S.I. No. 344/1995 - European Communities (General Provisions on The Control of Additives, and in Particular Colours and Sweeteners For Use in Foodstuf

(1)on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption.

(1)O.J. No. L40, 11.2.89, pp 27-33 European Parliament and Council Directive 94/35/EC

(2)on sweeteners for use in foodstuffs.

(2)O.J. No. L237, 10.9.94, pp 3-12 European Parliament and Council Directive 94/36/EC

(3)on colours for use in foodstuffs.

(3)O.J. No. L237, 10.9.94, pp 13-29 Commission Directive 95/31/EC

(4)laying down specific criteria of purity concerning sweeteners for use in foodstuffs.

(4)O.J. No. L178, 28.7.95, pp 1-19 Commission Directive 95/45/EC

(5)laying down specific purity criteria concerning colours for use in foodstuffs.

(5)O.J. No. L226, 22.9.95, pp 1-45

1. These Regulations may be cited as the European Communities (General Provisions on the Control of Additives, and in particular Colours and Sweeteners for use in Foodstuffs) Regulations,
3. These Regulations shall come into force on the 31st day of December,
5. In these Regulations words and phrases shall, except where otherwise indicated, be construed as a reference to an article contained in these Regulations or, as may be, to the Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article. PART I GENERAL PROVISIONS ON FOOD ADDITIVES 4.

(1)Subject to sub-article

(3)of this article, these Regulations shall apply to all food additives coming within the various categories of food additives listed in Schedule I and which are used or intended to be used as ingredients during the manufacture or preparation of a foodstuff and are still present in the final product, even if in altered form, hereinafter called "food additives".

(2)For the purposes of these Regulations "food additive" means 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.

(3)These regulations shall not apply to: ( a ) processing aids; ( b ) substances used in the protection of plants and plant products in conformity with Community rules relating to plant health; ( c ) flavourings for use in foodstuffs for human consumption in accordance with EC (Flavourings for use in Foodstuffs for Human Consumption) Regulations, 1992 ( S.I. No. 22 of 1992 ). ( d ) substances added to foodstuffs as nutrients (for example, minerals, trace elements or vitamins).

1. ( a ) For the purposes of these Regulations, "processing aid" means any substance not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, food or their ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product. ( b ) The term "quantum satis" when used in the Schedule to these Regulations means that no maximum level is specified. However, the additives in question shall 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. ( c ) For the purposes of these Regulations "unprocessed" means not having undergone any treatment resulting in a substantial change in the original state of the foodstuffs. However, they may have been, for example, divided, parted, severed, boned, minced, skinned, pared, peeled, ground, cut, cleaned, trimmed, deep-frozen, frozen, chilled, milled or husked, packed or unpacked. ( d ) For the purposes of these Regulations: (i) the word "infant(s)" shall mean a child/ children under the age of twelve months; (ii) the words "young children" shall mean children aged between one and three years. ( e ) For the purposes of these Regulations the term "import" shall be construed to mean "from any place outside the European Union". ( f ) For the purposes of these Regulations "sell" shall be construed to include possess for sale or offer, expose or advertise for sale, and "sale" shall be construed accordingly.
2. Where the Minister for Health is of the view that the use or intended use in foodstuffs of any food additive, although complying with these Regulations, endangers human health he may take appropriate measures including the temporary suspension or restriction of trade in that food or food additive in order to protect public health. 7.

(1)Food additives not intended for sale to the ultimate consumer shall not be marketed, imported, manufactured, sold, distributed, offered or kept for sale, unless their packaging or containers bear the following information, which must be conspicuous, clearly legible and indelible; (a ) (

1. i)in the case of food additives sold singly or mixed with each other, for each additive, the name laid down by any regulation made by the Minister for Health and its EEC number or, in the absence of such regulations, a description of the additive that is sufficiently precise to enable it to be distinguished from additives with which it could be confused, in descending order of the proportion by weight in the total; (
2. ii)when other substances or materials or food ingredients to facilitate storage, sale, standardisation, dilution or dissolution of a food additive or food additive are incorporated in the additives, the name of the additive in accordance with subarticle

(1)(

1. a)(
2. i)and an indication of each component in descending order to the proportion by weight in the total. ( b ) either the statement "for use in 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 use; ( d ) directions for use, if the omission thereof would preclude appropriate use of the additive; ( e ) a mark identifying the batch or lot; ( f ) the name or business name and address of the manufacturer or packer, or of a seller established within the European Economic Community; ( g ) an indication of the percentage of any component which is subject to a quantitative limitation in a food or adequate compositional information to enable the purchaser to comply with any European Economic Community provisions applying to the food. Where the same quantitive limitation applies to a group of components used singly or in combination, the combined percentage may be given as a single figure; ( h ) the net quantity.

(2)By way of derogation from paragraph 1, the information required in sub-article

(1)(

1. a)(
2. ii)and sub-article

(1)(d) to (g), 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 "intended for manufacture of foodstuffs and not for retail sale" appears on a conspicuous part of the packaging or container of the product in question. 8. Food additives intended for sale to the ultimate consumer shall not be marketed, imported, distributed, manufactured, sold or offered for sale, unless their packaging or containers bear the following information which must be conspicuous, clearly legible and indelible. ( a ) the name under which the product is sold (this name shall be constituted by the name laid down by any Regulation made by the Minister for Health in relation to the product in question plus its EEC number or, in the absence of such provisions, by a description of the product that is sufficiently precise to enable it to be distinguished from products with which it could be confused); ( b ) the information required by article 7

(1)(

1. a)to (
2. f)and (h); ( c ) the date of minimum durability within the meaning of the Council Directive 79/112/EEC

(1), as amended. OJ No. L33, 8.2.1979, page 1 9.

(1)Articles 7 and 8 of these Regulations shall not affect 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 the transport of such substances.

(2)The particulars required by articles 7 and 8 shall be given in the Irish or English languages unless other measures have been taken to ensure that the purchaser is informed. The provision shall not prevent such particulars from also being indicated in various other languages. 10.

(1)A person shall not import, manufacture, sell, distribute, or offer for sale or keep for sale, food additives except in conformance with these Regulations.

(2)However, and where appropriate, Article 20 may be relied upon by way of derogation from sub-article

(1)of this Article. PART II SWEETENERS FOR USE IN FOODSTUFFS 11.

(1)For the purposes of these Regulations, the term "sweeteners" refers to food additives which are used: — to impart a sweet taste to foodstuffs — as table-top sweeteners These Regulations do not apply to foodstuffs with sweetening properties.

(2)A sweetener listed in Schedule II to these Regulations must satisfy the purity criteria for that sweetener as set out in Schedule III laying down specific criteria of purity concerning sweeteners for use in foodstuffs.

(3)For the purpose of these Regulations, "with no added sugar" and 'energy-reduced' in column III of Schedule II shall be defined as follows: —'with no added sugar': without any added mono-or disaccharides or any other foodstuff used for its sweetening properties; —'energy-reduced': with an energy value reduced by at least 30% compared with the original foodstuff or a similar product. 12.

(1)Only those sweeteners listed in Schedule II may be placed on the market with a view to: —sale to the ultimate consumer; or —use in the manufacture of foodstuffs.

(2)Sweeteners referred to in the second indent of sub-article

(1)may only be used in the manufacture of the foodstuffs listed in Schedule II under the conditions specified therein.

(3)Except where specifically provided for, sweeteners may not be used in foods for infants or young children, as specified in the Health (Foods for Particular Nutritional Uses) Regulations, 1991 ( S.I. No. 331 of 1991 ).

(4)The maximum usable doses indicated in Schedule II refer to ready-to-eat foodstuffs prepared according to the instructions for use. 13.

(1)These Regulations shall apply without prejudice to any other Regulations permitting additives listed in Schedule II to be used for purposes other than sweetening.

(2)These Regulations shall also apply without prejudice to national or Community provisions governing the composition and the description of foodstuffs. 14.

(1)The sale description of a table-top sweetener must include the term 'x based table-top sweetener', where 'x' is the name(s) of the sweetening substances(s) used in its composition.

(2)The labelling of a table-top sweetener containing polyols and/or aspartame must bear the following warnings: —polyols: `excessive consumption may induce laxative effects', —aspartame: `contains a source of phenylalanine'. PART III COLOURS FOR USE IN FOODSTUFFS 15.

(1)For the purposes of these Regulations, 'colours' are substances which add or restore colour in a food, and include natural constituents of foodstuffs and natural sources which are normally not consumed as foodstuffs as such and not normally used as characteristic ingredients of food. Preparations obtained from foodstuffs and other 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 these Regulations. The following substances shall not be considered colours for the purposes of these Regulations. (i) foodstuffs, whether dried or in concentrated form and flavourings incorporated during the manufacturing of compound foodstuffs, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect, such as paprika, turmeric and saffron. (ii) colours used for the colouring of the inedible external parts of foodstuffs, such as cheese coatings and sausage casings.

(2)Only the substances listed in Schedule IV, Part A may be used as colours in foodstuffs.

(3)Colours may be used only in the foodstuffs listed in Schedule IV, Part C, D and E and under the conditions specified therein; colours may be used in those same foodstuffs when they are intended for particular uses in accordance with Health (Foods for Particular Nutritional Uses) Regulations, 1991 ( S.I. No. 331 of 1991 ).

(4)Colours may not be used in the foodstuffs listed in Schedule IV, Part B except where specifically provided for in Schedule IV, Part C, Part D or Part E.

(5)Colours permitted for certain uses only are listed in Schedule IV, Part D.

