The European Chemicals Agency (ECHA) has released a comprehensive screening report assessing the potential health risks associated with the use of 1,2-dichloroethane (EDC) in various articles. This report, prepared under the REACH Regulation (Article 69(2)), evaluates whether the presence of EDC in imported and domestically produced goods poses significant risks that necessitate regulatory action.
Background and Scope
ECHA's screening reports, prepared in accordance with Article 69(2) of the REACH Regulation (EC) No. 1907/2006, focus on substances listed in Annex XIV. The objective is to determine if the risks from these substances are adequately controlled or if restrictions need to be implemented. This particular report examines the risks posed by 1,2-dichloroethane (EDC), a known carcinogen.
Identified Uses and Concerns
Industrial Applications
1,2-Dichloroethane is primarily used in the manufacturing of vinyl chloride monomer (VCM), which is a precursor for polyvinyl chloride (PVC) production. It is also used as an intermediate under strictly controlled conditions.
Use as a Biocide
EDC is utilised as a biocide for fumigating freight containers. Residues of EDC can remain in fumigated articles, potentially leading to human exposure.
Consumer and Worker Exposure
Although no consumer uses of articles containing EDC were identified, imported goods such as polyresin figurines, sex toys, children's toys, and holiday decorations have been found to emit EDC. Workers handling these fumigated containers and articles are at risk of exposure to EDC and other hazardous substances, often at levels exceeding national or EU occupational limit values.
Hazard Assessment
EDC is classified as a carcinogenic substance for which no safe exposure threshold can be determined. The presence of EDC in articles, particularly those fumigated with the substance, raises significant health concerns.
Regulatory Framework and Risk Management
Existing Regulations
- Biocidal Products Regulation (EU No 528/2012): Prohibits articles treated with non-approved biocidal substances, including EDC, from being placed on the market.
- Toys Safety Directive (2009/48/EC): Bans carcinogenic substances in toys at concentrations equal to or above 0.1%.
- Occupational Safety and Health (OSH) Directive (89/391/EEC) and Chemical Agents Directive (98/24/EC): Require risk assessments and appropriate protective measures for workers handling hazardous substances.
ECHA's Conclusions
ECHA concludes that the risks associated with EDC in articles are addressed by existing regulatory measures and there is no immediate need for additional restrictions under REACH Article 69(2). However, ECHA emphasises the need for continued monitoring and enforcement to ensure compliance with these regulations.
Recommendations
ECHA recommends enhancing enforcement practices to ensure that fumigated containers are properly labelled and that regulations are effectively translated into operational practices by companies. Adequate guidance and preventive measures, such as active ventilation of containers and the use of personal protective equipment, are crucial to minimising exposure risks for workers.
Conclusion
The ECHA screening report underscores the carcinogenic risks posed by 1,2-dichloroethane and highlights the importance of stringent regulatory measures to protect human health. While current regulations appear adequate, ongoing vigilance and enforcement are essential to mitigate the risks associated with this hazardous substance.
