# C_2022130EN.01000901.xml

| 23.3.2022 | EN | Official Journal of the European Union | C 130/9 |
| --- | --- | --- | --- |

23.3.2022

EN

Official Journal of the European Union

C 130/9

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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

| 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 |

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

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(1)  OJ L 396, 30.12.2006, p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu).

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