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Paraiškos dėl autorizacijos

Paraiškos dėl autorizacijos

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

Rodoma 30 rezultatų.
 
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
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.
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.
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
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.
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.
0210-01 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.
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).
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
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
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
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).
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.
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
0200-02 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
0200-04 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
0200-07 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
0200-06 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)
0200-08 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
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
0200-05 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)
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
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)
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
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
0201-01 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
Rodoma 30 rezultatų.



 

 

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