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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. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.
On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.
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| 0169-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
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. | Commission decided | |
| 0046-02 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
AKZO Nobel Car Refinishes B.V. Habich GmbH Henkel Global SupplyChain B.V. Indestructible Paint Ltd. Finalin GmbH Mapaero PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative] PPG Industries (UK) Ltd PPG Coatings SA Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name] |
Application of paints, primers and specialty coatings containing Strontium Chromate in the construction of aerospace and aeronautical parts, including aeroplanes / helicopters, spacecraft, satellites, launchers, engines, and for the maintenance of such constructions. | Commission decided | |
| 0256-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KaVo Dental GmbH | Chromium trioxide based functional chrome plating of dental instruments applied by professionals for dental treatment | Opinions adopted | |
| 0289-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Fabbrica d'armi Pietro Beretta SPA | Chromium trioxide based functional chrome plating of gun barrel bores and auxiliary parts for semi-automatic shotguns, over/under, side-by-side shotguns, pistols and carbines for civilian uses. | Opinion development | |
| 0289-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Fabbrica d'armi Pietro Beretta SPA | Chromium trioxide based functional plating of gun barrel bores and auxiliary parts for assault rifles, carbines and pistols for non-civilian uses. | Opinion development | |
| 0220-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SRG Global Ibi, S.L. | Chromium trioxide-based etching as pre-treatment step for electroplating of plastics for transportation applications. | Opinions adopted | |
| 0286-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hartchrom-beck GmbH.; Heinrich Schnarr GmbH; Kreft & Röhrig GmbH; Rudolf Jatzke Galvanik-Hartchrom Günter Holthöfer GmbH & Co. KG; Johann Maffei GmbH & Co. KG; Schornberg Galvanik GmbH; Wissing Hartchrom GmbH | Chromium trioxide-based functional chrome plating of axially/rotationally symmetrical components requiring high wear resistant surfaces to withstand abrasive forces occurring in their application | Opinion development | |
| 0286-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hartchrom-beck GmbH.; Heinrich Schnarr GmbH; Kreft & Röhrig GmbH; Rudolf Jatzke Galvanik-Hartchrom Günter Holthöfer GmbH & Co. KG; Johann Maffei GmbH & Co. KG; Schornberg Galvanik GmbH; Wissing Hartchrom GmbH | Chromium trioxide-based functional chrome plating of axially/rotationally symmetrical components requiring optimal tribological surface properties (resulting from microcracked surface) to ensure low surface friction under lubrication | Opinion development | |
| 0286-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hartchrom-beck GmbH.; Kreft & Röhrig GmbH; Rudolf Jatzke Galvanik-Hartchrom Günter Holthöfer GmbH & Co. KG; Johann Maffei GmbH & Co. KG; Schornberg Galvanik GmbH; Wissing Hartchrom GmbH | Chromium trioxide-based functional chrome plating of components with complex 3-dimensional geometry (not axially/rotationally symmetrical) requiring high wear resistant surfaces to withstand abrasive forces occurring in their application | Opinion development | |
| 0286-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hartchrom-beck GmbH.; Kreft & Röhrig GmbH; Rudolf Jatzke Galvanik-Hartchrom Günter Holthöfer GmbH & Co. KG; Johann Maffei GmbH & Co. KG; Schornberg Galvanik GmbH; Wissing Hartchrom GmbH | Chromium trioxide-based functional chrome plating of components with complex 3-dimensional geometry (not axially/rotationally symmetrical) requiring optimal tribological surface properties ( resulting from microcracked surface) to ensure low surface friction under lubrication | Opinion development | |
| 0233-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Betz-Chrom GmbH | Chromium trioxide-based functional chrome plating of components with diverse geometries and dimensions, requiring specialized equipment and process knowledge, for applications in demanding industry sectors such as mechanical engineering, metalworking and processing, aerospace, automotive, and medical technology. | Opinions adopted | |
| 0234-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Maschinenfabrik Kaspar Walter GmbH & Co KG | Chromium trioxide-based functional chrome plating of cylinders used in the rotogravure printing and embossing industry. | Opinions adopted | |
| 0282-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hazet Werk Hermann Zerver GmbH & Co. KG | Chromium trioxide-based functional chrome plating of hand tools to achieve a high level of abrasion resistance as well as corrosion and chemical resistance | Opinion development | |
| 0258-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Heinrich Schulte Söhne GmbH & Co. KG; Schulte Hartchrom GmbH | Chromium trioxide-based functional chrome plating of large components and small components with complex geometries and/or requiring special approval procedures for their application in demanding sectors such as medical, aerospace, defence and mining industry | Opinions adopted | |
| 0253-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | GEA Westfalia Separator Group GmbH | Chromium trioxide-based functional chrome plating of machine components for centrifugal separator and decanter centrifuges | Opinions adopted | |
| 0258-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Heinrich Schulte Söhne GmbH & Co. KG; Schulte Hartchrom GmbH | Chromium trioxide-based functional chrome plating of small components with simple geometries not requiring special approval procedures for their application in demanding sectors such as hydraulic systems, food, paper and chemical industry | Opinions adopted | |
