Заявления за разрешаване
Заявления за разрешаване
The application for authorisation process includes a period of 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 consultation process:
| Document | Description | |
|---|---|---|
| Submission of information on alternatives | Instructions of how interested third parties can submit information for the 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
Показване на30 резултати.
| 0200-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0200-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | QIAGEN GmbH | 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 | |
| 0200-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0200-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0200-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | QIAGEN GmbH; STAT-Dx Life S.L.; QIAGEN Ltd.; QIAGEN Manchester Ltd.; 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 the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) | |
| 0200-06 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | QIAGEN GmbH; QIAGEN Ltd.; QIAGEN Manchester Ltd.; 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 the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) | |
| 0200-07 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | QIAGEN GmbH; QIAGEN Ltd.; QIAGEN Manchester Ltd.; 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 | |
| 0200-08 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | QIAGEN GmbH; QIAGEN Ltd.; QIAGEN Manchester Ltd.; 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 | |
| 0201-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | Zoetis Belgium S.A.; Delpharm Biotech | Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary In Vitro Diagnostic devices (IVDs) for detecting infectious disease in farm animals | |
| 0201-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | Zoetis Belgium S.A.; Delpharm Biotech | 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 | |
| 0201-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0201-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0202-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0203-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; PPG Industries (UK) Ltd.; Boeing Distribution, Inc.; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); Wesco Aircraft EMEA, LTD (UK) | The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants. | |
| 0203-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; PPG Industries (UK) Ltd.; Boeing Distribution, Inc.; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); Wesco Aircraft EMEA, LTD (UK) | Mixing, by Aerospace and Defence Companies, and their associated supply chains, including the Applicants, of base polysulfide sealant components with OPE-containing hardener, resulting in mixtures containing < 0.1% w/w of OPE for Aerospace and Defence uses that are exempt from authorisation under REACH Art. 56(6)(a). | |
| 0204-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | Biokit S.A. | Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | |
| 0204-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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. | |
| 0205-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | Becton Dickinson Distribution Center NV | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) as a processing aid in imported Diagnostics | |
| 0206-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0206-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0206-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 08/07/2020 | 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 | |
| 0207-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | Chemetall GmbH; Chemetall PLC | The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants. | |
| 0207-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 08/07/2020 | Chemetall GmbH; Chemetall PLC | Mixing, by Aerospace Companies and their associated supply chains, including the Applicant, of base polysulfide sealant components with NPE-containing hardener, resulting in mixtures containing < 0.1% w/w of NPE for Aerospace uses that are exempt from authorisation under REACH Art. 56(6)(a). | |
| 0208-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | 08/07/2020 | Blue Cube Germany Assets GmbH & Co. KG | Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production | |
| 0209-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 08/07/2020 | Safran Aircraft Engines | Industrial use of chromium trioxide-based mixtures for the surface treatment of legacy spare parts of military aircraft engines, including safety-critical parts whose failure endangers airworthiness | |
| 0210-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 08/07/2020 | C. Hübner GmbH | The use of chromium trioxide in the etching of single-component (1K) plastic articles. | |
| 0210-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 08/07/2020 | C. Hübner GmbH | The use of chromium trioxide in the selective etching of multi-component (2K/3K) plastic articles. | |
| 0210-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 08/07/2020 | C. Hübner GmbH | The use of chromium trioxide in the functional electroplating of single-component (1K) and multi-component (2K/3K) plastic articles with the specific aim of obtaining a final Cr(0) coating with high durability and chemical resistance while preserving the lightweight nature of the plastic component. | |
| 0211-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 08/07/2020 | Tata Steel IJmuiden BV; Tata Steel UK Ltd. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | |
| 0211-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | 08/07/2020 | Tata Steel IJmuiden BV; Tata Steel UK Ltd. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | |
Показване на30 резултати.
Related links
- Authorisation list
- Applications for authorisation Regulations
- Applying for authorisation Support
- Applications for authorisation Addressing Chemicals of Concern
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