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ECHA looks at authorization for Tritons in medtech

Posted on 06.12.2018

In September, MedTech Europe and other life sciences associations joined the meetings of two scientific committees of the European Chemicals Agency; the Risk Assessment Committee (RAC) and the Committee for Socio-Economic Analysis (SEAC). At these meetings, we discussed the requirements for Authorisation of octylphenol ethoxylates (OPnEOs) under REACH and presented risk management measures that IVD companies apply to minimise emissions of OPnEOs/Tritons to the environment as well as efforts to substitute these substances by more environmentally friendly alternatives.

As of today, MedTech Europe is granted “observer” status at future Risk Assessment Committee meetings on topics of interest to the medical technology sector.
OPnEOs cover several substances, notably Triton X-100, which are used as a surfactant by the IVD industry, in the manufacturing process of IVDs as well as in finished IVD kits. These substances play a key role in the reaction mechanism of IVD assays, as they modulate critical performance parameters such as sensitivity, specificity and stability.

Continued use of OPnEOs in Europe after 4 January 2021 will only be allowed to companies that manage to obtain a REACH Authorisation. Deadline to submit an Application for Authorisation is 4 July 2019. Certain uses may benefit from an exemption from Authorisation, if they qualify as Scientific Research & Development as defined by REACH.
For further information on this dossier, please contact Nathalie Buijs (n.buijs@medtecheurope.org).