Requestor: European Commission Question number: EFSA-Q-2019-00759 Correspondence: nif@efsa.europa.euPeer reviewedPublisher PD

Bohn, Torsten

Castenmiller, Jacqueline

Cubadda, Francesco

De Henauw, Stefaan

Frenzel, Thomas

Heinonen, Marina

Hirsch‐Ernst, Karen Ildico

Knutsen, Helle Katrine

Maciuk, Alexandre

Mangelsdorf, Inge

Marchelli, Rosangela

McArdle, Harry J

Naska, Androniki

Neuhäuser‐Berthold, Monika

Pelaez, Carmen

Pentieva, Kristina

Poulsen, Morten

Prieto Maradona, Miguel

Schlatter, Josef Rudolf

Siani, Alfonso

Thies, Frank

Tsabouri, Sophia

Turck, Dominique

Turla, Emanuela

van Loveren, Henk

Vinceti, Marco

EFSA Journal

English

PubMed

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

PubMed Central

Safety of freeze‐dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283

Requestor: European Commission Question number: EFSA-Q-2019-00759 Correspondence: nif@efsa.europa.euPeer reviewe

Hirsch-Ernst, Karen Ildico

Neuhäuser-Berthold, Monika

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)

Aberdeen University Research

Safety of freeze-dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283

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 beta-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

McArdle, Harry J.

Neuhauser-Berthold, Monika

Maradona, Miguel Prieto

Nutr Novel Foods Food A, EFSA Panel

Ghent University Academic Bibliography

https://aura.abdn.ac.uk/bitstream/2164/20516/1/Turck_etal_EFSAJ_Safety_Of_Freeze_Dried_VoR.pdf

Safety of freeze-dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283

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Aberdeen University Research

Ghent University Academic Bibliography