Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women
Open accessAbstract
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a supplementary dietary exposure and safety assessment of synthetic l-ergothioneine for those groups of the population which had been excluded by the applicant in the original application, i.e. infants and young children (i.e. toddlers), pregnant and breastfeeding women. Thus, intake estimates were calculated for these population groups and the following maximum anticipated daily intakes of l-ergothioneine from the NF, in addition to the background diet, were calculated: 2.82 mg/kg body weight (bw) per day for infants, 3.39 mg/kg bw per day for toddlers and 1.31 mg/kg bw per day for adults including pregnant and breastfeeding women. The Panel considers that based on the overall toxicological data the no-observed-adverse-effect level (NOAEL) of 800 mg/kg bw per day as established in the original assessment also pertains to pregnant and breastfeeding women as well as to young children (i.e. toddlers) and infants. The corresponding margins of exposure (i.e. the ratio between the NOAEL and the maximum anticipated daily intakes) are 284 for infants, 236 for young children and 610 for pregnant and breastfeeding women. These margins of exposure are considered sufficient. The Panel concludes that the novel food, synthetic l-ergothioneine, is safe under the proposed uses and use levels for infants, young children (i.e. toddlers) and pregnant and breastfeeding women.
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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 [362]
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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. R., Ackerl, R., & van Loveren, H.
- ORCID
- Venue
- EFSA Journal
- Publisher
- Wiley
- Published
- 2017-11
- Volume
- 15
- Issue
- 11
- Pages
- e05060-e05060
- ISSN
- 1831-4732 (ISSN-L)
- PMC
- PMC7010164
- OpenAlex
- W2769315410
- Cited by
- 62
- References
- 3
- Citations by year
- 2026: 8 · 2025: 16 · 2024: 9 · 2023: 11 · 2022: 6 · 2021: 4 · 2020: 4 · 2019: 2 · 2018: 1 · 2017: 1
- FWCI
- 2.46
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nd
- Locations
- EFSA Journal (publishedVersion, cc-by-nd)
- PubMed Central (publishedVersion, cc-by-nd)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (publishedVersion, cc-by-nd)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by-nd)
- 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 › Plant Science › Mycotoxins in Agriculture and Food
- Keywords
- L-ergothioneine, novel foods, dietary exposure assessment, infants, young children, pregnant women, lactating women, no-observed-adverse-effect level, margin of exposure, food safety
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