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EU Considers Regulatory Action for Fatty Acid Oligomers in Consumer and Industrial Products

REACH
CLP
13
November 2024
•
400
Dr Steven Brennan
The ECHA is assessing regulatory needs for fatty acid oligomers due to environmental concerns.
Manufacturing lubricant oil
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The European Chemicals Agency (ECHA) has issued an assessment on fatty acid oligomers, including dimers and trimers used across consumer and industrial applications. With potential environmental risks such as persistence and mobility in water and soil, the ECHA suggests initial compliance checks to confirm these hazards before implementing further regulatory actions.

Overview of Fatty Acid Oligomers

The ECHA’s report groups five fatty acid oligomers, substances derived from C16 and C18 unsaturated fatty acids, used extensively in products like cleaning agents, cosmetics, lubricants, and fertilisers. Due to their widespread use in consumer and industrial products, these substances are present in settings ranging from household environments to heavy industries.

Environmental Concerns and Proposed Actions

The primary concern highlighted by ECHA is the potential for these oligomers to be persistent and mobile in the environment (PMT/vPvM), suggesting a likelihood of lingering in surface waters, soil, and groundwater. The ECHA proposes that a compliance check (CCH) be conducted on all group members to confirm these environmental risks. If confirmed, a harmonised classification and labelling (CLH) process may follow to formally recognise these hazards across the EU.

Human Health Impact

Although fatty acid oligomers are broadly utilised, they do not appear to pose significant risks to human health based on current studies. No carcinogenic, mutagenic, or reproductive (CMR) toxicity, nor endocrine disruption properties were found. Additionally, an evaluation of skin sensitisation and toxicity yielded no indications of acute health risks, allowing for the same risk conclusions across this group based on structural similarity.

Widespread Applications and Exposure Potential

The report underscores the extensive use of these oligomers in products such as cosmetics, personal care, and fertilisers, where consumers and professionals face potential exposure. The environmental release of these substances is anticipated due to their usage profile, raising concerns about contamination across various ecosystems. The ECHA recommends further studies to clarify the persistence and mobility characteristics of these substances.

This initial assessment by the ECHA lays the groundwork for potentially stricter regulation of fatty acid oligomers if their environmental risks are validated. Companies using these substances should stay informed about potential regulatory changes and consider exploring safer alternatives or reformulations to avoid potential compliance issues.

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