
PART 1
1 

(1) These Regulations may be cited as the Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024 and come into force on 28 June 2024.
(2) These Regulations extend to Scotland only.
2 

(1) In these Regulations—
 “Regulation (EC) No 1333/2008” means Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives,
 “Regulation (EC) No 1334/2008” means Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC,
 “Commission Regulation (EU) No231/2012” means Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council,
 “Regulation (EU) No 609/2013” means Regulation (EU) No609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009,
 “Regulation (EU) 2015/2283” means Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001,
 “Commission Implementing Regulation (EU) 2017/2470” means Commission Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
(2) Unless the contrary intention appears, any expression used both in these Regulations and in Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008, Commission Regulation (EU) No 231/2012 or Commission Implementing Regulation (EU) 2017/2470 has the same meaning as it has in Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008, Commission Regulation (EU) No 231/2012 or Commission Implementing Regulation (EU) 2017/2470, as the case may be.
PART 2
3 
Annex 2 (domestic list of food additives approved for use in foods and conditions for use) to Regulation (EC) No 1333/2008 is amended in accordance with schedule 1.
4 

(1) The Annex to Commission Regulation (EU) No 231/2012 is amended in accordance with paragraphs (2) to (6).
(2) At the beginning, for “Note: Ethylene oxide may not be used for sterilising purposes in food additives” substitute—“Restrictions on ethylene oxide in food additivesEthylene oxide may not be used for sterilising purposes in food additives.Total residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol, expressed as ethylene oxide (i.e. ethylene oxide + (0.55 x 2-chloroethanol))), regardless of origin, in food additives listed in Annexes II and III to Regulation (EC) No 1333/2008, or mixtures of those food additives, must not exceed 0.1 mg/kg.”.
(3) In the entries for the following food additives—
(a) E 431 Polyoxyethylene (40) Stearate,
(b) E 432 Polyoxyethylene Sorbitan Monolaurate (Polysorbate 20),
(c) E 433 Polyoxyethylene Sorbitan Monooleate (Polysorbate 80),
(d) E 434 Polyoxyethylene Sorbitan Monopalmitate (Polysorbate 40),
(e) E 435 Polyoxyethylene Sorbitan Monostearate (Polysorbate 60),
(f) E 436 Polyoxyethylene Sorbitan Tristearate (Polysorbate 65),
(g) E 1209 Polyvinyl Alcohol-Polyethylene Glycol-Graft-Copolymer,
(h) E 1521 Polyethylene Glycol,
omit the row for “Ethylene oxide”.
(4) After the table for E 960a (Steviol glycosides from Stevia), insert the heading and table in schedule 2.
(5) In the heading for the entry for E 960c (rebaudioside M produced via enzyme modification of steviol glycosides from Stevia) for “E 960c” substitute “E 960c(i)”.
(6) After the table for E 960c(i), (Rebaudioside M produced via enzyme modification of steviol glycosides from Stevia) insert the heading and table in schedule 3.
PART 3
5 
The Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 is amended in accordance with schedules 4 to 8.
PART 4
6 

(1) Annex 1 (domestic list of flavourings and source materials approved for use in and on foods) to Regulation (EC) No 1334/2008 is amended in accordance with paragraph (2).
(2) In Part A (domestic list of flavouring substance), Section 2, in Table 1, the following entries are omitted—
(a) FL No. 07.030, chemical name 1-(4-Methoxyphenyl)pent-1-en-3-one, CAS No. 104-27-8,
(b) FL No. 07.046, chemical name Vanillylidene acetone, CAS No. 1080-12-2,
(c) FL No. 07.049, chemical name 1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one, CAS No. 103-13-9,
(d) FL No. 07.206, chemical name 4-(2,3,6-Trimethylphenyl)but-3-en-2-one, CAS No. 56681-06-2,
(e) FL No. 07.258, chemical name 6-Methyl-3-hepten-2-one, CAS No. 2009-74-7,
(f) FL No. 10.034, chemical name 5,6-Dihydro-3,6-dimethylbenzofuran-2(4H)-one, CAS No. 80417-97-6,
(g) FL No. 10.036, chemical name 5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one, CAS No. 13341-72-5,
(h) FL No. 10.042, chemical name 3,4-Dimethyl-5-pentylidenefuran-2(5H)-one, CAS No. 774-64-1,
(i) FL No. 10.043, chemical name 2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone, CAS No. 78548-56-8,
(j) FL No. 10.046, chemical name Hex-2-eno-1,4-lactone, CAS No. 2407-43-4,
(k) FL No. 10.054, chemical name Non-2-eno-1,4-lactone, CAS No. 21963-26-8,
(l) FL No. 10.060, chemical name 2-Decen-1,4-lactone, CAS No. 2518-53-8,
(m) FL No. 10.170, chemical name 5-Pentyl-3H-furan-2-one, CAS No. 51352-68-2,
(n) FL No. 13.004, chemical name Allyl 2-furoate, CAS No. 4208-49-5,
(o) FL No. 13.034, chemical name 3-(2-furyl)acrylaldehyde, CAS No. 623-30-3,
(p) FL No. 13.043, chemical name Furfurylidene-2-butanal, CAS No. 770-27-4,
(q) FL No. 13.044, chemical name 4-(2-Furyl)but-3-en-2-one, CAS No. 623-15-4,
(r) FL No. 13.046, chemical name 3-(2-Furyl)-2-methylprop-2-enal, CAS No. 874-66-8,
(s) FL No. 13.066, chemical name 3-Acetyl-2,5-dimethylfuran, CAS No. 10599-70-9,
(t) FL No. 13.103, chemical name 2-Butylfuran, CAS No. 4466-24-4,
(u) FL No. 13.137, chemical name 3-(2-Furyl)-2-phenylprop-2-enal, CAS No. 65545-81-5,
(v) FL No. 13.150, chemical name 3-(5-Methyl-2-furyl)prop-2-enal, CAS No. 5555-90-8.
7 

(1) The flavouring substances referred to in regulation 6(2) and foods containing them may, until their date of minimum durability of a food or ‘use by’ date, be placed on the market and, as the case may be, added to other foods, if—
(a) present in the United Kingdom and were, or could have been, lawfully placed on the market in Great Britain before the end of 27 June 2024, or
(b) in transit to Great Britain before the end of 27 June 2024, and could have lawfully been imported, or moved into Great Britain, and placed on the market as at the date of dispatch.
(2) Foods containing one or more flavouring substances to which paragraph (1) applies may, until their date of minimum durability of a food or ‘use by’ date, be placed on the market and, as the case may be, added to other foods.
(3) In this regulation—
 “date of minimum durability of a food” has the same meaning as provided in Regulation (EU) No1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC of the European Parliament and of the Council, Commission Directives 2022/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (see Articles 2(2)(r) and 24),
 “‘use by’ date” has the same meaning as in Article 24 of Regulation (EU)1169/2011.
JENNI MINTO
Authorised to sign by the Scottish Ministers
St Andrew’s House,
Edinburgh
28th May 2024
SCHEDULE 1
Regulation 3
1 
In Part B (list of all additives), in paragraph 2 (sweeteners) after the entry for E 960a (Steviol glycosides from Stevia), insert—“
E 960b Steviol glycosides from fermentation”.
2 
In Part C (definitions of groups of additives), in sub-part 5 (other additives that may be regulated combined), in paragraph (v)—
(a) for the heading of the paragraph, substitute “E 960a – E 960c: Steviol glycosides”,
(b) after the entry for E 960a (Steviol glycosides from Stevia), insert—“
E 960b Steviol glycosides from fermentation”.
3 
In Part E (authorised food additives and conditions of use in food categories), in the table—
(a) in each place it occurs, for “E 960a and E 960c” substitute “E 960a – E 960c”,
(b) in category 03 (edible ices), after the entry for E 473-474 (sucrose esters of fatty acids – sucroglycerides), insert—“
E 476 Polyglycerol polyricinoleate 4000  except sorbets”,
(c) in category 05.1 (cocoa and chocolate products), at the end, insert the following footnote—“
(1) The additives may be added individually or in combination.
”,
(d) in category 05.2 (other confectionary including breath freshening microsweets)—
(i) in the third entry for Group IV (polyols), for “only cocoa or dried fruit-based, milk or fat-based sandwich spreads, energy-reduced or with no added sugar” substitute “sandwich spreads made with a base of cocoa, milk, dried fruit or fat; energy reduced or with no added sugar”,
(ii) in the first entry for E 960a – E960c Steviol glycosides for “only cocoa or dried-fruit-based, energy-reduced or with no added sugar”, substitute “only cocoa or dried fruit based; energy reduced or with no added sugar”,
(iii) in the second entry for E 960a – E960c Steviol glycosides for “only cocoa, milk, dried-fruit-based or fat-based sandwich spreads, energy-reduced or with no added sugar”, substitute “sandwich spreads made with a base of cocoa, milk, dried fruit or fat; energy reduced or with no added sugar”,
(e) in category 05.4 (decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4), for the second entry for E 960a – E 960c Steviol glycosides for “only cocoa or dried-fruit-based, energy-reduced or with no added sugar”, substitute “only cocoa or dried fruit based; energy reduced or with no added sugar”,
(f) in category 12.6 (sauces), for the entry for “E 476” (polyglycerol polyricinoleate), substitute—“
E 476 Polyglycerol polyricinoleate 4000  only emulsified sauces with a fat content of less than 20%
E 476 Polyglycerol polyricinoleate 8000  only emulsified sauces with a fat content of 20% or more”.
SCHEDULE 2
Regulation 4(4)
1 
In the appropriate place, insert the following entry—“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 esterRebaudioside B: 13-[(2-O-β–D-glucopyranosyl-3-O-β– D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acidRebaudioside 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 esterRebaudioside 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 A, rebaudioside B, rebaudioside D and rebaudioside M 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)
hPurity
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”.
SCHEDULE 3
Regulation 4(6)
1 
In the appropriate place, insert the following entry—“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) from 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 esterRebaudioside 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 esterRebaudioside 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 H90 O33 0.25
Rebaudioside D C50 H80 O28 0.29
Rebaudioside AM C50 H80 O28 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”.
SCHEDULE 4
Regulation 5
1 
In Table 1 (authorised novel foods), after the entry for Astaxanthin-rich oleoresin from Haematococcus pluvialis algae insert the following entry—
2 
In Table 2 (specifications), after the entry for Astaxanthin-rich oleoresin from Haematococcus pluvialis algae insert the following entry—“

