Final opinion on
The safety of the use of bisphenol A in medical devices
The opinion assesses the safety of bisphenol A (BPA) in medical devices focusing on vulnerable groups such as infants, pregnant and breast-feeding women. Such medical devices include implants, catheters, and most dental devices.
A public consultation on this opinion was opened on the website of the non-food Scientific Committees from 29 January 2014 to 26 March 2014. Information about the public consultation was broadly communicated to national authorities, international organisations and other stakeholders.
Fourteen organisations participated in the public consultation providing input to the main scientific questions (in total 119 contributions were received). Out of the 14 organisations participating in the consultation, there were six industry associations, three private companies, two professional organisations, two national authorities and one non-governmental organization.
Each submission was carefully considered by the SCENIHR and the scientific opinion has been revised to take account of relevant comments. The literature has been accordingly updated with relevant publications.
Content of the opinion:
When drafting the final opinion, the SCENIHR considered the recently temporary oral TDI (t-TDI) of 4 µg/kg b.w./day derived by EFSA which represents a solid base for carrying out a risk assessment for the use of bisphenol A in medical devices. Several exposure scenarios have been evaluated taking into account the material used, information related to BPA leaching, the duration of a single treatment and the frequency of treatments, giving rise to toxicologically relevant acute, short and long term exposure. However, the information available is very limited and in many cases due to the lack of experimental data, only estimations were used.
Concerning exposure via the oral route, it can be concluded that the long term exposure to BPA via dental material is far below the recently derived t-TDI and poses negligible risk for human health associated to BPA exposure.
The SCENIHR concludes that risk for adverse effects of BPA may exist when the BPA is directly available for systemic exposure after non-oral exposure routes, especially for neonates in intensive care units, infants undergoing prolonged medical procedures and for dialysis patients. Although the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials. However, better data on exposure would be beneficial for the refinement of the present risk assessment, to be carried out when new data on exposure via medical devices will become available.