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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

(1)

OJ L 327, 11.12.2015, p. 1

(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (

OJ L 351, 30.12.2017, p. 72

(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (

OJ L 183, 12.7.2002, p. 51

(4) EFSA Journal 2020;18(5):6099.

(5) Pasics Szakonyiné I, 2011 (unpublished study report). Repeated dose 28-day oral gavage toxicity study with AstraGinTM in rats. Study No: 413.407.3084. Toxi-Coop Zrt., Hungary.

(6) Zin HM, 2016 (unpublished study report). Bacterial reverse mutation test (Ames test) for AstraGinTM. Study code: GLP/J165/2016/48). Environmental Technology Research Centre (ETRC). Shah Alam, Selangor, Malaysia.

(7) Upadhyaya S and Wang R, 2017 (unpublished study report). 90-days repeated dose oral toxicity study of Astragin® in Wistar rats. 161101/NVS/PC. July 2017. 319pp. Vedic Life Sciences Pvt, Ltd. Mumbai, India.

(8) Vedic Lifesciences, 2019a (unpublished study report). Panax notoginseng proprietary extract: in vitro micronucleus test in CHO-K1 cells. Study Nr. 190503/NL/PC. Mumbai, India.

(9) Vedic Lifesciences, 2019b (unpublished study report). Astragalus membranaceus extract: in vitro micronucleus test in CHO-K1 cells. Study Nr. 190502/NL/PC. Mumbai, India.

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: