20 Authorisations granted for 2 substances

On 30 June-1 August 2023, the European Commission granted 20 Authorisations for the following substances:

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

2. 4-Nonylphenol, branched and linear, ethoxylated (4-NPnEO)

The Authorisations are held by 6 companies and concern 17 Authorised uses:

1. Authorisation number REACH/23/12/0 is held by Siemens Healthcare Diagnostics Products GmbH, and approves the use of 4-tert-OPnEO in isolation of protein from recombinant cell cultures for the production of IVD kits (protein cell extraction).

2. Authorisation number REACH/23/12/1 is held by Siemens Healthcare Diagnostics Products GmbH, and approves the use of 4-tert-OPnEO in formulation of IVD kit reagents.

3. Authorisation number REACH/23/12/2 is held by Siemens Healthcare Diagnostics Products GmbH, and approves the use of 4-tert-OPnEO in formulation of IVD-wash solutions.

4. Authorisation number REACH/23/12/3 is held by Siemens Healthcare Diagnostics Products GmbH, and approves the use of 4-tert-OPnEO in IVD-kit reagents on diagnostic analyser systems.

5. Authorisation number REACH/23/12/4 is held by Siemens Healthcare Diagnostics Products GmbH, and approves the use of 4-tert-OPnEO in IVD-wash solutions on diagnostic analyser systems.

6. Authorisation numbers REACH/23/13/0, REACH/23/13/1, REACH/23/13/2, REACH/23/13/3, REACH/23/13/4, REACH/23/13/5, and REACH/23/13/6 are held by ABBOTT Ireland, ABBOTT GmbH, and ABBOTT Diagnostics GmbH, and approve the industrial use of 4-tert-OPnEO as a surfactant in the formulation of in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems; the professional use of 4-tert-OPnEO as a surfactant in the final use of in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems; the industrial use of 4-tert-OPnEO as a surfactant in the formulation of system solutions (Pre-Trigger and Trigger), for use with in-vitro diagnostic devices on ARCHITECT and Alinity automated analyser system; and the industrial use of 4-tert-OPnEO as a surfactant in the extraction and purification of antigens for incorporation into in-vitro diagnostic devices for clinical testing using ARCHITECT, Alinity and ABBOTT PRISM automated analyser systems.

7. Authorisation number REACH/23/14/0 is held by Biokit S.A., and approves the industrial use of 4-tert-OPnEO as a detergent in the preparation of reagents for incorporation into latex-based, ELISA and CLIA in-vitro-diagnostic kits.

8. Authorisation number REACH/23/14/1 is held by Biokit S.A., and approves the professional use of 4-tert-OPnEO as a detergent during the final use of latex-based, ELISA and CLIA in-vitrodiagnostic kits.

9. Authorisation number REACH/23/16/0 is held by Roche Diagnostics GmbH, and approves the use of 4-tert-OPnEO in the formulation and filling of in vitro diagnostic (IVD) assays as specified in Table 1 of the Annex.

10. Authorisation number REACH/23/16/1 is held by Roche Diagnostics GmbH, and approves the use of 4-NPnEO in the formulation and filling of in vitro diagnostic (IVD) assays as specified in Table 1 of the Annex.

11. Authorisation number REACH/23/16/2 is held by Roche Diagnostics GmbH, and approves the use of 4-tert-OPnEO in in vitro diagnostic (IVD) assays as specified in Table 2 of the Annex.

12. Authorisation number REACH/23/16/3 is held by Roche Diagnostics GmbH, and approves the use of 4-NPnEO in in vitro diagnostic (IVD) assays as specified in Table 2 of the Annex.

13. Authorisation number REACH/23/16/4 is held by Roche Diagnostics GmbH, and approves the use of 4-tert-OPnEO in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other analytical applications, as specified in Table 3 of the Annex.

14. Authorisation number REACH/23/16/5 is held by Roche Diagnostics GmbH, and approves the use of 4-NPnEO in the production of proteins and the conjugation of latex beads, both being used as components or for the production of components of in vitro diagnostic (IVD) assays, research or quality control products and other analytical applications, as specified in Table 3 of the Annex.