Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju
This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.
On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.
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There are currently no ongoing consultations.
| 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 | Details |
| 0270-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAIER S. COOP. MAIER CZ s.r.o.; MAIER CROMOPLASTICA S.p.A | Etching of plastics with chromium trioxide as pre-treatment step for electroplating of plastics for automotive applications | Opinions adopted | Details |
| 0270-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAIER S. COOP. MAIER CZ s.r.o.; MAIER CROMOPLASTICA S.p.A | Functional chrome plating with decorative character for automotive applications | Opinions adopted | Details |
| 0234-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Maschinenfabrik Kaspar Walter GmbH & Co KG | Chromium trioxide-based functional chrome plating of cylinders used in the rotogravure printing and embossing industry. | Commission decided | Details |
| 0234-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Maschinenfabrik Kaspar Walter GmbH & Co KG | Formulation of chromium trioxide-based electrolyte for electroplating process. | Commission decided | Details |
| 0299-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | 9036-19-5 | MeiraGTx Ireland Designated Activity Company | Use of 4-tert-OPnEO as a manufacturing aid in the production of gene therapies | Commission decided | Details |
| 0305-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Meoni e Bartoletti S.p.A. | Use of Chromium Trioxide for the hard-chrome plating of hydraulic and pneumatic cylinders for various applications, and inner tubes of motorbike front suspension for the automotive industry. | Opinions adopted | Details |
| 0157-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Merck Biodevelopment SAS Fujifilm Diosynth Biotechnologies (UK) Ltd - [Application void as of 01/01/2021] |
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 | Commission decided | Details |
| 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 | Commission decided | Details |
| 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 | Details |
| 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). | Commission decided | Details |
| 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. | Commission decided | Details |
| 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 | Commission decided | Details |
| 0261-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Metalbrass s.r.l. | Electroplating of metal substrates using chromium trioxide to achieve functional surfaces for the sanitary sector | Commission decided | Details |
| 0312-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Metalplast sas; CO.BE. sas di Colombo Nadia e Flavia | Industrial use of chromium trioxide for plating on plastic materials to create a long-lasting high durability chromium decorative surface in the electroplating process for various applications. | Opinions adopted | Details |
| 0312-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Metalplast sas; CO.BE. sas di Colombo Nadia e Flavia | Industrial use of hexavalent chromium for a pre-treatment step (etching) in the electroplating process for plastic materials with various applications. | Opinions adopted | Details |
| 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 | Details |
| 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 | Details |
| 0317-01 | Initial | Acids generated from chromium trioxide and their oligomers | - | - | Micron srl | Dilution of chromic acid solution at concentrations lower than 0.1% for the use in passivation baths | Opinions adopted | Details |
| 0242-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as extraction solvent in the manufacture of polyethylene separators for lead-acid batteries | Commission decided | Details |
| 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 | Details |
| 0273-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MIKRO METAL S.R.L. | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance | Opinions adopted | Details |
| 0249-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Monroe Czechia s.r.o. | The use of Chromium Trioxide (EC 215-607-8) by Monroe Czechia s.r.o. in the functional chrome plating of shock absorber rods. | Commission decided | Details |
| 0232-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Monroe Czechia s.r.o. | Use of dichromium tris(chromate) in a post-treatment step of the autodeposition coating process of shock absorbers for automotive vehicles. | Commission decided | Details |
| 0259-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MT METAL TECH S.r.l. [application transferred from “ST SRL” due to a notified legal entity change] | Use 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) | Opinions adopted | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 0235-01 | Initial | Chromic acid | 231-801-5 | 7738-94-5 | Neoperl GmbH | The use of chromic acid in the functional electroplating of brass-made sanitary articles with the specific purpose of obtaining a final Cr(0) coating that provides a surface with high durability and chemical resistance. | Commission decided | Details |
| 0245-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | NEWFORM S.P.A. | Electroplating of different types of substrates using Chromium Trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Commission decided | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 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 | Details |
| 0109-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Nouryon Chemicals SPA [name of the applicant in the original application: Akzo Nobel Chemicals SpA updated due to a change of corporate name] | The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant | Commission decided | Details |
| 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 | Details |
| 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. | Commission decided | Details |
| 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. | Commission decided | Details |
| 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 | Commission decided | Details |
| 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 | Commission decided | Details |
| 0266-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | OLIVARI B SPA | Electroplating of brass substrates using chromium trioxide to achieve functional surfaces for architectural fittings | Opinions adopted | Details |
| 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 | Details |
| 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 | Details |
| 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 | Commission decided | Details |
| 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 | Commission decided | Details |
| 0263-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Orelec | Industrial use of chromium trioxide for the hard chrome plating of injection moulds in order to provide hardness, wear resistance and good demoulding properties, critical for the manufacture of high-quality plastic parts. | Commission decided | Details |
| 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 | Details |
| 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 | Details |