Regulation (EC) No 1333/2008 of the European Parliament and of the Council

of 16 December 2008

on food additives

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee1,
Acting in accordance with the procedure laid down in Article 251 of the Treaty2,

Whereas:

(1)

The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(2)

A high level of protection of human life and health should be assured in the pursuit of Community policies.

(3)

This Regulation replaces previous Directives and Decisions concerning food additives permitted for use in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests, via comprehensive and streamlined procedures.

(4)
This Regulation harmonises the use of food additives in foods in the Community. This includes the use of food additives in foods covered by Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses3 and the use of certain food colours for the health marking of meat and the decoration and stamping of eggs. It also harmonises the use of food additives in food additives and food enzymes thus ensuring their safety and quality and facilitating their storage and use. This has not previously been regulated at Community level.
(5)
Food additives are substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose described in this Regulation, such as the preservation of food. All food additives should be covered by this Regulation, and therefore in the light of scientific progress and technological development the list of functional classes should be updated. However, substances should not be considered as food additives when they are used for the purpose of imparting flavour and/or taste or for nutritional purposes, such as salt replacers, vitamins and minerals. Moreover, substances considered as foods which may be used for a technological function, such as sodium chloride or saffron for colouring and food enzymes should also not fall within the scope of this Regulation. However, preparations obtained from foods and other natural source material that are intended to have a technological effect in the final food and which are obtained by selective extraction of constituents (e.g. pigments) relative to the nutritive or aromatic constituents, should be considered additives within the meaning of this Regulation. Finally, food enzymes are covered by Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes4, which excludes the application of this Regulation.
(6)

Substances not consumed as food itself but used intentionally in the processing of foods, which only remain as residues in the final food and do not have a technological effect in the final product (processing aids), should not be covered by this Regulation.

(7)

Food additives should be approved and used only if they fulfil the criteria laid down in this Regulation. Food additives must be safe when used, there must be a technological need for their use, and their use must not mislead the consumer and must be of benefit to the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product, including its fruit and vegetable content. The approval of food additives should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls. The use and maximum levels of a food additive should take into account the intake of the food additive from other sources and the exposure to the food additive by special groups of consumers (e.g. allergic consumers).

(8)
Food additives must comply with the approved specifications, which should include information to adequately identify the food additive, including origin, and to describe the acceptable criteria of purity. The specifications previously developed for food additives included in Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs5, Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs6 and Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners7 should be maintained until the corresponding additives are entered in the Annexes to this Regulation. At that time, the specifications related to such additives should be set out in a Regulation. Those specifications should relate directly to the additives included in the Community lists in the Annexes to this Regulation. However, considering the complex character and substance of such specifications, for the sake of clarity they should not be integrated as such in the Community lists but should be set out in one or more separate Regulations.
(9)

Some food additives are permitted for specific uses for certain authorised oenological practices and processes. The use of such food additives should comply with this Regulation and with the specific provisions laid down in the relevant Community legislation.

(10)
In order to ensure harmonisation, the risk assessment and approval of food additives should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings8
(11)
Under Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety9, the European Food Safety Authority (hereinafter referred to as the Authority) is to be consulted on matters likely to affect public health.
(12)
A food additive which falls within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed10 should be authorised in accordance with that Regulation as well as under this Regulation.
(13)

A food additive already approved under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the specifications laid down, should be submitted for evaluation by the Authority. ‘Significantly different’ could mean, inter alia, a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size, including the use of nanotechnology.

(14)

Food additives should be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. Where necessary, the Commission together with the Member States should consider appropriate action.

(15)
Member States which maintained on 1 January 1992 prohibitions on the use of certain additives in certain specific foods which are considered traditional and are produced on their territory should be permitted to continue to apply those prohibitions. Moreover, as regard products such as ‘Feta’ or ‘Salame cacciatore’, this Regulation should be without prejudice to more restrictive rules linked to the use of certain denominations under Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs11 and Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed12.
(16)

Unless subject to further restrictions, an additive may be present in food, other than by direct addition, as a result of carry-over from an ingredient in which the additive was permitted, provided that the level of the additive in the final food is no greater than would be introduced by the use of the ingredient under proper technological conditions and good manufacturing practice.

