(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

On 7 October 2019, the company Medika Natura Sdn. Bhd. (‘the applicant’, initially Orchid Life Sdn Bhd) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place aqueous ethanolic extract of Labisia pumila on the Union market as a novel food. The applicant requested for aqueous ethanolic extract of Labisia pumila to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) intended for the adult population, excluding pregnant and lactating women, at the maximum use level of 750 mg per day.

(4)

On 7 October 2019, the applicant also made a request to the Commission for the protection of proprietary data, namely, pharmacokinetic study in rats (4), bacterial reverse mutation test (5), in vitro mammalian chromosome aberration test (6), mammalian erythrocyte micronucleus test in mice (7), repeated dose (90 days) oral toxicity study in rats (8), solubility test (9), in vitro micronucleus test (10) and one year chronic toxicity test (11).

(5)

On 14 April 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of aqueous ethanolic extract of Labisia pumila as a novel food.

(6)

On 28 September 2022, the Authority adopted its scientific opinion on the ‘Safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to Regulation (EU) 2015/2283’ (12) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that aqueous ethanolic extract (1:1) of the whole plant of Labisia pumila mixed with maltodextrin (2:1) which serves as a drying aid, is safe for the target population at levels of up to 350 mg per day. Therefore, that scientific opinion gives sufficient grounds to establish that aqueous ethanolic extract of Labisia pumila, when used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for the adult population, excluding pregnant and lactating women, at the maximum use level of 350 mg per day, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the solubility test and toxicological information (studies on pharmacokinetics, genotoxicity, subchronic and chronic oral toxicity) without which it could not have assessed the novel food and reached its conclusion.

(9)

The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(10)

The applicant declared that it held proprietary and exclusive rights of reference to the pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11)

The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place aqueous ethanolic extract of Labisia pumila on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)

However, restricting the authorisation of aqueous ethanolic extract of Labisia pumila and the reference to the data contained in the applicant’s file for its sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(13)

It is appropriate that the inclusion of aqueous ethanolic extract of Labisia pumila as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In this regard, in line with the conditions of use of food supplements containing aqueous ethanolic extract of Labisia pumila as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers by appropriate labelling that food supplements containing aqueous ethanolic extract of Labisia pumila should only be consumed by adults excluding pregnant and lactating women.

(14)

Aqueous ethanolic extract of Labisia pumila should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,