Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai): authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC for adult population: 175 mg/day

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)’. The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition

The mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray drying

Composition of the extract of mixture of the 3 herbal roots

Cynanchum wilfordii root: 32,5 % (w/w)

Phlomis umbrosa root: 32,5 % (w/w)

Angelica gigas root: 35,0 % (w/w)

Specifications

Loss on drying: NMT 100 mg/g

Assay

Cinnamic acid: 0,012 - 0,039 mg/g

Shanzhiside methyl ester: 0,20 - 1,55 mg/g

Nodakenin: 3,35 - 10,61 mg/g

Methoxsalen: < 3 mg/g

Phenols: 13,0 - 40,0 mg/g

Coumarins: 13,0 - 40,0 mg/g

Iridoids: 13,0 - 39,0 mg/g

Saponins: 5,0 - 15,5 mg/g

Nutritive components

Carbohydrates: 600 - 880 mg/g

Proteins: 70 - 170 mg/g

Fats: < 4 mg/g

Microbiological parameters

Total viable plate count: < 5000 CFU/g

Total mold and yeast: < 100 CFU/g

Coliform bacteria: < 10 CFU/g

Salmonella: Negative/25 g

Escherichia coli: Negative/25 g

Staphylococcus aureus: Negative/25 g

Heavy metals

Lead: < 0,65 mg/kg

Arsenic: < 3,0 mg/kg

Mercury: < 0,1 mg/kg

Cadmium: < 1,0 mg/kg

CFU: Colony Forming Units

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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