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Downstream Users

Downstream Users

Downstream users source  their chemicals in the EU and use them in their industrial or professional activities. Downstream users include end-users who do not supply further down the supply chain, formulators and re-fillers.

Key duties of downstream users under REACH

  • Provide information regarding their uses to their supplier; this enables the supplier to include the use in the registration dossier
  • Implement the measures for safe use specified by the supplier,
  • Contact their supplier if the conditions of use indicated by the supplier do not match the actual conditions of use
  • Inform their supplier of any  new information on the hazards of the substance, or if the risk management advice is not appropriate
  • Comply with the conditions of any restriction which apply to the substance
  • Communicate with their supplier if they are using a substance included in the Authorisation List. A downstream user may apply for an authorisation themselves or have their use included in an authorisation applied for by a supplier or manufacturer
  • Formulators must provide their customers with appropriate information on hazards and conditions of safe use for their mixture.

Communication with suppliers and exposure scenarios received from suppliers

Substances may be  supplied to a downstream user with an extended safety data sheet (eSDS), which includes exposure scenarios that describe how the substance can be used safely. Once the eSDS is received, the downstream user must check whether the exposure scenarios cover their uses and if the conditions of use correspond to the conditions under which they use the substance. The conditions of use must be implemented within twelve months of receipt of the eSDS.

If the use(s) or the conditions of use differ from those described in the eSDS, then the downstream users must do one of the following:

  • Request their supplier to include the different use(s) in their chemical safety assessment, or
  • Change their conditions of safe use to match those given by the supplier, or
  • Find another supplier who will cover their use, or
  • Carry out their own downstream user chemical safety assessment (see below), or
  • Stop using the substance and use an alternative technical process instead.

Communication with customers

Formulators must communicate relevant safety information further down the supply chain to their own customers, for example, by including the information in the SDS.

Downstream user report

If a downstream user’s use is not covered in, or the conditions of use are outside those described in, the  exposure scenario provided by the supplier, then the downstream user  has an obligation to report to ECHA, by submitting a downstream user report, within six months from receipt of the eSDS, if:

  • They prepare a downstream user chemical safety report, or
  • They claim exemptions due to the use of a substance in a quantity of less than one tonne per year, or they use the substance for product and process oriented research and development (PPORD), or
  • They have a different classification of the substance to their supplier,

There are two options available for the downstream user report:

  1. A Webform via the downstream user pages of the ECHA website: this is recommended for most downstream users, in particular those who are not familiar with IUCLID
  2. Via REACH-IT/IUCLID: this is recommended for downstream users who are already users of IUCLID and who want to maintain their report records in the REACH-IT system.

Downstream users chemical safety report

A downstream user may choose to carry out their own chemical safety assessment in the following cases:

  • They use a substance outside the conditions described in the exposure scenario provided by their supplier.
  • Their use is advised against by the supplier.
  • They wish to keep the information on their use confidential.

The chemical safety assessment itself is documented in a downstream user chemical safety report, which must be completed within twelve months of receipt of the eSDS, but does not have to be submitted to ECHA. The downstream user should report to ECHA that they intend preparing a chemical safety report within six months in a downstream user report (see above).

There are a number of cases where the downstream user does not need to carry out a chemical safety assessment;

  • An SDS is not required for the substance.
  • A chemical safety report is not required for the substance.
  • The substance is present in a mixture in a concentration lower than any of the concentrations set out in Article 14 (2) of REACH.
  • They use the substance in a quantity of less than one tonne per year (must report this exemption to ECHA; see above).
  • They use the substance for PPORD(must report this exemption to ECHA; see above).

Further information for downstream users can be found on the   ECHA website.