Fact Sheet on the Application for Authorisation (AfA) for the continued use of DEHP in blood bag sets

The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation is an EU text, originally published in 2006, that regulates the use of chemicals across the EU in all industries in order to improve human health and the environment.

DEHP is one of the phthalates identified as a substance of very high concern (SVHC) and as such, has been subject to authorization for specific uses (Annex XIV of REACH). The authorisation process aims to ensure that SVHCs are progressively replaced by alternative substances or technologies where technically and economically feasible.

Until now medical devices have been exempted from authorisation. However, the European Chemicals Agency’s (ECHA) published a recommendation in 2019 to remove the exemption of medical devices from authorisation for the use of DEHP above a certain concentration, leading to a sunsetting of DEHP in blood bag sets.

The BTA has published a Fact Sheet to explain the specificities of the AfA process in relation to DEHP, and the implications for blood bag sets in Europe. Click here to access the Fact Sheet.


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