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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0076-01	Initial	1,2-dichloroethane (EDC)	203-458-1	107-06-2	BASF SE	Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO)	Commission decided
0060-01	Initial	1,2-Dichloroethane (EDC)	203-458-1	107-06-2	BASF SE	Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane	Commission decided
0110-01	Initial	1,2-Dichloroethane (EDC)	203-458-1	107-06-2	Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change]	Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist®	Commission decided
0186-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Beckman Coulter Ireland Inc.	In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles.	Opinions adopted
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
0186-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Beckman Coulter Ireland Inc.; Immunotech S.R.O.; Immunotech S.A.S.	Formulation of OPnEO 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
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
0186-04	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Beckman Coulter Ireland Inc. Immunotech S.R.O. 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 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
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
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

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