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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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
0198-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Pfizer Ireland Pharmaceuticals	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes.	Commission decided
0197-02	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	MERCK MILLIPORE LIMITED	Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes.	Opinions adopted
0197-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	MERCK MILLIPORE LIMITED	Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes).	Opinions adopted
0196-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Vetter Pharma-Fertigung GmbH & Co. KG	Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers (syringes and cartridges) used as primary packaging material for 44 medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the AoA. These products cover several therapeutic areas, and approx. 40 % of them are listed on the WHO Model List of Essential Medicines (EML).	Commission decided
0195-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	RSI ChemRep Europe Ltd (O002) OR for OraSure Technologies Inc	Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as surfactant in in –vitro diagnostic device developer solution.	Opinions adopted
0194-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Instrumentation Laboratory SpA	Use as a lysing agent for red blood cells in blood analysis diagnostic device.	Commission decided
0193-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Yposkesi	Use of 4-tert-OPnEO for its non-ionic detergent properties for the cell membrane lysis and viral clearance during the development and manufacturing of viral vectors in medicinal products dedicated to human use (Investigational and Authorized Advanced Therapy Medicinal Product).	Commission decided
0192-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Pfizer Manufacturing Belgium NV	The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products.	Commission decided
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
0190-01	Initial	4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated	-	-	Teva Baltics UAB	The use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated (TritonX-100) as a nonionic surfactant for bacteria cells disruption and washing of inclusion bodies in Biological Drug Substance manufacturing process	Commission decided

Showing 161 - 170 of 486 results.

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