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

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 1333/2008 of the European Parliament and of the Council on food additives(1),

“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(2),

“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(3),

“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(4),

“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(5).

(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.

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 1333/2008 is amended in accordance with schedule 1.

Amendment of Commission Regulation (EU) No 231/2012

4.—(1) The Annex to Commission Regulation (EU) No 231/2012 is 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)(6), (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) 2017/2470 is 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 1334/2008 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.(7) 07.030, chemical name 1-(4-Methoxyphenyl)pent-1-en-3-one, CAS No. 104-27-8(8),

(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) No1169/2011 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(9) (see Articles 2(2)(r) and 24),

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

JENNI MINTO

Authorised to sign by the Scottish Ministers

St Andrew’s House,

Edinburgh

28th May 2024