UK REACH application for authorisation: publication of final opinion

by Posted on

2023-02-09

The Agency for UK REACH has produced final opinions on the below applications for authorisation.

Reference: AFA005-01

Substance:4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO) (EC: 618-344-0, CAS: 9002-93-1; EC: 618-541-1, CAS: 9036-19-5)

Use:Professional use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems

HSE sent the final opinion to the Appropriate Authorities on 21 December 2022.

Reference: AFA007-01

Substances:4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (OPEO) (EC: 618-344-0, CAS: 9002-93-1; EC: 618-541-1, CAS: 9036-19-5) and 4-Nonylphenol, branched and linear, ethoxylated (NPEO) (EC: 500-024-6, CAS: 9016-45-9)

Use: Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and use of 4-Nonylphenol, branched and linear, ethoxylated in in-vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions

HSE sent the final opinion to the Appropriate Authorities on 19 December 2022.

The Defra Secretary of State (SoS) with the consent of the Appropriate Authorities have 6 months from receipt of the final opinions in which to make decisions on whether to grant the authorisations. As we have two applications listed on the bulletin the SoS will be making separate decisions.

Read More

HSE, 09-02-23
; https://www.hse.gov.uk/reach/applications-for-authorisation.htm