The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024

Scottish Statutory Instruments

2024 No. 156

Food

[F1 The Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024

Made

28th May 2024

Laid before the Scottish Parliament

30th May 2024

Coming into force

28th June 2024

The Scottish Ministers make these Regulations in exercise of the powers conferred by Articles 7(4) and (5)(1) 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(2), and Articles 12(1) and 32A(3)(b) of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001(3), and all other powers enabling them to do so.

In relation to Parts 2 and 4, the Scottish Ministers have sought the advice of Food Standards Scotland in accordance with Article 7(4) and (5) 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.

There has been consultation 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(4).

Textual Amendments

F1 Regulations revoked (except for reg. 7 and regs. 1, 2, 6(2)(a)-(v) so far as they relate to reg. 7) (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. 1 para. (h) (with reg. 23)

PART 1 S Introduction

Citation, commencement and extent S

1.— (1) These Regulations may be cited as the Food Additives and Novel Foods (Authorisations and Miscellaneous Amendments) and Food Flavourings (Removal of Authorisations) (Scotland) Regulations 2024 and come into force on 28 June 2024.

(2) These Regulations extend to Scotland only.

Commencement Information

I1 Reg. 1 in force at 28.6.2024, see reg. 1(1)

Interpretation S

2.— (1) In these Regulations—

“Regulation (EC) No 1333/2008” means Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives(5),

“Regulation (EC) No 1334/2008” means 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 and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC(6),

“Commission Regulation (EU) No231/2012” means 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(7),

“Regulation (EU) No 609/2013” means Regulation (EU) No609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009(8),

“Regulation (EU) 2015/2283” means Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001,

“Commission Implementing Regulation (EU) 2017/2470” means 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(9).

(2) Unless the contrary intention appears, any expression used both in these Regulations and in Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008, Commission Regulation (EU) No 231/2012 or Commission Implementing Regulation (EU) 2017/2470 has the same meaning as it has in Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008, Commission Regulation (EU) No 231/2012 or Commission Implementing Regulation (EU) 2017/2470, as the case may be.

Commencement Information

I2 Reg. 2 in force at 28.6.2024, see reg. 1(1)

PART 2 S Food Additives Authorisations

Amendment of Regulation (EC) No 1333/2008 S

F1 3.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Commission Regulation (EU) No 231/2012 S

F1 4.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 S Novel Foods Authorisations

Amendment of Commission Implementing Regulation (EU) 2017/2470 S

F1 5.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 4 S Food Flavourings Authorisations

Amendment of Regulation (EC) No 1334/2008 S

6.— (1) Annex 1 (domestic list of flavourings and source materials approved for use in and on foods) to Regulation (EC) No 1334/2008 is amended in accordance with paragraph (2).

(2) In Part A (domestic list of flavouring substance), Section 2, in Table 1, the following entries are omitted—

(a) FL No.(10) 07.030, chemical name 1-(4-Methoxyphenyl)pent-1-en-3-one, CAS No. 104-27-8(11),

(b) FL No. 07.046, chemical name Vanillylidene acetone, CAS No. 1080-12-2,

(c) FL No. 07.049, chemical name 1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one, CAS No. 103-13-9,

(d) FL No. 07.206, chemical name 4-(2,3,6-Trimethylphenyl)but-3-en-2-one, CAS No. 56681-06-2,

(e) FL No. 07.258, chemical name 6-Methyl-3-hepten-2-one, CAS No. 2009-74-7,

(f) FL No. 10.034, chemical name 5,6-Dihydro-3,6-dimethylbenzofuran-2(4H)-one, CAS No. 80417-97-6,

(g) FL No. 10.036, chemical name 5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one, CAS No. 13341-72-5,

(h) FL No. 10.042, chemical name 3,4-Dimethyl-5-pentylidenefuran-2(5H)-one, CAS No. 774-64-1,

(i) FL No. 10.043, chemical name 2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone, CAS No. 78548-56-8,

