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Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud

Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

 

 
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
0157-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merck Biodevelopment SAS
Fujifilm Diosynth Biotechnologies (UK) Ltd - [Application void as of 01/01/2021]
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
0205-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Becton Dickinson Distribution Center NV Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO)) as a processing aid in imported Diagnostics Opinion development
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
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
0154-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products Ltd - [Application void as of 01/01/2021] Use of OPE in formulation of IVD-kit reagents Application void as of 01 January 2021
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
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
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
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
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
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
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
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
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. – [Decision discontinued as of 01/01/2021]; 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
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
0154-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products Ltd - [Application void as of 01/01/2021] Use of OPE in isolation of protein from recombinant cell cultures for the production of IVD-kits (protein cell extraction) Application void as of 01 January 2021
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
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
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 - [Application void as of 01/01/2021]
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
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
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
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
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
0154-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Siemens Healthcare Diagnostics Products Ltd - [Application void as of 01/01/2021] Use of OPE in formulation of IVD- wash solutions Application void as of 01 January 2021
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
0206-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, 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
0139-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Ortho-Clinical Diagnostics - [Application void as of 01/01/2021] 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. Application void as of 01 January 2021
0189-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Lonza Biologics Porriño, SL.
Lonza Biologics, plc. - [Application void as of 01/01/2021]
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
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
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



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