HELSINKI, Finland, 12 November 2026 — The European Chemicals Agency (ECHA) has opened public consultations on requests to extend existing authorisations for two hazardous chemicals used in manufacturing. Poland's Grupa Azoty seeks to continue using trichloroethylene (TCE; CAS 79-01-6) in caprolactam production, while France's Yposkesi wants more time to use 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO), present in Triton X-100, to manufacture viral vectors for gene therapies.
Grupa Azoty is requesting an extension until 21 April 2040, while Yposkesi seeks permission until 4 January 2034. Neither request has been approved. Interested parties have until 7 January 2027 to submit information on alternatives and substitution.
Why Both Companies Need More Time
Under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, certain hazardous substances generally cannot be used after their designated sunset dates without authorisation or another applicable legal basis.
Grupa Azoty applied for authorisation in August 2014, before TCE's sunset date of 21 April 2016, and received approval in 2017. Yposkesi applied in 2019, before the 4 January 2021 sunset date for 4-tert-OPnEO, and received approval in February 2023.
Their existing authorisations have review dates of 21 April 2028 and 4 January 2028, respectively.
These reviews are not automatic. Both companies submitted review reports requesting extensions and providing evidence concerning alternatives, substitution and the consequences of discontinuing use.
The 2028 dates are not necessarily mandatory stop-use deadlines. Under REACH, an existing authorisation remains valid while the European Commission considers a qualifying review report submitted at least 18 months before the review date.
If the Commission approves an extension, the company may continue its specified use under the conditions established in the decision. If it refuses, the authorisation ceases to apply when the refusal takes legal effect, and the company must discontinue the affected use unless another legal basis permits it.
Grupa Azoty: Replacing TCE in Nylon Production
Grupa Azoty uses TCE as an extraction solvent to purify caprolactam (CAS 105-60-2) at its Tarnów facility in Poland. Caprolactam is a raw material for polyamide 6, or nylon 6, used in automotive components, packaging, electrical equipment and other industrial products.
TCE is recovered and reused in a closed manufacturing process rather than intentionally incorporated into nylon products. It is classified in the EU as a presumed human carcinogen and suspected mutagen.
The company has identified toluene (CAS 108-88-3) as its preferred replacement but says the alternative is not yet technically feasible at the facility.
According to its analysis of alternatives and socio-economic assessment, substitution would require extensive equipment modifications. The proposed process also has not produced ammonium sulphate, a co-product sold for fertiliser production, at the quality required by customers.
Grupa Azoty proposes a six-phase substitution programme involving laboratory research, pilot testing, engineering, construction and commissioning through 2040. However, it acknowledges that the feasibility of the replacement process remains unproven.
The company argues that losing authorisation before completing substitution could disrupt caprolactam production, affecting nylon 6 and fertiliser operations, employment and customers in Poland and Germany. These are applicant projections rather than findings accepted by ECHA.
Its review documents describe measures to control TCE exposure and releases, including enclosed equipment, vapour detection, monitoring and wastewater treatment.
Yposkesi: Replacing Triton X-100 in Gene Therapy Manufacturing
Yposkesi uses Triton X-100 to break open production cells and inactivate unwanted enveloped viruses during viral vector manufacturing. The detergent is a processing aid, not an intended active ingredient in the finished medicine.
4-tert-OPnEO is subject to REACH authorisation because of environmental concerns associated with endocrine-disrupting degradation products.
Yposkesi has already replaced Triton X-100 with Tween 80 (polysorbate 80) in its other relevant manufacturing programmes. The remaining use concerns GNT0004, an investigational gene therapy developed by Genethon for Duchenne muscular dystrophy.
Although Tween 80 can replace Triton X-100's cell-disruption function, it does not provide equivalent viral inactivation. Substitution therefore requires an additional viral-clearance step and studies demonstrating that the revised manufacturing process produces comparable material.
Yposkesi also reports that the European Medicines Agency advised against changing a critical manufacturing material during GNT0004's ongoing pivotal clinical trial. The company argues that modifying the process could require additional studies and delay treatment development.
The requested six-year extension would allow Yposkesi to continue manufacturing GNT0004 while developing and validating a Triton-free process.
What Happens Next?
The consultations opened on 11 November 2026 and close on 7 January 2027. Interested parties can submit evidence about available alternatives, their feasibility and the time required for substitution.
ECHA's scientific committees will assess the applications before the European Commission decides whether to extend either authorisation. The Commission may grant a shorter period than requested, impose conditions or refuse continued use.
The decisions will determine whether Grupa Azoty can continue using TCE while developing its replacement process and whether Yposkesi can retain Triton X-100 in GNT0004 manufacturing while completing its transition.