PART 1 Introduction

Citation, commencement and extent

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.

Interpretation

2.—(1) In these Regulations—

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

“Regulation (EC) No 1334/2008” means Regulation (EC) No 1334/2008of 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 2232/96and (EC) No 110/2008and Directive 2000/13/EC( 6),

“Commission Regulation (EU) No231/2012” means Commission Regulation (EU) No 231/2012laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008of the European Parliament and of the Council( 7),

“ Regulation (EU) No 609/2013” means Regulation (EU) No609/2013of 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/ECand 2006/141/EC, Directive 2009/39/ECof the European Parliament and of the Council and Commission Regulations (EC) No 41/2009and (EC) No 953/2009( 8),

“ Regulation (EU) 2015/2283” means Regulation (EU) 2015/2283of the European Parliament and of the Council on novel foods, amending Regulation (EU) No1169/2011of the European Parliament and of the Council and repealing Regulation (EC) No 258/97of 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) 2017/2470establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283of 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 231/2012or Commission Implementing Regulation (EU) 2017/2470has the same meaning as it has in Regulation (EC) No 1333/2008, Regulation (EC) No 1334/2008, Commission Regulation (EU) No 231/2012or Commission Implementing Regulation (EU) 2017/2470, as the case may be.

PART 2 Food Additives Authorisations

Amendment of Regulation (EC) No 1333/2008

3.  Annex 2 (domestic list of food additives approved for use in foods and conditions for use) to Regulation (EC) No 1333/2008is amended in accordance with schedule 1.

Amendment of Commission Regulation (EU) No 231/2012

4.—(1) The Annex to Commission Regulation (EU) No 231/2012is amended in accordance with paragraphs (2) to (6).

(2) At the beginning, for “Note: Ethylene oxide may not be used for sterilising purposes in food additives” substitute—

“Restrictions on ethylene oxide in food additives

Ethylene oxide may not be used for sterilising purposes in food additives.

Total residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol, expressed as ethylene oxide (i.e. ethylene oxide + (0.55 x 2-chloroethanol))), regardless of origin, in food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 , or mixtures of those food additives, must not exceed 0.1 mg/kg. ”.

(3) In the entries for the following food additives—

(a) E 431 Polyoxyethylene (40) Stearate,

(b) E 432 Polyoxyethylene Sorbitan Monolaurate (Polysorbate 20),

(c) E 433 Polyoxyethylene Sorbitan Monooleate (Polysorbate 80),

(d) E 434 Polyoxyethylene Sorbitan Monopalmitate (Polysorbate 40),

(e) E 435 Polyoxyethylene Sorbitan Monostearate (Polysorbate 60),

(f) E 436 Polyoxyethylene Sorbitan Tristearate (Polysorbate 65),

(g) E 1209 Polyvinyl Alcohol-Polyethylene Glycol-Graft-Copolymer,

(h) E 1521 Polyethylene Glycol,

omit the row for “Ethylene oxide”.

(4) After the table for E 960a (Steviol glycosides from Stevia), insert the heading and table in schedule 2.

(5) In the heading for the entry for E 960c (rebaudioside M produced via enzyme modification of steviol glycosides from Stevia) for “E 960c” substitute “E 960c(i)”.

(6) After the table for E 960c(i)( 10), (Rebaudioside M produced via enzyme modification of steviol glycosides from Stevia) insert the heading and table in schedule 3.

PART 3 Novel Foods Authorisations

Amendment of Commission Implementing Regulation (EU) 2017/2470

5.  The Annex (domestic list of novel foods authorised to be placed on the market within Great Britain) to Commission Implementing Regulation (EU) 2017/2470is amended in accordance with schedules 4 to 8.

PART 4 Food Flavourings Authorisations

Amendment of Regulation (EC) No 1334/2008

6.—(1) Annex 1 (domestic list of flavourings and source materials approved for use in and on foods) to Regulation (EC) No 1334/2008is 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.( 11) 07.030, chemical name 1-(4-Methoxyphenyl)pent-1-en-3-one, CAS No. 104-27-8( 12),

(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.

