EU Regulation: Food Supplements, Novel Foods, Health Claims and Traditional Herbal Medicines

The European Union does not treat a herbal product as one thing. Depending on how a product is presented, it can be a food supplement, a novel food or a herbal medicine, and each route has different rules. This page summarizes what the European Commission, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) say on their own pages, read on 2026-10-23. It does not describe the rules of any single member state, which can differ. For the US picture, see US regulation.

The three routes at a glance

Food supplements

The European Commission describes food supplements as concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form. [1] The objective of Directive 2002/46/EC is to protect consumers against potential health risks from these products. [1] The Directive sets a list of vitamins and minerals that may be used, and the Commission says trade in products with vitamins and minerals not on the permitted source list has been prohibited since 1 August 2005. [1]

For substances other than vitamins and minerals, the Commission page says it prepared a report to the Council and Parliament on their use. [1] On maximum and minimum amounts of vitamins and minerals, the page says no proposal has yet been presented because of the complexity of the issue. [1] We did not find on the pages we read a single EU-wide list of permitted herbal ingredients for food supplements, so we make no claim about one. EU countries may, for monitoring, ask for notification to their authority when a food supplement is placed on their market. [1]

Novel foods

The Commission defines a novel food as food not consumed to a significant degree by humans in the EU before 15 May 1997. [2] Its examples include chia seeds and noni fruit juice. [2] EFSA says the European Commission is responsible for authorising novel foods following a safety evaluation by EFSA, and that over 200 are approved and listed in the Union list. [4] Whether a given plant ingredient is novel is a separate question for each ingredient; this page does not assign any plant to the category.

Health claims on foods

EFSA says it is responsible for verifying the scientific substantiation of submitted claims, and that the European Commission and member states then decide whether to authorise them. [5] EFSA describes a health claim as any statement on labels, in marketing or in advertising that health benefits can result from consuming a food or one of its components. [5] A key objective of the claims Regulation is that any claim made on a food label in the EU is clear and substantiated by scientific evidence. [5] Compare this with the US system described in Claims on labels.

Traditional herbal medicines

EMA says the Committee on Herbal Medicinal Products issues scientific opinions on herbal substances and preparations to give companies and national authorities a reference point. [3] Companies bringing herbal medicines to market follow the national procedures of member states. [3] Under the traditional use route (Article 16a of Directive 2001/83/EC), EMA lists these features:

• No clinical tests and trials on safety and efficacy are required as long as sufficient safety data and plausible efficacy are demonstrated. [3]
• The product must have been used for at least 30 years, including at least 15 years within the EU. [3]
• It is intended to be used without the supervision of a medical practitioner and is not administered by injection. [3]

EMA adds that a full quality dossier is required for all herbal medicinal products, whatever the safety and efficacy route. [3] The simplified registration procedure was introduced in 2004 through Directive 2004/24/EC. [3] EMA also warns that EU herbal monographs should not be confused with European Pharmacopoeia monographs, which cover quality requirements. [3]

"Traditionally used" in this context is a regulatory category based on documented long use; it is not the same as proof of benefit from trials, and EMA's own wording says trials are not required for this route.

Safety takeaways

• The same plant can sit in different legal categories, so a label such as "food supplement" or "traditional herbal medicinal product" tells you the route, not that benefit was shown in trials.
• Ask a pharmacist or clinician before combining any herbal product with medicines; see How interactions work.
• Check the label for the legal category and be cautious with imported products; see Imported and traditional medicine products.