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Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) controls the sale and use of all types of biocidal products which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. These substances and biocidal products have to be authorized before being used or sold on the European Union market1.
Historically each European country has set its own rules as to the way biocidal products are handled and registered within its borders. Now and in the future, the Biocidal Products Regulation (BPR) will create a pan-European consistency in the way we deal with biocidal products.
There are 22 product types (PT) of biocidal products that are regulated under BPR2. PT 1 to 5 cover disinfectants and biocidal products for consumer or professional cleaning and hygiene applications.
Before biocidal products can be authorized by the European Chemicals Agency (ECHA), the active substances contained in those products, as well as the suppliers of these substances, must first be approved. This is a lengthy process, whereby many substances are reviewed, one by one, to ensure their efficacy and safe use.
Consumer or professional users of antimicrobial products or disinfectants may notice little of BPR if the suppliers of these products have ensured that they are compliant with the new regulation. Users may see some changes on the labels, such as different dosing or stricter use instructions as a result of the tighter safety and efficacy requirements.
Products currently in use may continue to be used until the active substance in the product has been reviewed by ECHA. If the active is not approved, all products with that active must be removed from the market. If the active is approved, all products with that active should still be submitted for authorization. If authorization is not requested or is not granted, the product may no longer be sold or used, with a grace period of 6 months for sale and another 6 months for final use.
1 ECHA PRACTICAL GUIDES ON BIOCIDAL PRODUCTS REGULATION – Approval of active substance