The European Chemicals Agency (ECHA) has completed its assessment of regulatory needs for linear aliphatic dicarboxylic acids with carbon chain lengths of C3-C8 and their salts. As of October 2024, ECHA has determined that no immediate regulatory risk management (RRM) actions are required at the EU level, except for substances that may pose skin sensitisation risks, such as maleic acid and disodium maleate.
Overview of Regulatory Assessment
The assessment, part of ECHA’s ongoing efforts to ensure chemical safety in the EU, evaluated 17 substances from this chemical group, including widely used acids such as succinic, fumaric, and adipic acids. These substances are integral to many industries, with applications in polymer preparations, cosmetics, adhesives, coatings, and cleaning products, contributing to significant professional and consumer exposure. However, the review found no substantial human health or environmental hazards requiring EU-wide intervention, aside from the risk of skin sensitisation.
Key Substances and Findings
Among the 17 substances, maleic acid (CAS 110-16-7) and disodium maleate (CAS 371-47-1) were identified as having potential skin sensitising properties, which could impact consumers through widespread applications in cleaning products and cosmetics. ECHA noted that risk management measures at the company level, such as proper labelling, should be sufficient to mitigate these concerns. The agency also highlighted ongoing investigations into the presence of sensitising substances in consumer mixtures.
Why No EU-Wide Action Is Required
ECHA’s report concluded that other hazardous properties, such as carcinogenicity, mutagenicity, reproductive toxicity, and aquatic toxicity, are unlikely for this group of substances. Thus, no further EU-level regulatory actions, such as restrictions or authorisations, are currently necessary. Adequate risk management practices by companies and correct classifications under the Classification, Labelling, and Packaging (CLP) regulation are considered sufficient for ensuring safety in most cases.
Ongoing Monitoring and Future Actions
While no immediate regulatory actions are planned, ECHA will continue to monitor new data and update assessments as necessary. Future revisions could arise from ongoing evaluations of skin sensitisation risks across various chemical groups.
