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)

CHAPTER II U.K. [F13 AUTHORISATION OF] FOOD ADDITIVES

[F14 Article 4 U.K. Requirement for authorisation

1. Only food additives authorised for primary use may be placed on the market as such and used in foods under the conditions of use specified in the authorisation concerned.

2. Only food additives authorised for secondary use may be used in food additives, food enzymes, food flavourings and in nutrients under the conditions of use specified in the authorisation concerned.

3. Where a food additive is authorised for primary use, the authorisation must include the categories of food to which the additive may be added.

4. Where a food additive is authorised for secondary use, the authorisation must include the food additives, food enzymes, food flavourings and nutrients or categories thereof to which the food additive may be added.

5. Food additives must comply with the specifications referred to in Article 14.]

Textual Amendments

F14 Art. 4 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(6) (with reg. 23)

Article 5 U.K. Prohibition of non-compliant food additives and/or non-compliant food

No person shall place on the market a food additive or any food in which such a food additive is present if the use of the food additive does not comply with this Regulation.

Article 6 U.K. [F15 General conditions for authorisation of food additives]

1. A food additive may be [F16 authorised] only if it meets the following conditions and, where relevant, other legitimate factors, including environmental factors:

(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed;

(b) there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means; and

(c) its use does not mislead the consumer.

2. To be [F17 authorised] a food additive must have advantages and benefits for the consumer and therefore serve one or more of the following purposes:

(a) preserving the nutritional quality of the food;

(b) providing necessary ingredients or constituents for foods manufactured for groups of consumers with special dietary needs;

(c) enhancing the keeping quality or stability of a food or improving its organoleptic properties, provided that the nature, substance or quality of the food is not changed in such a way as to mislead the consumer;

(d) aiding in the manufacture, processing, preparation, treatment, packing, transport or storage of food, including food additives, food enzymes and food flavourings, provided that the food additive is not used to disguise the effects of the use of faulty raw materials or of any undesirable practices or techniques, including unhygienic practices or techniques, during the course of any such activities.

3. By way of derogation from paragraph 2(a), a food additive which reduces the nutritional quality of a food may be [F18 authorised for primary use] provided that:

(a) the food does not constitute a significant component of a normal diet; or

(b) the food additive is necessary for the production of foods for groups of consumers with special dietary needs.

Textual Amendments

F15 Art. 6 heading 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(7)(a) (with reg. 23)

F16 Word in Art. 6(1) 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(7)(b) (with reg. 23)

F17 Word in Art. 6(2) 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(7)(c) (with reg. 23)

F18 Words in Art. 6(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(7)(d) (with reg. 23)

Article 7 U.K. Specific conditions for sweeteners

A food additive may be [F19 authorised for primary use] for the functional class of sweetener only if, in addition to serving one or more of the purposes set out in Article 6(2), it serves one or more of the following purposes:

(a)

replacing sugars for the production of energy-reduced food, non-cariogenic food or food with no added sugars; or

(b)

replacing sugars where this permits an increase in the shelf-life of the food; or

(c)

producing food intended for particular nutritional uses as defined in Article 1(2)(a) of Directive 89/398/EEC.

Textual Amendments

F19 Words in Art. 7 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(8) (with reg. 23)

Article 8 U.K. Specific conditions for colours

A food additive may be [F20 authorised for primary use] for the functional class of colour only if, in addition to serving one or more of the purposes set out in Article 6(2), it serves one of the following purposes:

(a)

restoring the original appearance of food of which the colour has been affected by processing, storage, packaging and distribution, whereby visual acceptability may have been impaired;

(b)

making food more visually appealing;

(c)

giving colour to food otherwise colourless.

Textual Amendments

F20 Words in Art. 8 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(9) (with reg. 23)

Article 9 U.K. Functional classes of food additives

1. [F21 An authorisation may state that a food additive is assigned] to one of the functional classes in Annex I on the basis of the principal technological function of the food additive.

Allocating a food additive to a functional class shall not preclude it from being used for several functions.

2. Where necessary, as a result of scientific progress or technological development, the measures, designed to amend non-essential elements of this Regulation, relating to additional functional classes which may be added to Annex I [F22 are to be prescribed by the appropriate authority].

