REACH requires industry to mitigate risks from chemicals by providing information on their properties and risks and registering that data with the European Chemicals Agency (ECHA). What this means, in effect, is that the responsibility for ensuring that chemicals are used safely is shifted from the regulatory authorities to the manufacturers and importers of chemicals.
The goal of REACH is to provide a greater level of protection for humans and the environment by ensuring that proper information on handling, storage and use together with risk management measures, if appropriate, are readily available.
All EU manufacturers or importers of substances manufactured or imported in quantities above 1 ton per year are required to hold a registration before the start of such manufacture/import, unless specifically exempted.
The obligation to register non-EU manufactured substances falls on the EU importer established within the European Union. However, non-EU manufacturers and formulators may choose to relieve the EU importers from the obligation to register by appointing an EU-based legal entity as their Only Representative (OR). The OR then assumes the same REACH obligations as an EU importer and submits the registration on behalf of the non-EU manufacturer.
Registrations are submitted jointly by all manufacturers/importers wishing to register the same substance. Registrants of the same substance need to cooperate, exchange and share registration data in order to avoid unnecessary testing and agree on the same hazard classification and risk assessment for the substance. Downstream users will be informed about potential hazard and risk management measures via the Safety Data Sheet.
After Registration, ECHA performs a dossier evaluation to check the compliance of the registration dossiers and/or assess the testing proposals made by registrants. ECHA also coordinates the evaluation of the substances to be conducted by the Member States through its Community Rolling Action Plan, CoRAP. As part of this exercise, the evaluating Member State reviews the data on the substance and may request more data or conclude that no further action is required. The Member State can also propose a harmonized hazard classification for the substance, its inclusion on the Candidate List of Substances of Very High Concern (SVHC) or any other restriction.
The route to authorisation starts with the identification of a Substance of Very High Concern (SVHC). Substances of Very High Concern are substances meeting the following criteria: carcinogenic, mutagenic, toxic for reproduction, persistent, bioaccumulative and toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) or substances posing an equivalent level of concern.
An SVHC may then move to the Authorization List (Annex XIV of REACH). After a sunset date, substances on the Authorization List can no longer be placed on the market or used, unless an authorization for a specific use has been granted. . The authorisation process will include an assessment of whether the risks are adequately controlled, whether a suitable alternative exists and whether the socio-economic benefit of the continued use of a substance may outweigh the risks associated with its use.
Substances registered as intermediates are not subject to authorisation.
REACH applies to chemical substances, whether on their own, in mixtures (a solution composed of two or more substances) and to some extent, substances in articles. There are few exemptions to REACH requirements. Below are some examples of exemptions:
Exempted from REACH:
- Non-isolated intermediates
- Radioactive substances
- Substances under customs supervision
Exempted from REACH registration:
- Substances manufactured/imported below 1 ton/year (per manufacturer/importer)
- Substances occurring in nature, if not chemically modified (e.g. natural gas, crude oil)
- Polymers (but monomers and certain additives are subject to REACH requirements)
- Substances with well-known properties and low hazard listed in Annex IV (e.g. water, nitrogen)
- Substances already registered under EU REACH that are exported and re-imported into the EU under conditions of substance sameness
- Substances for Product and Process-Oriented Research and Development (notification required)
- Substances used in products covered by specific end use legislation, such as medicinal products, foodstuffs