| 0296-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAHLE - Componentes de Motores, S.A. | Chromium-trioxide-based functional chrome plating of piston rings for automotive applications | 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 | Opinions adopted | |
| 0012-08 | Initial | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Distribution and mixing pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles for non consumer use | Commission decided | |
| 0012-07 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Distribution and mixing pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles for non consumer use | Commission decided | |
| 0012-02 | Initial | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer use | Commission decided | |
| 0012-01 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer use | Commission decided | |
| 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. | Opinions adopted | |
| 0186-05 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Beckman Coulter GmbH Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] 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. | Opinions adopted | |
| 0186-07 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Beckman Coulter GmbH Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] 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. | Opinions adopted | |
| 0186-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Immunotech S.R.O. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o.; Beckman Coulter UK - [Application void as of 01/01/2021] 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. | Opinions adopted | |
| 0186-06 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Immunotech S.R.O Immunotech S.A.S. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] 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. | Opinions adopted | |
| 0266-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | OLIVARI B SPA | Electroplating of brass substrates using chromium trioxide to achieve functional surfaces for architectural fittings | Opinions adopted | |
| 0273-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MIKRO METAL S.R.L. | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance | Opinion development | |
| 0132-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinions adopted | |
| 0284-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C.G.S. SRL | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinion development | |
| 0245-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | NEWFORM S.P.A. | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinions adopted | |
| 0277-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Rubinetterie Ritmonio Srl | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinion development | |
| 0133-01 | Iitital | Chromium trioxide | 215-607-8 | 1333-82-0 |
Ideal Standard - Vidima AD; Ideal Standard Produktions-GmbH; Jado Iberia-Produtos Metalurgicos Sociedade Unipessoal LDA (withdrawn) |
Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinions adopted | |
| 0269-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RUBINETTERIE 3M SRL | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications. | Opinion development | |
| 0264-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | CRISTINA SRL A SOCIO UNICO | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications. | Opinion development | |
| 0216-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega GmbH & Co. KG. [name of applicant in the original application: Viega Supply Chain GmbH & Co. KG updated due to a notified corporate name change] | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright silvery appearance for sanitary applications | Opinions adopted | |
| 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 | Opinions adopted | |
| 0272-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RIGHI S.p.A. | Electroplating of metal substrates using chromium trioxide to achieve functional surfaces for the sanitary sector | Opinion development | |
| 0261-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Metalbrass s.r.l. | Electroplating of metal substrates using chromium trioxide to achieve functional surfaces for the sanitary sector | Opinion development | |
| 0270-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAIER S. COOP. MAIER CZ s.r.o.; MAIER CROMOPLASTICA S.p.A | Etching of plastics with chromium trioxide as pre-treatment step for electroplating of plastics for automotive applications | Opinions adopted | |
| 0132-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinions adopted | |
| 0133-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Ideal Standard - Vidima AD | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinions adopted | |
| 0216-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega GmbH & Co. KG. [name of applicant in the original application: Viega Supply Chain GmbH & Co. KG updated due to a notified corporate name change] | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinions adopted | |
| 0095-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] | Formulation of mixtures of chromium trioxide for functional chrome plating, functional chrome plating with decorative character and surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering | Commission decided | |
| 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 | Opinions adopted | |
| 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 | Opinions adopted | |
| 0139-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Ortho-Clinical Diagnostics - [Application void as of 01/01/2021] | Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) for use in the manufacture of in vitro diagnostic VITROS® products used for infectious disease screening, endocrinology, and oncology testing. | Application void as of 01 January 2021 | |
| 0163-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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 | Commission decided | |
| 0188-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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 | Commission decided | |
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