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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
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	Details
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	Withdrawn	Details
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	Details
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	Details
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	Commission decided	Details
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	Details
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	Details
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	Commission decided	Details
0191-01	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	Sekisui S-lec BV Roermond	Industrial use as polymer additive in the manufacture of interlayer polymer films for laminated safety glass	Commission decided	Details
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.	Commission decided	Details

Showing 181 - 190 of 567 results.

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