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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. 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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
Related links
0032-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Functional Chrome Plating | Commission decided | |
0032-06 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Passivation of tin-plated steel (ETP) | Commission decided | |
0099-02 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
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Use of sodium chromate for sealing after anodizing, chemical conversion coating, pickling and etching applications by aerospace companies and their suppliers | Commission decided | |
0099-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
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Formulation of Mixtures of sodium chromate for sealing after anodizing, chemical conversion coating, pickling and etching applications by aerospace companies and their suppliers | Commission decided | |
0032-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Functional chrome plating with decorative character | Opinions adopted | |
0032-05 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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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) | Commission decided | |
0032-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Formulation of mixtures | Commission decided | |
0032-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Surface treatment for applications in the aeronautics and aerospace industries, unrelated to Functional chrome plating or Functional chrome plating with decorative character | Commission decided | |
0030-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
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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 | |
0078-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
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Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins | Commission decided | |
0023-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | A.L.P.A.-AZIENDA LAVORAZIONE PRODOTTI AUSILIARI S.P.A.; CAFFARO INDUSTRIE S.P.A | Use of trichloroethylene as solvent in the synthesis of vulcanization accelerating agents for fluoroelastomers | Commission decided | |
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. | Commission decided | |
0182-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Abbott Diagnostics GmbH | Professional use as a surfactant in an onboard solution (Detergent B) as an accessory to In-Vitro Diagnostic Devices (IVDs) to wash the reagent probes, the mixers and the reaction cuvettes between tests to prevent interference with the test result on ARCHITECT and Alinity automated analyser systems. | Withdrawn | |
0167-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] | Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | Opinions adopted | |
0167-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott Ireland | Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. | Opinions adopted | |
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. | Withdrawn | |
0167-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Abbott Ireland Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] |
Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | Opinions adopted | |
0167-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Abbott Ireland Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] 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. | 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 | |
0217-02 | 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) | Commission decided | |
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). | Commission decided | |
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). | Commission decided | |
0217-01 | 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) | Commission decided | |
0187-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | AGC Biologics A/S | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts in projects where processes have been approved by the authorities (GMP compliant) | Opinions adopted | |
0187-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
AGC Biologics A/S; AGC Biologics GmbH |
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as a detergent during the purification process of recombinant biopharmaceuticals derived from microbial expression hosts in projects where processes have been approved by the authorities (GMP compliant) | Opinions adopted | |
0046-02 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
AKZO Nobel Car Refinishes B.V. Habich GmbH Henkel Global SupplyChain B.V. Indestructible Paint Ltd. Finalin GmbH Mapaero 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 Industries (UK) Ltd 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] |
Application of paints, primers and specialty coatings containing Strontium Chromate in the construction of aerospace and aeronautical parts, including aeroplanes / helicopters, spacecraft, satellites, launchers, engines, and for the maintenance of such constructions. | Commission decided | |
0046-01 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
AKZO Nobel Car Refinishes B.V. Habich GmbH Henkel Global SupplyChain B.V. Ramboll Belgium BVBA [application transferred from: “Indestructible Paint Ltd.” due to a notified legal entity change] Finalin GmbH Mapaero 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 Industries (UK) Ltd 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 | |
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 | |
0041-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Akzo Nobel Pulp and Performance Chemicals AB |
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 potassium chlorate. | Commission decided | |
0041-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Akzo Nobel Pulp and Performance Chemicals AB Akzo Nobel Pulp and Performance Chemicals Oy Akzo Nobel Pulp and Performance Chemicals S.A.S. |
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. | Commission decided | |
0240-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Alexion Pharma International Operations Unlimited Company | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation in the manufacture Andexanet alfa for treatment of adult patients treated with a direct factor Xa (FXa) inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding | Opinion development | |
0274-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS); also known as Tin Free Steel (TFS) | Opinion development | |
0274-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinion development | |
0274-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinion development | |
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. | Commission decided | |
0136-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Ariston Thermo SpA | Use of sodium chromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 0.70% by weight (as Cr6+) in the refrigerant solution | Commission decided | |
0002-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | 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)] | Withdrawn | |
0002-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | |
0035-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ARKEMA FRANCE | 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 | |
0042-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ARLANXEO Netherlands B.V. [application transferred from original Applicant: Lanxess Elastomers B.V. due to a notified legal entity change] | Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems | Commission decided | |
0292-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Artech SRL | Industrial use of chromium trioxide for the functional chrome plating with decorative character of steel tubes and plates incorporated in machines for the agri-food industry, leisure, household furniture and automotive industries | Opinion development | |
0126-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | AVX NI [application transferred from: "AVX Limited" due to a notified legal entity change] | Industrial use in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors. | Commission decided | |
0287-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Bacrom S.L. | Industrial use of chromium trioxide for the hard plating of various end-products made of steel for the industry manufacturers to provide hardness, corrosion resistance, low friction coefficient, good surface roughness, thickness, and excellent surface condition | Opinion development | |
0106-01 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 |
BAE Systems (Operations) Limited – [Decision discontinued as of 01/01/2021] Qioptiq Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of Ammonium Dichromate in the process of manufacturing holographic combiners for diffractive head-up displays intended to be used in military aircrafts | Discontinued as of 01 January 2021 | |
0076-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF plc - [Decision discontinued as of 01/01/2021; application transferred from original Applicant: BASF SE due to a notified legal entity change] | Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) | Discontinued as of 01 January 2021 | |
0076-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) | Commission decided | |
0060-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane | Commission decided | |
0178-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Baxter AG [name of the applicant in the original application: Takeda Manufacturing Austria AG updated due to a change of corporate name]; Baxalta Belgium Manufacturing SA | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (as a detergent) for virus inactivation via S/D (Solvent/Detergent) treatment in recombinant and plasma-derived medicinal products. | Opinions adopted | |
0110-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change] | 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 | |
0186-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Beckman Coulter Ireland Inc. | In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles. | Opinions adopted | |
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