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Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

Pareri adottati e consultazioni precedenti sulle domande di autorizzazione

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.

 

 
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
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
0032-04 Initial Chromium trioxide 215-607-8 1333-82-0
  • Chemservice GmbH in its legal capacity as Only Representative of Brother CISA (Pty) Ltd. [application transferred from: “LANXESS Deutschland GmbH in its legal capacity as Only Representative of LANXESS CISA (Pty) Ltd.” due to a notified legal entity change]
  • Atotech Deutschland GmbH
  • Boeing Distribution, Inc. [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name]
  • Prospere Chemical Logistic OÜ as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan [application transferred from: “Prospere Logistic Baltic OÜ as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan” due to a notified change of Only Representative] [application transferred from original Applicant: "BONDEX TRADING LTD in its legal capacity as Only Representative of Aktyubinsk Chromium Chemicals Plant, Kazakhstan" due to a notified change of Only Representative]
  • CROMITAL S.P.A. in its legal capacity as Only Representative of Soda Sanayii A.S.
  • Elementis Minerals B.V. in its legal capacity as Only Representative of Elementis Chromium Inc. [application transferred from original Applicant: “Elementis Chromium LLP in its legal capacity as Only Representative of Elementis Chromium Inc.” due to a notified change of Only Representative]
  • MacDermid Enthone GmbH [name of co-applicant in the original application: Enthone GmbH updated due to a notified legal entity name change]
Surface treatment for applications in the aeronautics and aerospace industries, unrelated to Functional chrome plating or Functional chrome plating with decorative character Commission decided
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
0207-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Chemetall GmbH; Chemetall PLC The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants. Opinions adopted
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); 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
0001-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Rolls-Royce plc The processing of a stop-off formulation containing DEHP during the diffusion bonding and manufacture of aero engine fan blades. 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
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
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
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
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
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
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
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
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 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
0146-01 Initial Chromium trioxide 215-607-8 1333-82-0 Tata Steel UK Ltd The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS) Opinions adopted
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
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
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
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
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
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. Opinion development
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. Opinion development
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. Opinion development
0030-01 Initial Sodium chromate 231-889-5 7775-11-3
  • Dometic GmbH
  • Dometic Hűtőgépgyártó és Kereskedelmi Zrt.
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
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
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
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
0017-01 Initial Trichloroethylene 201-167-4 79-01-6 ENTEK International Limited 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 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
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
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
0107-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 emp Biotech GmbH Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes Commission decided
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
0022-01 Initial Trichloroethylene 201-167-4 79-01-6 SPOLANA a.s. Use as an extraction solvent in caprolactam production Commission decided
0081-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 GRUPA LOTOS S.A. Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. Commission decided
0110-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Bayer Pharma AG 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
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
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
0029-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Laboratoires Expanscience Use as process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients Commission decided
0176-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - LFB BIOMEDICAMENTS Use as virus inactivation into the manufacture process of plasma-derived immunoglobulins. Opinions adopted
0195-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - RSI ChemRep Europe Ltd (O002) OR for OraSure Technologies Inc Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as surfactant in in –vitro diagnostic device developer solution. Opinion development
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
0163-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments Opinions adopted
0139-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics France [application transferred from: “Ortho-Clinical Diagnostics” due to a notified legal entity change]. 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
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



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