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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.
| 0012-09 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCC Maastricht B.V. OR | Industrial use of solid or liquid colour premixes and pre-compounds containing pigment to colour plastic or plasticised articles for non-consumer use | Commission decided | |
| 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 | |
| 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 | |
| 0004-03 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Pending decision | |
| 0005-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | |
| 0005-03 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Industrial use of DBP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Authorisation expired | |
| 0005-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. |
Use of DBP in propellants Formulation: Industrial use of DBP as a burning rate surface moderant, plasticiser and/or coolant in the formulation of nitrocellulose-based propellant grains. Use at industrial site: Industrial use of DBP-containing propellant grains in manufacture of ammunition for military and civilian uses, and pyrocartridges for aircraft ejection seat safety systems [includes propellants for police force ammunition and excludes propellants intended for manual, private reloading of ammunition cartridges by civilian users, i.e., licensed individual sports shooters and hunters. No direct consumer use of DBP or its mixtures is covered by this Use.] | Commission decided | |
| 0148-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | DEZA a.s. | Use of CTPht as a binder in the manufacture of clay targets | Opinion development | |
| 0183-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGAST | Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system. | Opinion development | |
| 0140-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays). | Opinion development | |
| 0140-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO in view of controlling the amount of non-specific reactions in the production of in-vitro diagnostic reagents (STA® - Liatest® D-Di assays). | Opinion development | |
| 0181-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DiaSorin S.p.A. | Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology. | Opinion development | |
| 0106-02 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 | Display Technologies Limited | Industrial use of Ammonium Dichromate in the process of manufacturing Cathode Ray Tubes for head up displays intended to be used in military and civilian aircrafts | Commission decided | |
| 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 | |
| 0128-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Doosan Electro-Materials Luxembourg SARL Doosan Energy Solution Kft | 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 | |
| 0036-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | ELECTROQUÍMICA DE HERNANI, S.A. | Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide or sodium chlorite | Commission decided | |
| 0165-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Eli Lilly Kinsale Limited | Industrial use of a 4-tert-octylphenol ethoxylate compound, as a patient safety viral inactivation reagent in the manufacture of human medicines produced from biological systems | Opinion development | |
| 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 | |
| 0107-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | emp Biotech GmbH | Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes | Commission decided | |
| 0017-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ENTEK International Limited | Trichloroethylene as an extraction solvent for removal of process oil and formation of the porous structure in polyethylene based separators used in lead-acid batteries | Commission decided | |
| 0037-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Ercros SA | Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide or sodium chlorite | Commission decided | |
| 0028-01 | Initial | Lead chromate | 231-846-0 | 7758-97-6 | Etienne LACROIX | Industrial use of lead chromate in manufacture of pyrotechnical delay devices contained into ammunition for naval self-protection | Commission decided | |
| 0083-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives | Commission decided | |
| 0103-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Euro Cryospace France | The use of chromium trioxide for the surface preparation of aluminium alloy cryogenic tanks used in the Ariane 5 launcher | 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 | |
| 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 | |
| 0070-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
FN HERSTAL S.A. BROWNING VIANA, FABRICA DE ARMAS E ARTIGOS DE DESPORTO SA | Industrial use of chromium trioxide in the hard chromium coating of civilian firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide a low friction coefficient as well as heat, corrosion and wear resistance properties. | Commission decided | |
| 0070-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
FN HERSTAL S.A. MANROY ENGINEERING LTD | Industrial use of chromium trioxide in the hard chromium coating of military small- and medium-caliber firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide hardness, heat resistance and thermal barrier properties, as well as corrosion resistance, adhesion and low friction properties | Commission decided | |
| 0082-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | GE Healthcare Bio-Sciences AB | Industrial use of 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. | Commission decided | |
| 0172-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | GE Healthcare Bio-Sciences AB | Industrial use of emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia | Opinion development | |
