EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52022XC0419(02)
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 163/05
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 163/05
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 163/05
C/2022/2191
OJ C 163, 19.4.2022, p. 5–5
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
19.4.2022 |
EN |
Official Journal of the European Union |
C 163/5 |
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 163/05)
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(2022) 2191 |
11 April 2022 |
4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) EC No: -, CAS No:- |
Hospira Zagreb d.o.o., a Pfizer company, Prudnicka cesta 60, 10291 Prigorje Brdovecko, Croatia |
REACH/22/23/0 |
As a surfactant in the manufacture of one biopharmaceutical protein, a biosimilar product, used to prevent infection and neutropenic fevers |
4 January 2033 |
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)