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New Regulatory Measures Proposed for Aziridine Compounds

REACH
CLP
28
August 2024
•
20
Dr Steven Brennan
Aziridines are commonly used in adhesives, sealants, coatings, and textile treatments.
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The European Chemicals Agency (ECHA) has identified significant health and environmental risks associated with a group of 14 aziridine compounds, which are widely used in industrial and professional settings. Key hazards include carcinogenicity, mutagenicity, reproductive toxicity, and specific target organ toxicity (STOT). The agency highlights aziridine (EC 205-793-9) and 2-methylaziridine (EC 200-878-7) as particularly dangerous, both classified as Category 1B carcinogens. ECHA proposes urgent regulatory actions, including compliance checks (CCHs) to confirm the hazards, harmonised classification and labelling (CLH), and potential EU-wide restrictions on professional use. Environmental risks are also noted, particularly for substances identified as persistent, mobile, and toxic (PMT/vPvM).

What are the primary health risks associated with aziridine compounds?

Aziridine compounds pose several significant health risks, including carcinogenicity (the potential to cause cancer), mutagenicity (the ability to cause genetic mutations), reproductive toxicity (adverse effects on sexual function and fertility), and specific target organ toxicity (STOT), which can damage specific organs through repeated exposure. Substances like aziridine (EC 205-793-9) and 2-methylaziridine (EC 200-878-7) have been classified as Category 1B carcinogens, meaning they are highly likely to cause cancer in humans. These risks are particularly concerning given the widespread use of these chemicals in industrial and professional environments, where worker exposure can be significant.

In which sectors and products are aziridine compounds primarily used?

Aziridine compounds are predominantly used in industrial and professional sectors. They are commonly found in adhesives, sealants, coatings, and paints, as well as in textile dyes and leather treatment products. These substances are also used in the manufacture of pharmaceuticals, as well as in the preparation of polymers and other specialised compounds. Given their application in both professional and industrial settings, there is considerable potential for exposure to workers, particularly in sectors involving coatings, paints, and leather treatment, where these compounds are applied through methods such as spraying, brushing, and roller application.

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The European Chemicals Agency (ECHA) has issued a comprehensive assessment report outlining the urgent need for regulatory action concerning a group of 14 substances containing the aziridine moiety. These chemicals, extensively utilised in industrial and professional applications, have been identified as posing serious risks to both human health and the environment.

Health and Environmental Risks

Aziridines, commonly employed in adhesives, sealants, coatings, and textile treatments, have come under scrutiny due to their structural similarities and shared hazardous properties. The assessment, published on 12 August 2024, highlights the potential dangers associated with these substances, including carcinogenicity, mutagenicity, reproductive toxicity, and specific target organ toxicity (STOT). The widespread use of these chemicals in professional and industrial environments increases the likelihood of exposure for workers and the risk of environmental contamination.

Key Hazardous Substances

Among the substances assessed, aziridine (EC 205-793-9) and 2-methylaziridine (EC 200-878-7) have been singled out as particularly hazardous. Both are classified as Category 1B carcinogens, indicating a significant risk of cancer. Aziridine is also classified under Category 1B for mutagenicity, suggesting a high potential to cause genetic mutations. These classifications are supported by existing harmonised classifications and national occupational exposure limits (OELs) in several EU member states.

Proposed Regulatory Actions

The report outlines a series of proposed regulatory actions aimed at mitigating these risks. Immediate measures include compliance checks (CCHs) for specific aziridine compounds to further clarify their hazardous properties. Depending on the results, ECHA suggests prioritising harmonised classification and labelling (CLH), which would lead to broader regulatory restrictions under REACH Annex XVII. These could include banning the use of these substances in consumer products, such as textiles and footwear, unless explicitly authorised.

Additionally, ECHA recommends considering an EU-wide restriction on the professional use of these substances. This approach would be more effective than authorising individual uses, particularly given the widespread application of aziridines with relatively low levels of operational controls. The agency also proposes setting binding occupational exposure limits (OELs) under the Chemical Agents Directive, which would further safeguard industrial workers from inhalation and dermal exposure.

Environmental Concerns

Environmental risks associated with certain aziridines, identified as persistent, mobile, and toxic (PMT/vPvM), are also of concern. Although some of these environmental hazards remain inconclusive, further data generation through proposed CCHs is expected to clarify the need for additional regulatory measures.

In summary, ECHA's assessment calls for urgent regulatory interventions to manage the significant risks posed by aziridine compounds. These actions are expected to enhance protection for workers, consumers, and the environment, ensuring that these hazardous substances are controlled more effectively across the European Union.

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