Publicat în Jurnalul Oficial C nr. 463 din 16-11-2021

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)

(2021/C 463/16)

Decision 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(2021) 7884

9 November 2021

4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated

(4-tert-OPnEO)

EC No: -, CAS No:-

Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany

REACH/21/9/0

As emulsifier in the siliconisation of glass containers used as primary packaging for two specific medicinal products (NutropinAq® and Lucentis®) of one pharmaceutical company.

4 January 2026

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


(1)  OJ L 396, 30.12.2006 , p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)