Trichloroethylene Authorised for Biotransformation Process

Substance and Decision Details

Decision Reference: C(2023) 8409Date of Decision: 8 December 2023Substance Name: Trichloroethylene (TCE), EC No: 201-167-4; CAS No: 79-01-6Holder of the Authorisation: Roquette Frères, FranceAuthorisation Number: REACH/23/37/0/R1Authorised Use: As a processing aid in the biotransformation of starch to obtain betacyclodextrinExpiry of Review Period: 31 December 2031Repealed 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.