The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (England) Regulations 2024

Regulation 3(4)

SCHEDULE 1 Insertion of entry in the Annex to Commission Regulation (EU) 231/2012 for E 960b for Steviol Glycosides from Fermentation (Yarrowia Lipolytica)

“E 960b STEVIOL GLYCOSIDES FROM FERMENTATION (YARROWIA LIPOLYTICA)

Synonyms
Definition	Steviol glycosides from Yarrowia lipolytica consist of a mixture predominantly composed of rebaudioside M, with some rebaudioside D, and smaller amounts of rebaudioside A and rebaudioside B. The manufacturing process comprises two main phases. The first phase involves fermentation of a non-toxigenic non-pathogenic strain of Yarrowia. lipolytica VRM that has been genetically modified with heterologous genes to overexpress steviol glycosides. Removal of biomass by solid-liquid separation and heat treatment is followed by concentration of the steviol glycosides. The second phase involves purification by employing ion-exchange chromatography, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95% of rebaudiosides M, D, A, and B. Viable cells or the DNA of Yarrowia Lipolytica VRM must not be detected in the food additive.
Chemical name	Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester Rebaudioside B: 13-[(2-O-β–D-glucopyranosyl-3-O-β– D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid Rebaudioside D: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester
Molecular formula	Trivial name	Formula	Conversion factor
	Rebaudioside A	C44 H70 O23	0.33
	Rebaudioside B	C38 H60 O18	0.40
	Rebaudioside D	C50 H80 O28	0.29
	Rebaudioside M	C56 H90 O33	0.25
Molecular weight and CAS No.	Trivial name	CAS Number	Molecular weight (g/mol)
	Rebaudioside A	58543-16-1	967.01
	Rebaudioside B	58543-17-2	804.88
	Rebaudioside D	63279-13-0	1129.15
	Rebaudioside M	1220616-44-3	1291.29
Assay	Not less than 95% of rebaudioside M, rebaudioside D, rebaudioside A, and rebaudioside B on the dried basis.
Description	White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5% sucrose equivalency).
Identification
Solubility	Freely soluble to slightly soluble in water.
pH	Between 4.5 and 7.0 (1 in 100 solution)
Purity
Total ash	Not more than 1%
Loss on drying	Not more than 6 % (105 °C, 2h)
Residual solvent	Not more than 5000 mg/kg ethanol
Arsenic	Not more than 0.1 mg/kg
Lead	Not more than 0.1 mg/kg
Cadmium	Not more than 0.01 mg/kg
Mercury	Not more than 0.05 mg/kg
Residual protein	Not more than 20 mg/kg
Microbiological criteria
Total (aerobic) plate count	Not more than 1000 CFU/g
Yeast	Not more than 100 CFU/g
Moulds	Not more than 100 CFU/g
Escherichia coli	Negative in 1g
Salmonella spp.	Negative in 25g”

Regulation 3(6)

SCHEDULE 2 Insertion of entry in the Annex to Commission Regulation (EU) 231/2012 for E 960c(ii) for Rebaudioside M, AM and D Produced via Enzymatic Conversion of Highly Purified Steviol Glycosides from Stevia Leaf Extracts

“E 960c(ii) REBAUDIOSIDE M, AM AND D PRODUCED VIA ENZYMATIC CONVERSION OF HIGHLY PURIFIED STEVIOL GLYCOSIDES FROM STEVIA LEAF EXTRACTS

