On 21 February 2023, the European Commission granted 16 Authorisations for the following substance:

1. 4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO)

The Authorisations are held by 4 companies and concern 3 Authorised uses:

1. Authorisation numbers REACH/23/3/0 and REACH/23/3/1 are held by Takeda Manufacturing Austria AG and Baxalta Belgium Manufacturing SA respectively, and approve the use of 4-tert-OPnEO as a detergent for virus inactivation via solvent or detergent treatment in the recombinant and plasma-derived medicinal products listed in the Annex.

2. Authorisation number REACH/23/4/0 is held by Yposkesi, and approves the use of 4-tert-OPnEO for its non-ionic detergent properties for the cell membrane lysis and viral clearance during the development and manufacturing of viral vectors in medicinal products dedicated to human use (Investigational and Authorized Advanced Therapy Medicinal Product).

3. Authorisation number REACH/23/6/0 is held by Rousselot bvba, and approves the use of 4-tert-OPnEO as a surfactant in the manufacturing of low endotoxin gelatin.