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.
Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283 / Null, Null; Turck, Dominique; Bohn, Torsten; Castenmiller, Jacqueline; De , ; Henauw, Stefaan; Hirsch‐ernst, Karen Ildico; Maciuk, Alexandre; Mangelsdorf, Inge; Mcardle, Harry J.; Naska, Androniki; Pentieva, Kristina; Siani, Alfonso; Thies, Frank; Tsabouri, Sophia; Vinceti, Marco; Aguilera‐gómez, Margarita; Cubadda, Francesco; Frenzel, Thomas; Heinonen, Marina; Marchelli, Rosangela; Neuhäuser‐berthold, Monika; Peláez, Carmen; Poulsen, Morten; Maradona, Miguel Prieto; Schlatter, Josef Rudolf; Siskos, Alexandros; van Loveren, Henk; Magani, Maura; Muñoz, Alejandra; Rossi, Annamaria; Knutsen, Helle Katrine. - In: EFSA JOURNAL. - ISSN 1831-4732. - 22:1(2024), pp. 1-10. [10.2903/j.efsa.2024.8492]
Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283
Vinceti, Marco;Marchelli, Rosangela;
2024
Abstract
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.
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