Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006 (1) )

(Text with EEA relevance)

(2019/C 30/06)

Decisions granting an authorisation

Reference of the decision (2)

Date of decision

Substance name

Holder of the authorisation

Authorisation number

Authorised use

Date of expiry of review period

Reasons for the decision

C(2019)53

17 January 2019

1,2-dichloroethane

EC No 203-458-1

CAS No 107-06-2

Bayer Pharma AG, Muellerstr. 178, 13353, Berlin, Germany

REACH/19/10/0

Use of 1,2-dichloroethane 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®

22 November 2029

In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health arising from the use of the substance and there are no suitable alternative substances or technologies in terms of their technical and economic feasibility.

(1) OJ L 396, 30.12.2006, p. 1.

(2) The decision is available on the European Commission website at: http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm