On 23 November, the amendment to Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), originally planned for Q3 2021, was published. The decision sets in stone the proposed sunset date for removing products containing DEHP from the EU market.
DEHP is one of the phthalates identified as a substance of very high concern by the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). By recommendation of the European Chemicals Agency (ECHA), the newly adopted amendement to the REACH regulation removes the exemption of medical devices from authorisation to use DEHP. The now adopted deadline means that blood bag sets containing DEHP cannot be sold nor used on the EU market as of 28 May 2025 – unless authorisation is granted to the user.
The official DEHP sunset date under REACH and a possible up-classification of blood bags to Class III under the MDR will likely lead to serious overlap of regulatory requirements. In light of this, the BTA, in cooperation and agreement with the European Blood Alliance (EBA), has requested a high-level meeting with the European Commission to explore options on how the sunsetting of DEHP can be ensured in a sustainable manner for all involved stakeholders while also safeguarding the proper functioning of the European blood supply system and ensuring a safe and consistent supply of blood in the EU.