The EU Court of Justice-in line with Austria’s Federal Ministry of Social Affairs, Health, Care and Consumer Protection-qualifies buckwheat sprouts produced in an aqueous solution rich in spermidine as novel food (1,2).
This decision was by no means a foregone conclusion, given that buckwheat has an important consumption tradition in the European Union. However, the cultivation of its shoots-just as traditional-is qualified as ‘innovative’ in this case.
1) Buckwheat and its sprouts, the tradition of consumption.
Buckwheat is a food of Asian origin, as noted, with a long history and tradition of consumption in Europe as well, especially in Italy. (3) It is consumed mainly in the achene (fruit) form and can also be used as an ingredient in gluten-free processed products intended for people with celiac disease (e.g., “gluten free bread, pasta, cookies, meat analogues, tea, beer).
Buckwheat sprouts-as well as those of many other plants, cereals and legumes above all-have themselves become part of European and Western traditions, thanks to the beneficial properties associated with their high concentration of nutrients and bioactive substances. Siberian buckwheat sprouts, in particular, are distinguished by their higher content of polyphenols and, in particular, rutin, which is characteristic of this species. (4)
2) Spermidine
Spermidine is a polyamine found in many foods of plant origin (e.g., wheat germ, cereals and legumes, soybeans, citrus fruits) and animal origin (e.g., meat, fish), as well as in mushrooms. The human body can synthesize it, but its dietary intake remains important, especially for infants and the elderly, who tend to be deficient in it.
Polyamines (spermine, spermidine putrescine) play important roles in cell growth, RNA transcription, protein synthesis, and modulation of the immune system. Their antioxidant and anti-inflammatory properties also play a role in the prevention of cardiovascular disease.
High levels of polyamines are on the other hand associated with cancer diseases, linked to alterations in their homeostasis. And there are no official recommendations for their daily intake in different age groups, although some authors have proposed levels well above the intake estimates made in different countries. (5)
3) Buckwheat and spermidine, agronomic and food innovations.
In agronomy, spermidine-in addition to being naturally present in buckwheat-has been tested as a seed treatment agent. Demonstrating the ability to increase tolerance to water stresses, promote germination, antioxidant enzyme activity, and proline content. (6)
The innovation under analysis by the Court of Justice of the European Union (EUCJ) involves germinating buckwheat achenes in solutions enriched in synthetic spermidine to stimulate its bioaccumulation and produce a flour ‘rich in‘ spermidine. With a view to its use in the production of foods and food supplements thus enriched.
4) Controversy in Austria
A dietary supplement manufacturer , TLL, sued competitor Optimize Health for unfair competition in the Civil Court of the Land of Graz, Austria. Denouncing the use of sprouted buckwheat flour as above-according to him, an unauthorized novel food under reg. EU 2015/2282 – to produce a food supplement rich in spermidine. TLL in turn makes a food supplement rich in spermidine, which, however, it extracts, with a lower yield, from unsprouted wheat germ.
The Austrian court then stayed the proceedings to refer a number of questions to the Court of Justice for a preliminary ruling, of which the first absorbs the others. The main question is therefore, in summary, ‘whether buckwheat sprout meal is a novel food belonging to the category of novel foods consisting of, isolated from, or obtained from plants not significantly consumed before May 15, 1997.’ (7)
5) Decision of the Court of Justice
Court of Justice
of the European Union (EUCJ) – in its judgment May 25, 2023, in Case C-141/22 – confirmed that buckwheat flour derived from sprouted achenes in solutions enriched in synthetic spermidine qualifies as a novel food for three essential reasons:
- the procedure used should not be understood as a cultivation technique, but rather as a process of enriching buckwheat with spermidine,
- that process results in an o, which among other things affects a plant,
- no documented evidence has been collected of a history of use and consumption in the form presented as of May 15, 1997, or for at least 25 years. (8)
6) Novel food, outcome of consultation in Austria
The manufacturer of the spermidine-sprouted buckwheat food supplement, Optimize Health, had in turn activated a consultation procedure in Austria regarding its novel food status under Reg. (EU) 2018/456. (9) Late and recklessly, since the product was meanwhile already on the market. And the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) – ironically, just days after the EUCJ ruling – provided a similar response, meanwhile published in the Novel Food Catalogue.
