Trichloroethylene Authorised for Biotransformation Process

Substance and Decision Details

• Decision Reference: C(2023) 8409
• Date of Decision: 8 December 2023
• Substance Name: Trichloroethylene (TCE), EC No: 201-167-4; CAS No: 79-01-6
• Holder of the Authorisation: Roquette Frères, France
• Authorisation Number: REACH/23/37/0/R1
• Authorised Use: As a processing aid in the biotransformation of starch to obtain betacyclodextrin
• Expiry of Review Period: 31 December 2031
• Repealed Decision: C(2017) 7581

Rationale Behind the Decision

The Commission’s decision to grant this authorisation comes after careful consideration of various factors. Primarily, it has been determined that the socio-economic benefits presented by the use of TCE in this specific application significantly outweigh the risks to human health and the environment. This decision aligns with Article 60(4) of the REACH Regulation, which necessitates a balancing act between economic interests and safety concerns.

Understanding Trichloroethylene

TCE, a volatile organic compound, has been a subject of regulatory scrutiny due to its environmental and health impacts. Its use in the industrial sector has been under tight control, and this authorisation marks a notable exception, granted under stringent conditions and for a specific, controlled use.

This decision opens doors for Roquette Frères and potentially others in their supply chain allowing them to utilise TCE under closely monitored conditions.