SCHEER - Public consultation on the preliminary update of the SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices

Public health community

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published the preliminary update of the SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.

Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment 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).

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 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.

SCHEER again encourages manufacturers to generate high-quality data on the alternatives for CMR/ED phthalates in medical devices.

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