Chemical safety report
The chemical safety report documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios. It also forms a basis for other REACH processes including substance evaluation, authorisation and restriction.
The chemical safety assessment is carried out to demonstrate that the risks from the exposure to a substance, during its manufacture and use, are controlled when specific operational conditions and risk management measures are applied. These conditions of use of a substance constitute the exposure scenario, which is an essential component of the chemical safety report.
The chemical safety report should be readily understandable in all its parts as a stand-alone document and it should include all the relevant information for the chemical safety assessment. The principles applied in the hazard and exposure assessments, the assumptions made and the conclusions drawn should be transparent and well documented. The key data should be easily identifiable without the need to revert to the underlying substance datasets (IUCLID substance dataset).
The elements to be included in the chemical safety report are listed in Annex I, section 7 of REACH.
An exposure scenario is a set of conditions that describe how a substance is manufactured or used, and the measures necessary to control exposure to humans and releases to the environment.
The final exposure scenario defines the operational conditions and risk management measures required to ensure the safe use of the substance for each exposed population during all the lifecycle stages of the substance, including the waste stage and the article service life, where applicable. It is achieved through refinement of the operational conditions and risk management measures until the risks for humans and the environment are shown to be controlled.
The final exposure scenario should be documented in a standardised way to accurately describe the conditions of use to promote adequate and achievable risk management measures. The relevant exposure scenarios will be communicated to downstream users via the extended safety data sheets.
For substances registered at and above ten tonnes per year, which meet the classification criteria, each identified use of a substance should have an exposure scenario that will document all the relevant routes of exposures and releases associated with that use.