2023 No. 334

Food, England

The Food Additives, Food Flavourings and Novel Foods (Authorisations) (England) Regulations 2023

Made15th March 2023

Laid before Parliament16th March 2023

Coming into force15th May 2023

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

As required by Article 9 of Regulation (EC) No. 178/2002 of 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 safety3, there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

PART 1Introduction

Citation, commencement extent and application1.

(1)

These Regulations may be cited as the Food Additives, Food Flavourings and Novel Foods (Authorisations) (England) Regulations 2023 and come into force on 15th May 2023.

(2)

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

PART 2Food Additives

Amendment of Regulation (EC) No. 1333/20082.

(1)

Annex 2 to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additives4 is amended as follows.

(2)

In Part B, paragraph 2, in the table headed “Sweeteners”—

(a)

for the entry “E 960” (Steviol glycosides) substitute the following entries—

“E 960a
Steviol glycosides from Stevia
E 960c
Enzymatically produced steviol glycosides”.

(3)

In Part C, paragraph 5, after paragraph (u) insert—

“(v)
E 960a and E 960c: Steviol glycosides
E Number
Name
E 960a
Steviol glycosides from Stevia
E 960c
Enzymatically produced steviol glycosides”.

(4)

In Part E, the table is amended in accordance with Schedule 1.

Amendment of Commission Regulation (EU) No. 231/20123.

(1)

The Annex to 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 Council5 is amended as follows.

(2)

For the heading “E 960 STEVIOL GLYCOSIDES” substitute “E 960a STEVIOL GLYCOSIDES FROM STEVIA”.

(3)

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

Transitional provision4.

(1)

The food additive E 960a Steviol glycosides from Stevia, and any foods containing it, labelled before the end of 14th November 2024 may continue to be labelled as E 960 Steviol glycosides and placed on the market, and used, until stocks are exhausted.

(2)

Any expression used in both paragraph (1) and Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additives has the meaning it bears in that Regulation.

PART 3Food Flavourings

Amendment of Regulation (EC) No. 1334/20085.

(1)

Annex 1 to 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 etc6 is amended as follows.

(2)

In Part A, Section 2, Table 1, after the entry for FL No. “16.126” (3-[(4-amino-2,2-dioxido-1H-2,1,3-benzothiadiazin-5-yl)oxy]-2,2-dimethyl-N-propylpropanamide) insert the entry in Schedule 3.

PART 4Novel Foods

Amendment of Commission Implementing Regulation (EU) 2017/24706.

(1)

The Annex to 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 foods7 is amended as follows.

(2)

In Table 1 (Authorised novel foods)—

(a)

for the entry for “UV-treated baker’s yeast (Saccharomyces cerevisiae)” substitute the entry in Schedule 4.

(b)

after the entry for “Vitamin D₂ mushroom powder” insert the entry in Schedule 5.

(3)

In Table 2 (Specifications)—

(a)

for the entry for “UV-treated baker’s yeast (Saccharomyces cerevisiae)” substitute the entry in Schedule 6.

(b)

after the entry for “Vitamin D₂ mushroom powder” insert the entry in Schedule 7.

Neil O’Brien

Parliamentary Under Secretary of State,

Department of Health and Social Care

15th March 2023

SCHEDULE 1Amendment of the table in Part E of Annex 2 to Regulation (EC) No. 1333/2008

Regulation 2(4)

1.

In category 01.4 (Flavoured fermented milk products including heat-treated products), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
100
(1) (60)
only energy-reduced products or with no added sugar”

2.

In category 03 (Edible ices), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)
only energy-reduced products or with no added sugar”

3.

In category 04.2.2 (Fruit and vegetables in vinegar, oil, or brine), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
100
(1) (60)
only sweet-sour preserves of fruit and vegetables”

4.

In category 04.2.4.1 (Fruit and vegetable preparations excluding compote), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)
only energy-reduced”

5.

In category 04.2.5.1 (Extra jam and extra jelly), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)
only energy-reduced jams, jellies and marmalades”

6.

In category 04.2.5.2 (Jam, jellies and marmalades and sweetened chestnut purée), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)
only energy-reduced jams, jellies and marmalades”

7.

In category 04.2.5.3 (Other similar fruit or vegetable spreads), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)
only energy-reduced fruit or vegetable spreads and dried-fruit-based sandwich spreads, energy-reduced or with no added sugar”

8.

