TY - JOUR
T1 - Safety of synthetic N-acetyl-d-neuraminic acid as a novel food pursuant to Regulation (EC) No 258/97
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
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 - Neuhäuser-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 - Turla, Emanuela
AU - van Loveren, Henk
N1 - Publisher Copyright:
© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2017/7/1
Y1 - 2017/7/1
N2 - 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 N-acetyl-d-neuraminic acid (NANA) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information on the composition, the specifications, the batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is intended to be marketed as an ingredient in formulae and foods for infants and young children as well as an ingredient in a variety of foods and in food supplements for the general population. NANA is naturally present in human milk, in a bound and free form. The Margin of Exposure, which was based on the no-observed-adverse effect level (NOAEL) of 493 mg/kg body weight (bw) per day from a subchronic study and the anticipated daily intake of the NF, was considered to be sufficient for fortified foods for the general population and for food supplements for individuals above 10 years of age, as the anticipated daily intake was in the range of the exposure to free NANA from the consumption of early human milk, which is considered to be safe. The Panel concludes that the NF is safe when added to foods other than food supplements at the proposed uses and use levels for the general population; is safe in food supplements alone at the proposed uses and use levels for individuals above 10 years of age; is safe at the combined intake from fortified foods plus food supplements in individuals above 10 years of age; the safety of the NF is not established in food supplements alone at the proposed uses and use levels for individuals below 10 years of age.
AB - 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 N-acetyl-d-neuraminic acid (NANA) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information on the composition, the specifications, the batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is intended to be marketed as an ingredient in formulae and foods for infants and young children as well as an ingredient in a variety of foods and in food supplements for the general population. NANA is naturally present in human milk, in a bound and free form. The Margin of Exposure, which was based on the no-observed-adverse effect level (NOAEL) of 493 mg/kg body weight (bw) per day from a subchronic study and the anticipated daily intake of the NF, was considered to be sufficient for fortified foods for the general population and for food supplements for individuals above 10 years of age, as the anticipated daily intake was in the range of the exposure to free NANA from the consumption of early human milk, which is considered to be safe. The Panel concludes that the NF is safe when added to foods other than food supplements at the proposed uses and use levels for the general population; is safe in food supplements alone at the proposed uses and use levels for individuals above 10 years of age; is safe at the combined intake from fortified foods plus food supplements in individuals above 10 years of age; the safety of the NF is not established in food supplements alone at the proposed uses and use levels for individuals below 10 years of age.
KW - N-acetyl-d-neuraminic acid
KW - NANA
KW - ingredient
KW - novel food
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=85078394520&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2017.4918
DO - 10.2903/j.efsa.2017.4918
M3 - Article
AN - SCOPUS:85078394520
SN - 1831-4732
VL - 15
JO - EFSA Journal
JF - EFSA Journal
IS - 7
M1 - e04918
ER -