Rheoliad 2
1. Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “3’-Sialyllactose (3’-SL) sodium salt (microbial source)” (fel y’i mewnosodir gan baragraff 1 o Atodlen 4 i’r Rheoliadau hyn) mewnosoder y cofnod a ganlyn—
| "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”.
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 30 June 2022. This inclusion is authorised 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, 6’-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 | 0.5 g/L | ||||
| 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) 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 (EU) No 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) No 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) No 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 (products other than beverages) | ||||
| Milk based drinks and similar products intended for young children | 0.3 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 | 1.0 g/L (beverages) 10.0 g/kg (products other than beverages) | ||||
| Food for special medical purposes as defined under 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 | 1.0 g/day |
2. Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “3’-Sialyllactose (3’-SL) sodium salt (microbial source)” (fel y’i mewnosodir gan baragraff 2 o Atodlen 4 i’r Rheoliadau hyn) mewnosoder y cofnod a ganlyn—
| "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." |