In category 05.1 (Cocoa and Chocolate products), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
270
(1) (60)
only energy-reduced or with no added sugar”

9.

In category 05.2 (Other confectionery including breath freshening microsweets) —

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
270
(1) (60)
only cocoa or dried-fruit-based, energy-reduced or with no added sugar”

(b)

for the second entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
330
(1) (60)
only cocoa, milk, dried-fruit-based or fat-based sandwich spreads, energy-reduced or with no added sugar”

(c)

for the third entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
350
(1) (60)
only confectionery with no added sugar
only energy-reduced hard confectionery such as candies and lollies
only energy-reduced soft confectionery such as chewy candies, fruit gums and foam sugar products/marshmallows
only energy-reduced liquorice
only energy-reduced nougat
only energy-reduced marzipan”

(d)

for the fourth entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
2000
(1) (60)
only breath-freshening microsweets, energy-reduced or with no added sugar”

(e)

for the fifth entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
670
(1) (60)
only strongly flavoured freshening throat pastilles, energy-reduced or with no added sugar”

10.

In category 05.3 (Chewing gum), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
3300
(1) (60)
only with no added sugar”

11.

In category 05.4 (Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4) —

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
330
(1) (60)
only confectionery with no added sugar”

(b)

for the second entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
270
(1) (60)
only cocoa or dried-fruit-based, energy-reduced or with no added sugar”

12.

In category 06.3 (Breakfast cereals), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
330
(1) (60)
only breakfast cereals with a fibre content of more than 15%, and containing at least 20% bran, energy-reduced or with no added sugar”

13.

In category 07.2 (Fine bakery wares), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
330
(1) (60)
only essoblaten – wafer paper”

14.

In category 09.2 (Processed fish and fishery products including molluscs and crustaceans), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)
only sweet-sour preserves and semi preserves of fish and marinades of fish, crustaceans and molluscs”

15.

In category 11.4.1 (Table-top sweeteners in liquid form), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
quantum satis8
(60)”

16.

In category 11.4.2 (Table-top sweeteners in powder form), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
quantum satis
(60)”

17.

In category 11.4.3 (Table-top sweeteners in tablets), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
quantum satis
(60)”

18.

In category 12.4 (Mustard), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
120
(1) (60)”

19.

In category 12.5 (Soups and broths), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
40
(1) (60)
only energy-reduced soups”

20.

In category 12.6 (Sauces) —

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
120
(1) (60)
except soy-bean sauce (fermented and non-fermented)”

(b)

for the second entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
175
(1) (60)
only soy-bean sauce (fermented and non-fermented)”

21.

In category 13.2 (Dietary foods for special medical purposes (excluding products from food category 13.1.5))—

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
330
(1) (60)”

(b)

in the second entry for “E 960” (Advantame) for “E 960” substitute “E 969”.

22.

In category 13.3 (Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet))—

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
270
(1) (60)”

(b)

in the second entry for “E 960” (Advantame) for “E 960” substitute “E 969”.

23.

In category 14.1.3 (Fruit nectars and vegetable nectars and similar products) for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
100
(1) (60)
only energy-reduced or with no added sugar
(1): The additives may be added individually or in combination”

24.

In category 14.1.4 (Flavoured drinks), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
80
(1) (60)
only energy-reduced or with no added sugar”

25.

In category 14.1.5.2 (Other)—

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
30
(1) (60) (93)
only coffee, tea and herbal infusion beverages, energy-reduced or with no added sugar”

(b)

for the second entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
30
(1) (60) (93)
only flavoured instant coffee and instant cappuccino products, energy-reduced or with no added sugar”

(c)

for the third entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
20
(1) (60) (93)
only malt-based and chocolate/cappuccino flavoured drinks, energy-reduced or with no added sugar”

26.

In category 14.2.1 (Beer and malt beverages), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
70
(1) (60)
only alcohol-free beer or with an alcohol content not exceeding 1.2% volume.; ‘Bière de table/Tafelbier/Table beer’ (original wort content less than 6%) except for ‘Obergäriges Einfachbier’; beers with a minimum acidity of 30 milli-equivalents expressed as NaOH; Brown beers of the ‘oud bruin’ type”

27.

In category 14.2.8 (Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15% alcohol), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
150
(1) (60)”

28.

