Commission launches a call for information to update the 2019 SCHEER Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
date: 08/05/2023
Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is inviting interested parties 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.
Submission of information:
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.
The deadline for submitting information is 17 July 2023, 23:59. However the SCHEER 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.
Further information:
More information about SCHEER and the other Scientific Committees of the European Commission can be found here.
These Guidelines describe the methodology on how to perform a benefit-risk assessment (BRA) for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or or parts or materials used therein at percentages above 0.1% by weight (w/w).
They also consider the evaluation of possible alternatives for these phthalates used in medical devices.
They are intended to be used by the relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies.
The approach of these Guidelines may also be used for a benefit risk-assessment of other CMR/ED substances present in medical devices.