- ECHA
- Search for chemicals
- 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
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
Related links
There are currently no ongoing consultations.
| 0319-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SK Nexilis Poland sp. z o.o. | Manufacture of passivated copper foil used in Lithium-ion batteries (LiB). | Opinion development | 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 |
| 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 |
| 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 |
| 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). | Opinion development | Details |
| 0350-02 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc.; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. | Mixing, by Airbus, and their associated supply chains, including the Applicant, 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) | Opinion development | Details |
| 0332-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O; Henkel Global Supply Chain B.V. | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0342-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7) | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0342-02 | Review report | Potassium dichromate | 231-906-6 | 7778-50-9 | Brenntag Chemicals Distribution (Ireland) Ltd | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0332-02 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0332-03 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0342-03 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Passivation of (non-Al) metallic coatings using chromium trioxide or sodium dichromate or potassium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0345-02 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0334-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Henkel Global Supply Chain B.V. | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0334-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | HAAS GROUP INTERNATIONAL SP. Z.O.O | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0345-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Passivation of stainless steel using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0032-06 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Passivation of tin-plated steel (ETP) | Commission decided | Details |
| 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 |
| 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 Winning Plastics – Diepersdorf GmbH [application transferred from “Bolta Werke GmbH” due to a notified legal entity change.] 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 | Details |
| 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 | Commission decided | Details |
| 0294-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Kludi GmbH & Co. KG | Pre-treatment (“etching”) of plastic substrates using chromium trioxide in electroplating processes for sanitary applications | Opinions adopted | Details |
| 0333-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O; Henkel Global Supply Chain B.V. | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0343-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Boeing Distribution Deutschland GmbH; Chemservice GmbH - (B1P7); CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S. | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0343-02 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Pre-treatments: Deoxidising, pickling, etching and/or desmutting using chromium trioxide or sodium dichromate in aerospace and defence industry and its supply chains | Opinion development | Details |
| 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 | Commission decided | Details |
| 0200-07 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0201-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A. | Professional use as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary In Vitro Diagnostic devices (IVDs) including one SERELISA, six ProFLOK, six WITNESS and five VetScan. The use is carried out by professional users in diagnostic laboratories and veterinary clinics to detect certain diseases in pets and farm animals | Commission decided | Details |
| 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. | Commission decided | Details |
| 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. | Commission decided | Details |
| 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. | Commission decided | Details |
| 0012-12 | Initial | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking | Authorisation expired | Details |
| 0012-11 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional use of solid or liquid colour premixes and pre-compounds containing pigment in the application of hotmelt road marking | Authorisation expired | Details |
| 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. | Withdrawn | Details |
| 0012-06 | Initial | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) | 235-759-9 | 12656-85-8 | DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking | Authorisation expired | Details |
| 0012-05 | Initial | Lead sulfochromate yellow (C.I. Pigment Yellow 34) | 215-693-7 | 1344-37-2 | DCL Corporation (NL) B.V. OR2 [application transferred from “DCL Corporation (NL) B.V. OR” due to a notified legal entity change. Name of applicant in the original application: DCC Maastricht B.V. OR updated due to a notified change of corporate name] | Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking | Authorisation expired | Details |
| 0350-01 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc.; PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. | Repackaging hardener formulations containing OPE as a surfactant in a concentration above 0.1%, to be used within two-part polysulphide sealants by Airbus and their associated supply chains | Opinion development | Details |
| 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 | Details |
| 0344-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O; CROMITAL S.P.A. in its legal capacity as Only Representative of Türkiye Şişe ve Cam Fabrikaları A.S.; Chemservice GmbH - (B1P7); Boeing Distribution Deutschland GmbH | Slurry coating using chromium trioxide in aerospace and defence industry and its supply chains | Opinion development | Details |
| 0354-02 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Airbus Helicopters Technik GmbH | Surface treatment (as corrosion inhibitor, no connection with functional chrome plating) in the manufacture of helicopter transmissions and the maintenance of helicopters. | Opinion development | Details |
| 0095-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | REGARTIS s.r.o. in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” [application transferred from: “REACHLaw” in its legal capacity as Only Representative of Joint Stock Company “Novotroitsk Plant of Chromium Compounds” due to a notified legal entity change] | Surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering | Commission decided | Details |
| 0032-05 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Surface treatment (except passivation of tin-plated steel (ETP)) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering (unrelated to Functional chrome plating or Functional chrome plating with decorative character) | Commission decided | Details |
| 0066-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MTU Aero Engines AG | Surface treatment for aerospace applications for civil and military uses, comprising treatment of new components for aircraft engines as well as maintenance, repair and overhaul work on aircraft engine components, unrelated to functional chrome plating | 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 |
| 0032-04 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
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 |
| 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 | Commission decided | Details |
| 0355-01 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Airbus Helicopters Technik GmbH | Surface treatment of metals (such as aluminium, steel, zinc, magnesium, titanium, alloys), composites and sealings of anodic films, in the production of transmissions for helicopters and in maintenance of helicopters. | Opinions adopted | 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 |
