Exposure assessment and risk characterisation
You need to carry out exposure assessment and risk characterisation for substances registered at or above 10 tonnes per year, if they are classified as dangerous or as having persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties.
- Your exposure assessment and risk characterisation must cover all hazards identified based on the standard information requirements, and not be limited to classified hazards only.
- Identified hazards include:
- hazards for which no classification criteria currently exist, but where there is evidence that the substance can cause adverse effects (typically relevant for soil and sediment);
- hazards for endpoints with classification criteria, but where the dose or concentration triggering effects do not fulfil the classification criteria, and so the substance is not classified for the endpoint.
The chemical safety report (CSR) and safety data sheet (SDS) must include information on all identified hazards, not only those leading to classification under the CLP Regulation.
- Report all uses of your substance and information on the conditions of its use.
- Make sure the description of use is clear and consistent with the uses of the substance in the supply chain.
- Provide an adequate explanation of the conditions of use that lead to the assumed release rate of the substance into the environment.
- Show clearly how you minimise the release of your substance if it is persistent, bioaccumulative and toxic (PBT).
- Follow the advice in REACH Guidance, Chapters R.8 and R.10 to get the derived no-effect level (DNEL) or the predicted no-effect concentration (PNEC). If you need to deviate from the default assessment factors presented in that Guidance, justify and document any changes with scientific arguments that are specific to your substance.
- Ensure that the model you use to estimate the exposure applies to your substance and use appropriate modelling parameters, justifying their selection.
- Make sure that your exposure scenarios are transparent, specific and exhaustive. The operational conditions and the risk management measures must be given in detail to ensure safe use.
- Do not use tier 1 tools to automate mass production of exposure scenarios since this can easily lead to unhelpful or misleading risk management advice in the exposure scenarios.
- Cover all uses of the substance during its lifecycle.
- Provide a brief general description of the identified uses in Section 3.5 of IUCLID.
- Make sure that the short titles of the exposure scenarios are consistent with the use description in Section 3.5 of IUCLID, the exposure scenario annex, and Section 1.2 of the extended safety data sheet.
- Describe all actual uses.
- Provide use names that are easy to understand, preferably using terminology that is harmonised throughout your sector.
- Give a short explanation on the process or activities covered by the use. Do not only rely on standard use descriptors, as they are too generic to transparently describe the use for informing authorities and customers.
- If you are a member registrant, make sure the use description in your IUCLID dossier covers the process you are registering. Copying the use description from other registrants or from the generic chemical safety report may lead to a high number of inconsistencies.
- Choose the right level of differentiation between uses so that safety information can be communicated in a targeted way to different user groups.
- Too little differentiation may lead to complex and overly conservative exposure scenarios.
- Too much differentiation may lead to repetition or replication of the same generic exposure scenario information.
- Identify the conditions of use that ensure control of risks for each use described and predict the exposure to both humans and the environment under these conditions.
- Use the available information to create the exposure assessment inputs:
- specific environmental release categories (SPERCs) for the environment
- sector-specific workers exposure descriptions (SWEDs) for workers
- specific consumer exposure determinants (SCEDs) for consumers; and
- use maps providing common uses in a sector and the related SPERCs, SWEDs and SCEDs.
- Use maps are developed at sector level to provide a brief description of the main uses relevant for the industry sectors
- They provide relevant and realistic information on uses and conditions of use, and they can be used in your chemical safety assessment (CSA).
- They are available in Chesar (ECHA’s chemical safety assessment and reporting tool) format.
- Uses not covered by any use map need to be described according to the conditions of use and be included in the chemical safety assessment.