ANNEXSupplementary provisions
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’