Biocides dossiers for disinfectant cleaning products: basics and specific issues
Disinfectant cleaning products are not only cleaning products, but also biocidal products. As such, they are regulated by a specific European regulation. Their active substances have to be approved at the European level, and the products need to be authorized at the national level. For biocidal products, data is required on storage stability, physico-chemical properties, analytical methods, efficacy, toxicological and ecotoxicological properties. This data is used to prepare human and environmental risk assessments. Specific tools such as IUCLID and SPC Editor must be used, and all the demands are submitted through the R4BP platform.
Cleaning products are widely used in our private and/or professional environments. Where such products also make claims of disinfectant properties they are considered as biocidal products and must comply with Regulation (EU) No. 528/2012 (Biocidal Product Regulation, BPR) which concerns the making available on the market and use of biocidal products. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for human and animal health, and the environment.
To achieve this, the BPR uses a two-stage approval and authorisation process prior to placing biocidal products on the market. Firstly, the active substance(s) in a product need to be approved at the EU level and then, after all active substances within a product are approved, the product requires authorisation at the national or EU level.
ACTIVE SUBSTANCE APPROVAL
Active substances don’t simply require approval; they need to be approved for the specific product type in which they will be used. There are twenty-two product types (PTs) split over f ...