| 0062-02 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Gentrochema BV | Use of potassium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Opinions adopted | |
| 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. | Opinions adopted | |
| 0063-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Gentrochema BV | Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites and sealings of anodic films. | Opinions adopted | |
| 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. | Opinions adopted | |
| 0063-03 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Gentrochema BV | Use of Sodium dichromate for the electrolytic passivation of tin plated steel for the packaging industry. | Opinions adopted | |
| 0071-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Gerhardi Kunststofftechnik GmbH
C. Hübner GmbH SAXONIA Galvanik GmbH Simon Systems GmbH & Co. KG [name of co-applicant in the original application: Karl Simon GmbH & Co. KG updated due to a notified legal entity name change] Galvanoplast Fischer Bohemia, s.r.o. [correction of the name of the original Applicant: Fischer GmbH & Co. surface technologies KG and of the successor Applicant: Fischer Surface Technologies GmbH] Fischer Oberflächentechnologie GmbH [correction of the name of the original Applicant: Fischer GmbH & Co. surface technologies KG and of the successor Applicant: Fischer Surface Technologies GmbH] WAFA Germany GmbH Boryszew Oberflächentechnik Deutschland GmbH Bolta Werke GmbH Heinze Gruppe GmbH C+C Krug GmbH BIA Kunststoff- und Galvanotechnik GmbH & Co KG Aludec Galvanic s.a. | Plating on Plastics for Automotive Applications (PoPAA) | Opinions adopted | |
| 0034-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium Trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | |
| 0034-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional electroplating with decorative character) | 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 | |
| 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)] | Pending decision | |
| 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 | Pending decision | |
| 0081-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | GRUPA LOTOS S.A. | Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. | Commission decided | |
| 0113-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Gruppo Colle.S.r.l. | Use of Sodium dichromate as mordant in wool dyeing | 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 | |
| 0124-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 |
H&R Ölwerke Schindler GmbH; H&R Chemisch-Pharmazeutische Spezialitäten GmbH | Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems, applied for the dewaxing and deoiling process steps of petroleum raffinate. | Commission decided | |
| 0114–01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional plating with decorative character) | Commission decided | |
| 0114–02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | |
| 0093-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of brass, bronze, copper and other copper alloys for medical engineering, aviation and automation products | Opinions adopted | |
| 0092-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of plastic, with or without current flow | Opinions adopted | |
| 0064-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of Chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category I. | Opinions adopted | |
| 0064-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category II. | Opinions adopted | |
| 0064-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of Chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category III. | Opinions adopted | |
| 0064-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in dissolved and solid form to produce aqueous solutions of any composition for industrial application. | Opinions adopted | |
| 0112-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | HAPOC GmbH & Co KG | Use of sodium dichromate in molten bath form to modify surfaces, especially by blackening, of delicate medical products, specifically micro-surgical instruments | 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 | Opinions adopted | |
| 0045-02 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 |
Henkel AG & Co. KGaA Henkel Global Supply Chain B.V. | Use of dichromium tris(chromate) for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Opinions adopted | |
| 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 | |
| 0174-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Hospira Zagreb d.o.o., a Pfizer company | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers. | 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 | |
| 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 | |
| 0185-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | IDEXX EUROPE B.V. | Use of 4-Nonylphenol, branched and linear, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions | Opinion development | |
| 0185-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
IDEXX EUROPE B.V.; IDEXX Montpellier SAS | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions | Opinion development | |
| 0185-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | IDEXX Montpellier SAS | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as detergent in the technical manufacturing of in vitro diagnostic veterinary ELISA Plate tests (plate coating) to prevent the non-specific binding of unwanted macromolecules | Opinion development | |
| 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 | Opinion development | |
| 0105-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | ILARIO ORMEZZANO - SAI s.r.l. [name of applicant in the original application: Ilario Ormezzano Sai Spa updated due to a notified name change] | Repackaging of Sodium Dichromate to be supplied as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings | Opinions adopted | |
