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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. The table below will be updated at a later stage.
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. | Opinions adopted | |
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 | |
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. | 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 | |
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 Ltd; 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 Ltd; 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 Ltd; 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 Ltd; 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 | |
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 | |
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 | |
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 | |
0215-01 | 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 | |
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 | |
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 | |
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 | |
0095-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | REACHLaw Ltd as Only Representative on behalf of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” | 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 | 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 | |
0139-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Ortho-Clinical Diagnostics | 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. | Opinions adopted | |
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 | Opinions adopted | |
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 | Opinions adopted | |
0185-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | IDEXX Montpellier SAS | Formulation of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in the manufacture of sample diluents and standard solutions used in in vitro diagnostic veterinary ELISA Plate tests used for the detection of infectious diseases in livestock and poultry | Opinions adopted | |
0090-01 | Initial | Formaldehyde, oligomeric reaction products with aniline | 500-036-1 | 25214-70-4 | Polynt Composites France | Formulation of an epoxy resin hardener containing technical MDA | Commission decided | |
0004-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Pending decision | |
0002-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | |
0003-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | |
0011-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Linxens France SA | Formulation of diarsenic trioxide into a mixture | Commission decided | |
0013-01 | Initial | Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane |
221-695-9 247-148-4 | 3194-55-6 25637-99-4 134237-50-6 134237-51-7 134237-52-8 | INEOS Styrenics Netherlands BV INEOS Styrenics Ribecourt SAS INEOS Styrenics Wingles SAS Synthos Dwory 7 spółka z ograniczoną odpowiedzialnością spółka komandytowo-akcyjna. Synthos Kralupy a.s. StyroChem Finland Oy Monotez SA RP Compounds GmbH Synbra Technology bv Sunpor Kunststoff GmbH Dunastyr Polystyrene Manufacturing C. Co. Ltd Versalis SpA Unipol Holland bv | Formulation of flame retarded expanded polystyrene (EPS) to solid unexpanded pellets using hexabromocyclododecane as the flame retardant additive (for onward use in building applications) | Authorisation expired | |
0118-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Boeing Distribution, Inc. [name of applicant
in the original application: Aviall Services Inc updated due to a notified change of corporate name]; Finalin GmbH | Formulation of mixture | Commission decided | |
0032-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Formulation of mixtures | Commission decided | |
0045-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Henkel AG & Co. KGaA Henkel Global SupplyChain B.V. | Formulation of Mixtures | Commission decided | |
0121-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Indestructible Paint Ltd. | Formulation of mixtures | Commission decided | |
0044-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag UK Ltd | Formulation of Mixtures | Commission decided | |
0047-01 | Initial | Potassium hydroxyoctaoxodizincatedichromate | 234-329-8 | 11103-86-9 |
PPG Industries (UK) Ltd Finalin GmbH 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 Coatings SA Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name] | Formulation of Mixtures | Commission decided | |
0043-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Brenntag UK Ltd Henkel AG & Co. KGaA AD International BV | Formulation of Mixtures | Commission decided | |
0046-01 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
AKZO Nobel Car Refinishes B.V. Habich GmbH Henkel Global SupplyChain B.V. Ramboll Belgium BVBA [application transferred from: “Indestructible Paint Ltd.” due to a notified legal entity change] 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] | Formulation of Mixtures | Commission decided | |
0062-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Gentrochema BV | Formulation of mixtures of potassium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Commission decided | |
0099-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
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Formulation of Mixtures of sodium chromate for sealing after anodizing, chemical conversion coating, pickling and etching applications by aerospace companies and their suppliers | Commission decided | |
0063-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Gentrochema BV | Formulation of mixtures of sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films; and the electrolytic passivation of tin plated steel for the packaging industry. | Commission decided | |
0186-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Beckman Coulter GmbH | Formulation of NPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. | Opinions adopted | |
0186-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Immunotech S.R.O.; Immunotech S.A.S. | Formulation of OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. | Opinions adopted | |
0122-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Withdrawn | |
0123-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Plastic Planet srl | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Opinions adopted | |
0008-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Authorisation expired | |
0055-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
CROMOMED S.A. CRONOR S.A. Cromo Europa S.A. CHROMATLANTIQUE INDUSTRIEL VILA ELECTROQUIMICAS.A. | Functional Chrome Plating | Commission decided | |
0100-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Luftfahrttechnik GmbH | Functional chrome plating | Commission decided | |
0095-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | REACHLaw Ltd as Only Representative on behalf of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” | Functional Chrome Plating | Commission decided | |
0032-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Functional Chrome Plating | Commission decided | |
0066-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MTU Aero Engines AG | Functional chrome plating for aerospace applications for civil and military uses, comprising coating of new components for aircraft engines as well as maintenance, repair and overhaul work on aircraft engine components | Commission decided | |
0052-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Federal Mogul Burscheid GmbH | Functional chrome plating of piston rings for automotive engines as applied in the segments light vehicle petrol, light vehicle diesel, middle range diesel and heavy duty | Commission decided | |
0050-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Federal-Mogul Friedberg GmbH | Functional chrome plating of piston rings for two-stroke and four-stroke large bore engines as applied in the industrial sectors Construction & Industry, Power Generation, Railway and Maritime. | Commission decided | |
