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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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
Related links
0274-02 | Initial | Sodium dichromate | 234-190-3 | 10588-01-9 | ArcelorMittal France; ARCELORMITTAL ESPAÑA S.A. | Use of Chromium (VI) Trioxide and Sodium Dichromate for Passivation of Electrolytic Tinplate (ETP) | Opinions adopted | Details |
0041-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Akzo Nobel Pulp and Performance Chemicals AB Akzo Nobel Pulp and Performance Chemicals Oy Akzo Nobel Pulp and Performance Chemicals S.A.S. |
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. | Commission decided | Details |
0072-06 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Souriau sas; TE UK Ltd – [Decision discontinued as of 01/01/2021] |
Industrial use of a mixture containing hexavalent chromium compounds for the conversion of cadmium coated circular and rectangular connectors in order to achieve a higher level of performances than the requirements of international standards as well as to withstand harsh environments and high safety applications (such as in the military, aeronautic, aerospace, mining, offshore and nuclear industries or for the application in safety devices for road vehicles, rolling stock and vessels). | Commission decided | Details |
0040-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
CAFFARO BRESCIA S.r.l | 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 chlorite | Commission decided | Details |
0072-07 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Souriau sas “Amphenol Limited – [Decision discontinued as of 01/01/2021] AMPHENOL SOCAPEX |
Industrial use of a mixture containing hexavalent chromium compounds in conversion coating and passivation of circular and rectangular connectors in order to meet the requirements of international standards and special requirements of industries subject to harsh environments. | Commission decided | Details |
0043-02 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
Brenntag Chemicals Distribution (Ireland) Ltd [application transferred from original Applicant: Brenntag UK Ltd due to a notified legal entity change] Henkel AG & Co. KGaA AD International BV |
Use of Sodium dichromate for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites and sealings of anodic films | Commission decided | Details |
0137-01 | Initial | Sodium dichromate | 234-190-3 |
10588-01-9 7789-12-0 |
SOCIETA' CHIMICA BUSSI S.P.A. | Use of sodium dichromate as an additive for suppressing parasitic reactions and oxygen evolution, pH buffering and cathode corrosion protection in the electrolytic manufacturing of sodium chlorite. | 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 |
0107-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | emp Biotech GmbH | Use as a solvent in manufacture of polymeric particles for pharmaceutical and research purification processes | Commission decided | Details |
0108-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as a process solvent in the manufacture of an Active Pharmaceutical Ingredient: Flecainide acetate | Commission decided | 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 |
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 |
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 |
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 |
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 |
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 |
0109-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Akzo Nobel Chemicals SpA | The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant | Commission decided | Details |
0111-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | OLON Spa | The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient for epirubicin. | Commission decided | Details |
0111-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | OLON Spa | The use of 1,2 dichloroethane (1,2-DCE) as a solvent in the manufacturing of the active pharmaceutical ingredient prednisolone steaglate. | 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 |
0110-01 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | Bayer AG [application transferred from original applicant: Bayer Pharma AG, due to a notified legal entity change] | Use as an industrial solvent in the manufacture of the high-grade pure final intermediate of Iopromide, the Active Pharmaceutical Ingredient for the X-ray contrast medium Ultravist® | 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 |
0108-02 | Initial | 1,2-Dichloroethane (EDC) | 203-458-1 | 107-06-2 | ORGAPHARM | Use as an process solvent in the manufacture of an Active Pharmaceutical Ingredient: Nefopam hydrochloride | 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 |
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 |
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 |
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 |
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 |
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 |
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 |
0217-01 | 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 |
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 |
0278-01 | Review report | Bis(2-methoxyethyl) ether | 203-924-4 | 111-96-6 | PMC ISOCHEM | Use as a process solvent in one step of manufacturing of an active pharmaceutical ingredient used in an anti-protozoal drug | Opinions adopted | 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
0047-01 | Initial | Potassium hydroxyoctaoxodizincatedichromate | 234-329-8 | 11103-86-9 | PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - OR23 [application transferred from original Applicant: “PPG Industries (UK) Ltd” due to a notified change of Only Representative]; Finalin GmbH; PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]; PPG Coatings SA; Boeing Distribution Deutschland GmbH [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name] | Formulation of Mixtures | Commission decided | Details |
0047-02 | Initial | Potassium hydroxyoctaoxodizincatedichromate | 234-329-8 | 11103-86-9 | PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd. - OR23 [application transferred from original Applicant: “PPG Industries (UK) Ltd” due to a notified change of Only Representative]; Finalin GmbH; PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc. [application transferred from original Applicant: “PPG Central (UK) Ltd in its legal capacity as Only Representative of PRC DeSoto International Inc.” due to a notified change of Only Representative]; PPG Coatings SA; Boeing Distribution Deutschland GmbH [name of applicant in the original application: Aviall Services Inc updated due to a notified change of corporate name] | Use of potassium hydroxyoctaoxodizincatedichromate in paints, in primer, sealants, and coatings (including as wash primers) | Commission decided | 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 |
0122-02 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 |
VINYLOOP FERRARA S.p.A. |
Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrials workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. | Withdrawn | 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 |
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 |
0123-02 | Review report | Bis(2-ethylhexyl) phthalate | 204-211-0 | 117-81-7 | Plastic Planet srl | Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrial workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces. | Opinions adopted | Details |