Today, 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).
These guidelines are intended to be used by the relevant stakeholders, e.g. manufacturers, notified bodies and regulatory bodies…