EU REACH: Registration, Evaluation, Authorisation and Restriction of Chemicals

Who it applies to

REACH applies to manufacturers and importers of substances in the EU (and the wider European Economic Area), to downstream users who formulate mixtures or use chemicals industrially, and to distributors. Producers and importers of articles also have obligations when the articles contain certain hazardous substances. Companies outside the EU must typically appoint an "only representative" or rely on their EU importers for registration. The regulation is administered by the European Chemicals Agency (ECHA) and enforced by member states.

The four pillars

• Registration. Substances manufactured or imported at one tonne or more per year must be registered with ECHA with a technical dossier; at ten tonnes or more per year a chemical safety report is also required.
• Evaluation. ECHA and member states check dossiers and substances.
• Authorisation. Substances of very high concern (SVHCs) can be put on a candidate list and eventually require authorisation to be used.
• Restriction. Restrictions limit or ban uses of substances that pose unacceptable risk, listed in Annex XVII.

What REACH requires for SDSs

Article 31 and Annex II set when an SDS must be supplied and its format. A supplier must provide an SDS, free of charge and on paper or electronically, for substances and mixtures that meet the hazard criteria of CLP, for substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, and for substances on the candidate list. For substances registered above a certain tonnage and with a chemical safety report, the SDS includes exposure scenarios as an annex (an "extended SDS"). The format itself is explained on the REACH Annex II page. Suppliers must update the sheet when new information arises, for instance after registration, authorisation or restriction, and must provide the revised version free of charge to everyone they supplied within the preceding 12 months.

Article 33 adds a duty to inform recipients and, on request, consumers when an article contains a candidate list substance above a threshold concentration.

Key differences versus OSHA HazCom

• Registration. REACH is chemical-control legislation as well as hazard communication. HazCom does not register chemicals; the nearest US equivalent is TSCA.
• Exposure scenarios. Extended SDSs describe safe conditions of use, which HazCom sheets do not.
• All 16 sections expected. OSHA does not enforce sections 12 to 15; REACH expects them, including the PBT and vPvB assessment where required.
• Environmental hazard. Included through CLP classification; see EU CLP.
• Language and responsible party. SDSs must be in an official language of the member state where the substance is placed on the market.
• Supply chain communication. REACH requires information flows both down and up the chain.

Practical points

• When importing into the EU, check that the substance is registered or exempt, and that the SDS matches the REACH format.
• Check Section 15 and Section 3 of the SDS for REACH status, SVHC content and registration numbers. See Section 15.
• Use ECHA's public databases to look up classification and registration information. Our data sources page explains how ECHA data is used here.
• Note that Great Britain has its own version after Brexit; see UK REACH and GB CLP.

Worked scenario: a downstream user checks an exposure scenario

A manufacturing company receives an extended SDS for a registered solvent. Attached is an exposure scenario describing the process category, the duration, the ventilation required and the gloves to be used. The company compares it with its own process. Its use is on the list, but its ventilation is weaker than the scenario assumes. It has to either improve the ventilation, check with the supplier whether another scenario applies, or carry out its own assessment. This is the kind of two-way supply chain communication REACH is designed to produce.

Frequently asked questions