TCE authorisation REF:836

RPA was contracted by the Polish chemical manufacturer Grupa Azoty S.A. to support the preparation of an application for the authorisation of the continued use of trichloroethylene (TCE, EC No.: 201-167-4, CAS No.: 79-01-6) in the manufacture of caprolactam in Grupa Azoty S.A.’s plant in Tarnow, Poland.  For this project, RPA acted as a sub-contractor to its long-term partner on REACH Authorisation matters Forschungs- und Beratungsinstitut Gefahrstoffe GmbH (FoBiG).

According to its harmonised classification and labelling, TCE may cause cancer and was added to the Annex XIV Authorisation list of the REACH Regulation (Regulation (EC) No 1907/2006) with a sunset date of 21 April 2016.  This meant that users of the substance in the EU should have submitted an Application for the Authorisation of their uses to ECHA by 21 October 2014.

Grupa Azoty S.A. uses TCE in its Tarnow plant as an extraction solvent in the industrial manufacture of caprolactam from cyclohexanone (i.e. via Beckman rearrangement).  TCE has a favourable combination of physico-chemical properties (i.e. density, boiling point) which allow the selective and efficient extraction of caprolactam, whilst maximising the quality of both caprolactam and its ammonium sulphate by-product.  TCE is also readily recycled within the process.  In turn, caprolactam is used as a precursor in the manufacture of polymers, notably nylon, which finds a wide variety of industrial and consumer uses.

RPA was responsible for developing the analysis of possible alternatives, which demonstrated that there were no technically and economically feasible substitutes for TCE in Grupa Azoty’s manufacturing process.  In addition, starting from the assessment of the cancer risks from the continued use of TCE which was generated by FoBiG, RPA quantified and monetised the human health cost of the continued use of TCE (in terms of statistical cases of cancer occurring) and compared this to the economic and social costs that would arise if the continued use of TCE was not authorised.  This analysis was presented in a separate document, the socio-economic assessment.

The application submitted by Grupa Azoty S.A. received a favourable opinion from ECHA’s Risk Assessment (RAC) and Socio-Economic Assessment (SEAC) Committees, which was issued on 18 May 2015 and recommended a 12-year review period for the continued use of TCE, the maximum length that the Committees are able to recommend at present.  Subsequently, the European Commission agreed to adopt the opinion of the two ECHA Committees and granted Grupa Azoty S.A. an Authorisation for 12 years under Decision C(2017) 649, which was published in the Official Journal on 15 February 2017.  This positive result allows the continuation of Grupa Azoty S.A.’s business operations and supports the company in its ongoing effort to develop and switch to a feasible and safer alternative.