The European Chemicals Agency (ECHA) has published a comprehensive report identifying potential regulatory actions for a group of 43 substances derived from reaction products of carboxylic acids and polyethylenepolyamines (PEPAs). These chemicals, commonly used in industrial processes and consumer products such as lubricants and cleaning agents, have raised concerns due to potential human health risks, including reproductive toxicity, and significant environmental hazards, particularly aquatic toxicity. The report calls for immediate action through compliance checks and sets the stage for future regulatory measures across the EU.
Key Concerns in the ECHA Report
The primary concerns identified in the report revolve around the toxicity risks posed by these substances, specifically reproductive toxicity and skin sensitisation, along with hazards to aquatic environments. The grouping of these substances was based on structural similarities and their widespread industrial and consumer uses. According to ECHA, these chemicals could cause widespread exposure to humans and the environment, particularly through professional applications, where operational controls may not always be stringent.
Human Health Hazards
Many of the substances assessed have been flagged for potential reproductive toxicity, a key issue that will be further evaluated through harmonised classification (CLH). ECHA noted that developmental immunotoxicity, driven by the chelation properties of these substances, is a particular concern. This means these chemicals could interfere with essential metal ions, such as copper, which are crucial for normal development. Further, 27 of the substances have been self-classified as skin sensitisers, posing risks particularly in consumer products like cosmetics, textiles, and cleaning agents.
Environmental Risks
Aquatic toxicity is a significant environmental hazard associated with these substances, with 23 of the substances already classified as likely hazards to aquatic life. The report highlights the persistence of these chemicals in the environment, as most are not readily biodegradable, raising concerns about their long-term impact on ecosystems. Additionally, inconclusive data on their bioaccumulative properties and potential as persistent, bioaccumulative, and toxic (PBT) substances further stresses the need for regulatory scrutiny.
Proposed Regulatory Actions
The ECHA report outlines a series of suggested regulatory actions, with the first step being compliance checks (CCH) for the substances under evaluation. The goal is to confirm the reproductive toxicity of these substances via harmonised classification. If these substances are classified as reproductive toxicants (Repr. 1B), several regulatory outcomes are expected:
- Restrictions on Consumer Products: If confirmed, substances with Repr. 1B classification will face automatic restrictions in consumer products under REACH Entry 30. This could lead to the prohibition of these chemicals in everyday items like cleaning products, textiles, and personal care products, thereby limiting human exposure.
- Professional Use Restrictions: Due to the widespread use of these chemicals in industrial and professional applications, restrictions on their use in mixtures by professionals are also likely. This could involve stringent risk management measures and labelling requirements for any products containing these substances.
- Sector-Specific Bans: In sectors such as cosmetics and biocidal products, where strict limits on carcinogenic, mutagenic, or reproductive toxic (CMR) substances are enforced, these chemicals may face outright bans unless exceptions are granted. Similarly, substances used in plant protection products and toys would also be subject to tighter restrictions.
Future Implications and the Path Forward
As the report notes, these assessments mark the beginning of the regulatory journey for these substances. With data still being generated and evaluated, the regulatory landscape is likely to evolve. If reproductive toxicity and other hazards are confirmed through further research, ECHA has indicated that restrictions will expand beyond immediate consumer products to include textiles and other goods where exposure risks are significant.
The next steps include ongoing data collection and compliance checks to strengthen hazard conclusions and clarify the substances' uses. If warranted, a wider push for EU-wide restrictions could follow, potentially limiting the availability of these substances in key industries.
This proactive approach by ECHA reflects a broader European Commission strategy aimed at ensuring chemical safety and sustainability across the EU, particularly by addressing substances that may cause irreversible harm to both human health and the environment.
