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Commission authorizes aqueous ethanolic extract of Labisia pumila as a novel food

European Union

May 17, 2023

The NF is a standardised hydroalcoholic extract from a dried whole plant (including roots) of L. pumila, mixed with maltodextrin (as a drying aid), and proposed by the applicant to be used as a food supplement in amounts up to 750 mg/day. The target population is the general adult population, except pregnant and lactating women. The major constituents of this NF are carbohydrates (up to 85.5%), with a smaller amount of proteins (up to 6.5%), gallic acid (up to 3.7%) and fats (up to 1.6%). EFSA had considered that taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. The provided genotoxicity studies do not raise concerns about the genotoxicity of the NF. Based on the available toxicological data, the Panel considered an intake of up to 5 mg/kg body weight per day as safe. For the target population, this level corresponds to 350 mg/day, which is lower than the use level proposed by the applicant. The Panel concluded that the NF is safe for the target population up to 350 mg/day.


Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘Aqueous ethanolic extract of Labisia pumila

Specified food category

Maximum levels


The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘aqueous ethanolic extract of Labisia pumila’.



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.


Authorised on 6 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Medika Natura Sdn. Bhd., No. 44B Jalan Bola Tampar 13/14 Section 13, 40100 Shah Alam Selangor, Malaysia. During the period of data protection, the novel food aqueous ethanolic extract of Labisia pumila is authorised for placing on the market within the Union only by Medika Natura Sdn. Bhd., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Medika Natura Sdn. Bhd.

End date of the date protection: 6 June 2028.’

Food supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women

350 mg/day

Cf. Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470

For further information (in English), click on the Link

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