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Document 52023XC0303(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) 2023/C 80/05
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) 2023/C 80/05
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) 2023/C 80/05
C/2023/1181
OJ C 80, 3.3.2023, p. 53–53
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
3.3.2023 |
EN |
Official Journal of the European Union |
C 80/53 |
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)
(2023/C 80/05)
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(2023) 1181 |
24 February 2023 |
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (‘4-tert-OPnEO’) EC No.-; CAS No.- |
Pfizer Ireland Pharmaceuticals, Ringaskiddy, Cork, Ireland |
REACH/23/7/0 |
Surfactant in the manufacture of biopharmaceuticals, as a processing aid in viral inactivation and associated purification processes |
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. |
|
REACH/23/7/1 |
Surfactant in the manufacture of biopharmaceuticals for filter cleaning in viral inactivation processes |
4 January 2028 |
(1) OJ L 396, 30.12.2006, p. 1.
(2) The decision is available on the European Commission website at: Authorisation (europa.eu).