| 0348-01 | Review report | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH | The formulation of a hardener component containing NPE within Aerospace two-part polysulfide sealants. | Opinion development | 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 |
| 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 |
| 0111-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | OLON Spa | The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin. | Commission decided | Details |
| 0111-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | OLON Spa | The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate. | Commission decided | Details |
| 0109-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Akzo Nobel Chemicals SpA | The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant | Commission decided | Details |
| 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 | 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 |
| 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. | 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 |
| 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. | 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 |
| 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 | Opinions adopted | 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 |
| 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. | Opinions adopted | Details |
| 0146-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tata Steel UK Ltd - [Application void as of 01/01/2021] | The use of Chromium (VI) Trioxide for the manufacture of Electrolytic Chromium/Chromium oxide Coated Steel (ECCS) | Application void as of 01 January 2021 | Details |
| 0228-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Eaton S.R.L; Eaton Automotive Systems sp.zoo | The use of Chromium Trioxide (EC 215-607-8) by Eaton Vehicle Group (Eaton) across two legal entities in the functional chrome plating of engine valves and valve actuation (“lash adjusters”) | Commission decided | Details |
| 0249-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Monroe Czechia s.r.o. | The use of Chromium Trioxide (EC 215-607-8) by Monroe Czechia s.r.o. in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0252-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Eastern Europe Sp. z o.o. | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Eastern Europe Sp. z o.o. in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0251-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Europe BVBA | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Europe BVBA in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0250-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tenneco Automotive Ibérica | The use of Chromium Trioxide (EC 215-607-8) by Tenneco Automotive Ibérica S.A in the functional chrome plating of shock absorber rods. | Opinions adopted | Details |
| 0114–02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | Details |
| 0034-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium Trioxide for a pre-treatment step (etching) in the electroplating process | Commission decided | Details |
| 0034-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Grohe AG | The use of Chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional electroplating with decorative character) | Commission decided | Details |
| 0114–01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hansgrohe SE | The use of chromium trioxide for electroplating of different types of substrates with the purpose to create a long-lasting high durability surface with bright (shiny) or matte look (Functional plating with decorative character) | Commission decided | Details |
| 0271-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Villeroy & Boch Gustavsberg AB FM Mattsson Mora Group AB | The use of chromium trioxide for electroplating of metal substrates with the purpose to create a long-lasting high durability surface with bright look for kitchen and bathroom sanitary ware | Opinions adopted | Details |
| 0103-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Euro Cryospace France | The use of chromium trioxide for the surface preparation of aluminium alloy cryogenic tanks used in the Ariane 5 launcher | Commission decided | Details |
| 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. | Opinions adopted | Details |
| 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. | Opinions adopted | Details |
| 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. | Opinions adopted | Details |
| 0030-01 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 |
|
The use of sodium chromate as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75% by weight (Cr6+) in the cooling solution | Commission decided | Details |
| 0104-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Borealis Plastomers B.V. | The use of sodium dichromate as in-situ corrosion inhibitor in a closed water/ammonia absorption cooling system | Commission decided | Details |
| 0031-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Boliden Mineral AB | The use of sodium dichromate in copper/lead separation in concentrators handling complex sulphide ores | Commission decided | Details |
| 0069-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Topocrom GmbH | TOPOCROM functional chrome plating in closed reactor systems for the establishment of adjustable hemispherical surface structures. | Commission decided | Details |
| 0363-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Ramboll Belgium BVBA (Indestructible Paints) | Treatment of components used in industrial gas turbines and associated components using slurry coating products containing chromium trioxide to enhance corrosion resistance, chemical resistance, high temperature oxidation resistance, adhesion to components which produce a smooth finish and enhance the technical performance of turbines. | Opinion development | Details |
| 0017-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ENTEK International Limited – [Decision discontinued as of 01/01/2021] | Trichloroethylene as an extraction solvent for removal of process oil and formation of the porous structure in polyethylene based separators used in lead-acid batteries | Discontinued as of 01 January 2021 | Details |
| 0016-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as degreasing solvent in the manufacture of polyethylene separators for lead-acid batteries | Commission decided | Details |
| 0242-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | Microporous GmbH | Trichloroethylene used as extraction solvent in the manufacture of polyethylene separators for lead-acid batteries | Opinions adopted | 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 |
| 0278-01 | Review report | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | PMC ISOCHEM | Use as a process solvent in one step of manufacturing of an active pharmaceutical ingredient used in an anti-protozoal drug | Opinions adopted | Details |
| 0108-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as a process solvent in the manufacture of an Active Pharmaceutical Ingredient: Flecainide acetate | Commission decided | Details |
| 0227-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | Details |
| 0107-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | emp Biotech GmbH | Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes | Commission decided | Details |
| 0354-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Airbus Helicopters Technik GmbH | Use as a surface hardener (functional chrome plating) in the manufacture of helicopter transmissions and the maintenance of helicopters. | Opinion development | Details |
| 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 | Commission decided | Details |
| 0022-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SPOLANA a.s. | Use as an extraction solvent in caprolactam production | Commission decided | Details |
| 0081-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Rafineria Gdańska Sp. z o.o. [name of applicant in the original application: GRUPA LOTOS S.A. updated due to a notified legal entity change] | Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. | Commission decided | Details |
| 0110-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change] | Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist® | Commission decided | Details |
| 0108-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as an process solvent in the manufacture of an Active Pharmaceutical Ingredient: Nefopam hydrochloride | Commission decided | Details |