TY - JOUR
T1 - Statement on the safety of synthetic L-ergothioneine as a novel food
T2 - supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women
AU - Turck, Dominique
AU - Bresson, Jean Louis
AU - Burlingame, Barbara
AU - Dean, Tara
AU - Fairweather-Tait, Susan
AU - Heinonen, Marina
AU - Hirsch-Ernst, Karen Ildico
AU - Mangelsdorf, Inge
AU - McArdle, Harry J.
AU - Naska, Androniki
AU - Neuhauser-Berthold, Monika
AU - Nowicka, Grażyna
AU - Pentieva, Kristina
AU - Sanz, Yolanda
AU - Siani, Alfonso
AU - Sjödin, Anders
AU - Stern, Martin
AU - Tomé, Daniel
AU - Vinceti, Marco
AU - Willatts, Peter
AU - Engel, Karl-Heinz
AU - Marchelli, Rosangela
AU - Pöting, Annette
AU - Poulsen, Morten
AU - Schlatter, Josef Rudolf
AU - Ackerl, Reinhard
AU - van Loveren, Henk
N1 - Publisher Copyright:
© 2017 European Food Safety Authority.
This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
PY - 2017/11
Y1 - 2017/11
N2 - 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.
AB - 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.
KW - Food supplements
KW - L-ergothioneine
KW - Novel foods
UR - http://www.scopus.com/inward/record.url?scp=85137707248&partnerID=8YFLogxK
U2 - 10.2903/J.EFSA.2017.5060
DO - 10.2903/J.EFSA.2017.5060
M3 - Article
AN - SCOPUS:85137707248
SN - 1831-4732
VL - 15
JO - EFSA Journal
JF - EFSA Journal
IS - 11
M1 - 5060
ER -