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Document 52022XC1028(04)
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) 2022/C 414/03
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) 2022/C 414/03
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) 2022/C 414/03
C/2022/7399
OJ C 414, 28.10.2022, p. 40–40
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
28.10.2022 |
EN |
Official Journal of the European Union |
C 414/40 |
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)
(2022/C 414/03)
Decision granting an authorisation
Reference of the decision (2) |
Date of decision |
Substance name |
Holder(s) of the authorisation |
Authorisation number |
Authorised use |
Date of expiry of review period |
Reasons for the decision |
C(2022) 7399 |
21 October 2022 |
4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) EC No: -, CAS No:- |
Roche Diagnostics GmbH, Sandhoferstrasse 116, 68305 Mannheim, Germany |
REACH/22/37/0 |
Emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®) |
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 uses 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).