Food Additive Legislation

What legislation regulates food additives?
Food additives in the EU are currently regulated by Regulation 1333/2008 on food additives. This piece of legislation has been in force since January 2010. Prior to this new legislation, food additives were regulated by three separate pieces of EU legislation ( plus amendments ) - Food additives other than colours and sweeteners ( Directive 95/2/EC ); Sweeteners ( Directive 94/35/EC ), and Food colours ( Directive 94/36/EC ).

These pieces of legislation have now been repealed. However, the Annexes to accompany Regulation 1333/2008, containing the lists of approved additives and conditions for their use, have only recently been agreed upon at Member State level and have not yet been adopted (expected October 2011). Until such time as Annexes II and III of Regulation 1333/2008 are adopted and a transitional period of 18 months has passed (expected to be April 2013), the conditions of use of the currently authorised food additives as set out in the Annexes to the three repealed Directives above continue to apply.

Access the full list of currently approved EU additives

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 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 2001/111/EC
Dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 2009/39/EC
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 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 Directive 89/398/EEC 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 Directive 2009/39/EC 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 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 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 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.