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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.

 
0027-01 Initial Trichloroethylene 201-167-4 79-01-6 RAG Aktiengesellschaft, RAG Anthrazit Ibbenbüren GmbH Use of Tricholoroethylene-containing vulcanising and bonding agents for endless connections and repair of chloroprene rubber coated conveyor belts in underground hard coal mining Authorisation expired
0200-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L.; QIAGEN Ltd.; QIAGEN Manchester Ltd.; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) Opinion development
0200-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L. Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Opinion development
0200-07 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd.; QIAGEN Manchester Ltd.; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing Opinion development
0200-08 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd.; QIAGEN Manchester Ltd.; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing Opinion development
0200-06 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd.; QIAGEN Manchester Ltd.; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) Opinion development
0200-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Opinion development
0200-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Opinion development
0200-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH Industrial use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing Opinion development
0054-02 Initial Chromium trioxide 215-607-8 1333-82-0 Praxair Surface Technologies GmbH Industrial spraying of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment to ensure either a low temperaturecured coating for corrosion protection, or a high temperature corrosion & oxidation resistance with reduction of surface roughness or a high temperature adhesive, for aviation, power generation machinery, Oil and Gas and marine applications. Commission decided
0054-01 Initial Chromium trioxide 215-607-8 1333-82-0 Praxair Surface Technologies GmbH Industrial spraying or brush application of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment, to ensure a high temperature corrosion & oxidation resistance, as well as anti-fouling properties or lubricity at high temperature, for automotive, aviation, power generation machinery, Oil and Gas and marine applications. Commission decided
0047-02 Initial Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 PPG Industries (UK) Ltd
Finalin GmbH
PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]
PPG Coatings SA
Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
Use of potassium hydroxyoctaoxodizincatedichromate in paints, in primer, sealants, and coatings (including as wash primers) Commission decided
0047-01 Initial Potassium hydroxyoctaoxodizincatedichromate 234-329-8 11103-86-9 PPG Industries (UK) Ltd
Finalin GmbH
PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]
PPG Coatings SA
Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
Formulation of Mixtures Commission decided
0203-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; PPG Industries (UK) Ltd.; Boeing Distribution, Inc.; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); Wesco Aircraft EMEA, LTD (UK) The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants. Opinion development
0203-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Sealants Europe SAS; PPG Industries (UK) Ltd.; Boeing Distribution, Inc.; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); Wesco Aircraft EMEA, LTD (UK) Mixing, by Aerospace and Defence Companies, and their associated supply chains, including the Applicants, of base polysulfide sealant components with OPE-containing hardener, resulting in mixtures containing < 0.1% w/w of OPE for Aerospace and Defence uses that are exempt from authorisation under REACH Art. 56(6)(a). Opinion development
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
0090-01 Initial Formaldehyde, oligomeric reaction products with aniline 500-036-1 25214-70-4 Polynt Composites France Formulation of an epoxy resin hardener containing technical MDA Commission decided
0089-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 PMC ISOCHEM [application transferred from original Applicant: ISOCHEM due to a notified legal entity change] Use of diglyme as a process solvent in one step of the manufacturing of an Active Pharmaceutical Ingredient used in an anti-protozoal drug 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
0123-01 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Plastic Planet srl Formulation of recycled soft PVC containing DEHP in compounds and dry-blends Opinions adopted
0206-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Phadia GmbH; Thermo Fisher Scientific Baltics UAB Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB Opinion development
0206-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Phadia GmbH; Thermo Fisher Scientific Baltics UAB Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB Opinion development
0206-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Phadia GmbH; B∙R∙A∙H∙M∙S GmbH Coating Thyroid Stimulating Hormone Receptor onto articles used as components of IVD reagent systems at B∙R∙A∙H∙M∙S GmbH and Phadia GmbH Opinion development
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. 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
0057-03 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
0057-01 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
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
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
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
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
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



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