The Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (England) Regulations 2022

Valid from 30/06/2022

Regulation 2(2)(d)

SCHEDULE 3 E+W

Commencement Information

I1 Sch. 3 in force at 30.6.2022, see reg. 1(3)

“3’-Sialyllactose (3’-SL) sodium salt (microbial source)	Specified food category	Maximum levels	The designation of the novel food on the labelling of the foodstuffs containing it is ‘3’-Sialyllactose sodium salt’.  The labelling of food supplements containing 3’-Sialyllactose sodium salt must bear a statement that they should not be consumed:   (a) if foods containing added 3’-Sialyllactose sodium salt are consumed the same day (b) by infants and young children.		Included in the list on 30th June 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283. Applicant: Glycom A/S of Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, 3’-Sialyllactose sodium salt 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 2015/2283 or with the agreement of Glycom A/S. The data protection will expire at the end of 29th June 2027.
	Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	0.25 g/L
	Flavoured fermented milk-based products including heat-treated products	0.25 g/L (beverages)   2.5g/kg (products other than beverages)
	Unflavoured fermented milk-based products	0.25 g/L (beverages)    0.5g/kg  (products other than beverages)
	Beverages (flavoured drinks, excluding drinks with a pH less than 5)	0.25 g/L
	Cereal bars	2.5g/kg
	Infant formula as defined in Regulation 609/2013	0.2 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 609/2013	0.15 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 609/2013	0.15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. 1.25 g/kg for products other than beverages
	Milk-based drinks and similar products intended for young children	0.15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Total diet replacement foods for weight control as defined in Regulation 609/2013	0.5 g/L (beverages)    5g/kg (products other than beverages)
	Food for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
	Food Supplements as defined the Food Supplements (England) Regulations 2003, excluding food supplements for infants and young children	0.5 g/day
6’-Sialyllactose (6’-SL) sodium salt (microbial source)	Specified food category	Maximum levels	The designation of the novel food on the labelling of the foodstuffs containing it is ‘6’-Sialyllactose sodium salt’.    The labelling of food supplements containing 6’-Sialyllactose sodium salt must bear a statement that they should not be consumed:   (a) if foods containing added 6’-Sialyllactose sodium salt are consumed the same day (b) by infants and young children.		Included in the list on 30th June 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283. Applicant: Glycom A/S of Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, 6’-Sialyllactose sodium salt 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 2015/2283 or with the agreement of Glycom A/S. The data protection will expire at the end of 29th June 2027.
	Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	0.5 g/L
	Unflavoured fermented milk-based products	0.5 g/L (beverages) 2.5g/kg (products other than beverages)
	Flavoured fermented milk-based products including heat-treated products	0.5 g/L (beverages) 5.0 g/kg (products other than beverages)
	Beverages (flavoured drinks, excluding drinks with a PH less than 5)	0.5 g/L
	Cereal bars	5.0 g/kg
	Infant formula as defined in Regulation 609/2013	0.4 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 609/2013	0.3 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 609/2013	0.3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer   2.5 g/kg for products other than beverages
	Milk based drinks and similar products intended for young children	0.3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Total diet replacement foods for weight control as defined in Regulation 609/2013	1.0 g/L (beverages) 10.0 g/kg (products other than beverages)
	Food for special medical purposes as defined in Regulation 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
	Food Supplements as defined in the Food Supplements (England) Regulations 2003, excluding food supplements for infants and young children	1.0 g/day”