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The application for authorisation process includes a period of public consultation. It lasts for eight weeks.

 

Instructions for providing comments

Anyone can provide information on alternative substances or technologies for the uses of Annex XIV substances included in applications for authorisation. Those most likely to be interested are companies, organisations representing industry or civil society, individual citizens, as well as public authorities.

The following documents describe the public consultation process:

 

Document Description  
Submission of information on alternatives Instructions of how interested third parties can submit information for the public consultation on alternatives for applications for authorisation. Download
Format for "Public version" Download
Format for "Complete version" Download

 

Provide your comments

In order to facilitate the work of ECHA's Committees in reviewing the comments received, you are kindly invited to provide your comments in English preferably. By clicking on a link in the table below, you will get access to the full broad information on the use applied for, and to the related commenting form. Comments are welcomed from the EU or beyond.

Consultations close at 23:59 Helsinki time (EET).

Adopted opinions and previous consultations on applications for authorisation

Visar 35 resultat.
 
0173-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Siemens Healthcare Diagnostics Products Ltd Use of OPE as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platform
0174-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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.
0175-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0176-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 LFB BIOMEDICAMENTS Use as virus inactivation into the manufacture process of plasma-derived immunoglobulins.
0177-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0178-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Baxter AG; 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.
0179-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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.
0180-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Bio-Rad Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections
0180-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 Bio-Rad Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections
0180-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Bio-Rad Industrial use of 4-tert-OPnEO for its non-ionic detergent property in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles
0180-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Bio-Rad Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications
0180-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Bio-Rad Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application
0181-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 DiaSorin S.p.A. Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology.
0182-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 Abbott Diagnostics GmbH Professional use as a surfactant in an onboard solution (Detergent B) as an accessory to In-Vitro Diagnostic Devices (IVDs) to wash the reagent probes, the mixers and the reaction cuvettes between tests to prevent interference with the test result on ARCHITECT and Alinity automated analyser systems.
0183-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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.
0184-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0185-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0185-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 IDEXX Montpellier SAS Formulation of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in the manufacture of sample diluents and standard solutions used in in vitro diagnostic veterinary ELISA Plate tests used for the detection of infectious diseases in livestock and poultry
0185-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 IDEXX EUROPE B.V.;
IDEXX Montpellier SAS
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions
0185-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 IDEXX EUROPE B.V. Use of 4-Nonylphenol, branched and linear, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions
0186-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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.
0186-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc.;
Beckman Coulter GmbH
Formulation of NPnEO 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.
0186-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc. In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles.
0186-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc.;
Immunotech S.R.O.;
Beckman Coulter S.A.S.;
Beckman Coulter Česká republika s.r.o.;
Beckman Coulter UK Ltd;
Beckman Coulter S.L.U;
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of OPnEO-containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays.
0186-05 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc.;
Beckman Coulter GmbH;
Beckman Coulter S.A.S.;
Beckman Coulter Česká republika s.r.o.;
Beckman Coulter UK Ltd;
Beckman Coulter S.L.U;
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of NPnEO-containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays.
0186-06 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc.;
Immunotech S.R.O;
Immunotech S.A.S.;
Beckman Coulter S.A.S.;
Beckman Coulter Česká republika s.r.o.;
Beckman Coulter UK Ltd;
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.
0186-07 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc.; Beckman Coulter GmbH; Beckman Coulter S.A.S.;
Beckman Coulter Česká republika s.r.o.;
Beckman Coulter UK Ltd;
Beckman Coulter S.L.U;
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development.
0186-08 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Beckman Coulter Ireland Inc.; Immunotech S.R.O.; Immunotech S.A.S.; Beckman Coulter S.A.S.; Beckman Coulter Česká republika s.r.o.; Beckman Coulter UK Ltd; Beckman Coulter S.L.U; Beckman Coulter SPA Italy; BC Distribution B.V Phase out of OPnEO-containing laboratory products from the market due to obsolescence or next generation formulations.
0187-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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)
0187-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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)
0188-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0188-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0189-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 Lonza Biologics Porriño, SL.; Lonza Biologics, plc. Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures
0190-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - 08/01/2020 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
0191-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 08/01/2020 Sekisui S-lec BV Roermond Industrial use as polymer additive in the manufacture of interlayer polymer films for laminated safety glass
Visar 35 resultat.



 

 

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