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Statutory Instruments

2024 No. 685

Food, England

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

Made

22nd May 2024

Laid before Parliament

23rd May 2024

Coming into force

28th June 2024

The Secretary of State makes the following Regulations in exercise of the powers conferred by Articles 7(4), (5), and 14A(2)(b) of Regulation (EC) No. 1331/2008of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings ( 1) and Articles 12(1) and 32A(3)(b) of Regulation (EU) 2015/2283of the European Parliament and of the Council on novel foods, etc.( 2).

In relation to Parts 2 and 3, the Secretary of State sought, and had regard to, advice from the Food Standards Agency as required by Article 7(4) and (5) of Regulation 1331/2008.

As required by Article 9 of Regulation (EC) No. 178/2002of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety( 3), there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

PART 1 Introduction

Citation, commencement, extent and application

1.—(1) These Regulations may be cited as the Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (England) Regulations 2024 and come into force on 28th June 2024.

(2) These Regulations extend to England and Wales, but apply in relation to England only.

PART 2 Food Additives

Amendment of Regulation (EC) No. 1333/2008

2.—(1) Annex 2 to Regulation (EC) No. 1333/2008of the European Parliament and of the Council on food additives( 4) is amended as follows.

(2) In Part B, paragraph 2, in the table headed “Sweeteners” after the entry for “ E 960a” (Steviol glycosides from Stevia) insert the following entry—

“E 960b

Steviol glycosides from fermentation ”.

(3) In Part C, paragraph 5—

(a) for “(v) E 960a and E 906c: Steviol glycosides” substitute “(v) E 960a – E 960c: Steviol glycosides”; and

(b) in the table at (v), after the entry for “ E 960a” (Steviol glycosides from Stevia) insert the following entry —

“E 960b

Steviol glycosides from fermentation ”.

(4) In Part E, in the table—

(a) in each place in which 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 the following entry—

“E 476

Polyglycerol polyricinoleate

4000

except sorbets ”.

(c) in category 05.1 (Cocoa and Chocolate products) after table footnote “(*)” (E 170, E 500-504, E 524-528 and E 530: 7 % on dry matter, without fat, expressed as potassium carbonates) insert the following footnote “(1): The additives may be added individually or in combination”;

(d) in category 05.2 (Other confectionery 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 and 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”;

(iii) in the second entry for “ E 960a and E 960c” (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 and 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”; and

(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 ”.

Amendment of Commission Regulation (EU) No. 231/2012

3.—(1) The Annex to Commission Regulation (EU) No. 231/2012laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No. 1333/2008of the European Parliament and of the Council( 5) is amended as follows.

(2) In the first paragraph, for “Note: Ethylene oxide may not be used for sterilising purposes in food additives” substitute —

“Restrictions on ethylene oxide in food additives

Ethylene 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))), irrespective 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 following tables headed—

(a) “E 431 POLYOXYETHYLENE (40) STEARATE”;

(b) “E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)”;

(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”; and

(h) “E 1521 POLYETHYLENE GLYCOL”;

omit “Ethylene oxide” and “Not more than 0,2 mg/kg”.

(4) After the table for “ E 960a” (Steviol glycosides from stevia), insert the heading and table in Schedule 1.

(5) In the heading for the table for “ E 960c” (Rebaudioside M produced via enzyme modification of steviol glycosides from stevia) for “E 960c” substitute “E 960c(i)”.

(6) In alphabetical order, insert the heading and table in Schedule 2.

PART 3 Food Flavourings

Amendment of Regulation (EC) No. 1334/2008

4.—(1) Annex 1 to Regulation (EC) No. 1334/2008of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods etc( 6) is amended as follows.

(2) In Part A, Section 2, Table 1 (the domestic list), the entries for the following are omitted in full—

(a) FL No. “07.030” chemical name “1-(4-Methoxyphenyl)pent-1-en-3-one”;

(b) FL No. “07.046” chemical name “Vanillylidene acetone”;

(d) FL No. “07.206” chemical name “4-(2,3,6-Trimethylphenyl)but-3-en-2-one”;

(e) FL No. “07.258” chemical name “6-Methyl-3-hepten-2-one”;

(f) FL No. “10.034” chemical name “5,6-Dihydro-3,6-dimethylbenzofuran-2(4H)-one”;

(g) FL No. “10.036” chemical name “5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one”;

(h) FL No. “10.042” chemical name “3,4-Dimethyl-5-pentylidenefuran-2(5H)-one”;

(i) FL No. “10.043” chemical name “2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone”;

(j) FL No. “10.046” chemical name “Hex-2-eno-1,4-lactone”;

(k) FL No. “10.054” chemical name “Non-2-eno-1,4-lactone”;

(l) FL No. “10.060” chemical name “2-Decen-1,4-lactone”;

(m) FL No. “10.170” chemical name “5-Pentyl-3H-furan-2-one”;

(n) FL No. “13.004” chemical name “Allyl 2-furoate”;

(o) FL No. “13.034” chemical name “3-(2-furyl)acrylaldehyde”;

(p) FL No. “13.043” chemical name “Furfurylidene-2-butanal”;

(q) FL No. “13.044” chemical name “4-(2-Furyl)but-3-en-2-one”;

(r) FL No. “13.046” chemical name “3-(2-Furyl)-2-methylprop-2-enal”;

(s) FL No. “13.066” chemical name “3-Acetyl-2,5-dimethylfuran”;

(t) FL No. “13.103” chemical name “2-Butylfuran”;

(u) FL No. “13.137” chemical name “3-(2-Furyl)-2-phenylprop-2-enal”; and

(v) FL No. “13.150” chemical name “3-(5-Methyl-2-furyl)prop-2-enal”.

