Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. 

 

There are currently no ongoing consultations.
 
0242-01 Review report Trichloroethylene 201-167-4 79-01-6 Microporous GmbH Trichloroethylene used as extraction solvent in the manufacture of polyethylene separators for lead-acid batteries Commission decided Details
0014-02 Initial Trichloroethylene 201-167-4 79-01-6 Vlisco Netherlands BV Use of trichloroethylene as a solvent in a process to recover and purify resin from process water Commission decided Details
0208-01 Review report Trichloroethylene 201-167-4 79-01-6 SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production Commission decided Details
0024-03 Initial Trichloroethylene 201-167-4 79-01-6 SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] Use of tricholoroethylene in packaging Commission decided Details
0014-01 Initial Trichloroethylene 201-167-4 79-01-6 Vlisco Netherlands BV Use of trichloroethylene as a solvent for the removal and recovery of resin from dyed cloth Commission decided Details
0024-02 Initial Trichloroethylene 201-167-4 79-01-6 SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] Industrial use as process chemical (enclosed systems) in Alcantara Material production Commission decided Details
0023-01 Initial Trichloroethylene 201-167-4 79-01-6 A.L.P.A.-AZIENDA LAVORAZIONE PRODOTTI AUSILIARI S.P.A.; CAFFARO INDUSTRIE S.P.A Use of trichloroethylene as solvent in the synthesis of vulcanization accelerating agents for fluoroelastomers Commission decided Details
0024-05 Initial Trichloroethylene 201-167-4 79-01-6 SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] Use of Trichloroethylene as Extraction Solvent for Bitumen in Asphalt Analysis Commission decided Details
0227-01 Review report Trichloroethylene 201-167-4 79-01-6 ROQUETTE Frères Use as a processing aid in the biotransformation of starch to obtain betacyclodextrin Commission decided Details
0361-01 Initial tetraethyllead 201-075-4 78-00-2 Trafigura Ventures V.B.V. Blending of TEL in Avgas formulations Opinion development Details
0353-01 Initial Tetraethyllead 201-075-4 78-00-2 Shell Nederland Raffinaderij B.V. Use of tetraethyl lead in the formulation of aviation fuel Opinion development Details
0362-01 Initial tetraethyllead 201-075-4 78-00-2 Warter Fuels Spółka Akcyjna FUEL FORMULATION WITH ADDED TETRAETHYL LEAD Opinion development Details
0139-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics - [Application void as of 01/01/2021] Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) for use in the manufacture of in vitro diagnostic VITROS® products used for infectious disease screening, endocrinology, and oncology testing. Application void as of 01 January 2021 Details
0140-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DIAGNOSTICA STAGO Industrial use of 4-tert-OPnEO in view of controlling the amount of non-specific reactions in the production of in-vitro diagnostic reagents (STA® - Liatest® D-Di assays). Commission decided Details
0200-07 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, 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 Commission decided Details
0169-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Janssen Vaccines & Prevention BV
Janssen Biologics B.V.
4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step. Commission decided Details
0206-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Phadia GmbH; Thermo Fisher Scientific Baltics UAB Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB Commission decided Details
0161-01 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 used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company. Commission decided Details
0167-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name]
Abbott Diagnostics GmbH
Professional use as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Commission decided Details
0187-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - AGC Biologics A/S Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts in projects where processes have been approved by the authorities (GMP compliant) Commission decided Details
0200-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, 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 Commission decided Details
0141-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - SEBIA Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests. Commission decided Details
0163-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments Commission decided Details
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). Commission decided Details
0188-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (as Triton X-100) in the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity Commission decided Details