorisations.
Tine Vandenbrouck
Contact Our Expert.
Placing an article on the market which has been treated with or intentionally incorporates a biocidal product is subject to the requirements set out by the BPR. Not sure what to do or whether this applies to you? Read on…
Articles treated with biocidal products can only be placed on the market when containing active substances approved in the EU. This requirement applies since the 1st of September 2013! Furthermore, when you place a treated article on the market, you need to verify whether specific labelling requirements apply to you. In addition, you must be ready to communicate the necessary information to consumers.
WE CAN HELP YOU TO:
- Evaluate whether the treated article definition is fulfilled for your product,
- Identify your obligations,
- Define whether the relevant conditions are fulfilled for placing your treated article on the market.
Contact our expert
If you want to find out more!