(17)
Food additives remain subject to the general labelling obligations as provided for in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs13 and, as the case may be, in Regulation (EC) No 1829/2003 and in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms14. In addition, specific provisions on the labelling of food additives sold as such to the manufacturer or to the final consumer should be contained in this Regulation.
(18)

Sweeteners authorised under this Regulation may be used in table-top sweeteners sold directly to consumers. Manufacturers of such products should make information available to the consumer by appropriate means to allow them to use the product in a safe manner. Such information could be made available in a number of ways including on product labels, Internet websites, consumer information lines or at the point of sale. In order to adopt a uniform approach to the implementation of this requirement, guidance drawn up at Community level may be necessary.

(19)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission15.
(20)

In particular the Commission should be empowered to amend the Annexes of this Regulation and to adopt appropriate transitional measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(21)

On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of certain amendments to Annexes II and III relating to substances already authorised under other Community law as well as any appropriate transitional measures related to these substances.

(22)
In order to develop and update Community law on food additives in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States. For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process. It is appropriate that the Community finance such studies as part of its budgetary procedure. The financing of such measures is covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules16.
(23)

Member States are to carry out official controls in order to enforce compliance with this Regulation in accordance with Regulation (EC) No 882/2004.

(24)

Since the objective of this Regulation, namely to lay down Community rules on food additives, cannot be sufficiently achieved by the Member States and can therefore, in the interests of market unity and a high level of consumer protection, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(25)

Following the adoption of this Regulation the Commission, assisted by the Standing Committee on the Food Chain and Animal Health, should review all the existing authorisations for criteria, other than safety, such as intake, technological need and the potential to mislead the consumer. All food additives that are to continue to be authorised in the Community should be transferred to the Community lists in Annexes II and III to this Regulation. Annex III to this Regulation should be completed with the other food additives used in food additives and food enzymes as well as carriers for nutrients and their conditions of use in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings]. To allow a suitable transition period, the provisions in Annex III, other than the provisions concerning carriers for food additives and food additives in flavourings, should not apply until 1 January 2011.

(26)

Until the future Community lists of food additives are established, it is necessary to provide for a simplified procedure allowing the current lists of food additives contained in the existing Directives to be updated.

(27)

Without prejudice to the outcome of the review referred to in recital 25, within one year following the adoption of this Regulation the Commission should set up an evaluation programme for the Authority to re-evaluate the safety of the food additives that were already approved in the Community. That programme should define the needs and the order of priorities according to which the approved food additives are to be examined.

(28)
This Regulation repeals and replaces the following acts: 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 consumption17, Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorised for use in foodstuffs intended for human consumption18, Council Directive 78/663/EEC of 25 July 1978 laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs19, Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumption20, First Commission Directive 81/712/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity21, Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption22, Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs23, Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs24, Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners25, Decision No 292/97/EC of the European Parliament and of the Council of 19 December 1996 on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs26 and Commission Decision 2002/247/EC of 27 March 2002 suspending the placing on the market and import of jelly confectionary containing the food additive E 425 konjac27. However, it is appropriate that certain provisions of those acts remain in force during a transitional period to allow time for the preparation of the Community lists in the Annexes to this Regulation,

HAVE ADOPTED THIS REGULATION:

CHAPTER ISUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1Subject 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:

  1. (a)

    F2the authorisation of food additives;

  2. (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 foods28;
  3. (c)

    rules on the labelling of food additives sold as such.

Article 2Scope

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 F6F7assimilated 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 consumption29;

(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 F8start 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 F9F10assimilated law concerning the use of food additives:

(a)

in specific foods;

(b)

for purposes other than those covered by this Regulation.

Article 3Definitions

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:

  1. (i)

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

  2. (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;

  3. (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;

  4. (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);

  5. (v)

    chewing gum bases;

  6. (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;

  7. (vii)

    ammonium chloride;

  8. (viii)

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

  9. (ix)

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

  10. (x)

    caseinates and casein;

  11. (xi)

    inulin;

(b)

‘processing aid’ shall mean any substance which:

  1. (i)

    is not consumed as a food by itself;

  2. (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

  3. (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:

  1. (i)

    any added monosaccharides or disaccharides;

  2. (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—

  1. (i)

    as regards England and Wales, the Food Standards Agency;

  2. (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.

