In the European Union the manufacturing, import, sale, and use of chemical substances are highly regulated. Biocidal products are regulated under (EU) No. 528/2012 (EU Biocides Regulation). The EU Biocides Regulation entered into force in EU Member States on Sept. 1, 2013. However, the European legislature has provided for a gradual implementation of the rules on biocides, biocidal products, and articles that contain or have been treated with biocides (so-called “treated articles”). Producers and importers of biocides should be aware of the relevant deadlines to ensure timely compliance. The next important deadline is Sept. 1, 2016.
Existing EU Authorization Requirements for Active Substances in Biocides
Biocides are used to protect humans, animals, materials, or articles against harmful organisms (e.g., against pests and bacteria). The EU Biocides Regulation covers biocidal products and “treated articles”. It applies to substances or micro-organisms that have an effect on or against harmful organisms, and products containing those substances or micro-organisms. This is called an “active substance.” Under the EU Biocides Regulation, the active substances in biocides generally require prior authorization by the European Chemicals Agency (ECHA) if the manufacturer wants to place the biocide on the European market.