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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
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
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
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 Commission decided Details
0154-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of IVD-wash solutions on diagnostic analyser systems Commission decided Details
0167-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland Professional use of system solutions (Pre-Trigger and Trigger) in the final use of the In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. Withdrawn Details
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 Details
0138-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Boehringer Ingelheim Pharma
GmbH & Co. KG; Boehringer
Ingelheim RCV GmbH & Co KG
Use of 4-tert-OPnEO in a washing buffer to purify biological APIs (active pharmaceutical ingredients) during the production of Palivizumab and Moxetumomab pasudotox-tdfk. Commission decided Details
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. Commission decided Details
0180-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Bio-Rad Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application Commission decided Details
0201-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A. Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs Commission decided Details
0170-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Octapharma AB Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII Commission decided Details
0185-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX Montpellier SAS Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as detergent in the technical manufacturing of in vitro diagnostic veterinary ELISA Plate tests (plate coating) to prevent the non-specific binding of unwanted macromolecules Commission decided Details
0162-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Novo Nordisk A/S Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as a solvent/detergent agent for virus inactivation in the manufacture of pharmaceutical products used in the treatment of rare bleeding disorders. Commission decided Details
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. Commission decided Details
0183-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DIAGAST Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system. Commission decided Details
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. Commission decided Details
0186-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.;
Immunotech S.R.O.;
Immunotech S.A.S.
Formulation of OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. Commission decided Details
0200-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L. 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 Commission decided Details
0168-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Diagnostics GmbH Professional use as a surfactant, in wash buffer components used in conjunction with Fluorescence In Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents, in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions. Commission decided Details
0163-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) into enhancement solutions and DELFIA standard and maintenance solutions used in In Vitro Diagnostic assays and RUO products as well as maintenance of instruments as a critical ingredient for detection process while measuring europium (or other lanthanide) content of the assay solution Commission decided Details
0299-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - 9036-19-5 MeiraGTx Ireland Designated Activity Company Use of 4-tert-OPnEO as a manufacturing aid in the production of gene therapies Opinions adopted Details
0186-06 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.
Immunotech S.R.O
Immunotech S.A.S.
Beckman Coulter France S.A.S.
Beckman Coulter Česká republika s.r.o.
Beckman Coulter UK - [Application void as of 01/01/2021]
Beckman Coulter S.L.U
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development. Commission decided Details
0188-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Formulation of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (as Triton X-100) for use in the assay buffer for the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity Commission decided Details
0226-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - LETI Pharma, S.L.U. [name of applicant in the original application: Laboratorios LETI, S.L.U. updated due to a notified change of corporate name] Use of 4-tert-OPnEO in aqueous buffers during the manufacturing process of the active pharmaceutical ingredient (Protein Q) of the veterinary vaccine LetiFend® Commission decided Details
0201-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A. Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary In Vitro Diagnostic devices (IVDs) including one SERELISA, six ProFLOK, six WITNESS and five VetScan. The use is carried out by professional users in diagnostic laboratories and veterinary clinics to detect certain diseases in pets and farm animals Commission decided Details
0141-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - SEBIA Industrial use of 4-tert-OPnEO for its wetting detergent properties in the production of buffers, reagents and gel supports allowing the dissolution, the dilution and the good spreading of substrates and reagents, necessary to optimize the functioning and the sensitivity of gel electrophoresis in vitro diagnostic tests. Commission decided Details
0154-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of IVD-kit reagents on diagnostic analyser systems Commission decided Details
0239-01 initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Prionics Lelystad B.V Use as component of buffer solutions to produce antigens (Cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and in-process and final Quality Control of antigens intended for use as veterinary and human health laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications Commission decided Details
0158-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swords Laboratories Unlimited Company [name of applicant in the original application: Swords Laboratories updated due to a notified corporate name change] Industrial use of the substance as a surfactant in the purification of the biopharmaceutical drug Orencia, used for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis and Adult Psoriatic Arthritis Commission decided Details
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. Commission decided Details
0247-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Boehringer Ingelheim RCV GmbH & Co KG Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification of lipidated OspA protein subsequently used for manufacturing of Lyme disease vaccine candidate. Commission decided Details
0143-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - bioMérieux SA Industrial use of 4-tert-OPnEO for its non-ionic detergent to control the level of non-specific reactions in the formulation of in vitro reagents for clinical and industrial in vitro testing immunoassays. Commission decided Details
0187-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - AGC Biologics A/S;
AGC Biologics GmbH
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as a detergent during the purification process of recombinant biopharmaceuticals derived from microbial expression hosts in projects where processes have been approved by the authorities (GMP compliant) Commission decided Details
0145-01 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 an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB). Commission decided Details
0166-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Rousselot bvba Use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated as a surfactant in the manufacturing of low endotoxin gelatin Commission decided Details
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 Details
0201-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] Industrial use in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary In Vitro Diagnostic devices (IVDs) used for detecting certain diseases in pets and farm animals Commission decided Details
0202-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merckle-GmbH-Ulm The use of 4-OPnEO as an emulsifier in a silicone oil emulsion for siliconization of pre-filled syringes in a medicinal product Opinions adopted Details
0349-01 Review report 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - bioMérieux SA Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, used for the extraction of biological material which is further formulated and coated on articles intended for clinical and industrial in vitro testing applications Opinion development Details
0184-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Lilly France S.A.S.; Eli Lilly Italia S.p.A. Industrial formulation (dilution) of a silicone solution containing 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices Commission decided Details