Rebaudioside M, a sweetener derived from stevia through GMO enzymes and yeasts, has been authorized through EU Regulation 2021/1156. (1)
The authorization follows EFSA’s two-year scientific assessment of the absence of health risks to consumers. (2)
The resulting product is distinguished by special code from other steviol glycosides in the list of authorized additives in the EU.
Stevia rebaudiana and Rebuaudioside M
Stevia rebaudiana Bertoni
, the ‘sweet herb,’ has garnered increasing interest from the agribusiness supply chain in recent years. In fact, steviol glycosides extracted from its leaves are the first Non-Nutritive Sweeteners (calorie-free sweeteners) of natural origin, in addition to being stable at high temperatures. Their use has therefore become widespread, as an additive inBulk Sweeteners (bulk sweeteners, e.g., erythritol), to replace sugar. At the bar but also in the kitchen, in artisanal and industrial food production. (3)
Rebaudioside M, present in the plant in low concentrations, is one of several steviol glycosides. And it differs from the others in its sensory profile, which is more like table sugar, with less bitter and/or metallic aftertaste. (4) The industry has therefore devoted itself to developing an innovative production method to increase the yield of this active ingredient.
Rebuaudioside M, the production method
The Rebaudioside M production method, described in the EFSA opinion, involves the use of enzymes produced and extracted from GMO yeasts, of which no trace remains in the finished product) on a purified leaf extract. The process consists of three steps:
1) Enzyme production. The enzymes are produced in batches by genetically modified Komagaetella phaffii yeasts for the purpose of converting steviol glycosides present in the leaf extract to Rebaudioside M,
2) production of Rebaudioside M. Enzymes are added to the extract so as to initiate the bioconversion reaction that leads to the formation of the desired steviol glycoside,
3) purification of Rebaudioside M. The use of solvents, condensation and crystallization allow crystals to be treated with activated carbon, dried and processed to extract a finished product of high purity (> 95%).
Less sugar, more health?
Reducing simple sugars in the diet is certainly an important health benefit, as confirmed by EFSA’s recent interim opinion. In the face of evidence of correlations between excessive sugar consumption and the risk of developing chronic metabolic diseases, as well as dental caries. (5)
Excessive intake of steviol glycosides and polyols, on the other hand, may result in a laxative effect. And it could possibly induce alterations in the microbiota that have been found in animal tests (pregnant women then mothers and pups). Pending further studies that can confirm a genuinely positive balance of the use of these plant-based sweeteners. (6)
Information about the applicant
Sweegen is a U.S.-based sweetener company, the first to obtain a favorable EFSA opinion on the marketing of a steviol glycoside obtained from alternative technologies. Its Bestevia® Reb M has been produced since 2017 and is distributed in several countries around the world.
Sweegen’s goal is to gain significant market share, including in Europe, also taking into account the goals of UNESDA – Soft Drink Europe. Reduce sugar in soft drinks, -10% over the period 2019-2025, so as to achieve an overall reduction of 33% in a quarter century (from 2000). (7)
New additive codes and transition period
Regulation (EC) No. 1333/08, on food additives, has been updated by replacing the current E 960 (steviol glycosides) nomenclature with the two codes:
– E 960a, Steviol glycosides from Stevia,
– E 960c, Enzymatically produced steviol glycosides.
The change was reflected in Regulation (EU) 231/2012. (8) Products still bearing the words E 960 – steviol glycosides and foods referring to them, ‘labeled or placed on the market‘ up to 18 months after 2.8.21 and complying with the former rules may be marketed by that date (EU Reg. 2021/1156, Article 3).
Dario Dongo and Andrea Adelmo Della Penna
Notes
(1) European Union (2021) Commission Regulation (EU) 2021/1156 of July 13, 2021 Amending Annex II of Regulation (EC) No. 1333/2008 of the European Parliament and of the Council and the Annex to Regulation (EU) No. 231/2012 by the Commission regarding steviol glycosides (E 960) and rebaudioside M produced by enzymatic modification of steviol glycosides from Stevia. EUR-Lex. https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32021R1156
(2) EFSA FAF Panel (2019). Safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: Rebaudioside M produced via enzyme-catalysed bioconversion of purified stevia leaf extract. EFSA Journal 17(10):5867. https://doi.org/10.2903/j.efsa.2019.5867
(3) Dario Dongo. Stevia, sweet superfood at biotech risk. GIFT(Great Italian Food Trade), 2.4.18. https://www.greatitalianfoodtrade.it/dolcificare/stevia-dolce-superfood-a-rischio-biotech
(4) Wang et al. (2021) Comparative transcriptomic of Stevia rebaudiana provides insight into rebaudioside D and rebaudioside M biosynthesis. Plant Physiology and Biochemistry 167:541-549, https://doi.org/10.1016/j.plaphy.2021.08.028
(5) EFSA. Safety of dietary sugars: published draft opinion for public consultation. 7/22/2021, https://www.efsa.europa.eu/it/news/safety-dietary-sugars-draft-opinion-open-public-consultation
(6) Camilla Fincardi and Dario Dongo. Intensive sweeteners, microbiome and health risks. Scientific study. GIFT(Great Italian Food Trade), 1.3.20, https://www.greatitalianfoodtrade.it/sicurezza/dolcificanti-intensivi-microbioma-e-rischi-per-la-salute-studio-scientifico
(7) UNESDA. Europe’s soft drinks industry announces new commitment to reduce average added sugars in its beverages by another 10% across Europe. 6/29/21, https://www.unesda.eu/wp-content/uploads/2021/06/UNESDA-new-sugar-reduction-commitment-_PRESS-RELEASE.pdf
(8) Reg. EU 231/2012, Establishing specifications for food additives listed in Annexes II and III of Regulation (EC) No. 1333/2008. Consolidated text as of 3.8.21 on Europa Lex, https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32012R0231&qid=1630306874498
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.
