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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

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