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- Adopted opinions and previous consultations on applications for authorisation
Adopted opinions and previous consultations on applications for authorisation
Adopted opinions and previous consultations on applications for authorisation
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
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| 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 | 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 |
| 0239-01 | initial | 4-(1,1,3,3-tetramethylbutyl)phenol, 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 |
| 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 |
| 0029-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Laboratoires Expanscience | Use as process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients | Commission decided | Details |
| 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. | Commission decided | Details |
| 0237-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Carlo Nobili SPA Rubinetterie | Use at industrial site electroplating of different types of substrates to achieve functional surfaces with high durability and a bright or matt silvery appearance for sanitary applications | Opinions adopted | Details |
| 0259-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MT METAL TECH S.r.l. [application transferred from “ST SRL” due to a notified legal entity change] | Use 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) | Opinions adopted | Details |
| 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. | 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 |
| 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 |
| 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 |
| 0162-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Novo Nordisk A/S | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as a solvent/detergent agent for virus inactivation in the manufacture of pharmaceutical products used in the treatment of rare bleeding disorders. | Commission decided | Details |
| 0170-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Octapharma AB | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII | Commission decided | Details |
| 0170-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Octapharma AB Octapharma Pharmazeutika Produktionsgesellschaft m.b.H Octapharma S.A.S. Octapharma Produktionsgesellschaft Deutschland mbH |
Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated as detergent for a virus inactivation step (solvent/detergent treatment) during the manufacture of plasma-derived and recombinant medicinal products | Commission decided | Details |
| 0177-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Rentschler Biopharma SE | Use of 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated in a washing buffer applied during a purification step in the manufacture of the monoclonal antibody Dinutuximab beta | Commission decided | Details |
| 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 | 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 |
| 0188-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Wallac Oy | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (as Triton X-100) in the assay buffer of the GSP® Neonatal GALT kit used for the semi-quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity | Commission decided | Details |
| 0175-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Merck KGaA | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (technical grade) as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert according to IPEC standards | Commission decided | Details |
| 0247-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Boehringer Ingelheim RCV GmbH & Co KG | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a detergent in the purification of lipidated OspA protein subsequently used for manufacturing of Lyme disease vaccine candidate. | 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 |
| 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 | Commission decided | Details |
| 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) | Commission decided | Details |
| 0187-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | AGC Biologics A/S | Use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as Triton X-100 as detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts in projects where processes have been approved by the authorities (GMP compliant) | 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 |
| 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 |
| 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 |
| 0299-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | 9036-19-5 | MeiraGTx Ireland Designated Activity Company | Use of 4-tert-OPnEO as a manufacturing aid in the production of gene therapies | 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 |
| 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). | Commission decided | Details |
| 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. | Commission decided | Details |
| 0226-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | LETI Pharma, S.L.U. [name of applicant in the original application: Laboratorios LETI, S.L.U. updated due to a notified change of corporate name] | Use of 4-tert-OPnEO in aqueous buffers during the manufacturing process of the active pharmaceutical ingredient (Protein Q) of the veterinary vaccine LetiFend® | Commission decided | Details |
| 0115-03 | Initial | Potassium chromate | 232-140-5 | 7789-00-6 | Saes Getters S.p.A. | Use of alkali metal dispensers containing potassium chromate for production of photocathodes. | Commission decided | Details |
| 0115-04 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Saes Getters S.p.A. | Use of alkali metal dispensers containing sodium chromate for production of photocathodes. | Commission decided | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0088-01 | 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 |
| 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 |
| 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 |
| 0211-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0301-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | LIBERTY GALATI SA [application transferred from original Applicant: "Liberty Liège Dudelange (BE)” due to a notified legal entity change] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0274-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0211-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Tata Steel IJmuiden BV; Tata Steel UK Ltd - [Application void as of 01/01/2021] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0301-02 | initial | Sodium dichromate | 234-190-3 | 10588-01-9 | LIBERTY GALATI SA [application transferred from original Applicant: "Liberty Liège Dudelange (BE)” due to a notified legal entity change] | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0274-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
| 0134-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ThyssenKrupp Rasselstein GmbH | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) | Commission decided | Details |
| 0297-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Acciaierie d'Italia S.p.A. | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS) | Opinions adopted | Details |
| 0274-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide for Electrolytic Chromium Coating of Steel (ECCS); also known as Tin Free Steel (TFS) | Opinions adopted | Details |
| 0221-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | U. S. Steel Košice, s.r.o. | Use of Chromium (VI) Trioxide for Passivation of Electrolytic Tinplate (ETP). | Commission decided | Details |
| 0134-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ThyssenKrupp Rasselstein GmbH | Use of Chromium (VI) Trioxide for Passivation of tinplated steel (ETP) | Commission decided | 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 |
| 0213-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Steel Color S.p.A. | Use of chromium trioxide as colouring and hardening agent for stainless steel plates | Commission decided | Details |
