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Przyjęte opinie i wcześniejsze konsultacje dotyczące wniosków o zezwolenie

Przyjęte opinie i wcześniejsze konsultacje dotyczące wniosków o zezwolenie

 

This page provides further information on the applications for authorisation or review reports, which have undergone public 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.

 
0090-02 Initial Formaldehyde, oligomeric reaction products with aniline 500-036-1 25214-70-4 Polynt Composites France Industrial use of an epoxy resin hardener containing technical MDA aimed at immobilising spent ion exchange resins in a high containment matrix Commission decided
0059-01 Initial Arsenic acid 231-901-9 7778-39-4 CIRCUIT FOIL LUXEMBOURG SARL Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of Printed Circuit Board Commission decided
0058-01 Initial Chromium trioxide 215-607-8 1333-82-0 CIRCUIT FOIL LUXEMBOURG SARL Industrial use of chromium trioxide for the treatment of copper foil used in the manufacture of Printed Circuit Board 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
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 Commission decided
0007-02 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 Roxel (UK Rocket Motors) Ltd Industrial use of DBP in manufacture of solid propellants and motor charges for rockets and tactical missiles Commission decided
0007-03 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 Roxel (UK Rocket Motors) Ltd Industrial use of DBP within a specialty paint in manufacture of motors for rockets and tactical missiles Commission decided
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
0007-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Roxel (UK Rocket Motors) Ltd Industrial use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles Commission decided
0015-01 Initial Diarsenic trioxide 215-481-4 1327-53-3 Yara France Industrial use of diarsenic trioxide as a processing aid to activate the absorption and desorption of carbon dioxide by potassium carbonate from synthesis gas formed in the production of ammonia Authorisation expired
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
0010-01 Initial Diarsenic trioxide 215-481-4 1327-53-3 Nordenhamer Zinkhütte GmbH Industrial use of diarsenic trioxide to produce a copper concentrate in the purification of the leaching solution in a zinc electrowinning process 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
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
0094-01 Initial 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 REACHLaw Ltd in its legal capacity as Only Representative of Suzhou Xiangyuan Special Fine Chemical Co., Ltd Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production Opinions adopted
0144-01 Initial Pitch, coal tar, high-temp 266-028-2 65996-93-2 ArianeGroup SAS Industrial use of pitch, coal tar, high temp. as precursor of carbon matrix in the manufacturing of thermally and thermo-mechanically highly loaded carbon/carbon parts including nozzle throats and other critical carbon-carbon composite parts, resistant to very harsh erosion conditions, and very high temperature ranges, dedicated to high-performance civilian and military aerospace launchers. Opinion development
0048-02 Initial Potassium dichromate 231-906-6 7778-50-9 SOFRADIR Industrial use of potassium dichromate based mixture during the etching of both InSb substrate sides during the production of optoelectronic components gathering a readout and an infrared detecting circuit with the InSb technology Commission decided
0048-01 Initial Potassium dichromate 231-906-6 7778-50-9 SOFRADIR Industrial use of potassium dichromate-based mixtures during the steps of initial and final etching of CZT layers during the production of opto-electronic components gathering a readout and an infrared detecting circuit with the MCT technology Commission decided
0008-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles Commission decided
0123-02 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Plastic Planet srl Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrial workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. Opinions adopted
0122-02 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 VINYLOOP
FERRARA
S.p.A.
Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrials workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. Withdrawn
0012-10 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 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
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
0158-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swords Laboratories Industrial use of the substance as a surfactant in the purification of the biopharmaceutical drug Orencia, used for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis and Adult Psoriatic Arthritis Opinion development
0025-01 Initial Trichloroethylene 201-167-4 79-01-6 Chimcomplex S.A. Borzesti Industrial use of trichloroethylene (TCE) as a solvent as a degreasing agent in closed systems Commission decided
0057-04 Initial Chromium trioxide 215-607-8 1333-82-0 Nexter Mechanics
Nexter Systems
Industrial use, of a qualified mixture of chromium trioxide by spraying or immersion, and of a qualified mixture of dichromium tris(chromate) by pen application, for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military use, and requiring a maintained electrical conductivity after severe climatic environments, atmospheric corrosion resistance and paint adhesion. Commission decided
0057-05 Initial Dichromium tris(chromate) 246-356-2 24613-89-6 Nexter Systems Industrial use, of a qualified mixture of chromium trioxide by spraying or immersion, and of a qualified mixture of dichromium tris(chromate) by pen application, for the chromate conversion coating of welded mechanical structures of armoured vehicles and associated parts made of high mechanical properties aluminium alloys for military use, and requiring a maintained electrical conductivity after severe climatic environments, atmospheric corrosion resistance and paint adhesion. Commission decided
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
0032-06 Initial Chromium trioxide 215-607-8 1333-82-0
  • LANXESS Deutschland GmbH in its legal capacity as Only Representative of LANXESS CISA (Pty) Ltd.
  • Atotech Deutschland GmbH
  • Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
  • Prospere Logistic Baltic OÜ in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan [application transferred from original Applicant: "BONDEX TRADING LTD in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan" due to a notified change of Only Representative]
  • CROMITAL S.P.A. in its legal capacity as Only Representative of Soda Sanayii A.S.
  • Elementis GmbH in its legal capacity as Only Representative of Elementis Chromium Inc [application transferred from original Applicant: "Elementis Chromium LLP in its legal capacity as Only Representative of Elementis Chromium Inc" due to a notified change of Only Representative]
  • MacDermid Enthone GmbH [name of co-applicant in the original application: Enthone GmbH updated due to a notified legal entity name change]
Passivation of tin-plated steel (ETP) 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
0167-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland
Abbott GmbH & Co. KG
Abbott Diagnostics GmbH
Professional use as a surfactant in the final use of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Opinion development
0168-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Diagnostics GmbH Professional use as a surfactant, in wash buffer components used in conjunction with Fluorescence In Situ Hybridisation (FISH) test kits and/or their Laboratory Developed Test (LDT) equivalents, in clinical diagnostic use for medical analysis of human tissue and blood samples to identify characteristic genetic abnormalities related to specific disease conditions. Opinion development
0012-12 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCC Maastricht B.V. OR Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired
0012-11 Initial Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 DCC Maastricht B.V. OR Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking Authorisation expired
0167-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott Ireland Professional use of system solutions (Pre-Trigger and Trigger) in the final use of the In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. Opinion development
0012-06 Initial Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9 12656-85-8 DCC Maastricht B.V. OR Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired
0012-05 Initial Lead sulfochromate yellow (C.I. Pigment Yellow 34) 215-693-7 1344-37-2 DCC Maastricht B.V. OR Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking Authorisation expired
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
0095-04 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” Surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering Opinions adopted
0032-05 Initial Chromium trioxide 215-607-8 1333-82-0
  • LANXESS Deutschland GmbH in its legal capacity as Only Representative of LANXESS CISA (Pty) Ltd.
  • Atotech Deutschland GmbH
  • Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
  • Prospere Logistic Baltic OÜ in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan [application transferred from original Applicant: "BONDEX TRADING LTD in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan" due to a notified change of Only Representative]
  • CROMITAL S.P.A. in its legal capacity as Only Representative of Soda Sanayii A.S.
  • Elementis GmbH in its legal capacity as Only Representative of Elementis Chromium Inc [application transferred from original Applicant: "Elementis Chromium LLP in its legal capacity as Only Representative of Elementis Chromium Inc" due to a notified change of Only Representative]
  • MacDermid Enthone GmbH [name of co-applicant in the original application: Enthone GmbH updated due to a notified legal entity name change]
Surface treatment (except passivation of tin-plated steel (ETP)) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering (unrelated to Functional chrome plating or Functional chrome plating with decorative character) Opinions adopted
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
0100-02 Initial Chromium trioxide 215-607-8 1333-82-0 ZF Luftfahrttechnik GmbH Surface treatment for applications in the aeronautics and aerospace industries (unrelated to Functional chrome plating or Functional chrome plating with decorative character) Commission decided
0032-04 Initial Chromium trioxide 215-607-8 1333-82-0
  • LANXESS Deutschland GmbH in its legal capacity as Only Representative of LANXESS CISA (Pty) Ltd.
