2023 No. 343 (W. 50)

Food, Wales

Agriculture, Wales

The Food Additives, Food Flavourings, and Novel Foods (Authorisations) and Food and Feed (Miscellaneous Amendments) (Wales) Regulations 2023

Made20 March 2023

Laid before Senedd Cymru20 March 2023

Coming into force in accordance with regulation 1(3) and (4)

The Welsh Ministers make these 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 flavourings1;
Article 12(1) of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods2;
sections 16(1)(a) and (2)(b), and 48(1)(c) of the Food Safety Act 19903;
sections 74A(1) and 84(1) of the Agriculture Act 19704.

The Welsh Ministers have sought, and had regard to, advice from the Food Standards Agency as required by Article 7(5) of Regulation (EC) No 1331/20085 (in relation to Parts 2 and 3) and section 48(4A) of the Food Safety Act 19906 (in relation to regulations 7 and 8).

There has been open and transparent public consultation during the preparation of these Regulations in accordance with the requirements of 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 safety7 or, in the case of provisions relating to feed for non food-producing animals, of section 84(1) of the Agriculture Act 1970.

PART 1Introduction

Title, extent, application and coming into force1.

(1)

The title of these Regulations is the Food Additives, Food Flavourings, and Novel Foods (Authorisations) and Food and Feed (Miscellaneous Amendments) (Wales) Regulations 2023.

(2)

These Regulations—

(a)

extend to England and Wales;

(b)

apply in relation to Wales.

(3)

Parts 1 and 5 come into force on 14 April 2023.

(4)

Parts 2, 3 and 4 come into force on 15 May 2023.

PART 2Food Additives Authorisation

Amendment of Regulation (EC) No 1333/20082.

Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives8 is amended in accordance with Schedule 1.

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

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 Council9 is amended in accordance with Schedule 2.

Transitional provision4.

(1)

Any food additive or food labelled before the end of 14 November 2024 as E 960 steviol glycosides, or as containing E 960 steviol glycosides, that is otherwise compliant with the conditions of use and the specification for E 960a steviol glycosides from Stevia, may continue to be placed on the market and used until stocks are exhausted.

(2)

Expressions used in paragraph (1) and in Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives have the same meaning as in that Regulation.

PART 3Food Flavourings Authorisation

Amendment of Regulation (EC) No 1334/20085.

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 foods10 is amended in accordance with Schedule 3.

PART 4Novel Foods Authorisation

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

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 foods11 is amended in accordance with Schedules 4 and 5.

PART 5Miscellaneous Amendments

Amendment of the Materials and Articles in Contact with Food (Wales) Regulations 20127.

In the Materials and Articles in Contact with Food (Wales) Regulations 201212, in regulation 12(2), for the words from “table 1” to the end substitute “Table 1 of Schedule 6 and subject to the restrictions in that Table”.

Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 20138.

In the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 201313, in regulation 2(1), in the definition of “the retained EU Regulations”—

(a)

in the Welsh language text, for “(“the EU Regulations”)” substitute “(“the retained EU Regulations”)”;

(b)

in the English language text, after ““the retained EU Regulations”” insert “(“Rheoliadau’r UE a ddargedwir”)”.

Amendment of the Animal Feed (Composition, Marketing and Use) (Wales) Regulations 20169.

(1)

The Animal Feed (Composition, Marketing and Use) (Wales) Regulations 201614 are amended as follows.

(2)

In Schedule 1B, in Table 1, in the Welsh language text, in the entry for “1. Arsenig”, in the second column, for “deunyddiau blawd”, in each place it occurs, substitute “deunyddiau bwyd anifeiliaid”.

Lynne Neagle

Deputy Minister for Mental Health and Wellbeing, under the authority of the Minister for Health and Social Services, one of the Welsh Ministers

20 March 2023

SCHEDULE 1Amendments to the domestic list of food additives approved for use in foods in Annex 2 to Regulation (EC) No 1333/2008 concerning amendment of the designation of the food additive E 960a steviol glycosides from Stevia (formerly E 960 steviol glycosides) and for the addition of E 960c rebaudioside M produced via enzyme modification of steviol glycosides from Stevia

Regulation 2

1.

In Regulation (EC) No 1333/2008, Annex 2 (domestic list of food additives approved for use in foods) is amended as follows.

2.

In Part B (list of all additives), in paragraph 2 (sweeteners), in the table—

(a)

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

“E 960a
Steviol glycosides from Stevia”;

(b)

in the appropriate place, insert the following entry—

“E 960c
Enzymatically produced steviol glycosides”.

