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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 public 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.
| 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. | Opinion development | |
| 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). | 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. | Opinion development | |
| 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. | Opinion development | |
| 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. | Opinion development | |
| 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. | Opinion development | |
| 0142-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | SEBIA | Industrial use of 4-NPnEO for its detergent properties in the production of buffers and reagents in view of ensuring the positioning of specific proteins necessary for the interpretation of gel electrophoresis in vitro diagnostic tests results based on the determination of isoenzymes. | Opinion development | |
| 0141-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests. | Opinion development | |
| 0141-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties in the production of electrophoresis gels in view of ensuring the positioning of specific proteins necessary for the interpretation of results of gel electrophoresis in vitro diagnostic tests. | ||
| 0141-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its wetting detergent properties in the production of buffers, reagents and gel supports allowing the dissolution, the dilution and the good spreading of substrates and reagents, necessary to optimize the functioning and the sensitivity of gel electrophoresis in vitro diagnostic tests. | Opinion development | |
| 0140-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO in view of controlling the amount of non-specific reactions in the production of in-vitro diagnostic reagents (STA® - Liatest® D-Di assays). | Opinion development | |
| 0140-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays). | Opinion development | |
| 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. | Opinion development | |
| 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. | Opinion development | |
| 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. | Opinion development | |
| 0137-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 | SOCIETA' CHIMICA BUSSI S.P.A. | Use of sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacturing of sodium chlorite. | Opinion development | |
| 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 | Opinion development | |
| 0135-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Thyssenkrupp Electrical Steel GmbH; Thyssenkrupp Electrical Steel UGO S.A.S. | Surface treatment for the manufacture of grain-oriented electrical steel used in magnetic circuits of electric devices, in particular magnetic cores of high-performance transformers | Opinion development | |
| 0134-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ThyssenKrupp Rasselstein GmbH | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) | Opinion development | |
| 0134-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ThyssenKrupp Rasselstein GmbH | Use of Chromium (VI) Trioxide for Passivation of tinplated steel (ETP) | Opinion development | |
| 0133-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Ideal Standard - Vidima AD | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinion development | |
| 0133-01 | Iitital | Chromium trioxide | 215-607-8 | 1333-82-0 |
Ideal Standard - Vidima AD; Ideal Standard Produktions-GmbH; Jado Iberia-Produtos Metalurgicos Sociedade Unipessoal LDA (withdrawn) | 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 | Opinion development | |
| 0132-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinion development | |
| 0132-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | 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 | Opinion development | |
| 0131-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Schell GmbH & Co. KG Armaturentechnologie | Functional chrome plating with decorative character for sanitary applications | Opinion development | |
| 0130-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Aloys F. Dornbracht GmbH & Co.KG | Functional chrome plating with decorative character for sanitary applications | Opinion development | |
| 0129-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | SPOLANA s.r.o. [name of applicant in the original application: SPOLANA a.s. updated due to a notified change of corporate name] | Use as an extraction solvent in caprolactam production | Opinions adopted | |
| 0128-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Doosan Electro-Materials Luxembourg SARL Doosan Energy Solution Kft | Industrial formulation of a chromium trioxide solution below 0.1% w/w concentration for the passivation of copper foil used in the manufacture of Lithium Ion Batteries (LiB) for motorised vehicles | Opinions adopted | |
| 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 | Opinions adopted | |
| 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 | |
| 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 | |
| 0124-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 |
H&R Ölwerke Schindler GmbH; H&R Chemisch-Pharmazeutische Spezialitäten GmbH | Use of sodium dichromate as corrosion inhibitor in ammonia absorption deep cooling systems, applied for the dewaxing and deoiling process steps of petroleum raffinate. | 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 | |
| 0122-02 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. | 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 industrials 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. | Withdrawn | |
| 0122-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Withdrawn | |
| 0121-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Indestructible Paint Ltd. | Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications | Commission decided | |
| 0121-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Indestructible Paint Ltd. | Formulation of mixtures | Commission decided | |
| 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 | |
| 0119-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Friedrichshafen AG | Functional chrome plating of piston rods for automotive and rail applications | Commission decided | |
| 0118-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Aviall Services Inc; 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 | Opinions adopted | |
| 0118-01 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 |
Aviall Services Inc; Finalin GmbH | Formulation of mixture | Opinions adopted | |
| 0117-01 | Initial | Strontium chromate | 232-142-6 | 7789-06-2 |
Wesco Aircraft EMEA, LTD.; PPG Central (UK) Ltd. in its legal capacity as Only Representative of PRC DeSoto International Inc. – OR5; Cytec Engineered Materials Ltd. in its legal capacity as Only Representative of Cytec Industries Inc. | Use of strontium chromate in primers applied by aerospace and defence companies and their associated supply chains | Opinions adopted | |
| 0116-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Wesco Aircraft EMEA, LTD. | Use of dichromium tris(chromate) for chemical conversion coating applications by aerospace and defence companies and their associated supply chains | Opinions adopted | |
| 0115-04 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Saes Getters S.p.A. | Use of alkali metal dispensers containing sodium chromate for production of photocathodes. | Commission decided | |
| 0115-03 | Initial | Potassium chromate | 232-140-5 | 7789-00-6 | Saes Getters S.p.A. | Use of alkali metal dispensers containing potassium chromate for production of photocathodes. | Commission decided | |
| 0115-02 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Saes Getters S.p.A. | Use of sodium chromate in the fabrication of alkali metal dispensers for production of photocathodes. | Commission decided | |
| 0115-01 | Initial | Potassium chromate | 232-140-5 | 7789-00-6 | Saes Getters S.p.A. | Use of potassium chromate in the fabrication of alkali metal dispensers for production of photocathodes. | Commission decided | |
| 0114–02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | |
| 0114–01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide 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 plating with decorative character) | Commission decided | |
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