Botanical nutraceuticals (food supplements and fortified and functional foods) and novel foods in the EU, with a main focus on legislative controls on safety aspects

Abstract Botanical nutraceuticals with nutritional and/or physiological effects can be considered food supplements, fortified foods, or functional foods. They do not easily fall into the legal categories of food or drug. This is discussed by entering into ongoing debates on the regulatory framework. Quality, efficacy, safety, and consumer's trust are well-recognized pillars of the success of botanical nutraceuticals and novel foods in the European Union. Quality and safety issues are discussed in light of their impact on efficacy (enhanced performance and reduction of disease risk), particularly as they comply with the mandatory requirements of the Novel Food Regulation, which entered into legislation on Jan. 1, 2018. This chapter focuses mainly on legislation governing botanical nutraceuticals and novel foods. In May 2012, the European Commission (EC) published a list of permitted nutrition and health claims. The role of the EC and the European Food Safety Authority (EFSA) during the evaluation process, the preparation of opinions, and decision-making procedures is described in light of ongoing experience with EFSA guidelines.