Details

Autor(en) / Beteiligte

• 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
• Prieto Maradona, Miguel
• Neuhäuser‐Berthold, Monika
• Poulsen, Morten
• Schlatter, Josef Rudolf
• Siskos, Alexandros
• Loveren, Henk
• Glymenaki, Maria
• Kouloura, Eirini
• Knutsen, Helle Katrine

Titel

Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283

Ist Teil von

• EFSA journal, 2024-03, Vol.22 (3), p.e8645-n/a

Ort / Verlag

United States: John Wiley & Sons, Inc

Erscheinungsjahr

2024

Link zum Volltext

Quelle

Wiley Online Library Journals

Beschreibungen/Notizen

• 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 ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%–2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day.