Public consultation to Annex XIV (REACH Regulation) concerning chemicals of very high concern

Originally published in 2016, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation regulates the use of chemicalsacross 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) within Annex XIV of the REACH Regulation, and has been subject to authorization for specific uses. 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.

Following the above-mentioned recommendation from ECHA to remove the exemption from Authorization for the use of DEHP in medical devices, the European Commission has proposed an amendment to Annex XIV of the REACH Regulation. According to the Commission proposal, after 27 May 2025 the placing on the market and use of DEHP in medical devices would be prohibited unless an authorization is granted (sunset date). Between December 2020 and January 2021, the Commission published a consultation on its proposed amendment of Annex XIV.

Although the BTA members are committed to identifying viable alternatives for developing new materials, they are concerned that the envisaged timeframe for sunsetting the use of DEHP combined with the revision of the EU Blood legislation and the potential change in the classification of blood bag sets under the Medical Devices Regulation (MDR) would greatly hamper the availability of blood bag sets across the EU. In this context, the BTA recommends scheduling the phasing-out of DEHP in blood bags between 2027 and 2030, to better facilitate the transition.

A number of responses to the public consultation demonstrated alignment with the BTA’s concerns and position, with the Paul-Ehrlich-Institute noting “the planned ban of DEHP will probably cause a reduction of quality and stability of red blood cell concentrates and will likely lead to a shortage in supply of life saving red blood cell concentrates” and Health Care Without Harm (HCWH) Europe further stating that “in Europe, phthalate-free or PVC-free medical devices are available for nearly all product categories except blood bags for red blood cells”.

You can find the public consultation on the draft Commission’s Regulation amending Annex XIV to the REACH Regulation through this link, and the BTA's comment here.

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