Rheoliad 6
1. Yn Rheoliad Gweithredu’r Comisiwn (EU) 2017/2470, mae’r Atodiad (rhestr o fwydydd newydd) wedi ei ddiwygio fel a ganlyn.
2. Yn Nhabl 1 (bwydydd newydd awdurdodedig), ar ôl y cofnod ar gyfer “Lactitol” mewnosoder y cofnod a ganlyn—
| “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) No609/2013 Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No609/2013 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)) Food for special medical purposes as defined in Regulation (EU) No609/2013 Total diet replacement for weight control as defined in Regulation (EU) No609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (Wales) Regulations 2003 for infants (persons under the age of 1 year (12 months)) and young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) Food supplements as defined in the Food Supplements (Wales) 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 as instructed 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 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 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 will expire at the end of 27 June 2029.” |
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3. Yn Nhabl 2 (manylebau), ar ôl y cofnod ar gyfer “Lactitol” mewnosoder y cofnod a ganlyn—
| “Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture | Description/Definition Lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture is a purified carbohydrate powder or agglomerate obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1 containing at least 75% of LNFP-I and 2’-FL of dry matter, where ≥ 50% is LNFP-I (dry weight) and ≥ 15% is 2’-FL (dry weight). Characteristics/Composition Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water-free) Specified saccharides (includes LNFP-I, 2’-FL, lacto- N-tetraose, difucosyl-D-lactose, 3-fucosyllactose, D-lactose, L-fucose and 2’-fucosyl-lactitol, LNFP-I fructose isomer, and 2’-fucosyl-D-lactulose): ≥ 90.0 % (w/w) Assay (water-free) – LNFP-I and 2’-FL: ≥ 75.0 % (w/w) Assay (water-free) – LNFP-I: ≥ 50.0 % (w/w) Assay (water-free) – 2’-FL: ≥ 15.0 % (w/w) Lacto- N-tetraose: ≤ 5.0 % (w/w) 3-Fucosyllactose: ≤ 1.0 % (w/w) Sum of L-Fucose and 2’-fucosyl-lactitol: ≤ 1.0 % (w/w) D-Lactose: ≤ 10.0 % (w/w) Difucosyl-D-lactose: ≤ 2.0 % (w/w) LNFP-I fructose isomer: ≤ 1.5 % (w/w) 2’-Fucosyl-D-lactulose: ≤ 1.0 % (w/w) Sum of other carbohydrates: ≤ 6.0 % (w/w) pH in 5% solution (20°C): 4.0–7.0 Water: ≤ 8.0 % (w/w) Ash, sulphated: ≤ 0.5 % (w/w) Residual protein by Bradford assay: ≤ 0.01 % (w/w) Heavy metals Arsenic: ≤ 0.2 mg/kg Mycotoxins Residual endotoxins: ≤ 10 EU/mg Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: Absent in 10g Salmonella spp.: Absent in 25 g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: Absent in 25g Cronobacter spp.: Absent in 10g EU: Endotoxin Units CFU: Colony Forming Units”. |
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