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Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

 

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.

 
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
0054-02 Initial Chromium trioxide 215-607-8 1333-82-0 Praxair Surface Technologies GmbH Industrial spraying of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment to ensure either a low temperaturecured coating for corrosion protection, or a high temperature corrosion & oxidation resistance with reduction of surface roughness or a high temperature adhesive, for aviation, power generation machinery, Oil and Gas and marine applications. Commission decided
0054-01 Initial Chromium trioxide 215-607-8 1333-82-0 Praxair Surface Technologies GmbH Industrial spraying or brush application of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment, to ensure a high temperature corrosion & oxidation resistance, as well as anti-fouling properties or lubricity at high temperature, for automotive, aviation, power generation machinery, Oil and Gas and marine applications. Commission decided
0021-01 Initial Trichloroethylene 201-167-4 79-01-6 Grupa Azoty S.A. Industrial use as a process chemical in caprolactam purification Commission decided
0077-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Eli Lilly Kinsale Limited [application transferred from original Applicant: Eli Lilly S.A. - Irish Branch due to a notified legal entity change] Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride Commission decided
0060-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 BASF SE Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane Commission decided
0080-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 H&R Ölwerke Schindler GmbH
H&R Chemisch-Pharmazeutische Spezialitäten GmbH
Industrial use as a solvent and anti-solvent of the feedstock and intermediate product streams in the combined de-waxing and de-oiling of refining of petroleum vacuum distillates for the production of base oils and hard paraffin waxes Commission decided
0078-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2

  • DOW ITALIA S.R.L.
  • Dow France SAS [name of co-applicant in the original application: Rohm and Haas France SAS updated due to a notified legal entity name change]

Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins Commission decided
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
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
0079-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Lanxess Deutschland GmbH Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins 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
0079-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Lanxess Deutschland GmbH Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins Commission decided
0020-01 Initial Trichloroethylene 201-167-4 79-01-6 DOMO Caproleuna GmbH Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil Commission decided
0024-02 Initial Trichloroethylene 201-167-4 79-01-6 Blue Cube Germany Assets GmbH & Co. KG [application transferred from original Applicant: DOW DEUTSCHLAND ANLAGENGESELLSCHAFT mbH due to a notified legal entity change] Industrial use as process chemical (enclosed systems) in Alcantara Material production Commission decided
0076-02 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 BASF SE Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) Commission decided
0076-01 Initial 1,2-dichloroethane (EDC) 203-458-1 107-06-2 BASF SE Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) Commission decided
0002-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 ARKEMA FRANCE Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Withdrawn
0004-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 DEZA a.s. Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Pending decision
0003-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Pending decision
0083-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 EURENCO Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives Commission decided
0082-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 GE Healthcare Bio-Sciences AB Industrial use of 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. Commission decided
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
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
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. 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
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
0143-01 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
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
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
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
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
0072-01 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
0072-04 Initial Potassium dichromate 231-906-6 7778-50-9 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
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
0072-05 Initial Potassium dichromate 231-906-6 7778-50-9 Connecteurs Electriques Deutsch 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
0057-03 Initial Chromium trioxide 215-607-8 1333-82-0 Nexter Mechanics Industrial use of a mixture of chromium trioxide for the black colour hard chromium plating of exterior surface of steel weapon barrel designed for military use, to ensure, during the whole gun barrel service life, stealth, erosion, corrosion and high temperature resistances in the condition of uses. Commission decided
0057-02 Initial Chromium trioxide 215-607-8 1333-82-0 Nexter Mechanics Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament parts in order to ensure surface hardness, resistance to atmospheric corrosion, abrasive wear resistance and friction coefficient for parts in relative movement. Commission decided
0057-01 Initial Chromium trioxide 215-607-8 1333-82-0 Nexter Mechanics Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament steels parts which are thermomechanically stressed and in contact with oxidizing gas at high temperature, so as to ensure a thermal barrier with high melting point, resistance to wear and oxidation associated with weapons as well as resistance to impact and atmospheric corrosion. Commission decided
0106-02 Initial Ammonium dichromate 232-143-1 7789-09-5 Display Technologies Limited Industrial use of Ammonium Dichromate in the process of manufacturing Cathode Ray Tubes for head up displays intended to be used in military and civilian aircrafts Commission decided
0106-01 Initial Ammonium dichromate 232-143-1 7789-09-5 BAE Systems (Operations) Limited
Qioptiq Ltd
Industrial use of Ammonium Dichromate in the process of manufacturing holographic combiners for diffractive head-up displays intended to be used in military aircrafts Commission decided
0090-02 Initial Formaldehyde, oligomeric reaction products with aniline 500-036-1 25214-70-4 Polynt Composites France Industrial use of an epoxy resin hardener containing technical MDA aimed at immobilising spent ion exchange resins in a high containment matrix Commission decided
0059-01 Initial Arsenic acid 231-901-9 7778-39-4 CIRCUIT FOIL LUXEMBOURG SARL Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of Printed Circuit Board Commission decided
0058-01 Initial Chromium trioxide 215-607-8 1333-82-0 CIRCUIT FOIL LUXEMBOURG SARL Industrial use of chromium trioxide for the treatment of copper foil used in the manufacture of Printed Circuit Board Commission decided
0070-02 Initial Chromium trioxide 215-607-8 1333-82-0 FN HERSTAL S.A.
BROWNING VIANA, FABRICA DE ARMAS E ARTIGOS DE DESPORTO SA
Industrial use of chromium trioxide in the hard chromium coating of civilian firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide a low friction coefficient as well as heat, corrosion and wear resistance properties. Commission decided
0070-01 Initial Chromium trioxide 215-607-8 1333-82-0 FN HERSTAL S.A.
MANROY ENGINEERING LTD
Industrial use of chromium trioxide in the hard chromium coating of military small- and medium-caliber firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide hardness, heat resistance and thermal barrier properties, as well as corrosion resistance, adhesion and low friction properties Commission decided
0005-03 Initial Dibutyl phthalate (DBP) 201-557-4 84-74-2 DEZA a.s. Industrial use of DBP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements Commission decided



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