Active substances – Approval
Approval of a biocidal active substance:
Your biocidal active substance needs to be included in the list of approved active substances? Together with you we will work on the optimal approach to meet the extensive data requirements for active substance approval. In addition to new studies, existing/literature data are also used. This data gap analysis will be discussed and agreed on with the competent national authority. Moreover, we can support you in the selection of suitable test laboratories and perform the study monitoring on request. We evaluate the studies, discuss the results, estimate exposure, assess the resulting risks and prepare the dossier (IUCLID).
- Joint definition of the approval application strategy
- Research, data gap analysis and definition of the cost-optimized test approach
- Mandatory consultation with competent authority
- on request: study management and monitoring
- Toxicology, ecotoxicology, efficacy against target organisms, discussion of all endpoints and documentation of the studies in the dossier (IUCLID)
- Exposure assessment, risk assessment and documentation in dossier
- Completion of the application for approval
- Submission of the application to the authorities (ECHA / national authorities) via R4BP
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.