One of the core elements of the REACH regulation is the responsibility of producers, importers and downstream users to provide information on the safe use of a substance (Chemical Safety Assessment). A Chemical Safety Assessment involves characterising each identified use of a substance with the help of exposure scenarios that determine the substance-specific Operational Conditions (OC) and the Risk Management Measures (RMM) necessary for safe use.
Until now, we’ve been using the term “Exposure Modeling” on our website. This is actually not the full story. It would be more accurate to talk about “Risk assessments for the environment and human toxicology and the development of exposure scenarios”.
This information allows quantitative and/or qualitative risk assessments to be done for all phases of a substance’s life-cycle. It involves determining the concentrations at which the substance is likely to be found in the environment, in the workplace, or to reach the consumer (estimation of exposure).
In some cases, this process can involve iterative steps before the conditions for the safe use of a substance can be determined. Besides the use of recommend risk mitigation measures, specific Environmental Release Categories (spERCs) and/or Generic Exposure Scenarios (GES) can be applied. This approach is generally accepted by ECHA and the industry associations if complex supply relationships are involved.
The REACH regulation also requires that the results of a substance’s chemical safety assessment be disseminated down the supply chain (Title IV, Article 31, REACH Reg.). The producer/importer must transfer all the relevant information about exposure scenarios to the next user in line in the form of an extended safety data sheet (eSDB). The downstream user must be able, on the basis of the information provided, to estimate whether or not they operate within the limits that have been determined in the exposure scenarios. The smooth flow of information down the supply chain depends strongly on the availability of clearly structured and coherent exposure scenarios.
Dr. Knoell Consult possesses many years of collective experience in the area of risk assessment for the environment and human toxicology, and the preparation of scientific dossiers. Our staff are experts in calculating, applying and communicating exposure scenarios. We use the latest versions of the prevailing IT-Tools (e.g. CHESAR, EUSES, ECETOC TRA, easyTRA, ConsExpo, RISKOFDERM, ART, Stoffenmanager) to do the calculations that underlie the quantitative exposure assessments for individual exposure scenarios and subsequent risk characterisation.
This means that our team is well positioned to provide an understanding of how the system of use descriptors (SU, ERC, PROC, PC, AC) can be used appropriately in the context of REACH, and how operational conditions and risk mitigation measures can be correctly defined, in order to ensure legally-compliant and effective communication down the supply chain.
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