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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0204-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Biokit S.A.	Professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA In-Vitro-Diagnostic kits.	Opinions adopted
0206-03	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Phadia GmbH; B∙R∙A∙H∙M∙S GmbH	Coating Thyroid Stimulating Hormone Receptor onto articles used as components of IVD reagent systems at B∙R∙A∙H∙M∙S GmbH and Phadia GmbH	Opinions adopted
0140-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	DIAGNOSTICA STAGO	Industrial use of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays).	Commission decided
0141-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	SEBIA	Industrial use of 4-tert-OPnEO for its detergent properties in the production of electrophoresis gels in view of ensuring the positioning of specific proteins necessary for the interpretation of results of gel electrophoresis in vitro diagnostic tests.	Commission decided
0143-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	bioMérieux SA	Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of reagents for molecular clinical and industrial in vitro preparative and testing applications.	Commission decided
0145-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	BioMarin International Limited	Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population.	Commission decided
0156-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Sanofi Pasteur	Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines	Commission decided
0165-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Eli Lilly Kinsale Limited	Industrial use of a 4-tert-octylphenol ethoxylate compound, as a patient safety viral inactivation reagent in the manufacture of human medicines produced from biological systems	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
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

Showing 81 - 90 of 486 results.

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