The information required to determine the properties of the substances varies according to the tonnage in which the substance is manufactured or imported. The higher the tonnage, the more information on the intrinsic properties of the substance is required. The information requirements and possible adaptations are set out in the Annexes VI to XI of REACH.
REACH requires the submission of information on:
- substance identity
- physicochemical properties
- mammalian toxicity
- environmental fate, including abiotic and biotic degradation
- information on manufacture and uses as well as risk management measures
The registrant has to compare the information requirements with the information gathered and to identify where there are information gaps and consider how any missing information can be generated.
The information gaps can be filled by data sharing and by using different sources of information other than in vivo testing. The registrant may use a variety of alternative methods such as (Q)SAR, in vitro tests, grouping of substances/a category approach and a read across approach.
Chemical safety assessment
Registrants who manufacture or import a substance at ten or more tonnes per year must conduct a chemical safety assessment to define the conditions of use under which the risks can be controlled. The conditions of use include operational conditions, such as temperature and risk management measures, for example the requirement to use personal protective equipment.
Downstream users may choose to carry out a chemical safety assessment if they use a substance outside the conditions described in the exposure scenario provided by the supplier, or if the use is advised against by the supplier.
The chemical safety assessment is an iterative process with the following steps:
- Collection and generation of information on intrinsic properties of the substance
- Human health hazard assessment
- Physicochemical hazard assessment
- Environmental hazard assessment
- Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative (vPvB) assessment
If, after these steps, the conclusion is that the substance is hazardous, the following steps are also needed:
- Exposure assessment
- Risk characterisation
The process needs to be repeated by re-assessing the hazard information and/or revising the conditions of use, the exposure information or the scope of exposure scenarios until it can be concluded that the risks are controlled.
The results of the chemical safety assessment are documented in a chemical safety report (CSR), which is submitted as part of the registration dossier to ECHA.
For meeting the higher-tier studies of the Annexes IX and X of REACH, registrants must submit a testing proposal when they conclude that alternative methods cannot fill an information gap. The proposal must demonstrate that the results of the test will provide information on the properties of the substance which are appropriate to ensure the protection of human health and the environment.
Upon receiving the proposal, ECHA will publish the name of the substance and the hazard endpoint for which vertebrate animal testing is proposed, so third parties can submit scientifically valid information and studies that address the relevant substance and hazard endpoint as covered in the testing proposal within 45 days.
Taking into account the received information, ECHA will examine the proposal and draft a decision in which it states whether it accepts or rejects the proposal, or requires modification to the conditions under which the test is carried out.