Annex XIV REACH updated

In December 2020, a new amendment of the Annex XIV REACH (Regulation (EU) 2020/2160) has been published in the Official Journal.

This new amendment updates the entry 42 concerning the 4-(1,1,3,3 Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) by adding a derogation related to the deadlines of the “latest application date” to introduce an application for authorisation” and of the “sunset date”.

The substance group is used in the diagnosis of COVID-19 and in the production of tools for that purpose. Currently it is used for the production of in-vitro diagnostic kits. The substance group is also used in the development of vaccines to combat COVID-19 and is expected to be used in their production. Furthermore, it cannot be excluded that the substance group is used for the development and the production of active pharmaceutical ingredients and finished dosage forms to combat COVID-19.

Due to the situation of public health emergency, it has been decided to postpone the latest application date and the sunset date set for the substance group with regard to the uses for the research, development and production of medicinal products, medical devices, or accessories to medical devices, including in vitro diagnostic medical devices, for the diagnosis, treatment or prevention of COVID-19 and use in such medical devices or accessories.