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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
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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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| 0341-04 | Review report | Sodium dichromate | 234-190-3 | 10588-01-9 | Brenntag Chemicals Distribution (Ireland) Ltd; AD International BV | Formulation of mixtures with soluble Cr(VI) compounds for use in aerospace and defence industry and its supply chains for surface treatments | Opinion development | Details |
| 0186-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Beckman Coulter GmbH |
Formulation of NPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. | Commission decided | Details |
| 0186-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - |
Beckman Coulter Ireland Inc.; Immunotech S.R.O.; Immunotech S.A.S. |
Formulation of OPnEO solutions in European sites for use as laboratory products. Laboratory products are used as intermediate solutions for preparation of finished laboratory products (finished goods) or in-process use. | Commission decided | Details |
| 0360-02 | Initial | 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate | 239-622-4 | 15571-58-1 | Galata Chemicals GmbH; REAGENS SPA; PMC Vlissingen Netherlands B.V. | Formulation of PVC dry mixtures (granules and pellets) containing DOTE | Opinion development | Details |
| 0123-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Plastic Planet srl | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Opinions adopted | Details |
| 0122-01 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. |
Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Withdrawn | Details |
| 0008-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl | Formulation of recycled soft PVC containing DEHP in compounds and dry-blends | Authorisation expired | Details |
| 0362-01 | Initial | tetraethyllead | 201-075-4 | 78-00-2 | Warter Fuels Spółka Akcyjna | FUEL FORMULATION WITH ADDED TETRAETHYL LEAD | Opinion development | Details |
| 0095-02 | 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] | Functional Chrome Plating | Commission decided | Details |
| 0055-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
CROMOMED S.A. CRONOR S.A. Cromo Europa S.A. CHROMATLANTIQUE INDUSTRIEL VILA ELECTROQUIMICAS.A. |
Functional Chrome Plating | Commission decided | Details |
| 0100-01 | 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] | Functional chrome plating | Commission decided | Details |
| 0032-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Functional Chrome Plating | Commission decided | Details |
| 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 | Details |
| 0302-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Thoma Metallveredelung GmbH | Functional chrome plating for hydraulic applications, other cylindrical components and further industrial applications | Opinion development | Details |
| 0238-01 | initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Hueck-Engraving GmbH & Co.KG | Functional chrome plating of high-quality stainless-steel press plates for the premium wood-based materials industry | Opinions adopted | Details |
| 0275-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SICROM S.r.l. | Functional chrome plating of hydraulic cylinders and swivel joints using chromium trioxide | Opinions adopted | Details |
| 0310-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromotecnica FIDA S.r.l. | Functional chrome plating of hydraulic cylinders, stems, pistons and rollers using chromium trioxide | Opinion development | Details |
| 0314-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Benoni S.r.l.; Cromatura Cristofoletti s.r.l. | Functional chrome plating of mechanical components (including hydraulic cylinders, columns, moulds and various machinery parts) using chromium trioxide | 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 |
| 0280-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | TECNOCROM INDUSTRIAL, S.A.;ALLION ESPAÑOLA S.A.; CROMADO INDUSTRIAL SARRASIN S.L.; CROMECAL, S.L. ; Talleres Acro, S. L. [name of the applicant in the original application: Talleres Acro, S.A. updated due to a change of corporate name]; DUROKROM, SL; IkanKronitek, S.L.; CROMO DURO ANFER S.A.; GIROCLAD, SL; OVIDICROM S.L.; RECTIFICADOS DELVAL S.A; REQUEL S.L.; Talleres Durocrom S. L.; TALLERES GUMILA, S.L. | Functional chrome plating of parts with at least one axis of symmetry and simple surface geometry | Opinions adopted | Details |
| 0280-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | TECNOCROM INDUSTRIAL, S.A.;ALLION ESPAÑOLA S.A.; CROMADO INDUSTRIAL SARRASIN S.L.; CROMECAL, S.L. ; Talleres Acro, S. L. [name of the applicant in the original application: Talleres Acro, S.A. updated due to a change of corporate name]; DUROKROM, SL; IkanKronitek, S.L.; CROMO DURO ANFER S.A.; GIROCLAD, SL; OVIDICROM S.L.; RECTIFICADOS DELVAL S.A; REQUEL S.L.; Talleres Durocrom S. L.; TALLERES GUMILA, S.L. | Functional chrome plating of parts with complex surface geometry and requiring the use of an auxiliary anode | Opinions adopted | Details |
| 0052-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Federal Mogul Burscheid GmbH | Functional chrome plating of piston rings for automotive engines as applied in the segments light vehicle petrol, light vehicle diesel, middle range diesel and heavy duty | Commission decided | Details |
| 0050-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Federal-Mogul Friedberg GmbH | Functional chrome plating of piston rings for two-stroke and four-stroke large bore engines as applied in the industrial sectors Construction & Industry, Power Generation, Railway and Maritime. | Commission decided | Details |
