Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (Text with EEA relevance)

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down rules on food additives used 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 and fair practices in food trade, taking into account, where appropriate, the protection of the environment.

For those purposes, this Regulation provides for:

(a) Community lists of approved food additives as set out in Annexes II and III;

(b) conditions of use of food additives in foods, including in food additives and in food enzymes as covered by Regulation (EC) No 1332/2008 [on food enzymes], and in food flavourings as covered by Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 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.

Article 2

Scope

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 Community rules 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].

This Regulation shall apply without prejudice to any specific Community rules concerning the use of food additives:

(a) in specific foods;

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

Article 3

Definitions

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.

CHAPTER II

COMMUNITY LISTS OF APPROVED FOOD ADDITIVES

Article 4

Community lists of food additives

Article 5

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

General conditions for inclusion and use of food additives in Community lists

A food additive may be included in the Community lists in Annexes II and III 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.

To be included in the Community lists in Annexes II and III 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.

By way of derogation from paragraph 2(a), a food additive which reduces the nutritional quality of a food may be included in the Community list in Annex II 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 7

Specific conditions for sweeteners

A food additive may be included in the Community list in Annex II 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.

Article 8

Specific conditions for colours

A food additive may be included in the Community list in Annex II 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.

Article 9

Functional classes of food additives

Food additives may be assigned in Annexes II and III 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.

Article 10

The content of the Community lists of food additives

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 included in:

(a) the Community list in Annex II to this Regulation; and/or

(b) the Community list in Annex III to this Regulation.

The entry for a food additive in the Community lists in Annexes II and III shall specify:

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

(b) the foods 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.

Article 11

Levels of use of food additives

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.

Article 12

Changes in the production process or starting materials of a food additive already included in a Community list

When a food additive is already included in a Community 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 entry in the Community lists or a change in the specifications shall be required before it can be placed on the market.

Article 13

Food additives falling within the scope of Regulation (EC) No 1829/2003

Article 14

Specifications of food additives

The specifications of food additives relating, in particular, to origin, purity criteria and any other necessary information, shall be adopted when the food additive is included in the Community lists in Annexes II and III for the first time, 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].

CHAPTER III

USE OF FOOD ADDITIVES IN FOODS

Article 15

Use of food additives in unprocessed foods

Food additives shall not be used in unprocessed foods, except where such use is specifically provided for in Annex II.

Article 16

Use of food additives in foods for infants and young children

Food additives 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 Annex II to this Regulation.

Article 17

Use of colours for markings

Only food colours listed in Annex II to this Regulation may be used 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).

Article 18

Carry-over principle

The presence of a food additive shall be permitted:

(a) in a compound food other than as referred to in Annex II, 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 or food flavouring has been added, where the food additive: (i) is permitted in the food additive, food enzyme or food flavouring in accordance with this Regulation; and (ii) has been carried over to the food via the food additive, food enzyme or food flavouring; 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.

Article 19

Interpretation decisions

Where necessary, it may be decided in accordance with the regulatory procedure referred to in Article 28(2) whether or not:

(a) a particular food belongs to a category of food referred to in Annex II; or

(b) a food additive listed in Annexes II and III and permitted at ‘quantum satis’ is used in accordance with the criteria referred to in Article 11(2); or

(c) a given substance meets the definition of food additive in Article 3.

Article 20

Traditional foods

The Member States listed in Annex IV may continue to prohibit the use of certain categories of food additives in the traditional foods produced on their territory as listed in that Annex.

CHAPTER IV

LABELLING

Article 21

Labelling of food additives not intended for sale to the final consumer

Article 22

General labelling requirements for food additives not intended for sale to the final consumer

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 in 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 Community 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.

Article 23

Labelling of food additives intended for sale to the final consumer

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 in 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.

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’.

Article 24

Labelling requirement for foods containing certain food colours

Article 25

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

PROCEDURAL PROVISIONS AND IMPLEMENTATION

Article 26

Information obligation

Article 27

Monitoring of food additive intake

Article 28

Committee

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.