Food Additive Legislation

Questions and Answers about food additive legislation

What legislation regulates food additives?

Food additives in the EU are regulated by Regulation (EC) No. 1333/2008 on food additives.
Where can I find the list of approved food additives?

Annex II to Regulation (EC) No. 1333/2008 lists all the approved additives and conditions for their use. In addition, the European Commission have developed a database where you can search for additives, the foods in which they are permitted for use and associated conditions for their use.
What is contained in the Annexes to the legislation?
The Annexes to the legislation are set out as follows:
- Annex I - Functional classes of food additives in foods and of food additives in food additives and food enzymes, e.g., sweeteners, colours, preservatives, etc.
- Annex II - Food categories and the additives permitted for use within them and their conditions of use
- Annex III - Food additives permitted for use in food additives, enzymes and flavourings and their conditions of use
- Annex IV - Traditional foods where certain EU Member States may continue to prohibit certain categories of additives (none in Ireland)
- Annex V - Certain food colours and their associated labelling requirements – Southampton Colours
What are the Food Categories?

Part D of Annex II lists 19 food categories and their associated sub-categories. Additives that are permitted for use in specific food types are listed against each category/sub-category, together with conditions for use. The EU has produced a guidance document describing the food categories which is a useful tool when trying to determine which additives are permitted in a particular food type.
Are there any foodstuffs in which the use of additives is not permitted?
The following foodstuffs are not permitted to contain food additives, except where specified in the relevant Annex:
- Unprocessed foodstuffs as defined in Article 3 of Regulation (EC) No. 1333/2008
- Honey as defined in Directive 2001/110/EC
- Non-emulsified oils and fats of animal or vegetable origin
- Butter
- Pasteurised and sterilised (including UHT) milk (including plain, skimmed and semi-skimmed) and plain pasteurised cream
- Unflavoured, live fermented milk products
- Natural mineral water as defined in Directive 2009/54/EC and spring water and all other bottled or packed waters
- Coffee (excluding flavoured instant coffee) and coffee extracts
- Unflavoured leaf tea
- Sugars as defined in Directive 2001/110/EC
- Dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets (diets containing reduced amount of protein), in accordance with Regulation (EU) No. 609/2013
- Natural unflavoured buttermilk (excluding sterilised buttermilk)
The following foodstuffs are not permitted to contain food colours, except where specified in the relevant Annex:
- Unprocessed foodstuffs as defined in Article 3 of Regulation (EC) No. 1333/2008
- All bottled or packed waters
- Milk, semi-skimmed and skimmed milk, pasteurised or sterilised (including UHT sterilisation) (unflavoured)
- Chocolate milk
- Fermented milk (unflavoured)
- Preserved milks as mentioned in Directive 2001/114/EC (unflavoured)
- Butter-milk (unflavoured)
- Cream and cream powder (unflavoured)
- Oils and fats of animal or vegetable origin
- Eggs and egg products as defined in Regulation (EC) 853/2004
- Flour and other milled products and starches
- Bread and similar products
- Pasta and gnocchi
- Sugar as defined in Directive 2001/111/EC
- Tomato paste and canned and bottled tomatoes
- Tomato-based sauces
- Fruit juice and fruit nectar as mentioned in Directive 2001/112/EC and vegetable juice and vegetable nectars
- Fruit, vegetables (including potatoes) and mushrooms — canned, bottled or dried; processed fruit, vegetables (including potatoes) and mushrooms
- Extra jam, extra jelly, and chestnut purée as mentioned in Directive 2001/113/EC crème de pruneaux
- Fish, molluscs and crustaceans, meat, poultry and game as well as their preparations, but not including prepared meals containing these ingredients
- Cocoa products and chocolate components in chocolate products as mentioned in Directive 2000/36/EC
- Roasted coffee, tea, chicory; tea and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products
- Salt, salt substitutes, spices and mixtures of spices
- Wine and other products defined by Regulation (EEC) No 822/87
- Korn, Kornbrand, fruit spirit drinks, fruit spirits, Ouzo, Grappa, Tsikoudia from Crete, Tsipouro from Macedonia, Tsipouro from Thessaly, Tsipouro from Tyrnavos, Eau de vie de marc Marque nationale luxembourgeoise, Eau de vie de seigle Marque nationale luxembourgeoise, London gin, as defined in Regulation (EEC) No 1576/89
- Sambuca, Maraschino and Mistra as defined in Regulation (EEC) No 1180/91
- Sangria, Clarea and Zurra as mentioned in Regulation (EEC) No 1601/91
- Wine vinegar
- Foods for infants and young children as mentioned in Regulation (EC) No. 609/2013 including foods for infants and young children not in good health
- Honey
- Malt and malt products
- Ripened and unripened cheese (unflavoured)
- Butter from sheep and goats' milk
Food additives must not be used in foods for infants and young children as referred to in Regulation (EU) No. 609/2013 on foodstuffs intended for particular nutritional uses, including dietary foods for infants and young children for special medical purposes, except where specifically provided for in the relevant Annex.
What types of substances are not considered food additives?
The following substances fall outside the scope of food additive legislation (Regulation (EC) No. 1333/2008):
- Monosaccharides, disaccharides or oligosaccharides and foods containing these substances used for their sweetening properties
- 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
- 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
- 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)
- Chewing gum bases
- 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
- Ammonium chloride
- Blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten
- Amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts having no technological function
- Caseinates and casein
- Inulin
- Food additives/substances used as processing aids
- Food additives/substances added to foods as nutrients (e.g., ascorbic acid) Added nutrients
- Food additives/substances used for the protection of plants and plant products in accordance with community rules relating to plant health
- Food additives/substances used for the treatment of water for human consumption falling within the scope of Council Directive 98/83/EC (NO LONGER IN FORCE) on the quality of water intended for human consumption
Are food ingredients food additives?

Although some ingredients may have additive functions in food, acting as sweeteners, colours, etc., (such as sugar, coffee, salt, concentrated fruit juice) they are not additives as defined in legislation and do not need to be listed as such.
What is the carry-over principle?
There are certain circumstances where an additive ends up in a food product indirectly, for example, by virtue of being an additive in an ingredient of the product. This is known as carry-over and it is permitted in the following instances:
- 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;
- 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 Regulation(EC) No 1333/2008 ; 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
- in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with Regulation (EC) No 1333/2008
  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), are not covered by this Regulation
There is also a provision in legislation for what is known as reverse carry-over. In this instance, an intermediate ingredient can contain an additive that it would not normally be permitted to contain, on the basis that the additive is permitted for use in the final foodstuff and that the intermediate ingredient is used solely for the final foodstuff.

However, the carry-over and reverse carry-over principle does 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 (NO LONGER IN FORCE), except where specifically provided for.
What is purity criteria legislation for additives?

Food additives must comply with the approved specifications set out in the purity criteria legislation, which includes information to adequately identify the food additive, including origin, and to describe the acceptable criteria of purity.

Find the legislation on purity criteria
What does “quantum satis” mean?

The term “quantum satis” is applied to usage for a large number of additives. “Quantum satis” indicates that no maximum level is specified. However, additives must be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer.
Where maximum levels apply, is the level “as marketed” or “as manufactured”?

Maximum levels indicated in food additive legislation refer to foodstuffs “as marketed”, unless otherwise stated.