The European Chemicals Agency (ECHA) has released a screening report evaluating the necessity of imposing restrictions on the use of Bis(2-methoxyethyl) ether (Diglyme) in articles as per REACH Article 69(2). This substance, identified under EC number 203-924-4 and CAS number 111-96-6, is recognized for its toxic reproductive properties. Despite its potential hazards, current evaluations indicate no immediate risk associated with its use in articles within the European Economic Area (EEA).
Introduction to Diglyme Assessment
Diglyme, listed as entry 25 in REACH Annex XIV, has undergone rigorous assessment by ECHA's Committee for Risk Assessment. The committee has established specific dermal and inhalation Derived No-Effect Levels (DNELs) due to its classification as toxic for reproduction. However, available data does not suggest any significant human exposure risk from articles containing Diglyme, leading to the preliminary conclusion that no further restrictions are required at this time.
Methodology and Findings
The screening focused on the current usage of Diglyme in the EEA, especially in the production of articles like vehicle parts, electronic components, and potentially in batteries. Despite its applications as a solvent or processing aid, there is no indication that Diglyme remains in finished articles, except possibly as an electrolyte in batteries—a use not yet commercialized in Europe.
Identified Uses and Regulatory Context
- Automotive and Electronics: Diglyme's presence in vehicle parts, electronics, and LCD screens is acknowledged but not deemed a risk due to its low concentration or absence in final products.
- Plastics Industry: No evidence suggests Diglyme's involvement in plastic or rubber production, aligning with ECHA's findings and the lack of notifications to ECHA of Diglyme in articles.
- Battery Production: Although potential future uses in battery electrolytes are explored, current market applications within the EU are non-existent. Regulatory oversight, including the recent EU Batteries Regulation, is expected to manage any future risks effectively.
Risk Assessment and Conclusion
The report underscores that there is no current risk from Diglyme in articles based on its unlikely presence in automotive parts, electronic components, and plastic products. The situation regarding batteries remains under surveillance, with future developments to be regulated under the EU Batteries Regulation.
Future Outlook and Recommendations
ECHA recommends continuous monitoring of Diglyme's use in the EU, especially in emerging applications like battery production. Any significant changes or evidence of risk could prompt a reassessment and potential regulatory actions to ensure public health and environmental safety.
The assessment was conducted in line with REACH Article 69(2), focusing on after-sunset date evaluations of substances listed in Annex XIV for their risk management in articles, highlighting the specific approach to human health and environmental hazards associated with Diglyme.