3.

In Part C (definitions of groups of additives), in paragraph 5 (other additives that may be regulated combined), after sub-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 (authorised food additives and conditions of use in food categories), in the table—

(a)

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”;

(b)

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”;

(c)

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”;

(d)

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”;

(e)

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”;

(f)

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”;

(g)

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”;

(h)

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”;

(i)

in category 05.2 (other confectionery including breath freshening microsweets)—

(i)

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”;

(ii)

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”;

(iii)

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”;

(iv)

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”;

(v)

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”;

(j)

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”;

(k)

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

(i)

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”;

(ii)

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”;

(l)

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”;

(m)

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”;

(n)

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”;

(o)

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 satis15
(60)”;

(p)

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)”;

(q)

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)”;

(r)

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

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

(s)

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”;

(t)

in category 12.6 (sauces)—

(i)

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)”;

(ii)

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)”;

(u)

in category 13.2 (dietary foods for special medical purposes (excluding products from food category 13.1.5))—

(i)

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

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

(ii)

in the entry for “E 960” (Advantame), for “E 960” substitute “E 969”;

(v)

in category 13.3 (dietary foods for weight control diets intended to replace total daily food intake or an individual meal)—

(i)

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

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

(ii)

in the entry for “E 960” (Advantame), for “E 960” substitute “E 969”;

(w)

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”;

(x)

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”;

(y)

in category 14.1.5.2 (other)—

(i)

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”;

(ii)

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”;

(iii)

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”;

(z)

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”;

(aa)

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

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

(bb)

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)”;

(cc)

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)”;

(dd)

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”;

(ee)

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

(i)

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

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

(ii)

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”;

(ff)

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

(i)

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

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

(ii)

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 2Amendments to Annex to Regulation (EU) No 231/2012 concerning the specification for E 960a steviol glycosides from Stevia (formerly E 960 steviol glycosides) and for the addition of a specification for E 960c rebaudioside M produced via enzyme modification of steviol glycosides from Stevia

Regulation 3

1.

In Commission Regulation (EU) No 231/2012, the Annex (specifications for food additives including colours and sweeteners listed in Annexes 2 and 3 to Regulation (EC) No 1333/2008) is amended as follows.

2.

For the heading of the entry for “E 960 STEVIOL GLYCOSIDES” substitute—

“E 960a STEVIOL GLYCOSIDES FROM STEVIA”

3.

In the appropriate place, insert the following entry—

“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. phaffi UGT-a or K. phaffi 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 number
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 3Amendments to the domestic list of flavouring substances in Annex 1 to Regulation (EC) No 1334/2008 for the addition of 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione

Regulation 5

1.

In Regulation (EC) No 1334/2008, Annex 1 (domestic list of flavourings and source materials) is amended as follows.

2.

In Part A (domestic list of flavouring substances), in Section 2, in Table 1, in the appropriate place insert the following entry—

“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:
The Authority16
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”.

SCHEDULE 4Amendments to the list of novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of UV-treated baker’s yeast (Saccharomyces cerevisiae) as a novel food

Regulation 6

1.

In Commission Implementing Regulation (EU) 2017/2470, the Annex (list of novel foods) is amended as follows.

2.

In Table 1 (authorised novel foods), for the entry for “UV-treated baker’s yeast (Saccharomyces cerevisiae)” substitute—

“UV-treated baker’s yeast (Saccharomyces cerevisiae)
Specified food category
Maximum levels of vitamin D₂
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
The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂yeast”.
Yeast-leavened fine bakery wares
5 µg/100 g
Food supplements as defined in the Food Supplements (Wales) Regulations 200317
In accordance with any relevant requirements contained in regulations applying in relation to Wales and made under regulation 4 of the Nutrition (Amendment etc.) (EU Exit) Regulations 201918
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 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 5µg/100g 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 609/201319
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”

3.

In Table 2 (specifications) for the entry for “UV-treated baker’s yeast (Saccharomyces cerevisiae)” substitute—

“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: ≤ 10³CFU/g
Escherichia coli: ≤ 10 CFU/g
Salmonella spp.: Absence in 25 g
CFU: Colony Forming Units”.

SCHEDULE 5Amendments to the list of novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of vitamin D₂ mushroom powder as a novel food

Regulation 6

1.

In Commission Implementing Regulation (EU) 2017/2470, the Annex (list of novel foods) is amended as follows.

2.

