The biocid SAXOCON team consists of 3 former toxicologists at Danish Environmental Protection Agency.
In 2012 the harmonized European regulation of biocidal products was introduced with the Biocidal Products Regulation (EU) No 528/2012 (BPR), which has increased the scope of biocidal active substances and the obligations of the industry. So whether you market a biocidal active substance, a biocidal product, a precursor that could be used to generate an active substance, an article that has been treated with a biocidal product or simply make a claim that is considered biocidal, a market authorization is needed.
The SAXOCON team can help you understand what your obligations are and advice you in the strategical aspects of planning the market authorization in order to achieve regulatory compliance.
- Human health hazards
Assessment of the possible health hazards of the biocidal active substance or product for all required toxicological endpoint and according to the current data requirements.
- Human exposure assessment
The human exposure assessment can vary significantly depending on the product type and market application. The SAXOCON team includes specialists within the human exposure of biocidal products, who are experienced users of the current exposure scenarios and computational tools.
- Study management
Should further toxicological testing be needed, we can offer guidance in choice of vendor, method and other test parameters, and act as sponsor.
The issue of purity is increasing in the biocidal active substance assessments and for this the computational toxicology is essential to assess the mutagenicity of impurities. The technique can also be applied to application for technical equivalence for the inclusion of a chemical source to the Article 95 list