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European Union: New Regulation on Biocides

(Sept. 4, 2013) On September 1, 2013, a new European Union Regulation on Biocides entered into force. Biocides are chemicals used to control organisms that are harmful to human and animal health and to the environment, such as pests and germs (e.g., molds and bacteria). The Regulation also applies to insect repellents, disinfectants, and industrial chemicals like anti-fouling paints for ships and construction material preservatives. (Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012, Concerning the Making Available on the Market and Use of Biocidal Products, 2012 O.J. (L167) 1, available at EUROPA.)

The Regulation, which replaces Directive 98/8/EC on the Placing on the Market of Biocidal Products, aims to ensure better functioning of the internal EU market by harmonizing the rules on biocides. (Id.) Highlights of the Regulation are:

· establishment of a list of substances that may be used in biocidal products. Active substances, that is, substances or micro-organisms that acts on or against harmful organisms, will be approved for a period of either five or ten years, depending on certain requirements;

· establishment of a Union authorization of biocidal products that have similar conditions of use across the Member States, to be valid throughout the EU;

· authorization of biocidal products for marketing purposes, provided that the biocidal products meet a number of conditions;

· mutual recognition of national authorizations within the Union;

· rules consistent with EU requirements for the use of biocidal products and for making the products available on the market within one or more Member States or Union-wide; and

· specific rules on the classification, packaging, and labeling of biocidal products. (Id.)

The European Chemicals Agency (ECHA) will provide scientific and technical support to the Commission and the Member States for better implementation of the Regulation. The ECHA’s tasks include adoption of opinions on the approval of active substances. Those opinions are taken under consideration by the Commission, which has the authority to include them in the list of approved substances. (Id.)

EU Environment Commissioner Janez Potocnik stated, “[t]his Regulation is another step towards ensuring that only safe, authorized products are made available throughout the EU. The simplification of authorization procedures will bring significant economic benefits to companies while ensuring a high level of environmental protection for citizens.” (Press Release, IP/13/796, European Commission, Environment: New Biocides Regulation Improves Human Health and Environmental Protection (Aug. 30, 2013), EUROPA.)