(j) FL No. 10.046, chemical name Hex-2-eno-1,4-lactone, CAS No. 2407-43-4,

(k) FL No. 10.054, chemical name Non-2-eno-1,4-lactone, CAS No. 21963-26-8,

(l) FL No. 10.060, chemical name 2-Decen-1,4-lactone, CAS No. 2518-53-8,

(m) FL No. 10.170, chemical name 5-Pentyl-3H-furan-2-one, CAS No. 51352-68-2,

(n) FL No. 13.004, chemical name Allyl 2-furoate, CAS No. 4208-49-5,

(o) FL No. 13.034, chemical name 3-(2-furyl)acrylaldehyde, CAS No. 623-30-3,

(p) FL No. 13.043, chemical name Furfurylidene-2-butanal, CAS No. 770-27-4,

(q) FL No. 13.044, chemical name 4-(2-Furyl)but-3-en-2-one, CAS No. 623-15-4,

(r) FL No. 13.046, chemical name 3-(2-Furyl)-2-methylprop-2-enal, CAS No. 874-66-8,

(s) FL No. 13.066, chemical name 3-Acetyl-2,5-dimethylfuran, CAS No. 10599-70-9,

(t) FL No. 13.103, chemical name 2-Butylfuran, CAS No. 4466-24-4,

(u) FL No. 13.137, chemical name 3-(2-Furyl)-2-phenylprop-2-enal, CAS No. 65545-81-5,

(v) FL No. 13.150, chemical name 3-(5-Methyl-2-furyl)prop-2-enal, CAS No. 5555-90-8.

Commencement Information

I3 Reg. 6 in force at 28.6.2024, see reg. 1(1)

Transitional provision S

7.— (1) The flavouring substances referred to in regulation 6(2) and foods containing them may, until their date of minimum durability of a food or ‘use by’ date, be placed on the market and, as the case may be, added to other foods, if—

(a) present in the United Kingdom and were, or could have been, lawfully placed on the market in Great Britain before the end of 27 June 2024, or

(b) in transit to Great Britain before the end of 27 June 2024, and could have lawfully been imported, or moved into Great Britain, and placed on the market as at the date of dispatch.

(2) Foods containing one or more flavouring substances to which paragraph (1) applies may, until their date of minimum durability of a food or ‘use by’ date, be placed on the market and, as the case may be, added to other foods.

(3) In this regulation—

“date of minimum durability of a food” has the same meaning as provided in Regulation (EU) No1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC of the European Parliament and of the Council, Commission Directives 2022/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004(12) (see Articles 2(2)(r) and 24),

“‘use by’ date” has the same meaning as in Article 24 of Regulation (EU)1169/2011.

Commencement Information

I4 Reg. 7 in force at 28.6.2024, see reg. 1(1)

JENNI MINTO

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

28th May 2024

Regulation 3

SCHEDULE 1 S Amendments to Annex 2 (domestic list of food additives approved for use in foods and conditions for use) to Regulation (EC) No 1333/2008 concerning steviol glycosides from Stevia (E 960a – E 960c) and the extension of use of polyglycerol polyricinoleate (E 476)

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 2.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 3.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 4(4)

SCHEDULE 2 S Amendment to the Annex to Commission Regulation (EU) No 231/2012 for the authorisation of steviol glycosides from fermentation (Yarrowia lipolytica) (E 960b)

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 4(6)

SCHEDULE 3 S Amendment to the Annex to Commission Regulation (EU) No 231/2012 for the re-numbering of rebaudioside M produced via enzyme modification of steviol glycosides from Stevia E 960c(i) (formerly E 960c) and for the addition of a specification for rebaudioside M, AM and D produced via enzymatic conversion of highly purified steviol glycosides from Stevia leaf extracts (E 960c(ii))

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 5

SCHEDULE 4 S Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 2.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 5

SCHEDULE 5 S Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of cetylated fatty acids as a novel food

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 2.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 5

SCHEDULE 6 S Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of 3-fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1) as a novel food

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 2.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 5

SCHEDULE 7 S Amendments to the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture as a novel food

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 2.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

Regulation 5

SCHEDULE 8 S Corrections to existing entries in the Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470 concerning the authorisation of bovine milk basic whey protein isolate and xylo-oligosaccharides

F1 1.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S

F1 2.   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .] S

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision regarding the authorisation of—

• food additives under 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 (EUR 2008/1331),

• food flavourings under EUR 2008/1331, and

• novel foods under Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (EUR 2015/2283).

