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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.

 
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
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
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
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
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
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
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. 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
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
0181-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - DiaSorin S.p.A. Industrial use, as non-ionic surfactant, employed in the purification of antigens in in vitro diagnostics tests for infectious diseases, auto-immunity markers, bone metabolism, hepatitis and retrovirus, oncology and endocrinology. Opinions adopted
0185-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX EUROPE B.V.;
IDEXX Montpellier SAS
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions Opinions adopted
0186-04 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Beckman Coulter Ireland Inc.;
Immunotech S.R.O.;
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 clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays. Opinions adopted
0187-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - AGC Biologics A/S;
AGC Biologics GmbH
Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as a detergent during the purification process of recombinant biopharmaceuticals derived from microbial expression hosts in projects where processes have been approved by the authorities (GMP compliant) Opinions adopted
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). Opinions adopted
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
0163-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Wallac Oy Formulation of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) into enhancement solutions and DELFIA standard and maintenance solutions used in In Vitro Diagnostic assays and RUO products as well as maintenance of instruments as a critical ingredient for detection process while measuring europium (or other lanthanide) content of the assay solution 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
0167-01 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]
Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated 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
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
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
0186-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Beckman Coulter Ireland Inc.;
Beckman Coulter GmbH
Formulation of NPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. Opinions adopted
0172-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - 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 emulsifiers containing nonylphenols ethoxylated for the manufacture of chromatography resins used by the biopharmaceutical industry, food & beverage sector and academia Opinions adopted
0186-07 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Beckman Coulter Ireland Inc.; Beckman Coulter GmbH;
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 NPnEO-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
0185-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - IDEXX EUROPE B.V. Use of 4-Nonylphenol, branched and linear, ethoxylated in vitro diagnostic veterinary products (SNAP tests and ELISA Plate tests) as an ingredient in the wash solutions, sample diluents, control solutions, conjugate solutions, SNAP wash solutions, tissue soaking buffers and detection solutions Opinions adopted
0180-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Bio-Rad Industrial use of 4-NPnEO 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
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
0207-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Chemetall GmbH; Chemetall PLC Mixing, by Aerospace Companies and their associated supply chains, including the Applicant, of base polysulfide sealant components with NPE-containing hardener, resulting in mixtures containing < 0.1% w/w of NPE for Aerospace uses that are exempt from authorisation under REACH Art. 56(6)(a). Opinions adopted
0182-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Abbott Diagnostics GmbH Professional use as a surfactant in an onboard solution (Detergent B) as an accessory to In-Vitro Diagnostic Devices (IVDs) to wash the reagent probes, the mixers and the reaction cuvettes between tests to prevent interference with the test result on ARCHITECT and Alinity automated analyser systems. Opinions adopted
0186-05 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Beckman Coulter Ireland Inc.;
Beckman Coulter GmbH;
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 NPnEO-containing clinical laboratory products that require registration, licensing, approval and monitoring by country-based health authorities, designed for use in dedicated clinical chemistry, immunology, hematology and flow cytometry laboratory instruments and assays. 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
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
0152-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon bvba Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0150-02 Initial Anthracene oil 292-602-7 90640-80-5 Koppers Denmark ApS Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0151-02 Initial Anthracene oil 292-602-7 90640-80-5 Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0153-02 Initial Anthracene oil 292-602-7 90640-80-5 BILBAINA DE ALQUITRANES, S.A. Use of AO for manufacture of formulations for various industrial uses Opinions adopted
0123-01 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Plastic Planet srl Formulation of recycled soft PVC containing DEHP in compounds and dry-blends Opinions adopted
0123-02 Review report Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Plastic Planet srl Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrial workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. Opinions adopted
0088-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (in-house processes). Opinions adopted
0088-02 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Acton Technologies Limited Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity (downstream user processes). Opinions adopted
0092-01 Initial Chromium trioxide 215-607-8 1333-82-0 HAPOC GmbH & Co KG Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of plastic, with or without current flow Opinions adopted
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
0132-02 Initial Chromium trioxide 215-607-8 1333-82-0 KEUCO GmbH & Co KG Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes 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
0133-02 Initial Chromium trioxide 215-607-8 1333-82-0 Ideal Standard - Vidima AD Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes Opinions adopted
0130-01 Initial Chromium trioxide 215-607-8 1333-82-0 Aloys F. Dornbracht GmbH & Co.KG Functional chrome plating with decorative character for sanitary applications Opinions adopted
0064-04 Initial Chromium trioxide 215-607-8 1333-82-0 HAPOC GmbH & Co KG Use of Chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category I. Opinions adopted



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