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BPR Biocides Regulation

The BPR, or Regulation (EU) 528/2012, governs the marketing and use of biocides in the EU: disinfectants, preservatives, non-agricultural pesticides and others.

A biocide is any substance or mixture intended to destroy, deter, render harmless or control harmful organisms by any means other than mere physical or mechanical action. What makes a product a biocide is the function attributed to it: if it is presented as capable of eliminating bacteria, fungi or viruses, it falls within the scope of the regulation, whatever it is called. The BPR has applied since 1 September 2013 and replaced Directive 98/8/EC. It classifies biocides into 22 product types; among the disinfectants are, for example, PT2 (disinfection of surfaces not intended for direct contact with people or animals), PT3 (veterinary hygiene) and PT4 (surfaces in contact with food and feed).

The system works on two levels. First, each active substance is evaluated and, where appropriate, approved at European level for specific product types; the European Chemicals Agency (ECHA) coordinates the evaluation. Then each product needs its own authorisation before it is placed on the market. While the review of an active substance is ongoing, the products containing it are governed by national rules; in Spain they are entered in the register of the Ministry of Health. The regulation also covers treated articles, such as textiles or surfaces that incorporate a biocide.

In addition to the BPR, the label of a biocide must comply with the CLP Regulation (pictograms, hazard statements and precautionary statements) and include, among other data, the authorisation or registration number, the authorised uses, the dose and the type of user. The Safety Data Sheet follows the format set by the REACH Regulation. As a user, the practical thing is to check that the registration number appears on the label and to use the product only for the uses and at the doses it indicates.

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