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Cited by 39Agricultural safety and regulationsDye analysis and toxicityFood and Agricultural Sciences

Safety of synthetic l‐ergothioneine (Ergoneine®) as a novel food pursuant to Regulation (EC) No 258/97

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EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Turck, Dominique, Bresson, Jean‐Louis, Burlingame, Barbara, Dean, Tara, Fairweather‐Tait, Susan, Heinonen, Marina, Hirsch‐Ernst, Karen Ildico +20 more·2016·EFSA Journal
DOI 10.2903/j.efsa.2016.4629
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Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on synthetic L-ergothioneine, marketed as Ergoneine ® , as a novel food submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council.The novel food, synthetic L-ergothioneine, is produced by a one-pot patented manufacturing process.Chemically, L-ergothioneine is a derivative of thiolhistidine, and it is naturally present in a number of foodstuffs such as mushrooms, some varieties of black and red beans, offal and cereals.The production process for the novel food is sufficiently described and does not raise concerns about the safety of the novel food.The information on the composition, specifications, batch-to-batch variability and stability of the novel food is sufficient and does not raise safety concerns.The applicant intends to use the novel food in quantities of up to 5 mg per serving in alcohol-free beverages, cereal bars, milk, fresh dairy products and chocolate.The applicant also proposes to provide the novel food as a food supplement, with a daily dose of up to 30 mg/day for adults and 20 mg/day for children.The target population is children above 3 years of age and the general adult population, except pregnant and breastfeeding women.Considering the NOAEL of 800 mg/kg bw per day, which was based on two subchronic toxicity studies in rats, and the maximum estimated intake levels for L-ergothioneine from all sources, the Panel concludes that the margins of safety of 470 for adults (except pregnant and breastfeeding women) and of 216 for children above 3 years of age are sufficient.The Panel concludes that the novel food, synthetic L-ergothioneine (marketed as Ergoneine ® ), is safe under the intended conditions of use as specified by the applicant.

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  • A number of high-dose studies indicate ERG is safe for mammalian consumption at levels far in excess of those likely in foodstuffs, and it has been declared safe by EFSA.

    “Notwithstanding the highly variable intake between individuals(358), however, a number of high-dose studies have indicated that ERG is safe for mammalian consumption at levels far in excess of those likely to be encountered in foodstuffs(125,131,359,360), and it has been declared safe by relevant committees such as those of the European Food Standards Agency(361,362).”

    From The biology of ergothioneine, an antioxidant nutraceutical (2020) · cites this paper as [361]

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Authors
EFSA Panel on Dietetic Products, N. A. A. (., Turck, D., Bresson, J., Burlingame, B., Dean, T., Fairweather‐Tait, S., Heinonen, M., Hirsch‐Ernst, K. I., Mangelsdorf, I., McArdle, H. J., Naska, A., Neuhäuser‐Berthold, M., Nowicka, G., Pentieva, K., Sanz, Y., Siani, A., Sjödin, A., Stern, M., Tomé, D., Vinceti, M., Willatts, P., Engel, K., Marchelli, R., Pöting, A., Poulsen, M., Schlatter, J., Ackerl, R., & van Loveren, H.
Affiliations
European Food Safety Authority (IT)
ORCID
Venue
EFSA Journal
Publisher
Wiley
Published
2016-11
Volume
14
Issue
11
ISSN
1831-4732 (ISSN-L)
DOI
10.2903/j.efsa.2016.4629
OpenAlex
W2553156460
Cited by
39
References
47
Citations by year
2026: 6 · 2025: 5 · 2024: 4 · 2023: 5 · 2022: 3 · 2021: 6 · 2020: 5 · 2019: 3 · 2017: 2
FWCI
2.10
Type
journal article
Language
en
Open access
Licence
cc-by-nd
Locations
  • EFSA Journal (publishedVersion, cc-by-nd)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
  • Ulster University Research Portal (Ulster University) (publishedVersion, other-oa)
  • IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by-nd)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Työväentutkimus Vuosikirja (submittedVersion)
  • Technical University of Denmark, DTU Orbit (Technical University of Denmark, DTU) (submittedVersion, other-oa)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
  • Physical Sciences › Chemistry › Analytical Chemistry › Dye analysis and toxicity
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Food and Agricultural Sciences
Keywords
L-ergothioneine, novel foods, food safety assessment, subchronic toxicity, no-observed-adverse-effect level, safety margin, dietary supplements, dietary exposure

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