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- Adopted opinions and previous consultations on applications for authorisation
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
0200-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | QIAGEN GmbH; STAT-Dx Life S.L. | Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing | Opinion development | |
0204-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Opinion development | |
0206-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Phadia GmbH; B∙R∙A∙H∙M∙S GmbH | Coating Thyroid Stimulating Hormone Receptor onto articles used as components of IVD reagent systems at B∙R∙A∙H∙M∙S GmbH and Phadia GmbH | Opinion development | |
0202-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Merckle-GmbH-Ulm | The use of 4-OPnEO as an emulsifier in a silicone oil emulsion for siliconization of pre-filled syringes in a medicinal product | Opinion development | |
0226-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | LETI Pharma, S.L.U. [name of applicant in the original application: Laboratorios LETI, S.L.U. updated due to a notified change of corporate name] | Use of 4-tert-OPnEO in aqueous buffers during the manufacturing process of the active pharmaceutical ingredient (Protein Q) of the veterinary vaccine LetiFend® | Opinion development | |
0198-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Ireland Pharmaceuticals | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals – Post-Production Cleaning. | Opinion development | |
0200-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | QIAGEN GmbH | Industrial 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 of the product groups sample preparation, PCR and sequencing | Opinion development | |
0201-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A.; Delpharm Biotech | Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary In Vitro Diagnostic devices (IVDs) for detecting infectious disease in farm animals | 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 | |
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 | |
0198-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Pfizer Ireland Pharmaceuticals | The use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO))(Triton X-100) as a surfactant in the manufacture of biopharmaceuticals - Viral Inactivation and associated processes. | Opinion development | |
0206-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Phadia GmbH; Thermo Fisher Scientific Baltics UAB | Use as component of buffer solutions for the production of purified proteins (cell extraction, chromatographic purification and solvent exchange) and in-process and final Quality Control testing; intended for use as laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications at Thermo Fisher Scientific Baltics UAB | Opinion development | |
0200-08 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | QIAGEN GmbH; 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 Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing | Opinion development | |
0200-06 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | QIAGEN GmbH; 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 | |
0200-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | QIAGEN GmbH | Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing | Opinion development | |
0200-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | QIAGEN GmbH | Industrial 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 of the product groups sample preparation, PCR and sequencing | Opinion development | |
0217-01 | 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) | Opinion development | |
0217-02 | 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) | Opinion development | |
0215-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Oras Oy Oras Olesno Sp.z.o.o. | Electroplating of metal and plastic substrates using chromium trioxide to achieve functional surfaces for sanitary applications | Opinion development | |
0216-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega Supply Chain GmbH & Co KG | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Opinion development | |
0212-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. | Industrial use of chromium trioxide for the etching, pre-treatment step in the electroplating process of functional chrome plating with decorative character | Opinion development | |
0212-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. | Industrial use of chromium trioxide for the functional chrome plating with decorative character for automotive and sanitary industry | Opinion development | |
0215-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Oras Oy | Pre-treatment (“etching”) of plastic substrates using chromium trioxide for electroplating processes in sanitary applications | Opinion development | |
0210-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the selective etching of multi-component (2K/3K) plastic articles. | Opinion development | |
0221-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | U. S. Steel Košice, s.r.o. | Use of Chromium (VI) Trioxide for Passivation of Electrolytic Tinplate (ETP). | 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 | |
0219-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Husqvarna AB | Industrial use of a mixture containing Chromium Trioxide in functional chrome plating of the saw chain cutter links in order to meet stay sharp and durability requirements for use with chainsaws. | Opinion development | |
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 | |
0210-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the functional electroplating of single-component (1K) and multi-component (2K/3K) plastic articles with the specific aim of obtaining a final Cr(0) coating with high durability and chemical resistance while preserving the lightweight nature of the plastic component. | 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 | |
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 | |
0216-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Viega Supply Chain GmbH & Co KG | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright silvery appearance for sanitary applications | Opinion development | |
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 | |
0210-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | C. Hübner GmbH | The use of chromium trioxide in the etching of single-component (1K) plastic articles. | Opinion development | |
0218-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | DOURECA - Produtos Plásticos, Lda. | Industrial use of chromium trioxide to create a long-lasting and high durability chromium decorative surface on plastic substrates in the electroplating process for automotive applications. | Opinion development | |
