The Health and Safety Executive (HSE) recommends that MeiraGTx UK II Limited receive a 12-year review period for its use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO). The applicant uses the substance as a manufacturing aid in the production of gene therapy products at its manufacturing facility in London, UK.
4-ter-OPnEO is known to have endocrine-disrupting properties in the environment. The use applied for may result in <100 grams per year releases of the substance to the environment. HSE also recommends that the applicant identify and implement additional risk management measures.
The opinion is of significance to the applicant and to other companies that use or place substances on the market that are subject to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) authorization requirement. The Department for Environment, Food & Rural Affairs (Defra) Secretary of State will consider the HSE’s opinion before making a decision on the application.