Public Hearing on the SCHEER guidelines on the presence of phthalates in certain medical devices

On 11 April 2024, the Scientific Committee on Health, Environmental and Emerging and Risks (SCHEER) will organise a public hearing in Brussels on the Preliminary update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.

The guidelines cover phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.

• Draft program of the public hearing

The request made to the SCHEER for the first update of these scientific guidelines is available here: SCHEER - Mandates (europa.eu).

Stakeholders are invited to submit their comments via the public consultation process.

The public hearing aims to complement the public consultation to gather information, comments, suggestions, explanations or contributions on the scientific basis for the update of the guidelines.

According to the Rules of Procedure of the Scientific Committees (Annex V, page 48), when registering, potential participants will be asked to provide full professional details, to specify the subject they wish to address in the hearing and to submit a 1-2 page technical justification for their request.

The persons attending the public hearing should be scientists with appropriate expertise in the field who can present and understand the scientific arguments.

The persons attending the public hearing should limit their interventions to scientific matters related to the subject (for example, to provide additional scientific evidence, discuss interpretation of data or clarify data). Invitees shall under no circumstances engage in public relations or lobbing activities.

Approval for participation to the public hearing will be decided by the Commission on the basis of the following criteria:

• interested participants should be scientists or technical experts with appropriate expertise in the field who are able to present and understand the scientific arguments;
• interested participants have clearly identified the subject matter they would wish to contribute to and have provided sufficient technical justification;

All registered participants will be informed on their approved participation at least two weeks before the public hearing.

DG SANTE, Health and Food Safety reserve the right to cancel the public hearing if the number of register participant at the closure of the registrations is low.

In case of confirmation of the public hearing, DG SANTE, Health and Food Safety will publish the final program of the public hearing together with the names of the registered interested parties on the Scientific Committees’ website.

REGISTRATION

Should you be interested in attending the public hearing, please register using the link below by the deadline of 17 March 2024. A response confirming your participation will be sent to you as soon as possible and no later than two weeks before the event.

Please note that, as space to this meeting is limited, the registration is based on first come first served basis and not more than 2 representatives from the same organisation are invited to participate. Potential participants are strongly advised not to make any travel or accommodation arrangements until they receive a positive registration reply.

The entrance to the public hearing is free of charge; however, the European Commission will not reimburse any costs made for travel or accommodation.