Due to the COVID crisis, Commission Regulation (EU) 2020/2160 of 18 December 2020 extended the permission of using Octylphenol ethoxylate (Triton-X-100) in medical devices, in-vitro diagnostic medical devices and their accessories for the diagnosis, treatment or prevention of COVID-19. However, its use will become restricted on December 22, 2023.
Manufacturers that are intending to include octylphenol ethoxylate (Triton-X-100) in their COVID-19 devices after 22 December 2023 are requested to:
- Apply for an authorization to ECHA at least 18 months in advance, i.e., by 22 June 2022.
However, it is highly advised to:
- Notify ECHA already 6 months prior to the latest application date about their intention to apply for authorization, i.e., by 22 December 2021.
Importers are equally obliged to follow the authorization process.
For more information on the process, have a look at the European Chemicals Agency’s dedicated page.
DPM Publications department
Are you a medical device manufacturer placing your products on the EU market? We will gladly guide you to achieve full compliance!
MDCG. (2021). Agenda Point 3.1: Use of octylphenol ethoxylate (Triton-X-100) in medical devices and in vitro diagnostic medical devices for diagnosis, treatment or prevention of COVID-19 -information about sunset date (22.12.2023).