Source: European Parliament
Question for written answer E-000744/2025
to the Commission
Rule 144
Costas Mavrides (S&D)
This inquiry concerns the escalating public health crisis stemming from the widespread use of plastic orthodontic aligners. Given the increasing prevalence of orthodontic treatment across Europe, there are valid concerns about the resulting human ingestion of microplastics. Users wear their plastic aligners for 22 hours a day, over 1 to 2 years (or more). The aligners are also renewed every week. These aligners then degrade into microplastics, which are subsequently directly ingested by patients.
Considering the potential harmful effects of the presence of microplastics in the body, and bearing in mind the relevant EU regulations such as the Medical Devices Regulation[1], as well as the EU rules on the restriction of hazardous substances, can the Commission answer the following:
- 1.Is the Commission aware of this issue concerning plastic orthodontic aligners? And is it aware of the findings of medical studies on the impact of microplastics on the human body resulting from their indirect ingestion?
- 2.Are there any existing or proposed regulations concerning the safety of materials used in the manufacture of orthodontic aligners specifically addressing the potential for the release of microplastics and their direct ingestion?
Submitted: 18.2.2025
- [1] Regulation (EU) 2017/745 of 5 April 2017 on medical devices, ELI: http://data.europa.eu/eli/reg/2017/745/oj.