Authorisation of your biocidal product under BPR
You would like to market a biocidal product with your own data? We can develop the optimal procedure for obtaining product approval in Europe (Union authorisation) or in individual European member states (national authorisation). Together with you, we develop an optimal test strategy, supervise the tests and discuss the results from an (eco-) toxicological point of view in the product application dossier.
work flow
- Joint definition of the strategy to obtain product authorisation
- Determination of the cost-optimized test strategy, taking literature data, study management and monitoring into account
- Consultation with competent authorities
- Physicochemical data, efficacy against target organisms, toxicology, ecotoxicology, exposure and risk assessment: compilation of the dossier
- Submission of the application for authorisation to the authorities (ECHA / competent national authorities)
We also offer biocide training courses tailored specifically to your needs – for example for entering substance data in IUCLID or for handling ECHA’s R4BP portal.
Options for cost optimization in the approval of a biocidal product
The extensive requirements and associated costs of a biocidal product authorisation under the BPR can appear prohibitive for some manufacturers of biocidal products or active substances, especially for so-called SMEs (small and medium-sized enterprises). However, the BPR also offers possibilities for cost reduction in the approval of a biocidal product. For example:
- reduced fees for SMEs
- Multiple trade names for a single registration number
- Mutual recognition (MR, parallel or in sequence)
- Union Authorisation (UA)
- same biocidal product authorisation (SBP)
- Parallel trade
We will be happy to examine whether an option for cost reduction is suitable for you, so that your product can remain on the market under the BPR. Please contact us at biocides@cfcs-consult.de.