The European Chemicals Agency (ECHA) has published a proposal from Austria to classify 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid as a Substance of Very High Concern (SVHC) under the REACH Regulation. The substance, also known as Tetra-PSCA, is identified by the EC number 701-118-1 and CAS number 2156592-54-8.
Substance Classification and Risks
Tetra-PSCA is being proposed for inclusion on the SVHC list due to its classification as toxic for reproduction. The substance has been categorised under hazard class 1B, indicating it may cause reproductive harm, including potential damage to fertility and the unborn child. This classification aligns with the criteria set out in Article 57(c) of the REACH Regulation (EC) No 1907/2006, which covers substances that may have serious and irreversible effects on human health.
The primary health risks associated with Tetra-PSCA stem from its potential to disrupt reproductive functions, posing significant dangers to both fertility and foetal development. This concern has led to its proposed classification as a Substance of Very High Concern, warranting stricter regulatory scrutiny and potentially leading to restrictions or bans on its use.
Uses and Applications
Despite the health risks, Tetra-PSCA is currently used widely across various industries in the European Union. It is primarily utilised in the manufacturing of lubricants, greases, release products, and metalworking fluids. These applications typically involve industrial and professional settings, where Tetra-PSCA contributes to the performance characteristics required for effective lubrication and metal processing.
The substance is registered for these specific uses but is not listed for consumer applications, indicating its use is limited to controlled environments where occupational safety measures are likely in place. However, even in industrial settings, the potential for exposure to a substance with reproductive toxicity raises concerns about worker safety and the need for stringent handling protocols.
Next Steps and Public Involvement
The proposal to list Tetra-PSCA as an SVHC is now open for public comment until 14 October 2024. Stakeholders, including industry representatives, public health advocates, and other interested parties, are encouraged to review the Annex XV report and submit their comments through the ECHA's dedicated form. This public consultation process will help determine the final regulatory approach for managing the risks associated with this substance.
The identification of Tetra-PSCA as an SVHC could lead to further regulatory actions, including restrictions on its use, requirements for authorisation before use, or potential inclusion in Annex XIV of the REACH Regulation, which lists substances subject to authorisation.
