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HSE REACH ebulletin

Date issued: 31 May 2024

This ebulletin contains information relating to UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.

UK REACH application for authorisation: publication of final opinions

The Agency for UK REACH has published final opinions on the following applications for authorisation.

• Reference: AFA018-01
  Applicant: Siemens Healthcare Diagnostics Products GmbH
  Substances: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
  Use: Use of IVD kit reagents on diagnostic analyser systems by professional users.
  
  
• Reference: AFA018-02
  Applicant: Siemens Healthcare Diagnostics Products GmbH
  Substances: 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
  Use: Use of IVD wash solutions on diagnostic analyser systems by professional users.
  
  
• Reference: AFA020-01
  Applicant: Abbott Laboratories Limited
  Substance: 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
  Use: Professional use as a surfactant, in Wash Buffer components used in conjunction with Fluorescence in Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents, in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions.
  
  
• Reference: AFA021-01
  Applicant: Becton Dickinson U.K. Limited
  Substance: 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)
  Use: Use of 4-(1,1,3,3 tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO) for the lysis of different types of cells in order to release the cell contents for subsequence analysis in diagnostics.

The opinions and other related documentation can be found on the HSE website.