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- 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. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.
| 0217-02 | Initial | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | Acton Technologies Limited | Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes) | Opinion development | |
| 0217-01 | Initial | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | Acton Technologies Limited | Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (in-house processes) | Opinion development | |
| 0216-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega Supply Chain GmbH & Co KG | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinion development | |
| 0216-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega Supply Chain GmbH & Co KG | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright silvery appearance for sanitary applications | Opinion development | |
| 0215-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Oras Oy | Pre-treatment (“etching”) of plastic substrates using chromium trioxide for electroplating processes in sanitary applications | Opinion development | |
| 0215-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Oras Oy Oras Olesno Sp.z.o.o. | Electroplating of metal and plastic substrates using chromium trioxide to achieve functional surfaces for sanitary applications | Opinion development | |
| 0214-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Salzgitter Flachstahl GmbH | Pretex® functional chrome plating using chromium trioxide in closed reactor systems for the establishment of adjustable hemispherical surface structures on working rolls applied in the steel industry for the manufacture of cold-rolled, high quality textured sheet metal | Opinion development | |
| 0214-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Salzgitter Flachstahl GmbH | Functional chrome plating using chromium trioxide in closed reactor systems for the establishment of a ‘conventional’ hard chrome coating on working rolls applied in the steel industry for the pre-manufacturing of cold-rolled, high-quality textured sheet metal | Opinion development | |
| 0213-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Steel Color S.p.A. | Use of chromium trioxide as colouring and hardening agent for stainless steel plates | Opinion development | |
| 0212-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. | Industrial use of chromium trioxide for the functional chrome plating with decorative character for automotive and sanitary industry | Opinion development | |
| 0212-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. | Industrial use of chromium trioxide for the etching, pre-treatment step in the electroplating process of functional chrome plating with decorative character | Opinion development | |
| 0211-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Tata Steel IJmuiden BV; Tata Steel UK Ltd. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinion development | |
| 0211-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tata Steel IJmuiden BV; Tata Steel UK Ltd. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinion development | |
| 0210-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 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. | Opinion development | |
| 0210-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the selective etching of multi-component (2K/3K) plastic articles. | Opinion development | |
| 0210-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the etching of single-component (1K) plastic articles. | Opinion development | |
| 0209-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | 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 | Opinion development | |
| 0208-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG | Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production | Opinion development | |
| 0207-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 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). | Opinion development | |
| 0207-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH; Chemetall PLC | The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants. | Opinion development | |
| 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 | Opinion development | |
| 0206-02 | Initial | 4-Nonylphenol, branched and linear, 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 | Opinion development | |
| 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 | Opinion development | |
| 0205-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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 | Opinion development | |
| 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. | Opinion development | |
| 0204-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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. | Opinion development | |
| 0203-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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). | Opinion development | |
| 0203-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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. | Opinion development | |
| 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 | Opinion development | |
| 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 | Opinion development | |
| 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 | Opinion development | |
| 0201-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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 | Opinion development | |
| 0201-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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 | Opinion development | |
| 0200-08 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 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 | Opinion development | |
| 0200-07 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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 | Opinion development | |
| 0200-06 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 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) | Opinion development | |
| 0200-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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) | Opinion development | |
| 0200-04 | Initial | 4-Nonylphenol, branched and linear, 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 | Opinion development | |
| 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 | Opinion development | |
| 0200-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | 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 | Opinion development | |
| 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 | Opinion development | |
| 0199-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Sanquin Reagents B.V. | Use of Triton™ X-100 (4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated) in formulation of components for IVD kits. | Opinion development | |
| 0198-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Ireland Pharmaceuticals | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals – Post-Production Cleaning. | Opinion development | |
| 0198-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Ireland Pharmaceuticals | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes. | Opinion development | |
| 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. | Opinion development | |
| 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). | Opinion development | |
| 0196-01 | 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 (syringes and cartridges) used as primary packaging material for 44 medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the AoA. These products cover several therapeutic areas, and approx. 40 % of them are listed on the WHO Model List of Essential Medicines (EML). | Opinion development | |
| 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. | Opinion development | |
| 0194-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Instrumentation Laboratory SpA | Use as a lysing agent for red blood cells in blood analysis diagnostic device. | Opinion development | |
| 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). | Opinion development | |
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