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

Regulation 3

SCHEDULE 5 Authorisation of 6′‐Sialyllactose (6′‐SL) sodium salt (microbial source)

1.  In Table 1 (authorised novel foods), after the entry for 3’Sialyllactose (3’-SL) sodium salt (microbial source)(1) insert the following entry—

“6’-Sialyllactose (6’-SL) sodium salt (microbial source)	Specified food category	Maximum levels (expressed as 6’-Sialyllactose)	The designation of the novel food on the labelling of the foodstuffs containing it is “6’-Sialyllactose sodium salt”.		Included in the list on 30 June 2022.
	Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	0.5 g/L			This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
			The labelling of food supplements containing 6’-Sialyllactose (6’-SL) sodium salt must bear a statement that they should not be consumed: (a) if foods containing added 6’-Sialyllactose sodium salt are consumed on the same day, (b) by infants and young children.
	Unflavoured fermented milk-based products	0.5 g/L (beverages)
		2.5 g/kg (products other than beverages)
	Flavoured fermented milk-based products including heat-treated products	0.5 g/L (beverages)			Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark.
		5.0 g/kg (products other than beverages)
					During the period of data protection, the novel food 6’-sialyllactose sodium salt is authorised for placing on the market within Scotland 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.
	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 (EU) 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 (EU) 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 (EU) 609/2013	0.3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer			The data protection will expire at the end of 29 June 2027.
		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 (EU) 609/2013	1.0 g/L (beverages)
		10.0 g/kg (products other than beverages)
	Food for special medical purposes as defined in Regulation (EU) 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 (Scotland) Regulations 2003, excluding food supplements for infants and young children	1.0 g/day.”

2.  In Table 2 (specifications), after the entry for 3’Sialyllactose (3’-SL) sodium salt (microbial source) insert the following entry—

“6′‐Sialyllactose (6′‐SL) sodium salt (microbial source)	Description:
	6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acid.
	Source: Genetically modified strain of Escherichia coli K-12 DH1.
	Definition:
	Chemical formula: C23H38NO19Na Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt  Molecular mass: 655.53 Da  CAS No 157574-76-0
	Characteristics/Composition:
	Appearance: White to off-white powder or agglomerate  Sum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94.0 % (w/w)  6’-Sialyllactose sodium salt (% of dry matter): ≥ 90.0 % (w/w)  D-Lactose: ≤ 5.0 % (w/w)  Sialic acid: ≤ 2.0 % (w/w)  6’-Sialyl-lactulose: ≤ 3.0 % (w/w)  Sum of other carbohydrates: ≤ 3.0 % (w/w)  Moisture: ≤ 6.0 % (w/w)  Sodium: 2.5-4.5 % (w/w)  Chloride: ≤ 1.0 % (w/w)  pH (20 °C, 5 % solution): 4.5-6.0  Residual protein: ≤ 0.01 % (w/w)
	Microbiological criteria:
	Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g  Enterobacteriaceae: ≤ 10 CFU/g  Salmonella sp.: Absence in 25 g  Yeast: ≤ 100 CFU/g  Mould: ≤ 100 CFU/g  Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units”

(1)

Inserted by S.S.I. 2022/168.