Aqueous ethanolic extract of Labisia pumila: 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 the adult population, excluding pregnant and lactating women: 350 mg/day

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘aqueous ethanolic extract of Labisia pumila’. 2. The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 18 years of age excluding pregnant and lactating women.

Specification (Table 2)

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

Description/Definition:

The novel food is a hydroalcoholic extract obtained from a dried whole plant of Labisia pumila (Blume) Fern.-Vill.

The production process of the novel food starts with washing, drying and grinding of the plant Labisia pumila. The ground plant material is then extracted twice with a mixture of water and ethanol (50/50 v/v). The liquid extract is then concentrated, mixed with maltodextrin (which is used as a drying aid) in a ratio of 2:1 and spray-dried.

Characteristics/composition (including maltodextrin):

Particle size: > 90 % through 120 mesh (125 μm)

Ash: < 10 %

Acid-insoluble ash: < 1 %

Moisture: < 8 %

Ethanol: < 1 % (w/w)

Gallic acid: 2-10 % (w/w)

Carbohydrate: 70-90 g/100 g

Protein: < 9 % (w/w)

Total fat: < 3 % (w/w)

Saponin (as ardisiacripsin A): < 1,5 % (w/w)

Microbiological criteria:

Aerobic plate count: < 1×104 CFU/g

Yeast and mould: < 5×102 CFU/g

E. coli: not detected in 10 g

S.aureus: not detected in 10 g

Salmonella: not detected in 25 g

P. aeruginosa: not detected in 10 g

cfu: colony forming units

w/w: weight per weight

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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