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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0171-05	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Roche Diagnostics GmbH	Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA)	Opinions adopted
0173-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Siemens Healthcare Diagnostics Products Ltd - [Application void as of 01/01/2021]	Use of OPE as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platform	Application void as of 01 January 2021
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	Opinions adopted
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
0200-08	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 Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing	Opinions adopted
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
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.	Opinions adopted
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
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
0200-02	Initial	4-Nonylphenol, branched and linear, ethoxylated	-	-	QIAGEN GmbH	Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing	Opinions adopted

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