Stakeholders should bear in mind that updated European guidelines for assessing benefits versus risks of phthalates in medical devices are not just applicable to phthalates that have carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting properties, but can be used in evaluating other CMR/ED substances in medical devices as well.
EU Guidelines On Justifying Phthalates In Medical Devices Applicable To Growing List Of Regulated Substances
The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks makes minor changes to its phthalates benefit-risk guidelines based on stakeholder feedback. The guidelines could be increasingly relevant given their applicability to other carcinogenic, mutagenic or reprotoxic (CMR) and endocrine-disrupting (ED) substances, lists that are bound to go on growing as the EU implements its Chemicals Strategy for Sustainability under the Green Deal.
