Active substance approval/prolongation
The application for approval or renewal of an active substance is the first major step for being allowed to sell biocidal products. Within the frame of an application you need to generate basic data for the properties of the active substance and a sample formulation ("Dummy-Product") and have this data scientifically evaluated and summarized.
The following data is required (Annexes II & III of BPR):
- Physical-Chemical properties
- Technical properties
- (Human) Toxicology
- Environmental Fate and Behaviour
Together with our partner laboratories we are able to perform all necessary tests. The results will afterwards be evaluated by our experienced scientific experts "in-house". Our primary goal is to inform and educate our clients as well as possible so that they can gain the knowledge and understanding necessary to make the significant business decisions about the products.
We offer a holistic support where we deal with all aspects of the processes as well as support for single activities including:
- Communication with authorities
- "Data-Gap-Analysis" and test-strategies
- Literature search
- Negotiations with data holders
- Placing and monitoring studies
- Preparation of the technical dossier (IUCLID 6)
- Preparation of a scientific assessment and summary
- General support throughout the authorisation process
Feel free to contact us with any questions related to this topic.