(6)Colours permitted in general in foodstuffs and the conditions of use therefor are listed in Schedule IV, Part E.

(7)The maximum levels indicated in Schedule IV to these Regulations (

1. i)relate to ready-to-eat foodstuffs, prepared according to the instructions for use, (
2. ii)refer to the quantities of colouring principle contained in the colouring preparation.

(8)For the purpose of health marking as provided in Directive 91/497/EEC

(1)and other marking required on meat products, only E155 Brown HT, E133 Brilliant Blue FCF or E129 Allura Red AC or an appropriate mixture of E133 Brilliant Blue FCF and E129 Allura Red AC may be used.

(1)OJ No. L268, 24.9.1991, p. 69

(9)Only those colours mentioned in Schedule IV, Part A may be used for the decorative colouring of eggshells or for the stamping of eggshells as provided in Regulations (EEC) No. 1274/91

(2).

(2)OJ No. L121, 16.5.1991, p. 11

(10)Only those colours listed in Schedule IV, Part A, except E123, E127, E128, E154, E160b, E161g, E173 and E180 may be sold directly to consumers.

(11)A colour listed in Schedule IV to these Regulations must satisfy the purity criteria for that colour as set out in Schedule V, laying down specific criteria of purity concerning colours for use in foodstuffs. 16. Without prejudice to other European Community provisions, the presence of a colour in a foodstuff is permissible: (

1. i)in a compound foodstuff other than one mentioned in Schedule IV, Part B to the extent that the colour is permitted in one of the ingredients of the compound foodstuff; (
2. ii)if the foodstuff is destined to be used solely in the preparation of a compound foodstuff and to such an extent that the compound foodstuff conforms to the provisions of these Regulations. PART IV FINAL PROVISIONS 17. ( a ) These Regulations shall be enforced and executed by each health board, established in accordance with the Health Act 1970 (No. 1 of 1970) in respect of its functional area through its authorised officers and/or the officers of the Minister for Health who are authorised officers for the purposes of these Regulations. ( b ) For the purposes of these Regulations, "authorised officer" means ( a ) an officer of the Minister for Health who is authorised in writing by the Minister for Health to be an authorised officer for the purposes of these Regulations; or ( b ) an officer of a health board who is authorised in writing by the Chief Executive Officer of the health board to be an authorised officer for the purposes of these Regulations. 18.

(1)Where an authorised officer reasonably suspects or believes that a foodstuff or food additive does not comply with these regulations, the authorised officer may seize, remove and/or detain such foodstuffs or food additive as being a foodstuff or food additive which is unfit for human consumption.

(2)With the consent in writing of the owner or person responsible for such foodstuff or food additive, an authorised officer may destroy or otherwise dispose of it so as to prevent its use for human consumption.

(3)An authorised officer who has seized any foodstuff or food additive in pursuance of the provisions of this article may, on giving notice in writing to the owner or person responsible for such foodstuff or food additive apply to a Judge of the District Court for an Order directing that such food or food additive be destroyed or otherwise disposed of as being a foodstuff or food additive which is unfit for human consumption.

(4)A Judge of the District Court to whom the application is made for an Order under sub-article

(3)of this article shall, if satisfied that such foodstuff or food additive does not comply with these Regulations, order that it be destroyed or otherwise disposed of after such period, not exceeding fourteen days, as may be specified in such order, as being a foodstuff or food additive which is unfit for human consumption and an officer shall destroy or dispose of it accordingly.

1. A person shall give to any authorised officer all reasonable assistance that the officer may require in the performance of his duties under these Regulations and such assistance shall include the giving of information relating to the composition and use of any foodstuff or food additive and the identity of the person from whom or the place from which any such foodstuff or food additive has been obtained and the person to whom and the place to which it has been consigned or the manner in which it has been consigned or the manner in which it has otherwise been disposed of.
2. In any proceedings for an offence under these Regulations it shall be a defence for the person charged to show that the food in respect of which the offence is alleged to have been committed was intended for export and complied with the domestic food legislation of the importing country relevant to the alleged offence. 21.

(1)Any person who contravenes any Article or Sub Article of these Regulations shall be guilty of an offence.

(2)A person guilty of an offence under the Regulations shall be liable on summary conviction to a fine not exceeding £1,000 or at the discretion of the Court, to imprisonment for a term not exceeding 6 months or to both.

(3)Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of a director, manager, secretary or other officer of the body corporate, the director, manager, secretary or other officer or any person purporting to act in such capacity shall, as well as the body corporate, be guilty of an offence and shall be liable to be proceeded against and punished accordingly.

(4)Notwithstanding section 10

(4)of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted within 12 months from the date of the offence.

1. An offence under these Regulations shall be prosecuted by the Minister for Health or by a health board in whose functional area the offence was committed.
2. The following Regulations are hereby revoked:— Health (Colouring Agents in Food) Regulations, 1973 ( S.I. No. 149 of 1973 ), Health (Colouring Agents in Food) (Amendment) Regulations, 1978 ( S.I. No. 140 of 1978 ). Health (Colouring Agents in Food) (Amendment) Regulations, 1981 (S.I. No. 336 of 1981), Health (Colouring Agents in Food) (Amendment) Regulations, 1992 ( S.I. No. 68 of 1992 ), Health (Cyclamate in Food) Regulations, 1970 ( S.I. No. 49 of 1970 ), Health (Cyclamate in Food) (Amendment) Regulations, 1992 ( S.I. No. 73 of 1992 ), and European Communities (Labelling of Additives for use in Foodstuffs) Regulations, 1992 ( S.I. No. 23 of 1992 ). SCHEDULES SCHEDULE I Categories of Food Additives SCHEDULE II Sweeteners for use in Foodstuffs SCHEDULE III Specific Criteria of Purity concerning Sweeteners for use in foodstuffs SCHEDULE IV List of Permitted Food Colours SCHEDULE II Specific Purity Criteria concerning Colours for use in Foodstuffs SCHEDULE I Categories of Food Additives Colour Preservative Anti-oxidant Emulsifier Emulsifying salt Thickener Gelling agent Stabilizer

(1)Flavour enhancer Acid Acidity regulator

(2)Anti-caking agent Modified starch Sweetener Raising agent Anti-foaming agent Glazing agent

(3)Flour treatment agent Firming agent Humectant Sequestrant

(4)Enzyme

(5)Bulking agent Propellent gas and packaging gas

(1)This category also comprises foam stabilizers.

(2)These can act as two-way acidity regulators.

(3)These substances include lubricants.

(4)Inclusion of these terms in this list is without prejudice to any future decision or mention thereof in the labelling of foodstuffs intended for the final consumer.

(5)Only those used as additives. SCHEDULE II Sweetenersfor use in Foodstuffs EC No. Name Foodstuffs Maximum usable dose E420 Sorbitol Desserts and similar products quantum satis (

