Registration, evaluation, authorisation and restriction of chemicals
REACH stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals.” EC Regulation No. 1907/2006 (REACH Regulation) entered into force on July 1, 2007 and is directly applicable in all EU Member States. It is also applicable in the EEA countries, as it was also integrated in the EEA Agreement.
The REACH Regulation aims at improving the protection of human health and the environment from the potential risks of chemicals. On the one hand, this is to be achieved by means of appropriate risk management measures – on the other, substances of very high concern are to be substituted step by step by other suitable, but less dangerous substances. To achieve this objective, the core provisions of the REACH Regulation cover the following key aspects:
- Obligation to register substances, including detailed information on the substance’s properties, in order to build a substances database
- Obligation to share information regarding the properties of substances and risk management measures along the supply chain
- Evaluation of the substances by the Member States
- Determination of restrictions or authorizations for certain substances
According to the principle “no data, no market,” substances regulated by the REACH Regulation may be placed onto the market within the EU or the EEA only if they have been registered beforehand with the European Chemical Agency ECHA. The obligation to register lies with manufacturers of the substances within the EU, and/or with the importers who import such substances from non-EU/EEA countries into the EU/EEA. When registering a substance, its composition and properties must be indicated, and a chemical safety report submitted. The latter contains a description of the exposure routes* of a substance, its effect on human health and the environment, and based thereon a risk evaluation when handling these substances, and recommendations for risk management measures if applicable. The latter are meant to minimize any potential negative effects on human health and the environment when handling the substance.
In determining whether a substance is to be classified as dangerous, REACH explicitly refers to the criteria of the “CLP Regulation” (Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures). If a substance is dangerous, its properties and any necessary risk-management measures must be compiled in a safety data sheet, which has to be forwarded along the entire supply chain.
All EU Member States nominate their national authorities which are responsible for evaluating the substances in coordination with the European Chemicals Agency ECHA. The prioritization of substances in this evaluation process is based on a risk-driven approach – i.e. those substances associated with the highest risk will be evaluated first. The risk of a substance is based on its properties (e.g. persistent, bio-accumulating), exposure routes, or the overall production or import volume.
Depending on the results of this evaluation, and based on the stipulations in the REACH Regulation, substances may be subject to restrictions or an authorization process. Restrictions may cover manufacturing, the placing on the market, or the use of a substance on its own, in a mixture, or in articles. The authorization procedure is designed to ensure that the risks related to substances of very high concern are well managed and that these substances are gradually replaced by other suitable alternatives.
*Way in which the substance enters the body/a given area, e.g. airborne (inhalation), skin contact etc.
Status: December 2015
All information subject to change. Errors and omissions excepted.