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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
 
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. Commission decided Details
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) Commission decided Details
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 Commission decided Details
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 Commission decided Details
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. Commission decided Details
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) Commission decided Details
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 Commission decided Details
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 Details
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 Commission decided Details
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. Commission decided Details
0204-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Biokit S.A. Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. Commission decided Details
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). Commission decided Details
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. Commission decided Details
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 - [Application void as of 01/01/2021]
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. Commission decided Details
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. Commission decided Details
0200-05 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - QIAGEN GmbH; STAT-Dx Life S.L.; 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
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; Wesco Aircraft EMEA Ltd; Boeing Distribution UK, Inc. – [Decision discontinued as of 01/01/2021]; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - [name of the co-applicant in the original application OR23 PPG Industries (UK) Ltd. updated due to a notified appointment of only representative]; 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. Commission decided Details
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 Commission decided Details
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 Commission decided Details
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 Commission decided Details
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. Commission decided Details
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®). Commission decided Details
0178-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Takeda Manufacturing Austria AG [name of the applicant in the original application: Baxter AG updated due to a change of corporate name]; 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. Commission decided Details
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. Commission decided Details
0185-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX B.V. [name of the applicant in the original application: “IDEXX EUROPE B.V.” updated due to a notified corporate name change]
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 Commission decided Details
0201-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] 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. Commission decided Details
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 Commission decided Details
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. Commission decided Details
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. Commission decided Details
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; Wesco Aircraft EMEA Ltd; Boeing Distribution UK, Inc. – [Decision discontinued as of 01/01/2021]; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - [name of the co-applicant in the original application OR23 PPG Industries (UK) Ltd. updated due to a notified appointment of only representative]; 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). 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
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
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
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
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
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
0230-01 Initial 4-Nonylphenol, branched and linear, ethoxylated - - Safran Landing Systems; SOCIETE DE TRAITEMENTS ELECTROLYTIQUES NORMALISES S.T.E.N. Industrial use of 4-NPnEO as non-reactive surfactant in the sealing product in sulfuric acid anodization process of aluminium alloy parts of aircraft landing gears Withdrawn Details
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
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
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. 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
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 - [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 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. Commission decided 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
0200-08 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
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
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
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
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
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
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
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
0317-01 Initial Acids generated from chromium trioxide and their oligomers - - Micron srl Dilution of chromic acid solution at concentrations lower than 0.1% for the use in passivation baths Opinions adopted Details
0106-02 Initial Ammonium dichromate 232-143-1 7789-09-5 Display Technologies Limited - [Decision discontinued as of 01/01/2021] Industrial use of Ammonium Dichromate in the process of manufacturing Cathode Ray Tubes for head up displays intended to be used in military and civilian aircrafts Discontinued as of 01 January 2021 Details
0073-01 Initial Ammonium dichromate 232-143-1 7789-09-5 Veco B.V. Use of ammonium dichromate as photosensitive component in a polyvinyl alcohol photolithographic lacquer system for the manufacturing of mandrels which are used in nickel electroforming processes. Commission decided Details
0106-01 Initial Ammonium dichromate 232-143-1 7789-09-5 BAE Systems (Operations) Limited – [Decision discontinued as of 01/01/2021]
Qioptiq Ltd – [Decision discontinued as of 01/01/2021]
Industrial use of Ammonium Dichromate in the process of manufacturing holographic combiners for diffractive head-up displays intended to be used in military aircrafts Discontinued as of 01 January 2021 Details
0049-01 Initial Ammonium dichromate 232-143-1 7789-09-5 Micrometal GmbH The use of Ammonium dichromate (ADC) as a photosensitizer for production of micro components Commission decided Details
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 Commission decided Details
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 Commission decided Details
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 Commission decided Details
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 Commission decided Details
0059-01 Initial Arsenic acid 231-901-9 7778-39-4 CIRCUIT FOIL LUXEMBOURG SARL Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of Printed Circuit Board Commission decided Details
0352-02 Initial Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd Use of DEHP-containing plastics for immediate packaging of medicinal products Opinion development Details
