The EU Amends the Conditions for the Use of 2'-Fucosyllactose as a New Type of Food
On 31 July 2024, the Commission promulgated Regulation (EU) 2024/2102 amending the conditions for the use of novel food 2' -fucosyllactose (2'Fucosyllactose) in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council. Updated the annex to Regulation (EU) 2017/2470. The regulation will enter into force 20 days after its publication in the Official Journal of the European Union. The details of the revision are as follows:
| Permission for New Foods | Conditions for Using New Foods | Other Specific Labeling Requirements | |
| 2'-fucosyllactose | Specified food categories | Maximum levels | 1. The name on the label of a food containing the new food ingredient should be "2'-fucosyllactose". 2. The label of a food supplement containing 2'-fucosyllactose should state that the supplement should not be used if other foods containing 2'-fucosyllactose are consumed on the same day. 3. The label of an infant food supplement containing 2'-fucosyllactose should state that the supplement should not be used if breast milk or other foods containing 2'-fucosyllactose are consumed on the same day. |
| Unflavoured pasteurised and sterilised (including UHT) milk-based products | 1.2 g/L | ||
| Unflavoured fermented milk-based products | Beverages at 1.2 g/L | ||
| Products other than beverages at 19.2 g/kg | |||
| Flavoured fermented milk-based products, including heat-treated products | Beverages at 1.2 g/L | ||
| Products other than beverages at 19.2 g/kg | |||
| Milk product analogues, including beverage whiteners | Beverages at 1.2 g/L | ||
| Products other than beverages at 12 g/kg | |||
| Beverage whiteners at 400 g/kg | |||
| Cereal bars | 12 g/kg | ||
| Table top sweeteners | 200 g/kg | ||
| Infant formula as defined in Regulation (EU) No 609/2013 | 3.0 g/L, applicable to the final product, marketed as such or reconstituted as instructed by the manufacturer | ||
| Follow-on formula as defined in Regulation (EU) No 609/2013 | 3.64 g/L, applicable to the final product, marketed as such or reconstituted as instructed by the manufacturer | ||
| Processed cereal-based foods and baby foods as defined in Regulation (EU) No 609/2013 | Products other than beverages at 12 g/kg | ||
| 1.2 g/L, applicable to ready-to-eat liquid foods, marketed as such or reconstituted as instructed by the manufacturer | |||
| Milk-based drinks and similar products intended for young children | 1.2 g/L, applicable to the milk-based drinks and similar products in final ready-to-drink forms, marketed as such or reconstituted as instructed by the manufacturer | ||
| Food for special medical purposes as defined in Regulation (EU) No 609/2013 | According to the specific nutritional requirements of the population for which the product is intended | ||
| Meal replacement for weight control as defined in Regulation (EU) No 609/2013 | Beverages at 4.8 g/L | ||
| Snacks at 40 g/kg | |||
| Bread and pasta products bearing a gluten-free or reduced gluten claim as required by Regulation (EU) No 609/2013 | 60 g/kg | ||
| Flavoured drinks | 1.2 g/L | ||
| Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; extracts of tea, herbal and fruit infusions and chicory; and tea, plant, fruit or cereal preparations, and mixtures of these, and instant infusions of these | 9.6 g/L - Maximum level refers to the ready-to-use product | ||
| Food supplements as defined in Directive 2002/46/EC, intended for the general population, excluding infants | General population 3.0 g/day | ||
| Young children 1.2 g/day | |||
The entry in Table 1 of the annex to Regulation (EU) 2017/2470 concerning "2' -fucosyllactose" has been replaced by the following:
For more information, please visit: https://eur-lex.europa.eu/legal-content/EN/TXT/? uri=OJ:L_202402102
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2026-09-09
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