Commission Implementing Regulation (EU) 2020/1821 of 2 December 2020 authorising the placing on the market of an extract from Panax notoginseng and Astragalus membranaceus as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1821
• Articles: 5

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:

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Company: NuLiv Science,

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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 .

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

‘ 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/kg

Microbiological criteria:

Total plate count: ≤ 5 000 CFU/g

Total yeast and mould count: ≤ 500 CFU/g

Enterobacteriaceae: < 10 CFU/g

Escherichia coli : Absence in 25 g

Salmonella : Absence in 375 g

Staphylococcus aureus : Absence in 25 g

CFU: colony forming units’