1. i)Sorbital (
2. ii)Sorbital syrup E421 Mannitol —Water-based flavoured desserts, energy-reduced or with no added E953 Isomalt sugar E965 Maltitol —Milk and milk-derivative-based preparations, energy-reduced or with (
3. i)Maltitol no added sugar (
4. ii)Maltitol syrup —Fruit- and vegetable-based desserts, energy-reduced or with no added E966 Lactitol sugar E967 Xylitol —Egg-based desserts, energy-reduced or with no added sugar —Cereal-based desserts, energy reduced or with no added sugar —Breakfast cereals or cereal-based products, energy reduced or with no added sugar —Fat-based desserts, energy-reduced or with no added sugar —Edible ices, energy-reduced or with no added sugar —Jams, jellies, marmalades and crystallized fruit, energy-reduced or with no added sugar —Fruit preparations, energy-reduced or with no added sugar, with the exception of those intended for the manufacture of fruit-juice-based drinks Confectionery —Confectionery with no added sugar —Dried-fruit-based confectionery, energy-reduced or with no added sugar —Starch-based confectionery, energy-reduced or with no added sugar E 420, E 421, E 953, E 965, E 966, E 967 —contd. —Cocoa-based products, energy-reduced or with no added sugar —Cocoa, milk, dried-fruit or fat-based sandwich spreads, energy-reduced or with no added sugar —Chewing gum with no added sugar —Sauces —Mustard —Fine bakery products, energy-reduced or with no added sugar —Products intended for particular nutritional uses —Solid food supplements/dietary integrators E 950 Acesulfame K Non-alcoholic drinks —Water-based flavoured drinks, energy-reduced or with no added sugar 350 mg/l —Milk and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar 350 mg/l Desserts and similar products —Water-based flavoured desserts, energy-reduced or with no added sugar 350 mg/kg —Milk and milk-derivative-based preparations, energy-reduced or with no added sugar 350 mg/kg —Fruit and vegetable-based desserts, energy-reduced or with no added sugar 350 mg/kg —Egg-based desserts, energy-reduced or with no added sugar 350 mg/kg —Cereal-based desserts, energy-reduced or with no added sugar 350 mg/kg —Fat-based desserts, energy-reduced or with no added sugar 350 mg/kg —'snacks': certain flavours or ready to eat, prepacked, dry, savoury starch products and coated nuts 350 mg/kg E 950—contd. Confectionery —Confectionery with no added sugar 500 mg/kg —Cocoa- or dried-fruit-based confectionery, energy-reduced or with no added sugar 500 mg/kg —Starch-based confectionery, energy-reduced or with no added sugar 1 000 mg/kg —Cocoa, milk, dried-fruit or fat-based sandwich spreads, energy-reduced or with no added sugar 1 000 mg/kg —Chewing gum with no added sugar 2 000 mg/kg —Cider and perry 350 mg/l —Alcohol-free beer or with an alcohol content not exceeding 1,2% vol 350 mg/l —'Biere de table/Tafelbier/Table Beer' (original wort content less than 6%) except for 'Obergariges Einfachbier' 350 mg/l —Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 350 mg/l —Brown beers of the 'oud bruin' type 350 mg/l — Edible ices, energy-reduced or with no added sugar 800 mg/kg —Canned or bottled fruit, energy-reduced or with no added sugar 350 mg/kg —Energy-reduced jams, jellies and marmalades 1 000 mg/kg —Energy-reduced fruit and vegetable preparations 350 mg/kg —Sweet-sour preserves of fruit and vegetables 200 mg/kg —Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 200 mg/kg —Sauces 350 mg/kg —Mustard 350 mg/kg —Fine bakery products for special nutritional uses 1 000 mg/kg —Complete formulae for weight control intended to replace total daily food intake or an individual meal 450 mg/kg —Complete formulae and nutritional supplements for use under medical supervision 450 mg/kg —Liquid food supplements/dietary integrators 350 mg/l —Solid food supplements/dietary integrators 500 mg/l —Vitamins and dietary preparations 2 000 mg/kg E 951 Aspartame Non-alcoholic drinks —Water-based flavoured drinks, energy-reduced or with no added sugar 600 mg/l —Milk and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar 600 mg/l Desserts and similar products —Water-based flavoured desserts, energy-reduced or with no added sugar 1 000 mg/kg —Milk and milk-derivative-based preparations, energy-reduced or with no added sugar 1 000 mg/kg —Fruit and vegetable-based desserts, energy-reduced or with no added sugar 1 000 mg/kg —Egg-based desserts, energy-reduced or with no added sugar 1 000 mg/kg —Cereal-based desserts, energy-reduced or with no added sugar 1 000 mg/kg —Fat-based desserts, energy-reduced or with no added sugar 1 000 mg/kg —'snacks': certain flavours of ready to eat, prepacked, dry, savoury starch products and coated nuts 500 mg/kg Confectionery —Confectionery with no added sugar 1 000 mg/kg —Cocoa or dried-fruit-based confectionery, energy-reduced or with no added sugar 2 000 mg/kg —Starch-based confectionery, energy-reduced or with no added sugar 2 000 mg/kg —Cocoa-, milk-, dried-fruit or fat-based sandwich spreads, energy reduced or with no added sugar 1 000 mg/kg —Chewing gum with no added sugar 5 500 mg/kg —Cider and perry 600 mg/l —Alcohol-free or with an alcohol content not exceeding 1,2% vol 600 mg/l —'Biere de table/Tafelbier Beer' (original wort content less than 6%) except for 'Obergariges Einfachbier' 600 mg/l —Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 600 mg/l —Brown Beers of the 'oud bruin' type 600 mg/l E 951—contd. —Edible ices, energy-reduced or with no added sugar 800 mg/kg —Canned or bottled fruit, energy-reduced or with no added sugar 1 000 mg/kg —Energy-reduced jams, jellies and marmalades 1 000 mg/kg —Energy-reduced fruit and vegetable preperations 1 000 mg/kg —Sweet-sour preserves of fruit and vegetables 300 mg/kg —Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 300 mg/kg —Sauces 350 mg/kg —Mustard 350 mg/kg —Fine bakery products for special nutritional uses 1 700 mg/kg —Complete formulae for weight control intended to replace total daily food intake or an individual meal 800 mg/kg —Complete formulae and nutritional supplements for use under medical supervision 1 000 mg/kg —Liquid food supplements/dietary integrators 600 mg/kg —Solid food supplements/dietary integrators 2 000 mg/kg Vitamins and dietary preperations 5 500 mg/kg E 952 Cyclamic acid and its Na and Ca salts Non-alcoholic drinks —Water-based flavoured drinks, energy-reduced or with no added sugar 400 mg/l —Milk and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar 400 mg/l Desserts and similar products —Water-based flavoured desserts, energy-reduced or with no added sugar 250 mg/kg —Milk-and milk-derivative-based preparations, energy-reduced or with no sugar added 250 mg/kg —Fruit-and vegetable-based desserts, energy-reduced or with no added sugar 250 mg/kg —Egg-based desserts, energy-reduced or with no added sugar 250 mg/kg —Cereal-based desserts, energy-reduced or with no added sugar 250 mg/kg —Fat-based desserts, energy-reduced or with no added sugar 250 mg/kg E 952—contd. Confectionery —Confectionery with no added sugar 500 mg/kg —Cocoa or dried-fruit-based confectionery, energy-reduced or with no added sugar 500 mg/kg —Starch-based confectionery, energy-reduced or with no added sugar 500 mg/kg —Cocoa, milk, dried-fruit or fat-based sandwich spreads, energy-reduced or with no added sugar 500 mg/kg —Chewing gum with no added sugar 1 500 mg/kg —Edible ices, energy-reduced or with no added sugar 250 mg/kg —Canned or bottled fruit, energy-reduced or with no added sugar 1 000 mg/kg —Energy-reduced jams, jellies, and marmalades 1 000 mg/kg —Energy-reduced fruit and vegetable preparations 250 mg/kg —Fine bakery products for special nutritional uses 1 600 mg/kg —Complete formulae for weight control intended to replace total daily food intake or an individual meal 400 mg/kg —Complete formulae and nutritional supplements for use under medical supervision 400 mg/kg —Liquid food supplements/dietary integrators 400 mg/kg —Solid food supplements/dietary integrators 500 mg/kg E 954 Saccharin and its Na, K and Ca salts Non-alcoholic drinks —Water-based flavoured drinks, energy-reduced or with no added sugar 80 mg/l —Milk-and milk-derivative-based or fruit-based drinks, energy-reduced or with no added sugar 80 mg/l —'Gaseosa': non-alcoholic water-based drink with added carbon dioxide, sweeteners and flavourings 100 mg/l E 954—contd. Desserts and similar products —Water-based flavoured desserts, energy-reduced or with no added sugar 100 mg/kg —Milk-and milk-derivative-based preperations, energy-reduced or with no added sugar 100 mg/kg —Fruit and vegetable-based desserts, energy-reduced or with no added sugar 100 mg/kg —Egg-based desserts, energy-reduced or with no added sugar 100 mg/kg —Cereal-based desserts, energy-reduced or with no added sugar 100 mg/kg —Fat-based desserts, energy-reduced or with no added sugar 100 mg/kg —'snacks': certain flavours of ready to eat, prepacked, dry savoury starch products and coated nuts 100 mg/kg Confectionery —Confectionery with no added sugar 500 mg/kg —Cocoa-or dried-fruit-based confectionery, energy reduced or with no added sugar 500 mg/kg —Starch-based confectionery, energy-reduced or with no added sugar 300 mg/kg —Essoblaten 800 mg/kg —Cocoa-, milk, dried-fruit or fat-based sandwich spreads, energy-reduced or with no added sugar 200 mg/kg —Chewing gum with no added sugar 1 200 mg/kg —Cider and perry 80 mg/l —Alcohol-free beer or with an alcohol content not exceeding 1.2% vol 80 mg/l —'Biere de table/Tafelbier/Table beer' (original wort content less than 6%) except 'Obergariges Einfachbier' 80 mg/l —Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 80 mg/l —Brown beers of the 'oud bruin' type 80 mg/l —Edible ices, energy-reduced or with no added sugar 100 mg/kg —Canned or bottled fruit, energy-reduced or with no added sugar 200 mg/kg —Energy-reduced jams, jellies and marmalades 200 mg/kg E 954 — contd. —Energy-reduced fruit and vegetable preperations 200 mg/kg —Sweet-sour preserves of fruit and vegetables 160 mg/kg —Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 160 mg/kg —Sauces 160 mg/kg —Mustard 320 mg/kg —Fine bakery products for special nutritional uses 170 mg/kg —Complete formulae for weight control intended to replace total daily food intake or an individual meal 240 mg/kg —Complete formulae and nutritional supplements for use under medical supervision 200 mg/kg —Liquid food supplements/dietary integrators 80 mg/kg —Solid food supplements/dietary integrators 500 mg/kg —Vitamins and dietary preparations 1 200 mg/kg E 957 Thaumatin Confectionery —Confectionery with no added sugar 50 mg/kg —Cocoa-or dried-fruit-based