# 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), Annex II: AUTHORISED USES OF LACTO-N-NEOTETRAOSE Extent: E+W+S+N.I. 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’. 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 41/2009 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 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 --- Source: https://www.legislation.gov.uk/eudn/2016/375/annex/II (the official version) Page: https://openlegislation.uk/eu-decision-2016-375/annex-II Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.