TY - JOUR
T1 - Safety of freeze-dried mycelia of Antrodia camphorata 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 - Pelaez, Carmen
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Marchelli, Rosangela
AU - Neuhäuser-Berthold, Monika
AU - Poulsen, Morten
AU - Prieto Maradona, Miguel
AU - Schlatter, Josef Rudolf
AU - van Loveren, Henk
AU - Turla, Emanuela
AU - Knutsen, Helle Katrine
AU - EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
N1 - © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
PY - 2022/6/29
Y1 - 2022/6/29
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 freeze-dried mycelia of
Antrodia camphorata as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced by solid-state cultivation from tissue cultures derived from the fungus
Antrodia camphorata. The applicant intends to market the NF in food supplements at a maximum dose of 990 mg per day. The target population is the general population. The NF mainly consists of carbohydrates, proteins and fats, and it contains numerous constituents, such as β-glucans, antroquinonol and triterpenoids. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day repeated dose toxicity study and a prenatal developmental toxicity study performed with the NF, the Panel derives a safe level of 16.5 mg/kg body weight per day. The Panel concludes that the NF, freeze-dried mycelia of
Antrodia camphorata, is safe at the proposed use level for individuals aged 14 years and above.
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 freeze-dried mycelia of
Antrodia camphorata as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced by solid-state cultivation from tissue cultures derived from the fungus
Antrodia camphorata. The applicant intends to market the NF in food supplements at a maximum dose of 990 mg per day. The target population is the general population. The NF mainly consists of carbohydrates, proteins and fats, and it contains numerous constituents, such as β-glucans, antroquinonol and triterpenoids. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day repeated dose toxicity study and a prenatal developmental toxicity study performed with the NF, the Panel derives a safe level of 16.5 mg/kg body weight per day. The Panel concludes that the NF, freeze-dried mycelia of
Antrodia camphorata, is safe at the proposed use level for individuals aged 14 years and above.
UR - https://pubmed.ncbi.nlm.nih.gov/35784815
U2 - 10.2903/j.efsa.2022.7380
DO - 10.2903/j.efsa.2022.7380
M3 - Article
C2 - 35784815
SN - 1831-4732
VL - 20
SP - e07380
JO - EFSA Journal
JF - EFSA Journal
IS - 6
ER -