The Food Additives, Food Flavourings and Novel Foods (Authorisations) (England) Regulations 2023 (S.I. 2023 No. 334)

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. STATUTORY INSTRUMENTS 2023 No. 334 FOOD, ENGLAND The Food Additives, Food Flavourings and Novel Foods (Authorisations) (England) Regulations 2023 Made - - - - 15th March 2023 Laid before Parliament 16th March 2023 Coming into force - - 15th 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 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, 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. (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. http://www.legislation.gov.uk/european/regulation/2008/1331 http://www.legislation.gov.uk/european/regulation/2002/0178 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2019/702 http://www.legislation.gov.uk/id/uksi/2019/641 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. PART 2 Food Additives Amendment of Regulation (EC) No. 1333/2008 2.—(1) Annex 2 to Regulation (EC) No. 1333/2008 of 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”— (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. 231/2012 3.—(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 Council(5) 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 provision 4.—(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. (4) EUR 2008/1333; amended by S.I. 2019/860. (5) EUR 2012/231; amended by S.I. 2019/860. 2 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2012/0231 http://www.legislation.gov.uk/european/regulation/2012/0231 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2019/860 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. PART 3 Food Flavourings Amendment of Regulation (EC) No. 1334/2008 5.—(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 etc(6) 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 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) 2015/2283 of the European Parliament and of the Council on novel foods(7) 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. 15th March 2023 Neil O’Brien Parliamentary Under Secretary of State, Department of Health and Social Care (6) EUR 2008/1334; amended by S.I. 2019/860. (7) EUR 2017/2470; amended by S.I. 2019/702; there are other amending instruments but none is relevant. 3 http://www.legislation.gov.uk/european/regulation/2008/1334 http://www.legislation.gov.uk/european/regulation/2008/1334 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2019/702 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. SCHEDULE 1 Regulation 2(4) Amendment of the table in Part E of Annex 2 to Regulation (EC) No. 1333/2008 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— 4 http://www.legislation.gov.uk/european/regulation/2008/1333 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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 5 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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— 6 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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 satis(8) (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)” (8) “quantum satis” is defined in Article 3(2)(h) of EUR 2008/1333. 7 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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”. 8 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 23. In category 14.1.3 (Fruit nectars and vegetable nectars and similar products) for the entry for “E 960” (Steviol glycosides) substitute— Steviol glycosides 100 (1) (60) only energy reduced or with no added sugar “E 960a and E 960c (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— 9 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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— 10 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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 2 Regulation 3(3) Amendment of the Annex to Commission Regulation (EU) No. 231/2012 “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 11 http://www.legislation.gov.uk/european/regulation/2012/0231 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 Trivial name Formula Conversion factorMolecular formula Rebaudioside M C56 H90 O33 0.25 Trivial name CAS Number Molecular weight (g/ mol) Molecular weight and CAS No 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 3 Regulation 5(2) Amendment of Table 1 in Part A, Section 2 of Annex 1 to Regulation (EC) No. 1334/2008 “16.127 3-(1 ((3,5 dimethylisoxazol-4 yl)methyl)-1H pyrazol-4 yl)-1-(3 1119831-25-22161 At least 99 %, assay (HPLC/ UV) Restrictions of use as a flavouring substance The Authority(9) (9) “Authority” is defined in Article 3(2)(l) of EUR 2008/1334. 12 http://www.legislation.gov.uk/european/regulation/2008/1334 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. hydroxybenzyl)imidazolidine-2,4 dione 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 13 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 14 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. SCHEDULE 4 Regulation 6(2)(a) Substitution of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 Specified food category Maximum level of vitamin D2 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 2003(10) 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 2019(11) The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D2 yeast”. “UV-treated baker’s yeast (Saccharomyces cerevisiae) 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 The novel food must be inactivated for use in infant formula, follow on formula, processed cereal based food and food for special medical purposes. (10) S.I. 2003/1387, to which there are amendments not relevant to these Regulations. (11) S.I. 2019/651, amended by S.I. 2020/1476; there are other amending instruments but none is relevant. 15 http://www.legislation.gov.uk/id/uksi/2003/1387 http://www.legislation.gov.uk/id/uksi/2019/651 http://www.legislation.gov.uk/id/uksi/2020/1476 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 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. 609/2013(12) 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 The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D2 yeast”. (12) EUR 2013/609, amended by S.I. 2019/651; there are other amending instruments but none is relevant. 16 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/id/uksi/2019/651 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 5 Regulation 6(2)(b) Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470 Specified food category Maximum levels of vitamin D2 Breakfast cereals 2.1 µg/100 g “Vitamin D2 mushroom powder Yeast leavened bread and similar pastries 2.1 µg/100 g The designation of the novel food on the labelling of food containing it is “UV-treated mushroom powder Included in the list on 15 May 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in 17 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 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. 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 D2 mushroom 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, 18 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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” Monaghan Mushrooms. The data protection will expire at the end of 14 May 2028. SCHEDULE 6 Regulation 6(3)(a) Substitution of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470 “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 19 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 http://www.legislation.gov.uk/european/regulation/2013/0609 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 7 Regulation 6(3)(b) Insertion of entry in Table 2 in the Annex to Commission Implementing Regulation (EU) 2017/2470 “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% 20 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 Salmonellaspp.: 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.” 21 Document Generated: 2023-05-15 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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. 22 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2012/0231 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2008/1334