lacto-N-fucopentaose I (LNFP-I) and 2'-fucosyllactose (2'-FL) mixture
Product details
- Definition/Description
- Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture is a purified carbohydrate powder or agglomerate obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1 containing at least 75% of lacto-N-fucopentaose I and 2’-fucosyllactose of dry matter, where ≥ 50% is lacto-N-fucopentaose I. -l (dry weight) and ≥ 15% is 2’-fucosyllactose (dry weight).
- Original application
- RP-549
- 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
-
Food category Maximum level Unflavoured pasteurised and unflavoured sterilised (including UHT) milk 1.0 g/L Unflavoured fermented milk-based products 1.0 g/L (beverages) or 2.0 g/kg (products other than beverages) Flavoured fermented milk-based products including heat-treated products 1.0 g/L (beverages) or 10.0 g/kg (products other than beverages) Cereal bars 10.0 g/kg Infant formula as defined in Regulation (EU) No 609/2013 1.5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Follow-on formula as defined in Regulation (EU) No 609/2013 1.5 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 (under 3 years) as defined in Regulation (EU) No 609/2013 1.0 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 8.33 g/kg (products other than beverages) Milk-based drinks and similar products intended for young children (children aged 1-3 years) 1.2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 10.0 g/kg (products other than beverages) Foods for special medical purposes 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 20.0 g/kg (products other than beverages) Flavoured drinks (excluding cola flavoured/flavour drinks) 1.0 g/L Food supplements (as defined in the Food Supplements (England) Regulations 2003, Food Supplements (Wales) Regulations 2003 and Food Supplements (Scotland) Regulations 2003), infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months)). 1.5 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 supplements for infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months)). 3.0 g/day
- Additional specific labelling requirements
- In the case of this novel food, its designation on the labelling of foodstuffs containing it shall be lacto-N-fucopentaose I and 2’-fucosyllactose mixture. The labelling of food supplements containing lacto-N-fucopentaose I (LNFP-I) and 2'-fucosyllactose (2'-FL) mixture shall bear a statement that the supplements should not be used if other foods with added lacto-N-fucopentaose I (LNFP-I) and 2'-fucosyllactose (2'-FL) mixture are consumed on the same day. The labelling of food supplements containing lacto-N-fucopentaose I (LNFP-I) and 2'-fucosyllactose (2'-FL) mixture intended for infants under 12 months or young children aged 1 year to 3 years shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-N-fucopentaose I (LNFP-I) and 2'-fucosyllactose (2'-FL) mixture 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. 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, Lacto-N-fucopentaose I and 2'-fucosyllactose mixture (LNFP-I/2'-FL) are 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.
- Legislation links
-
-
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 2024
Updates
- Last updated
- The date the item authorisation was last updated.