SCHEER - Call for information for updating the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices

Public health community

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has received a request for updating the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical device covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting properties.

Link to the mandate: SCHEER - Mandate Guidelines Phthalates 2024 

Scope of the call for information:

This call for information is being launched according to the stakeholders dialogue procedures laid down in the Rules of procedure  of the Scientific Committees.

The objective of this call for information is to ensure that all relevant scientific information is available to the Scientific Committee for its assessment.

Interested parties are invited to submit any relevant information that could assist the scientific committee with their assessment and update of the existing guidelines document.

Information is requested on the following subjects:

• Experience with the application and the frequency of use of the existing guidelines
• Critical issues encountered during the use of the various steps presented in the guidelines
• Information on phthalates currently used as plasticizer in medical devices
• Information on potential patient or user exposure to the plasticizers used in medical devices, including information on biomonitoring
• Information on possible substances, materials, designs, or medical treatments actually used as alternative to phthalates in medical devices
• Information on the justification why possible substance and/or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product. This information should include vulnerable groups, e.g. neonatal children and dialysis patients.

The information and submitted studies will be considered by the SCHEER following the criteria defined by their Memorandum on weight of evidence and uncertainties - Revision 2018.

Only submissions directly related to the call and complying with its specifications will be considered.

All information should be submitted in electronic form (readable and copyable) to SANTE-SCHEER@ec.europa.eu specifying “Call for Information – update of guidelines on the benefit-risk assessment of the presence of phthalates in medical devices” in the subject line of the e-mail.

All information is considered public unless otherwise stated by the provider.

A document on guidelines for submission of contributions, containing criteria for the call for information and guidance for submission can be found here.

The deadline for submitting information is 17 July 2023, 23:59. However the call for information will remain open also after this date and additional studies (e.g. on-going studies and research that are not completed by the deadline) may be passed to the working group at a later stage, if needed.