European Commission Issues Novel Food Assessments for Botanicals

The European Commission has announced immediate decisions regarding the classification of several plant extracts as novel foods. The plants under review include Greater Celandine, Japanese Pagoda Tree, Cycloastragenol, Apigenin, Pterostilbene, Southern Ginseng, and Gotu Kola. These assessments will impact the use of these botanicals in food and supplements across Europe.

Greater Celandine (Chelidonium majus), a member of the poppy family found in Asia and Europe, has been confirmed as a novel food. This classification means that its leaves, known for their alkaloid content and traditional medicinal uses including gastrointestinal and liver health, cannot be utilized in any food or supplement sold within Europe.

In contrast, the young cooked leaves, flowers, flower buds, and decoctions of the Japanese Pagoda Tree (Styphnolobium japonicum) have been assessed as not novel, allowing their use in supplements. This tree is recognized for its bioflavonoid richness, specifically quercetin and rutin, which have been linked to cardiovascular and metabolic health, as well as benefits related to skin and immune function.

The Commission has classified several purified active compounds as novel foods. For instance, Cycloastragenol (≥ 98%) from Astragalus membranaceus is recognized for its potential in promoting cellular aging and longevity. It has also been associated with benefits for the immune and cardiovascular systems. Similarly, Apigenin (≥ 98%) derived from Matricaria chamomilla is noted for its role as an epigenetic modifier, with research highlighting its neuroprotective and anti-inflammatory properties.

Another significant extract, Pterostilbene (≥ 99%), is an antioxidant polyphenol found in blueberries and grapes. Its health benefits include anti-inflammatory effects and neuroprotection, particularly in combating oxidative stress. Southern Ginseng (Gynostemma pentaphyllum), standardized to 80% gypenosides, has been studied for its contributions to exercise performance and metabolic health. Furthermore, Gotu Kola (Centella asiatica), standardized to 40% triterpenes, is celebrated for its skin-repairing properties and potential benefits for eye and liver health. While the stem, flower, and leaves of Gotu Kola are not classified as novel, other extracts will require individual assessments.

Regulatory Challenges for Botanical Extracts

The approval process for novel foods typically takes around two and a half years, but botanical extracts often face longer delays due to their complex identities. These extracts are defined not only by their chemical composition but also by their source and manufacturing methods. Many sellers of botanical supplements rely on traditional uses as indicators of safety and efficacy. Yet, this traditional use is inconsistently recognized under EU food law and does not exempt these extracts from novel food classification, particularly when modern processing techniques or high concentrations are involved.

Jerome Le Bloch, PhD, head of scientific affairs at Foodchain ID, expressed concerns about the regulatory landscape. “The novel food framework creates significant uncertainty for the market,” he stated. He noted that authorities are increasingly strict in applying the May 1997 cut-off date, leading to a lengthy process for obtaining regulatory clarity. This clarity often emerges only after formal requests are submitted by food business operators, gradually resulting in clearer conclusions regarding the ingredients used in food supplements.

As the European Commission continues to navigate the complexities of botanical assessments, the implications for manufacturers and consumers alike remain significant. The evolving regulatory environment highlights the need for comprehensive understanding and adherence to guidelines surrounding novel foods in Europe.