COMMISSION IMPLEMENTING REGULATION (EU) 2022/2535
of 21 December 2022
authorising the placing on the market of the freeze-dried powder form of
Antrodia camphorata
mycelia as a novel food and amending Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
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‘ Antrodia camphorata mycelia powder |
Specified food category |
Maximum levels |
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Food supplements as defined in Directive 2002/46/EC, excluding infants, children, and adolescents younger than 14 years of age |
990 mg/day |
Authorised novel food |
Specification |
‘ Antrodia camphorata mycelia powder |
Description/Definition: The novel food is the freeze-dried mycelia of the fungus Antrodia camphorata (strain BCRC 39106), which has been grown by solid-state cultivation. The freeze-dried mycelia are then milled into a powder. Antrodia camphorata is a synonym of Taiwanofungus camphoratus (family: Fomitopsidaceae). Characteristics/Composition: Loss on drying (Moisture): < 10 % Carbohydrates: ≤ 80 g/100 g Protein: ≤ 20 g/100 g Ash: ≤ 6 g/100g Fat: ≤ 6 g/100 g Total triterpenoids: 1,0 – 10,0 g/100 g Antroquinonol: 1,0 – 20,0 mg/g Heavy metals: Arsenic: < 0,5 mg/kg Microbiological criteria: Total aerobic microbial count: ≤ 103 *CFU/g Total yeast and mould count: ≤ 100 CFU/g Escherichia coli: Not detected in 10 g Salmonella spp.: Not detected in 25 g Staphylococcus aureus: Not detected in 10 g *CFU: Colony Forming Units’ |