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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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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| 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 |
| 0038-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Kemira Chemicals Oy | Use of Sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacture of sodium chlorate with or without subsequent production of chlorine dioxide or sodium chlorite | 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 |
| 0132-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes | Commission decided | Details |
| 0132-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KEUCO GmbH & Co KG | Electroplating of different types of substrates using chromium trioxide to achieve functional surfaces with high durability and a bright or matt silvery appearance for 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 |
| 0294-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Kludi GmbH & Co. KG; Kludi-Armaturen Austria Ges.m.b.H. | Functional chrome plating with decorative character of metal and plastic substrates for sanitary applications | Opinions adopted | 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 |
| 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 |
| 0283-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | KYB SUSPENSIONS EUROPE, S.A.U.; KYB Manufacturing Czech s.r.o. | Functional chrome plating of piston rods for shock absorbers for automotive applications | Opinions adopted | 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 |
| 0079-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins | Commission decided | Details |
| 0223-01 | Review report | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins. | Commission decided | Details |
| 0079-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Lanxess Deutschland GmbH | Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins | Commission decided | Details |
| 0212-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. |
Industrial use of chromium trioxide for the etching, pre-treatment step in the electroplating process of functional chrome plating with decorative character | Opinions adopted | Details |
| 0212-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
LARS Chemie, spol. s r.o. CASTELCROM SRL; MATRIDOS S.L.U; PLATING BRAP S.A.U. |
Industrial use of chromium trioxide for the functional chrome plating with decorative character for automotive and sanitary industry | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0285-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Liebherr-Aerospace Lindenberg GmbH | Industrial use of chromium trioxide for functional chrome plating of actuation and landing gear systems for the aviation industry. | Opinions adopted | Details |
| 0285-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Liebherr-Aerospace Lindenberg GmbH | Industrial use of chromium trioxide for surface treatment of aluminium alloys for applications in the aerospace industries unrelated to functional chrome plating | Opinions adopted | Details |
| 0311-01 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | Liebherr-Aerospace Lindenberg GmbH | Industrial use of sodium dichromate for the sealing after anodizing of aluminium alloys and passivation of metallic coatings of actuation and landing gear system parts for the aviation industry that meet the airworthiness certification requirements | 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 |
| 0184-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Lilly France S.A.S.; Eli Lilly Italia S.p.A. | Industrial formulation (dilution) of a silicone solution containing 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices | Commission decided | Details |
| 0225-02 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for heavy-duty rollers, tensioner pads and spring blocks with high reliability requirements for offshore energy and renewables sectors. | Commission decided | Details |
| 0225-01 | Initial | 4,4'-methylenebis[2-chloroaniline] | 202-918-9 | 101-14-4 | Limburgse Urethane Castings NV | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of high-performance polyurethanes specifically for custom-made rollers with high reliability requirements for steel and aluminium sectors. | Commission decided | Details |
| 0054-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Linde AMT GmbH [name of the applicant in the original application: Praxair Surface Technologies GmbH updated due to a change of corporate name] | Industrial spraying or brush application of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment, to ensure a high temperature corrosion & oxidation resistance, as well as anti-fouling properties or lubricity at high temperature, for automotive, aviation, power generation machinery, Oil and Gas and marine applications. | Commission decided | Details |
| 0054-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Linde AMT GmbH [name of the applicant in the original application: Praxair Surface Technologies GmbH updated due to a change of corporate name] | Industrial spraying of chromium trioxide mixtures for the coating of metallic articles subject to harsh environment to ensure either a low temperaturecured coating for corrosion protection, or a high temperature corrosion & oxidation resistance with reduction of surface roughness or a high temperature adhesive, for aviation, power generation machinery, Oil and Gas and marine applications. | Commission decided | Details |
| 0011-02 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Linxens France SA | Industrial use of diarsenic trioxide as processing aid in gold electroplating | Commission decided | Details |
| 0011-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Linxens France SA | Formulation of diarsenic trioxide into a mixture | Commission decided | Details |
| 0321-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | LMC S.r.l. | Industrial use of Chromium Trioxide for the functional chrome plating of food slicer’s circular blades. | Opinion development | 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 |
| 0357-01 | Review report | potassium dichromate | 231-906-6 | 7778-50-9 | LYNRED | Industrial use of potassium dichromate-based mixtures during the step of final etching of CZT layers during the production of opto-electronic components gathering a readout and an infrared detecting circuit with the MCT technology. | Opinion development | Details |
| 0048-01 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | LYNRED [name of applicant in the original application: “SOFRADIR” updated due to a notified corporate name change] | Industrial use of potassium dichromate-based mixtures during the steps of initial and final etching of CZT layers during the production of opto-electronic components gathering a readout and an infrared detecting circuit with the MCT technology | Commission decided | Details |
| 0048-02 | Initial | Potassium dichromate | 231-906-6 | 7778-50-9 | LYNRED [name of applicant in the original application: “SOFRADIR” updated due to a notified corporate name change] | Industrial use of potassium dichromate based mixture during the etching of both InSb substrate sides during the production of optoelectronic components gathering a readout and an infrared detecting circuit with the InSb technology | 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 |
| 0296-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAHLE - Componentes de Motores, S.A. | Chromium-trioxide-based functional chrome plating of piston rings for automotive applications | Opinions adopted | 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 |
| 0270-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAIER S. COOP. MAIER CZ s.r.o.; MAIER CROMOPLASTICA S.p.A | Functional chrome plating with decorative character for automotive applications | Opinions adopted | Details |
| 0270-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | MAIER S. COOP. MAIER CZ s.r.o.; MAIER CROMOPLASTICA S.p.A | Etching of plastics with chromium trioxide as pre-treatment step for electroplating of plastics for automotive applications | Opinions adopted | 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. | Opinions adopted | Details |
| 0234-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Maschinenfabrik Kaspar Walter GmbH & Co KG | Chromium trioxide-based functional chrome plating of cylinders used in the rotogravure printing and embossing industry. | Opinions adopted | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 0197-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | MERCK MILLIPORE LIMITED | Downstream use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as component of mixed cellulose ester membranes. | Commission decided | Details |