In a European context of increasing pressure towards tighter rules on the use of endocrine disruptors, including the phthalate DEHP in blood bag sets, this topic has been identified as a priority by the BTA Members. As the amendment to annex XIV of REACH may lead to sunsetting of DEHP. The European Chemicals Agency’s (ECHA) has published a recommendation to remove the exemption of medical devices from authorisation for the use of DEHP above a certain concentration, unless a "proper justification" is proper. For this purpose, the The BTA Members have decided to convene their companies’ scientific experts to find a common approach to the BRA for the justification of the use of DEHP in medical devices in accordance with the Scientific Committee on Health, Environmental and Emerging Risk (SCHEER) guidelines.
An internal Working Group was created in order to develop a common approach to the Benefit Risk Assessment for the justification of the use of phthalates in medical devices. The Working Group has already convened and will continue to work on this regard.
Details on the SCHEER Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties can be found here.