3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) is a purified carbohydrate powder or agglomerate containing at least 90% of 3-fucosyllactose on a dry matter basis obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1.
Product details
- Definition/Description
- 3-fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) is a purified carbohydrate powder or agglomerate containing at least 90% of 3-fucosyllactose of dry matter obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1. Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose. Chemical formula: C18H32O15 Molecular mass: 488,44 Da. CAS No: 41312-47-4. Source: Genetically modified strain of Escherichia coli K-12 DH1
- Original application
- RP-1202
- Specification
- https://www.legislation.gov.uk/uksi/2024/685/made
- Traditional food
- No
Status
- Status
- Authorised
- Applies in
- England, Scotland, Wales
- Status change date
-
The date the status was last changed.
Terms of authorisation
- Conditions under which the novel food may be used
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Food category Maximum level Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 2.0 g/L Unflavoured fermented milk-based products 2.0 g/L (beverages) or 4.0 g/kg (products other than beverages) Flavoured fermented milk-based products including heat-treated products 2.0 g/L (beverages) or 12.0 g/kg (products other than beverages) Cereal bars 25.0 g/kg Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 2.0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Milk-based drinks and similar products intended for young children (children aged 1-3 years) 2.0 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. 12 g/kg (products other than beverages) Foods 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 Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 2.0 g/L (beverages) or 25.0 g/kg (products other than beverages) Flavoured drinks (excluding cola flavoured/flavour drinks) 1.25 g/L Food supplements (as defined in the Food Supplements (England) Regulations 2003, Food Supplements (Wales) Regulations 2003 and Food Supplements (Scotland) Regulations 2003), for infants and young children (under 3 years) 2.0 g/day Food supplements (as defined in the Food Supplements (England) Regulations 2003, Food Supplements (Wales) Regulations 2003 and Food Supplements (Scotland) Regulations 2003), excluding food supplements for infants and young children (under 3 years) 4.0 g/day
- Additional specific labelling requirements
- In the case of this novel food, its designation on the labelling of foodstuffs containing it shall be 3-fucosyllactose For infants under 12 months and young children aged 1 year to 3 years, food supplements are not intended to be used if breast milk or other foods with added 3-fucosyllactose are consumed on the same day.
- Other requirements
- not specified
- Data protection
-
This application includes a request for the protection of proprietary data according to Article 26 of assimilated Regulation 2015/2283.
Included in the list on 28 June 2024
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, 2970 Hørsholm, Denmark. During the period of data protection, 3-fucosyllactose (3-FL) is authorised for placing on the market, within Great Britain, 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. The data protection will expire at the end of 27 June 2029.
- Legislation links
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-
Wales: Assimilated EU Regulations 2017/2470 , Rheoliadau Ychwanegion Bwyd a Bwydydd Newydd (Awdurdodiadau a Diwygiadau Amrywiol) a Chyflasynnau Bwyd (Dileu Awdurdodiadau) (Cymru) 2024 , The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Wales) Regulations 2022.
Updates
- Last updated
- The date the item authorisation was last updated.