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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0171-06	Initial	4-Nonylphenol, branched and linear, 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
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
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
0174-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Hospira Zagreb d.o.o., a Pfizer company	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers.	Commission decided
0175-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Merck KGaA	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (technical grade) as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert according to IPEC standards	Commission decided
0176-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	LFB BIOMEDICAMENTS	Use as virus inactivation into the manufacture process of plasma-derived immunoglobulins.	Opinions adopted
0177-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Rentschler Biopharma SE	Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated in a washing buffer applied during a purification step in the manufacture of the monoclonal antibody Dinutuximab beta	Commission decided
0178-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Takeda Manufacturing Austria AG [name of the applicant in the original application: Baxter AG updated due to a change of corporate name]; Baxalta Belgium Manufacturing SA	Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (as a detergent) for virus inactivation via S/D (Solvent/Detergent) treatment in recombinant and plasma-derived medicinal products.	Commission decided
0179-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	bioMérieux SA	Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products.	Commission decided

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