The Food Additives, Food Flavourings, and Novel Foods .(Authorisations) and Food and Feed (Miscellaneous Amendments) (Wales) Regulations 2023 (S.I. 2023 No. 343 (W. 50))

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. WELSH STATUTORY INSTRUMENTS 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 Made - - - - 20 March 2023 Laid before Senedd Cymru 20 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 flavourings(1); • Article 12(1) of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods(2); • sections 16(1)(a) and (2)(b), and 48(1)(c) of the Food Safety Act 1990(3); • sections 74A(1) and 84(1) of the Agriculture Act 1970(4). (1) EUR 2008/1331, amended by S.I. 2019/860 and 2022/1351. S.I. 2019/860 was amended by S.I. 2020/1504. The terms “domestic list”, “prescribe” and “appropriate authority” are defined in Article 2 of EUR 2008/1331. The term “sectoral food law” is defined in Article 1(2) of EUR 2008/1331. In relation to Part 2 of these Regulations, Article 7(5) of EUR 2008/1331 applies in accordance with Articles 10(3), 14 and 30(4) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (EUR 2008/1333). In relation to Part 3 of these Regulations, Article 7(5) of EUR 2008/1331 applies in accordance with Article 11(3) of 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 (EUR 2008/1334). (2) EUR 2015/2283, amended by S.I. 2019/702 ; there are other amending instruments but none is relevant. S.I. 2019/702 was amended by S.I. 2020/1504. The terms “prescribe”, “appropriate authority” and “list” are defined in Article 3 of EUR 2015/2283. Article 12(1) of EUR 2015/2283 applies in accordance with Articles 9 and 27(1) of that Regulation. (3) 1990 c. 16. Sections 16(1) and (2), and 48(1) were amended by section 40(1) of, and paragraphs 7 and 8 of Schedule 5 to, the Food Standards Act 1999 (c. 28) (“the 1999 Act”). There are other amendments not relevant to these Regulations. Those functions, formerly exercisable by “the Ministers”, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act. Those functions are now exercisable by the Welsh Ministers by virtue of section 162 of, and paragraph 30 of Schedule 11 to, the Government of Wales Act 2006 (c. 32). (4) 1970 c. 40. Section 74A was inserted by paragraph 6 of Schedule 4 to the European Communities Act 1972 (c. 68); that section was subsequently amended by section 33(3) of the Agriculture Act 2020 (c. 21). Section 84 was amended by S.I. 2004/3254. The terms “the Ministers”, “prescribed” and “regulations” are defined in section 66(1) of the Agriculture Act 1970. Functions formerly exercisable by “the Ministers”, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672. Those functions are now exercisable by the Welsh Ministers by virtue of section 162 of, and paragraph 30 of Schedule 11 to, the Government of Wales Act 2006. http://www.legislation.gov.uk/european/regulation/2008/1331 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2022/1351 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2020/1504 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2008/1334 http://www.legislation.gov.uk/id/uksi/2019/702 http://www.legislation.gov.uk/id/uksi/2019/702 http://www.legislation.gov.uk/id/uksi/2020/1504 http://www.legislation.gov.uk/id/ukpga/1990/16 http://www.legislation.gov.uk/id/ukpga/1999/28 http://www.legislation.gov.uk/id/uksi/1999/672 http://www.legislation.gov.uk/id/ukpga/2006/32 http://www.legislation.gov.uk/id/ukpga/1970/40 http://www.legislation.gov.uk/id/ukpga/1972/68 http://www.legislation.gov.uk/id/ukpga/2020/21 http://www.legislation.gov.uk/id/uksi/2004/3254 http://www.legislation.gov.uk/id/uksi/1999/672 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 1331/2008(5) (in relation to Parts 2 and 3) and section 48(4A) of the Food Safety Act 1990(6) (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 safety(7) or, in the case of provisions relating to feed for non food-producing animals, of section 84(1) of the Agriculture Act 1970. PART 1 Introduction Title, extent, application and coming into force 1.—(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 2 Food Additives Authorisation Amendment of Regulation (EC) No 1333/2008 2. Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives(8) is amended in accordance with Schedule 1. Amendment of Commission Regulation (EU) No 231/2012 3. 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(9) is amended in accordance with Schedule 2. (5) The term “Authority” is defined in Article 2(3) of EUR 2008/1331. (6) Section 48(4A) was inserted by paragraph 21 of Schedule 5 to, the 1999 Act. (7) EUR 2002/178, amended by S.I. 2019/641; there are other amending instruments but none is relevant. (8) EUR 2008/1333, amended by S.I. 2019/860. S.I. 2019/860 was amended by S.I 2020/1504. (9) EUR 2012/231, amended by S.I. 2019/860. 2 http://www.legislation.gov.uk/european/regulation/2008/1331 http://www.legislation.gov.uk/european/regulation/2002/0178 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/id/uksi/2019/641 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2019/860 http://www.legislation.gov.uk/id/uksi/2020/1504 http://www.legislation.gov.uk/id/uksi/2019/860 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. Transitional provision 4.—(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 3 Food Flavourings Authorisation Amendment of Regulation (EC) No 1334/2008 5. 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(10) is amended in accordance with Schedule 3. PART 4 Novel Foods Authorisation Amendment of Commission Implementing Regulation (EU) 2017/2470 6. 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(11) is amended in accordance with Schedules 4 and 5. PART 5 Miscellaneous Amendments Amendment of the Materials and Articles in Contact with Food (Wales) Regulations 2012 7. In the Materials and Articles in Contact with Food (Wales) Regulations 2012(12), 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 2013 8. In the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013(13), 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”)”; (10) EUR 2008/1334; amended by S.I. 2019/860. S.I. 2019/860 was amended by S.I 2020/1504. (11) EUR 2017/2470, amended by S.I. 2019/702 and 2022/575 (W. 133); there are other amending instruments but none is relevant. (12) S.I. 2012/2705 (W. 291), amended by S.I. 2022/1362 (W. 273); there are other amending instruments but none is relevant. (13) S.I. 2013/2591 (W. 255), amended by S.I. 2022/1362 (W. 273); there are other amending instruments but none is relevant. 3 http://www.legislation.gov.uk/european/regulation/2008/1333 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/2019/860 http://www.legislation.gov.uk/id/uksi/2020/1504 http://www.legislation.gov.uk/id/uksi/2019/702 http://www.legislation.gov.uk/id/wsi/2022/575 http://www.legislation.gov.uk/id/wsi/2012/2705 http://www.legislation.gov.uk/id/wsi/2022/1362 http://www.legislation.gov.uk/id/wsi/2013/2591 http://www.legislation.gov.uk/id/wsi/2022/1362 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. (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 2016 9.