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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. The table below will be updated at a later stage.
| 0032-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
| Functional Chrome Plating | Commission decided | |
| 0032-06 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Passivation of tin-plated steel (ETP) | Commission decided | |
| 0099-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
|
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 | |
| 0099-02 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
|
Use of sodium chromate for sealing after anodizing, chemical conversion coating, pickling and etching applications by aerospace companies and their suppliers | Commission decided | |
| 0032-05 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
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 |
|
Formulation of mixtures | Commission decided | |
| 0032-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Functional chrome plating with decorative character | Opinions adopted | |
| 0032-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
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 |
|
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 |
|
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. | Opinions adopted | |
| 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. | Opinions adopted | |
| 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. | Opinions adopted | |
| 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) | 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 | |
| 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) | Opinion development | |
| 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 | |
| 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 | Opinions adopted | |
| 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 | |
| 0126-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | AVX Limited | Industrial use in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors. | Commission decided | |
| 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 | |
| 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 | |
| 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 | |
| 0178-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Baxter AG; 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 | |
| 0186-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Beckman Coulter GmbH | Formulation of NPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. | Opinions adopted | |
| 0186-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Immunotech S.R.O.; Immunotech S.A.S. | Formulation of OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. | Opinions adopted | |
| 0186-05 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Beckman Coulter GmbH Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U; Beckman Coulter SPA Italy BC Distribution B.V | Downstream use of NPnEO-containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays. | Opinions adopted | |
| 0186-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Immunotech S.R.O. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o.; Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U Beckman Coulter SPA Italy BC Distribution B.V | Downstream use of OPnEO-containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays. | Opinions adopted | |
| 0186-08 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Immunotech S.R.O. Immunotech S.A.S. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U Beckman Coulter SPA Italy BC Distribution B.V | Phase out of OPnEO-containing laboratory products from the market due to obsolescence or next generation formulations. | Opinions adopted | |
| 0186-06 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Immunotech S.R.O Immunotech S.A.S. Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U Beckman Coulter SPA Italy; BC Distribution B.V | Downstream use of OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development. | Opinions adopted | |
| 0186-07 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc. Beckman Coulter GmbH Beckman Coulter France S.A.S. Beckman Coulter Česká republika s.r.o. Beckman Coulter UK - [Application void as of 01/01/2021] Beckman Coulter S.L.U; Beckman Coulter SPA Italy BC Distribution B.V | Downstream use of NPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development. | Opinions adopted | |
| 0205-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Becton Dickinson Distribution Center NV | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) as a processing aid in imported Diagnostics | 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 | Opinions adopted | |
| 0153-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Opinions adopted | |
| 0147-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht as a binder in the manufacture of clay targets | Opinions adopted | |
| 0180-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications | Opinions adopted | |
| 0180-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent property in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles | Opinions adopted | |
| 0180-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application | Opinions adopted | |
| 0180-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Opinions adopted | |
| 0180-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Bio-Rad | Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Opinions adopted | |
| 0204-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Opinion development | |
| 0204-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Opinion development | |
| 0145-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population. | Opinions adopted | |
| 0145-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB). | Opinions adopted | |
| 0143-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its detergent properties, used for the extraction of biological material which is further formulated and intended for clinical and industrial in vitro testing applications. | Opinions adopted | |
| 0143-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent to control the level of non-specific reactions in the formulation of in vitro reagents for clinical and industrial in vitro testing immunoassays. | Opinions adopted | |
| 0143-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of reagents for molecular clinical and industrial in vitro preparative and testing applications. | Opinions adopted | |
| 0179-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products. | Opinions adopted | |
| 0208-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG | Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production | Opinions adopted | |
| 0024-03 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] | Use of tricholoroethylene in packaging | Commission decided | |
| 0024-05 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] | Use of Trichloroethylene as Extraction Solvent for Bitumen in Asphalt Analysis | Commission decided | |
| 0024-04 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] | Use of tricholoroethylene in formulation | Commission decided | |
| 0024-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] | Use Of Trichloroethylene in Industrial Parts Cleaning by Vapour Degreasing in Closed Systems where specific requirements (system of use-parameters) exist | Authorisation expired | |
| 0024-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] | Industrial use as process chemical (enclosed systems) in Alcantara Material production | Commission decided | |
| 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. | Opinions adopted | |
| 0118-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Boeing Distribution, Inc. [name of applicant
in the original application: Aviall Services Inc updated due to a notified change of corporate name]; Finalin GmbH | Use of pentazinc chromate octahydroxide in wash primer, fuel tank primer and aluminized primer for the purpose of corrosion protection in aeronautic applications | Commission decided | |
| 0118-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Boeing Distribution, Inc. [name of applicant
in the original application: Aviall Services Inc updated due to a notified change of corporate name]; Finalin GmbH | Formulation of mixture | Commission decided | |
| 0009-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Boliden Kokkola Oy | Use of diarsenic trioxide in the purification of metal impurities from the leaching solution in the zinc electrowinning process | 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 | |
| 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 | |
| 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 | |
| 0044-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag UK Ltd | Formulation of Mixtures | Commission decided | |
| 0044-02 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag UK Ltd | Use of potassium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films | Commission decided | |
| 0043-02 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 | Brenntag UK Ltd Henkel AG & Co. KGaA AD International BV | Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites and sealings of anodic films | Commission decided | |
| 0043-03 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Brenntag UK Ltd Henkel AG & Co. KGaA AD International BV | Use of Sodium dichromate for the electrolytic passivation of tin plated steel for the packaging industry | Commission decided | |
| 0043-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Brenntag UK Ltd Henkel AG & Co. KGaA AD International BV | Formulation of Mixtures | Commission decided | |
| 0210-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the selective etching of multi-component (2K/3K) plastic articles. | Opinions adopted | |
| 0210-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the functional electroplating of single-component (1K) and multi-component (2K/3K) plastic articles with the specific aim of obtaining a final Cr(0) coating with high durability and chemical resistance while preserving the lightweight nature of the plastic component. | Opinions adopted | |
| 0210-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the etching of single-component (1K) plastic articles. | Opinions adopted | |
| 0040-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 | CAFFARO BRESCIA S.r.l | 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 chlorite | Commission decided | |
| 0207-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021] | Mixing, by Aerospace Companies and their associated supply chains, including the Applicant, of base polysulfide sealant components with NPE-containing hardener, resulting in mixtures containing < 0.1% w/w of NPE for Aerospace uses that are exempt from authorisation under REACH Art. 56(6)(a). | Opinions adopted | |
| 0207-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021] | The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants. | Opinions adopted | |
| 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 | Authorisation expired | |
| 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 | |
| 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 | |
| 0072-05 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | Connecteurs Electriques Deutsch | Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. | Commission decided | |
| 0072-04 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 |
Connecteurs Electriques Deutsch TE UK Ltd – [Decision discontinued as of 01/01/2021] | Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). | Commission decided | |
| 0055-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
CROMOMED S.A. CRONOR S.A. Cromo Europa S.A. CHROMATLANTIQUE INDUSTRIEL VILA ELECTROQUIMICAS.A. | Functional Chrome Plating | Commission decided | |
| 0172-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name] | Industrial use of emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia | Opinions adopted | |
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