The Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) Regulation (EC) No 1907/2006 came into force on 1st June 2007. The central principle of this regulation is to integrate approximately 40 pieces of existing chemical legislation, thereby enhancing the regulatory framework to ensure there is sufficient protection for human health and the environment from chemical substances. Though REACH is a European chemical regulation, it has wide implications beyond the chemical industry direcltly and throughout the world. A full copy of REACH Regulation (EC) No 1907/2006 can be found here.
The REACH regulation applies to substances that are manufactured in the EU or imported into the EU in quantities of 1 tonne or more per annum. The scope of the legislation covers chemical substances by themselves, chemical substances in preparations or chemical substances with intended release from articles.
Substance: ‘..means a chemical element and its compounds in the natural state or obtained by any manufacturing process..’ (Article 3 (1)).
Preparation: A mixture or solution composed of two or more substances (Article 3 (2)). Substances in preparations should be examined separately, to ascertain if registration is required. e.g. ink
Article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition (Article 3 (3)) e.g. ink cartridge
With the REACH Regulation, the balance of responsibility for the management of potential risks of substances has shifted towards the entities that manufacture, import, place on the market or use these substances in the course of their business activities. These entities are now obliged to gather relevant data on their substances and, through appropriate assessment procedures, generate risk management measures to minimise potential risks to human and environmental health.
Who is responsible for administering the REACH Regulation?
The European Chemicals Agency (ECHA) was established on the 1st June 2008, under Article 75 of (EC 1907/2006) to manage the registration of chemicals that come under the scope of REACh. They are responsible for dossier and substance evaluation and also manage the authorization and restriction of substances. The full description of ECHAs role can be found under Article 75 – Article 111 of the Regulation.
Who is responsible for the enforcement of the REACH Regulation?
The REACH Regulation applies in all 27 EU Member states (MS) and in the European Economic Area (EEA) i.e. Norway, Liechtenstein and Iceland. The enforcement of REACh is described under Articles 125, 126 and 127 of the Regulation. ECHA has no enforcement responsibilities, since it is a Community-level institution. Each country has their own law-enforcement department, eg, in Ireland, supervision and enforcement is conducted by the Health and Safety Authority (HSA); in the UK the enforcement body is the Health and Safety Executive (HSE). Each MS will have their own penalties for non-compliance (Article 126), which include both penalties and fines.
The Forum for Exchange of Information on Enforcement (or 'Forum'; Article 76 (1), Article 77 (4), Article 86) was set up to co-ordinate the enforcement of REACh by the MS authorities. More information on Strategies for Enforcement of REACH and the Minimum Criteria for REACH Inspections, please go here.
