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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

 

 
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
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
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
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
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
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
0115-03 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
0115-04 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
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
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
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
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
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. 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
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
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
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
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
0154-05 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
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
0154-04 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
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
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
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
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
0039-01 Initial Sodium dichromate 234-190-3
7789-12-0
10588-01-9
SOLVAY PORTUGAL - PRODUTOS QUIMICOS S.A. 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
0072-03 Initial Chromium trioxide 215-607-8 1333-82-0 Souriau sas Industrial use of a mixture containing chromium trioxide for the etching of composite connectors used by industries subject to harsh environments, to mainly ensure adhesive deposit to meet the requirements of international standards. Commission decided
0072-06 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Souriau sas; TE UK Ltd 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
0072-02 Initial Chromium trioxide 215-607-8 1333-82-0 Souriau sas
Amphenol Limited
AMPHENOL SOCAPEX
ITT Cannon GmbH
TE UK Ltd
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
0072-07 Initial Sodium dichromate 234-190-3
10588-01-9
7789-12-0
Souriau sas
Amphenol Limited
AMPHENOL SOCAPEX
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
0072-01 Initial Chromium trioxide 215-607-8 1333-82-0 Souriau sas
Amphenol Limited
AMPHENOL SOCAPEX
ITT Cannon GmbH
Connecteurs Electriques Deutsch
TE UK Ltd
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
0022-01 Initial Trichloroethylene 201-167-4 79-01-6 SPOLANA a.s. Use as an extraction solvent in caprolactam production 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
0220-02 Initial Chromium trioxide 215-607-8 1333-82-0 SRG Global Ibi, S.L. Functional chrome plating with decorative character for transportation applications. Opinion development
0220-01 Initial Chromium trioxide 215-607-8 1333-82-0 SRG Global Ibi, S.L. Chromium trioxide-based etching as pre-treatment step for electroplating of plastics for transportation applications. Opinion development
0213-01 Initial Chromium trioxide 215-607-8 1333-82-0 Steel Color S.p.A. Use of chromium trioxide as colouring and hardening agent for stainless steel plates 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
0158-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Swords Laboratories Industrial use of the substance as a surfactant in the purification of the biopharmaceutical drug Orencia, used for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis and Adult Psoriatic Arthritis Opinions adopted
0211-01 Initial Chromium trioxide 215-607-8 1333-82-0 Tata Steel IJmuiden BV; Tata Steel UK Ltd. Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) Opinions adopted
0211-02 Initial Sodium dichromate 234-190-3 10588-01-9 Tata Steel IJmuiden BV; Tata Steel UK Ltd. Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) Opinions adopted
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
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



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