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Roles and obligations under EU REACH

A company’s obligations under REACH will depend on their role in the supply chain. The information provided here gives an overview of the roles a company may have and their responsibilities under REACH. All actors in a supply chain have a responsibility to ensure that the substances, mixtures and articles they place onthe market are compliant with REACH, ensuring protection of human health and the environment.

Manufacturer of substances

A manufacturer is defined under REACH as any natural or legal person established within the EEA who produces or extracts a chemical substance.

 A substance manufacturer is obliged to:

  • Register the substance(s) they manufacture at or above one tonne per year.
  • Apply for, and be granted, an authorisation for any substance they manufacture and place on the market for a use that is subject to REACH authorisation (substances listed in Annex XIV of REACH).
  • Comply with relevant REACH restrictions (substances listed in Annex XVII of REACH).
  • Provide a Safety Data Sheet (SDS), prepared in accordance with REACH Annex II, where required.

Importer of substances and mixtures

An importer is any natural or legal person established within the EU/EEA who is responsible for the physical introduction of a substance, mixture or article into the customs territory of the EU/EEA from a non-EU country.

Importers of substances have the same obligations as substance manufacturers under REACH. Importers are responsible for ensuring that the products they place on the market are compliant with REACH. For those that import mixtures, registration obligations apply to each individual substance within the mixture, imported at or above one tonne per year.

Producer and importer of articles

EU producers and importers of articles are obliged to:

  • Register substance(s) with intended release from the article during normal use in total quantities at or above one tonne per year, unless they have been already registered for that use.
  • Notify ECHA regarding substances of very high concern (SVHC) contained in the article(s), if the SVHC is present in concentrations above 0.1% and in quantities totalling one tonne or more per year.
  • Provide the recipient of the article with sufficient information to allow the safe use of that article when the article contains a SVHC in concentrations above 0.1%.
  • Provide consumers with sufficient information to allow the safe use of the article, upon request.
  • Comply with relevant REACH restrictions with respect to restricted substances contained in the article(s).

Article importers will need information on the substances contained in the imported articles to ensure they can fulfil their obligations under REACH.

Distributor

A distributor is established in the EEA and source their substance, mixture or article within the EEA and then place it on the market. They can place it on the market for someone else or under their own brand, without changing the chemical composition of the substance or mixture.

For example, retailers and wholesalers are distributors under REACH.

A company is not a distributor if they source chemicals within the EEA and formulate them with other chemicals, dilute them or (re)fill them into containers, before supplying them to others. If they carry out these activities, then they are a downstream user.

Distributors are obliged to:

  • Communicate safety information on the hazards and risks of the hazardous chemicals they distribute by providing the safety data sheet when supplying to industrial or professional users.
  • Provide industrial and professional customers with sufficient information to allow the safe use of an article, including, as a minimum, the name of the hazardous substance, when supplying articles containing substances of very high concern. Consumers have a right to this information upon request (within 45 days).
  • Pass information from their customers to their suppliers, e.g. new information on hazardous properties of the substances or mixtures or information on risk management measures.

Only Representative

Companies based outside the EEA do not have obligations under REACH, but they can appoint an EU-based Only Representative to take over the REACH responsibilities of their EU customers (importers).

Only Representatives (OR) must be:

  • A natural person or legal entity physically established in the EEA.
  • Knowledgeable in the practical handling of the substances and information related to them.
  • Appointed by mutual agreement with the non-EU manufacturer, formulator or article producer.
  • Responsible for complying with the legal requirements for importers under REACH.

The non-EEA company must inform the importer(s) within the same supply chain of the appointment of the OR. The importers are then regarded as downstream users under REACH.

Only Representatives have the same obligations under REACH as importers.  

Downstream User

A downstream user is established in the EEA, and their supplier(s) are also established in the EEA. Downstream users use chemicals in their industrial or professional activities, including for example in formulating.

Downstream users do not have registration obligations under REACH, but they must:

  • Use chemicals safely.
  • Implement the operational conditions and risk management measures included in the safety data sheets provided by their supplier.
  • Inform their supplier about how they use their chemicals, particularly if their uses are not covered in the information they receive, or the safety advice is not appropriate.

Further Information

HSA: Chemicals Importer Information Sheet https://www.hsa.ie/publications_and_forms/publications/chemical_and_hazardous_substances/chemicals_importer_information_sheet/

ECHA: REACH Guidance documents https://www.echa.europa.eu/guidance-documents/guidance-on-reach