Synonyms
Definition	Steviol glycosides produced via enzymatic conversion of highly purified steviol glycosides (rebaudioside A or stevioside) stevia leaf extracts are composed predominantly of rebaudioside M, rebaudioside D, and rebaudioside AM. Rebaudiosides D, M and AM are produced via enzymatic conversion of highly purified steviol glycoside (rebaudioside A or stevioside) extracts (95% steviol glycosides) obtained from Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by genetically modified strains of Escherichia coli (pPM294, pFAH170, and pSK041) that facilitate the transfer of glucose from sucrose and UDP-glucose to steviol glycosides via glycosidic bonds. After removal of the enzymes by solid-liquid separation and heat treatment, the purification involves concentration of the steviol glycosides by resin adsorption, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95 % of total steviol glycosides, including one or more of rebaudiosides D, M and AM. Viable cells or DNA of Escherichia coli (pPM294, pFAH170, and pSK041) must not be detected in the food additive.
Chemical name	Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside D: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside AM: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester
Molecular formula	Trivial name	Formula	Conversion factor
	Rebaudioside M	C56 H90O33	0.25
	Rebaudioside D	C50H80O28	0.29
	Rebaudioside AM	C50H80O28	0.29
Molecular weight and CAS No	Trivial name	CAS Number	Molecular weight (g/mol)
	Rebaudioside M	1220616-44-3	1291.29
	Rebaudioside D	63279-13-0	1129.15
	Rebaudioside AM	2222580-26-7	1129.15
Assay	Not less than 95 % of steviol glycosides on the dried basis, including one or more of rebaudiosides D, M and AM.
Description	White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5 % sucrose equivalency).
Identification
Solubility	Freely soluble to slightly soluble in water.
pH	Between 4.5 and 7.0 (1 in 100 solution)
Purity
Total ash	Not more than 1 %
Loss on drying	Not more than 6 % (105 °C, 2h)
Residual solvent	Not more than 5000 mg/kg ethanol
Arsenic	Not more than 0.015 mg/kg
Lead	Not more than 0.2 mg/kg
Cadmium	Not more than 0.015 mg/kg
Mercury	Not more than 0.07 mg/kg
Residual protein	Not more than 5 mg/kg”

Regulation 6(2)(a)

SCHEDULE 3 Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa)

“Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa)

Specified food category Bread and similar products Fine bakery wares Breakfast cereals Margarines and similar Butter and margarine/oil blends Pasta and rice (or other cereal)-based dishes Fried or extruded cereal, seed, and root-based products Fruit/vegetables spreads and similar Confectionary including chocolate Dairy imitates Milk and dairy products Dessert sauces/toppings Syrups (molasses and other syrups) Meat analogues Soups (marketed as such or reconstituted as instructed by the manufacturer) Stock cubes and granules (bouillon base) Gravy ingredients Savoury sauces Condiments (including table-top formats) Hummus Nut/seeds paste emulsion/mass Energy drinks Carbohydrate-rich energy food products for sports people Protein and protein components for sports people Meal replacement for weight control

Maximum levels 15 g/100 g 15 g/100 g 30 g/100 g 10 g/100 g 10 g/100 g 30 g/100 g 30 g/100 g 30 g/100 g 15 g/100 g 50 g/100 ml (beverages) 50 g/100 g (products other than beverages) 50 g/100 ml (beverages) 50 g/100 g (products other than beverages) 15 g/100 g 15 g/100 g 30 g/100 g 15 g/100 g 15 g/100 g 10 g/100 g 10 g/100 g 10 g/100 g 30 g/100 g 20 g/100 g 90 g/100 ml 30 g/100 g 90 g/100 g 90 g/100 g

The designation of the novel food on the labelling of food containing it is “partially hydrolysed protein from spent barley and rice”.

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: Evergrain LLC, 1 Busch Place, St. Louis, Missouri 63118 USA. During the period of data protection, partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) is authorised for placing on the market, within England, only by Evergrain LLC 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 Evergrain LLC. The data protection will expire at the end of 27 June 2029.”

Regulation 6(2)(b)

SCHEDULE 4 Substitution of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Bovine milk basic whey protein isolate

“Bovine milk basic whey protein isolate

Specified food category Infant formula as defined in Regulation (EU) No. 609/2013(1) Follow-on formula as defined in Regulation (EU) No. 609/2013 Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013 Foods for special medical purposes as defined in Regulation (EU) No. 609/2013 Food supplements as defined in the Food Supplements (England) Regulations 2003

Maximum levels 30 mg/ 100g (powder 3.9 mg/100 ml (reconstituted) 30 mg/ 100 g (powder) 4.2 mg/100 ml (reconstituted) 300 mg/day 30 mg/100 g (powder formula for infants (persons under the age of 1 year (12 months)) during first months of life until the introduction of appropriate complementary feeding) 3.9 mg/100 ml (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding) 30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced) 4.2 mg/100 ml (reconstituted formula for infants when appropriate complementary feeding is introduced) 58 mg/day for young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months)) 380 mg/day for children and adolescents (aged 3 years (36 months) to 18 years of age) 610 mg/day for persons aged 18 years or above 25 mg/day for infants (persons under the age of 1 year (12 months)) 58 mg/day for young children (persons aged 1 year (12 months) up to the age of 3 years (36 months)) 250 mg/day for children and adolescents (aged 3 years (36 months) to 18 years of age) 610 mg/day for persons aged 18 years or above

The designation of the novel food on the labelling of food containing it is “Milk whey protein isolate”. The labelling of food supplements must bear a statement, as appropriate, that they should not be consumed by infants (persons under the age of 1 year)/infants or young children (persons under the age of 3 years)/infants, children or adolescents (persons under the age of 18 years).”

Regulation 6(2)(c)

SCHEDULE 5 Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Cetylated fatty acids

“Cetylated fatty acids

Specified food category Food supplements as defined in the Food Supplements (England) Regulations 2003(2) for persons aged 18 years or above

Maximum levels 2.1 g/day

The designation of the novel food on the labelling of food containing it is “cetylated fatty acids preparation”. The labelling of food supplements must bear a statement that they should not be consumed by persons under 18 years of age.

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: Pharmanutra S.p.A, Via Delle Lenze 216/b, 56122 Pisa, Italy. During the period of data protection, cetylated fatty acids is authorised for placing on the market, within England, only by Pharmanutra S.p.A 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 Pharmanutra S.p.A. The data protection will expire at the end of 27 June 2029.”

Regulation 6(2)(d)

SCHEDULE 6 Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for 3-Fucosyllactose (produced by a derivative strain of Escherichia coli K-12 DH1)

“3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1)

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) No. 609/2013 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)) Foods for special medical purposes as defined in Regulation (EU) No. 609/2013 Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (England) 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 (England) Regulations 2003 excluding food supplements for infants and young children

Maximum levels 2.0 g/l 2.0 g/l (beverages) 4.0 g/kg (products other than beverages) 2.0 g/l (beverages) 12.0 g/kg (products other than beverages) 25.0 g/kg 2.0 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 2.0 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 12 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) 25.0 g/kg (products other than beverages) 1.25 g/l 2.0 g/day 4.0 g/day

The designation of the novel food on the labelling of food containing it is “3-fucosyllactose”. The labelling of food supplements for infants and young children must bear a statement that they should not be consumed if breast milk or food with added 3-fucosyllactose 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, 3-fucosyllactose 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 (EU) 2015/2283 or with the agreement of Glycom A/S. The data protection will expire at the end of 27 June 2029.”

Regulation 6(2)(e)

SCHEDULE 7 Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Lacto-N-fucopentaose I and 2’-fucosyllactose mixture

“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) No. 609/2013 Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No. 609/2013 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)) Foods for special medical purposes as defined in Regulation (EU) No. 609/2013 Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013 Flavoured drinks (excluding cola flavour and cola flavoured drinks) Food supplements as defined in the Food Supplements (England) Regulations 2003 for infants (persons under the age of 1 year (12 months)) and young children (persons aged between 1 year (12 months) up to the age of 3 years (36 months)) Food supplements as defined in the Food Supplements (England) 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 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 other 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 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 (EU) 2015/2283 or with the agreement of Glycom A/S. The data protection will expire at the end of 27 June 2029.”

