TY - JOUR
T1 - Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J.
AU - Naska, Androniki
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Aguilera-Gómez, Margarita
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Marchelli, Rosangela
AU - Neuhäuser-Berthold, Monika
AU - Peláez, Carmen
AU - Poulsen, Morten
AU - Maradona, Miguel Prieto
AU - Schlatter, Josef Rudolf
AU - Siskos, Alexandros
AU - van Loveren, Henk
AU - Magani, Maura
AU - Muñoz, Alejandra
AU - Rossi, Annamaria
AU - Knutsen, Helle Katrine
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - Publisher Copyright:
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2024/1/24
Y1 - 2024/1/24
N2 - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on HelixComplex Snail Mucus (HSM) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of snail mucus collected from Helix aspersa maxima and is proposed to be used by adults as a food supplement. The data provided by the applicant about the composition and stability of the NF together with the report of the subchronic toxicity study were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the certificates of analysis and of the data on the subchronic toxicity provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.
AB - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on HelixComplex Snail Mucus (HSM) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of snail mucus collected from Helix aspersa maxima and is proposed to be used by adults as a food supplement. The data provided by the applicant about the composition and stability of the NF together with the report of the subchronic toxicity study were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the certificates of analysis and of the data on the subchronic toxicity provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.
KW - food supplement
KW - novel foods
KW - snail
KW - snail mucus
UR - http://www.scopus.com/inward/record.url?scp=85182993821&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/38269034
U2 - 10.2903/j.efsa.2024.8492
DO - 10.2903/j.efsa.2024.8492
M3 - Article
C2 - 38269034
AN - SCOPUS:85182993821
SN - 1831-4732
VL - 22
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - e8492
ER -