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May 2, 2022

HSE Produces a Final Opinion on the First New REACH Application for Authorization

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...