CHAPTER IIF13AUTHORISATION OF FOOD ADDITIVES

F14Article 4Requirement 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.

Article 5Prohibition 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 6F15General conditions for authorisation of food additives

1.

A food additive may be F16authorised 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 F17authorised 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 F18authorised 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.

Article 7Specific conditions for sweeteners

A food additive may be F19authorised 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. (a)

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

  2. (b)

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

  3. (c)

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

Article 8Specific conditions for colours

A food additive may be F20authorised 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. (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;

  2. (b)

    making food more visually appealing;

  3. (c)

    giving colour to food otherwise colourless.

Article 9Functional classes of food additives

1.

F21An 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 F22are to be prescribed by the appropriate authority.

Article 10The content of F23an 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 F24authorised.

2.

The F25authorisation 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.

F283.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 11Levels 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:

  1. (i)

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

  2. (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 F29the 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 F30the authorisation for primary use concerned shall apply to the quantities of colouring principle contained in the colouring preparation unless otherwise stated.

Article 12Changes in the production process or starting materials of a food additive already F31authorised

When a food additive is already included in a F32domestic 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 F33authorisation or a modification to the existing authorisation shall be required before it can be placed on the market.

Article 13Food additives falling within the scope of Regulation (EC) No 1829/2003 F34or, in relation to England, the Genetic Technology (Precision Breeding) Act 2023

1.

A food additive falling within the scope of Regulation (EC) No 1829/2003 may be F35authorised 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 F36that 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.

F373.

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.

Article 14Specifications of food additives

The specifications of food additives relating, in particular, to origin, purity criteria and any other necessary information, shall be F38set out in the authorisation concerned when the food additive is F39authorised, 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].

F40Article 14AEthylene 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.

Article 14BDetails 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.

CHAPTER IIIUSE OF FOOD ADDITIVES IN FOODS

Article 15Use of food additives in unprocessed foods

Food additives F41authorised for primary use shall not be used in unprocessed foods, except where such use is specifically provided for in F42the authorisations concerned.

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

Food additives F43authorised 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 F44the authorisations concerned.

Article 17Use of colours for markings

Only food colours F45that 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 meat30 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 origin31.

Article 18Carry-over principle

1.

The presence of a food additive shall be permitted:

(a)

in a compound food other than as referred to in F46an 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 F47, food flavouring or nutrient has been added, where the food additive:

  1. (i)

    is permitted in the food additive, food enzyme F47, food flavouring or nutrient in accordance with this Regulation; and

  2. (ii)

    has been carried over to the food via the food additive, food enzyme F47, food flavouring or nutrient; and

  3. (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 F48, 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 F48, 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.

F49(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.

F50Article 19Interpretation decisions

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F51Article 20Traditional foods

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CHAPTER IVLABELLING

Article 21Labelling 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 F52English, or in English and Welsh.

F532.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 22General 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 F54under 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 F55assimilated 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.

Article 23Labelling 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 belongs32 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 F56under 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. F57...

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.

Article 24Labelling 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 F58prescribed by the appropriate authority, designed to amend non-essential elements of this Regulation, F59....

Article 25Other 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 VPROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 26Information obligation

1.

A producer or user of a food additive shall inform the F60Authority 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 F61Authority, inform it of the actual use of the food additive. F62...

F63Article 27Monitoring of food additive intake

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F64Article 28Committee

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F65Article 28ARegulations 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;

F66Article 29Community financing of harmonised policies

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CHAPTER VITRANSITIONAL AND FINAL PROVISIONS

F67Article 30Establishment of Community lists of food additives

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F68Article 31Transitional measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F69Article 32Re-evaluation of approved food additives

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 33Repeals

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.

F70Article 34Transitional provisions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 35Entry 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.

F71 ...

ANNEX I

Functional classes of food additives in foods and of food additives in food additives and food enzymes

  1. 1.

