Under the Biocidal Products Regulation, active substance approval is a key part of the regulatory pathway. For companies formulating or placing biocidal products on the EU market, it provides an essential starting point for assessing what may be possible.
A biocidal product containing an approved active substance still needs to be considered in its own regulatory context. Under the BPR, market access depends on several connected elements: the status of the active substance, the Article 95 position, the relevant product type, the intended use, the formulation, the claims, the user category and the envisaged authorisation route. When these elements are considered together, they provide a much stronger basis for a practical, defensible and efficient route to market.
Triskelion helps companies translate active substance status into a clear product authorisation strategy. With regulatory consultancy, dossier support and in house scientific expertise under one roof, we support BPR decision making from early route selection through to submission and beyond.
If you are unsure whether your active substance status, Article 95 position and product authorisation route align, Triskelion can help clarify the next step. Discuss what this means for your product with Isabel van Laanen.
A biocidal active substance is the ingredient that enables the product to act against harmful organisms. Under the BPR, active substances are assessed at EU level for specific product types. That means the approval is not a general permission for every product or every use. It applies to defined active substance and product type combinations.
Product authorisation then brings the assessment to the product level. The final formulation, intended use, exposure profile, efficacy, labelling, user category and risk profile all affect the authorisation strategy. A disinfectant for professional use, a preservative in an industrial system and an insecticide for consumer use will require different regulatory considerations, even when the same BPR framework applies.
This is why the first practical question is rarely only whether the active substance is approved. The more strategic question is whether the approved active substance status supports the specific product, use pattern and market route you are considering.
Under Regulation (EU) No 528/2012, market access for biocidal products depends on several connected regulatory layers. Active substance approval concerns the substance and the relevant product type. Article 95 compliance concerns access to the active substance dossier through an eligible substance supplier or product supplier for that product type. Product authorisation concerns the biocidal product itself, including its formulation, efficacy, risk assessment and proposed conditions of use.
For product authorisation, companies may need to consider national authorisation, mutual recognition or Union authorisation, depending on the product, intended markets and conditions of use. For the Dutch market, Ctgb is the competent authority responsible for national biocidal product approvals. For EU wide market access, the assessment of a Union authorisation may be carried out by a competent authority in another Member State.
The choices to be made here matter because a product may appear straightforward from a formulation perspective while still requiring a careful regulatory route decision.
This question becomes relevant when you are preparing to introduce a new biocidal product in the EU, or when you are changing formulation, use or product claims.
It is also relevant when a supplier confirms that an active substance is approved or Article 95 covered. Those confirmations are relevant in themselves, though they remain part of a broader product level assessment. Checking product type alignment, efficacy requirements, exposure scenarios and market strategy at an early stage helps avoid unnecessary delays later in the process.
Triskelion supports manufacturers, formulators, suppliers and regulatory affairs teams with BPR questions from early strategy through to dossier submission. Our focus is on clarifying what is already covered, what still needs to be demonstrated and which route is proportionate for the product and market plan.
Our support can include active substance and product type checks, Article 95 strategy, data gap analysis, efficacy testing strategy, toxicological and ecotoxicological input, dossier preparation, submission support through R4BP and interpretation of how the European BPR framework connects to Ctgb procedures.
The value lies in the combination of regulatory interpretation, scientific expertise and project coordination. Regulatory insight determines which data are needed. Scientific expertise helps ensure that the data answer the right questions. Project coordination keeps the route manageable before the dossier becomes too advanced to adjust efficiently.
For this type of BPR question, the method is a regulatory assessment rather than a laboratory method. Triskelion typically starts by mapping the active substance, product type, supplier position, intended use, target organism, user category, formulation and intended markets.
From there, we assess which authorisation route may be appropriate and which data package is needed to support it. This may include efficacy data, toxicological information, exposure considerations, risk assessment elements, labels, summaries of product characteristics and dossier documents required for submission.
The outcome is a clearer route to authorisation, with fewer assumptions between active substance status and product level compliance.
No. Active substance approval is only one part of the BPR framework. The product itself still needs to be assessed through the relevant authorisation route.
Active substance approval concerns whether the use of a substance is authorised for a specific product type. Article 95 concerns whether the relevant supplier is listed for access to the active substance dossier. Product authorisation concerns the specific biocidal product, including its formulation, efficacy, risk assessment and conditions of use.
The product type defines the intended biocidal use. Active substances are assessed in relation to product types, and product level data requirements depend on how and where the product will be used. Correct product type alignment is therefore crucial to the authorisation strategy.
Ctgb is the competent authority for biocidal product authorisation in the Netherlands. If the Dutch market is part of your strategy, Ctgb procedures, national assessment expectations and timelines should be considered early within the wider EU BPR route.
If you are unsure whether your active substance status, Article 95 position and product authorisation route align, Triskelion can help clarify the next step. Discuss what this means for your product with Isabel van Laanen.
