Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
Autoriseerimistaotluste teemalised vastuvõetud arvamused ja eelnevad arutelud
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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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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0248-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | FYSOL SAS [name of applicant in the original application: OCV Chambéry France S.A.S. updated due to a notified legal entity change] | Mixing by the Applicant of a NPnEO-containing epoxy resin, resulting in mixtures containing < 0.1% w/w of NPnEO for the manufacture of glass fiber articles for critical composite helicopter parts, that is exempt from authorisation under REACH Art. 56(6)(a) | Commission decided | Details |
0207-01 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Chemetall GmbH; Chemetall PLC - [Application void as of 01/01/2021] | The formulation of a hardener component containing NPE in Aerospace two-part polysulphide sealants. | Commission decided | Details |
0200-08 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | QIAGEN GmbH; QIAGEN Ltd. [Application void as of 01/01/2021]; QIAGEN Manchester Ltd. [Application void as of 01/01/2021]; QIAGEN Distribution B.V. | Professional downstream use of 4-tert-OPnEO/4-NPnEO in the purification of biomaterial and blocking of non-specific bindings for Life Sciences kits without regulatory impact of the product groups sample preparation, PCR and sequencing | Commission decided | Details |
0317-01 | Initial | Acids generated from chromium trioxide and their oligomers | - | - | Micron srl | Dilution of chromic acid solution at concentrations lower than 0.1% for the use in passivation baths | Opinions adopted | Details |
0106-02 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 | Display Technologies Limited - [Decision discontinued as of 01/01/2021] | Industrial use of Ammonium Dichromate in the process of manufacturing Cathode Ray Tubes for head up displays intended to be used in military and civilian aircrafts | Discontinued as of 01 January 2021 | 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 |
0049-01 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 | Micrometal GmbH | The use of Ammonium dichromate (ADC) as a photosensitizer for production of micro components | Commission decided | Details |
0106-01 | Initial | Ammonium dichromate | 232-143-1 | 7789-09-5 |
BAE Systems (Operations) Limited – [Decision discontinued as of 01/01/2021] Qioptiq Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of Ammonium Dichromate in the process of manufacturing holographic combiners for diffractive head-up displays intended to be used in military aircrafts | Discontinued as of 01 January 2021 | 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 |
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 |
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 |
0059-01 | Initial | Arsenic acid | 231-901-9 | 7778-39-4 | CIRCUIT FOIL LUXEMBOURG SARL | Industrial use of arsenic acid for the treatment of copper foil used in the manufacture of Printed Circuit Board | 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 |
0352-01 | Initial | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Baxter SA; Baxter Healthcare SA; Gambro Dasco SpA; Baxter (Malta) Trading Co Ltd; Colorite Europe Ltd. | Formulation of DEHP mixtures for application in immediate packaging of medicines and medical devices | 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 |
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 |
0004-03 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Industrial use of DEHP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements | Withdrawn | 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 |
0001-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Rolls-Royce plc – [Decision discontinued as of 01/01/2021] | The processing of a stop-off formulation containing DEHP during the diffusion bonding and manufacture of aero engine fan blades. | Discontinued as of 01 January 2021 | Details |
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 |
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 |
0002-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | ARKEMA FRANCE | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | Details |
0007-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Roxel (UK Rocket Motors) Ltd | Industrial use of DEHP in manufacture of solid propellants and motor charges for rockets and tactical missiles | Authorisation expired | Details |
0008-02 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | VINYLOOP FERRARA S.p.A.; Stena Recycling AB; Plastic Planet srl | Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles | Authorisation expired | Details |
0003-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | Grupa Azoty Zakłady Azotowe Kędzierzyn S.A. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | Details |
0004-01 | Initial | Bis(2-ethylhexyl) phthalate (DEHP) | 204-211-0 | 117-81-7 | DEZA a.s. | Formulation of DEHP in compounds, dry-blends and Plastisol formulations | Withdrawn | 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
0235-01 | Initial | Chromic acid | 231-801-5 | 7738-94-5 | Neoperl GmbH | The use of chromic acid in the functional electroplating of brass-made sanitary articles with the specific purpose of obtaining a final Cr(0) coating that provides a surface with high durability and chemical resistance. | Opinions adopted | Details |
0100-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Airbus Helicopters Technik GmbH [name of applicant in the original application: “ZF Luftfahrttechnik GmbH” updated due to a notified corporate name change] | Surface treatment for applications in the aeronautics and aerospace industries (unrelated to Functional chrome plating or Functional chrome plating with decorative character) | Commission decided | Details |
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 |
0070-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
FN HERSTAL S.A. MANROY ENGINEERING LTD – [Decision discontinued as of 01/01/2021] |
Industrial use of chromium trioxide in the hard chromium coating of military small- and medium-caliber firearms barrel bores and auxiliary parts subject to thermal, mechanical and chemical stresses, in order to provide hardness, heat resistance and thermal barrier properties, as well as corrosion resistance, adhesion and low friction properties | Commission decided | Details |
0300-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | WEBER-HYDRAULIK GMBH | Chromium trioxide-based functional chrome plating of solid and hollow piston rods for hydraulic applications | Opinions adopted | Details |
0032-06 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 |
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Passivation of tin-plated 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 |
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 |
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 |
0309-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Cromatura Staff Srl | Industrial use of chromium trioxide for the plating of brass valves destined for applications involving industrial and technical fluids and brass fittings for oxygen cylinders | Opinions adopted | Details |