  • Atotech Deutschland GmbH
  • Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
  • Prospere Logistic Baltic OÜ in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan [application transferred from original Applicant: "BONDEX TRADING LTD in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan" due to a notified change of Only Representative]
  • CROMITAL S.P.A. in its legal capacity as Only Representative of Soda Sanayii A.S.
  • Elementis GmbH in its legal capacity as Only Representative of Elementis Chromium Inc [application transferred from original Applicant: "Elementis Chromium LLP in its legal capacity as Only Representative of Elementis Chromium Inc" due to a notified change of Only Representative]
  • MacDermid Enthone GmbH [name of co-applicant in the original application: Enthone GmbH updated due to a notified legal entity name change]
Surface treatment for applications in the aeronautics and aerospace industries, unrelated to Functional chrome plating or Functional chrome plating with decorative character Opinions adopted
0135-01 Initial Chromium trioxide 215-607-8 1333-82-0 Thyssenkrupp Electrical Steel GmbH;
Thyssenkrupp Electrical
Steel UGO S.A.S.
Surface treatment for the manufacture of grain-oriented electrical steel used in magnetic circuits of electric devices, in particular magnetic cores of high-performance transformers Opinion development
0001-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Rolls-Royce plc The processing of a stop-off formulation containing DEHP during the diffusion bonding and manufacture of aero engine fan blades. Commission decided
0111-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 OLON Spa The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin. Commission decided
0111-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 OLON Spa The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate. Commission decided
0109-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Akzo Nobel Chemicals SpA The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant Commission decided
0164-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swedish Orphan Biovitrum The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in manufacture of biopharmaceuticals by Swedish Orphan Biovitrum AB. Opinion development
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
0146-01 Initial Chromium trioxide 215-607-8 1333-82-0 Tata Steel UK Ltd The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS) Opinion development
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
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
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
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
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
0030-01 Initial Sodium chromate 231-889-5 7775-11-3
  • Dometic GmbH
  • Dometic Hűtőgépgyártó és Kereskedelmi Zrt.
The use of sodium chromate as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75% by weight (Cr6+) in the cooling solution Commission decided
0104-01 Initial Sodium dichromate 234-190-3
7789-12-0
10588-01-9
Borealis Plastomers B.V. The use of sodium dichromate as in-situ corrosion inhibitor in a closed water/ammonia absorption cooling system Commission decided
0031-01 Initial Sodium dichromate 234-190-3
7789-12-0
10588-01-9
Boliden Mineral AB The use of sodium dichromate in copper/lead separation in concentrators handling complex sulphide ores Commission decided
0069-01 Initial Chromium trioxide 215-607-8 1333-82-0 Topocrom GmbH TOPOCROM functional chrome plating in closed reactor systems for the establishment of adjustable hemispherical surface structures. 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
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
0108-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 ORGAPHARM Use as a process solvent in the manufacture of an Active Pharmaceutical Ingredient: Flecainide acetate 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
0022-01 Initial Trichloroethylene 201-167-4 79-01-6 SPOLANA a.s. Use as an extraction solvent in caprolactam production Commission decided
0129-01 Review report Trichloroethylene 201-167-4 79-01-6 SPOLANA s.r.o. [name of applicant in the original application: SPOLANA a.s. updated due to a notified change of corporate name] Use as an extraction solvent in caprolactam production Opinions adopted
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
0110-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Bayer Pharma AG Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist® Commission decided
0108-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 ORGAPHARM Use as an process solvent in the manufacture of an Active Pharmaceutical Ingredient: Nefopam hydrochloride Commission decided
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
0163-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments Opinion development
0139-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in two in vitro diagnostic VITROS® products used by professional diagnostic laboratories to detect antibodies to human hepatitis A virus and IgG antibodies to rubella virus. Opinions adopted
0162-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Novo Nordisk A/S Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as a solvent/detergent agent for virus inactivation in the manufacture of pharmaceutical products used in the treatment of rare bleeding disorders. Opinion development
0170-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Octapharma AB Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII Opinion development
0170-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Octapharma AB
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H
Octapharma S.A.S.