Transitional provision

5.—(1) The flavouring substances referred to in regulation 4(2)(a) to (v), 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 27th June 2024; or

(b) in transit to Great Britain before the end of 27th 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 regulation 5(1)(a) or (b) 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) The following expressions have the same meaning as they bear in Regulation (EU) No.1169/2011of the European Parliament and of the Council on the provision of food information to consumers etc( 7) —

(a) “date of minimum durability of a food”; and

(b) “‘use by’ date”.

(4) Any expression used in both this regulation and Regulation (EC) No. 1334/2008of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods etc( 8) has the meaning it bears in that Regulation.

PART 4 Novel Foods

Amendment of Commission Implementing Regulation (EU) 2017/2470

6.—(1) The Annex to Commission Implementing Regulation (EU 2017/2470 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283of the European Parliament and of the Council on novel foods( 9) is amended as follows.

(2) In Table 1 (Authorised novel foods: England)—

(a) after the entry for “Astaxanthin-rich oleoresin fromHaematococcus pluvialisalgae” insert the entry in Schedule 3.

(b) for the entry for “Bovine milk basic whey protein isolate” substitute the entry in Schedule 4;

(d) after the entry for “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)” insert the entry in Schedule 6; and

(e) after the entry for “Lactitol” insert the entry in Schedule 7.

(3) In Table 2 (Specifications: England)—

(a) after the entry for “Astaxanthin-rich oleoresin fromHaematococcus pluvialisalgae” insert the entry in Schedule 8;

(b) after the entry for “Calanus finmarchicusoil” insert the entry in Schedule 9;

(c) after the entry for “2’-Fucosyllactose/Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source)” insert the entry in Schedule 10;

(d) after the entry for “Lactitol” insert the entry in Schedule 11; and

(e) in the entry for “Xylo-oligosaccharides”, in the second column (Specifications), after the row for “Moisture (%)” insert the following row—

“Dry material (%)

70-75 ”.

Andrea Leadsom

Parliamentary Under Secretary of State

Department of Health and Social Care

22nd May 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 )

Molecular formula	Trivial name	Formula	Conversion factor
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
	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

Molecular formula	Trivial name	Formula	Conversion factor
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
	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 ”

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

30 g/100 g

10 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

30 g/100 g

15 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

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( 2)

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( 3) 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 ofEscherichia coliK-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 (I₂ g/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 ofEscherichia coliK-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: C₁₈ H₃₂ O₁₅

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 ”

EXPLANATORY NOTE

(This note is not part of the Regulations)

Regulation 2 amends Regulation (EC) No. 1333/2008of the European Parliament and of the Council on food additives (EUR 2008/1333) to add a new food additive, amend the conditions of use for an existing food additive, and makes consequential amendments and corrections.

Regulation 3 amends Commission Regulation (EU) No. 231/2012laying down specifications for food additives listed in Annexes II and III of Regulation (EC) No. 1333/2008of the European Parliament and of the Council (EUR 2012/231) to set a maximum limit for ethylene oxide in all food additives, add a new production method for an existing additive and makes a consequential change to subcategorise the E numbers for that additive.

Regulation 4 amends Regulation (EC) No. 1334/2008of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods etc. (EUR 2008/1334) to remove 22 flavouring substances from the authorised list of flavourings.

Regulation 5 creates a transitional measure to allow the 22 flavouring substances and foods containing them to remain on the market, and be added to foods, if already present in the United Kingdom or in transit to Great Britain before the authorisation was removed and to allow foods to which they are added to be placed on the market, and used, until they reach their date of minimum durability.

Regulation 6 amends Commission Implementing Regulation (EU) 2017/2470establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283of the European Parliament and of the Council on novel foods (EUR 2017/2470) to add four new novel foods, amends the conditions of use for one existing novel food and correct the specifications for another existing novel food in the list of authorised novel foods.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the public, private or voluntary sector is foreseen.

( 1)

EUR 2008/1331, amended by S.I. 2019/860; there are other amending instruments but none is relevant. The terms “domestic list”, “ prescribe” and “ appropriate authority” are defined in Article 2.

( 2)

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).

( 3)

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

( 4)

EUR 2008/1333; amended by S.I. 2019/860and 2023/334; there are other amending instruments but none is relevant.

( 5)

EUR 2012/231; amended by S.I. 2019/860and 2023/334; there are other amending instruments but none is relevant.

( 6)

EUR 2008/1334; amended by S.I. 2019/860; there are other amending instruments but none is relevant.

( 7)

EUR 2011/1169; to which there are amendments not relevant to these Regulations.

( 8)

EUR 2008/1334; amended by S.I. 2019/860; there are other amending instruments but none is relevant.

( 9)

EUR 2017/2470; amended by S.I. 2019/702; there are other amending instruments but none is relevant.