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 412/08)

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) 7411

20 October 2022

4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated

(4-tert-OPnEO)

EC No: -, CAS No:-

Lonza Biologics Porriño SL, La Relba s/n, 36400 Porriño (Pontevedra), Spain

REACH/22/35/0

Virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures

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.

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

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