Regulation 6(3)(a)

SCHEDULE 8 Insertion of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa)

“Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa)

Description/Definition Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) is an off-white powder, produced by concentration of proteins from a mixture of barley and rice from the mash step of beer production using a series of enzymatic hydrolysis and mechanical purification steps. Characteristics/Composition Protein (dry basis): ≥ 85% Moisture: < 8% Total Carbohydrates: < 10% Fat: < 2% Ash: < 8% Heavy metals Arsenic: < 0.1 mg/kg Cadmium: < 0.1 mg/kg Lead: < 0.2 mg/kg Mercury: < 0.1 mg/kg Microbiological criteria Aerobic plate count: < 30,000 CFU/g Coliforms: < 10 CFU/g Yeast and Mould: < 50 CFU/g Salmonella spp: Negative in 25 g Escherichia coli: < 10 CFU/g Staphylococcus aureus: < 10 CFU/g Listeria spp.: Negative in 25 g CFU: Colony Forming Units”

Regulation 6(3)(b)

SCHEDULE 9 Insertion of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Cetylated fatty acids

“Cetylated fatty acids

Description/Definition The novel food is a mixture of 70 – 80% cetylated fatty acids which are produced from the reaction of cetyl alcohol with myristic acid and oleic acid. Characteristics/Composition Physical status at 25°C: Solid Colour (APHA Colour): ≤ 600 Acid value (mg KOH/g): ≤ 5 Iodine value (I2g/100 g): 30 – 50 Saponification value (mg KOH/g): 130 – 150 Hydroxyl value (mg KOH/g): ≤ 20 Ester content (%): 70 – 80 Cetyl oleate (%): 22 – 30 Cetyl myristate (%): 41 – 56 Triglycerides(%): 22 - 25 Microbiological criteria Total aerobic microbial count (CFU/g): ≤ 1000 Yeasts and moulds (CFU/g): ≤ 100 APHA: American Public Health Association KOH: potassium hydroxide CFU: Colony Forming Units”

Regulation 6(3)(c)

SCHEDULE 10 Insertion of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for 3-Fucosyllactose (produced by a derivative strain of Escherichia coli K-12 DH1)

“3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1)

Description/Definition 3-Fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) is a purified carbohydrate powder or agglomerate containing at least 90% of 3-fucosyllactose on a dry matter basis obtained from microbial fermentation with a genetically modified strain of Escherichia coli K-12 DH1. Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose Chemical formula: C18H32O15 Molecular mass: 488.44 Da CAS No: 41312-47-4 Characteristics/Composition Appearance: Powder, agglomerates, powder with agglomerates Colour: White to off-white Assay (water-free) – Specified saccharides (includes 3-FL, D-lactose, L-fucose and 3-fucosyllactulose): ≥ 92.0 w/w % Assay (water-free) – 3-FL: ≥ 90.0 w/w % L-Fucose: ≤ 1.0 w/w % D-Lactose: ≤ 5.0 w/w % 3-fucosyllactulose: ≤ 1.5 w/w % Sum of other carbohydrates: ≤ 5.0 w/w % pH in 5% solution (20°C): 3.2–7.0 Water: ≤ 6.0 w/w % Ash, sulphated: ≤ 0.5 w/w % Acetic acid (relevant only for crystallised 3-FL): ≤ 1.0 w/w % Residual protein by Bradford assay: ≤ 0.01 w/w % Residual endotoxins: ≤ 10 EU/mg Heavy metals Lead: ≤ 0.1 mg/kg Arsenic: ≤ 0.2 mg/kg Mycotoxins Aflatoxin M1: ≤ 0.025 µg/kg Microbiological criteria Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: absent in 10 g Salmonella spp: absent in 25 g Bacillus cereus: ≤ 50 CFU/g Listeria monocytogenes: absent in 25 g Cronobacter spp.: absent in 10 g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g EU: Endotoxin Units CFU: Colony Forming Units”

Regulation 6(3)(d)

SCHEDULE 11 Insertion of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470 for Lacto-N-fucopentaose I and 2’-fucosyllactose mixture

“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”

(1)

EUR 2015/2283, amended by S.I. 2019/702; there are other amending instruments but none is relevant. The terms “prescribe”, “appropriate authority”, and “list” are defined in Article 3. Article 12(1) applies in accordance with Articles 9 and 27(1).

(2)

EUR 2002/178, amended by S.I. 2019/641; there are other amending instruments but none is relevant.