Exposure assessment and risk characterisation
You need to carry out exposure assessment and risk characterisation for substances registered at above ten tonnes per year, if they are classified as dangerous or as having persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) properties.
- Your exposure assessment and risk characterisation must cover all hazards identified based on the standard information requirements, and they should not be limited to classified hazards.
- Identified hazards go beyond hazards that warrant classification, and include:
- hazards for which currently no classification criteria exist, but where there is evidence that the substance can cause adverse effects (typically relevant for soil and sediment);
- hazards for endpoints for which there are classification criteria, but where the dose/concentration triggering effects in the test are lower than the threshold for classification, 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 the hazards leading to classification under the CLP Regulation.
- Report all uses and the information on the corresponding conditions of use.
- Make sure that the description of use is clear and consistent with the uses of the substance in the supply chain.
- For the environmental exposure assessment, make sure that you provide an adequate explanation of the conditions of use that lead to the assumed release rate of the substance into the environment.
- If your substance is persistent, bioaccumulative and toxic (PBT), show clearly in the chemical safety report how you are minimising its release.
- When you derive the derived no-effect level (DNEL) or the predicted no-effect concentration (PNEC), justify and document any deviation from the default assessment factors presented in REACH Guidance, Chapter R.8 and R.10 with scientific arguments that are specific to your substance.
- When using a model to estimate the exposure, ensure that the model applies to your substance and use appropriate modelling parameters, justifying their selection.
- Make sure that your exposure scenarios in the chemical safety report are transparent, specific and exhaustive in coverage. The operational conditions and the risk management measures have to be given in sufficient detail and ensure safe use.
- Do not use tier 1 tools for mass production of exposure scenarios in an automated manner, as 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 of your substance 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 relevant uses.
- Provide intuitive use names, preferably using terminology that is harmonised throughout your sector.
- Give a short explanation on the process or activities covered by the use. Do not rely only on standard use descriptors, as they are too generic to transparently inform authorities and customers on what a use is about.
- If you are a member registrant, make sure that the use description in your IUCLID dossier covers the process you want to register. Do not just copy the use description from other registrants or the generic chemical safety report for your substance, as this may lead to a high number of inconsistencies.
- If you register the substance as an intermediate, you should not have to report any consumer uses, uses by professional workers, or uses of the substance in an article’s service life, as these are incompatible with the intermediate status of a substance.
- Choose the right level of differentiation between uses so that you make it possible for safety information to be communicated in a targeted way to 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 ensuring control of risks for each use described and predict the exposure to both humans and environment under these conditions
Use the available information for creating the exposure assessment inputs: specific environmental release categories (SERCs) for the environment, specific consumer exposure determinants (SCEDs) for consumers and use maps 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 sector – take advantage of them in your registration:
- They use an agreed template that can be made available also in Chesar (ECHA’s chemical safety assessment and reporting tool) format.
- They provide information on uses and conditions of use reflecting relevant and realistic information: they can be fed into your chemical safety assessment (CSA).
- Keep in mind that uses not covered by any use map still need to be described according to the condition of use and be included in the chemical safety assessment.