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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. 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.

 
0048-02 Initial Potassium dichromate 231-906-6 7778-50-9 SOFRADIR Industrial use of potassium dichromate based mixture during the etching of both InSb substrate sides during the production of optoelectronic components gathering a readout and an infrared detecting circuit with the InSb technology Commission decided
0048-01 Initial Potassium dichromate 231-906-6 7778-50-9 SOFRADIR Industrial use of potassium dichromate-based mixtures during the steps of initial and final etching of CZT layers during the production of opto-electronic components gathering a readout and an infrared detecting circuit with the MCT technology Commission decided
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. Commission decided
0173-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products Ltd Use of OPE as detergent in the production of bead components for in-vitro diagnostic kits for an immunoassay platform Opinions adopted
0154-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of OPE in formulation of IVD-kit reagents Opinions adopted
0154-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of OPE in formulation of IVD- wash solutions Opinions adopted
0154-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of IVD-kit reagents on diagnostic analyser systems Opinions adopted
0154-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction) Opinions adopted
0154-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products GmbH Use of IVD-wash solutions on diagnostic analyser systems Opinions adopted
0191-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Sekisui S-lec BV Roermond Industrial use as polymer additive in the manufacture of interlayer polymer films for laminated safety glass Opinions adopted
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. Opinions adopted
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. Opinions adopted
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. Opinions adopted
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. Opinions adopted
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 Opinions adopted
0006-01 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 Sasol-Huntsman GmbH & Co. KG Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride Commission decided
0199-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Sanquin Reagents B.V. Use of Triton™ X-100 (4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated) in formulation of components for IVD kits. Opinion development
0156-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Sanofi Pasteur Use of Octoxynol-9 for virus splitting and inactivation step in the manufacturing of influenza vaccines Opinions adopted
0214-02 Initial Chromium trioxide 215-607-8 1333-82-0 Salzgitter Flachstahl GmbH Pretex® functional chrome plating using chromium trioxide in closed reactor systems for the establishment of adjustable hemispherical surface structures on working rolls applied in the steel industry for the manufacture of cold-rolled, high quality textured sheet metal Opinion development
0214-01 Initial Chromium trioxide 215-607-8 1333-82-0 Salzgitter Flachstahl GmbH Functional chrome plating using chromium trioxide in closed reactor systems for the establishment of a ‘conventional’ hard chrome coating on working rolls applied in the steel industry for the pre-manufacturing of cold-rolled, high-quality textured sheet metal Opinion development
0065-01 Initial Chromium trioxide 215-607-8 1333-82-0 Safran Aircraft Engines [name of applicant in the original application: SNECMA updated due to a notified change of corporate name] Industrial use of a chromium trioxide based surface treatment mixture applied on safety-critical rotating components of commercial and military aircraft engines, whose failure endangers airworthiness Commission decided
0209-01 Initial Chromium trioxide 215-607-8 1333-82-0 Safran Aircraft Engines Industrial use of chromium trioxide-based mixtures for the surface treatment of legacy spare parts of military aircraft engines, including safety-critical parts whose failure endangers airworthiness Opinion development
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
0115-01 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
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
0115-02 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
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
0007-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Roxel (UK Rocket Motors) Ltd Industrial use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles Authorisation expired
0007-03 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 Roxel (UK Rocket Motors) Ltd Industrial use of DBP within a specialty paint in manufacture of motors for rockets and tactical missiles Authorisation expired
0007-02 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 Roxel (UK Rocket Motors) Ltd Industrial use of DBP in manufacture of solid propellants and motor charges for rockets and tactical missiles Authorisation expired
0166-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Rousselot bvba Use of 4-(1,1,3,3-tetramethylbutyl)phenol ethoxylated as a surfactant in the manufacturing of low endotoxin gelatin Opinions adopted
0018-01 Initial Trichloroethylene 201-167-4 79-01-6 ROQUETTE Frères Use of trichloroethylene as a processing aid in the biotransformation of starch to obtain betacyclodextrin Commission decided
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
0171-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) Opinions adopted
0171-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
0160-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®). Opinions adopted
0171-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
0171-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
0171-06 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) Opinions adopted
0171-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Roche Diagnostics GmbH Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. Opinions adopted
0084-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Roche Diagnostics GmbH Use of diglyme as a process chemical in the manufacture of one specific type of Dynabeads® used in immunodiagnostic assays (in vitro diagnostic) Commission decided
0053-01 Initial Chromic acid
231-801-5
236-881-5
13530-68-2
7738-94-5
Robert Bosch GmbH Hard chrome plating for gasoline and diesel injection applications Commission decided
0056-01 Initial Chromium trioxide 215-607-8 1333-82-0 Rimex Metals (UK) Ltd Use of chromium trioxide as an oxidising and hardening agent in the manufacture of coloured stainless steel Commission decided
0026-01 Initial Trichloroethylene 201-167-4 79-01-6 Richard Geiss GmbH Use of tricholoroethylene in formulation Commission decided
0026-02 Initial Trichloroethylene 201-167-4 79-01-6 Richard Geiss GmbH Use of tricholoroethylene in packaging Commission decided
0177-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Rentschler Biopharma SE Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated in a washing buffer applied during a purification step in the manufacture of the monoclonal antibody Dinutuximab beta Opinions adopted
0095-02 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” Functional Chrome Plating Opinions adopted
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 Opinions adopted
0095-01 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” Formulation of mixtures of chromium trioxide for functional chrome plating, functional chrome plating with decorative character and surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering Opinions adopted
0095-03 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” Functional chrome plating with decorative character Opinions adopted



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