On June 1, 2007, the European Union’s (EU) Registration, Evaluation, Authorization, and Restrictions of Chemicals (REACH) legislation entered into force. The legislation can be found here: European Parliament and Council Regulation (EC) No 1907/2006 and Directive 2006/121/EC. REACH is a major reform of EU chemicals policy, affecting all global supply chains that produce and use chemicals.
The main aims of REACH are to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals. It also aims to promote alternative test methods, allow for free circulation of substances on the internal market, and enhance competitiveness and innovation. REACH makes industry responsible for assessing and managing the risks posed by chemicals as well as providing appropriate safety information to their users. The regulation also calls for the substitution of the most dangerous chemicals when suitable alternatives are available.
The European Chemicals Agency
(ECA) is responsible for managing the REACH system. The agency provides the databases necessary to operate the system, coordinate in-depth evaluations of suspicious chemicals, and manage a public database in which consumers and professionals can find hazard information.
REACH will be implemented step by step until 2018. The first major obligation – pre-registration – took place from June 1 to December 1, 2008, for existing substances, manufactured or imported as well as substances intended to be released from articles (finished products) on the EU and EEA market. Now products must be registered immediately and it will be dependent on the tonnage manufactured or imported.
Since October 28, 2008:
Suppliers of articles (finished products) containing substances on the Candidate List
in concentration above 0.1% must provide sufficient information, to their customers and on request to consumers within 45 days of the receipt of a request. This information must ensure safe use of the article and, as a minimum, include the name of the substance (REACH article 33).
By 30 November 2010:
Registration of CMRs 1 and 2 (carcinogens) above 1 ton/ year/ manufacturer, substances classified as very toxic to aquatic organisms above 100 ton/year/ manufacturer and substances as such, in preparations (mixtures) or intended to be released from articles (finished products) in quantities above 1000 ton/year/manufacturer is required.
The process of registering chemical substances requires much more information than pre-registration. Registration requires submission of a registration dossier documenting information about the chemical that includes a complete set of hazard data. The timelines for registering substances have been prioritized by volume and hazard.
The ECHA will evaluate registration dossiers to assess testing proposals made by a registrant or to check that the registration dossiers comply with the requirements. It may result in a request for more information on a substance from a registrant. The ECHA also will coordinate substance evaluation, which will be conducted by the EU to investigate chemicals of concern.
Substances of very high concern, regardless of the quantity on the market, will require authorization. Suppliers of these substances must demonstrate their use of appropriate risk management measures, the socio-economic benefit from substance use, and a substitution plan for the substance. Each authorized substance will be reviewed after a certain time limit that is specific to each substance. Downstream users must report use of authorized substances to the ECHA.
These substances include:
Class 1 and 2 carcinogens, mutagens and reproductive toxins (CMRs).
Substances classified as persistent, bioaccumulative and toxic (PBTs).
Substances classified as very persistent and very bioaccumulative (vPvB).
Other substances causing probable serious and irreversible effects to humans or the environment.
The European Union can impose restrictions and prohibit or set conditions for the manufacture, sale or use of certain dangerous substances or group of substances when unacceptable risks to humans or the environment have been identified.