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As of 1 September 2013, the Biocides Directive 98/8/EC was repealed and replaced by the Biocidal Products Regulation (BPR, Regulation (EU) No. 58/2012). The BPR concerns the placing on the market and use of biocidal products which are used to protect humans, animals, materials or articles against harmful organisms by the action of active substances which are contained in the product

From 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, cannot be placed on the EU market if the substance supplier or product supplier is not included in the Article 95 list for the product type(s) to which the product belongs.

Active substances contained in biocidal products must be approved before the product can be placed on the EU market. Companies apply for approval by submitting a dossier, prepared in the IT Tool IUCLID 5, to ECHA via the Register for Biocidal Products (R4BP 3).

Once an active substance has been approved, companies who wish to place a biocidal product on the market have to apply for product authorisation at national or union level, depending on their product and where they wish to sell it.

  • National authorisation: for products which are to be placed only on a single market
  • Mutual recognition: for products which are to be placed on the market in several countries
  • Union authorisation: for products which are to be placed on the market EU-wide.
  • Simplified authorisation: for products which meet certain criteria specified in the regulation e.g. do not contain any substances of concern

Click here for an example of the BPR-related services we offer or contact us now for information on how we can help you comply with the BPR.

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