Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the final version of the Guidelines on the benefit-risk assessment (BRA) of the presence, in the medical devices specified in the mandate, of phthalates which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED).

On the basis of the preliminary version, the Commission launched a public consultation where interested parties were invited to submit their comments on the scientific evidence from 18 March to 29 April 2019 and results are published.

These Guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or parts or materials used therein at percentages above 0.1% by weight (w/w).
They also describe the evaluation of possible alternatives for these phthalates used in medical devices, including alternative materials, designs or medical treatments.
They are intended to be used by the relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies.

For more information:

• On the work of the independent scientific committees of the Commission