4-(1,1,3,3-tetramethylbutyl)phenol ethoxylate (4-tert-OPnEO) (EC -, CAS -) is included in Annex XIV (authorisation list) of the REACH Regulation, which implies that this substance may not be used or placed on the market of the European Union unless an authorisation is granted for a use covered by the REACH Regulation.
4-tert-OPnEO is used as lysing agent1, emulsifier and surfactant in various industrial and medical applications: siliconisation of glass containers, viral inactivation of biological proteins in the manufacture of biopharmaceutical substances...
The European Commission granted on 09 November 2021 authorisations for the following 11 uses of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylate:
- use by Vetter PharmaFertigung GmbH & Co. KG
- use by Nuova Ompi S.r.l. Unipersonale
- use by Abbott Diagnostics GmbH
- use by OrthoClinical Diagnostics France
- use by Novo Nordisk A/S
- uses by BioMarin International Limited
- uses by Janssen Vaccines & Prevention B.V. and Janssen Biologics B.V.
- uses by Boehringer Ingelheim Pharma GmbH & Co. KG and Boehringer Ingelheim RCV GmbH & Co KG
1 Agent for the destruction of the membrane of a biological cell