confectionery, energy-reduced or with no added sugar 50 mg/kg —Chewing gum with no added sugar 50 mg/kg —Vitamins and dietary preparations 400 mg/kg E 959 Neohesperidine DC Non-alcoholic drinks —Water based flavoured drinks, energy-reduced or with no added sugar 30 mg/l —Milk and milk-derivative-based drinks, energy-reduced or with no added sugar 50 mg/l —Fruit-juice-based drinks, energy-reduced or with no added sugar 30 mg/l Desserts and similar products —Water-based flavoured desserts, energy-reduced or with no added sugar 50 mg/kg —Milk-and milk-derivative-based preparations, energy-reduced or with no added sugar 50 mg/kg E959 — contd. —Fruit and vegetable-based desserts, energy-reduced or with no added sugar 50 mg/kg —Egg-based desserts, energy-reduced or with no added sugar 50 mg/kg —Cereal-based desserts, energy-reduced or with no added sugar 50 mg/kg —Fat-based desserts, energy-reduced or with no added sugar 50 mg/kg Confectionery —Confectionery with no added sugar 100 mg/kg —Cocoa or dried-fruit-based confectionery, energy- reduced or with no added sugar 100 mg/kg —Starch-based confectionery, energy-reduced or with no added sugar 150 mg/kg —Essoblaten 50 mg/kg —Cocoa-, milk-, dried-fruit or fat-based sandwich spreads, energy-reduced or with no added sugar 50 mg/kg —Chewing gum with no added sugar 400 mg/kg —Cider and perry 20 mg/l —Alcohol-free beer or with an alcohol content not exceeding 1.2% vol 10 mg/l —'Biere de table/Tafelbier/Table beer' (original wort content less than 6%) except 'Obergariges Einfachbier' 10 mg/l —Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 10 mg/l —Brown beers of the 'oud bruin' type 10 mg/l —Edible ices, energy-reduced or with no added sugar 50 mg/kg —Canned or bottled fruit, energy-reduced or with no added sugar 50 mg/kg —Energy-reduced jams, jellies and marmalades 50 mg/kg —Sweet-sour preserves of fruit and vegetables 100 mg/kg —Energy-reduced fruit and vegetable preparations 50 mg/kg —Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 30 mg/kg —Sauces 50 mg/kg —Mustard 50 mg/kg —Fine bakery products for special nutritional uses 150 mg/kg —Complete formulae for weight control intended to replace total daily food intake or an individual meal 100 mg/kg —Liquid food supplements/dietary integrators 50 mg/kg —Solid food supplements/dietary integrators 100 mg/kg SCHEDULE III Specific Criteria of Purity concerning Sweeteners for use in foodstuffs E 420 (
5. i)— SORBITOL D-glucitol, D-sorbitol Definition Chemical name D-glucitol Einics 200-061-5 E number E 420 (
6. i)Chemical formula C6H14O6 Relative molecular mass 182,17 Assay Content not less than 97% of total glycitols and not less than 91% of D-sorbitol on the dry weight basis. Glycitols are compounds with the structural formula CH2OH(CHOH)nCH2OH, where "n" is an integer. Description White hygroscopic powder, cystalline powder, flakes or granules having a sweet taste. Identification A. Solubility Very soluble in water, slightly soluble in ethanol B. Melting range 88 to 102°C C. Sorbitol monobenzylidene derivative To 5g of the sample add 7 ml of methanol, 1ml of benzaldehyde and 1ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20ml of boiling water containing 1g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179°C. Purity Water content Not more than 1% (Karl Fischer method) Sulphated ash Not more than 0.1% expressed on dry weight basis Reducing sugars Not more than 0.3% expressed as glucose on dry weight basis Total sugars Not more than 1 % expressed as glucose on dry weight basis Chlorides Not more than 50 mg/kg expressed on dry weight basis Sulphates Not more than 100 mg/kg on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis E 420 (
7. ii)SORBITOL SYRUP Synonyms D-glucitol syrup Definition Chemical name Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides. The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystalising) or mannitol. Minor quantities of glycitols where n4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where 'n' is an integer Einics 270-337-8 E number E 420 (
8. ii)Assay Content not less than 69% total solids and not less than 50% of D-sorbitol on the anhydrous basis Description Clear colourless aand sweet tasting aqueous solution Identification A. Solubility Miscible with water, with glycerol, and with propane -1,2-diol B. Sorbitol monobenzylidene derivative To 5g of the sample add 7 ml of methanol, 1ml of benzaldehyde and 1ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20ml of boiling water containing 1g of sodium bicarbonate, filter while hot. Cool the filtrate, filter with suction, wash with 5ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179°C. Purity Water content Not more than 31% (Karl Fischer method) Sulphated ash Not more than 0,1% expressed on dry weight basis Reducing sugars Not more than 0,3% expressed as glucose on dry weight basis Chlorides Not more than 50 mg/kg expressed on dry weight basis Sulphates Not more than 100 mg/kg expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis E 421 — MANNITOL Synonyms D-Mannitol Definition Chemical name D-mannitol Einics 200-711-8 E number E 421 Chemical formula C6H14O6 Relative molecular mass 182,2 Assay Content not less than 96% D-mannitol on the dried basis Description Sweet tasting, white, odourless, cyrstalline powder Identification A. Solubility Soluble Purity Loss on drying Not more than 0,3% (105 °C, four hours) pH Between 5 and 8 Add 0,5ml of a saturated solution of potassium chloride to 10ml of a 10% w/v solution of the sample then measure the pH Specific rotation α Specific rotation in a borated solution calculated with reference to the anhydrous substance is between + 23 and + 25° Sulphated ash Not more than 0,1% expressed on dry weight basis Reducing sugars Not more than 0,3% expressed as glucose on dry weight basis Total sugars Not more than 1% expressed as glucose on dry weight basis Chlorides Not more than 70 mg/kg expressed on dry weight basis Sulphates Not more than 100 mg/kg expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis E 953 — ISOMALT Synonyms Hydrogenated isomaltulose, hydrogenated palatinose Definition Chemical name Isomalt is a mixture of: D-glucopyranosyl-1.6-D-glucitol and D-glucopyranosyl-1.1-D-mannitol dihydrate Einics E number E 953 Chemical formula D-glucopyranosyl-1.6-D-glucitol: C12H24O11 D-glucopyranosyl-1,1-D-mannitol dihydrate: C12H24O112H2O Relative molecular mass D-glucopyranosyl-1,6-D-glucitol: 344,32 D-glucopyranosyl-1,1-D-mannitol dihydrate: 380,32 Assay Content not less than 95% of the mixture of D-glucopyranosyl-1,6-D-glucitol and D-glucopyranosyl-1,1-D-mannitol dihydrate determined on the anhydrous basis Description Odourless, white, sweet tasting, crystalline slightly hygroscopic substance Identification A. Solubility Slightly soluble in water, insoluble in ethanol B. Specific rotation α : between + 90 and + 92° (4% w/v solution) C. Melting range 145 to 150 °C Tests Water content Not more than 7% (Karl Fischer method) Sulphated ash Not more than 0,05% expressed on dry weight basis Reducing sugars Not more than 1,5% expressed as glucose on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed on dry weight basis E 965 (
9. i)— MALTITOL Synonyms D-maltitol, hydrogenated maltose Definition Chemical name (α)-D-glucopyranosyl-1,4-D-glucitol Einics 209-567-0 E number E 965 (
10. i)Chemical formula C12H24O11 Relative molecular mass 344,31 Assay Content not less than 98% D-mannitol C12H24O11 on the anhydrous basis Description Sweet tasting, white crystalline powder Identification A. Solubility Very soluble in water, slightly soluble in ethanol B. Melting range 148 to 151 °C C. Specific rotation (α) = + 105,5 to + 105,5° (5% w/v solution) Purity Water content Not more than 1% (Karl Fischer method) Sulphated ash Not more than 0,1% expressed on dry weight basis Reducing sugars Not more than 0,1% expressed as glucose on dry weight basis Chlorides Not more than 50 mg/kg expressed on dry weight basis Sulphates Not more than 100 mg/kg expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed on dry weight basis E 965 (
11. ii)— MALTITOL SYRUP Synonyms Hydrogenated high maltose-glucose syrup, hydrogenated glucose syrup Definition Chemical name A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup. The article of commerce is supplied both as a syrup and as a solid product Einics 270-337-8 E number E 965 (
12. ii)Assay The following ranges apply on the anhydrous basis: Maltitol not less than 50% Sorbitol not more than 8% Maltitol not more than 25% Hydrogenated polysaccharides containing more than three glucose or glucitol units not more than 30% Description Sweet-tasting, colourless and odourless, clear viscous liquids or sweet-tasting white crystalline masses Identification Description Identification A. Solubility Very soluble in water, slightly soluble in ethanol B. Thin layer chromatography Examine by the thin layer chromatography using a plate coated with a 0,25 mm layer of chromatographic silica gel Purity Water content Not more than 31% (Karl Fischer method) Sulphated ash Not more than 0,1% expressed on dry weight basis Reducing sugars Not more than 0,3% expressed as glucose on dry weight basis Chlorides Not more than 50 mg/kg expressed on dry weight basis Sulphates Not more than 100 mg/kg expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis E 966 — LACTITOL Synonyms Lactit, lactositol, lactobiosit Definition Chemical name 4-0-ß-D-galactopyranosyl-D-glucitol Einics 209-566-5 E number E 966 Chemical formula C12H24O11 Relative molecular mass 344,32 Assay Not less than 95% on the dry weight basis Description Sweet-tasting, crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms Identification A. Solubility Very soluble in water B. Specific rotation (α) = + 13 to + 16° calculated on the anhydrous basis (10% w/v aqueous solution) Purity Water content Crystalline products; not more than 10.5% (Karl Fischer method) Other polyols Not more than 2,5% on the anhydrous basis Reducing sugars Not more than 0,2% expressed as glucose on dry weight basis Chlorides Not more than 100 mg/kg expressed on dry weight basis Sulphates Not more than 200 mg/kg expressed on dry weight basis Sulphated ash Not more than 0,1% expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis E 967 — XYLITOL Synonyms Xylitol Definition Chemical name D-xylitol Einics 201-788-0 E number E 967 Chemical formula C5H12O5 Relative molecular mass 152,15 Assay Not less than 98,5% as xylitol on the anhydrous basis Description White, Crystalline Powder, practically odourless with a very sweet taste Identification A. Solubility Very soluble in water, sparingly soluble in ethanol B. Melting range 92 to 96 °C C. pH 5 to 7 (10 w/v aqueous solution) Purity Loss on drying Not more than 0,5%. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours Sulphated ash Not more than 0,1% expressed on dry weight basis Reducing sugars Not more than 0,2% expressed as glucose on dry weight basis Other polyhydric alcohols Not more than 1% expressed on dry weight basis Nickel Not more than 2 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Chlorides Not more than 100 mg/kg expressed on dry weight basis Sulphates Not more than 200 mg/kg expressed on dry weight basis E 950 — ACESULFAME K Synonyms Acesulfame potassium, acesulfam, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one-2,2-dioxide Definition Chemical name 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt Einecs 259-715-3 E number E 950 Chemical formula C4H4NO4SK Relative molecular mass 201,24 Assay Not less than 99% of C4H4NO4SK on the anhydrous basis Description Odourless, white, crystalline powder having an intensively sweet taste. Approximately 200 times as sweet as sucrose Identification A. Solubility Very soluble in water, very slightly soluble in ethanol B. Ultra-violet absorption Maximum 227 ± 2 nm for a solution of 10 mg in 1,000 ml of water Purity Loss on drying Not more than 1% (105 °C, two hours) Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Fluoride Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis E 951 — ASPARTAME Synonyms Aspartyl phenylalanine methyl ester Definition Chemical name N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(a-carbomethoxy-phenethyl)-succinamic acid-N-methy ester Einecs 245-261-3 E number E 951 Chemical formula C14H18N2O5 Relative molecular mass 294,31 Assay Not less than 98% and not more than 102% of C14H18N2O5on the anhydrous basis Description White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as Sucrose Identification Solubility Slightly soluble in water and in ethanol Purity Loss on drying Not more than 4,5% (105°C, four hours) Sulphated ash Not more than 0,2% expressed on dry weight basis pH Between 4,5 and 6,0 (1 in 125 solution) Transmittance The transmittance of a 1% solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022 Specific rotation (α) : + 14,5 to + 16,5° Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed on dry weight basis 5-Benzyl-3,6-dioxo-2-piperazineacetic acid Not more than 1,5% expressed on dry weight basis E 952 — CYCLAMIC ACID AND ITS Na AND Ca SALTS (I) CYCLAMIC ACID Synonyms Cyclohexylsulphamic acid, cyclamate Definition Chemical name Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid Einecs 202-898-1 E number E 952 Chemical formula C6H13NO3 S Relative molecular mass 179,24 Assay Cyclohexylsulphamic acid contains not less than 98% and not more than the equivalent of 102% of C6H13NO3S, calculated on the anhydrous basis Description A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose Purity Loss on drying Not more than 1% (105°C, one hour) Not more than 8,5% (140°C, four hours) for the dihydrate form Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis Aniline Not more than 1 mg/kg expressed on dry weight basis E 952 — CYCLAMIC ACID AND ITS Na AND Ca SALTS—contd. (II) SODIUM CYCLAMATE Synonyms Cyclamate, sodium salt of cyclamic acid Definition Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate Chemical name 205-348-9 Einecs E 952 E number C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O Chemical formula 201,22 calculated on the anhydrous form Relative molecular mass 237,22 calculated on the hydrated form Assay Not less than 98% and not more than 102% on the dried basis Dihydrate form: not less than 84% on the dried basis Description White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose Identification Solubility Soluble in water, practically insoluble in ethanol Purity Loss on drying Not more than 1% (105°C, one hour) Not more than 15,2% (105°C, two hours) for the dihydrate form Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis Aniline Not more than 1 mg/kg expressed on dry weight basis E 952 — CYCLAMIC ACID AND ITS Na AND Ca SALTS — contd. (III) CALCIUM CYCLAMATE Synonyms Cyclamate, calcium salt of cyclamic acid Definition Chemical name Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate Einecs 205-349-4 E number E 952 Chemical formula C12H24 CaN2O6S2·22O Relative molecular mass 432,57 Assay Not less than 98% and not more than 10% on the dried basis Description White, colourless crystals or crystaline powder. Approximately 30 times as sweet as sucrose Identification Solubility Soluble in water, sparingly soluble in ethanol Purity Not more than 1% (105°C, one hour) Loss on drying Not more than 8,5% (140°C, four hours) for the dihydrate form Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis Aniline Not more than 1 mg/kg expressed on dry weight basis E 954 — SACCHARIN AND ITS Na. K AND Ca SALTS (I) SACCHARIN Definition Chemical name 3-oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide Einecs 201-321-0 E number E 954 Chemical formula C7H5NO3S Relative molecular mass 183,18 Assay Not less than 99% and not more than 101,0% of C7H5NO3S on the anhydrous basis Description White crystals or a white crystalline powder, odourless or with a faint, aromatic odour having a sweet taste even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose Identification Solubility Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol Purity Loss on drying Not more than 1% (105°C, two hours) Melting range 226 to 230°C Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Sulphated ash Not more than 0,2% expressed on dry weight basis Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis P-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonizable substances Absent E 954 — SACCHARIN AND ITS Na. K AND Ca SALTS — contd. (II) SODIUM SACCHARIN Synonyms Saccharin, sodium salt of saccharin Definition Chemical name Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulfonazole, oxobenzisosulfonazole, 1,2-benzisotfhiazolin-3-one-1, 1-dioxide sodium salt dihydrate Einecs 204-886-1 E number E 954 Chemical formula C7H4NNaO3S·2H2O Relative molecular m{ass 241,19 Assay Not less than 99% and not more than 101% of C7H4NNaO3S·on the anhydrous basis Description White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions Identification Solubility Freely soluble in water, sparingly soluble in ethanol Purity Loss on drying Not more than 15% (120°C, four hours) Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis P-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonizable substances Absent E 954 — SACCHARIN AND ITS Na. K AND Ca SALTS — contd. (III) CALCIUM SACCHARIN Synonyms Saccharin, calcium salt of saccharin Definition Chemical name Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7) Einecs 229-349-0 E number E 954 Chemical formula C14H8CaN2O6S2 3½H2O Relative molecular mass 467,48 Assay Not less than 95% of C14H8CaN2O6S2 on the anhydrous basis Description White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions Identification Solubility Freely soluble in water, soluble in ethanol Purity Loss on drying Not more than 13,5% (120°C, four hours) Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis P-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonizable substances Absent E 954 — SACCHARIN AND ITS Na. K AND Ca SALTS — contd. (IV) POTASSIUM SACCHARIN Synonyms Saccharin, potassium salt of saccharin Definition Chemical name Potassium o-benzosulphimide, potassium salt of- 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate Einecs E number E 954 Chemical formula C7H4KNO3SH2O Relative molecular mass 239,77 Assay Not less than 99% and not more than 101% of C7H4KNO3S2on the anhydrous basis Description White crystals or a white crystalline powder, odourless or with a faint odour having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose Identification Solubility Freely soluble in water, sparingly soluble in ethanol Purity Loss on drying Not more than 8% (120 °C, four hours) Arsenic Not more than 3 mg/kg expressed on dry weight basis Selenium Not more than 30 mg/kg expressed on dry weight basis Lead Not more than 1 mg/kg expressed on dry weight basis Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis P-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis Readily carbonizable substances Absent E 957 — THAUMATIN Synonyms Definition Chemical name Thaumatin is obtained by aqueous extraction (pH 2.5 to 4) of the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material Einecs 258-822-2 E number E 957 Chemical formula Polypeptide of 207 amino acids Relative molecular mass Thaumatin I 22209 Thaumatin II 22293 Assay Not less than 16% nitrogen on the dried basis equivalent to not less than 94% proteins (N x 5,8) Description Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose Identification Solubility Very soluble in water, insoluble in acetone Purity Loss on drying Not more than 9% (105 °C to constant weight) Carbohydrates Not more than 3% expressed on dry weight basis Sulphated ash Not more than 2% expressed on dry weight basis Aluminium Not more than 100 mg/kg expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead 3 mg/kg expressed on dry weight basis Microbiological criteria Total aerobic microbial count: Max 1,000/g E. Coli: absent in 1g E959 — NEOHESPERIDINE DIHYDROCHALCONE Synonyms Neohesperidine dihydrochalcone, NHDC, hesperetin dihydrochalcone-4'-ß- neohesperidoside, neohesperidin DC Definition Chemical name 2-O-α-L-rhamnopyranosyl-4'-ß-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin Einecs 243-978-6 E number E 959 Chemical formula C28H36O15 Relative molecular mass 612,6 Assay Content not less than 96% on the dried basis Description Off while, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose Identification A. Solubility Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene B. Ultraviolet absorption maximum 282 to 283 nm for a solution of 2 mg in 100 ml methanol C. Neu's test Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1% 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced Purity Loss on drying Not more than 11% (105°C, three hours) Sulphated ash Not more than 0.2% expressed on dry weight basis Arsenic Not more than 3 mg/kg expressed on dry weight basis Lead Not more than 2 mg/kg expressed on dry weight basis Heavy metal Not more than 10 mg/kg expressed as Pb on dry weight basis SCHEDULE IV PART A List of Permitted Food Colours Note: Aluminium lakes prepared from colours mentioned in this Part are authorized EC Number Common Name Colour Index Number

