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.

In line with the Stakeholder Dialogue Procedures (Annex V to the Rules of Procedures of the Scientific Committees), the Scientific Committees seek feedback from the scientific community and stakeholders on this preliminary update of the SCHEER guidelines.

All interested parties are invited to submit written comments on the document by 28^th April 2024.

In this context, gathering specific comments, suggestions, explanations, or contributions on the scientific basis of the guidelines, and other scientific information regarding the questions addressed, enables the Scientific Committees to focus on issues that need to be further investigated.

The electronic template provided with the documents should only be used for submitting comments, reference lines and page numbers.

Please note that comments submitted by email or post cannot be taken into account.

As stated in the Rules of Procedures (Annex V), a submission will not be considered if:

• submitted after the deadline set out in the call;
• presented in any other form than the template provided;
• it exceeds the maximum length indicated for each section, or contains comments which do not correspond to the indicated title of that particular section;
• it contains information on individual cases or any other material not included in published reports;
• it contains complaints against institutions, personal accusations or irrelevant or offensive statements or material. Complaints should be made according to the existing procedures;
• related to policy or risk management aspects.

The Scientific Committee will assess all comments from interested parties submitted in line with the criteria above. Comments will be considered if relevant.

The European Commission reserves the right to publish all comments received on the Scientific Committees' website. Please read the Privacy statement before submitting comments.