Regulation (EU) No 528/2012, also known as BPR (Biocidal Product Regulation), was established to harmonize the placing on the EU market and the related use of biocides. It simplifies the approval of active substances and product authorizations, promotes the reduction of animal testing, introduces obligations regarding data sharing, and encourages the use of alternative testing methods.
What is considered a biocidal product?
– Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing, or capable of generating one or more active substances, with the purpose of destroying, neutralizing, rendering harmless, preventing the action of, or exerting any other controlling effect on any harmful organism by means other than mere physical or mechanical action.
– Any substance or mixture, generated from substances or mixtures not falling under the above definition, used with the intent of destroying, neutralizing, rendering harmless, preventing the action of, or exerting any other controlling effect on any harmful organism by means other than mere physical or mechanical action.
– A treated article (i.e., a substance/mixture/article treated with or intentionally containing one or more biocides) that has a primary biocidal function is also considered a biocidal product.
Biocides are essential for fighting organisms harmful to human or animal health and those that damage natural or manufactured materials. They typically act against pests, bacteria, viruses, and fungi.
However, biocidal products themselves can pose risks to humans, animals, and the environment due to their intrinsic properties and methods of use. For example, widely used products like alcohol-based hand disinfectants, water treatment and cleaning products, pesticides, insecticides, fungicides in agriculture, preservatives in the wood and paint industries, and rodenticides used to combat rodents and prevent structural damage.
For this reason, we offer specialized support on various topics: preliminary assessments for companies needing regulatory categorization of their biocidal products/treated articles (correct labeling, SDS compliance, management of the transitional period for an active substance not yet approved according to the national legislation of the specific EU country); assistance in Imported biocides by helping clients collect and evaluate supplier information; support on laboratory testing; assistance in the complex preparation of Biocide Authorization Dossiers—including consortium participation and opportunities provided by specific task forces—through to the sales phase, including e-commerce activities and the use of marketing claims.