In category 15.1 (Potato-, cereal-, flour- or starch-based snacks), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
20
(1) (60)”

29.

In category 15.2 (Processed nuts), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
20
(1) (60)”

30.

In category 16 (Desserts excluding products covered in categories 1, 3 and 4), for the entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
100
(1) (60)
only energy-reduced or with no added sugar”

31.

In category 17.1 (Food supplements supplied in a solid form, excluding food supplements for infants and young children)—

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
670
(1) (60)”

(b)

for the second entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
1800
(1) (60)
only food supplements in chewable form”

32.

In category 17.2 (Food supplements supplied in a liquid form, excluding food supplements for infants and young children)—

(a)

for the first entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
200
(1) (60)”

(b)

for the second entry for “E 960” (Steviol glycosides) substitute—

“E 960a and E 960c
Steviol glycosides
1800
(1) (60)
only food supplements in syrup form”

SCHEDULE 2Amendment of the Annex to Commission Regulation (EU) No. 231/2012

Regulation 3(3)

“E 960c REBAUDIOSIDE M PRODUCED VIA ENZYME MODIFICATION OF STEVIOL GLYCOSIDES FROM STEVIA
Synonyms
Definition
Rebaudioside M is a steviol glycoside composed predominantly of rebaudioside M with minor amounts of other steviol glycosides such as rebaudioside A, rebaudioside B, rebaudioside D, rebaudioside I, and stevioside.
Rebaudioside M is obtained via enzymatic bioconversion of puriﬁed steviol glycoside leaf extracts (95% steviol glycosides) of the Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by the genetically modified yeasts K. phaffi (formerly known as Pichia pastoris) UGT-a and K. phaffi UGT-b 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 rebaudioside M by resin adsorption, followed by recrystallisation of rebaudioside M resulting in a final product containing not less than 95 % of rebaudioside M. Viable cells or the DNA of the yeasts K. phafﬁi UGT-a or K. phafﬁi UGT-b 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
Molecular formula
Trivial name
Formula
Conversion factor
Rebaudioside M
C₅₆ H₉₀ O₃₃
0.25
Molecular weight and CAS No
Trivial name
CAS Number
Molecular weight (g/mol)
Rebaudioside M
1220616-44-3
1291.29
Assay
Not less than 95 % 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)
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
Particle size
Not less than 74 μm (using a mesh #200 sieve with a particle size limit of 74 μm)”

SCHEDULE 3Amendment of Table 1 in Part A, Section 2 of Annex 1 to Regulation (EC) No. 1334/2008

Regulation 5(2)

“16.127
3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione
1119831-25-2
2161
At least 99 %, assay (HPLC/UV)
Restrictions of use as a flavouring substance
In category 1.4 – not more than 4 mg/kg
In category 1.8 – not more than 8 mg/kg
In category 3 – not more than 4 mg/kg
In category 5.1 – not more than 15 mg/kg
In category 5.2 – not more than 16 mg/kg
In category 5.3 – not more than 30 mg/kg
In category 5.4 – not more than 15 mg/kg
In category 6.3 – not more than 25 mg/kg
In category 12.1 – not more than 75 mg/kg
In category 12.2 – not more than 100 mg/kg
In category 12.3 – not more than 25 mg/kg
In category 12.4 – not more than 25 mg/kg
In category 12.5 – not more than 4 mg/kg
In category 13.2 – not more than 4 mg/kg
In category 13.3 – not more than 4 mg/kg
In category 14.1.4, dairy-based drinks only – not more than 4 mg/l
In category 14.1.5 – not more than 8 mg/kg
In category 15.1 – not more than 20 mg/kg
In category 16, dairy-based desserts only – not more than 4 mg/l
The Authority9

SCHEDULE 4Substitution of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470

Regulation 6(2)(a)

