SCHEDULE 1Amendments to Annex 2 (domestic list of food additives approved for use in foods and conditions for use) to Regulation (EC) No 1333/2008 concerning steviol glycosides from Stevia (E 960a – E 960c) and the extension of use of polyglycerol polyricinoleate (E 476)
1.
“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)
“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)
“E 476
Polyglycerol polyricinoleate
4000
except sorbets”,
(c)
“(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 glycosides14 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)
“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 2Amendment to the Annex to Commission Regulation (EU) No 231/2012 for the authorisation of steviol glycosides from fermentation (Yarrowia lipolytica) (E 960b)
1.
“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 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 3Amendment to the Annex to Commission Regulation (EU) No 231/2012 for the re-numbering of rebaudioside M produced via enzyme modification of steviol glycosides from Stevia E 960c(i) (formerly E 960c) and for the addition of a specification for rebaudioside M, AM and D produced via enzymatic conversion of highly purified steviol glycosides from Stevia leaf extracts (E 960c(ii))
1.
“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 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 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 4Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food
1.
In Table 1 (authorised novel foods), after the entry for Astaxanthin-rich oleoresin from Haematococcus pluvialis algae insert the following entry—
2.
“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”.
SCHEDULE 5Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of cetylated fatty acids as a novel food
1.
In Table 1 (authorised novel foods), after the entry for Calanus finmarchicus oil insert the following entry—
2.
“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/100g): 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
CFU: Colony Forming Units
KOH: potassium hydroxide”.
SCHEDULE 6Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of 3-fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) as a novel food
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.
“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-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): 3.2–7.0
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 10g
Salmonella spp: absent in 25g
Bacillus cereus: ≤ 50 CFU/g
Listeria monocytogenes: absent in 25g
Cronobacter spp.: absent in 10g
Yeasts: ≤ 100 CFU/g
Moulds: ≤ 100 CFU/g
EU: Endotoxin Units
CFU: Colony Forming Units”.
SCHEDULE 7Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture as a novel food
1.
In Table 1 (authorised novel foods), after the entry for Lactitol insert the following entry—
2.
“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 25g
Yeasts: ≤ 100 CFU/g
Moulds: ≤ 100 CFU/g
Bacillus cereus: ≤ 50 CFU/g
Listeria monocytogenes: Absent in 25g
Cronobacter spp.: Absent in 10g
CFU: Colony Forming Units
EU: Endotoxin Units”.
SCHEDULE 8Corrections to existing entries in the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 concerning the authorisation of bovine milk basic whey protein isolate and xylo-oligosaccharides
1.
In Table 1 (authorised novel foods), for the entry for bovine milk basic whey protein isolate substitute the following entry—
2.
“Dry Material (%)
-
-
70 -75”