Phthalates: Final SCHEER guidelines published

Posted on 03.10.2019

On 9 September, the Scientific Committee on Health and Environmental Risks (SCHEER) published the final version of its Guidelines on benefit-risk assessment (BRA) of phthalates in certain medical devices.

The Commission mandated SCHEER to develop such Guidelines in accordance with Annex I, Section 10.4.3. of the Medical Device Regulation.

The Guidelines describe the methodology on how to perform a BRA for the justification of the presence of phthalates in medical devices and/or parts or materials used therein at percentages above 0.1% by weight. 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.

More information: The final version of the guidelines is available here. The results of the public consultation (including SCHEER’s responses) can be accessed here.