“UV-treated baker’s yeast (Saccharomyces cerevisiae)
Specified food category
Maximum level of vitamin D₂
The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂yeast”.
The novel food must be inactivated for use in infant formula, follow-on formula, processed cereal-based food and food for special medical purposes.
Yeast-leavened breads and rolls
5 µg/100 g
Yeast-leavened fine bakery wares
5 µg/100 g
Food supplements as defined in the Food Supplements (England) Regulations 200310
In accordance with any relevant requirements contained in regulations applying in relation to England and made under regulation 4 of the Nutrition (Amendment etc.) (EU Exit) Regulations 201911
Pre-packed fresh or dry yeast for home baking
45 µg/100 g for fresh yeast, 200 µg/100 g for dry yeast
The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂ yeast”.
The labelling of the novel food must bear a statement that the food is only intended for baking and it should not be eaten raw.
The labelling of the novel food must bear instructions for use for the final consumer to ensure a maximum concentration of 5 µg/100 g of vitamin D₂ in the final home-baked product is not exceeded.
Dishes, including ready-to-eat meals (excluding soups and salads)
3 µg/100 g
The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂ yeast”.
Soups and salads
5 µg/100 g
Fried or extruded cereal, seed or root-based products
5 µg/100 g
Infant formula and follow-on formula as defined in Regulation (EU) No. 609/201312
In accordance with Regulation (EU) No. 609/2013
Processed cereal-based food as defined in Regulation (EU) No. 609/2013
In accordance with Regulation (EU) No. 609/2013
Processed fruit products
1.5 µg/100 g
Processed vegetables
2 µg/100 g
Bread and similar products
5 µg/100 g
Breakfast cereals
4 µg/100 g
Pasta, doughs and similar products
5 µg/100 g
Other cereal-based products
3 µg/100 g
Spices, seasonings, condiments, sauce ingredients, dessert sauces/toppings
10 µg/100 g
Protein products
10 µg/100 g
Cheese
2 µg/100 g
Dairy desserts and similar products
2 µg/100 g
Fermented milk or fermented cream
1.5 µg/100 g
Dairy powders and concentrates
25 µg/100 g
Milk based products, whey and cream
0.5 µg/100 g
Meat and dairy analogues
2.5 µg/100 g
Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013
5 µg/100 g
Meal replacement for weight control
5 µg/100 g
Food for special medical purposes as defined in Regulation (EU) No. 609/2013
In accordance with the particular nutritional requirements of the persons for whom the products are intended.”

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

Regulation 6(2)(b)

“Vitamin D₂ mushroom powder
Specified food category
Maximum levels of vitamin D₂
The designation of the novel food on the labelling of food containing it is “UV-treated mushroom powder containing vitamin D₂”.
The labelling of food supplements, as defined in the Food Supplements (England) Regulations 2003, containing vitamin D₂ mushroom powder must bear a statement that they should not be consumed by infants and children under 3 years of age.
Included in the list on 15 May 2023.
This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283.
Applicant: MBio, Monaghan Mushrooms of Tullygony, Tyholland Co Monaghan, Ireland, H18 FW95.
During the period of data protection, Vitamin D₂mushroom powder is authorised for placing on the market, within England, only by MBio, Monaghan Mushrooms 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 2015/2283 or with the agreement of MBio, Monaghan Mushrooms.
The data protection will expire at the end of 14 May 2028.
Breakfast cereals
2.1 µg/100 g
Yeast leavened bread and similar pastries
2.1 µg/100 g
Grain products and pasta and similar products
2.1 µg/100 g
Fruit/vegetable juices and nectars
1.1 µg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
Dairy products and analogues other than beverages
2.1 µg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
Dairy products and analogues as beverages
1.1 µg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
Milk and dairy powders
21.3 µg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
Meat analogues
2.1 µg/100 g
Soups
2.1 µg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
Extruded vegetable snacks
2.1 µg/100 g
Meal replacement for weight control
2.1 µg/100 g
Food for special medical purposes as defined in Regulation (EU) No. 609/2013 excluding those intended for infants
In accordance with the particular nutritional requirements of the persons for whom the products are intended.
Food supplements as defined in the Food Supplements (England) Regulations 2003 excluding food supplements for infants and children under 3 years of age.
15 µg of vitamin D₂/day”

SCHEDULE 6Substitution of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470

Regulation 6(3)(a)

“UV-treated baker’s yeast (Saccharomyces cerevisiae)
Description/Definition
Baker’s yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D₂ (ergocalciferol). Vitamin D₂ content in the yeast concentrate varies between 800,000 – 3,500,000 IU vitamin D/100 g (200-875 μg/g).
The yeast is inactivated for use in infant formula, follow-on formula, processed cereal-based food and food for special medical purposes as defined in Regulation (EU) No. 609/2013. The yeast can be active or inactive for use in other foods.
The yeast concentrate is blended with regular baker’s yeast in order not to exceed the maximum level in the pre-packed fresh or dry yeast for home baking.
Tan-coloured, free-flowing granules.
Vitamin D₂
Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
Synonym: Ergocalciferol
CAS No.: 50-14-6
Molecular weight: 396.65 g/mol
Microbiological criteria for the yeast concentrate
Coliforms: ≤ 10³ CFU/g
Escherichia coli: ≤ 10 CFU/g
Salmonella spp.: Absence in 25 g
CFU: Colony Forming Units ”

