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

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[^f00001];

Article 12 (1) of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods[^f00002];

sections 16(1)(a) and (2)(b), and 48(1)(c) of the Food Safety Act 1990[^f00003];

sections 74A(1) and 84(1) of the Agriculture Act 1970[^f00004].

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[^f00007] 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

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• (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

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Amendment of Commission Regulation (EU) No 231/2012

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Transitional provision

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• (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

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PART 4 — Novel Foods Authorisation

Amendment of Commission Implementing Regulation (EU) 2017/2470

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PART 5 — Miscellaneous Amendments

Amendment of the Materials and Articles in Contact with Food (Wales) Regulations 2012

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In the Materials and Articles in Contact with Food (Wales) Regulations 2012[^f00012], 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

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In the Food Additives, Flavourings, Enzymes and Extraction Solvents (Wales) Regulations 2013[^f00013], 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 2016

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• (1) The Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016[^f00014] 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”.

SCHEDULE 1 — 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

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SCHEDULE 2 — 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

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SCHEDULE 3 — 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

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SCHEDULE 4 — 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

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SCHEDULE 5 — 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

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Signed

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 — 2023-03-20

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

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 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.

Footnotes

[^f00001]: 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).

[^f00002]: 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.

[^f00003]: 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).

[^f00004]: 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.

[^f00005]: The term “Authority” is defined in Article 2(3) of EUR 2008/1331.

[^f00006]: Section 48(4A) was inserted by paragraph 21 of Schedule 5 to, the 1999 Act.

[^f00007]: EUR 2002/178, amended by S.I. 2019/641; there are other amending instruments but none is relevant.

[^f00012]: S.I. 2012/2705 (W. 291), amended by S.I. 2022/1362 (W. 273); there are other amending instruments but none is relevant.

[^f00013]: S.I. 2013/2591 (W. 255), amended by S.I. 2022/1362 (W. 273); there are other amending instruments but none is relevant.

[^f00014]: S.I. 2016/386 (W. 120), amended by S.I. 2022/1362 (W. 273); there are other amending instruments but none is relevant.

Editorial notes

[^key-3e4c9776a5c60f982488b4cd8b245866]: Reg. 1 in force at 14.4.2023, see reg. 1(3)

[^key-9d0eec59c653acb47db15f93a1e972c6]: Reg. 7 in force at 14.4.2023, see reg. 1(3)

[^key-ab4a34866439336db145867d1ee2b12f]: Reg. 8 in force at 14.4.2023, see reg. 1(3)

[^key-d01d35dbafcb8af6860e832b7dc43e7e]: Reg. 9 in force at 14.4.2023, see reg. 1(3)

[^key-a54b7e198d2b6c5dd2e3858c2928ddc2]: Reg. 4 in force at 15.5.2023, see reg. 1(4)

[^key-9d69acaba369c9e5cea5bd623b6b86ef]: Reg. 6 in force at 15.5.2023, see reg. 1(4)

[^key-d5e1e0d7a9d8bd04fab7ea53b766ca12]: Regulations revoked (except for regs. 4, 7-9 and reg. 1 so far as it relates to regs. 4, 7-9) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (with reg. 23)

Enwi, rhychwant, cymhwyso a dod i rym

Diwygio Rheoliad (EC) Rhif 1333/2008