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 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/972
• Articles: 5

Article 1

1.   Aqueous ethanolic extract of Labisia pumila is authorised to be placed on the market within the Union.

Aqueous ethanolic extract of Labisia pumila 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.

Article 2

Only the company Medika Natura Sdn. Bhd.  ( 13 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 6 June 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Medika Natura Sdn. Bhd.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Medika Natura Sdn. Bhd.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

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

Data protection

‘ Aqueous ethanolic extract of Labisia pumila

Specified food category

Maximum levels

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.

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

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specification

‘ Aqueous ethanolic extract of Labisia pumila

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: < 1×10 4 CFU/g

Yeast and mould: < 5×10 2 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’