16 Authorisations granted for 4-tert-OPnEO

On 4-6 January 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 9 companies and concern 5 Authorised uses:

1. Authorisation numbers REACH/22/40/0, REACH/22/40/1, REACH/22/40/2, REACH/22/40/3, and REACH/22/40/4 are held by PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc., Sealants Europe SAS, PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd., Boeing Distribution, Inc., and Haas Group International SP. Z.O.O. respectively, and approve the use of 4-tert-OPnEO for formulation of a hardener component containing 4-tert-OPnEO in aerospace and defence two-part polysulphide sealants.

2. Authorisation numbers REACH/22/40/5, REACH/22/40/6, REACH/22/40/7, REACH/22/40/8, and REACH/22/40/9 are held by PPG Europe B.V. in its legal capacity as Only Representative of PRC DeSoto International Inc., Sealants Europe SAS, PPG Europe B.V. in its legal capacity as Only Representative of PPG Industries (UK) Ltd., Boeing Distribution, Inc., and Haas Group International SP. Z.O.O. respectively, and approve the use of 4-tert-OPnEO for mixing of base polysulfide sealant components with 4-tert-OPnEO-containing hardener, resulting in mixtures containing less than 0.1 % w/w of 4-tert-OPnEO for aerospace and defence uses that are exempt from authorisation under REACH Article 56(6), point (a), in the aerospace and defence sector and associated supply chains.

3. Authorisation numbers REACH/22/44/0 and REACH/22/44/1 are held by Lilly France and Eli Lilly Italia S.p.A. respectively, and approve the use of 4-tert-OPnEO for industrial formulation (dilution) of a silicone solution containing 4-tert-OPnEO and its subsequent use as a lubricant in the manufacture of medicinal product delivery devices.

4. Authorisation numbers REACH/22/45/0 and REACH/22/45/1 are held by AGC Biologics A/S and AGC Biologics GmbH respectively, and approve the use of 4-tert-OPnEO as a detergent for the inactivation of viruses in the production of therapeutic proteins using mammalian cell hosts.

5. Authorisation numbers REACH/22/45/2 and REACH/22/45/3 are held by AGC Biologics A/S and AGC Biologics GmbH respectively, and approve the use of 4-tert-OPnEO as a detergent during the purification process of recombinant biopharmaceuticals derived from microbial expression hosts I projects where processes have been approved by authorities (where processes are Good Manufacturing Practice compliant).