0119-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Friedrichshafen AG | Functional chrome plating of piston rods for automotive and rail applications | Commission decided | |
0051-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Federal-Mogul Valvetrain GmbH | Functional chrome plating of valves for the use in petrol and diesel engines for light-and heavy duty vehicles. | Commission decided | |
0068-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Hoogovens Court Roll Surface Technologies V.O.F. WAVEC GmbH Trattamento Cilindri Laminazione S.r.l. Walzen-Service-Center GmbH NORD CHROME SAS RHENAROLL SA Texturing Technology Limited NC POLAND Sp.z. o.o. | Functional chrome plating of work rolls used in the steel and aluminium industry. | Commission decided | |
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 | |
0095-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | REACHLaw Ltd as Only Representative on behalf of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” | Functional chrome plating with decorative character | Opinions adopted | |
0032-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Functional chrome plating with decorative character | Opinions adopted | |
0131-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Schell GmbH & Co. KG Armaturentechnologie | Functional chrome plating with decorative character for sanitary applications | Opinions adopted | |
0130-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Dornbracht AG & Co. KG [name of applicant in the original application: Aloys F. Dornbracht GmbH & Co.KG updated due to a notified change of corporate name] | Functional chrome plating with decorative character for sanitary applications | Opinions adopted | |
0220-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SRG Global Ibi, S.L. | Functional chrome plating with decorative character for transportation applications. | Opinion development | |
0053-01 | Initial | Chromic acid |
231-801-5 236-881-5 | 13530-68-2 7738-94-5 | Robert Bosch GmbH | Hard chrome plating for gasoline and diesel injection applications | Commission decided | |
0186-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Beckman Coulter Ireland Inc. | In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles. | Opinions adopted | |
0126-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | AVX Limited | Industrial use in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors. | Commission decided | |
0091-01 | Initial | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | Merck KGaA | Industrial use of diglyme as solvent in the manufacturing process of cryptand intermediates for further conversion into cryptand 221 and cryptand 222 | Commission decided | |
0012-04 | 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] | Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.) | Commission decided | |
0012-03 | 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] | Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.) | Commission decided | |
0184-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Lilly France S.A.S.; Eli Lilly Italia S.p.A. | Industrial formulation (dilution) of a silicone solution containing 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices | Opinions adopted | |
0128-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Doosan Electro-Materials Luxembourg SARL Volta Energy Solutions Hungary Kft [name of applicant in the original application: Doosan Energy Solution Kft updated due to a notified corporate name change] | Industrial formulation of a chromium trioxide solution below 0.1% w/w concentration for the passivation of copper foil used in the manufacture of Lithium Ion Batteries (LiB) for motorised vehicles | Commission decided | |
0054-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Praxair Surface Technologies GmbH | Industrial spraying of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment to ensure either a low temperaturecured coating for corrosion protection, or a high temperature corrosion & oxidation resistance with reduction of surface roughness or a high temperature adhesive, for aviation, power generation machinery, Oil and Gas and marine applications. | Commission decided | |
0054-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Praxair Surface Technologies GmbH | Industrial spraying or brush application of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment, to ensure a high temperature corrosion & oxidation resistance, as well as anti-fouling properties or lubricity at high temperature, for automotive, aviation, power generation machinery, Oil and Gas and marine applications. | Commission decided | |
0021-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Grupa Azoty S.A. | Industrial use as a process chemical in caprolactam purification | Commission decided | |
0077-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Eli Lilly Kinsale Limited [application transferred from original Applicant: Eli Lilly S.A. - Irish Branch due to a notified legal entity change] | Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride | Commission decided | |
0060-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane | Commission decided | |
0080-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
H&R Ölwerke Schindler GmbH
H&R Chemisch-Pharmazeutische Spezialitäten GmbH | Industrial use as a solvent and anti-solvent of the feedstock and intermediate product streams in the combined de-waxing and de-oiling of refining of petroleum vacuum distillates for the production of base oils and hard paraffin waxes | Commission decided | |
0078-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
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Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins | Commission decided | |
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 | |
0167-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] | 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. | Opinions adopted | |
0167-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Abbott Ireland Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] | 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. | Opinions adopted | |
0167-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | 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. | Opinions adopted | |
0145-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB). | Opinions adopted | |
0145-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population. | Opinions adopted | |
0079-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins | Commission decided | |
0120-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | Microbeads AS | Industrial use as a swelling agent during the sulfonation reaction of crosslinked polystyrene beads in the manufacture of ion exchange resins for purification of radioactive waste | Commission decided | |
0079-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins | Commission decided | |
0223-01 | Review report | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins. | 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 | |
0020-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | |
0191-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Sekisui S-lec BV Roermond | Industrial use as polymer additive in the manufacture of interlayer polymer films for laminated safety glass | Opinions adopted | |
0024-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] | Industrial use as process chemical (enclosed systems) in Alcantara Material production | Commission decided | |
0076-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) | Commission decided | |
0076-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) | Commission decided | |
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 | |
0004-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Pending decision | |
0003-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | |
0002-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | |
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