Regulation 2
SCHEDULE 4Authorisation for the placing on the market of 3’-Sialyllactose (3’-SL) sodium salt (microbial source) as a novel food
1. In Table 1 (authorised novel foods), after the entry for “Selenium-containing yeast (Yarrowia lipolytica) biomass”, insert the following entry—
"3’-Sialyllactose (3’-SL) sodium salt (microbial source) | Specified food category | Maximum levels (expressed as 3’-Sialyllactose) | 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 30 June 2022. 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 Alle 4, DK-2970 Horsholm, Denmark. During the period of data protection, 3’-Sialyllactose sodium salt is authorised for placing on the market within Wales 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 ends at the end of 29 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) 0.5 g/kg (products other than beverages) | ||||
Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0.25 g/L | ||||
Cereal bars | 2.5 g/kg | ||||
Infant formula as defined in Regulation (EU) No 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 (EU) No 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 (EU) No 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 (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 (EU) No 609/2013 | 0.5 g/L (beverages) 5g/kg (products other than beverages) | ||||
Food 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 | ||||
Food supplements as defined in the Food Supplements (Wales) Regulations 2003, excluding food supplements for infants and young children | 0.5 g/day |
2. In Table 2 (specifications), after the entry for “Selenium-containing yeast (Yarrowia lipolytica) biomass” insert the following entry—
"3’-Sialyllactose (3’-SL) sodium salt (microbial source) | Description: 3’-Sialyllactose (3’-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, 3’-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→3)-β-D-galactopyranosyl-(1→4)-Dglucose, sodium salt Molecular mass: 655.53 Da CAS No 128596-80-5 Characteristics/Composition: Appearance: White to off-white powder or agglomerate Sum of 3’-Sialyllactose sodium salt, D-Lactose, and Sialic acid (% of dry matter): ≥ 90.0 % (w/w) 3’-Sialyllactose sodium salt (% of dry matter): ≥ 88.0 % (w/w) D-Lactose: ≤ 5.0 % (w/w) Sialic acid: ≤ 1.5 % (w/w) 3’-Sialyl-lactulose: ≤ 5.0 % (w/w) Sum of other carbohydrates: ≤ 3.0 % (w/w) Moisture: ≤ 8.0 % (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: ≤ 1000 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." |