Information on alternatives to substance in authorisation process sought

21 July 2021

The HSE has opened a consultation on alternatives under UK REACH after a company has applied for authorisation to use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in the development of gene therapies.

The aim of the authorisation process is to:

  • ensure that the risks related to substances of very high concern (SVHCs) are properly controlled throughout their life cycle

  • promote the progressive replacement of SVHCs by suitable alternatives (less dangerous substances, new technologies and processes), where technically and economically feasible alternatives are available.

The application is for use of the substance at a single UK site.

The applicant intends to use the substance as a cell lysing agent for the extraction of proteins and organelles during the manufacture of gene therapy products. The substance is formulated into a buffer solution which is subsequently introduced to cells in culture which have been engineered to produce the gene therapy vector; when the cells are lysed the vector is released into the lysate. The lysate is then filtered and purified via successive downstream processes in order to yield the applicants product.

During purification of the product, the majority of the substance used in the process is collected for offsite incineration as hazardous waste. A small proportion is discharged to sewer and could enter the aquatic environment.

The HSE is inviting information on possible alternatives. Comments should be submitted via Consultation Survey by 8 September 2021.