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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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.

ID	Application type	Name	EC Number	CAS Number	Applicant(s)	Use name	Status
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
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
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
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
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
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
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	Opinion development
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
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
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

Showing 181 - 190 of 486 results.

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