The European Commission has started 2023 with the green light to a series of novel foods on proteins from mushrooms, rice and peas, insects, milk. In addition to some oligosaccharides identical to those present in breast milk. Below is a brief review of the new foods authorized in the EU.
1) MUSHROOMS
1.1) Pea and rice protein, fermented from Shiitake mushroom
Shiitake, Lentinula edodes, is the protagonist of the cultivation and consumption of mushrooms (fresh and dried) in the Asian tradition. From Thailand to China to Korea and Japan. The USA MycoTechnology Inc. group used it in the fermentation of pea and rice concentrates, which were then subjected to spray drying, to obtain a fine powder (FermentIQ™). with a high content of vegetable proteins (> 75%) and free from allergens. (1)
The historicity of use of raw materials did not make it necessary to investigate toxicological and allergenic aspects. On the other hand, it status of traditional food in the EU was recognized only to the whole Shiitake mushroom and not also to the dried and dehydrated one. Permission is granted with exclusivity, for use in a myriad of foods. Baked goods, beverages, soups, meats, meat substitutes (as already other mycoproteins), meal replacements, etc., even at significant concentrations.(2)
1.2) Anthrodia camphorata in powder
Anthrodia camphorata is the mushroom also known as 'niu-chang-chih', The Taiwanofungus camphoratus. It is used in traditional Chinese medicine but also (mycelia and fruiting bodies) as an ingredient in various foods and beverages.
Golden Biotechnology Corp has requested non-exclusive authorization for use only in food supplements. (3) With favorable outcome for products intended for subjects aged > 14 years, in the absence of safety data for infants and children. (4)
1.3) Mushroom powder champignon containing vitamin D2
Monterey Mushrooms Inc. has received exclusive authorization for the marketing of a mushroom powder champignon (Agaricus bisporus), obtained by dehydration and grinding of the product irradiated with UV radiation. (5)
The product it is intended for various conventional foods (e.g. dairy products, soft drinks), as well as food supplements and diet-therapeutic foods (meal replacements for weight control, daily ration replacements and foods for special medical purposes. EU Reg. 609/2013).
They have been excluded ongoing infants (0-12 months) and small children (1-3 years), also due to some concerns about exposure to vitamin D, which has greatly increased due to theexploit of related supplements, according to the opinion of EFSA. (6)
1.4) Mushrooms Agaricus bisporus. novel food or trivial exclusives on traditional foods?
The mushrooms champignon (Agaricus bisporus) have been cultivated in Europe for some hundreds of years. Nonetheless, the European Commission has already granted four exclusive authorizations for the marketing of this 'novel foods', of which the existence of a ' is doubtedDisruptive innovation' compared to other foods already on the market.
More attention should therefore be dedicated – both in the application phase of reg. EU 2015/2283, and in its revision - to inhibit the instrumental use of the authorization procedure of novel foods with five-year exclusivity in favor of the applicant in via, to protect innovations not suitable for industrial patenting (see also the case of the so-called vegetable egg by Eat Just).
2) BUGS
2.1) Domestic cricket
The domestic cricket (acheta domesticus) has already received an authorization such as novel foods at the beginning of 2022, as seen. Only this year, however, the news has garnered populist reactions inspired by neophobia.
Nothing new substantial in this second authorization of the crickets as novel foods – again, exclusively in favor of the applicant – in the form of a degreased powder. Under conditions of use, by the way, very small (1–5%). (5) No gastronomic 'threats' in sight.
Cricket protein moreover, if taken as an alternative to red meat, they could improve the life expectancy and health of the populations. In addition to decreasing the number of years lost to disabling diseases (DALYs, Disability-Adjusted Life Years), such as already shown in the NovRBA research project.
2.2) Alfitobio
alphitobius diaperinus, known as the lesser mealworm, is a larva that develops into a beetle. Until now considered as a pest of grains and foodstuffs, it can in turn be exploited as food. And it has already been evaluated as safe, as well as nutritious, by the European Food Safety Authority (EFSA).
