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 in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data Protection
‘ Lacto- N -fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture (produced using a derivative strain of E. coli K-12 DH1)
Specified food category
Maximum levels
(expressed as Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture)
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lacto- N -fucopentaose I and 2'-Fucosyllactose mixture’.
The labelling of food supplements containing Lacto- N -fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture produced by a derivative strain of E. coli K-12 DH1 shall bear a statement that:
(a)
they should not be consumed by children under 3 years of age;
(b)
they should not be used, if other foods containing added Lacto- N -fucopentaose I and 2'-Fucosyllactose mixture and/or foods containing added 2'-Fucosyllactose are consumed on the same day.
Authorised on 19.8.2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: “Glycom A/S”, Kogle Allé 4, 2970 Hørsholm, Denmark. During the period of data protection, the novel food Lacto- N -fucopentaose I and 2'-Fucosyllactose mixture produced using a derivative strain of E. coli K-12 DH1 is authorised for placing on the market within the Union only by Glycom A/S 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 “Glycom A/S”.
End date of the data protection: 19.8.2029.’
Infant formula as defined under Regulation (EU) No 609/2013
2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Follow-on formula as defined under Regulation (EU) No 609/2013
2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products
1,5 g/L
Unflavoured fermented milk-based products
1,5 g/L (beverages)
3,0 g/kg (products other than beverages)
Flavoured fermented milk-based products including heat-treated products
1,5 g/L (beverages)
15,0 g/kg (products other than beverages)
Milk based drinks and similar products
1,5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013
In accordance with the particular nutritional requirements of the persons for whom the products are intended but in any case not higher than the maximum levels specified for the proposed food categories or higher than 2,0 g/L or 2,0 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children
In accordance with the particular nutritional requirements of the persons for whom the products are intended but in any case not higher than the maximum levels specified for the proposed food categories or higher than 4,5 g/day in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013
3,0 g/L (beverages)
4,5 g/kg (products other than beverages)
Beverages (flavoured drinks, excluding drinks with a pH less than 5)
1,5 g/kg
Cereal bars
15,0 g/kg
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013
1,5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
9,1 g/kg for products other than beverages
Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children
4,5 g/day
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised novel food
Specification
‘Lacto- N -fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture (produced using a derivative strain of E. coli K-12 DH1)
Description:
Lacto- N -fucopentaose I and 2'-Fucosyllactose mixture is a purified and concentrated white to off-white powder produced using genetically modified strain of Escherichia coli K-12 DH1.
Definition:
Lacto- N -fucopentaose I
Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→3)-2-(acetylamino)-2- deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
Chemical formula: C 32 H 55 NO 25
Molecular mass: 853,77 Da
CAS No: 7578-25-8
2'-Fucosyllactose
Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
Chemical formula: C 18 H 32 O 15
Molecular mass: 488,44 Da
CAS No: 41263-94-9
Characteristics/Composition:
Lacto- N -fucopentaose I and 2'-Fucosyllactose mixture (% w/w of dry matter): ≥ 75,0
Lacto- N -fucopentaose I (% w/w of dry matter): 50,0 – 75,0
2'-Fucosyllactose (% w/w of dry matter): 15,0 – 35,0
Lacto- N -Tetraose (% w/w): ≤ 5,0
3-Fucosyllactose (% w/w): ≤ 1,0
D-Lactose (% w/w): ≤ 10,0
Difucosyllactose (% w/w): ≤ 2,0
Lacto- N -fucopentaose I fructose isomer (% w/w): ≤ 1,5
2'-Fucosyl-D-lactulose (% w/w): ≤ 1,0
Sum of L-Fucose and 2′-Fucosyl-D-lactitol a (% w/w): ≤ 1,0
Sum of Lacto- N -fucopentaose I, 2'-Fucosyllactose, Lacto- N -Tetraose, Difucosyllactose, 3-Fucosyllactose, D-Lactose, L-Fucose, 2′-Fucosyl-D-lactitol, Lacto- N -fucopentaose I fructose isomer, and 2'-Fucosyl-D-lactulose (% w/w dry matter): ≥ 90,0
Sum of other carbohydrates (% w/w): ≤ 6,0
Moisture (% w/w): ≤ 8,0
pH (20 °C, 5 % solution): 4,0 -7,0
Ash (% w/w): ≤ 0,5
Residual protein (% w/w): ≤ 0,01
Heavy metals and contaminants:
Arsenic: ≤ 0,2 mg/kg
Cadmium: ≤ 0,1 mg/kg
Lead: ≤ 0,02 mg/kg
Mercury: ≤ 0,1 mg/kg
Aflatoxin M1: ≤ 0,025 μg/kg
Microbiological criteria:
Total plate count: ≤ 1 000 CFU/g
Enterobacteriaceae: Absence in 10 g
Salmonella spp.: Absence in 25 g
Yeasts and moulds: ≤ 100 CFU/g
Cronobacter spp.: Absence in 10 g
Listeria monocytogenes : Absence in 25 g
Presumptive Bacillus cereus : ≤ 50 CFU/g
Endotoxins: ≤ 10 EU/mg
a
L-Fucose and 2′-Fucosyl-D-lactitol peaks on the High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC–PAD) chromatogram overlap.
CFU: Colony Forming Units; EU: Endotoxin Units’
