Application of the “Novel Foods” Regulation to Botanicals in the European Union

The European Union classifies “novel foods” as those not widely consumed before 15 May 1997. This category includes recently created, innovative foods, as well as those made using new technologies and processes, and foods with a traditional consumption history outside the EU. Distinguishing between “novel” and “conventional” foods is legally significant, as the former require official authorization under the Novel Foods Regulation. The regulation prioritizes safety, accurate labeling, and nutritional parity with replaced foods. Regulation (EU) 2015/2283, effective from 1 January 2018, replaced prior regulations, facilitating access to the EU market for novel and innovative foods while maintaining high safety standards. Classifying botanical products as novel can be intricate. Safety assessments for plant products must consider diversity in species, varieties, ecotypes, and chemotypes, as cultivation practices influence chemical composition. The article reviews the legislation applicable to botanicals and proposes different ways to evaluate in advance whether a product is “novel” or not, emphasizing the evaluation of the origin and consumption history of foods of plant origin.