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ANNEX I
SPECIFICATION OF LACTO-N-NEOTETRAOSE
Definition:
Chemical name |
-d-Galactopyranosyl-(14)-2-acetamido-2-deoxy--d-glucopyranosyl-(13)--d-galactopyranosyl-(14)-d-glucopyranose |
Chemical formula |
C26H45NO21 |
Molecular weight |
707,63 g/mol |
CAS No |
13007-32-4 |
Description: Lacto-N-neotetraose is a white to off-white powder.
Purity:
Test |
Specification |
Assay |
Not less than 96 % |
D-Lactose |
Not more than 1,0 w/w % |
Lacto-N-triose II |
Not more than 0,3 w/w % |
Lacto-N-neotetraose fructose isomer |
Not more than 0,6 w/w % |
pH (20 C, 5 % solution) |
5,0-7,0 |
Water (%) |
Not more than 9,0 % |
Ash, sulphated |
Not more than 0,4 % |
Acetic acid |
Not more than 0,3 % |
Residual solvents (methanol, 2-propanol, methyl acetate, acetone) |
Not more than 50 mg/kg singly Not more than 200 mg/kg in combination |
Residual proteins |
Not more than 0,01 % |
Palladium |
Not more than 0,1 mg/kg |
Nickel |
Not more than 3,0 mg/kg |
Microbiological criteria:
Aerobic mesophilic bacteria total count |
Not more than 500 CFU/g |
Yeasts |
Not more than 10 CFU/g |
Moulds |
Not more than 10 CFU/g |
Residual endotoxins |
Not more than 10 EU/mg |
ANNEX II
AUTHORISED USES OF LACTO-N-NEOTETRAOSE
Food category |
Maximum levels |
Unflavoured pasteurised and sterilised (including UHT) milk-based products |
0,6 g/l |
Unflavoured fermented milk-based products |
0,6 g/l for beverages 9,6 g/kg for products other than beverages |
Flavoured fermented milk-based products including heat-treated products |
0,6 g/l for beverages 9,6 g/kg for products other than beverages |
Dairy analogues, including beverage whiteners |
0,6 g/l for beverages 6 g/kg for products other than beverages 200 g/kg for whitener |
Cereal bars |
6 g/kg |
Table-top sweeteners |
100 g/kg |
Infant formulae as defined in Directive 2006/141/EC |
0,6 g/l in combination with 1,2 g/l of 2-O-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Follow-on formulae as defined in Directive 2006/141/EC |
0,6 g/l in combination with 1,2 g/l of 2-O-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Processed cereal-based food and baby food for infants and young children as defined in Directive 2006/125/EC |
6 g/kg for products other than beverages 0,6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Milk-based drinks and similar products intended for young children |
0,6 g/l for milk-based drinks and similar products added alone or in combination with 2-O-fucosyllactose, at concentrations 1,2 g/l, at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Dietary foods for special medical purposes as defined in Directive 1999/21/EC |
In accordance with the particular nutritional requirements of the persons for whom the products are intended |
Foods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC (only for products presented as a replacement for the whole of the daily diet) |
2,4 g/l for drinks 20 g/kg for bars |
Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009(1) |
30 g/kg |
Flavoured drinks |
0,6 g/l |
Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products |
4,8 g/l(2) |
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants |
1,5 g/day for general population 0,6 g/day for young children |
(1)From 20 July 2016 the category Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009 shall be replaced by the following: Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014.
(2)The maximum level refers to the products ready to use.
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