2'-Fucosyllactose/Difucosyllactose mixture (' 2'-FL/DFL ') (microbial source)
Product details
- Definition/Description
- 2′-Fucosyllactose is a white to off-white powder that is produced by a microbial process.
Conditions of use
- Conditions under which the novel food may be used
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Food category Maximum levels Beverages (flavoured drinks) 2.0 g/L Cereal bars 20 g/kg Flavoured fermented milk-based products including heat-treated products 2.0 g/L (beverages) ; 20 g/kg (products other than beverages) Follow-on formula as defined in Regulation (EU) No 609/2013 1.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Food for special medical purposes as defined in Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the persons for whom the products are intended Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants 4.0 g/day Infant formula as defined in Regulation (EU) No 609/2013 1.6 g/L 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 Regulation (EU) No 609/2013 1.2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer ; 10 g/kg for products other than beverages Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013 4.0 g/L (beverages) ; 40 g/kg (products other than beverages) Unflavoured fermented milk-based products 2.0 g/L (beverages) ; 20 g/kg (products other than beverages) Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 2.0 g/L Milk-based drinks and similar products intended for young children 1.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
- Additional specific labelling requirements
- The designation of the novel food on the labelling of the foodstuffs containing it shall be '2'-Fucosyllactose/Difucosyllactose mixture'. The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.
- Other requirements
- not specified
- Data Protection
- Authorised on 19.12.2019 . This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S. End date of the data protection: 19.12.2024.
Dates
- Last updated
Legislation
- Link to legislation
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- Retained EU Regulations 2017/2470
- The Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (England) Regulations 2022
- The Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (Scotland) Regulations 2022
- The Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (Wales) Regulations 2022
- Rheoliadau Bwydydd Newydd (Awdurdodiadau) a Chyflasynnau Mwg (Addasu Awdurdodiadau) (Cymru) 2022
- Retained EU Regulation 2019/1979