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Document 52022XC0323(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 130/07
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) 2022/C 130/07
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) 2022/C 130/07
C/2022/1506
OJ C 130, 23.3.2022, p. 9–9
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
23.3.2022 |
EN |
Official Journal of the European Union |
C 130/9 |
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 130/07)
Decision granting an authorisation
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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) 1506 |
16 March 2022 |
4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO) EC No: -, CAS No:- |
Octapharma AB, Lars Forssells gata 23, SE-11275 Stockholm, Sweden Octapharma Produktionsgesel schaft Deutschland mbH, Wolfgang- Marguerre-Allee 1, 31832 Springe, Germany Octapharma S.A.S. 72 rue du Maréchal Foch, 67381 Lingolsheim, France |
REACH/22/5/0 REACH/22/5/1 REACH/22/5/2 REACH/22/5/3 |
As detergent for a virus inactivation step (solvent/detergent treatment) during the manufacture of plasma-derived and recombinant medicinal products |
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 uses of the substance and there are no suitable alternative substances or technologies. |
|
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H, Oberlaaer Straße 235, A-1100 Vienna, Austria |
REACH/22/5/4 |
As component of a chromatography column regeneration solution during the manufacture of a recombinant-derived Factor VIII |
4 January 2025 |
(1) OJ L 396, 30.12.2006, p. 1.
(2) The decision is available on the European Commission website at: Authorisation (europa.eu).