
Article 1 

1. Extract from Panax notoginseng and Astragalus membranaceus as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial applicant:
— Company: NuLiv Science,
— Address: 1050 W. Central Ave., Building C, Brea, CA 92821, USA,is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of NuLiv Science.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
Article 2 
The data contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, 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 NuLiv Science.
Article 3 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 2 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
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
‘Extract from Panax notoginseng and Astragalus membranaceus Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extract from Panax notoginseng and Astragalus membranaceus’The labelling of food supplements containing extract from Panax notoginseng and Astragalus membranaceus shall bear a statement that those food supplements should not be consumed by the population under 18 years of age and by pregnant women.  Authorised on 23 December 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.Applicant: NuLiv Science, 1050 W. Central Ave., Building C, Brea, CA 92821, USA.During the period of data protection, the novel food is authorised for placing on the market within the Union only by NuLiv Science, unless a subsequent applicant obtains authorisation for that 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 NuLiv Science.End date of the data protection: 23 December 2025. ’
Food supplements as defined in Directive 2002/46/EC for the general adult population, excluding food supplements for pregnant women 35 mg/day
((2)) in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food Specification
‘Extract from Panax notoginseng and Astragalus membranaceus Description/Definition:The novel food contains two extracts. One is an ethanol extract of the roots of Astragalus membranaceus (Fisch.) Bunge. The other is a hot water extract of the roots of Panax notoginseng (Burkill) F.H. Chen that is further concentrated using absorption on a resin and subsequent elution with 60 % ethanol. At the end of the manufacturing process both extracts are mixed (45–47,5 % of each extract) with maltodextrin (5–10 %).Characteristics/Composition:Total saponins: 1,5-5 %Ginsenoside Rb1: 0,1-0,5 %Astragaloside I: 0,01-0,1 %Carbohydrates: ≥ 90 %Protein: ≤ 4,5 %Ash: ≤ 1 %Moisture: ≤ 5 %Fat: ≤ 1,5 %Heavy metals:Arsenic: ≤ 0,3 mg/kgMicrobiological criteria:Total plate count: ≤ 5 000 CFU/gTotal yeast and mould count: ≤ 500 CFU/gEnterobacteriaceae: < 10 CFU/gEscherichia coli: Absence in 25 gSalmonella: Absence in 375 gStaphylococcus aureus: Absence in 25 gCFU: colony forming units’