SCHEDULE 7Insertion of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470

Regulation 6(3)(b)

“Vitamin D₂ mushroom powder
Description/Definition
The novel food is mushroom powder produced from dried whole Agaricus bisporus mushrooms. The process includes drying, milling and the controlled exposure of the mushroom powder to ultraviolet light.
Characteristics/Composition
Vitamin D₂content: 580-595 µg/g of mushroom powder
Ash: ≤ 13.5%
Water activity: < 0.5
Moisture content: ≤ 7.5%
Carbohydrates: ≤ 35%
Total dietary fibre: ≥ 15%
Crude protein (N x 6.25): ≥ 22%
Fat: ≤ 4.5%
Heavy metals
Lead: ≤ 0.5 mg/kg
Cadmium: ≤ 0.5 mg/kg
Mercury: ≤ 0.1 mg/kg
Arsenic: ≤ 0.3 mg/kg
Mycotoxins
Aflatoxin B1: ≤ 0.1 µg/kg
Aflatoxins (sum of B1 + B2 + G1 + G2): < 4 µg/kg
Microbiological criteria
Total plate count: ≤ 5000 CFU
Total yeast and mould count: ≤ 100 CFU/g
Escherichia coli: < 10 CFU/g
Salmonella spp.: Absence in 25 g
Staphylococcus aureus: ≤ 10 CFU/g
Coliforms: ≤ 10 CFU/g
Listeria spp.: Absence in 25 g
Enterobacteriaceae: < 10 CFU/g
CFU: Colony Forming Units.”

EXPLANATORY NOTE

(This note is not part of the Regulations)

Regulation 2 amends Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additives to amend the name and E number for an existing food additive, correct the E number for another food additive, and add a new food additive to the list of authorised additives.

Regulation 3 amends Commission Regulation (EU) No. 231/2012 laying down specifications for food additives listed in Annexes II and III of Regulation (EC) No. 1333/2008 of the European Parliament and of the Council to amend the heading of the specification for an existing food additive and add a specification for a new food additive.

Regulation 4 creates a transitional measure to allow stocks of an amended food additive labelled with the existing name or E number to be exhausted.

Regulation 5 amends 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 etc. to add a new food flavouring to the list of authorised flavourings.

Regulation 6 amends 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 to add one novel food and amend the conditions of use and specifications of one novel food on 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.

“E 960a	Steviol glycosides from Stevia
E 960c	Enzymatically produced steviol glycosides”.

E Number	Name
E 960a	Steviol glycosides from Stevia
E 960c	Enzymatically produced steviol glycosides”.

“E 960a and E 960c	Steviol glycosides	100	(1) (60)	only energy-reduced or with no added sugar
	(1): The additives may be added individually or in combination”

Synonyms
Definition	Rebaudioside M is a steviol glycoside composed predominantly of rebaudioside M with minor amounts of other steviol glycosides such as rebaudioside A, rebaudioside B, rebaudioside D, rebaudioside I, and stevioside. Rebaudioside M is obtained via enzymatic bioconversion of puriﬁed steviol glycoside leaf extracts (95% steviol glycosides) of the Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by the genetically modified yeasts K. phaffi (formerly known as Pichia pastoris) UGT-a and K. phaffi UGT-b 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 rebaudioside M by resin adsorption, followed by recrystallisation of rebaudioside M resulting in a final product containing not less than 95 % of rebaudioside M. Viable cells or the DNA of the yeasts K. phafﬁi UGT-a or K. phafﬁi UGT-b 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
Molecular formula	Trivial name	Formula	Conversion factor
	Rebaudioside M	C₅₆ H₉₀ O₃₃	0.25
Molecular weight and CAS No	Trivial name	CAS Number	Molecular weight (g/mol)
	Rebaudioside M	1220616-44-3	1291.29
Assay	Not less than 95 % 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)
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
Particle size	Not less than 74 μm (using a mesh #200 sieve with a particle size limit of 74 μm)”

