With decisions effective immediately, applications for extracts of the following plants have been assessed by the European Commission: Greater celandine, Japanese pagoda tree, Cycloastragenol, Apigenin, Pterostilbene, Southern ginseng, and Gotu Kola.
Greater celandine (Chelidonium majus) is a plant of the Poppy family which grows wild in Asia and Europe. The alkaloid rich leaves have been used in traditional medicine to support gastrointestinal, skin, liver, gallbladder and respiratory health. The entire plant is now confirmed as a novel food, meaning it cannot be used in any food or supplement sold in Europe.
Japanese pagoda tree (Styphnolobium japonicum) has been studied for its significant concentration of bioflavonoids—namely quercetin, rutin, and polysaccharides. The plant has been linked to cardiovascular, metabolic, skin and immune health, as well as offering health benefits during menopause. The EC has assessed the young cooked leaves, flower, flower bud, seed decoction, and stem decoction as not novel in food supplements, making them authorized for use in supplements.
All of the following purified actives (with the stated specific standardizations) have been assessed as novel, therefore not authorized for use in food or food supplements unless a pre-market novel food authorisation is granted:
Cycloastragenol (≥ 98%) (Astragalus membranaceus) is a triterpenoid saponin recognized as a telomerase activator, giving it utility in cellular aging and longevity. It has also been linked to benefits related to the immune and cardiovascular systems, cognitive and skin health, and metabolic function.
Apigenin (Matricaria chamomilla) extract (≥ 98%) is a plant-derived polyphenol categorized as an “epi-nutraceutical” due to its ability to act as an epigenetic modifier. It has been researched for its metabolic, neuroprotective, anti-inflammatory, antioxidant and anti-viral activity and formulated into supplements which aim to promote relaxation, improve sleep quality, and reduce anxiety.
Pterostilbene (Pterocarpus santalinus) extract (≥ 99%) is an antioxidant polyphenol primarily found in blueberries and grapes. It is primarily recognized for its role as an anti-inflammatory agent, an antioxidant shield, and for its neuroprotective benefits. In the context of cellular health, it is frequently used to combat oxidative stress and persistent inflammation.
Southern ginseng (Gynostemma pentaphyllum) extract (standardized to 80% gypenosides) is a traditional East Asian herbal medicine rich in saponins (gypenosides). It is researched for its benefits related to exercise performance, metabolic health, weight management, cardiovascular health, and hair care.
Gotu Kola (Centella asiatica) extract (standardized to 40% triterpenes), is a potent, antioxidant-rich plant native to the tropical regions of Asia, Africa, and Australia. Renowned for its ability to soothe, hydrate, and repair the skin, it’s said to boost collagen production, reduce fine lines, and calm inflammation. Beyond beauty, the extract has been researched for its benefits in eye and liver health.
The Gotu Kola stem, flower, and leaves themselves remain not novel so other types of extracts must be assessed on a case-by-case basis.
Regulatory clarity needed for botanical extracts
While the average wait time for a novel food approval is already a lengthy two and a half years, botanical extracts often face longer delays due to their complex identity. Plant extracts are not defined solely by their chemical identity but also by their source, manufacturing method, and potency.
Botanical supplement sellers will often rely on traditional use as a safety and efficacy signal. However traditional use is inconsistently recognised across EU food law and does not prevent novel food classification, especially for extracts using modern processing techniques, or with high concentrations.
“The novel food framework creates significant uncertainty for the market,” said Jerome Le Bloch, PhD, head of scientific affairs at Foodchain ID. “Authorities are increasingly strict in applying the May 1997 cut-off date, and regulatory clarity is often obtained only after formal requests submitted by [food business operators]. While this is a lengthy process, it gradually leads to clearer conclusions on ingredients used in food supplements.”
