7 Authorisations granted for 4-tert-OPnEO

On 20-21 October 2022, the European Commission granted 7 Authorisations for the following substance:

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

The Authorisations are held by 6 companies and concern 7 Authorised uses:

1. Authorisation number REACH/22/33/0 is held by Merck Biodevelopment SAS, and approves the use of 4-tert-OPnEO as a detergent in the purification process of G-CSF (Granulocyte Colony Stimulating Factor) inclusion bodies.

2. Authorisation number REACH/22/34/0 is held by Merck KGaA, and approves the use of 4-tert-OPnEO as raw material for the manufacturing of GMP Triton® X-100 Emprove® Expert in accordance with International Pharmaceutical Excipients Council Europe standards.

3. Authorisation number REACH/22/35/0 is held by Lonza Biologics Porriño SL, and approves the use of 4-tert-OPnEO for virus inactivation via solvent/detergent treatment in the manufacture of recombinant medicinal active pharmaceutical ingredients (APIs) from mammalian cell cultures.

4. Authorisation number REACH/22/36/0 is held by Teva Baltics UAB, and approves the use of 4-tert-OPnEO as a non-ionic surfactant for microbial cells disruption and washing of inclusion bodies in biological drug substance manufacturing process.

5. Authorisation number REACH/22/37/0 is held by Roche Diagnostics GmbH, and approves the use of 4-tert-OPnEO as emulsifier in the siliconisation of glass containers used as primary packaging for medicinal products (NeoRecormon® and MIRCERA®).

6. Authorisation number REACH/22/39/0 is held by Wallac Oy, and approves the use of 4-tert-OPnEO for formulation into enhancement solutions and DELFIA standard and maintenance solutions used in In Vitro Diagnostic assays and RUO products as well as maintenance of instruments as a critical ingredient for detection process while measuring europium (or other lanthanide) content of the assay solution.

7. Authorisation number REACH/22/39/1 is held by Wallac Oy, and approves the use of 4-tert-OPnEO in enhancement solutions and DELFIA standard and maintenance solutions as a critical ingredient for detection process while measuring europium (or other lanthanide) content in In Vitro Diagnostic assays and RUO products or during maintenance of instruments.