Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Directive

​Overview

• REACH  (EC 1907/2006) aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four processes of REACH, namely the registration, evaluation, authorization and restriction of chemicals. REACH also aims to enhance innovation and competitiveness of the EU chemicals industry.

• "No data no market": the REACH Regulation places responsibility on industry to manage the risks from chemicals and to provide safety information on the substances.  Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database in the European Chemicals Agency (ECHA) in Helsinki. The Agency is the central point in the REACH system: it manages the databases necessary to operate the system, co-ordinates the in-depth evaluation of suspicious chemicals and is building up a public database in which consumers and professionals can find hazard information.

• The Regulation also calls for the progressive substitution of the most dangerous chemicals (referred to as "substances of very high concern") when suitable alternatives have been identified.

• One of the main reasons for developing and adopting the REACH Regulation was that a large number of substances have been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, and yet there is insufficient information on the hazards that they pose to human health and the environment. There is a need to fill these information gaps to ensure that industry is able to assess hazards and risks of the substances, and to identify and implement the risk management measures to protect humans and the environment.

• Having entered into force in 2007, REACH provisions are being phased-in over 11 years.

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Registration

• All manufacturers and importers of chemicals have a general obligation to submit a registration to the European Chemicals Agency for each substance manufactured or imported in quantities of 1 tonne or more per year per company (legal entity). In the registration dossier, they must identify the risks that are linked to the substances they produce and market and indicate how these risks are managed.

• This obligation applies to substances as such and in mixtures. A special registration regime applies for substances in articles (e.g. manufactured goods such as cars, textiles, electronic chips).

• Without registration, substances cannot be manufactured or imported into the EU ("No data no market").

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Reference:

ec.europa