Food	Nutraceutical				Drug
Food	Functional food	Food supplement	Novel food	Botanical	Drug
Regulation (EC) No. 178/2002	The European Commission Concerted Action on Functional Food Science in Europe (FUFOSE) “a food that beneficially affects one or more target functions in the body beyond adequate nutritional effects in a way that is relevant to either an improved state of health and well-being and/or reduction of risk of disease”. consumed as part of a normal diet and is not a dietary supplement.	European Commission Directorate-General Health & Consumers 2013 a “concentrated sources of nutrients or other substances with nutritional or physiological effect whose purpose is to supplement the normal diet” Directive 2002/46/EC labelling requirements sold under the name “food supplements” The Annex I and II for vitamins and minerals Commission Directive 2008/100/EC (amending Directive 90/496/EEC) the recommended daily allowances (RDAs) for vitamins and minerals. The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)published the codex guideline CAC/GL 55-2005 for Vitamin and mineral food supplements. the safety, quality and fairness of international food trade. specific rules on composition, packaging and labelling of food supplements. National legislation Negative lists/Positive lists/ Restrictions or modalities for use/Maximum levels/ Specific labelling/	Novel Food Regulation (EC) No. 258/97 “Other substances” from food supplements often include botanicals without a traditional use in Europe.	No authorization procedure centralised at EU level for the use of botanicals and derived preparations in food. The European Food Safety Authority Regulation (EC) No. 178/2002 A Compendium of botanicals that have been reported to contain substances that may be of health concern when used in food or food supplements” without any judgment on whether they are suitable or not suitable for food applications in Europe (European Food Safety Authority 2012)	Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amendingas regards traditional herbal medicinal products Directive 2001/83/EC on the Community code relating to medicinal products for human use
(EC) No. 1924/2006 Health Claims
Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs