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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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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| 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 |
| 0115-01 | Initial | Potassium chromate | 232-140-5 | 7789-00-6 | Saes Getters S.p.A. | Use of potassium chromate in the fabrication of alkali metal dispensers 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 |
| 0115-02 | Initial | Sodium chromate | 231-889-5 | 7775-11-3 | Saes Getters S.p.A. | Use of sodium chromate in the fabrication of alkali metal dispensers for production of photocathodes. | Commission decided | Details |
| 0303-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Rubinetterie Stella S.p.A | Electroplating of metal substrates using chromium trioxide to achieve functional surfaces for the sanitary sector | Opinions adopted | Details |
| 0277-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Rubinetterie Ritmonio Srl | 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 | Details |
| 0269-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RUBINETTERIE 3M SRL | 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 | 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 |
| 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 |
| 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 |
| 0007-02 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Roxel (UK Rocket Motors) Ltd | Industrial use of DBP in manufacture of solid propellants and motor charges for rockets and tactical missiles | Authorisation expired | Details |
| 0007-03 | Initial | Dibutyl phthalate (DBP) | 201-557-4 | 84-74-2 | Roxel (UK Rocket Motors) Ltd | Industrial use of DBP within a specialty paint in manufacture of motors for rockets and tactical missiles | Authorisation expired | 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 |
| 0227-01 | Review report | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | Details |
| 0018-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | ROQUETTE Frères | Use of trichloroethylene as a processing aid in the biotransformation of starch to obtain betacyclodextrin | Commission decided | 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 |
| 0160-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octylphenolethoxylates as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®). | Commission decided | Details |
| 0171-03 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 0171-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 0171-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) | Commission decided | Details |
| 0171-02 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the formulation and filling of in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | Commission decided | Details |
| 0171-06 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other, e.g. analytical applications (processes specified in Appendix 1 to the AoA) | Commission decided | Details |
| 0171-04 | Initial | 4-Nonylphenol, branched and linear, ethoxylated | - | - | Roche Diagnostics GmbH | Use of Octyl- and Nonylphenolethoxylates in in vitro diagnostic (IVD) assays specified in Appendix 1 to the AoA. | 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 |
| 0236-01 | Initial | Sodium dichromate | 234-190-3 |
7789-12-0 10588-01-9 |
Robur S.p.A | Use of sodium dichromate as an anticorrosion agent of the carbon steel in sealed circuit of gas absorption appliances up to 1.05% w/w (corresponding to 0.42% w/w as Cr VI) in the refrigerant solution | 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 |
| 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 |
| 0272-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RIGHI S.p.A. | Electroplating of metal substrates using chromium trioxide to achieve functional surfaces for the sanitary sector | Opinions adopted | Details |
| 0026-02 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Richard Geiss GmbH | Use of tricholoroethylene in packaging | Commission decided | Details |
| 0026-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | Richard Geiss GmbH | Use of tricholoroethylene in formulation | 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 |
| 0095-04 | 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] | Surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering | Commission decided | 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 |
| 0095-01 | 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] | Formulation of mixtures of chromium trioxide for functional chrome plating, functional chrome plating with decorative character and surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering | Commission decided | 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 |
| 0094-01 | Initial | 2,2'-dichloro-4,4'-methylenedianiline (MOCA) | 202-918-9 | 101-14-4 | REACHLaw Ltd in its legal capacity as Only Representative of Suzhou Xiangyuan Special Fine Chemical Co., Ltd | Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production | Withdrawn | Details |
| 0254-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RATIER-FIGEAC | Industrial use of chromium trioxide for functional chrome plating of aircraft safety critical steel ball screws used in airplane's actuators, to decrease friction ratio, and enhance wear, corrosion, and endurance resistance, enabling targeted service life | Opinions adopted | Details |
| 0254-02 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | RATIER-FIGEAC | Industrial use of chromium trioxide for the chromic acid anodizing of aluminium spars as critical surface preparation phase for bonding with aircraft safety critical propeller blades to secure reliable bonding performance and enhance spars corrosion resistance | Opinions adopted | Details |
| 0121-02 | Initial | Pentazinc chromate octahydroxide | 256-418-0 | 49663-84-5 | Ramboll Belgium BVBA [application transferred from: “Indestructible Paint Ltd.” due to a notified legal entity change] | Use of pentazinc chromate octahydroxide in stoved epoxy primer for corrosion protection of aircraft engine components in aerospace and aeroderivative applications | Commission decided | Details |
| 0363-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | Ramboll Belgium BVBA (Indestructible Paints) | Treatment of components used in industrial gas turbines and associated components using slurry coating products containing chromium trioxide to enhance corrosion resistance, chemical resistance, high temperature oxidation resistance, adhesion to components which produce a smooth finish and enhance the technical performance of turbines. | Opinion development | 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 |
| 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 |
| 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 |
| 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 |
| 0027-01 | Initial | Trichloroethylene | 201-167-4 | 79-01-6 | RAG Aktiengesellschaft, RAG Anthrazit Ibbenbüren GmbH | Use of Tricholoroethylene-containing vulcanising and bonding agents for endless connections and repair of chloroprene rubber coated conveyor belts in underground hard coal mining | Authorisation expired | Details |
| 0081-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Rafineria Gdańska Sp. z o.o. [name of applicant in the original application: GRUPA LOTOS S.A. updated due to a notified legal entity change] | Use as an extraction solvent in the de-waxing of petroleum vacuum distillates and de-asphalted oil and de-oiling of slack wax for the production of base oils and paraffinic waxes. | Commission decided | Details |
| 0257-01 | Initial | Chromium trioxide | 215-607-8 | 1333-82-0 | QUALIPAC Aurillac; Etablissements R.GRAINDORGE | Industrial use of chromium trioxide for the etching of polypropylene (PP) substrates, as a pre-treatment step of the electroplating process, for the luxury sector and other applications | Opinions adopted | Details |
| 0200-05 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | QIAGEN GmbH; STAT-Dx Life S.L.; 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 the use in in-vitro Diagnostic and Life Sciences kits with regulatory impact of the product groups sample preparation, PCR, sequencing (and immunoassay for 4-tert-OPnEO only) | Commission decided | Details |
| 0200-01 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated | - | - | QIAGEN GmbH; STAT-Dx Life S.L. | Formulation and filling of buffer solutions containing 4-tert-OPnEO/4-NPnEO for the manufacturing of and use in in-vitro Diagnostic and Life Sciences kits of the product groups sample preparation, PCR and sequencing | Commission decided | Details |
| 0200-07 | Initial | 4-(1,1,3,3-tetramethylbutyl)phenol, 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 |