Textual Amendments

F21 Words in Art. 9(1) 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(10) (with reg. 23)

F22 Words in Art. 9(2) 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, 90; 2020 c. 1, Sch. 5 para. 1(1)

Article 10 U.K. The content of [F23 an authorisation] of food additives

1. A food additive which complies with the conditions set out in Articles 6, 7 and 8 may, in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] be [F24 authorised.]

2. The [F25 authorisation of a food additive] shall specify:

(a) the name of the food additive and its E number;

(b) the foods [F26 , food additives, food enzymes, food flavourings or nutrients or categories thereof] to which the food additive may be added;

(c) the conditions under which the food additive may be used;

(d) if appropriate, whether there are any restrictions on the sale of the food additive directly to the final consumer;

[F27 (e) any specifications concerned, in accordance with Article 14.]

F28 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F23 Words in Art. 10 heading 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(11)(a) (with reg. 23)

F24 Word in Art. 10(1) 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(11)(b) (with reg. 23)

F25 Words in Art. 10(2) 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(11)(c)(i) (with reg. 23)

F26 Words in Art. 10(2)(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(11)(c)(ii) (with reg. 23)

F27 Art. 10(2)(e) 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(11)(c)(iii) (with reg. 23)

F28 Art. 10(3) 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(11)(d) (with reg. 23)

Article 11 U.K. Levels of use of food additives

1. When establishing the conditions of use referred to in Article 10(2)(c):

(a) the level of use shall be set at the lowest level necessary to achieve the desired effect;

(b) the levels shall take into account:

(i)

any acceptable daily intake, or equivalent assessment, established for the food additive and the probable daily intake of it from all sources;

(ii)

where the food additive is to be used in foods eaten by special groups of consumers, the possible daily intake of the food additive by consumers in those groups.

2. Where appropriate, no maximum numerical level shall be fixed for a food additive (quantum satis). In that case, the food additive shall be used in accordance with the principle of quantum satis.

3. The maximum levels of food additives set out in [F29 the authorisation for primary use concerned,] shall apply to the food as marketed, unless otherwise stated. By way of derogation from this principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions on the label taking into account the minimum dilution factor.

4. The maximum levels for colours set out in [F30 the authorisation for primary use concerned] shall apply to the quantities of colouring principle contained in the colouring preparation unless otherwise stated.

Textual Amendments

F29 Words in Art. 11(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(12)(a) (with reg. 23)

F30 Words in Art. 11(4) 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(12)(b) (with reg. 23)

Article 12 U.K. Changes in the production process or starting materials of a food additive already [F31 authorised]

When a food additive is already included in a [F32 domestic] list and there is a significant change in its production methods or in the starting materials used, or there is a change in particle size, for example through nanotechnology, the food additive prepared by those new methods or materials shall be considered as a different additive and a new [F33 authorisation or a modification to the existing authorisation] shall be required before it can be placed on the market.

Textual Amendments

F31 Word in Art. 12 heading 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(13)(a) (with reg. 23)

F32 Word in Art. 12 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, 94; 2020 c. 1, Sch. 5 para. 1(1)

F33 Words in Art. 12 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(13)(b) (with reg. 23)

Article 13 U.K. Food additives falling within the scope of Regulation (EC) No 1829/2003

1. A food additive falling within the scope of Regulation (EC) No 1829/2003 may be [F34 authorised] in accordance with this Regulation only when it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.

2. When a food additive [F35 that is already authorised] is produced from a different source falling within the scope of Regulation (EC) No 1829/2003, it will not require a new authorisation under this Regulation, as long as the new source is covered by an authorisation in accordance with Regulation (EC) No 1829/2003 and the food additive complies with the specifications established under this Regulation.

Textual Amendments

F34 Word in Art. 13(1) 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(14)(a) (with reg. 23)

F35 Words in Art. 13(2) 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(14)(b) (with reg. 23)

Article 14 U.K. Specifications of food additives

The specifications of food additives relating, in particular, to origin, purity criteria and any other necessary information, shall be [F36 set out in the authorisation concerned] when the food additive is [F37 authorised], in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].

Textual Amendments

F36 Words in Art. 14 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(15)(a) (with reg. 23)

F37 Word in Art. 14 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(15)(b) (with reg. 23)

[F38 Article 14A U.K. Ethylene oxide: restrictions

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

2. 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))), irrespective of origin, in authorised food additives, or mixtures of those food additives, must not exceed 0.1 mg/kg.