(1)or description E100 Curcumin 75300 E101 (

1. i)Riboflavin (
2. ii)Riboflavin-5'-phosphate E102 Tartrazine 19140 E104 Quinoline Yellow 47005 E110 Sunset Yellow FCF 15985 Orange Yellow S E120 Cochineal, Carminic acid. Carmines 75470 E122 Azorubine, Carmoisine 14720 E123 Amaranth 16185 E124 Ponceau 4R, Cochineal Red A 16255 E127 Erythrosine 45430 E128 Red 2G 18050 E129 Allura Red AC 16035 E131 Patent Blue V 42051 E132 Indigotine, Indigo carmine 73015 E133 Brilliant Blue FCF 42090 E140 Chlorophylls and 75810 Chlorophyllins 75815 (
3. i)Chlorophylls (
4. ii)Chlorophyllins E141 Copper complexes of chlorophylls and chlorophyllins 75815 (
5. i)Copper complexes of chlorophylls (
6. ii)Copper complexes of chlorophyllins E 142 Greens S 44090 E150a Plain caramel

(2)E150b Caustic sulphite caramel E150c Ammonia caramel E150d Sulphite ammonia caramel E151 Brilliant Black BN, Black PN 28440 E153 Vegetable carbon E154 Brown FK E155 Brown HT 20285 E160a Carotenes: (

1. i)Mixed carotenes 75130 (
2. ii)Beta-carotene 40800 E160b Annatto, bixin, norbixin 75120 E160c Paprika extract, capsanthin, capsorubin E160d Lycopene

(1)Colour index numbers are taken from the third edition 1982 of the Colour Index, volumes 1 to 7, 1315. Also amendments 37 to 40

(125), 41 to 44 (127-50), 45 to 48

(130), 49 to 52 (132-50), 53 to 56

(135).

(2)The term caramel relates to products of a more or less intense brown colour which are intended for colouring. It does not correspond to the sugary aromatic product obtained from heating sugars and which is used for flavouring food (e.g. confectionery, pastry, alcoholic drinks). EC Number Common Name Colour Index Number

(1)or description E160e Beta-apo-8' carotenal (C 30) 40820 E160f Ethyl ester of beta-apo-8-'carotenic acid 40825 (C30) E161b Lutein E161g Canthaxanthin E162 Beetroot Red, betanin E163 Anthocyanins Prepared by physical means from fruits and vegetables E170 Calcium carbonate 77220 E171 Titanium dioxide 77891 E172 Iron oxides and hydroxides 77491 77492 77499 E173 Aluminium E174 Silver E175 Gold E180 Litholrubine BK

(1)Colour index numbers are taken from the third edition 1982 of the Colour Index, volumes 1 to 7, 1315. Also amendments 37 to 40

(125), 41 to 44 (127-50), 45 to 48

(130), 49 to 52 (132-50), 53 to 56

(135). PART B Foodstuffs which may not Contain Added Colours, Except Where Specifically Provided for in Parts, C, D or E (The designations used in Part B do not prejudice the "carry over'' principle in cases where products contain ingredients with legitimate colouring in their own right).

1. Unprocessed foodstuffs
2. All bottled or packed waters
3. Milk, 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 Directive 76/118/EEC
7. Butter-milk (unflavoured)
8. Cream and cream powder (unflavoured)
9. Oils and fats of animal or vegetable origin
10. Eggs and egg products as defined in Article 2

(1)of Directive 89/437/EEC 11. Flour and other milled products and starches 12. Bread and similar products 13. Pasta and gnocchi 14. Sugar, including all mono- and disaccharides 15. Tomato paste and canned and bottled tomatoes 16. Tomato-based sauces 17. Fruit juice and fruit nectar as mentioned in Directive 75/726/EEC and vegetable juice 18. Fruit, vegetables (including potatoes) and mushrooms — canned, bottled or dried; processed fruit, vegetables (including potatoes) and mushrooms) 19. Extra jam, extra jelly, and chestnut puree as mentioned in Directive 79/693/EEC, creme de pruneaux 20. Fish, molluscs and crustaceans, meat, poultry and game as well as their preparations, but not including prepared meals containing these ingredients. 21. Cocoa products and chocolate components in chocolate products as mentioned in Directive 73/241/EEC 22. 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 23. Salt, salt substitutes, spices and mixtures of spices 24. Wine and other products defined by Regulation (EEC) No. 822/87 25. 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 26. Sambuca, Maraschino and Mistra as defined in Regulation (EEC) No. 1180/91 27. Sangria, Clarea and Zurra as mentioned in Regulation (EEC) No. 1601/91 28. Wine vinegar 29. Foods for infants and young children as mentioned in Directive 89/398/EEC including foods for infants and young children not in good health 30. Honey 31. Malt and malt products 32. Ripened and unripened cheese (unflavoured) 33. Butter from sheep and goats' milk PART C Foodstuffs to Which Only Certain Permitted Colours May be Added Foodstuffs Permitted colour Maximum level Malt Bread E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel Beer E 150a Plain caramel quantum satis Cider bouché E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel Butter (including reduced fat butter and concentrated butter) E 160a Carotenes quantum satis Margarine, minarine, other fat emulsions, and fats essentially free from water E 160a Carotenes quantum satis E 100 Curcumin quantum satis E 160b Annatto, Bixine, 10 mg/kg Norbixine Foodstuffs Permitted colour Maximum level Sage Derby cheese E 140 Chlorophylls quantum satis Chlorophyllins E 141 Copper complexes of chlorophylls and chlorohyllins Ripened Orange, Yellow and broken- white cheese; unflavoured processed cheese E 160a Carotenes E 160c Paprika extract quantum satis E 160b Annatto, Bixin, Norbixin 15 mg/kg Red Leicester cheese E 160b Annatto, Bixin, Norbixin 50 mg/kg Mimolette cheese E 160b Annatto, Bixin, Norbixin 35 mg/kg Morbier cheese E 153 Vegetable carbon quantum satis Red marbled cheese E 120 Cochineal, Carminic acid. Carmines 125 mg/kg E 163 Anthocyanins quantum satis Vinegar E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel Whisky, Whiskey, grain spirit (other than Korn or Kornbrand or Eau de vie de seigle Marque nationale luxembourgeoise), wine spirit, rum. Brandy, Weinbrand, grape marc, grape marc spirit (other than Tsikoudia and Tsipouro and Eau de vie de marc Marque nationale luxembourgeoise), Grappa invecchiata, Bagaceira velha as mentioned in Regulation (EEC) No. 1576/89 E 150a Plain caramel E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel quantum satis Foodstuffs Permitted colour Maximum level Aromatized wine-based drinks (except bitter soda) and aromatized wines as mentioned in Regulation (EEC) No. 1601/91 E 150a Plain caramel E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel quantum satis Americano E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel E 163 Anthocyanins E 100 Curcumin E 101 (

