Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
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.
| 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 | |
| 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 | |
| 0212-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. | Industrial use of chromium trioxide for the functional chrome plating with decorative character for automotive and sanitary industry | Opinion development | |
| 0212-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. | Industrial use of chromium trioxide for the etching, pre-treatment step in the electroplating process of functional chrome plating with decorative character | Opinion development | |
| 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. | Opinions adopted | |
| 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 | Opinions adopted | |
| 0225-01 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for custom-made rollers with high reliability requirements for steel and aluminium sectors. | Opinion development | |
| 0225-02 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for heavy-duty rollers, tensioner pads and spring blocks with high reliability requirements for offshore energy and renewables sectors. | 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 | 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 | |
| 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 | Commission decided | |
| 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 | Opinions adopted | |
| 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 | Opinions adopted | |
| 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 | |
| 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 | |
| 0197-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes). | Opinions adopted | |
| 0202-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Merckle-GmbH-Ulm | The use of 4-OPnEO as an emulsifier in a silicone oil emulsion for siliconization of pre-filled syringes in a medicinal product | Opinion development | |
| 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 | |
| 0057-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Nexter Mechanics | Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament steels parts which are thermomechanically stressed and in contact with oxidizing gas at high temperature, so as to ensure a thermal barrier with high melting point, resistance to wear and oxidation associated with weapons as well as resistance to impact and atmospheric corrosion. | Commission decided | |
| 0057-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Nexter Mechanics | Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament parts in order to ensure surface hardness, resistance to atmospheric corrosion, abrasive wear resistance and friction coefficient for parts in relative movement. | Commission decided | |
| 0057-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Nexter Mechanics | Industrial use of a mixture of chromium trioxide for the black colour hard chromium plating of exterior surface of steel weapon barrel designed for military use, to ensure, during the whole gun barrel service life, stealth, erosion, corrosion and high temperature resistances in the condition of uses. | 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 | |
| 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 | |
| 0061-01 | Initial | Bis(2-methoxyethyl) ether (Diglyme) | 203-924-4 | 111-96-6 | Novartis Ringaskiddy Limited | Use of diglyme as solvent in the manufacturing process of an intermediate for further conversion into a pharmaceutical compound used in medicinal products for treatment of respiratory diseases | Commission decided | |
| 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. | Opinions adopted | |
| 0159-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Nuova Ompi S.r.l. unipersonale | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product (NeoRecormon®) of one pharmaceutical company. | Opinions adopted | |
| 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 | Opinions adopted | |
| 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 | Opinions adopted | |
| 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 | |
| 0215-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Oras Oy | Pre-treatment (“etching”) of plastic substrates using chromium trioxide for electroplating processes in sanitary applications | Opinion development | |
| 0215-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Oras Oy Oras Olesno Sp.z.o.o. | Electroplating of metal and plastic substrates using chromium trioxide to achieve functional surfaces for sanitary applications | Opinion development | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 0019-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Parker Hannifin Manufacturing Netherlands (Filtration & Separation) BV | Use of trichloroethylene (TCE) as a process solvent for the manufacturing of modules containing hollow fibre gas separation membranes | Commission decided | |
| 0198-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Ireland Pharmaceuticals | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals – Post-Production Cleaning. | Opinion development | |
| 0198-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Ireland Pharmaceuticals | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes. | Opinion development | |
| 0192-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Manufacturing Belgium NV | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant within a lubricant used in the manufacture of pharmaceutical drug products. | Opinions adopted | |
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