| 0119-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | ZF Friedrichshafen AG | Functional chrome plating of piston rods for automotive and rail applications | 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 |
| 0051-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Federal-Mogul Valvetrain GmbH | Functional chrome plating of valves for the use in petrol and diesel engines for light-and heavy duty vehicles. | Commission decided | Details |
| 0068-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Hoogovens Court Roll Surface Technologies V.O.F. WAVEC GmbH Trattamento Cilindri Laminazione S.r.l. Walzen-Service-Center GmbH NORD CHROME SAS RHENAROLL SA Texturing Technology Limited – [Decision discontinued as of 01/01/2021] NC POLAND Sp.z. o.o. |
Functional chrome plating of work rolls used in the steel and aluminium industry. | Commission decided | Details |
| 0214-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Salzgitter Flachstahl GmbH | Functional chrome plating using chromium trioxide in closed reactor systems for the establishment of a ‘conventional’ hard chrome coating on working rolls applied in the steel industry for the pre-manufacturing of cold-rolled, high-quality textured sheet metal | Commission decided | Details |
| 0032-03 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
|
Functional chrome plating with decorative character | Opinions adopted | Details |
| 0095-03 | 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] | Functional chrome plating with decorative character | Opinions adopted | 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 |
| 0131-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Schell GmbH & Co. KG Armaturentechnologie | Functional chrome plating with decorative character for sanitary applications | Commission decided | Details |
| 0130-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Dornbracht AG & Co. KG [name of applicant in the original application: Aloys F. Dornbracht GmbH & Co.KG updated due to a notified change of corporate name] | Functional chrome plating with decorative character for sanitary applications | Commission decided | Details |
| 0220-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | SRG Global Ibi, S.L. | Functional chrome plating with decorative character for transportation 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 |
| 0268-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Rubinetteria Paffoni S.p.A. | Functional chrome plating with decorative character of metal substrates for sanitary applications | Opinions adopted | Details |
| 0053-01 | Initial | Chromic acid |
231-801-5 236-881-5 |
13530-68-2 7738-94-5 |
Robert Bosch GmbH | Hard chrome plating for gasoline and diesel injection applications | Commission decided | Details |
| 0186-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Beckman Coulter Ireland Inc. | In-process production use of OPnEO as a washing buffer used in the coating of in vitro diagnostic immunoassay particles. | Commission decided | Details |
| 0126-01 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | AVX NI [application transferred from: "AVX Limited" due to a notified legal entity change] | Industrial use in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors. | 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 |
| 0012-04 | 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] | Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.) | Commission decided | Details |
| 0012-03 | 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] | Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.) | 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 |
| 0128-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
Doosan Electro-Materials Luxembourg SARL Volta Energy Solutions Hungary Kft [name of applicant in the original application: Doosan Energy Solution Kft updated due to a notified corporate name change] |
Industrial formulation of a chromium trioxide solution below 0.1% w/w concentration for the passivation of copper foil used in the manufacture of Lithium Ion Batteries (LiB) for motorised vehicles | Commission decided | Details |
| 0229-01 | Review report | Chromium trioxide | 215-607-8 | 1333-82-0 | Volta Energy Solutions Hungary Kft | Industrial formulation of a chromium trioxide solution below 0.1% w/w concentration for the passivation of copper foil used in the manufacture of Lithium Ion Batteries (LiB) for motorised vehicles | Opinions adopted | Details |
| 0360-03 | Initial | 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate | 239-622-4 | 15571-58-1 | Galata Chemicals GmbH; REAGENS SPA; PMC Vlissingen Netherlands B.V. | Industrial manufacture of PVC articles through extrusion, injection, calendering and coating using mixtures containing DOTE as stabilizer | Opinion development | 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 |
| 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 |
| 0265-02 | Initial | Trixylyl phosphate | 246-677-8 | 25155-23-1 | EDF S.A. | Industrial use as a hydraulic fluid in closed systems to drive and control main steam isolation valves | Opinions adopted | Details |
| 0265-01 | Initial | Trixylyl phosphate | 246-677-8 | 25155-23-1 | EDF S.A. | Industrial use as a hydraulic fluid in closed systems to drive and control the steam inlet valves of turbines | Opinions adopted | Details |
| 0021-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Grupa Azoty S.A. | Industrial use as a process chemical in caprolactam purification | Commission decided | Details |
