Biocidal active substances and biocidal products
Biocides are developed and used to deter or neutralise harmful organisms. Biocides have a wide range of active substances and applications, for example in disinfection, as a protective agent or for pest control.
Active substances and biocidal products are strictly regulated by law. For market acces, the European Biocidal Products Regulation (EU) No 528/2012 requires considerable effort on the part of the manufacturer: Biocidal active substances must be approved and biocidal products become subject to authorisation – this is the core statement of the Biocidal Products Regulation. This simple statement is about the only simple thing about the legal conditions for biocides.
The inclusion of a biocidal active substance in the list of approved active substances alone requires extensive data requirements and a great deal of background knowledge. The authorization of a biocidal product under the Biocidal Products Regulation (BPR) also requires a complex dossier and extensive tests. Assessing possible options for cost optimization also requires expertise. In addition to the approval under BPR, there is also the so-called transitional regulation, which is not subject to any uniform requirements within the EU. In addition, specific rules apply to the so-called treated articles. Strict regulations regarding labels and safety data sheets must also be observed.
Besides, the BPR also offers advantages. For example: Europe as a uniform sales market, competitive advantage through less competition (selection of suppliers) and high customer satisfaction due to safe, efficient products.