The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) relates to the commercialisation and use of biocidal products, which are utilised to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of active substances contained in the biocidal product.
Active substances need to be approved before authorisation for commercialising a biocidal product containing them can be granted. The approval of an active substance is granted for a defined number of years, not exceeding 10 years and is renewable.
It should be noted that the Biocidal Products Regulations also contains provisions that apply not only to biocidal products but also to manufactured goods if they have been treated with or incorporate a biocidal product. Article 58(2) of the Biocidal Products Regulations specifies that a treated article can only be placed on the EU market if it has been treated with active substances which have been approved in the EU for that purpose.
Manufacturers of non-compliant treated articles can:
i) switch to substances that are approved. A list of approved products is available here: http://echa.europa.eu/information-on-chemicals/biocidal-products
ii) undergo evaluation in the EU or submit either themselves or through a third party, an application for the approval of the active substance used to the European Chemical Agency by 01 September 2016. Further details on how to submit an application are available on the Agency’s website: http://echa.europa.eu/support/dossier-submission-tools/r4bp.