Textual Amendments

F38 Arts. 14A, 14B 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(16) (with reg. 23)

Article 14B U.K. Details to be included in the domestic list

The Authority must include the details described in Article 10(2) in the domestic list published and maintained under Regulation (EC) No 1331/2008.]

Textual Amendments

F38 Arts. 14A, 14B 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(16) (with reg. 23)

Textual Amendments

F13 Words in Ch. 2 heading 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(5) (with reg. 23)

CHAPTER III U.K. USE OF FOOD ADDITIVES IN FOODS

Article 15 U.K. Use of food additives in unprocessed foods

Food additives [F39 authorised for primary use] shall not be used in unprocessed foods, except where such use is specifically provided for in [F40 the authorisations concerned].

Textual Amendments

F39 Words in Art. 15 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(17)(a) (with reg. 23)

F40 Words in Art. 15 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(17)(b) (with reg. 23)

Article 16 U.K. Use of food additives in foods for infants and young children

Food additives [F41 authorised for primary use] shall not be used in foods for infants and young children as referred to in Directive 89/398/EEC, including dietary foods for infants and young children for special medical purposes, except where specifically provided for in [F42 the authorisations concerned].

Textual Amendments

F41 Words in Art. 16 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(18)(a) (with reg. 23)

F42 Words in Art. 16 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(18)(b) (with reg. 23)

Article 17 U.K. Use of colours for markings

Only food colours [F43 that are authorised for primary use may be used, as provided for in the authorisations concerned,] for the purpose of health marking as provided for in Council Directive 91/497/EEC of 29 July 1991 amending and consolidating Directive 64/433/EEC on health problems affecting intra-Community trade in fresh meat to extend it to the production and marketing of fresh meat(3) and other markings required on meat products, for the decorative colouring of eggshells and for the stamping of eggshells as provided for in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin(4).

Textual Amendments

F43 Words in Art. 17 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(19) (with reg. 23)

Article 18 U.K. Carry-over principle

1. The presence of a food additive shall be permitted:

(a) in a compound food other than as referred to in [F44 an authorisation for primary use for the food additive concerned], where the food additive is permitted in one of the ingredients of the compound food;

(b) in a food to which a food additive, food enzyme [F45 , food flavouring or nutrient] has been added, where the food additive:

(i)

is permitted in the food additive, food enzyme [F45 , food flavouring or nutrient] in accordance with this Regulation; and

(ii)

has been carried over to the food via the food additive, food enzyme [F45 , food flavouring or nutrient]; and

(iii)

has no technological function in the final food;

(c) in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation.

2. Paragraph 1 shall not apply to infant formulae, follow-on formulae, processed cereal-based foods and baby foods and dietary foods for special medical purposes intended for infants and young children as referred to in Directive 89/398/EEC, except where specifically provided for.

3. Where a food additive in a food flavouring, food additive [F46 , food enzyme or nutrient] is added to a food and has a technological function in that food, it shall be considered a food additive of that food and not a food additive of the added flavouring, food additive [F46 , food enzyme or nutrient], and must then comply with the conditions of use for that food as provided for.

4. Without prejudice to paragraph 1, the presence of a food additive used as a sweetener shall be permitted in a compound food with no added sugars, in an energy-reduced compound food, in compound dietary foods intended for low-calorie diets, in non-cariogenic compound foods, and in a compound food with an increased shelf-life, provided that the sweetener is permitted in one of the ingredients of the compound food.

[F47 5. Paragraph 1(a) does not apply to foods listed in Table 1, as regards food additives in general, or in Table 2, as regards food colours, in Annex Ia.]

Textual Amendments

F44 Words in Art. 18(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(20)(a) (with reg. 23)

F45 Words in Art. 18(1)(b) 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(20)(b) (with reg. 23)

F46 Words in Art. 18(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(20)(c) (with reg. 23)

F47 Art. 18(5) 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(20)(d) (with reg. 23)

F48 Article 19 U.K. Interpretation decisions

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Textual Amendments

F48 Art. 19 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, 97; 2020 c. 1, Sch. 5 para. 1(1)

F49 Article 20 U.K. Traditional foods

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Textual Amendments

F49 Art. 20 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, 98; 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER IV U.K. LABELLING

Article 21 U.K. Labelling of food additives not intended for sale to the final consumer

1. Food additives not intended for sale to the final consumer, whether sold singly or mixed with each other and/or with food ingredients, as defined in Article 6(4) of Directive 2000/13/EC, may only be marketed with the labelling provided for in Article 22 of this Regulation, which must be easily visible, clearly legible and indelible. The information shall be in [F50 English, or in English and Welsh].

