Regulatory Review Suggests Limited Need for Further Action on Lactate Esters

The substances assessed include Isobutyl lactate, Isopropyl lactate, 2-ethylhexyl lactate, and several others. These esters are commonly used in products ranging from washing and cleaning agents to cosmetics, biocidal products, plant protection products, fragrances, and lubricants. Their widespread application means they have a high potential for exposure to humans and the environment, prompting the need for careful regulatory scrutiny.

Key Findings of the Assessment

The ECHA's assessment focused on potential hazards related to human health and environmental safety, as well as the likely exposure pathways. Here are some key conclusions:

1. Human Health Hazards: Most lactate esters in this group do not pose a significant risk of causing skin sensitisation, with the exception of Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-. This substance is self-classified for skin sensitisation, necessitating risk management measures at the company level, particularly for workers handling these chemicals.
2. Environmental Hazards: While most substances in the group are not expected to be hazardous to the aquatic environment, a few, such as Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate, have been self-classified as potentially harmful. These classifications require companies to implement appropriate risk management measures to protect the environment.
3. Exposure and Usage: The substances are used in numerous consumer and professional products, indicating high potential for exposure and environmental release. Notably, some substances are used in metal and non-metal surface treatments, textile dyes, and paper products, which could result in further environmental exposure.
4. Regulatory Actions Proposed: ECHA has proposed compliance checks for certain substances to verify the adequacy of risk management measures. However, based on the current data, there is no immediate need for additional EU-level regulatory risk management for most substances in this group.

Justification for Limited Regulatory Action

ECHA's assessment suggests that, under current conditions, there is no pressing need to introduce further regulatory risk management actions for the group of lactate esters. This conclusion is based on the following factors:

• Low Hazard Profile: The substances generally exhibit a low hazard profile, with most being biodegradable and not classified as persistent, bioaccumulative, or toxic (PBT). The primary breakdown products are lactic acid and various alcohols, which do not pose significant health or environmental risks.
• Current Risk Management: Existing self-classifications and risk management measures by companies handling these substances are deemed sufficient. Furthermore, any presence of skin sensitisers in consumer mixtures is under ongoing review, and appropriate labelling and risk management measures are in place.
• Future Considerations: The assessment acknowledges that if new data emerge or if further risks are identified, the regulatory stance may be re-evaluated. For now, ECHA advises continued monitoring and compliance checks to ensure safety standards are maintained.

This review represents a proactive approach by ECHA to balance chemical safety with practical regulatory measures, reflecting a commitment to both public health and environmental protection while supporting industrial innovation.