Regulation 6(2)(e)
SCHEDULE 7Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Lacto-N-fucopentaose I and 2’-fucosyllactose mixture
| “Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture | Specified food category Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products Unflavoured fermented milk-based products Flavoured fermented milk-based products including heat-treated products Cereal bars Infant formula and follow-on formula as defined in Regulation (EU) No. 609/2013 Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No. 609/2013 Milk-based drinks and similar products intended for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Foods for special medical purposes as defined in Regulation (EU) No. 609/2013 Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (England) Regulations 2003 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)) Food supplements as defined in the Food Supplements (England) Regulations 2003 excluding supplements for infants and young children | Maximum levels of LNFP-I 1.0 g/l 1.0 g/l (beverages) 2.0 g/kg (products other than beverages) 1.0 g/l (beverages) 10.0 g/kg (products other than beverages) 10.0 g/kg 1.5 g/l (in the final product ready for use, marketed as such or reconstituted by the manufacturer 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) 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) In accordance with the particular nutritional requirements of the persons for whom the products are intended. 2.0 g/l (beverages) 20.0 g/kg (products other than beverages) 1.0 g/l 1.5 g/day 3.0 g/day | The designation of the novel food on the labelling of food containing it is “lacto-N-fucopentaose I and 2’-fucosyllactose mixture”. The labelling of food supplements intended for infants and young children must bear a statement that they should not be consumed if breast milk or food with added lacto-N-fucopentaose I (LNFP-I) or 2’-fucosyllactose (2’-FL) is consumed on the same day. The labelling of food supplements must bear a statement that they should not be consumed if other food with added lacto-N-fucopentaose I (LNFP-I) or 2’-fucosyllactose (2’-FL) is consumed on the same day. | 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, lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) is authorised for placing on the market, within England, 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.” |