0352-03 Initial Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd Use of DEHP-based mixtures as a lubricating/sealing agent for the insertion of port closures into empty bags and assembly/connection of parts, that are used in immediate packaging of medicines Opinion development Details
0352-01 Initial Bis(2-ethylhexyl) phthalate 204-211-0 117-81-7 Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd; Colorite Europe Ltd. (withdrawn) Formulation of DEHP mixtures for application in immediate packaging of medicines and medical devices Opinion development Details
0007-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Roxel (UK Rocket Motors) Ltd Industrial use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles Authorisation expired Details
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 Withdrawn Details
0001-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 Rolls-Royce plc – [Decision discontinued as of 01/01/2021] The processing of a stop-off formulation containing DEHP during the diffusion bonding and manufacture of aero engine fan blades. Discontinued as of 01 January 2021 Details
0008-01 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl Formulation of recycled soft PVC containing DEHP in compounds and dry-blends Authorisation expired Details
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 Details
0008-02 Initial Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles Authorisation expired Details
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 Details
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)] Withdrawn Details
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 Withdrawn Details
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 Details
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 Details
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). Commission decided Details
0125-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 N.V. Ajinomoto OmniChem S.A. Use of diglyme as a solvent for the synthesis of the anti-HIV active pharmaceutical ingredient (API) dapivirine. Commission decided Details
0089-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 PMC ISOCHEM [application transferred from original Applicant: ISOCHEM due to a notified legal entity change] Use of diglyme as a process solvent in one step of the manufacturing of an Active Pharmaceutical Ingredient used in an anti-protozoal drug Commission decided Details
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) Commission decided Details
0091-01 Initial Bis(2-methoxyethyl) ether 203-924-4 111-96-6 Merck KGaA Industrial use of diglyme as solvent in the manufacturing process of cryptand intermediates for further conversion into cryptand 221 and cryptand 222 Commission decided Details
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) Commission decided Details
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). Commission decided Details
0085-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Life Technologies AS Use of diglyme as a process chemical in the manufacture of Dynabeads. Commission decided Details
0086-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Bracco Imaging s.p.a Use of bis(2-methoxyethyl) ether (diglyme) as a processing aid in the purification of 5-amino-2,4,6-triiodoisophthalic acid dichloride (EC 417- 220-1; CAS 37441-29-5) by precipitation Commission decided Details
0061-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Novartis Ringaskiddy Limited Use of diglyme as solvent in the manufacturing process of an intermediate for further conversion into a pharmaceutical compound used in medicinal products for treatment of respiratory diseases Commission decided Details
0087-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 MAFLON S.P.A. 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. Commission decided Details
0084-01 Initial Bis(2-methoxyethyl) ether (Diglyme) 203-924-4 111-96-6 Roche Diagnostics GmbH Use of diglyme as a process chemical in the manufacture of one specific type of Dynabeads® used in immunodiagnostic assays (in vitro diagnostic) Commission decided Details
0053-01 Initial Chromic acid
231-801-5
236-881-5
13530-68-2
7738-94-5
Robert Bosch GmbH Hard chrome plating for gasoline and diesel injection applications Commission decided Details
0235-01 Initial Chromic acid 231-801-5 7738-94-5 Neoperl GmbH The use of chromic acid in the functional electroplating of brass-made sanitary articles with the specific purpose of obtaining a final Cr(0) coating that provides a surface with high durability and chemical resistance. Commission decided Details
0100-02 Initial Chromium trioxide 215-607-8 1333-82-0 Airbus Helicopters Technik GmbH [name of applicant in the original application: “ZF Luftfahrttechnik GmbH” updated due to a notified corporate name change] Surface treatment for applications in the aeronautics and aerospace industries (unrelated to Functional chrome plating or Functional chrome plating with decorative character) Commission decided Details
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 Details
0070-01 Initial Chromium trioxide 215-607-8 1333-82-0 FN HERSTAL S.A.
MANROY ENGINEERING LTD – [Decision discontinued as of 01/01/2021]
Industrial use of chromium trioxide in the hard chromium coating of military small- and medium-caliber firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide hardness, heat resistance and thermal barrier properties, as well as corrosion resistance, adhesion and low friction properties Commission decided Details
0300-01 Initial Chromium trioxide 215-607-8 1333-82-0 WEBER-HYDRAULIK GMBH Chromium trioxide-based functional chrome plating of solid and hollow piston rods for hydraulic applications Opinions adopted Details
0056-01 Initial Chromium trioxide 215-607-8 1333-82-0 Rimex Metals (UK) Ltd – [Decision discontinued as of 01/01/2021] Use of chromium trioxide as an oxidising and hardening agent in the manufacture of coloured stainless steel Discontinued as of 01 January 2021 Details
0234-01 Initial Chromium trioxide 215-607-8 1333-82-0 Maschinenfabrik Kaspar Walter GmbH & Co KG Formulation of chromium trioxide-based electrolyte for electroplating process. Commission decided Details
0253-01 Initial Chromium trioxide 215-607-8 1333-82-0 GEA Westfalia Separator Group GmbH Chromium trioxide-based functional chrome plating of machine components for centrifugal separator and decanter centrifuges Commission decided Details
0280-02 Initial Chromium trioxide 215-607-8 1333-82-0 TECNOCROM INDUSTRIAL, S.A.;ALLION ESPAÑOLA S.A.; CROMADO INDUSTRIAL SARRASIN S.L.; CROMECAL, S.L. ; Talleres Acro, S. L. [name of the applicant in the original application: Talleres Acro, S.A. updated due to a change of corporate name]; DUROKROM, SL; IkanKronitek, S.L.; CROMO DURO ANFER S.A.; GIROCLAD, SL; OVIDICROM S.L.; RECTIFICADOS DELVAL S.A; REQUEL S.L.; Talleres Durocrom S. L.; TALLERES GUMILA, S.L. Functional chrome plating of parts with complex surface geometry and requiring the use of an auxiliary anode Opinions adopted Details
0288-01 Initial Chromium trioxide 215-607-8 1333-82-0 Leonardo S.p.A. Functional chrome plating of military gun barrels and outer jacket surfaces using chromium trioxide Opinions adopted Details
0309-01 Initial Chromium trioxide 215-607-8 1333-82-0 Cromatura Staff Srl Industrial use of chromium trioxide for the plating of brass valves destined for applications involving industrial and technical fluids and brass fittings for oxygen cylinders Opinions adopted Details