REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

Scope

In principle, REACH applies to all chemicals — those used in industrial processes as well as those used in our day-to-day lives, such as cleaning products and paint, articles of clothing, furniture, and electrical appliances.

REACH covers all substances whether manufactured, imported, used as intermediates, or placed on the market, either on their own, in preparations or in articles, unless they are radioactive, subject to customs supervision, or are non-isolated intermediates. Waste is specifically exempted. Food is not subject to REACH as it is not a substance, preparation, or article.

Member states may exempt substances used in the interests of defense. Other substances are exempted from parts of REACH, where other equivalent legislation applies.

Regulatory citations

• None

Key definitions

• Downstream users: Companies within the EU who use chemicals in an industrial or professional activity, including companies who manufacture goods or offer services where chemicals are not the main element of their business (e.g., cleaning companies).
• European Chemicals Agency (ECHA): An agency of the European Union located in Helsinki, Finland, that manages the technical and administrative aspects of REACH.
• European Union (EU): A political and economic union of 28 member states located primarily in Europe.
• Importer: A company or individual within the EU who buys goods from outside the EU. This may be individual chemicals, mixtures for onwards sale or finished products, such as clothing, plastic goods, or furniture.
• Manufacturer: A company or individual within the EU who makes chemicals, either to use themselves or to supply to others (including for export).
• Non-EU distributor: A distributor located outside the European Union.
• Non-EU manufacturer: A manufacturer located outside the European Union.
• REACH: The European Union (EU) regulatory framework for Registration, Evaluation, Authorisation and Restriction of Chemicals.

Summary of requirements

• All EU manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which shall be submitted to the Agency.
  • Once the registration dossier has been received, the Agency may check that it is compliant with the Regulation and shall evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.
  • Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.
  • REACH includes an authorization requirement to ensure that the risks from substances of very high concern (SVHCs) are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies. Substances subject to authorization are listed in Annex XIV to the REACH Regulation. Once included in this Annex, a substance cannot be placed on the market for a use or used after a given date (the “sunset date”) unless the companies concerned are granted an authorization for the specific use(s).
  • Authorizations are granted by the European Commission, after obtaining the opinion of the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) of the European Chemicals Agency (ECHA). An authorization may be granted if either the risks from the use of the substance are adequately controlled or the socio-economic benefits outweigh the risks to human health or the environment.
• Non-EU manufacturers and distributors must either:
  1. Supply information to their customers on all chemical substances which they import into the EU at or above 1 tonne, so that the customers may register the chemicals, or
  2. Appoint a representative or establish a legal entity within the EU to manage the registration.