Downstream user chemical safety assessment

REACH knowledge base – Downstream user chemical safety assessment

 

Downstream users may be required to carry out their own chemical safety assessment when the conditions of use described in the exposure scenario received with the substance or mixture do not cover their own conditions of use or those of their customers.

This requirement does not apply if the substance or mixture does not require a safety data sheet or a chemical safety report for the following reasons:

  • It cannot be classified as hazardous.
  • The supplier manufactures or imports quantities of less than 10 tonnes per year.
  • The downstream user uses the substance in a quantity of less than one tonne per year.
  • The downstream user applies conditions for their own use that are at least as strict as the conditions recommended in the safety data sheet.
  • The substance is used for research and development purposes.

 

The downstream user’s chemical safety assessment must be directed to their own use and, where applicable, to those identified uses further down the supply chain that were not covered by the supplier.

The downstream user chemical safety assessment procedure differs from the standard procedure, because a hazard assessment is not mandatory, as the downstream user may use the information available in the safety data sheet.

Downstream users may decide to conduct their own chemical safety assessment for one or more uses advised against by the supplier. In that case, the downstream user should refine the initial assessment, including, where necessary, the hazard assessment, until the safe use of the substance can be demonstrated.

Downstream users are not obliged to submit their chemical safety report to the European Chemicals Agency, but they must provide information on the identification of the substance and the description of its use.

This notification is only compulsory if the use in question exceeds one tonne per year.

 

Chemical safety assessment for mixtures

A chemical safety assessment can also be carried out for mixtures.

A downstream user chemical safety assessment for mixtures may be prepared on a voluntary basis.

It may be particularly useful for mixtures that are significantly less hazardous than certain substances they contain. It is also useful where the mixture contains several substances for which an assessment would otherwise need to be carried out separately.

When a downstream user chemical safety report has been prepared for a mixture, it must be indicated in Section 15 of the safety data sheet which substances are covered by the assessment.

 

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