ReviewKeynoteIs the European regulatory framework sufficient to assure the safety of citizens using health products containing nanomaterials?

•European regulatory framework is very stratified and far to be consolidated.•EC definition of nanomaterials is not applicable to all healthcare products.•Nanomaterial characterization is limited by lack of validated analytical methods.•Safety assessment in cosmetics should exclude any internal exposure to nanomaterials.•Benefit/risk assessment of a medical device or nanomedicine is defined case-by-case.

The growing application of nanomaterials in healthcare products (i.e., cosmetics, medical devices, and medicinal products) has encouraged the upgrade of the regulatory framework within the European Community to better control their use and manage the risk of negative effects on human health and environment. Unfortunately, despite the efforts of European Authorities, the current legislation is still stratified and several criticisms remain because of the lack of well-established scientific knowledge on nanomaterials. Although the regulatory framework for cosmetic products is almost complete, the efficacy and/or safety assessment of nanomaterials in medicinal products and medical devices is still based on case-by-case evaluation because of the complexity of such systems.