On 4 May, the European Commission published a public consultation on the Inception Impact Assessment (IIA) of the REACH regulation, marking the first step in the potential revision of this regulation. Open for a period of 4 weeks, the aim of this IIA was to inform citizens and stakeholders about the Commission's plans in order to allow them to provide feedback on the revision of this regulation.
Against this background, the BTA submitted a response to highlight the importance of blood storage as a vital parameter to optimise blood supply, particularly in view of the impact external factors such as population ageing, climate change and the COVID-19 pandemic have on the availability of blood supply. It was further noted that blood bag sets with Di-2-ethylhexylphthalate (DEHP) have contributed to effectively storing blood, due to DEHP’s capacity of extending the storage life of red blood cells. However, recent developments have proposed sunsetting DEHP from medical devices on 27 May 2025, under the Annex XIV amendment of the REACH regulation.
In its response, the BTA further highlighted that it is committed to identifying viable alternatives for developing new materials. There is however concern among key stakeholders – including blood establishments as well as the industry - that the timeframe for sunsetting DEHP use combined with the revision of the EU Blood legislation and the potential up-classification of blood bag sets under the Medical Devices Regulation (MDR) is untenable, and would drastically reduce the availability of blood bag sets.
Considering the time taken to develop, CE mark and roll-out novel materials, the substitution of DEHP in blood bag sets is expected to take 6-9 years – without taking into account the potential up-classification of blood bag sets as well as the effects of the revision of the Blood, Tissues and Cells Directives would have on validation. Moreover, although potential alternatives to DEHP are already under investigation, existing data demonstrate that their blood storage properties do not match up to those of DEHP and their effects remain poorly understood.
In order to cover the time needed for the development of novel materials, the BTA further argued that by operationalising the essential use concept for DEHP, blood supply and patient safety would be safeguarded.
The BTA recommends that the phasing-out of DEHP in blood bag sets is scheduled for 2027-2030, a timeline broadly accepted by both industry and blood establishments as viable. The public consultation on IIA of the revision of the REACH regulation may be found here, and the BTA's official response through this link.