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Commission Implementing Decision (EU) 2016/375Show full title
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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Changes over time for: ANNEX II
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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 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 41/2009a | 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/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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