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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0248-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	FYSOL SAS [name of applicant in the original application: OCV Chambéry France S.A.S. updated due to a notified legal entity change]	Mixing by the Applicant of a NPnEO-containing epoxy resin, resulting in mixtures containing < 0.1% w/w of NPnEO for the manufacture of glass fiber articles for critical composite helicopter parts, that is exempt from authorisation under REACH Art. 56(6)(a)	Opinions adopted
0239-02	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Prionics Lelystad B.V.	Use as component of buffer solutions to produce antigens (Cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and in-process and final Quality Control of antigens intended for use as veterinary and human health laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications	Opinion development
0182-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Abbott Diagnostics GmbH	Professional use as a surfactant in an onboard solution (Detergent B) as an accessory to In-Vitro Diagnostic Devices (IVDs) to wash the reagent probes, the mixers and the reaction cuvettes between tests to prevent interference with the test result on ARCHITECT and Alinity automated analyser systems.	Withdrawn
0200-04	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	QIAGEN GmbH	Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing	Commission decided
0206-02	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Phadia GmbH; Thermo Fisher Scientific Baltics UAB	Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB	Opinions adopted
0186-07	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Beckman Coulter Ireland Inc. Beckman Coulter GmbH 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 NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development.	Commission decided
0230-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Safran Landing Systems; SOCIETE DE TRAITEMENTS ELECTROLYTIQUES NORMALISES S.T.E.N.	Industrial use of 4-NPnEO as non-reactive surfactant in the sealing product in sulfuric acid anodization process of aluminium alloy parts of aircraft landing gears	Withdrawn
0180-02	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Bio-Rad	Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections	Commission decided
0186-02	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Beckman Coulter Ireland Inc.; Beckman Coulter GmbH	Formulation of NPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use.	Commission decided
0171-02	Initial	4-Nonylphenol, branched and linear, 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.	Commission decided

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