In Table 1 (authorised novel foods), after the entry for “Vitamin D₂ mushroom powder” insert the following entry—

“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 (Wales) Regulations 2003, containing vitamin D₂mushroom 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 (EU) 2015/2283.
Applicant: MBio, Monaghan Mushrooms, Tullygony, Tyholland, Co. Monaghan, Ireland, H18 FW95.
During the period of data protection, vitamin D₂mushroom powder is authorised for placing on the market, within Wales, 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 (EU) 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 snack
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 (Wales) Regulations 2003 excluding food supplements for infants and children under 3 years of age
15 µg of vitamin D₂/day”

3.

In Table 2, (specifications), after the entry for “Vitamin D₂ mushroom powder” insert the following entry—

“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 D₂ content: 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)

These Regulations make provision, in relation to Wales, on regulated food product authorisations. They also make minor corrections to various Welsh subordinate instruments on food law and animal feed law.

Part 2 of these Regulations (regulations 2 to 4 and Schedules 1 and 2) is made in exercise of powers in Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (EUR 2008/1331). Together, the amendments made in Part 2 of these Regulations provide for the authorisation, in relation to Wales, of the placing on the market and use of the food additive E 960c rebaudioside M produced via enzyme modification of steviol glycosides from Stevia. The existing authorisation entries for food additive E 960 steviol glycosides are changed to reflect the amended name and E-number E 960a steviol glycosides from Stevia.

Regulation 2 and Schedule 1 update, in relation to Wales, the domestic list of food additives approved for use in foods in Annex 2 of Regulation (EC) No 1333/2008 on food additives (EUR 2008/1333). Schedule 1 also corrects the E-number in two entries in that Annex for the food additive E 969 Advantame.

Regulation 3 and Schedule 2 amend, in relation to Wales, Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 (EUR 2012/231).

Regulation 4 contains a transitional provision that allows for an 18-month period within which stocks of products may still be labelled as E 960 steviol glycosides, or as containing E 960 steviol glycosides. Stocks that are labelled within that timeframe may be placed on the market and used until those stocks are exhausted.

Part 3 of these Regulations (regulation 5 and Schedule 3) is also made in exercise of powers in EUR 2008/1331. Regulation 5 and Schedule 3 update, in relation to Wales, the domestic list of flavouring substances in Annex 1 to Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (EUR 2008/1334). These amendments provide for authorisation, in relation to Wales, of the placing on the market and use of the food flavouring 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione.

Part 4 of these Regulations (regulation 6 and Schedules 4 and 5) is made in exercise of powers in Regulation (EU) 2015/2283 on novel foods (EUR 2015/2283). Regulation 6 and Schedules 4 and 5 update, in relation to Wales, the list of authorised novel foods in Annex 1 to Commission Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (EUR 2017/2470):

Schedule 4 substitutes the entry for UV-treated baker’s yeast (Saccharomyces cerevisiae), extending the specified food categories for which that novel food is authorised.
Schedule 5 inserts a new entry, authorising the placing on the market of a new vitamin D₂mushroom powder as a novel food for use in the specified food categories.

Part 5 of these Regulations (regulations 7, 8 and 9) contains minor corrections to various Welsh Subordinate instruments on food law and animal feed law. Regulations 7 and 8 are made in exercise of powers in the Food Safety Act 1990 (c. 16). Regulation 9 is made in exercise of powers in the Agriculture Act 1970 (c. 40).

The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.

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. phaffi UGT-a or K. phaffi 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 number	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)”

“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:	The Authority16
					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”.

“UV-treated baker’s yeast (Saccharomyces cerevisiae)	*Specified food category*	*Maximum levels of vitamin D*₂		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	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D₂yeast”.
	Yeast-leavened fine bakery wares	5 µg/100 g
	Food supplements as defined in the Food Supplements (Wales) Regulations 200317	In accordance with any relevant requirements contained in regulations applying in relation to Wales and made under regulation 4 of the Nutrition (Amendment etc.) (EU Exit) Regulations 201918
	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 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 5µg/100g 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 609/201319	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 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 (Wales) Regulations 2003, containing vitamin D₂mushroom 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 (EU) 2015/2283. Applicant: MBio, Monaghan Mushrooms, Tullygony, Tyholland, Co. Monaghan, Ireland, H18 FW95. During the period of data protection, vitamin D₂mushroom powder is authorised for placing on the market, within Wales, 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 (EU) 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 snack	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 (Wales) Regulations 2003 excluding food supplements for infants and children under 3 years of age	15 µg of vitamin D₂/day”