The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use 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.
Biocides are used to protect humans, animals and materials against harmful organisms such as viruses, bacteria and mould. The European Union regulates the placing on the market and use of biocides via its Biocidal Products Regulation (EU) 528/2012 – the BPR.
The BPR defines rules for the approval of active substances in biocidal products, the authorisation of biocidal products containing such active substances and for the supply of treated articles in the European Union.
Silver substances have been under review as active substances for use in disinfectants and preservatives for materials. The aim of such review is to determine whether active substances are safe for use as biocides with respect to human and animal health and the environment and whether they have efficacy against organisms they intend to control.
Once an active substance is approved under the BPR, biocidal products containing such active substance must be authorised prior to being placed on the market. The authorisation process aims to show that the biocidal product is safe for the environment, human and animal health.
The BPR also sets rules for the placing on the market of so-called "treated articles". Treated articles cover any product treated with, or intentionally incorporating, one or more biocidal products. Treated articles can only be treated with active substances which have been approved under the BPR for this specific use. Moreover, the BPR requires manufacturers and importers of treated articles to label treated articles when they claim that the treated article has biocidal properties or when the conditions of the approval of the active substance used to treat the article require so.