The European Parliament and Council published (EU) regulation no. 528/2012 on the supply of biocidal products to the market and their use in the European Union’s Official Journal (L-167). This regulation will come into force on 1st September 2013 and replaces the former EU Directive 98/8/EU. The aim of the regulation is to improve the safety of marketing and use of biocidal products.
Article 3 of the EU regulation defines biocidal products in detail. In simple terms, biocidal products are substances/mixtures that destroy, deter, render harmless harmful organisms, such as bacteria, viruses, moulds, or prevent them from causing damage by some other means than pure physical or mechanical action. Any substance that has been treated with a biocide is also considered to be a biocidal product. For example, textiles with an antimicrobial treatment, surface coatings and other consumer products are therefore considered to be biocidal products.
In accordance with Article 25 a biocidal product may be considered for a simplified approval process, provided there is adequate proof of effectiveness. The Department for Hygiene, Environment & Medicine at the Hohenstein Institute in Bönnigheim tests the effectiveness of biocidal products against target organisms in accordance with the specifications in Appendices II and III of the Biocidal Products Regulation.