Adopted opinions and previous consultations on applications for authorisation

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.

ID	Application type	Name	EC Number	CAS Number	Applicant(s)	Use name	Status
0180-04	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Bio-Rad	Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications	Commission decided
0186-08	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Beckman Coulter Ireland Inc. Immunotech S.R.O. Immunotech S.A.S. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U Beckman Coulter SPA Italy BC Distribution B.V	Phase out of OPnEO-containing laboratory products from the market due to obsolescence or next generation formulations.	Opinions adopted
0195-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	RSI ChemRep Europe Ltd (O002) OR for OraSure Technologies Inc	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as surfactant in in –vitro diagnostic device developer solution.	Opinions adopted
0204-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Biokit S.A.	Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits.	Opinions adopted
0141-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	SEBIA	Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests.	Commission decided
0154-05	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Siemens Healthcare Diagnostics Products GmbH	Use of IVD-wash solutions on diagnostic analyser systems	Opinions adopted
0161-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Vetter Pharma-Fertigung GmbH & Co. KG	Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company.	Commission decided
0163-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Wallac Oy	Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments	Commission decided
0167-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Abbott Ireland	Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems.	Opinions adopted
0169-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Janssen Vaccines & Prevention BV Janssen Biologics B.V.	4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step.	Commission decided

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