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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.
Related links
| 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 |
| 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 |
| 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 |
| 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 |
| 0232-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | Monroe Czechia s.r.o. | Use of dichromium tris(chromate) in a post-treatment step of the autodeposition coating process of shock absorbers for automotive vehicles. | Opinions adopted | Details |
| 0045-02 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 |
Henkel AG & Co. KGaA Henkel Global Supply Chain B.V. |
Use of dichromium tris(chromate) for surface treatment of metals such as aluminium, steel, zinc, magnesium, titanium, alloys, composites, sealings of anodic films. | Commission decided | Details |
| 0116-01 | Initial | Dichromium tris(chromate) | 246-356-2 | 24613-89-6 | HAAS GROUP INTERNATIONAL SP. Z.O.O [application transferred from: “Wesco Aircraft EMEA, LTD (UK)” due to a notified legal entity change] | Use of dichromium tris(chromate) for chemical conversion coating applications by aerospace and defence companies and their associated supply chains | Commission decided | Details |
| 0009-01 | Initial | Diarsenic trioxide | 215-481-4 | 1327-53-3 | Boliden Kokkola Oy | Use of diarsenic trioxide in the purification of metal impurities from the leaching solution in the zinc electrowinning process | 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 |
| 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 |