Lupahakemukset
Lupahakemukset
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
Näytetään 46 tulosta.
| 0146-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 09/10/2019 | Tata Steel UK Ltd | The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS) | |
| 0147-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht as a binder in the manufacture of clay targets | |
| 0148-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | DEZA a.s. | Use of CTPht as a binder in the manufacture of clay targets | |
| 0149-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | Industrial Quimica del Nalon, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | |
| 0150-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | Koppers Denmark ApS | Use of CTPht for manufacture of formulations for various industrial uses | |
| 0150-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | 09/10/2019 | Koppers Denmark ApS | Use of AO for manufacture of formulations for various industrial uses | |
| 0151-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | RÜTGERS Germany GmbH | Use of CTPht for manufacture of formulations for various industrial uses | |
| 0151-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | 09/10/2019 | RÜTGERS Germany GmbH | Use of AO for manufacture of formulations for various industrial uses | |
| 0152-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | Rain Carbon bvba | Use of CTPht for manufacture of formulations for various industrial uses | |
| 0152-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | 09/10/2019 | Rain Carbon bvba | Use of AO for manufacture of formulations for various industrial uses | |
| 0153-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 09/10/2019 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | |
| 0153-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | 09/10/2019 | BILBAINA DE ALQUITRANES, S.A. | Use of AO for manufacture of formulations for various industrial uses | |
| 0154-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction) | |
| 0154-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in formulation of IVD-kit reagents | |
| 0154-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Siemens Healthcare Diagnostics Products GmbH | Use of OPE in formulation of IVD- wash solutions | |
| 0154-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-kit reagents on diagnostic analyser systems | |
| 0154-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-wash solutions on diagnostic analyser systems | |
| 0155-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Kedrion S.p.A | Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand | |
| 0156-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Sanofi Pasteur | Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines | |
| 0157-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 |
Merck Biodevelopment SAS FUJIFILM Diosynth Biotechnologies UK Limited | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies | |
| 0158-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Swords Laboratories | 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 | |
| 0159-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Nuova Ompi S.r.l. unipersonale | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product (NeoRecormon®) of one pharmaceutical company. | |
| 0160-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®). | |
| 0161-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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. | |
| 0162-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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. | |
| 0163-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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 | |
| 0163-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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 | |
| 0164-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Swedish Orphan Biovitrum | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in manufacture of biopharmaceuticals by Swedish Orphan Biovitrum AB. | |
| 0165-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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 | |
| 0166-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Rousselot bvba | Use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated as a surfactant in the manufacturing of low endotoxin gelatin | |
| 0167-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 |
Abbott Ireland Abbott GmbH & Co. KG | Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | |
| 0167-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 |
Abbott Ireland Abbott GmbH & Co. KG 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. | |
| 0167-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Abbott Ireland | Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. | |
| 0167-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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. | |
| 0167-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Abbott GmbH & Co. KG | Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | |
| 0168-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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. | |
| 0169-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 |
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. | |
| 0170-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 |
Octapharma AB Octapharma Pharmazeutika Produktionsgesellschaft m.b.H Octapharma S.A.S. Octapharma Produktionsgesellschaft Deutschland mbH | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as detergent for a virus inactivation step (solvent/detergent treatment) during the manufacture of plasma-derived and recombinant medicinal products | |
| 0170-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | 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 | |
| 0171-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | |
| 0171-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | |
| 0171-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | |
| 0171-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | |
| 0171-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) | |
| 0171-06 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 09/10/2019 | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) | |
| 0172-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 09/10/2019 | GE Healthcare Bio-Sciences AB | Industrial use of emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia | |
Näytetään 46 tulosta.
Related links
- Authorisation list
- Applications for authorisation Regulations
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