Use and Exposure Information

The REACH Regulation (1907/2006) requires that adequate control of risks be demonstrated for all identified uses of substances. For substances subject to chemical safety assessment, exposure scenarios covering the uses of substances have to be generated and communicated to downstream users.

According to Article 37(2) of the Regulation, any downstream user has the right to make a use known in writing to his supplier with the aim of making it an identified use. The deadline for doing so depends on the tonnage band within which the substance is manufactured or imported, which is not necessarily known to the downstream user. For example, this should be done before 1 December 2009 for substances to be registered by 1 December 2010. Assuming the use is assessed as being safe, it can then be integrated in the substance registration dossier.

Important: for cosmetic uses of substances, the Chemical Safety Report – and therefore the exposure scenario – does not need to include consideration of the risks for human health. This is in order to avoid duplication with the Cosmetics Directive (76/768/EEC) which adequately addresses the assessment of cosmetic products’ safety for human health.

In order to assist suppliers/registrants (manufacturers and importers) in preparing their Chemical Safety Assessments and Reports, and to avoid unnecessary mailings, Colipa has developed a use mapping (general use information) to help with the environmental and occupational exposure assessment of substances used in the cosmetics industry. The uses are reported according to the UseR format as developed by DUCC (the Downstream Users of Chemicals Coordination Group). They cover most uses of substances in the manufacturing of cosmetic products and their end use. If this information fits the exposure scenario of a given substance, no additional communication between supplier and downstream user is needed.