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Downstream Users

Downstream users are those who buy 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 the downstream user

The following points outline the main duties that downstream users have under REACH:

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

Registered substances are typically 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 such an eSDS is received, the downstream user must check whether the exposure scenarios cover his uses and if the conditions of use correspond to the conditions under which he actually uses the substance. The conditions of use must be implemented within twelve months of receipt of the safety data sheet.

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

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

 

Communication with customers

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

 

Communication with ECHA – Downstream user report

If a downstream user’s use is not supported, then he has a duty to report to ECHA within six months from receipt of the safety data sheet, if:

  • He prepares a downstream user chemical safety report
  • He claims exemptions due to the use of a substance in a quantity of less than one tonne per year, or he uses the substance for process oriented research and development (PPORD)
  • He has a different classification of a substance to his supplier

 

Downstream users chemical safety report

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

  • He uses a substance outside the conditions described in the exposure scenario provided by his supplier
  • His use is advised against by the supplier
  • He wishes to keep the information on his 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 safety data sheet, 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;

  • A safety data sheet 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
  • He uses the substance in a quantity of less than one tonne per year (must report this exemption to ECHA; see above)
  • He uses the substance for process oriented research and development (PPORD) (must report this exemption to ECHA; see above)

 

Further information

Anyone with questions regarding downstream user obligations is encouraged to contact our Chemicals helpdesk at chemicals@hsa.ie