| 0105-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | ILARIO ORMEZZANO - SAI s.r.l. [name of applicant in the original application: Ilario Ormezzano Sai Spa updated due to a notified name change] | Use of Sodium Dichromate as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings | Opinions adopted | |
| 0121-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Indestructible Paint Ltd. | Formulation of mixtures | Commission decided | |
| 0121-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Indestructible Paint Ltd. | Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications | Commission decided | |
| 0149-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Industrial Quimica del Nalon, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Opinion development | |
| 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 | |
| 0013-02 | 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 | Manufacture of flame retarded expanded polystyrene (EPS) articles for use in building applications | Authorisation expired | |
| 0075-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Jacobs Douwe Egberts DE GmbH Dr. Otto Suwelack Nachf. GmbH & Co. KG Européenne de Lyophilisation S.A. | Use of sodium dichromate as a corrosion inhibitor in ammonia absorption deep cooling systems as applied in the industrial production of freeze dried products such as coffee, herbs, spices and comparable products. | Commission decided | |
| 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. | Opinion development | |
| 0155-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Kedrion S.p.A | Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand | Opinion development | |
| 0038-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Kemira Chemicals Oy | Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide or sodium chlorite | Commission decided | |
| 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 | |
| 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 | |
| 0150-02 | Initial | Anthracene oil | 292-602-7 | 90640-80-5 | Koppers Denmark ApS | Use of AO for manufacture of formulations for various industrial uses | Opinion development | |
| 0150-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Koppers Denmark ApS | Use of CTPht for manufacture of formulations for various industrial uses | Opinion development | |
| 0029-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Laboratoires Expanscience | Use as process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients | Commission decided | |
| 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 | |
| 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 | |
| 0176-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | LFB BIOMEDICAMENTS | Use as virus inactivation into the manufacture process of plasma-derived immunoglobulins. | Opinion development | |
| 0085-01 | Initial | Bis(2-methoxyethyl) ether (Diglyme) | 203-924-4 | 111-96-6 | Life Technologies AS | Use of diglyme as a process chemical in the manufacture of Dynabeads. | 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 | Opinion development | |
| 0011-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Linxens France SA | Formulation of diarsenic trioxide into a mixture | Commission decided | |
| 0011-02 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Linxens France SA | Industrial use of diarsenic trioxide as processing aid in gold electroplating | Commission decided | |
| 0189-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Lonza Biologics Porriño, SL.; Lonza Biologics, plc. | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures | Opinion development | |
| 0087-01 | Initial | Bis(2-methoxyethyl) ether (Diglyme) | 203-924-4 | 111-96-6 | MAFLON S.P.A. | 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. | Commission decided | |
| 0127-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
MAHLE Ventiltrieb GmbH
MAHLE Polska Sp. z o.o. | Use of chromium trioxide in functional chrome plating of valves used in engines of light gasoline and diesel vehicles and in heavy duty diesel combustion engines | Opinions adopted | |
| 0157-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Merck Biodevelopment SAS FUJIFILM Diosynth Biotechnologies UK Limited | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies | Opinion development | |
| 0175-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Merck KGaA | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (technical grade) as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert according to IPEC standards | Opinion development | |
| 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 | |
| 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 | |
| 0049-01 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 | Micrometal GmbH | The use of Ammonium dichromate (ADC) as a photosensitizer for production of micro components | Commission decided | |
| 0016-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as degreasing solvent in the manufacture of polyethylene separators for lead-acid batteries | Commission decided | |
| 0066-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MTU Aero Engines AG | Surface treatment for aerospace applications for civil and military uses, comprising treatment of new components for aircraft engines as well as maintenance, repair and overhaul work on aircraft engine components, unrelated to 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 | |
| 0125-01 | Initial | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | N.V. Ajinomoto OmniChem S.A. | Use of diglyme as a solvent for the synthesis of the anti-HIV active pharmaceutical ingredient (API) dapivirine. | Commission decided | |
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