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/kgCadmium: <0.1 mg/kgLead: <0.2 mg/kgMercury: <0.1 mg/kgMicrobiological criteria:Aerobic plate count: <30,000 CFU/gColiforms: <10 CFU/gYeast and Mould: <50 CFU/gSalmonella spp: Negative in 25 gEscherichia coli: <10 CFU/gStaphylococcus aureus: <10 CFU/gListeria spp.: Negative in 25 gCFU: Colony Forming Units”.
SCHEDULE 5
Regulation 5
1 
In Table 1 (authorised novel foods), after the entry for Calanus finmarchicus oil insert the following entry—
2 
In Table 2 (specifications), after the entry for Calanus finmarchicus oil insert the following entry—“
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: SolidColour (APHA Colour): ≤ 600Acid value (mg KOH/g): ≤ 5Iodine value (I2g/100g): 30 – 50Saponification value (mg KOH/g): 130 – 150Hydroxyl value (mg KOH/g): ≤ 20Ester content (%): 70 – 80Cetyl oleate (%): 22 – 30Cetyl myristate (%): 41 – 56Triglycerides (%): 22 – 25Microbiological criteria:Total aerobic microbial count (CFU/g): ≤ 1000Yeasts and moulds (CFU/g): ≤ 100APHA: American Public Health AssociationCFU: Colony Forming UnitsKOH: potassium hydroxide”.
SCHEDULE 6
Regulation 5
1 
In Table 1 (authorised novel foods), after the entry for 2’-Fucosyllactose / Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) insert the following entry—
2 
In Table 2 (specifications), after the entry for 2’-Fucosyllactose / Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) insert the following entry—“

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-glucopyranoseChemical formula: C18H32O15Molecular mass: 488.44 DaCAS No: 41312-47-4Characteristics/Composition:Appearance: Powder, agglomerates, powder with agglomeratesColour: White to off-whiteAssay (water free) – Specified saccharides (includes 3-FL, D-lactose, L-fucose and 3-fucosyllactose): ≥ 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): 3.2–7.0Water: ≤ 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/mgHeavy metals:Lead: ≤ 0.1 mg/kgArsenic: ≤ 0.2 mg/kgMycotoxins:Aflatoxin M1: ≤ 0.025 µg/kgMicrobiological criteria:Aerobic mesophilic total plate count: ≤ 1000 CFU/gEnterobacteriaceae: absent in 10gSalmonella spp: absent in 25gBacillus cereus: ≤ 50 CFU/gListeria monocytogenes: absent in 25gCronobacter spp.: absent in 10gYeasts: ≤ 100 CFU/gMoulds: ≤ 100 CFU/gEU: Endotoxin UnitsCFU: Colony Forming Units”.
SCHEDULE 7
Regulation 5
1 
In Table 1 (authorised novel foods), after the entry for Lactitol insert the following entry—
2 
In Table 2 (specifications), after the entry for Lactitol insert the following entry—“

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 agglomeratesColour: White to off-whiteAssay (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 – 7.0Water: ≤ 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/kgMycotoxins:Residual endotoxins: ≤10 EU/mgAflatoxin M1: ≤0.025 µg/kgMicrobiological criteria:Aerobic mesophilic total plate count: ≤ 1000 CFU/gEnterobacteriaceae: Absent in 10gSalmonella spp: Absent in 25gYeasts: ≤ 100 CFU/gMoulds: ≤ 100 CFU/gBacillus cereus: ≤ 50 CFU/gListeria monocytogenes: Absent in 25gCronobacter spp.: Absent in 10gCFU: Colony Forming UnitsEU: Endotoxin Units”.
SCHEDULE 8
Regulation 5
1 
In Table 1 (authorised novel foods), for the entry for bovine milk basic whey protein isolate substitute the following entry—
2 
In Table 2 (specifications), for the entry for Xylo-oligosaccharides, in column 2 (description/definition), after the row specifying the moisture (%) content, insert—“
Dry Material (%) - - 70 -75”