CHAPTER II

AUTHORISATION OF FOOD ADDITIVES

Requirement for authorisation
Article 4
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.

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

General conditions for authorisation of food additives
Article 6
1
A food additive may be 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 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 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.

Specific conditions for sweeteners
Article 7
A food additive may be 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:
1. replacing sugars for the production of energy-reduced food, non-cariogenic food or food with no added sugars; or
2. replacing sugars where this permits an increase in the shelf-life of the food; or
3. producing food intended for particular nutritional uses as defined in Article 1(2)(a) of Directive 89/398/EEC.

Specific conditions for colours
Article 8
A food additive may be 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:
1. 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;
2. making food more visually appealing;
3. giving colour to food otherwise colourless.

Functional classes of food additives
Article 9
1
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 are to be prescribed by the appropriate authority.

The content of an authorisation of food additives
Article 10
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 authorised.
2
The authorisation of a food additive shall specify:
a
the name of the food additive and its E number;
b
the foods , 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;
e
any specifications concerned, in accordance with Article 14.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Levels of use of food additives
Article 11
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:
1. any acceptable daily intake, or equivalent assessment, established for the food additive and the probable daily intake of it from all sources;
2. 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 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 the authorisation for primary use concerned shall apply to the quantities of colouring principle contained in the colouring preparation unless otherwise stated.

Changes in the production process or starting materials of a food additive already authorised
Article 12
When a food additive is already included in a 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 authorisation or a modification to the existing authorisation shall be required before it can be placed on the market.

Food additives falling within the scope of Regulation (EC) No 1829/2003 or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023
Article 13
1
A food additive falling within the scope of Regulation (EC) No 1829/2003 may be 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 that is already authorisedis 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.
3.
In relation to England, a food additive falling within the scope of the Genetic Technology (Precision Breeding) Act 2023 may be authorised in accordance with this Regulation only when it is covered by a food and feed marketing authorisation under Part 3 of that Act.
4
In relation to England, when a food additive that is already authorised is produced from a different source falling within the scope of the Genetic Technology (Precision Breeding) Act 2023, it will not require a new authorisation under this Regulation, as long as the new source is covered by a food and feed marketing authorisation under Part 3 of that Act and the food additive complies with the specifications established under this Regulation.

Specifications of food additives
Article 14
The specifications of food additives relating, in particular, to origin, purity criteria and any other necessary information, shall be set out in the authorisation concerned when the food additive is 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].

Ethylene oxide: restrictions
Article 14A
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.

Details to be included in the domestic list
Article 14B
The Authority must include the details described in Article 10(2) in the domestic list published and maintained under Regulation
(EC) No 1331/2008
.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Words in Art. 13 heading inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 5(2)
Art. 13(3)(4) inserted (13.11.2025) by The Genetic Technology (Precision Breeding) Regulations 2025 (S.I. 2025/581), reg. 1(1), Sch. 5 para. 5(3)