Details
- Status
- Closed
- Opening date
- Deadline
Target audience
Public health community
Why we are consulting
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.
Respond to the consultation
The response period for this call has ended. Thank you for your input.
Consultation outcome
Final version of the update of 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
The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) published the final updated SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.
Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment of phthalates in certain medical devices. The guidelines cover phthalates 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 bodies and regulatory bodies)
- 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).
- describe the methodology for the evaluation of possible alternatives as replacement of CMR/ED phthalates currently used in medical devices, including alternative materials, designs or medical treatments.
- may also be used for a benefit-risk assessment of other CMR/ED substances present 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.
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 21 March to 28 April 2024.