Plants and their preparations are widely available on the EU market as foods or as herbal medicines, and their classification as “food” or medicine is of the responsibility of Member States. Thus, a plant substance classified as a “food” in one Member State, can be classified as “medicine” in another Member State.

The European Regulation (EC) No 1924/2006, regulates the nutrition and health claims made on foods. Since 2012, the Commission established an “on-hold” list of more than 2000 health claims relating to plant substances. These “on-hold” claims may still be used on the EU market under the responsibility of food business operators and under certain conditions. Hence, health claims on botanicals are currently “on-hold” and waiting for a decision about their evaluation process.

After a long wait, on the 20 May 2020, the Commission completed the evaluation of the regulation on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods, as part of the Regulatory Fitness and Performance programme (REFIT).

Concerning health claims on plants and their preparations and their regulatory framework, the evaluation findings showed:

  • Consumers continue to be exposed to unsubstantiated health claims from the “on-hold” list (claims that have not yet been assessed by EFSA).
  • Food business operators have benefited from the current situation, contrary to the pharmaceutical industry, 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.
  • The Claims Regulation is coherent with other EU legislation applicable to plants used in foods, but there is a discrepancy in the recognition of “traditional use” data for claims made on foods and Traditional Herbal Medicinal Products.
  • The safety of foods containing plants is adequately addressed by EU general rules on food safety. Potential risks to consumers might arise due to increased numbers of national rules that assess the safety of certain plant substances in foods.
  • It is not coherent to have harmonized rules on health claims while the use of plants in foods is governed by national rules.
  • A EU harmonization on plants used in foods through a positive or a negative list of plants would improve the situation with regard to safety and the smooth functioning of the internal market.

The full outcome of the evaluation was:

“Overall, the evaluation findings show that, in the current situation, the objectives of the Claims Regulation are not fully attained. It could be appropriate to explore the notion of ‘traditional use’ in the efficacy assessment of health claims on plants used in foods together with the effects of the coexistence, on the EU market, of Traditional Herbal Medicinal Products on the same plant substances. In the light of the shortcomings highlighted above about the smooth functioning of the internal market and the possible openness to the notion of ‘traditional use’ to substantiate health claims on plants, there are merits for further studying the potential EU harmonisation of the field of plants, including the safety aspect. “

Despite the urgent need for a harmonized decision concerning health claims on botanicals (currently “on-hold” claims), no final decision is to be expected soon.