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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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

 

There are currently no ongoing consultations.
 
0360-03 Initial 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate 239-622-4 15571-58-1 Galata Chemicals GmbH; REAGENS SPA; PMC Vlissingen Netherlands B.V. Industrial manufacture of PVC articles through extrusion, injection, calendering and coating using mixtures containing DOTE as stabilizer Opinion development Details
0360-02 Initial 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate 239-622-4 15571-58-1 Galata Chemicals GmbH; REAGENS SPA; PMC Vlissingen Netherlands B.V. Formulation of PVC dry mixtures (granules and pellets) containing DOTE Opinion development Details
0360-01 Initial 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate 239-622-4 15571-58-1 Galata Chemicals GmbH; REAGENS SPA Formulation of liquid mixtures containing DOTE Opinion development 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
0246-01 Initial 2,2'-dichloro-4,4'-methylenedianiline (MOCA) 202-918-9 101-14-4 Courbis Synthèse Annovi S.r.l.; Dansk Elastomer A/S; Durlast S.r.l.; Pieffe S.r.l.; Policart S.r.l.; R.B.M. Italia S.r.l.; Tecnocaucho S.A.; Tegea S.r.l.; Optibelt Urethane Belting Ltd.; Productos Salinas S.A.; V.M. SPA Industrial use of 2,2'-Dichloro-4,4'-methylenedianiline (MOCA) in the manufacture of hot cast polyurethane products 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
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 Nouryon Chemicals SPA [name of the applicant in the original application: Akzo Nobel Chemicals SpA updated due to a change of corporate name] The use of 1,2-dichloroethane as recyclable solvent in the production of a polyacrylate surfactant 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