F51 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F50 Words in Art. 21(1) 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, 99(a); 2020 c. 1, Sch. 5 para. 1(1)

F51 Art. 21(2) 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, 99(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 22 U.K. General labelling requirements for food additives not intended for sale to the final consumer

1. Where food additives not intended for sale to the final consumer are sold singly or mixed with each other and/or other food ingredients and/or with other substances added to them, their packaging or containers shall bear the following information:

(a) the name and/or E-number laid down [F52 under] this Regulation in respect of each food additive or a sales description which includes the name and/or E-number of each food additive;

(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its intended food use;

(c) if necessary, the special conditions of storage and/or use;

(d) a mark identifying the batch or lot;

(e) instructions for use, if the omission thereof would preclude appropriate use of the food additive;

(f) the name or business name and address of the manufacturer, packager or seller;

(g) an indication of the maximum quantity of each component or group of components subject to quantitative limitation in food and/or appropriate information in clear and easily understandable terms enabling the purchaser to comply with this Regulation or other relevant [F53 assimilated] law; where the same limit on quantity applies to a group of components used singly or in combination, the combined percentage may be given as a single figure; the limit on quantity shall be expressed either numerically or by the quantum satis principle;

(h) the net quantity;

(i) the date of minimum durability or use-by-date;

(j) where relevant, information on a food additive or other substances referred to in this Article and listed in Annex IIIa to Directive 2000/13/EC as regards the indication of the ingredients present in foodstuffs.

2. Where food additives are sold mixed with each other and/or with other food ingredients, their packaging or containers shall bear a list of all ingredients in descending order of their percentage by weight of the total.

3. Where substances (including food additives or other food ingredients) are added to food additives to facilitate their storage, sale, standardisation, dilution or dissolution, their packaging or containers shall bear a list of all such substances in descending order of their percentage by weight of the total.

4. By way of derogation from paragraphs 1, 2 and 3, the information required in paragraph 1 points (e) to (g) and in paragraphs 2 and 3 may appear merely on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication ‘not for retail sale’ appears on an easily visible part of the packaging or container of the product in question.

5. By way of derogation from paragraphs 1, 2 and 3, where food additives are supplied in tankers, all of the information may appear merely on the accompanying documents relating to the consignment which are to be supplied with the delivery.

Textual Amendments

F52 Word in Art. 22(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(21) (with reg. 23)

F53 Word in Art. 22(1)(g) 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(b)

Article 23 U.K. Labelling of food additives intended for sale to the final consumer

1. Without prejudice to Directive 2000/13/EC, Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs(5) and Regulation (EC) No 1829/2003, food additives sold singly or mixed with each other and/or other food ingredients intended for sale to the final consumer may be marketed only if their packaging contains the following information:

(a) the name and E-number laid down [F54 under] this Regulation in respect of each food additive or a sales description which includes the name and E-number of each food additive;

(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its intended food use.

2. By way of derogation from paragraph 1(a), the sales description of a table-top sweetener shall include the term ‘… -based table-top sweetener’, using the name(s) of the sweetener(s) used in its composition.

3. The labelling of a table-top sweetener containing polyols and/or aspartame and/or aspartame-acesulfame salt shall bear the following warnings:

(a) polyols: ‘excessive consumption may induce laxative effects’;

(b) aspartame/aspartame-acesulfame salt: ‘contains a source of phenylalanine’.

4. Manufacturers of table-top sweeteners shall make available by appropriate means the necessary information to allow their safe use by consumers. F55 ...

5. For the information provided for in paragraphs 1 to 3 of this Article, Article 13(2) of Directive 2000/13/EC shall apply accordingly.

Textual Amendments

F54 Word in Art. 23(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(22) (with reg. 23)

F55 Words in Art. 23(4) 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, 101; 2020 c. 1, Sch. 5 para. 1(1)

Article 24 U.K. Labelling requirement for foods containing certain food colours

1. Without prejudice to Directive 2000/13/EC, the labelling of food containing the food colours listed in Annex V to this Regulation shall include the additional information set out in that Annex.