    ‘sweeteners’ are substances used to impart a sweet taste to foods or in table-top sweeteners;

  2. 2.

    ‘colours’ are substances which add or restore colour in a food, and include natural constituents of foods and natural sources which are normally not consumed as foods as such and not normally used as characteristic ingredients of food. Preparations obtained from foods and other edible natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents are colours within the meaning of this Regulation;

  3. 3.

    ‘preservatives’ are substances which prolong the shelf-life of foods by protecting them against deterioration caused by micro-organisms and/or which protect against growth of pathogenic micro-organisms;

  4. 4.

    ‘antioxidants’ are substances which prolong the shelf-life of foods by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes;

  5. 5.

    ‘carriers’ are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive or a flavouring, food enzyme, nutrient and/or other substance added for nutritional or physiological purposes to a food without altering its function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use;

  6. 6.

    ‘acids’ are substances which increase the acidity of a foodstuff and/or impart a sour taste to it;

  7. 7.

    ‘acidity regulators’ are substances which alter or control the acidity or alkalinity of a foodstuff;

  8. 8.

    ‘anti-caking agents’ are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another;

  9. 9.

    ‘anti-foaming agents’ are substances which prevent or reduce foaming;

  10. 10.

    ‘bulking agents’ are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value;

  11. 11.

    ‘emulsifiers’ are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff;

  12. 12.

    ‘emulsifying salts’ are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components;

  13. 13.

    ‘firming agents’ are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel;

  14. 14.

    ‘flavour enhancers’ are substances which enhance the existing taste and/or odour of a foodstuff;

  15. 15.

    ‘foaming agents’ are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff;

  16. 16.

    ‘gelling agents’ are substances which give a foodstuff texture through formation of a gel;

  17. 17.

    ‘glazing agents’ (including lubricants) are substances which, when applied to the external surface of a foodstuff, impart a shiny appearance or provide a protective coating;

  18. 18.

    ‘humectants’ are substances which prevent foods from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium;

  19. 19.

    ‘modified starches’ are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached;

  20. 20.

    ‘packaging gases’ are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container;

  21. 21.

    ‘propellants’ are gases other than air which expel a foodstuff from a container;

  22. 22.

    ‘raising agents’ are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter;

  23. 23.

    ‘sequestrants’ are substances which form chemical complexes with metallic ions;

  24. 24.

    F72‘ stabilisers ’ are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff, substances which stabilise, retain or intensify colour of a foodstuff and substances which increase the binding capacity of the food, including the formation of cross-links between proteins enabling the binding of food pieces into re-constituted food;

  25. 25.

    ‘thickeners’ are substances which increase the viscosity of a foodstuff;

  26. 26.

    ‘flour treatment agents’ are substances, other than emulsifiers, which are added to flour or dough to improve its baking qualityF73;

  27. 27.

    F74‘ contrast enhancers ’ are substances which, when applied to the external surface of fruit or vegetables following depigmentation of predefined parts (e.g. by laser treatment), help to distinguish these parts from the remaining surface by imparting colour following interaction with certain components of the epidermis.

F75ANNEX IaCarry-over principle: Article 18(1)(a) – exceptions

F76Table 1 Foods in which the presence of an additive may not be permitted by virtue of the carry over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008

F781

Unprocessed foods as defined in Article 3 of Regulation (EC) No 1333/2008, excluding meat preparations as defined by Regulation (EC) No 853/2004

2

Honey as defined in Council Directive 2001/110/EC 34

3

Non-emulsified oils and fats of animal or vegetable origin

4

Butter

5

Unflavoured pasteurised and sterilised (including UHT) milk and unflavoured plain pasteurised cream (excluding reduced fat cream)

6

Unflavoured fermented milk products, not heat-treated after fermentation

7

Unflavoured buttermilk (excluding sterilised buttermilk)

8

Natural mineral water as defined in Directive 2009/54/EC of the European Parliament and of the Council 35 and spring water and all other bottled or packed waters

9

Coffee (excluding flavoured instant coffee) and coffee extracts

10

Unflavoured leaf tea

11

Sugars as defined in Council Directive 2001/111/EC 36

12

Dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 2009/39/EC of the European Parliament and of the Council 37

F7713

Foods for infants and young children as referred to in Regulation (EU) No 609/2013 38 , including foods for special medical purposes for infants and young children
38

F77Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 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 ( OJ L 181, 29.6.2013, p. 35 ).

