Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of lacto-N-neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2016) 1419)

• CELEX: Implementing Decision (EU) 2016/375
• Articles: 5

Article 1

Lacto- N -neotetraose as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the maximum levels established in Annex II without prejudice to the specific provisions of Directives 96/8/EC, 1999/21/EC, 2002/46/EC, 2006/125/EC, 2006/141/EC and Regulations (EC) No 1925/2006, (EC) No 41/2009 and Implementing Regulation (EU) No 828/2014.

Article 2

1.   The designation of lacto- N -neotetraose authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘lacto- N -neotetraose’.

2.   Information shall be given to the consumer that food supplements containing lacto- N -neotetraose should not be used if other foods with added lacto- N -neotetraose are consumed the same day.

3.   Information shall be given to the consumer that food supplements containing lacto- N -neotetraose intended for young children should not be used if breast milk or other foods with added lacto- N -neotetraose are consumed the same day.

Article 3

This Decision is addressed to Glycom A/S, Diplomvej 373, 2800 Kgs. Lyngby, Denmark.

Schedules & Appendices

ANNEX I

ANNEX I

SPECIFICATION OF LACTO- N -NEOTETRAOSE

Definition:

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

C 26 H 45 NO 21

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

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.