Regulation (EC) No 1333/2008 of the European Parliament and of the CouncilShow full title

CHAPTER I U.K. SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 U.K. Subject matter

This Regulation lays down rules on food additives used in foods with a view to ensuring the effective functioning of the F1 ... market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.

For those purposes, this Regulation provides for:

(a)

[F2 the authorisation of food additives;]

(b)

conditions of use of food additives in foods, including in food additives and in food enzymes [F3 , food flavourings or nutrients,] as covered by Regulation (EC) No 1332/2008 [on food enzymes], and F4 ... Regulation (EC) No 1334/2008 F5 ... on flavourings and certain food ingredients with flavouring properties for use in and on foods(1);

(c)

rules on the labelling of food additives sold as such.

Textual Amendments

F1 Word in Art. 1 omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 80(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 1(a) substituted (E.W.S.) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 8(2)(a) (with reg. 23)

F3 Words in Art. 1(b) inserted (E.W.S.) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 8(2)(b)(i) (with reg. 23)

F4 Words in Art. 1(b) omitted (E.W.S.) (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 8(2)(b)(ii) (with reg. 23)

F5 Words in Art. 1(b) omitted (E.W.S.) (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 8(2)(b)(iii) (with reg. 23)

Article 2 U.K. Scope

1. This Regulation shall apply to food additives.

2. This Regulation shall not apply to the following substances unless they are used as food additives:

(a) processing aids;

(b) substances used for the protection of plants and plant products in accordance with [F6 [F7 assimilated] law] relating to plant health;

(c) substances added to foods as nutrients;

(d) substances used for the treatment of water for human consumption falling within the scope of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption(2);

(e) flavourings falling within the scope of Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods].

3. This Regulation shall not apply to food enzymes falling within the scope of Regulation (EC) No 1332/2008 [on food enzymes], with effect from the [F8 start of the day after the day on which the appropriate authority has determined the authorisations status of all initial authorisation applications on the Register referred to in Article 17(3)] of that Regulation.

4. This Regulation shall apply without prejudice to any specific [F9 [F10 assimilated] law] concerning the use of food additives:

(a) in specific foods;

(b) for purposes other than those covered by this Regulation.

Textual Amendments

F6 Words in Art. 2(2)(b) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 81(a); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Art. 2(2)(b) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 14(a)

F8 Words in Art. 2(3) substituted (E.W.S.) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 8(3) (with reg. 23)

F9 Words in Art. 2(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 81(c); 2020 c. 1, Sch. 5 para. 1(1)

F10 Word in Art. 2(4) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 14(a)

Article 3 U.K. Definitions

1. For the purposes of this Regulation, the definitions laid down in Regulations (EC) No 178/2002 and (EC) No1829/2003 shall apply.

2. For the purposes of this Regulation the following definitions shall also apply:

(a) ‘food additive’ shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods;

The following are not considered to be food additives:

(i)

monosaccharides, disaccharides or oligosaccharides and foods containing these substances used for their sweetening properties;

(ii)

foods, whether dried or in concentrated form, including flavourings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect;

(iii)

substances used in covering or coating materials, which do not form part of foods and are not intended to be consumed together with those foods;

(iv)

products containing pectin and derived from dried apple pomace or peel of citrus fruits or quinces, or from a mixture of them, by the action of dilute acid followed by partial neutralisation with sodium or potassium salts (liquid pectin);

(v)

chewing gum bases;

(vi)

white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes;

(vii)

ammonium chloride;

(viii)

blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten;

(ix)

amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts having no technological function;

(x)

caseinates and casein;

(xi)

inulin;

(b) ‘processing aid’ shall mean any substance which:

(i)

is not consumed as a food by itself;

(ii)

is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and

(iii)

may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product;

(c) ‘functional class’ shall mean one of the categories set out in Annex I based on the technological function a food additive exerts in the foodstuff;

(d) ‘unprocessed food’ shall mean a food which has not undergone any treatment resulting in a substantial change in the original state of the food, for which purpose the following in particular are not regarded as resulting in substantial change: dividing, parting, severing, boning, mincing, skinning, paring, peeling, grinding, cutting, cleaning, trimming, deep-freezing, freezing, chilling, milling, husking, packing or unpacking;

(e) ‘food with no added sugars’ shall mean a food without the following:

(i)

any added monosaccharides or disaccharides;

(ii)

any added food containing monosaccharides or disaccharides which is used for its sweetening properties;

(f) ‘energy-reduced food’ shall mean a food with an energy value reduced by at least 30 % compared with the original food or a similar product;

(g) ‘table-top sweeteners’ shall mean preparations of permitted sweeteners, which may contain other food additives and/or food ingredients and which are intended for sale to the final consumer as a substitute for sugars;

(h) ‘quantum satis’ shall mean that no maximum numerical level is specified and substances shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled;

[F11 (i) “ Authority ” means—

(i)

as regards England and Wales, the Food Standards Agency;

(ii)

as regards Scotland, Food Standards Scotland;]

[F12 (j) ‘nutrients’ means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes, in accordance with Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods, the Food Supplements (Scotland) Regulations 2003, the Food Supplements (England) Regulations 2003, the Food Supplements (Wales) Regulations 2003 and Regulation (EU) No 609/2013 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, etc., for the purposes of secondary use;

(k) ‘primary use’ means the use of a food additive in food in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation;

(l) ‘secondary use’ means the use of a food additive, including carriers, in food additives, food enzymes, food flavourings or nutrients in accordance with the terms of its authorisation under Regulation (EC) No 1331/2008 and this Regulation.]

Textual Amendments

F11 Art. 3(i) inserted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 82; (as amended by S.I. 2020/1504, regs. 1(2), 18(14)); 2020 c. 1, Sch. 5 para. 1(1)

F12 Art. 3(2)(j)-(l) inserted (E.W.S.) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 8(4) (with reg. 23)

(1)

See page 34 of this Official Journal.

(2)

OJ L 330, 5.12.1998, p. 32.