Introduction to Biocidal Products on the EU Market
Biocidal products are used to control unwanted organisms that are harmful to human or animal health or to the environment, or that cause damage to human activities. These harmful organisms include pests (e.g. insects, rats or mice) and microorganisms (e.g. bacteria, viruses, mould).
EU Biocidal Product Legislation
Until the publication of the Biocidal Products Regulation 528/2012/EU on May 22, 2012 and the subsequent 1 year transition period, the Biocidal Products Directive 98/8/EC was the reigning legal framework for biocidal products.
From September 1, 2013, the Biocidal Products Regulation 528/2012/EU became fully applicable in the EU as the main legal framework for biocidal products.
- Any product to made available in the EU Market (either through e-commerce or brick-and-mortar) must comply with the Biocidal Regulation 528/2012/EU
- Non-EU based manufacturers must appoint an Authorized Representative ('authorisation holder') in order to ensure the compliance prior to EU Market entry and for as long as they are making it available in the EU
- ‘biocidal product’ is defined as:
any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,
any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
- Entering the EU Market with Biocidal Products
- Biocidal Legislation
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