The Austrian ministry, in addition to the arguments highlighted by EUCJ, adds that spermidine acts as a biostimulant in the germination process and is absorbed by the achene to increase concentration. The use of spermidine and its salts (e.g., spermidine trichlorohydrate) as fertilizers or biostimulants in agriculture, nonetheless, is a practice without a ‘significant industrial history‘ in the EU. And so, consequently, does the consumption of products obtained from such practices.
7) Interim Conclusions
Neither buckwheat, its sprouts, nor spermidine and other polyamines extracted by traditional methods-with at least 25 years of documented history of use and consumption within the EU-qualify as novel foods.
Process innovations, on the other hand, must be considered carefully, in light of the EUCJ ruling under review, whenever they result in‘significant changes in the composition or structure of the food such as to affect its nutritional value, metabolism or content of undesirable substances’ (EU Reg. 2015/2283, Article 4.2).
Moreover, the extreme vagueness of the rule under consideration is likely to halt food innovation in the Old Continent, particularly with regard to the use of enzymes and microorganisms for technological functions, such as reducing sugars in fruit juices. And the recent opinion of the European Commission, which in the example of fruit juices ruled out being novel foods, may be contradicted by EUCJ, which we recall is the only official interpreter of EU rules. Therefore, a reform of these rules is necessary to ensure legal certainty. (10)
Dario Dongo and Andrea Adelmo Della Penna
Notes
(1) EU Court of Justice, ruling May 25, 2023. TLL The Longevity Labs GmbH v Optimize Health Solutions mi GmbH and BM. Reference for a preliminary ruling from the Landesgericht für Zivilrechtssachen Graz. Case C-141/22. https://curia.europa.eu/juris/liste.jsf?language=en&td=ALL&num=C-141/22
(2) European Commission. Flour from buckwheat seedlings with a high spermidine content. Application for consultation to determine the status of a novel food, pursuant to Article 4(2) of the Regulation (EU) 2015/2283 of the European Parliament and of the Council of November 25, 2015 on novel foods. Austria – Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) https://food.ec.europa.eu/system/files/2022-06/novel-food_consult-status_flour-buckwheat.pdf
(3) Dario Dongo, Andrea Adelmo Della Penna. Buckwheat, a resilient plant for gluten-free nutrition. GIFT (Great Italian Food Trade). 5.6.23
(4) Suzuki et al. (2021) Breeding of Buckwheat for Usage of Sprout and Pre-Harvest Sprouting Resistance. Plants 10(5):997, https://doi.org/10.3390/plants10050997
(5) Muñoz-Esparza et al. (2019) Polyamines in Food. Front. Nutr. 6:108, https://doi.org/10.3389/fnut.2019.00108
(6) Reza Amerian et al. (2023). The effect of spermidine and melatonin on antioxidant enzymes, the amount of routine active ingredient and yield in Buckwheat (Fagopyrum esculentum Moench) under drought stress. Crop Production 15(4):63-84, https://doi.org/10.22069/ejcp.2023.19969.2484
(7) Article 3(2)(a) of Regulation (EU) 2015/2283 contains the definition of novel food, along with a set of reference categories. In the case at hand, the preliminary question seeks to ask whether the alleged novel food belongs to the category listed in (iv), namely ‘foods consisting of, isolated from, or produced by plants or parts thereof, except foods that have a history of safe use as food in the Union and are consisting of, isolated from, or produced by a plant or variety of the same species obtained by: – traditional breeding practices used for food production in the Union prior to May 15, 1997, or – non-traditional breeding practices not used for food production in the Union prior to May 15, 1997 where such practices do not result in significant changes in the composition or structure of the food that would affect its nutritive value, metabolism, or content of undesirable substances‘
(8) The reg. EU 2015/2283 refers only to ‘‘history of safe use as a food in a third country’: […] attested by data on its composition and experience of its continued use, over a period of at least 25 years, in the usual diet of a significant number of people in at least one third country […]..’ The Advocate General noted that this notion is also applicable to ‘history of safe use as food within the Union‘, referred to in Article 3.2.a.iv of reg. EU 2015/2283
(9) Commission implementing Regulation (EU) 2018/456, on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283
(10) Dario Dongo, Andrea Adelmo Della Penna. Horizon4Proteins. Protein research confronted with EU policies and rules. GIFT (Great Italian Food Trade). 21.5.23
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.
