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Document 52021XC1116(07)
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 (OJ L 396, 30.12.2006 , p. 1.)) (Text with EEA relevance) 2021/C 463/16
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 (OJ L 396, 30.12.2006 , p. 1.)) (Text with EEA relevance) 2021/C 463/16
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 (OJ L 396, 30.12.2006 , p. 1.)) (Text with EEA relevance) 2021/C 463/16
C/2021/7884
OJ C 463, 16.11.2021, p. 17–17
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
16.11.2021 |
EN |
Official Journal of the European Union |
C 463/17 |
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)