Table 2 Foods in which the presence of a food colour may not be permitted by virtue of the carry over principle set out in Article 18(1)(a) of Regulation (EC) No 1333/2008

1

Unprocessed foods as defined in Article 3 of Regulation (EC) No 1333/2008

2

All bottled or packed waters

3

Milk, full fat, semi-skimmed and skimmed milk, pasteurised or sterilised (including UHT sterilisation) (unflavoured)

4

Chocolate milk

5

Fermented milk (unflavoured)

6

Preserved milks as mentioned in Council Directive 2001/114/EC 39 (unflavoured)

7

Buttermilk (unflavoured)

8

Cream and cream powder (unflavoured)

9

Oils and fats of animal or vegetable origin

10

Ripened and unripened cheese (unflavoured)

11

Butter from sheep and goats’ milk

12

Eggs and egg products as defined in Regulation (EC) No 853/2004

13

Flour and other milled products and starches

14

Bread and similar products

15

Pasta and gnocchi

16

Sugar including all mono- and disaccharides

17

Tomato paste and canned and bottled tomatoes

18

Tomato-based sauces

19

Fruit juice and fruit nectar as mentioned in Council Directive 2001/112/EC 40 and vegetable juice and vegetable nectars

20

Fruit, vegetables (including potatoes) and mushrooms — canned, bottled or dried; processed fruit, vegetables (including potatoes) and mushrooms

21

Extra jam, extra jelly, and chestnut purée as mentioned in Council Directive 2001/113/EC 41 ; crème de pruneaux

22

Fish, molluscs and crustaceans, meat, poultry and game as well as their preparations, but not including prepared meals containing these ingredients

23

Cocoa products and chocolate components in chocolate products as mentioned in Directive 2000/36/EC of the European Parliament and of the Council 42

24

Roasted coffee, tea, herbal and fruit infusions, chicory; extracts of tea and herbal and fruit infusions and of chicory; tea, herbal and fruit infusions and cereal preparations for infusions, as well as mixes and instant mixes of these products

25

Salt, salt substitutes, spices and mixtures of spices

26

Wine and other products covered by Council Regulation (EC) No 1234/2007 43 , as listed in its Annex I, Part XII

27

Spirit drinks defined in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 of the European Parliament and of the Council 44 , spirits (preceded by the name of the fruit) obtained by maceration and distillation and London gin (Annex II paragraphs 16 and 22 of, respectively)

Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà as defined in Annex II, paragraphs 38, 39 and 43 of Regulation (EC) No 110/2008, respectively

28

Sangria, Clarea and Zurra as mentioned in Council Regulation (EEC) No 1601/91 45

29

Wine vinegar covered by Regulation (EC) No 1234/2007, as listed in its Annex I, Part XII

30

Foods for infants and young children as mentioned in Directive 2009/39/EC including foods for special medical purposes for infants and young children

31

Honey as defined in Directive 2001/110/EC

32

Malt and malt products

F79ANNEX II Domestic list of food additives approved for use in foods and conditions of use

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F80ANNEX III Domestic list of food additives including carriers approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F81ANNEX IVTraditional foods for which certain Member States may continue to prohibit the use of certain categories of food additives

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX VList of the food colours referred to in Article 24 for which the labelling of foods shall include additional information

Foods containing one or more of the following food colours

Information

Sunset yellow (E 110)85

‘name or E number of the colour(s)’: may have an adverse effect on activity and attention in children.

Quinoline yellow (E 104)85

Carmoisine (E 122)85

Allura red (E 129)85

Tartrazine (E 102)85

Ponceau 4R (E 124)85

85

F82With the exception of:

  1. (a)

    foods where the colour(s) has been used for the purposes of health or other marking on meat products or for stamping or decorative colouring on eggshells; and

  2. (b)

    beverages containing more than 1,2 % by volume of alcohol.