Approval and Renewal of Active Substances
The application for approval or renewal of a biocidal active substance is the first important step in the marketing of biocidal products.
The application must generate basic data on the properties of the active substance and a sample formulation ("dummy product"). The data generated must be scientifically evaluated and summarized.
Data essentially covers the following areas (Annex II & III BPR):
- Physico-chemical properties
- Technical properties
- Effectiveness
- Toxicology
- Ecotoxicology
- Environmental Fate and Behaviour
Together with our partner laboratories we are able to carry out all necessary tests. Subsequently the results are evaluated "in-house" by our experienced scientific experts.
It is our primary goal to provide our customers with the best possible information in order to give them an understanding of the complex processes involved, so that they can best determine the economic efficiency of the products and make a viable decision for the products.
We offer both comprehensive support in all aspects and support in individual steps of the process.
Our Services at a Glance
- Contact with authorities
- "Data gap analysis" & test strategies
- Literature search
- Communication with data owners
- Commissioning and monitoring of studies
- Creation of the technical dossier (IUCLID 6 data set)
- Preparation of a scientific evaluation and summary
- Supervision/ support during the approval process
Contact us today to find out more about our
Approval and Renewal of Active Substances services.
We manage your
regulatory challenges.
Contact us with specific questions, a defined project or as a full-service partner for your regulatory needs.