17 octobre 2024

Phthalates in certain medical devices: updated SCHEER guidelines published

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the update of their guidelines on the benefit-risk assessment of phthalates in certain medical devices. The guidelines cover phthalates which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED). […] They also describe the methodology for the evaluation of possible alternatives as replacement of CMR/ED phthalates currently used in medical devices, including alternative materials, designs or medical treatments. The guidelines may also be used for a benefit risk assessment of other CMR/ED substances present in medical devices.