—(1) The Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016(14) 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”. 20 March 2023 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 (14) S.I. 2016/386 (W. 120), amended by S.I. 2022/1362 (W. 273); there are other amending instruments but none is relevant. 4 http://www.legislation.gov.uk/id/wsi/2016/386 http://www.legislation.gov.uk/id/wsi/2022/1362 Document Generated: 2023-04-12 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 Amendments 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 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— 5 http://www.legislation.gov.uk/european/regulation/2008/1333 http://www.legislation.gov.uk/european/regulation/2008/1333 Document Generated: 2023-04-12 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”; (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”; 6 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. (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— 7 Document Generated: 2023-04-12 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 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 satis(15) (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)”; (15) “quantum satis” is defined in Article 3(2)(h) of EUR 2008/1333. 8 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. (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— 9 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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”; (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 10 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “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— 11 Document Generated: 2023-04-12 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)”; (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 2 Regulation 3 Amendments 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 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. 12 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 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 number 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 Amendments 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 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— 13 http://www.legislation.gov.uk/european/regulation/2008/1334 http://www.legislation.gov.uk/european/regulation/2008/1334 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 “16.127 3-(1 ((3,5 dimethylisoxazol-4 yl)methyl)-1H pyrazol-4 yl)-1-(3 hydroxybenzyl)imidazolidine-2,4 dione 1119831-25-22161 At least 99%, assay (HPLC/ UV) In category 12.5 – not more than 4 mg/kg The Authority(16) (16) “Authority” is defined in Article 3(2)(l) of EUR 2008/1334. 14 Document Generated: 2023-04-12 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 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 4 Regulation 6 Amendments 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 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— Specified food category Maximum levels of vitamin D2 Yeast-leavened breads and rolls 5 µg/100 g Yeast-leavened fine bakery wares 5 µg/100 g “UV-treated baker’s yeast (Saccharomyces cerevisiae) Food supplements as defined in the Food Supplements In accordance with any relevant requirements contained in regulations The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D2 yeast”. The novel food must be inactivated for use in infant formula, follow on formula, processed cereal based food and food for special medical purposes. 15 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. (Wales) Regulations 2003(17) applying in relation to Wales and made under regulation 4 of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019(18) 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 3 µg/100 g The designation of the novel food on the labelling (17) S.I. 2003/1719 (W. 186), to which there are amendments not relevant to these Regulations. (18) S.I. 2019/651, amended by S.I. 2020/1476 and 2023/28. 16 http://www.legislation.gov.uk/id/wsi/2003/1719 http://www.legislation.gov.uk/id/uksi/2019/651 http://www.legislation.gov.uk/id/uksi/2020/1476 http://www.legislation.gov.uk/id/uksi/2023/28 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. (excluding soups and salads) 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(19) 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 of food containing it is “vitamin D yeast” or “vitamin D2 yeast”. (19) EUR 2013/609, amended by S.I. 2019/651 and 2023/28. S.I. 2019/651 was amended by S.I. 2020/1476 and 2023/28. 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 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 http://www.legislation.gov.uk/id/uksi/2023/28 http://www.legislation.gov.uk/id/uksi/2019/651 http://www.legislation.gov.uk/id/uksi/2020/1476 http://www.legislation.gov.uk/id/uksi/2023/28 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 18 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 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 5 Regulation 6 Amendments 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 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— Specified food category Maximum levels of vitamin D 2 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 19 http://www.legislation.gov.uk/european/regulation/2013/0609 Document Generated: 2023-04-12 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 snack 2.1 µg/100 g Meal replacement for weight control 2.1 µg/100 g Food for special medical In accordance with the containing vitamin D2”. The labelling of food supplements, as defined in the Food Supplements (Wales) 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. 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 D2 mushroom 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, 20 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. purposes as defined in Regulation (EU) No 609/2013 excluding those intended for infants 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” Monaghan Mushrooms. The data protection will expire at the end of 14 May 2028. 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 21 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: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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”. 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 22 http://www.legislation.gov.uk/european/regulation/2008/1331 Document Generated: 2023-04-12 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. 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 D2 mushroom 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. 23 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/2008/1334 http://www.legislation.gov.uk/id/ukpga/1990/16 http://www.legislation.gov.uk/id/ukpga/1970/40