| 0096-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD” due to a notified legal entity change. Previously application transferred from original applicant: Haas Group International SCM Ltd due to a notified legal entity change] | Use of chromium trioxide for chemical conversion and slurry coating applications by aerospace companies and their suppliers | Commission decided | Details |
| 0231-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Kesseboehmer Beschlagsysteme GmbH&Co.KG | Use of chromium trioxide for decorative/functional application in the furniture, sanitary and automotive sector. | Opinions adopted | Details |
| 0241-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Gessi S.p.A. San Marco Rubinetteria S.r.l. |
Use of chromium trioxide for electroplating of metal substrates with the purpose of creating a long-lasting high durability surface with bright look for kitchen and bathroom sanitaryware (functional plating with decorative character) | Opinions adopted | Details |
| 0320-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Fratelli Creola S.r.l. | Use of chromium trioxide for electroplating of metal substrates with the purpose to creating a long-lasting high durability surface with bright (shiny) or matte look for sanitary and industrial applications | Opinion development | Details |
| 0262-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromoplastica C.M.C. S.r.l. | Use of chromium trioxide for electroplating of plastic substrates to achieve a protective and durable surface with a silvery finish | Opinions adopted | Details |
| 0262-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromoplastica C.M.C. S.r.l. | Use of chromium trioxide for etching of plastic substrates as a key pre-treatment step for creating an electrically conductive surface to enable electroplating | Opinions adopted | Details |
| 0305-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Meoni e Bartoletti S.p.A. | Use of Chromium Trioxide for the hard-chrome plating of hydraulic and pneumatic cylinders for various applications, and inner tubes of motorbike front suspension for the automotive industry. | Opinion development | Details |
| 0102-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Clariant Produkte (Deutschland) GmbH | Use of chromium trioxide in a catalyst for the dehydrogenation of propane to propene | Commission decided | Details |
| 0033-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Oy Kromatek Ab; Kova-Kromi Oy; CrTe-Plating Oy; Saizeri Plating Oy; Turun Kovakromi Oy; Veljekset Wallenius Oy; Pirkan Kovakromaus Oy | Use of chromium trioxide in Cr(VI) based functional plating | Commission decided | Details |
| 0064-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in dissolved and solid form to produce aqueous solutions of any composition for industrial application. | Opinions adopted | Details |
| 0067-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Abloy Oy | Use of chromium trioxide in electroplating of mechanical and electromechanical cylinders, cam- and padlocks, electromechanical lock cases and architectural hardware. | Commission decided | Details |
| 0127-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
MAHLE Ventiltrieb GmbH
MAHLE Polska Sp. z o.o. |
Use of chromium trioxide in functional chrome plating of valves used in engines of light gasoline and diesel vehicles and in heavy duty diesel combustion engines | Commission decided | Details |
| 0093-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of brass, bronze, copper and other copper alloys for medical engineering, aviation and automation products | 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 |
| 0064-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category II. | Opinions adopted | Details |
| 0064-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of Chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of metal or plastic, with or without current flow, in category III. | Opinions adopted | Details |
| 0092-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | HAPOC GmbH & Co KG | Use of chromium trioxide in solid form and in aqueous solution of any composition to modify the properties of surfaces made of plastic, with or without current flow | Opinions adopted | Details |
| 0267-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SPGPrints B.V. | Use of Cr(VI) in an integrated process to create a hard surface with selective adhesion properties on mandrels used to manufacture screens for Rotary Screen Printing (RSP) for textile and other (printing) applications | Opinions adopted | Details |
| 0148-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | DEZA a.s. | Use of CTPht as a binder in the manufacture of clay targets | Commission decided | Details |
| 0147-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht as a binder in the manufacture of clay targets | Commission decided | Details |
| 0151-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Rain Carbon Germany GmbH [name of applicant in the original application: RÜTGERS Germany GmbH updated due to a notified change of corporate name] | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0153-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | BILBAINA DE ALQUITRANES, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0150-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Koppers Denmark ApS | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0152-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Rain Carbon bvba | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0149-01 | Initial | Pitch, coal tar, high temp. | 266-028-2 | 65996-93-2 | Industrial Quimica del Nalon, S.A. | Use of CTPht for manufacture of formulations for various industrial uses | Commission decided | Details |
| 0006-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Sasol-Huntsman GmbH & Co. KG | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | Details |
| 0005-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. | Use of DBP as an absorption solvent in a closed system in the manufacture of maleic anhydride | Commission decided | Details |
| 0005-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | DEZA a.s. |
Use of DBP in propellants Formulation: Industrial use of DBP as a burning rate surface moderant, plasticiser and/or coolant in the formulation of nitrocellulose-based propellant grains. Use at industrial site: Industrial use of DBP-containing propellant grains in manufacture of ammunition for military and civilian uses, and pyrocartridges for aircraft ejection seat safety systems [includes propellants for police force ammunition and excludes propellants intended for manual, private reloading of ammunition cartridges by civilian users, i.e., licensed individual sports shooters and hunters. No direct consumer use of DBP or its mixtures is covered by this Use.] |
Commission decided | 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 |
| 0352-02 | 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 |
| 0009-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Boliden Kokkola Oy | Use of diarsenic trioxide in the purification of metal impurities from the leaching solution in the zinc electrowinning process | Commission decided | Details |
| 0116-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] | Use of dichromium tris(chromate) for chemical conversion coating applications by aerospace and defence companies and their associated supply chains | Commission decided | Details |
| 0045-02 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 |
Henkel AG & Co. KGaA Henkel Global Supply Chain B.V. |
Use of dichromium tris(chromate) for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Commission decided | Details |
| 0232-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Monroe Czechia s.r.o. | Use of dichromium tris(chromate) in a post-treatment step of the autodeposition coating process of shock absorbers for automotive vehicles. | Opinions adopted | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0154-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-kit reagents on diagnostic analyser systems | Commission decided | Details |
| 0154-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Siemens Healthcare Diagnostics Products GmbH | Use of IVD-wash solutions on diagnostic analyser systems | Commission decided | Details |