“UV-treated baker’s yeast (Saccharomyces cerevisiae)	*Specified food category*	*Maximum level of vitamin D*₂	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂yeast”.	The novel food must be inactivated for use in infant formula, follow-on formula, processed cereal-based food and food for special medical purposes.
	Yeast-leavened breads and rolls	5 µg/100 g
	Yeast-leavened fine bakery wares	5 µg/100 g
	Food supplements as defined in the Food Supplements (England) Regulations 200310	In accordance with any relevant requirements contained in regulations applying in relation to England and made under regulation 4 of the Nutrition (Amendment etc.) (EU Exit) Regulations 201911
	Pre-packed fresh or dry yeast for home baking	45 µg/100 g for fresh yeast, 200 µg/100 g for dry yeast	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂ yeast”. The labelling of the novel food must bear a statement that the food is only intended for baking and it should not be eaten raw. The labelling of the novel food must bear instructions for use for the final consumer to ensure a maximum concentration of 5 µg/100 g of vitamin D₂ in the final home-baked product is not exceeded.
	Dishes, including ready-to-eat meals (excluding soups and salads)	3 µg/100 g	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂ yeast”.
	Soups and salads	5 µg/100 g
	Fried or extruded cereal, seed or root-based products	5 µg/100 g
	Infant formula and follow-on formula as defined in Regulation (EU) No. 609/201312	In accordance with Regulation (EU) No. 609/2013
	Processed cereal-based food as defined in Regulation (EU) No. 609/2013	In accordance with Regulation (EU) No. 609/2013
	Processed fruit products	1.5 µg/100 g
	Processed vegetables	2 µg/100 g
	Bread and similar products	5 µg/100 g
	Breakfast cereals	4 µg/100 g
	Pasta, doughs and similar products	5 µg/100 g
	Other cereal-based products	3 µg/100 g
	Spices, seasonings, condiments, sauce ingredients, dessert sauces/toppings	10 µg/100 g
	Protein products	10 µg/100 g
	Cheese	2 µg/100 g
	Dairy desserts and similar products	2 µg/100 g
	Fermented milk or fermented cream	1.5 µg/100 g
	Dairy powders and concentrates	25 µg/100 g
	Milk based products, whey and cream	0.5 µg/100 g
	Meat and dairy analogues	2.5 µg/100 g
	Total diet replacement for weight control as defined in Regulation (EU) No. 609/2013	5 µg/100 g
	Meal replacement for weight control	5 µg/100 g
	Food for special medical purposes as defined in Regulation (EU) No. 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended.”

“Vitamin D₂ mushroom powder	*Specified food category*	*Maximum levels of vitamin D*₂	The designation of the novel food on the labelling of food containing it is “UV-treated mushroom powder containing vitamin D₂”. The labelling of food supplements, as defined in the Food Supplements (England) Regulations 2003, containing vitamin D₂ mushroom powder must bear a statement that they should not be consumed by infants and children under 3 years of age.	Included in the list on 15 May 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation 2015/2283. Applicant: MBio, Monaghan Mushrooms of Tullygony, Tyholland Co Monaghan, Ireland, H18 FW95. During the period of data protection, Vitamin D₂mushroom powder is authorised for placing on the market, within England, only by MBio, Monaghan Mushrooms 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 2015/2283 or with the agreement of MBio, Monaghan Mushrooms. The data protection will expire at the end of 14 May 2028.
	Breakfast cereals	2.1 µg/100 g
	Yeast leavened bread and similar pastries	2.1 µg/100 g
	Grain products and pasta and similar products	2.1 µg/100 g
	Fruit/vegetable juices and nectars	1.1 µg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
	Dairy products and analogues other than beverages	2.1 µg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
	Dairy products and analogues as beverages	1.1 µg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
	Milk and dairy powders	21.3 µg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
	Meat analogues	2.1 µg/100 g
	Soups	2.1 µg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
	Extruded vegetable snacks	2.1 µg/100 g
	Meal replacement for weight control	2.1 µg/100 g
	Food for special medical purposes as defined in Regulation (EU) No. 609/2013 excluding those intended for infants	In accordance with the particular nutritional requirements of the persons for whom the products are intended.
	Food supplements as defined in the Food Supplements (England) Regulations 2003 excluding food supplements for infants and children under 3 years of age.	15 µg of vitamin D₂/day”