The Unresolved Status of Botanical Health Claims in the European Union

Botanicals are commonly known for their traditional use in herbal medicine, therapeutic properties, and aromatic properties. Botanicals are derived from plants, algae, fungi, or lichens and are becoming increasingly popular on the European market (European Food Safety Authority, 2026). One of the most popular examples is ashwagandha, as well as aloe vera or peppermint. They are found on the European market in the form of food supplements, cosmetics, skincare and aromatherapy. Despite their growing popularity, botanicals remain challenging categories to regulate within the European Union due to differences in classification, safety assessment, and health claim requirements.

Why has popular ashwagandha been banned in Denmark but can still be bought in Germany and Sweden?

Under EU law, all food supplements are regulated as food and therefore fall under EU food law, in the General Food Law Regulation (EC) No 178/2002. The main piece of legislation specifically governing food supplements is Directive 2002/46/EC - the Food Supplements Directive. However, the Food Supplement Directive harmonised only vitamins and minerals, meaning that botanicals, plant extracts and herbs haven’t been included under this Directive. Because the EU has not established a harmonised framework for botanicals used in food supplement , the authority automatically defaulted back to individual national governments.

Therefore, each EU country created its own national laws, safety thresholds, and positive/negative plant lists for botanicals. That is why Denmark could ban ashwagandha, whereas in Sweden it is legal to buy. Additionally, because of the lack of EU harmonisation, botanicals can also be regulated as a medical products following the Traditional Herbal Medicinal Product Directive (2004/24/EC). ‘Thus, a plant substance classified as a “food” in one Member State can be classified as “medicine” in another Member State’(European Commission, 2020).

Botanicals health claims - “on hold” list

Any claims made about food products, including food supplements, must comply with the Nutrition and Health Claims made on foods Regulation (NHCR Regulation EC 1924/2006). The rules of the Regulation apply to nutrition claims like low sugar or low fat, and to health claims such as "Vitamin D is needed for the normal growth and development of bone in children" (European Commission, 2026). Article 13 of the NHCR Regulation indicates that all health claims are allowed to be used on food only after "generally accepted scientific evidence". Therefore, European Food Safety Authority (EFSA) evaluates and approves the health claim using high-level scientific evidence, while the European Commission and Member States (PAFF Committee) decide whether the claim is authorised.

Following EFSA's scientific assessment on botanical health claims in 2009, none of the botanical claims received a favourable opinion ‘mainly due to the absence of human intervention studies’ (European Commission, 2020). As a result, in 2010 the European Commission decided to suspend botanical health claims evaluation, while considering how to address the regulatory overlap between foods and traditional herbal medicinal products. In 2012, the European Commission created the status of an "on hold" list for 2,078 botanical health claims. These claims can still be used temporarily by companies, provided that they comply with the general principles and conditions of the NHCR Regulation and the relevant national provisions.

Consequences of the regulatory gap

The European Commission’s evaluation found that consumers remain exposed to unsubstantiated botanical health claims from the “on-hold” list. Additionally, 'food business operators have benefited from the current situation, as they have been able to continue using health claims on plant substances without having to undertake clinical trials to support the application for health claims’(European Commission 2020). The evaluation also highlighted that the lack of EU harmonisation rules on plant health claims has a negative influence on food businesses. This is because botanical health claims that are permitted in one Member State may not be permitted in another.

Final thought

The Commission’s 2020 evaluation concluded that greater harmonisation would improve consumer protection, trade and functioning of the internal market. In 2023, the European Parliament, in its own initiative procedure, suggested having an EU-level negative list of botanicals used in food. On 30 April 2025, the CJEU, ruling on a request for a preliminary ruling from a German court (Case C-386/23, Nutriology), clarified that, under Claims Regulation, health claims for foods containing botanicals are in principle prohibited unless they have been scientifically assessed by EFSA and authorised by the European Commission. As the evaluation of botanical claims has been suspended since 2010, no new claims can currently be authorised. Only “on-hold” claims benefiting from transitional provisions may be used, provided they comply with the general requirements of the Regulation.