1. i)Riboflavin (
2. ii)Riboflavin-5'- phosphate 100 mg/l (individually or in combination) E 102 Tartrazine E 104 Quinoline Yellow E 120 Cochineal, Carminic acid, Carmines E 122 Azorubine carmoisine E 123 Amaranth E 124 Ponceau 4R Bitter soda, bitter vino as mentioned in Regulation (EEC) No. 1601/91 E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel E 100 Curcumin 100 mg/l (individually or in combination) E 101 (
3. i)Riboflavin (
4. ii)Riboflavin-5'- phosphate E 102 Tartrazine E 104 Quinoline Yellow E 110 Sunset Yellow FCF Orange Yellow S E 120 Cochineal, Carminic acid, Carmines E 122 Azorubine, Carmoisine E 123 Amaranth E 124 Ponceau 4R, Cochineal Red A E 129 Allura Red AC Foodstuffs Permitted colour Maximum level Liqueur wines and quality liqueur wines produced in specified regions E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel Vegetables in vinegar, brine or oil (excluding olives) E 101 (
5. i)Riboflavin (
6. ii)Riboflavin-5'- phosphate quantum satis E 140 Chlorophylls, Chlorophyllins E 150a Plain caramel E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel E 141 Copper complexes of chlorophylls and chlorophyllins E 160a Carotenes: (
7. i)Mixed carotenes (
8. ii)Beta-carotene E 162 Beetroot Red, betanin E 163 Anthocyanins Extruded, puffed and/or fruit-flavoured breakfast cereals E 150c Ammonia caramel quantum satis E 160a Carotenes quantum satis E 160b Annatto, Bixin, Norbixin 25 mg/kg E 160c Paprika extract, Capsanthin, Capsorubin quantum satis Fruit-flavoured breakfast cereals E 120 Cochineal, Carminic acid, Carmines 200 mg/kg in E 162 Beetroot Red, betanine (individually or E 163 Anthocyanins combination) Jam, jellies and marmalades as mentioned in Directive 79/693/EEC and other similar fruit preparations including low calorie products E 100 Curcumin quantum satis E 140 Chlorophylls and chlorophyllins E 141 Copper complexes of chlorophylls and chlorophyllins E 150a Plain caramel E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel E 160a Carotenes: (
9. i)Mixed carotenes (
10. ii)Beta-carotene E 160c Paprika extract, Capsanthin, Capsorubin Foodstuffs Permitted colour Maximum level E 162 Beetroot Red, betanin E 163 Anthocyanins E 104 Quinoline Yellow 100 mg/kg (individually or in combination) E 110 Sunset Yellow E 120 Cochineal, Carminic acid, Carmines E 124 Ponceau 4R, Cochineal E 142 Green S E 160d Lycopene E 161b Lutein Sausages, pâtés and terrines E 100 Curcumin 20 mg/kg E 120 Cochineal, Carminic acid, Carmines 100 mg/kg E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel quantum satis E 150c Ammonia caramel quantum satis E 150d Sulphite ammonia caramel quantum satis E 160a Carotenes E 160c Paprika extract, Capsanthin, Capsorubin 20 mg/kg 10 mg/kg E 162 Beetroot Red, betanin quantum satis Luncheon meat E 129 Allura Red 25 mg/kg Breakfast sausages with a minimum cereal content of 6% E 129 Allura Red AC 25 mg/kg Burger meat with a minimum vegetable and/or cereal content of 4% E 120 Cochineal, Carminic acid. Carmines 100 mg/kg E 150a Plain caramel quantum satis E 150b Caustic sulphite caramel quantum satis E 150c Ammonia caramel quantum satis E 150d Sulphite ammonia caramel quantum satis Chorizo sausage E 120 Cochineal Carminic acid, Carmines 200 mg/kg Salchichon E 124 Ponceau 4R, Cochineal Red A 250 mg/kg Sobrasada E 110 Sunset Yellow FCF 135 mg/kg E 124 Ponceau 4R, Cochineal Red A 200 mg/kg Foodstuffs Permitted colour Maximum level Pasturmas (edible external coating) E 100 Curcumin quantum satis E 101 (
11. i)Riboflavin (
12. ii)Riboflavin-5'-phospate E 120 Cochineal, Carminic acid, Carmines Dried potato granules and flakes E 100 Curcumin quantum satis Processed mushy and garden peas (canned) E 102 Tartrazine 100mg/kg E 133 Brilliant Blue 20mg/kg E 142 Green S 10mg/kg PART D Colours Permitted for Certain Uses Only Colour Foodstuff Maximum level E 123 Amaranth Aperitif wines, spirit drinks including products with less than 15% alcohol by volume 30mg/l Fish roe 30 mg/kg E 127 Erythrosine Cocktail cherries and candied cherries 200 mg/kg Bigarreaux cherries in syrup and in cocktails 150 mg/kg E 128 Red 2G Breakfast sausages with a minimum cereal content of 6% Burger meat with a minimum vegetable and/or cereal content of 4% 20 mg/kg E 154 Brown FK Kippers 20 mg/kg E 161g Canthaxanthin Saucisses de Strasbourg 15 mg/kg E 173 Aluminium External coating of sugar confectionery for the decoration of cakes and pastries quantum satis E 174 Silver External coating of confectionery Decoration of chocolates Liqueurs quantum satis E 175 Gold External coating of confectionery quantum satis Decoration of chocolates Liqueurs E 180 Litholrubine BK Edible cheese rind quantum satis E 160b Annatto, Bixin, Norbixin Margarine, Minarine other fat emulsions, and fats essentially free from water 10 mg/kg Decorations and coatings 20mg/kg Fine bakery wares 10mg/kg Edible ices 20mg/kg Liqueurs, including fortified beverages with less than 15% alcohol by volume 10mg/l Flavoured processed cheese 15mg/kg Ripened Orange, Yellow and broken-white cheese 15mg/kg Unflavoured processed cheese 15 mg/kg Desserts 10 mg/kg Snacks: dry, savoury potato, cereal or starch-based snack products: —Extruded or expanded savoury snack products 20 mg/kg —Other savoury snack products and savoury coated nuts 10 mg/kg Smoked fish 10 mg/kg Edible cheese rind and edible casings 20 mg/kg Red Leicester cheese 50 mg/kg Mimolette cheese 35 mg/kg Extruded, puffed and/or fruit-flavoured breakfast cereals 25 mg/kg PART E Colours Permitted in Foodstuffs Other Than Those Mentioned in Parts B and C SECTION 1 The following colours may be used in foodstuffs mentioned in Part E Section 2 and in all other foodstuffs other than those listed in Parts B and C at quantum satis. E 101 (
13. i)Riboflavin (
14. ii)Riboflavin-5'- phosphate E 140 Chlorophylls and chlorophyllins E 141 Copper complexes of chlorophylls and chlorophyllins E 150a Plain caramel E 150b Caustic sulphite caramel E 150c Ammonia caramel E 150d Sulphite ammonia caramel E 153 Vegetable carbon E 160a Carotenes E 160c Paprika extract, capsanthin, capsorubin E 162 Beetroot Red, betanin E 163 Anthocyanins E 170 Calcium carbonate E 171 Titanium dioxide E 172 Iron oxides and hydroxides SECTION 2 The following colours may be used singly or in combination in the following foods up to the maximum level specified in the table. However, for non-alcoholic flavoured drinks, edible ices, desserts, fine bakery wares and confectionery, colours may be used up to the limit indicated in the appropriate table but the quantities of each of the colours E 110, E 122, E 124 and E 155 may not exceed 50 mg/kg or mg/1. E 100 Curcumin E 102 Tartrazine E 104 Quinoline Yellow E 110 Sunset Yellow FCF Orange Yellow S E 120 Cochineal, Carminic acid. Carmines E 122 Azorubine, Carmoisine E 124 Ponceau 4R, Cochineal Red A E 129 Allura Red AC E 131 Patent Blue V E 132 Indigotine, Indigo carmine E 133 Brilliant Blue FCF E 142 Green S E 151 Brilliant Black BN, Black PN E 155 Brown HT E 160d Lycopene E 160e Beta-apo-8' carotenal (C 30) E 160f Ethyl ester of beta-apo-8'-carotenic acid (C 30) E 161b Lutein Foodstuffs Maximum Level Non-alcoholic flavoured drinks 100 mg/l Candied fruits and vegetables, Mostarda di frutta 200 mg/kg Preserves of red fruits 200 mg/kg Confectionery 300 mg/kg Decorations and coatings 500 mg/kg Fine bakery wares (e.g. viennoiserie, biscuits, cakes and wafers) 200 mg/kg Edible ices 150 mg/kg Flavoured processed cheese 150 mg/kg Desserts including flavoured milk products 100 mg/kg Sauces, seasonings (for example, curry powder, tandoori), pickles, relishes, chutney and piccalilli 500 mg/kg Mustard 300 mg/kg Fish paste and crustacean paste 100 mg/kg Pre-cooked crustaceans 250 mg/kg Salmon substitutes 500 mg/kg Surimi 500 mg/kg Fish roe 300 mg/kg Smoked fish 100 mg/kg 'Snacks': dry, savoury potato, cereal or starch-based snack products: —Extruded or expanded savoury snack products 200 mg/kg —Other savoury snack products and savoury coated nuts 100 mg/kg Edible cheese rind and edible casings quantum satis Complete formulae for weight control intended to replace total daily food intake or an individual meal 50 mg/kg Complete formulae and nutritional supplements for use under medical supervision 50 mg/kg Liquid food supplements/dietary integrators 100 mg/l Solid food supplements/dietary integrators 300 mg/kg Soups 50 mg/kg Meat and fish analogues based on vegetable proteins 100 mg/kg Spirituous beverages (including products less than 15% alcohol by volume), except those mentioned in Part B and C 200 mg/l Aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails as mentioned in Regulation (EEC) No. 1601/91, except those mentioned on Parts B and C 200 mg/l Fruit wines (still or sparkling) cider (except cider bouche) and perry aromatised fruit wines, cider and perry 200 mg/l SCHEDULE V Specific Purity Criteria concerning Colours for use in Foodstuffs A. GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS Definition Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate of ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product. HCI insoluble matter Not more than 0,5% Ether extractable matter Not more than 0,2% (under neutral conditions) Specific purity criteria for the corresponding colours are applicable. B. SPECIFIC CRITERIA OF PURITY E 100 CURCUMIN Synonyms CI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane Definition Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizones of natural strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. The product consists essentially of curcumins; i.e. the colouring principle (l,7-bis(4-hydroxy-3-methoxyphenyl) hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in turmeric may be present. Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane. Class Dicinnamoylmethane Colour Index No. 75300 Einics 207-280-5 Chemical names I 1,7-Bis (4-hydroxy-3-methoxyphenyl) hepta-1,6-diene-3,5-dione II 1-(4-Hydroxyphenyl)-7-(4-hyaroxy-3-methoxy-phenyl-) hepta-l,6-diene-3,5-dione III 1,7-Bis(4-hydroxyphenyl) hepta-1,6-diene-3,5-dione Chemical formula I C21H20O6 II C20H18O5 III C19H16O4 Molecular weight I.368,39 II. 338,39 III. 308,39 Assay Content not less than 90% total colouring matters 1 607 at ca 426 nm in ethanol Description Orange-yellow crystalline powder Identification A. Spectrometry Maximum in ethanol at ca 426 nm B. Melting Range 179-182 °C Purity Ethylacetate Not more than 50 mg/kg, singly or in combination Solvent residues Acetone n-butanol Methanol Ethanol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy Metals (as Pb) Not more than 40 mg/kg E 101 (
15. i)RIBOFLAVIN Synonyms Lactoflavin Class Isoalloxazine Einecs 201—507-1 Chemical names 7, 8—Dimethyl-10-(D-ribo-2, 3, 4, 5-tetrahydroxypentyl) benzo(g)—pteridine-2, 4-(3H, 10H)-dione 7,8—dimethyl-10 (1'-D-ribityl) isoalloxazine Chemical formula C17H20N4O6 Molecular weight 376,37 Assay Content not less than 98% on the anhydrous basis 328 at ca 444 nm in aqueous solution Description Yellow to orange-yellow crystalline powder, with slight odour. Identification A. Spectrometry The ratio A375/A267 is between 0,31 and 0,33 The ratio A444/A267 is between 0,36 and 0,39 In aqueous solution Maximum in water at ca 375 nm. B. Specific rotation (α) between -115° and -140° in a 0,05 N sodium hydroxide solution Purity Loss on drying Not more than 1,5% after drying at 105°C for 4 hrs Sulfated ash Not more than 0,1% Primary aromatic amines Not more than 100 mg/kg (calculated as aniline) Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 10mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 101 (
16. ii)(
17. ii)RIBOFLAVIN-5'-PHOSPHATE Synonyms Riboflavin-5'-phosphate sodium Definition These specifications apply to riboflavin -5—'phosphate together with minor amounts of free riboflavin diphosphate Class Isoalloxazine Einics 204—988-6 Chemical names Monosodium (2R, 3R, 4S)—5—