0218-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | DOURECA - Produtos Plásticos, Lda. | Industrial use of hexavalent chromium trioxide for a pre-treatment step (etching) in the electroplating process for automotive 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 | |
0222-01 | Review report | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | Gruppo Colle.S.r.l. | Use of Sodium dichromate as mordant in wool dyeing with dark colours. | Opinion development | |
0221-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | U. S. Steel Košice, s.r.o. | Use of Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP). | Opinion development | |
0208-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Blue Cube Germany Assets GmbH & Co. KG | Industrial use of trichloroethylene as process chemical (enclosed systems) in Alcantara Material production | Opinion development | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
0193-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Yposkesi | Use of 4-tert-OPnEO for its non-ionic detergent properties for the cell membrane lysis and viral clearance during the development and manufacturing of viral vectors in medicinal products dedicated to human use (Investigational and Authorized Advanced Therapy Medicinal Product). | 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 | |
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 | |
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 | |
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 | |
0197-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes). | 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 | |
0188-01 | 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) for use in the assay buffer for the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | Opinions adopted | |
0167-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott Ireland | Professional use of system solutions (Pre-Trigger and Trigger) in the final use of the In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. | Opinions adopted | |
0167-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott Ireland | Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. | Opinions adopted | |
0197-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes. | 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 | |
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 | |
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 | |
0196-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Vetter Pharma-Fertigung GmbH & Co. KG | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers (syringes and cartridges) used as primary packaging material for 44 medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the AoA. These products cover several therapeutic areas, and approx. 40 % of them are listed on the WHO Model List of Essential Medicines (EML). | Opinions adopted | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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); HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] | 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). | 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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
0189-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Lonza Biologics Porriño, SL.; Lonza Biologics, plc. | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures | 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 | |
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 | |
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 | |
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 | |
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 | |
0169-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Janssen Vaccines & Prevention BV Janssen Biologics B.V. | 4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step. | 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 | |
0183-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGAST | Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system. | Opinions adopted | |
0187-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | AGC Biologics A/S | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts in projects where processes have been approved by the authorities (GMP compliant) | Opinions adopted | |
0180-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application | 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 | |
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 | |
0157-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Merck Biodevelopment SAS FUJIFILM Diosynth Biotechnologies UK Limited | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies | Opinions adopted | |
0186-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Immunotech S.R.O.; Immunotech S.A.S. | Formulation of OPnEO 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 | |
0159-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Nuova Ompi S.r.l. unipersonale | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for one specific medicinal product (NeoRecormon®) of one pharmaceutical company. | Opinions adopted | |
0186-08 | 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 | Phase out of OPnEO-containing laboratory products from the market due to obsolescence or next generation formulations. | Opinions adopted | |
0139-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Ortho-Clinical Diagnostics France [application transferred from: “Ortho-Clinical Diagnostics” due to a notified legal entity change]. | Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in two in vitro diagnostic VITROS® products used by professional diagnostic laboratories to detect antibodies to human hepatitis A virus and IgG antibodies to rubella virus. | Opinions adopted | |
0161-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Vetter Pharma-Fertigung GmbH & Co. KG | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company. | Opinions adopted | |
0179-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products. | 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 | |
0175-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Merck KGaA | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (technical grade) as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert according to IPEC standards | Opinions adopted | |
0170-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Octapharma AB | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII | Opinions adopted | |
0170-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Octapharma AB Octapharma Pharmazeutika Produktionsgesellschaft m.b.H Octapharma S.A.S. Octapharma Produktionsgesellschaft Deutschland mbH | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as detergent for a virus inactivation step (solvent/detergent treatment) during the manufacture of plasma-derived and recombinant medicinal products | Opinions adopted | |
