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The purpose of this chapter is to describe current European legislation on nanomaterials, with specific reference to their use in the cosmetic sector. The crucial point of the topic is the definition of “nanomaterial” formulated by the European Commission with Recommendation No. 2011/696 of October 18, 2011 compared and coexisting with the definition contained in EC Regulation No. 1223/2009 on cosmetic products (so-called “CPR”), as well as the provisions laid down with reference to cosmetics containing nanomaterials, such as the specific notification to EU Cosmetic Product Notification Portal. The provisions are primarily aimed at ensuring product safety, protecting the health of consumers, but at the same time protecting free movement of goods and legal certainty for manufacturers. The European Commission is still working to foster the proper balance between the “horizontal definition” of nanomaterial (cross-sectorial definition) and the so-called “cosmetic definition” as a result of the CPR. So, as it will be discussed, the issue is still an interesting “work in progress” to be read “under the light” of scientific evolution.

Unlike generics, biosimilars are similar, but not equivalent, to the reference biological medicinal product. Therefore, if a patient experiences an adverse event, or a loss of efficacy, when transitioned to a biosimilar, the distribution of medical liability will be different from the case of both the originator and generics. Moreover, the case of naive patients is different from that of non-naive patients. In the case of naive patients, physicians make their choice from a range of medicinal products that pose the same risk, since it is not possible to know with any certainty the patients' response to each therapeutic option until they have taken the drug. If physicians, instead, switch to a biosimilar for a patient already in treatment with the originator, they are switching from an option where the individual response is known, to an option where it is unknown. Given the evolving framework of biosimilar legislation, sharing choices with patients and obtaining their informed consent when switching to a biosimilar could represent an effective approach on the part of the prescribing physician. Moreover, a supranational database containing real-life data about patients in treatment with biological medicines, including information on the actual biological medicinal products administered, could complement the data obtained from clinical studies.