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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. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

 
0057-01 Initial Chromium trioxide 215-607-8 1333-82-0 Nexter Mechanics Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament steels parts which are thermomechanically stressed and in contact with oxidizing gas at high temperature, so as to ensure a thermal barrier with high melting point, resistance to wear and oxidation associated with weapons as well as resistance to impact and atmospheric corrosion. Commission decided
0057-02 Initial Chromium trioxide 215-607-8 1333-82-0 Nexter Mechanics Industrial use of a mixture of chromium trioxide for the hard chromium plating of military armament parts in order to ensure surface hardness, resistance to atmospheric corrosion, abrasive wear resistance and friction coefficient for parts in relative movement. Commission decided
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
0066-01 Initial Chromium trioxide 215-607-8 1333-82-0 MTU Aero Engines AG Functional chrome plating for aerospace applications for civil and military uses, comprising coating of new components for aircraft engines as well as maintenance, repair and overhaul work on aircraft engine components Commission decided
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
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
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
0120-01 Initial 1,2-dichloroethane (EDC) 203-458-1 107-06-2 Microbeads AS Industrial use as a swelling agent during the sulfonation reaction of crosslinked polystyrene beads in the manufacture of ion exchange resins for purification of radioactive waste Commission decided
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 Opinion development
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. Opinion development
0197-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - MERCK MILLIPORE LIMITED Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated as a surface-active ingredient for the production of two types of mixed cellulose ester membranes (lateral flow and microfiltration membranes). Opinion development
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 Opinions adopted
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
0157-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Merck Biodevelopment SAS
FUJIFILM Diosynth Biotechnologies UK Limited
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 Opinions adopted
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
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
0189-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Lonza Biologics Porriño, SL.; Lonza Biologics, plc. 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 Opinions adopted
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
0011-01 Initial Diarsenic trioxide 215-481-4 1327-53-3 Linxens France SA Formulation of diarsenic trioxide into a mixture Commission decided
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 Opinion development
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
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. Opinion development
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 Opinion development
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 Opinion development
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
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
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
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 Opinion development
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 Opinion development
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 Opinions adopted
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 Opinions adopted
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
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 Opinions adopted
0169-01 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - Janssen Vaccines & Prevention BV
Janssen Biologics B.V.
4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step. Opinions adopted
0075-01 Initial Sodium dichromate 234-190-3
7789-12-0
10588-01-9
Jacobs Douwe Egberts
DE GmbH
Dr. Otto Suwelack Nachf.
GmbH & Co. KG
Européenne de Lyophilisation S.A.
Use of sodium dichromate as a corrosion inhibitor in ammonia absorption deep cooling systems as applied in the industrial production of freeze dried products such as coffee, herbs, spices and comparable products. Commission decided
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. Opinion development
0013-02 Initial Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane
221-695-9
247-148-4
3194-55-6
25637-99-4
134237-50-6
134237-51-7
134237-52-8
INEOS Styrenics Netherlands BV
INEOS Styrenics Ribecourt SAS
INEOS Styrenics Wingles SAS
Synthos Dwory 7 spółka z ograniczoną odpowiedzialnością spółka komandytowo-akcyjna.
Synthos Kralupy a.s.
StyroChem Finland Oy
Monotez SA
RP Compounds GmbH
Synbra Technology bv
Sunpor Kunststoff GmbH
Dunastyr Polystyrene Manufacturing C. Co. Ltd
Versalis SpA
Unipol Holland bv
Manufacture of flame retarded expanded polystyrene (EPS) articles for use in building applications Authorisation expired
0013-01 Initial Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane
221-695-9
247-148-4
3194-55-6
25637-99-4
134237-50-6
134237-51-7
134237-52-8
INEOS Styrenics Netherlands BV
INEOS Styrenics Ribecourt SAS
INEOS Styrenics Wingles SAS
Synthos Dwory 7 spółka z ograniczoną odpowiedzialnością spółka komandytowo-akcyjna.
Synthos Kralupy a.s.
StyroChem Finland Oy
Monotez SA
RP Compounds GmbH
Synbra Technology bv
Sunpor Kunststoff GmbH
Dunastyr Polystyrene Manufacturing C. Co. Ltd
Versalis SpA
Unipol Holland bv
Formulation of flame retarded expanded polystyrene (EPS) to solid unexpanded pellets using hexabromocyclododecane as the flame retardant additive (for onward use in building applications) Authorisation expired
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 Opinion development
0121-01 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Indestructible Paint Ltd. Formulation of mixtures Commission decided
0121-02 Initial Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Indestructible Paint Ltd. Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications Commission decided
0105-02 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] Use of Sodium Dichromate as a mordant in the dyeing of wool as sliver and/or yarn with dark colours in industrial settings Opinions adopted
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
0185-02 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX Montpellier SAS Formulation of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated in the manufacture of sample diluents and standard solutions used in in vitro diagnostic veterinary ELISA Plate tests used for the detection of infectious diseases in livestock and poultry Opinions adopted
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 Opinions adopted
0185-03 Initial 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated - - IDEXX EUROPE B.V.;
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 Opinions adopted
0185-04 Initial 4-Nonylphenol, branched and linear, ethoxylated - - IDEXX EUROPE B.V. 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 Opinions adopted
0133-01 Iitital Chromium trioxide 215-607-8 1333-82-0 Ideal Standard - Vidima AD;
Ideal Standard Produktions-GmbH;
Jado Iberia-Produtos Metalurgicos Sociedade Unipessoal LDA (withdrawn)
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 Opinions adopted
0133-02 Initial Chromium trioxide 215-607-8 1333-82-0 Ideal Standard - Vidima AD Etching of plastics with chromium trioxide as pre-treatment step for electroplating processes Opinions adopted
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. Opinions adopted



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