Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
There are currently no ongoing consultations.
| 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 | |
| 0194-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Instrumentation Laboratory SpA | Use as a lysing agent for red blood cells in blood analysis diagnostic device. | Opinions adopted | |
| 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 | |
| 0017-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ENTEK International Limited – [Decision discontinued as of 01/01/2021] | Trichloroethylene as an extraction solvent for removal of process oil and formation of the porous structure in polyethylene based separators used in lead-acid batteries | Discontinued as of 01 January 2021 | |
| 0069-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Topocrom GmbH | TOPOCROM functional chrome plating in closed reactor systems for the establishment of adjustable hemispherical surface structures. | 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 | |
| 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 | |
| 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 | |
| 0103-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Euro Cryospace France | The use of chromium trioxide for the surface preparation of aluminium alloy cryogenic tanks used in the Ariane 5 launcher | 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 | |
| 0034-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | 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 electroplating with decorative character) | Commission decided | |
| 0034-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium Trioxide for a pre-treatment step (etching) in the electroplating process | 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 | |
| 0228-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Eaton S.R.L; Eaton Automotive Systems sp.zoo | The use of Chromium Trioxide (EC 215-607-8) by Eaton Vehicle Group (Eaton) across two legal entities in the functional chrome plating of engine valves and valve actuation (“lash adjusters”) | Opinion development | |
| 0146-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tata Steel UK Ltd - [Application void as of 01/01/2021] | The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS) | Application void as of 01 January 2021 | |
| 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. | Opinion development | |
| 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 | |
| 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 | Opinions adopted | |
| 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. | Opinions adopted | |
| 0174-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Hospira Zagreb d.o.o., a Pfizer company | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers. | Opinions adopted | |
| 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 | |
| 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 | |
| 0164-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Swedish Orphan Biovitrum | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in manufacture of biopharmaceuticals by Swedish Orphan Biovitrum AB. | Opinions adopted | |
| 0190-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Teva Baltics UAB | The use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated (TritonX-100) as a nonionic surfactant for bacteria cells disruption and washing of inclusion bodies in Biological Drug Substance manufacturing process | Opinions adopted | |
| 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 | |
| 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 | |
| 0001-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Rolls-Royce plc – [Decision discontinued as of 01/01/2021] | The processing of a stop-off formulation containing DEHP during the diffusion bonding and manufacture of aero engine fan blades. | Discontinued as of 01 January 2021 | |
| 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. – [Decision discontinued as of 01/01/2021]; Aviall UK Inc.; Wesco Aircraft EMEA Ltd (Poland); HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] | The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants. | 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 | |
| 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 | Opinions adopted | |
| 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 | |
| 0100-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Luftfahrttechnik GmbH | Surface treatment for applications in the aeronautics and aerospace industries (unrelated to Functional chrome plating or Functional chrome plating with decorative character) | 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 | |
| 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 | |
| 0095-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | REACHLaw Ltd as Only Representative on behalf of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” | Surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering | Commission decided | |
| 0105-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
ILARIO ORMEZZANO - SAI s.r.l. [name of applicant in the original application: Ilario Ormezzano Sai Spa updated due to a notified name change] | Repackaging of Sodium Dichromate to be supplied as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings | Opinions adopted | |
| 0012-06 | Initial | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking | Authorisation expired | |
| 0012-05 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking | Authorisation expired | |
| 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 | |
| 0012-12 | Initial | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking | Authorisation expired | |
| 0012-11 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCL Corporation (NL) B.V. OR [name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking | Authorisation expired | |
| 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. | Opinions adopted | |
| 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 | |
| 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 | |
| 0201-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A. | Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary In Vitro Diagnostic devices (IVDs) including one SERELISA, six ProFLOK, six WITNESS and five VetScan. The use is carried out by professional users in diagnostic laboratories and veterinary clinics to detect certain diseases in pets and farm animals | Opinion development | |
| 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 | |
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