2. In relation to the information provided in paragraph 1 of this Article, Article 13(2) of Directive 2000/13/EC shall apply accordingly.

3. Where necessary as a result of scientific progress or technical development, Annex V shall be amended by measures [F56 prescribed by the appropriate authority], designed to amend non-essential elements of this Regulation, F57 ....

Textual Amendments

F56 Words in Art. 24(3) 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, 102(a); 2020 c. 1, Sch. 5 para. 1(1)

F57 Words in Art. 24(3) 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, 102(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 25 U.K. Other labelling requirements

Articles 21, 22, 23 and 24 shall be without prejudice to more detailed or more extensive laws, regulations or administrative provisions regarding weights and measures or applying to the presentation, classification, packaging and labelling of dangerous substances and preparations or applying to the transport of such substances and preparations.

CHAPTER V U.K. PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 26 U.K. Information obligation

1. A producer or user of a food additive shall inform the [F58 Authority] immediately of any new scientific or technical information which might affect the assessment of the safety of the food additive.

2. A producer or user of a food additive shall, at the request of the [F59 Authority], inform it of the actual use of the food additive. F60 ...

Textual Amendments

F58 Word in Art. 26(1) 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, 103(a); 2020 c. 1, Sch. 5 para. 1(1)

F59 Word in Art. 26(2) 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, 103(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F60 Words in Art. 26(2) 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, 103(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F61 Article 27 U.K. Monitoring of food additive intake

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Textual Amendments

F61 Art. 27 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, 104; 2020 c. 1, Sch. 5 para. 1(1)

F62 Article 28 U.K. Committee

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Textual Amendments

F62 Art. 28 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, 104; 2020 c. 1, Sch. 5 para. 1(1)

[F63 Article 28A U.K. Regulations and devolved powers

1. Any power to make regulations under this Regulation—

(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;

2. Any power to make regulations under this Regulation includes power—

(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);

(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

3. Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—

(a) in the case of England, of either House of Parliament;

(b) in the case of Wales, of Senedd Cymru;

(c) in the case of Scotland, of the Scottish Parliament;

4. In this Regulation, any power—

(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;]

Textual Amendments

F63 Art. 28A 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, 105; (as amended by S.I. 2020/1504, regs. 1(2), 18(15)(a)-(c)); 2020 c. 1, Sch. 5 para. 1(1)

F64 Article 29 U.K. Community financing of harmonised policies

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Textual Amendments

F64 Art. 29 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, 106; 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER VI U.K. TRANSITIONAL AND FINAL PROVISIONS

F65 Article 30 U.K. Establishment of Community lists of food additives

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Textual Amendments

F65 Art. 30 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(23) (with reg. 23)

F66 Article 31 U.K. Transitional measures

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Textual Amendments

F66 Art. 31 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(24) (with reg. 23)

F67 Article 32 U.K. Re-evaluation of approved food additives

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Textual Amendments

F67 Art. 32 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, 109; 2020 c. 1, Sch. 5 para. 1(1)

Article 33 U.K. Repeals

1. The following acts shall be repealed:

(a) Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorised for use in foodstuffs intended for human consumption;

(b) Directive 65/66/EEC;

(c) Directive 78/663/EEC;

(d) Directive 78/664/EEC;

(e) Directive 81/712/EEC;

(f) Directive 89/107/EEC;

(g) Directive 94/35/EC;

(h) Directive 94/36/EC;

(i) Directive 95/2/EC;

(j) Decision No 292/97/EC;

(k) Decision 2002/247/EC.

2. References to the repealed acts shall be construed as references to this Regulation.

F68 Article 34 U.K. Transitional provisions

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Textual Amendments

F68 Art. 34 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(25) (with reg. 23)

Article 35 U.K. Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 20 January 2010.

However, Article 4(2) shall apply to Parts 2, 3 and 5 of Annex III from 1 January 2011 and Article 23(4) shall apply from 20 January 2011. Article 24 shall apply from 20 July 2010. Article 31 shall apply from 20 January 2009.

F69 ...

Textual Amendments

F69 Words in Signature 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, 111; 2020 c. 1, Sch. 5 para. 1(1)