Octapharma Produktionsgesellschaft Deutschland mbH
Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as detergent for a virus inactivation step (solvent/detergent treatment) during the manufacture of plasma-derived and recombinant medicinal products Opinion development
0166-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Rousselot bvba Use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated as a surfactant in the manufacturing of low endotoxin gelatin Opinion development
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
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
0138-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Boehringer Ingelheim Pharma
GmbH & Co. KG; Boehringer
Ingelheim RCV GmbH & Co KG
Use of 4-tert-OPnEO in a washing buffer to purify biological APIs (active pharmaceutical ingredients) during the production of Palivizumab and Moxetumomab pasudotox-tdfk. Opinion development
0115-03 Initial Potassium chromate 232-140-5 7789-00-6 Saes Getters S.p.A. Use of alkali metal dispensers containing potassium chromate for production of photocathodes. Commission decided
0115-04 Initial Sodium chromate 231-889-5 7775-11-3 Saes Getters S.p.A. Use of alkali metal dispensers containing sodium chromate for production of photocathodes. Commission decided
0073-01 Initial Ammonium dichromate 232-143-1 7789-09-5 Veco B.V. Use of ammonium dichromate as photosensitive component in a polyvinyl alcohol photolithographic lacquer system for the manufacturing of mandrels which are used in nickel electroforming processes. Commission decided
0151-02 Initial Anthracene oil 292-602-7 90640-80-5 RÜTGERS Germany GmbH Use of AO for manufacture of formulations for various industrial uses Opinion development
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
0153-02 Initial Anthracene oil 292-602-7 90640-80-5 BILBAINA DE ALQUITRANES, S.A. Use of AO for manufacture of formulations for various industrial uses Opinion development
0152-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon bvba Use of AO for manufacture of formulations for various industrial uses Opinion development
0088-02 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). Opinions adopted
0088-01 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). Opinions adopted
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
0086-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Bracco Imaging s.p.a Use of bis(2-methoxyethyl) ether (diglyme) as a processing aid in the purification of 5-amino-2,4,6-triiodoisophthalic acid dichloride (EC 417- 220-1; CAS 37441-29-5) by precipitation Commission decided
0134-02 Initial Chromium trioxide 215-607-8 1333-82-0 ThyssenKrupp Rasselstein GmbH Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) Opinions adopted
0134-01 Initial Chromium trioxide 215-607-8 1333-82-0 ThyssenKrupp Rasselstein GmbH Use of Chromium (VI) Trioxide for Passivation of tinplated steel (ETP) Opinions adopted
0056-01 Initial Chromium trioxide 215-607-8 1333-82-0 Rimex Metals (UK) Ltd Use of chromium trioxide as an oxidising and hardening agent in the manufacture of coloured stainless steel Commission decided
0096-01 Initial Chromium trioxide 215-607-8 1333-82-0 Wesco Aircraft EMEA, LTD. [application transferred from original Applicant: Haas Group International SCM Ltd due to a notified legal entity change] Use of chromium trioxide for chemical conversion and slurry coating applications by aerospace companies and their suppliers Commission decided
0102-01 Initial Chromium trioxide 215-607-8 1333-82-0 Clariant Produkte (Deutschland) GmbH Use of chromium trioxide in a catalyst for the dehydrogenation of propane to propene Commission decided
0033-01 Initial Chromium trioxide 215-607-8 1333-82-0 Oy Kromatek Ab; Kova-Kromi Oy; CrTe-Plating Oy; Saizeri Plating Oy; Turun Kovakromi Oy; Veljekset Wallenius Oy; Pirkan Kovakromaus Oy Use of chromium trioxide in Cr(VI) based functional plating Commission decided
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
0067-01 Initial Chromium trioxide 215-607-8 1333-82-0 Abloy Oy Use of chromium trioxide in electroplating of mechanical and electromechanical cylinders, cam- and padlocks, electromechanical lock cases and architectural hardware. 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



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