On 12/22/21 EFSA published scientific opinions on three candidate novel foods: turmeric extracts, Tongkat Ali and sea lentil.
Tetrahydrocurcuminoids received the green light, while so-called Malaysian ginseng-sold everywhere with aphrodisiac promises-was rejected.
In contrast, aquatic lentils register varying opinions, approved as traditional foods but not considered safe as dietary supplements.
1) TURMERIC EXTRACTS
1.1) Turmeric and curcuminoids
Turmeric (or turmeric, Curcuma longa) is a rhizome traditionally used in Asia (especially in curries in India) as a spice but also as a natural food coloring. In recent decades, it has also spread to the Old Continent, where it is surveyed fourth for the recurrence of food fraud on herbs and spices.
Curcuminoids-and tetrahydrocurcuminoids, in particular, because of their greater chemical stability, bioavailability, and antioxidant action-have been identified as potential allies in cancer prevention. Due to their abilities to reduce oxidative stress and inflammation, albeit pending further research on pharmacokinetics and oral bioavailability. (1)
1.2) Tetrahydrocurcuminoids, clearance with exclusivity coming soon
Sabinsa Europe GmbH applied for approval of tetrahydrocurcuminoids as novel foods for use in food supplement ingredients on 3.3.20. With request for protection on analytical data and certifications (FSSC 22000), in vitro and in vivo toxicological studies, human studies. Since EFSA considered these as determinants for dossier review, authorization will likely be granted with exclusivity (as with other novel foods from plants, e.g., UV-treated mushroom powder and miracle fruit).
The production process is similar to that used to make the food additive E 100 (curcumima). Curcuminoids extracted from pulverized rhizomes (> 95% on dry matter) are hydrogenated using palladium as a catalyst. Although the intake of this metal at the proposed dose (1.5 µg on 300 mg/day of product) is much lower than the risk threshold (100 µg/day), EFSA took a conservative approach by assessing the safe threshold for tetrahydrocurcuminoids at 140 mg/day. The target population excludes only pregnant and lactating women. (2)
2) TONGKAT ALI
2.1) Libido promises and identified risks.
Tongkat Ali(Eurycoma longifolia) is a traditional medicinal plant popular in Southeast Asia (Thailand, Indonesia, Malaysia, Vietnam, etc.). Different parts of the plant-leaves, stem, roots, barks-are used in various forms to treat a wide variety of ailments and also to boost libido. Some natural phytoconstituents in the plant (e.g., quassinoids, alkaloids of the cantin-6-one group and β-carboline derivatives) are also considered promising for the development of new drugs. (3)
Italy had already expressly banned the use of Eurycoma longifolia in the preparation of dietary supplements because long-term consumption of its stratum has been associated with problems of sleep apnea, skin redness, aggression, and testicular pain. (4) EFSA then found, based on in vitro toxicological studies and in vivo in-depth investigations, that the aqueous root extract that is the subject of the application has a high risk of causing DNA damage. Therefore, expressing an unfavorable opinion on its authorization as a novel food. (5)
2.2) Tongkat ali, precedents and current events.
Biotropics Malaysia Berhad already been recalled by the U.K. Food Standards Agency (FSA) – under the first Novel Foods Regulation (EC reg. 258/97) – which had highlighted the potential risks involved. Its use in the EU had already been ruled out, in the absence of favorable assessment that was due to take place by 1.1.18 (under the subsequent EU Reg. 2015/2283, Article 7, which is still in force).
Dietary supplements based on Tongkat Ali extract (also known as Longjack or Malaysian Ginseng) have been licensed first in Malaysia (2008), then in Hong Kong and other large markets such as Singapore, Russia, Japan, the US, and Canada. And they are also marketed online in the EU, outlawed, (6) with a number of health claims related to:
– libido enhancement,
– Restoration of hormonal balance,
– Increased sports performance,
– contribution to weight loss. (6)
3) WATER LENTIL
3.1) Water lentils, 38 species
Water lentils are a large family of aquatic plants, divided into 38 species and five genera(Spirodela, Landoltia, Lemna, Wolffiella and Wolffia). Their food use-Wolffia arrhiza and Wolffia globosa especially-is rooted and widespread in Thailand, Burma, and Laos, where the plants are grown and harvested twice a week, 9 months a year.
One appreciates its richness in protein with a full complement of essential amino acids, plenty of dietary fiber, and fat. In addition to micronutrients-most notably easy-to-assimilate vitamin B12 and iron (both of which are useful for veg consumers), polyphenols and carotenoids. These plants therefore seem to have good potential in human and animal nutrition, as noted. (7)
3.2) Wolffia globosa
Wolffia globosa
is already marketed in the U.S. (from March 2019) and Israel (from March 2020), where it is used as an ingredient in Alt Me at (plant-based alternatives to meat), functional beverages and baked goods. The Israeli company GreenOnyx Ltd. has already received a favorable EFSA opinion, following its notification to Brussels as a food with more than 25 years of tradition of consumption in third countries. (7) The inclusion of water lentil in the list of traditional foods authorized in the EU is thus awaited.
In contrast, the application for authorization with exclusivity submitted by Hinoman (Israel) received an unfavorable scientific opinion. Indeed, the dose of Wolffia globosa proposed as a supplement involves theintake of manganese (Mn) in an amount (2.33 mg/day) that could increase theintake by up to 39% over estimates of higher average values. But excessive Mn intakes are associated with adverse health effects, so EFSA did not consider it possible to establish the safety of the novel food. (9)
Dario Dongo and Andrea Adelmo Della Penna
Notes
(1) Lai et al. (2020). The Cancer Chemopreventive and Therapeutic Potential of Tetrahydrocurcumin. Biomolecules 10(6):831, https://doi.org/10.3390/biom10060831
(2) EFSA NDA Panel et al. (2021). Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283. 19(12):6936, https://doi.org/10.2903/j.efsa.2021.6936
(3) Rehman et al. (2016). Review on a Traditional Herbal Medicine, Eurycoma longifolia Jack (Tongkat Ali): Its Traditional Uses, Chemistry, Evidence-Based Pharmacology and Toxicology. Molecules 21(3) :331 , https://doi.org/10.3390/molecules21030331
(4) National Institute of Health. ISS (2015). Smart Drugs – Third Edition. Department of Pharmacy, https://www.politicheantidroga.gov.it/media/1715/smart_drugs.pdf
(5) EFSA NDA Panel et al. (2021). Safety of Eurycoma longifolia (Tongkat Ali) root extract as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 19(12) :6937 , https://doi.org/10.2903/j.efsa.2021.6937
(6) The US site Lucky Vitamins, for example, offers 12 dietary supplements that contain Tongkat Ali (or Longjack). V. https://www.luckyvitamin.com//c-267-tongkat-ali
(7) Marta Strinati. Water lentil, a superfood to be discovered. GIFT (Great Italian Food Trade). 3.11.19, https://www.greatitalianfoodtrade.it/mercati/lenticchia-d-acqua-un-superfood-da-scoprire
(8) EFSA(European Food Safety Authority), 2021. Technical Report on the notification of fresh plants of Wolffia arrhiza and Wolffia globosa as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283. EFSA Supporting Publication 2021;18(6):EN-6658. https://doi.org/10.2903/sp.efsa.2021.EN-6658
(9) EFSA NDA Panel et al. (2021). Safety of Wolffia globosa powder as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 19(12):6938, https://doi.org/10.2903/j.efsa.2021.6938
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
