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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. The freeze-dried powder form of Antrodia camphorata mycelia is authorised to be placed on the market within the Union. The freeze-dried powder form of Antrodia camphorata mycelia shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. 2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the following entry is inserted: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘ Antrodia camphorata mycelia powder Specified food category Maximum levels 1. The designation of the novel food on the labelling of food supplements containing it shall be ‘ Antrodia camphorata mycelia powder’. 2. The labelling of the food supplements containing Antrodia camphorata mycelia powder shall bear a statement that this food supplement should not be consumed by infants, children, and adolescents younger than 14 years of age.’ Food supplements as defined in Directive 2002/46/EC, excluding infants, children, and adolescents younger than 14 years of age 990 mg/day (2) in Table 2 (Specifications), the following entry is inserted: 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: ≤ 10 3 * 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’
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