Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the first update of their guidelines on the benefit-risk assessment (BRA) of phthalates, in medical devices specified in the mandate, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED).
Interested parties are invited to submit their comments on the scientific evidence until 28 April 2024
The guidelines:
- are intended to be used by the relevant stakeholders (manufacturers, notified and regulatory bodies).
- describe the evaluation of possible alternatives for phthalates used in medical devices, including alternative materials, designs or medical treatments.
- describe the methodology for performing a benefit risk assessment justifying keeping the presence of CMR category 1A or 1B and/or endocrine-disrupting phthalates (CMR/ED phthalates) in medical devices and/or parts or materials used therein at percentages above 0.1% by weight (w/w).
- may also be used for a benefit risk assessment of other CMR/ED substances in medical devices.
The current guidelines are an update of the SCHEER phthalates guidelines published in 2019.
According to the Medical Devices Regulation Annex I, Chapter II Section 10.4.3 the guidelines need to be updated at least every five years, depending on the latest scientific evidence.
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