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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0167-05	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]	Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems.	Opinions adopted
0170-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Octapharma AB	Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII	Commission decided
0171-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Roche Diagnostics GmbH	Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA.	Opinions adopted
0180-05	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Bio-Rad	Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application	Commission decided
0183-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	DIAGAST	Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system.	Commission decided
0185-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	IDEXX Montpellier SAS	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as detergent in the technical manufacturing of in vitro diagnostic veterinary ELISA Plate tests (plate coating) to prevent the non-specific binding of unwanted macromolecules	Commission decided
0186-06	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	Downstream use of OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development.	Opinions adopted
0188-02	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 the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity	Commission decided
0193-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Yposkesi	Use of 4-tert-OPnEO for its non-ionic detergent properties for the cell membrane lysis and viral clearance during the development and manufacturing of viral vectors in medicinal products dedicated to human use (Investigational and Authorized Advanced Therapy Medicinal Product).	Commission decided
0197-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	MERCK MILLIPORE LIMITED	Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes.	Opinions adopted

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