TY - JOUR
T1 - Safety of egg membrane hydrolysate as a novel food pursuant to Regulation (EU) 2015/2283
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel)
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 - Schlatter, Josef Rudolf
AU - Ackerl, Reinhard
AU - van Loveren, Henk
N1 - Publisher Copyright:
© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2018/7
Y1 - 2018/7
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 egg membrane hydrolysate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a water-soluble hydrolysate of egg membrane, produced by alkaline treatment of the thin layer lining the shells of chicken eggs. The main constituents of the NF are elastin, collagen and glycosaminoglycans. The information provided on the production process, batch-to-batch variability, composition and specifications of the NF is sufficient and does not raise safety concerns. The NF is proposed to be used as a food supplement for adults, at a maximum daily amount of 450 mg. The consumption of the NF is not nutritionally disadvantageous. One human study, which was not designed for safety but included a number of endpoints pertaining to safety, did not raise safety concerns. The Panel considers that taking into account the information provided and considering the nature, the source and the production process of the NF, there are no safety concerns for the NF at the proposed conditions of use. The Panel concludes that the NF, egg membrane hydrolysate, is safe as a food supplement at a dose of 450 mg/day. The target population for the NF is the general adult population.
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 egg membrane hydrolysate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a water-soluble hydrolysate of egg membrane, produced by alkaline treatment of the thin layer lining the shells of chicken eggs. The main constituents of the NF are elastin, collagen and glycosaminoglycans. The information provided on the production process, batch-to-batch variability, composition and specifications of the NF is sufficient and does not raise safety concerns. The NF is proposed to be used as a food supplement for adults, at a maximum daily amount of 450 mg. The consumption of the NF is not nutritionally disadvantageous. One human study, which was not designed for safety but included a number of endpoints pertaining to safety, did not raise safety concerns. The Panel considers that taking into account the information provided and considering the nature, the source and the production process of the NF, there are no safety concerns for the NF at the proposed conditions of use. The Panel concludes that the NF, egg membrane hydrolysate, is safe as a food supplement at a dose of 450 mg/day. The target population for the NF is the general adult population.
KW - egg membrane hydrolysate
KW - novel food
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=85062226952&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2018.5363
DO - 10.2903/j.efsa.2018.5363
M3 - Article
AN - SCOPUS:85062226952
SN - 1831-4732
VL - 16
JO - EFSA Journal
JF - EFSA Journal
IS - 7
M1 - e05363
ER -