Ynsect NL BV has been exclusively authorized to place it on the market as novel food in dried, powdered, paste or frozen and freeze-dried form. The use as an ingredient for bread, pasta, pizzas, soups, snack and other foods has no age restrictions. Conversely, the use in food supplements was limited to an adult public (>18 years), at the request of the applicant. (6)
3) MILK PROTEINS
Arla Foods Ingredients Group P/S has obtained exclusive authorization to place on the EU market an isolate of β-lactoglobulin (BLG) from cow's milk whey, dried by spray drying. Il novel foods (≥ 90% dry matter protein) consists of BLG as the primary component (≥ 90% of total protein), equivalent to the BLG found in bovine milk and whey protein isolate.
The news is represented by the separation process by crystallization, in acidic or neutral conditions. The product is not indicated in case of allergies to soy (as well as to milk and soy, due to the lecithin it carries potential allergenicity, also due to the use of soy lecithin used as an emulsifier. (9)
Il novel foods it is authorized for use in soft drinks, including milk based, whey powder (reconstituted) and food for special medical purposes. (10)
4) Oligosaccharides
Some oligosaccharides identical to those found in human milk (HiMO, Human identical Milk Oligosaccharides) were likewise authorized as novel foods, in the last months.
4.1) Lacto-N-tetraose
Lacto-N-tetraose is a HiMO that Chr. Hansen A/S obtained from two strains of Escherichia coli BL21 (DE3) genetically modified. The same sugar, produced from the K-12 strain of E.Coli, has already been authorized as novel foods. And the same strain has in turn already been authorized to produce other HiMOs, lacto-N-neotetraose and 2'-fucosyllactose. (11)
The novel foods exclusively granted provides for the use of lacto-N-tetraose in:
- infant formula and follow-on formula,
- cereal-based foods and baby foods,
- milk-based drinks and similar for early childhood,
- food for special medical purposes (for infants, children and others),
- food supplements. The latter cannot be intended for children under 3 years of age nor be administered on the same day, where other lacto-N-tetraose-based foods are made. (12)
4.2) 3-fucosyllactose
3-fucosyllactose is another HiMO produced by fermentation of the genetically modified strain of Escherichia coli BL21 (DE3). Like lacto-N-tetraose, this oligosaccharide was also obtained via the K12 strain of E.Coli already authorized as novel foods. (13)
Chr. Hansen A/S requested and obtained permission as novel foods, also in this case with exclusivity, at conditions similar to those provided for lacto-N-tetraose. (14)
5) CORRECTIONS
The Union List of Novel Foods (ULNF) – contained in reg. (EU) 2017/2470 and subsequent amendments - some inaccuracies have been corrected. THE novel foods affected by the adjustments are:
- xylo-oligosaccharides (EU regulation 2018/1648). The specifications relating to xylooligosaccharides in the form of syrup have been integrated with the parameter 'dry material',
- sweet whey protein isolate from cow's milk (EU regulation 2019/1686). Correspondence between food categories and uses, as well as the maximum authorized levels, have been clarified,
- 3'–sialyl-lactose from microbial sources (EU Reg. 2021/96). The maximum levels for the category of 'Flavored fermented milk products, including heat treated products'were incorrectly added to the food category'unflavoured fermented milk products' and viceversa. (15)
6) Provisional conclusions
The reg. EU 2015/2283 (Novel Food Regulation) is demonstrating its effectiveness in promoting innovation in the agri-food sector, without ever disregarding a rigorous analysis of food safety risks.
It is observed also the growing development of research activities, also with the support of European (Horizon Europe) and Euro-Mediterranean (PRIMA) projects. Especially in the context of alternative and sustainable protein sources such as mushrooms, microalgae and insects.
They can be glimpsed thus new possible solutions to contribute to the objectives of food security e nutrition security agreed in the context of Sustainable Development Goals (SDGs), in the UN Agenda 2030.