0188-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (as Triton X-100) in the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | 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); HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] | The formulation of a hardener component containing OPE in Aerospace and Defence (A&D) two-part polysulphide sealants. | Opinions adopted | |
0162-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Novo Nordisk A/S | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as a solvent/detergent agent for virus inactivation in the manufacture of pharmaceutical products used in the treatment of rare bleeding disorders. | 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 | |
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. | Opinions adopted | |
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). | 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 | |
0163-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (as Triton X-100) in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments | 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 | |
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). | 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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
0186-02 | 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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
0032-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Functional chrome plating with decorative character | 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 | |
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 | |
0135-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Thyssenkrupp Electrical Steel GmbH; Thyssenkrupp Electrical Steel UGO S.A.S. | Surface treatment for the manufacture of grain-oriented electrical steel used in magnetic circuits of electric devices, in particular magnetic cores of high-performance transformers | 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 | |
0133-01 | 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 | |
0071-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Gerhardi Kunststofftechnik GmbH
C. Hübner GmbH SAXONIA Galvanik GmbH Simon Systems GmbH & Co. KG [name of co-applicant in the original application: Karl Simon GmbH & Co. KG updated due to a notified legal entity name change] Galvanoplast Fischer Bohemia, s.r.o. [correction of the name of the original Applicant: Fischer GmbH & Co. surface technologies KG and of the successor Applicant: Fischer Surface Technologies GmbH] Fischer Oberflächentechnologie GmbH [correction of the name of the original Applicant: Fischer GmbH & Co. surface technologies KG and of the successor Applicant: Fischer Surface Technologies GmbH] WAFA Germany GmbH Boryszew Oberflächentechnik Deutschland GmbH Bolta Werke GmbH Heinze Gruppe GmbH C+C Krug GmbH BIA Kunststoff- und Galvanotechnik GmbH & Co KG Aludec Galvanic s.a. | Plating on Plastics for Automotive Applications (PoPAA) | 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 | |
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 | |
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 | |
0064-03 | 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 II. | Opinions adopted | |
0130-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Dornbracht AG & Co. KG [name of applicant in the original application: Aloys F. Dornbracht GmbH & Co.KG updated due to a notified change of corporate name] | Functional chrome plating with decorative character for sanitary applications | Opinions adopted | |
0132-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | 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 | |
0064-02 | 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 III. | 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 | |
0064-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in dissolved and solid form to produce aqueous solutions of any composition for industrial application. | Opinions adopted | |
0149-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Industrial Quimica del Nalon, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Opinions adopted | |
0150-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Koppers Denmark ApS | Use of CTPht for manufacture of formulations for various industrial uses | Opinions adopted | |
0151-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | 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 CTPht for manufacture of formulations for various industrial uses | Opinions adopted | |
0153-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Opinions adopted | |
0148-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | DEZA a.s. | Use of CTPht as a binder in the manufacture of clay targets | Opinions adopted | |
0152-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Rain Carbon bvba | Use of CTPht for manufacture of formulations for various industrial uses | Opinions adopted | |
0147-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht as a binder in the manufacture of clay targets | Opinions adopted | |
0136-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Ariston Thermo SpA | Use of sodium chromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 0.70% by weight (as Cr6+) in the refrigerant solution | Opinions adopted | |
0105-02 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | ILARIO ORMEZZANO - SAI s.r.l. [name of applicant in the original application: Ilario Ormezzano Sai Spa updated due to a notified name change] | Use of Sodium Dichromate as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings | Opinions adopted | |
0105-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 | ILARIO ORMEZZANO - SAI s.r.l. [name of applicant in the original application: Ilario Ormezzano Sai Spa updated due to a notified name change] | Repackaging of Sodium Dichromate to be supplied as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings | 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 | |
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 | |
0004-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Pending decision | |
0004-03 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Pending decision | |
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 | |
0122-02 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. | 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 industrials 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. | Withdrawn | |
0122-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Withdrawn | |
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 | |
0003-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | |
0002-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | |
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)] | Withdrawn | |
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