6 Authorisations granted for 2 substances

On 20 March 2023, the European Commission granted 6 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 2 companies and concern 6 Authorised uses:

1. Authorisation number REACH/23/8/0 is held by Becton Dickinson Distribution Center NV, and approves the use of 4-tert-OPnEO as a processing aid for specific processes in diagnostic instruments or in laboratory activities, as listed in the Annex.

2. Authorisation number REACH/23/9/0 is held by Bio-Rad, and approves the industrial use of 4-tert-OPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections.

3. Authorisation number REACH/23/9/1 is held by Bio-Rad, and approves the industrial use of 4-NPnEO for its non-ionic detergent properties in view of controlling reactions and chromatography support saturation required in the production of highly specific and sensitive in vitro immunoassays dedicated to the diagnosis of viral (HIV, HCV, Dengue) and parasitic infections.

4. Authorisation number REACH/23/9/2 is held by Bio-Rad, and approves the industrial use of 4-tert-OPnEO for its non-ionic detergent properties in the formulation of in vitro reagents dedicated to high-performance microbiological and immunological assays supported on microplates or magnetic particles.

5. Authorisation number REACH/23/9/3 is held by Bio-Rad, and approves the industrial use of 4-tert-OPnEO for its detergent properties used for extraction, viral inactivation and purification of biological material further formulated and /or coated on articles intended for IVD applications.

6. Authorisation number REACH/23/9/4 is held by Bio-Rad, and approves the industrial use of raw material containing 4-tert-OPnEO for protein stabilization for veterinary in vitro diagnostic application.