# SDG2, Zero Hunger. # SDG3, Ensure Health and Well-being.
Dario Dongo and Andrea Adelmo Della Penna
Cover cartoon from 'Japanese cooking with manga' (Tuttle books, 2018) https://www.tuttlepublishing.com/japan/japanese-cooking-with-manga
Footnotes
(1) EFSA NDA Panel (2022). Safety of pea and rice protein fermented by Shiitake (Lentinula edodes) mycelia as a Novel food pursuant to Reg. (EU) 2015/2283. EFSAJournal 20 (4): 7205, https://doi.org/10.2903/j.efsa.2022.7205
(2) Reg. (EU) 2023/6, authorizing the placing on the market of pea and rice protein fermented from the mycelia of Lentinula edodes (Shiitake mushroom) as a novel food http://data.europa.eu/eli/reg_impl/2023/6/oj (effective 24.1.23)
(3) EFSA NDA Panel (2022). Safety of freeze‐dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283. EFSAJournal 20 (6): 7380 https://doi.org/10.2903/j.efsa.2022.7380
(4) Reg. (EU) 2022/2535, authorizing the placing on the market of freeze-dried powdered mycelia of Antrodia camphorata as a novel food http://data.europa.eu/eli/reg_impl/2022/2535/oj (effective 11.1.23)
(5) Commission Implementing Regulation (EU) 2023/4 of 3 January 2023 authorizing the placing on the market of mushroom powder containing vitamin D2 as a novel food and amending reg. (EU) 2017/2470 http://data.europa.eu/eli/reg_impl/2023/4/oj (effective 24.1.23)
(6) EFSA NDA Panel (2022). Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2019/1471). EFSAJournal 20 (6): 7326, https://doi.org/10.2903/j.efsa.2022.7326
(7) Reg. (EU) 2023/5, authorizing the placing on the market of partially defatted powder of Acheta domesticus (house cricket) as a novel food http://data.europa.eu/eli/reg_impl/2023/5/oj (effective 24.1.23)
(8) Reg. (EU) 2023/58, authorizing the placing on the market of frozen, paste, dried and powdered larvae of Alphitobius diaperinus (minor mealworm) as a novel food http://data.europa.eu/eli/reg_impl/2023/58/oj (effective 26.1.23)
(9) EFSA NDA Panel (2022). Safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283. EFSAJournal 20 (4): 7204 https://doi.org/10.2903/j.efsa.2022.7204
(10) Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022 authorizing the placing on the market of beta-lactoglobulin (β-lactoglobulin) from cow's milk as a novel food http://data.europa.eu/eli/reg_impl/2022/2534/oj (effective 11.1.23)
(11) EFSA NDA Panel (2022). Safety of lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSAJournal 20 (5): 7242, https://doi.org/10.2903/j.efsa.2022.7242
(12) Reg. (EU) 2023/7 authorizing the placing on the market of lacto-N-tetraose produced from derived strains of Escherichia coli BL21 (DE3) as a novel food http://data.europa.eu/eli/reg_impl/2023/7/oj (effective 24.1.23)
(13) EFSA NDA Panel (2022). Safety of 3-fucosyllactose (3-FL) produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSAJournal 20 (5): 7329, https://doi.org/10.2903/j.efsa.2022.7329
(14) Reg. (EU) 2023/52 authorizing the placing on the market of 3-fucosyllactose produced from a derived strain of Escherichia coli BL21(DE3) as a novel food http://data.europa.eu/eli/reg_impl/2023/52/oj (effective 25.1.23)
(15) Reg. (EU) 2023/65 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Implementing Regulation (EU) 2018/1648 authorizing the placing on the market of xylo-oligosaccharides as a novel food, Implementing Regulation (EU) 2019/1686 authorizing an extension of the use of sweet whey protein isolate from cow's milk as a novel food and Implementing Regulation (EU) 2021/96 authorizing the placing on the market of sodium salt of 3'-sialyl-lactose as a novel food http://data.europa.eu/eli/reg_impl/2023/65/oj (effective 29.1.23)
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.
