6 Authorisations granted for 4-tert-OPnEO

On 27 October 2022, the European Commission granted 6 Authorisations for the following substance:

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

The Authorisations are held by 2 companies and concern 4 Authorised uses:

1. Authorisation numbers REACH/22/41/0 and REACH/22/41/1 are held by Zoetis Belgium S.A. and Delpharm Biotech respectively, and approve the industrial use of 4-tert-OPnEO as a surfactant in a lysis buffer for the release of proteins and antigens from biological material used in the manufacture of three SERELISA veterinary in vitro diagnostic devices for detecting infectious disease in farm animals.

2. Authorisation numbers REACH/22/41/2 and REACH/22/41/3 are held by Zoetis Belgium S.A. and Delpharm Biotech respectively, and approve the industrial use of 4-tert-OPnEO in formulation of kits, kit reagents and buffer solutions in two WITNESS and three SERELISA veterinary in vitro diagnostic devices used for detecting certain diseases in pets and farm animals.

3. Authorisation number REACH/22/41/4 is held by Zoetis Belgium S.A., and approves the professional use of 4-tert-OPnEO as a surfactant in kits, kit reagents and buffer solutions in 18 veterinary in vitro diagnostic devices including one SERELISA, six ProFLOK, six WITNESS and five VetScan, in diagnostic laboratories and veterinary clinics for detecting certain diseases in pets and farm animals.

4. Authorisation number REACH/22/41/5 is held by Zoetis Belgium S.A., and approves the industrial use of 4-tert-OPnEO as a viral inactivating agent in the manufacture of two veterinary biologic drugs for treatment of osteoarthritis in cats and dogs.