Transitional provision

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) No1169/2011of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006and (EC) No 1925/2006of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/ECof the European Parliament and of the Council, Commission Directives 2022/67/ECand 2008/5/ECand Commission Regulation (EC) No 608/2004( 13) (see Articles 2(2)(r) and 24),

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

Regulation 3

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

1.  In Part B (list of all additives), in paragraph 2 (sweeteners) after the entry for E 960a (Steviol glycosides from Stevia), insert—

2.  In Part C (definitions of groups of additives), in sub-part 5 (other additives that may be regulated combined), in paragraph (v)—

(a) for the heading of the paragraph, substitute “E 960a – E 960c: Steviol glycosides”,

(b) after the entry for E 960a (Steviol glycosides from Stevia), insert—

3.  In Part E (authorised food additives and conditions of use in food categories), in the table—

(a) in each place it occurs, for “E 960a and E 960c” substitute “E 960a – E 960c”,

(b) in category 03 (edible ices), after the entry for E 473-474 (sucrose esters of fatty acids – sucroglycerides), insert—

(c) in category 05.1 (cocoa and chocolate products), at the end, insert the following footnote—

^“(1)  The additives may be added individually or in combination. ”,

(d) in category 05.2 (other confectionary including breath freshening microsweets)—

(i) in the third entry for Group IV (polyols), for “only cocoa or dried fruit-based, milk or fat-based sandwich spreads, energy-reduced or with no added sugar” substitute “sandwich spreads made with a base of cocoa, milk, dried fruit or fat; energy reduced or with no added sugar”,

(ii) in the first entry for E 960a – E960c Steviol glycosides( 14) for “only cocoa or dried-fruit-based, energy-reduced or with no added sugar”, substitute “only cocoa or dried fruit based; energy reduced or with no added sugar”,

(iii) in the second entry for E 960a – E960c Steviol glycosides for “only cocoa, milk, dried-fruit-based or fat-based sandwich spreads, energy-reduced or with no added sugar”, substitute “sandwich spreads made with a base of cocoa, milk, dried fruit or fat; energy reduced or with no added sugar”,

(e) in category 05.4 (decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4), for the second entry for E 960a – E 960c Steviol glycosides for “only cocoa or dried-fruit-based, energy-reduced or with no added sugar”, substitute “only cocoa or dried fruit based; energy reduced or with no added sugar”,

(f) in category 12.6 (sauces), for the entry for “ E 476” (polyglycerol polyricinoleate), substitute—

Regulation 4(4)

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

1.  In the appropriate place, insert the following entry—

“E 960b STEVIOL GLYCOSIDES FROM FERMENTATION ( YARROWIA LIPOLYTICA )

Regulation 4(6)

SCHEDULE 3 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))

1.  In the appropriate place, insert the following entry—

“E 960C(ii) REBAUDIOSIDE M, AM AND D PRODUCED VIA ENZYMATIC CONVERSION OF HIGHLY PURIFIED STEVIOL GLYCOSIDES FROM STEVIA LEAF EXTRACTS

Regulation 5

SCHEDULE 4 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

1.  In Table 1 (authorised novel foods), after the entry for Astaxanthin-rich oleoresin fromHaematococcus pluvialisalgae insert the following entry—

2.  In Table 2 (specifications), after the entry for Astaxanthin-rich oleoresin fromHaematococcus pluvialisalgae insert the following entry—

Regulation 5

SCHEDULE 5 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

1.  In Table 1 (authorised novel foods), after the entry forCalanus finmarchicusoil insert the following entry—

2.  In Table 2 (specifications), after the entry forCalanus finmarchicusoil insert the following entry—

Regulation 5

SCHEDULE 6 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 ofEscherichia coliK-12 DH1) as a novel food

1.  In Table 1 (authorised novel foods), after the entry for 2’-Fucosyllactose / Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) insert the following entry—

2.  In Table 2 (specifications), after the entry for 2’-Fucosyllactose / Difucosyllactose mixture (‘2’-FL/DFL’) (microbial source) insert the following entry—

Regulation 5

SCHEDULE 7 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

1.  In Table 1 (authorised novel foods), after the entry for Lactitol insert the following entry—

2.  In Table 2 (specifications), after the entry for Lactitol insert the following entry—

Regulation 5

SCHEDULE 8 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

1.  In Table 1 (authorised novel foods), for the entry for bovine milk basic whey protein isolate substitute the following entry—

2.  In Table 2 (specifications), for the entry for Xylo-oligosaccharides, in column 2 (description/definition), after the row specifying the moisture (%) content, insert—

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision regarding the authorisation of—

• food additives under Regulation (EC) No 1331/2008of 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) 2015/2283of 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 1333/2008of 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 ofEscherichia coliK-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 1334/2008on 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.