| 0077-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Eli Lilly Kinsale Limited [application transferred from original Applicant: Eli Lilly S.A. - Irish Branch due to a notified legal entity change] | Industrial use as a reaction medium and a solvating agent in mediating subsequent chemical transformation reactions leading to the manufacture of an Active Pharmaceutical Ingredient, Raloxifene Hydrochloride | Commission decided | Details |
| 0060-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as a recyclable solvent and extraction agent in a closed system for purification of 1,3,5-trioxane | Commission decided | Details |
| 0080-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
H&R Ölwerke Schindler GmbH
H&R Chemisch-Pharmazeutische Spezialitäten GmbH |
Industrial use as a solvent and anti-solvent of the feedstock and intermediate product streams in the combined de-waxing and de-oiling of refining of petroleum vacuum distillates for the production of base oils and hard paraffin waxes | Commission decided | Details |
| 0078-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 |
|
Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins | Commission decided | Details |
| 0201-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] | Industrial use as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary In Vitro Diagnostic devices (IVDs) for detecting infectious disease in farm animals. | Commission decided | Details |
| 0167-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott GmbH [name of applicant in the original application: Abbott GmbH & Co. KG updated due to a notified change of corporate name] | Industrial use as a surfactant in the extraction and purification of antigens for incorporation into In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | Commission decided | Details |
| 0167-01 | 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] |
Industrial use as a surfactant in the formulation of In-Vitro Diagnostic Devices (IVDs) for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems. | Commission decided | Details |
| 0167-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Abbott Ireland | Industrial use as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with In-Vitro Diagnostic Devices (IVDs) on ARCHITECT and Alinity automated analyser systems. | Commission decided | Details |
| 0145-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for an Enzyme Replacement Therapy (BMN250) for the treatment of Mucopolysaccharidosis IIIB (MPS IIIB). | Commission decided | Details |
| 0145-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | BioMarin International Limited | Industrial use as a surfactant to perform viral inactivation of biological proteins in the manufacture of a biopharmaceutical Final Bulk Drug Substance (FBDS) for Gene Therapy products for the treatment of rare conditions in the human population. | 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 |
| 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 | 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 |
| 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 |
| 0201-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A. | Industrial use as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs | Commission decided | Details |
| 0020-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | Details |
| 0243-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | DOMO Caproleuna GmbH | Industrial use as an extraction solvent for the purification of caprolactam from caprolactam oil | Commission decided | Details |
| 0191-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Sekisui S-lec BV Roermond | Industrial use as polymer additive in the manufacture of interlayer polymer films for laminated safety glass | Commission decided | Details |
| 0024-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | SAFECHEM Europe GmbH [application transferred from original Applicant: "Blue Cube Germany Assets GmbH & Co. KG” due to a notified legal entity change] | Industrial use as process chemical (enclosed systems) in Alcantara Material production | Commission decided | Details |
| 0076-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF plc - [Decision discontinued as of 01/01/2021; application transferred from original Applicant: BASF SE due to a notified legal entity change] | Industrial use as solvent and crystallisation medium in the synthesis of the EU biocide flocoumafen (ISO) | Discontinued as of 01 January 2021 | Details |
| 0076-01 | Initial | 1,2-dichloroethane (EDC) | 203-458-1 | 107-06-2 | BASF SE | Industrial use as solvent and crystallisation medium in the synthesis of the EU pesticide bentazone (ISO) | Commission decided | Details |
| 0201-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Zoetis Belgium S.A.; Aguettant Diagnostics [name of co-applicant in the original application: “Delpharm Biotech” updated due to a notified corporate name change] | Industrial use in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary In Vitro Diagnostic devices (IVDs) used for detecting certain diseases in pets and farm animals | Commission decided | Details |
| 0003-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0004-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0002-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] | Withdrawn | Details |
| 0083-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives | Commission decided | Details |
| 0224-01 | Review report | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | EURENCO | Industrial use of 1,2-Dichloroethane as a solvent for the synthesis of Polyepichlorohydrin used as a precursor in the production of Glycidyl Azide Polymer, an oligomer with hydroxyl terminations used to increase the energetic performance of propellants and explosives. | Commission decided | Details |
