Commission Implementing Regulation (EU) 2023/961 of 12 May 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Lacto-N-neotetraose (Text with EEA relevance)

Implementing Regulation (EU) 2023/961 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for lacto- N -neotetraose is replaced by the following: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘ Lacto- N -neotetraose Specified food category Maximum levels 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto- N -neotetraose’. 2. The labelling of food supplements containing lacto- N -neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day. 3. The labelling of food supplements containing lacto- N -neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto- N -neotetraose are consumed the same day.’ 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 formula as defined under Regulation (EU) No 609/2013 0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Follow-on formula as defined under Regulation (EU) No 609/2013 0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013 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 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Foods for special medical purposes as defined under Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the persons for whom the products are intended Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 2,4 g/l for drinks 20 g/kg for bars 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 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 – the maximum level refers to the products ready to use Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants 1,5 g/day for general population 0,6 g/day for young children

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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