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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.

 
0133-01 Iitital Chromium trioxide 215-607-8 1333-82-0 Ideal Standard - Vidima AD;
Ideal Standard Produktions-GmbH;
Jado Iberia-Produtos Metalurgicos Sociedade Unipessoal LDA (withdrawn)
Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications Opinions adopted
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
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
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
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
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
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
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
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
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
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
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
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
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
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
0082-01 Initial 1,2-Dichloroethane (EDC) 203-458-1 107-06-2 Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name] 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
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
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
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
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
0094-01 Initial 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 REACHLaw Ltd in its legal capacity as Only Representative of Suzhou Xiangyuan Special Fine Chemical Co., Ltd Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production Opinions adopted
0225-01 Initial 4,4'-methylenebis[2-chloroaniline] 202-918-9 101-14-4 Limburgse Urethane Castings NV Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for custom-made rollers with high reliability requirements for steel and aluminium sectors. Opinion development
0225-02 Initial 4,4'-methylenebis[2-chloroaniline] 202-918-9 101-14-4 Limburgse Urethane Castings NV Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for heavy-duty rollers, tensioner pads and spring blocks with high reliability requirements for offshore energy and renewables sectors. Opinion development
0200-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L.; QIAGEN Ltd.; QIAGEN Manchester Ltd.; QIAGEN Distribution B.V. Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) Opinion development
0201-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A. Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs Opinion development
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
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
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
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
0184-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Lilly France S.A.S.; Eli Lilly Italia S.p.A. Industrial formulation (dilution) of a silicone solution containing 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices Opinions adopted
0186-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc. In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles. Opinions adopted
0186-06 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.;
Immunotech S.R.O;
Immunotech S.A.S.;
Beckman Coulter France S.A.S.;
Beckman Coulter Česká republika s.r.o.;
Beckman Coulter UK Ltd;
Beckman Coulter S.L.U;
Beckman Coulter SPA Italy;
BC Distribution B.V
Downstream use of OPnEO-containing laboratory products designed for use in flow cytometry, genomics and particle characterization laboratory instruments and assays for quality control and research and development. 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
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
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); Wesco Aircraft EMEA, LTD (UK) The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants. Opinion development
0203-02 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); Wesco Aircraft EMEA, LTD (UK) Mixing, by Aerospace and Defence Companies, and their associated supply chains, including the Applicants, of base polysulfide sealant components with OPE-containing hardener, resulting in mixtures containing < 0.1% w/w of OPE for Aerospace and Defence uses that are exempt from authorisation under REACH Art. 56(6)(a). Opinion development
0138-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Boehringer Ingelheim Pharma
GmbH & Co. KG; Boehringer
Ingelheim RCV GmbH & Co KG
Use of 4-tert-OPnEO in a washing buffer to purify biological APIs (active pharmaceutical ingredients) during the production of Palivizumab and Moxetumomab pasudotox-tdfk. Opinions adopted
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. Opinions adopted
0139-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) for use in the manufacture of in vitro diagnostic VITROS® products used for infectious disease screening, endocrinology, and oncology testing. Opinions adopted
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. Opinions adopted
0155-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Kedrion S.p.A Use of 4-tert-OPnEO as Triton X-100 as detergent for virus inactivation in the manufacturing process of the human plasma-derived medicinal products Plasmagrade/Plasmasafe and Resusix, as well as Plasminogen (pre-commercialization name) and any subsequent commercialization brand Opinions adopted
0165-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Eli Lilly Kinsale Limited Industrial use of a 4-tert-octylphenol ethoxylate compound, as a patient safety viral inactivation reagent in the manufacture of human medicines produced from biological systems Opinions adopted
0167-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. Opinions adopted
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
0180-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Bio-Rad Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections Opinions adopted
0180-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Bio-Rad Industrial use of 4-tert-OPnEO for its non-ionic detergent property in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles Opinions adopted
0180-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Bio-Rad Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications Opinions adopted
0185-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX Montpellier SAS Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as detergent in the technical manufacturing of in vitro diagnostic veterinary ELISA Plate tests (plate coating) to prevent the non-specific binding of unwanted macromolecules Opinions adopted
0185-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX Montpellier SAS Formulation of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in the manufacture of sample diluents and standard solutions used in in vitro diagnostic veterinary ELISA Plate tests used for the detection of infectious diseases in livestock and poultry Opinions adopted



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