DECISION (EU) 2016/375：根据欧洲议会和理事会条例(EC) No 258/97，批准乳糖-N-新四糖作为一种新型食品配料投放市场

Chemical name

β-d-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-d-glucopyranosyl-(1→3)-β-d-galactopyranosyl-(1→4)-d-glucopyranose

Chemical formula

C26H45NO21

Molecular weight

707,63 g/mol

CAS No

13007-32-4

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

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

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