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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0185-04	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	IDEXX B.V. [name of the applicant in the original application: “IDEXX EUROPE B.V.” updated due to a notified corporate name change]	Use of 4-Nonylphenol, branched and linear, ethoxylated 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	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.	Opinions adopted
0142-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	SEBIA	Industrial use of 4-NPnEO for its detergent properties in the production of buffers and reagents in view of ensuring the positioning of specific proteins necessary for the interpretation of gel electrophoresis in vitro diagnostic tests results based on the determination of isoenzymes.	Commission decided
0186-05	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 clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays.	Opinions adopted
0171-04	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Roche Diagnostics GmbH	Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA.	Opinions adopted
0172-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name]	Industrial use of emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia	Commission decided
0207-02	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021]	Mixing, by Aerospace Companies and their associated supply chains, including the Applicant, of base polysulfide sealant components with NPE-containing hardener, resulting in mixtures containing < 0.1% w/w of NPE for Aerospace uses that are exempt from authorisation under REACH Art. 56(6)(a).	Commission decided
0207-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021]	The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants.	Commission decided
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.	Opinions adopted
0200-06	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V.	Professional downstream 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 with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only)	Opinions adopted

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