Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

Usvojena mišljenja i prethodna savjetovanja o zahtjevima za autorizaciju

This page provides further information on the applications for authorisation or review reports, which have undergone 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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. 

 

There are currently no ongoing consultations.
 
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 Commission decided Details
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 - [Application void as of 01/01/2021]
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. Commission decided Details
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 Commission decided Details
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. Withdrawn Details
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. Commission decided Details
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. Commission decided Details
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 Commission decided Details
0185-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - IDEXX B.V. [name of the applicant in the original application: “IDEXX EUROPE B.V.” updated due to a notified corporate name change] 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 Commission decided Details
0239-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Prionics Lelystad B.V. Use as component of buffer solutions to produce antigens (Cell extraction, cell lysis, coating of biological antigens onto articles, inactivation of microorganisms that produce targeted antigen and solvent exchange) and in-process and final Quality Control of antigens intended for use as veterinary and human health laboratory reagents in Scientific Research and Development and In Vitro Diagnostic applications Commission decided Details
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. Commission decided Details
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 Commission decided Details
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 Commission decided Details
0207-02 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021] 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). Commission decided Details
0207-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021] The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants. Commission decided Details
0200-08 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; 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 Commission decided Details
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) Commission decided Details
0248-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - FYSOL SAS [name of applicant in the original application: OCV Chambéry France S.A.S. updated due to a notified legal entity change] Mixing by the Applicant of a NPnEO-containing epoxy resin, resulting in mixtures containing < 0.1% w/w of NPnEO for the manufacture of glass fiber articles for critical composite helicopter parts, that is exempt from authorisation under REACH Art. 56(6)(a) Commission decided Details
0348-02 Review report 4-Nonylphenol, branched and linear, ethoxylated - - Chemetall GmbH 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 Details
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 Commission decided Details
0200-06 Initial 4-Nonylphenol, branched and linear, ethoxylated - - QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; 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) Commission decided Details
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 Commission decided Details
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. Commission decided Details
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 Commission decided Details
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 Commission decided Details
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. Commission decided Details