| 0082-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Cytiva Sweden AB [name of applicant in the original application: GE Healthcare Bio-Sciences AB updated due to a notified change of corporate name] | Industrial use of 1,2-dichloroethane as an emulsifying solvent in the manufacture of porous particles for beaded chromatography and cell culture media. | 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 |
| 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 |
| 0246-01 | Initial | 2,2'-dichloro-4,4'-methylenedianiline (MOCA) | 202-918-9 | 101-14-4 | Courbis Synthèse Annovi S.r.l.; Dansk Elastomer A/S; Durlast S.r.l.; Pieffe S.r.l.; Policart S.r.l.; R.B.M. Italia S.r.l.; Tecnocaucho S.A.; Tegea S.r.l.; Optibelt Urethane Belting Ltd.; Productos Salinas S.A.; V.M. SPA | Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of hot cast polyurethane products | Commission decided | Details |
| 0240-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Alexion Pharma International Operations Unlimited Company | Industrial use of 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated for virus inactivation in the manufacture Andexanet alfa for treatment of adult patients treated with a direct factor Xa (FXa) inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding | Commission decided | Details |
| 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). | Commission decided | Details |
| 0230-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Safran Landing Systems; SOCIETE DE TRAITEMENTS ELECTROLYTIQUES NORMALISES S.T.E.N. | Industrial use of 4-NPnEO as non-reactive surfactant in the sealing product in sulfuric acid anodization process of aluminium alloy parts of aircraft landing gears | Withdrawn | Details |
| 0142-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | SEBIA | Industrial use of 4-NPnEO for its detergent properties in the production of buffers and reagents in view of ensuring the positioning of specific proteins necessary for the interpretation of gel electrophoresis in vitro diagnostic tests results based on the determination of isoenzymes. | Commission decided | Details |
| 0180-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Bio-Rad | Industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Commission decided | Details |
| 0204-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Biokit S.A. | Industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA In-Vitro-Diagnostic kits. | Commission decided | Details |
| 0183-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGAST | Industrial use of 4-tert-OPnEO for its amphiphilic, surfactant and non-haemolytic properties, to create controlled hydrophilic spots on porous hydrophobic membranes (solid form) for in vitro diagnostic kits for blood testing via antigen/antibody reaction in the following product ranges: ABTest Card®, ABD PAD® and M-TRAP® cartridges for the ONYX® system. | Commission decided | Details |
| 0140-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | DIAGNOSTICA STAGO | Industrial use of 4-tert-OPnEO for its detergent properties in the process of cell lysing for the production of in-vitro diagnostic reagents (Asserachrom® HPIA, Asserachrom® HPIA–IgG and Asserachrom® PF4 and STA®-Néoplastine® R15 assays). | Commission decided | Details |
| 0141-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties in the production of electrophoresis gels in view of ensuring the positioning of specific proteins necessary for the interpretation of results of gel electrophoresis in vitro diagnostic tests. | Commission decided | Details |
| 0141-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | SEBIA | Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests. | Commission decided | Details |
| 0180-04 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications | Commission decided | Details |
| 0143-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its detergent properties, used for the extraction of biological material which is further formulated and intended for clinical and industrial in vitro testing applications. | Commission decided | Details |
| 0143-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of reagents for molecular clinical and industrial in vitro preparative and testing applications. | Commission decided | Details |
| 0180-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections | Commission decided | Details |
| 0179-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, consisting in the filling of 4-tert-OPnEO-containing solutions into specific single-use ampoules to be included in clinical and industrial in vitro testing applications as part of the BioFire and BioFire Next Gen FA products. | Commission decided | Details |
| 0349-01 | Review report | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent properties, used for the extraction of biological material which is further formulated and coated on articles intended for clinical and industrial in vitro testing applications | Opinion development | Details |
| 0180-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Bio-Rad | Industrial use of 4-tert-OPnEO for its non-ionic detergent property in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles | Commission decided | Details |
| 0143-02 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | bioMérieux SA | Industrial use of 4-tert-OPnEO for its non-ionic detergent to control the level of non-specific reactions in the formulation of in vitro reagents for clinical and industrial in vitro testing immunoassays. | Commission decided | Details |