Chwilio Deddfwriaeth

Commission Implementing Decision (EU) 2016/375Dangos y teitl llawn

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) (Only the Danish text is authentic)

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ANNEX IIU.K. AUTHORISED USES OF LACTO-N-NEOTETRAOSE

a

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’.

b

The maximum level refers to the products ready to use.

Food categoryMaximum levels
Unflavoured pasteurised and sterilised (including UHT) milk-based products0,6 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 bars6 g/kg
Table-top sweeteners100 g/kg
Infant formulae as defined in Directive 2006/141/EC0,6 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/EC0,6 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 children0,6 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/ECIn 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 41/2009a30 g/kg
Flavoured drinks0,6 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 products4,8 g/lb
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

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