Downstream user chemical safety assessment

REACH knowledge base – Downstream user chemical safety assessment

Downstream users may be required to create an own chemical safety assessment when the conditions of use described in the exposure scenario received with the substance or mixture do not cover the conditions of use of their own or 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:

• 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 his 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 users chemical safety assessment shall be directed to their own use and, where applicable, for those identified uses downstream the supply chain that were not covered by the supplier.
The chemical safety assessment procedure differs from the standard procedure, because hazard assessment is not mandatory, as the downstream user can use the information available on 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 certified.

The downstream users are not obliged to submit their chemical safety report to the European Chemicals Agency, but they must disclose information regarding the identification of the substance and the description of its use.
This notification is only compulsory if the use in question exceeds the one tonne per year quantity.

Chemical safety assessment for mixtures

A chemical safety assessment can be made for mixtures as well.
A downstream user chemical safety assessment on mixtures might be made on a voluntary basis.
It might be particularly useful for mixtures that are much less hazardous than the certain substances they contain.  It is also useful if there are more substances in the mixture for which an assessment should be made for.

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

Recommended article(s) 

• Useful information for downstream users on safety data sheets
• The obligations of the downstream user in the REACH communication
• The obligations of distributors in the REACH communication