What is a Biocide Registration?
The EU Biocidal Products Regulation (BPR; 528/2012) concerns “the placing on the market and use of biocidal products. . . by the action of the active substances contained in the biocidal product.” The mere presence of a recognized “active substance” is not sufficient to identify a product as a Biocide; the company placing the product on the market must also be making claims regarding the function or use of the material in order for the product to be subject to this regulation. The BPR, combined with the Plant Protection Products Directive (PPP), would be similar to the US EPA requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA ).
Before a biocide (or pesticide) can be sold, the product must be registered. During the registration process, data must be presented to demonstrate that the material is not unreasonably hazardous to human or environmental health (other than the intended target).
Biocide registration is generally more specific and in depth than a “simple” product registration, in accordance with REACH, etc.
ChemADVISOR Services in Support of Biocidal Product Registration
ChemADVISOR’s experts will complete a product review that involves evaluation of the product (and substances within the product) to identify regulatory requirements for legal sale in accordance with the Biocidal Products Regulation (BPR). The review will summarize the current regulatory status of the any active substances, and further, any other ingredients and the product as a whole. The product re-view stage will identify any gaps that need to be addressed, and steps needed before your material can be legally registered and sold as a biocide.
The BPR outlines a step-wise process, which ChemADVISOR will help clients navigate:
- Active substances must be evaluated and approved for a particular product type
- Chemical similarity to existing active substances may be available through a Technical equivalence request
- After the active substance(s) have been approved, products must be submitted at either a national or Union level for market authorisation