REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. In principle, the REACH regulation applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users. If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.
How does REACH work?
REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance. ECHA receives and evaluates individual REACH registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientific committees assess whether the risks of substances can be managed. Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.
The Registration Process
Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance. This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.
Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles. Chemical substances that are already regulated by other legislations such as medicines, or radioactive substances are partially or completely exempted from REACH requirements.
Registration is based on the “one substance, one registration” principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. The analytical and spectral information provided should be consistent and sufficient to confirm the substance identity.
The Evaluation Process
ECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.
Evaluation under REACH focuses on three different areas:
- Examination of testing proposals submitted by registrants
- Compliance check of the dossiers submitted by registrants
- Substance evaluation
Once the evaluation is done, registrants may be required to submit further information on the substance.
In line with art. 54 of the REACH Regulation, by 28 February of each year, ECHA has to publish a report on the progress it has made over the previous calendar year on its obligations in relation to evaluation. ECHA is specifically required to include recommendations to potential registrants to foster improvement in the quality of future registrations, in these reports.
The Authorisation Process
The authorisation procedure aims to assure that the risks from Substances of Very High Concern are properly controlled and that these substances are progressively replaced by suitable alternatives while ensuring the good functioning of the EU internal market.
Substances with the following hazard properties may be identified as Substances of Very High Concern (SVHCs):
- Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B in accordance with Commission Regulation (EC) No 1272/2008 (CMR substances)
- Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH (Annex XIII)
- Substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances
After a two-step regulatory process, SVHCs may be included in the Authorisation List and become subject to authorisation. These substances cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation.
Manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation.
The Restriction Process
Restrictions are a tool to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market or use of a substance. A restriction applies to any substance on its own, in a mixture or in an article, including those that do not require registration. It can also apply to imports. A Member State, or ECHA on request of the European Commission, can propose restrictions if they find that the risks need to be addressed on an Union wide basis. ECHA can also propose a restriction on articles containing substances that are in the Authorisation list (Annex XIV).
Anyone can comment on a proposal to restrict a substance. Those most likely to be interested are companies, organisations representing industry or civil society, individual citizens, as well as public authorities. Comments are welcomed from the EU or beyond. ECHA works with experts from the Member States to provide scientific opinions on any proposed restriction that will help the European Commission, together with the Member States, to take the final decision.