Regulation 3 and schedule 1 amends the list of authorised food additives set out in Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (EUR 2008/1333) to add an entry thereby authorising the placing on the market and use of the food additive steviol glycosides from fermentation (Yarrowia lipolytica) (E 960b). Amendments are made to the list of authorised food additives consequential to that addition, and further amendments correct errors in that Regulation concerning steviol glycosides. Entries are added in that Regulation extending the use of the authorised food additive polyglycerol polyricinoleate (E 476).

Regulation 4 and schedules 2 and 3 amend the Annex to Commission Regulation (EU) No 231/2012 (EUR 2012/231) laying down specifications for food additives listed in Annexes II and III of EUR 2008/1333 to—

• provide a maximum limit for residues of ethylene oxide applicable to all food additives,

• add an entry concerning the authorisation of steviol glycosides from fermentation (Yarrowia lipolytica) (E 960b), and

• authorise rebaudioside M, AM and D produced via enzymatic conversion of highly purified steviol glycosides from Stevia leaf extracts (E 960c(ii)), which is a new production method for an existing food additive rebaudioside M produced via enzyme modification of steviol glycosides from Stevia E 960c(i) (formerly E 960c).

Regulation 5 and schedules 4 to 8 amend the list of authorised novel foods set out in the Annex to Commission Implementing Regulation (EU) 2017/2470 (EUR 2017/2470). Schedule 8 corrects errors to existing entries in the list concerning bovine milk basic whey protein isolate and xylo-oligosaccharides. Schedules 4 to 7 authorise the placing on the market of 4 new novel foods—

• partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa),

• cetylated fatty acids,

• 3-fucosyllactose (3-FL) (produced by a derivative strain of Escherichia coli K-12 DH1), and

• lacto-N-fucopentaose I (LNFP-I) and 2’-fucosyllactose (2’-FL) mixture.

Regulation 6 removes 22 flavouring substances from the domestic list of authorised 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).

Regulation 7 is a transitional measure allowing the 22 flavouring substances, the authorisation of which is removed by regulation 6, and foods containing them to be placed on the market, and be added to other foods, if already present in the United Kingdom or in transit to Great Britain before the removal of the authorisations. Foods to which such substances are added may be placed on the market, and used, until their date of minimum durability (‘best before’ date) or ‘use by’ date.

No business and regulatory impact assessment has been prepared for these Regulations as no impact upon business, charities or voluntary bodies is foreseen.

(1)

Article 2 makes provision as to how the regulation-making power in Article 7(5) is to be exercised.

(2)

EUR 2008/1331, as relevantly amended by S.I. 2019/860. The terms “domestic list”, “authority”, “prescribe” and “appropriate authority” are defined in Article 2. In relation to Part 2 of these Regulations, Articles 7(5) and 14(2)(b) of EUR 2008/1331 are applied by Articles 10(3), 14 and 30(4) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives as relevantly amended by S.I. 2019/860. In relation to Part 3 of these Regulations, Articles 7(5) and 14(2)(b) of EUR 2008/1331 are applied by 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 as relevantly amended by S.I. 2019/860.

(3)

EUR 2015/2283, as relevantly amended by S.I. 2019/702. The terms “list”, “prescribe” and “appropriate authority” are defined in Article 3. Article 9 makes provision as regards how the regulation-making power in Article 12(1) is to be exercised and Article 27(1) lays down requirements as regards the information to be included in the entry for a novel food on the list set out in Commission Implementing Regulation (EU) 2017/2470 where it is authorised based in proprietary scientific evidence or scientific data. In accordance with Article 12(1), the appropriate authority must prescribe updates to that list within seven months of the date of publication of the Food Safety Authority’s opinion.

(4)

EUR 2002/178, as relevantly amended by S.I. 2019/641.

(5)

EUR 2008/1333, as relevantly amended by S.I. 2019/860.

(6)

EUR 2008/1334, as relevantly amended by S.I. 2019/860.

(7)

EUR 2012/231.

(8)

EUR 2013/609, as relevantly amended by S.I. 2019/651.

(9)

EUR 2017/2470, as relevantly amended by S.I. 2019/702.

(10)

The FL No. is the unique identification number of the substance.

(11)

The CAS Registry Number assigned to the substance by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.

(12)

EUR 2011/1169, as relevantly amended by S.I. 2019/778.