(3)10'-dihydro-7, 8'-dimethyl-2', 4'-dioxo-10-'benzo [y]pteridinyl]-2, 3, 4- trihydroxypentyl phosphate; monosodium salt of 5'-monophosphate ester of riboflavin Chemical formula For the dihydrate form: C17H20N4NaO9P.2H2O For the anhydrous form: C17H20N4NaO9P Molecular weight 541,36 Assay Content not less than 95% total colouring matters calculated as C17H20N4NaO9P.2H2O 250 at ca 375 nm in aqueous solution Description Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste Identification A. Spectrometry The ratio A375/A267 is between 0,30 and 0,34 The ratio A444/A267 is between 0,35 and 0,40 In aqueous solution Maximum in water at ca 375 nm. B. Specific rotation (α) between +38° and +42° in a 5 molar HCI solution Purity Loss on drying Not more than 8% (100°C, 5 hrs in vacuum over P2O5) for the dihydrate form Sulfated ash Not more than 25% Inorganic phosphate Not more than 1,0% (calculated as PO4 on the anhydrous basis) Subsidiary colouring matters Riboflavin (free): Not more than 6% Riboflavin diphosphate: Not more than 6% Primary aromatic amines Not more than 70 mg/kg (calculated as aniline) Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 102 TARTRAZINE Synonyms CI Food Yellow 4 Definition Tartrazine consists essentially of trisodium 5—hydroxy-l-(4-sulfonatophenyl)—4-(4-sulfonatophenylazo-H-pyrazole-30-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components Tartrazine is described as the sodium salt The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 19140 Einics 217—699-5 Chemical names Trisodium-5—hydroxy-l-(4-sulfonatophenyl)—4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate Chemical formula C16H9N4 Na3O9S2 Molecular weight 534,37 Assay Content not less than 85% total colouring matters calculated as the sodium salt 530 at ca 426 nm in aqueous solution Description Light orange powder or granules Identification A. Spectrometry Maximum in water at ca 426 nm B. Yellow solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 1,0% Organic compounds other than colouring matters: 4—hydrazinobenzene sulfonic acid Total not more than 0,5% 4—aminobenzene-1-sulfonic acid 5—oxo-1-(4-sulfophenyl)—2-pyrazolin-e-3-carboxylic acid 4, 4'-diazoaminodi (benzene sulfonic acid) Tetrahydroxysuccinic acid Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 104 QUINOLINE YELLOW Synonyms CI Food Yellow 13 Definition Quinoline Yellow is prepared by sulfonating 2—(2-quinolyl) indan-1, 3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted. Class Quinophthalone Colour Index No 47005 Einecs 305—897-5 Chemical name The disodium salts of the disulfonates of 2—(2-quinolyl) indan-1,3-dione (principal component) Chemical formula C18H9N Na2O8S2(principal component) Molecular weight 477,38 (principal component) Assay Content not less than 70% total colouring matters calculated as the sodium salt Quinoline Yellow shall have the following composition: Of the total colouring matters present: —not less than 80% shall be disodium 2—(2-quinolyl:) indan-1, 3-dione-disulfonates —not more than 15% shall be sodium 2—(2-quinolyl) indan-1, 3-dione-monosulfonates —not more than 7.0% shall be trisodium 2—(2-quinolyl) indan-1, 3-dione-trisulfonate 865 (principal component) at ca 411 nm in aqueous acetic acid solution Description Yellow powder or granules Identification A. Spectrometry Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm B. Yellow solution in water E 104 QUINOLINE YELLOW—contd. Purity Water insoluble matter Not more than 0.2% Subsidiary colouring matters Not more than 4.0% Organic compounds other than colour matters 2-metyhylquinoline-sulfonic acid Total not more than 0,5% Phthalic acid 2,-6-dimethyl quinoline 2, 6-dimethyl quinoline sulfonic acid 2-(2-quinolyl) indan-1,3 dione Not more than 4 mg/kg Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 110 SUNSET YELLOW FCF Synonyms CI Food Yellow 3, Orange Yellow S Definition Sunset Yellow FCF consists essentially of disodium 2—hydroxy-l-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 15985 Einics 220—491-7 Chemical names Disodium 2—hydroxy-l-(4-sulfonatophenylazo) naphthalene-6-sulfonate Chemical formula C16H10N2Na2O7S2 Molecular weight 452,37 Assay Content not less than 85% total colouring matters calculated as the sodium salt 555 at ca 485 nm in aqueous solution at pH7 Description Orange-red powder or granules Identification A. Spectrometry Maximum in water at ca 485 nm at pH7 B. Orange solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters: Not more than 5,0% Organic compounds other than colouring matters 4-[aminobenzene-1-sulfonic acid Total not more than 0,5% 3-hydroxymaphthalene-2,7-disulfonic acid 6-hydroxymaphthalene-2-sulfonic acid 7-hydroxymaphthalene-1, 3-disulfonic acid 4, 4'-diazoaminodi (benzene sulfonic acid) 6,6'-oxydi(naphthalene-2-sulfonic acid) Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E120 COCHINEAL, CARMINIC ACID, CARMINES Definition Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa The colouring principle is carminic acid Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2 In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations Class Anthraquinone Colour index No 75470 Einecs Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4 Chemical names 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylicacid (carminic acid); Chemical formula Carmine is the hydrated aluminum chelate of this acid C22H20O13 (carminic add) Molecular weight 492,39(carminic acid) Assay Content not less than 2,0% carminic acid in the extracts containing carminic acid; not less than 50% carminic acid in the chelates Description Red to dark red, friable, solid or powder Cochineal extract is generally a dark read liquid but can also be dried as a powder Identification Spectrometry Maximum in aqueous ammonia solution at ca 518 nm. Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid Purity Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 122 AZORUBINE, CARMOISINE Synonyms CI Food Red 3 Definition Azorubine consists essentially of disodium 4—hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene -1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 14720 Einecs 222-657-4 Chemical name Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate Chemical formula C20H12N2Na2O7S2 Molecular weight 502,44 Assay Content not less than 85% total colouring matters, calculated as the sodium salt 510 at ca 516 nm in aqueous solution Description Red to maroon powder or granules Identification A. Spectrometry Maximum in water at ca 516 nm B. Red solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 2,0% Organic compounds other than colouring matters: 4—aminonaphthalene-l-sulfonic acid Total not more than 0,5% 4—hydroxynaphthalene-1-sulfonic acid Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/Kg Cadium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/Kg E 123 AMARANTH Synonyms CI Food Red 9 Definition Amaranth consists essentially of trisodium 2—hydroxyl-(4-sulfonato-l-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 16185 Einecs 213-022-2 Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate Chemical formula C20H11N2Na3O10S3 Molecular weight 604,48 Assay Content not less than 85% total colouring matters, calculated as the sodium salt 440 at ca 520 nm in aqueous solution Description Reddish-brown powder or granules Identification A. Spectrometry Maximum in water at ca 520 nm B. Red solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 3,0% Organic compounds other than colouring matters: 4-aminonapththalene-1-sulfonic acid Total not more than 0,5% 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-trisulfonic: acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 02% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/Kg E 124 PONCEAU 4R, COCHINEAL RED A Synonyms CI Food Red 7, New Coccine Definition Ponceau 4R consists essentially of trisodium 2—hydroxy-1(4-sulfonato-1-naphthylazo) naphthalene-6, 8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components Ponceau 4-R is described as the sodium salt. The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 16255 Einecs 220-036-2 Chemical name Trisodium-2-hydroxy-1-(4-sulfonato-1-naphthylazo)—naphthalene-6,8-disulfonate Chemical formula C20H11N2Na3O10S3 Molecular weight 604,48 Assay Content not less than 80% total colouring matters, calculated as the sodium salt 430 at ca 505 nm in aqueous solution Description Reddish powder or granules Identification A. Spectrom-etry Maximum in water at ca 505 nm B. Red solution in water Purity Water insoluble matter Subsidiary colouring matters Not more than 0,2% Organic compounds other than colouring matters: Not more than 1,0% 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5% 7-hydroxynaphthalene-1,3-disulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3,6-trisulfonic acid Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 127 ERYTHROSINE Synonyms CI Food Red 14 Definition Erythrosine consists essentially of disodium 2-(2,4,5,7tetraiodo-3-oxido-6-oxoxanthen-9-

1. yl)benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components. Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted Class Xanthene Colour Index No 45430 Einecs 240-474-8 Chemical name Disodium 2-(2,4,5,7-tetraido-3-oxido-6-oxoxanthen-9-
2. yl)benzoate monohydrate Chemical formula C20H6I4Na2O5H2O Molecular weight 897,88 Assay Content not less than 87% total colouring matters, calculated as the anhydrous sodium salt 1 100 at ca 526 nm in aqueous solution at pH7 Description Red powder or granules Identification A. Spectrometry Maximum in water at ca 526 nm at pH7 B. Red solution in water Purity Inorganic iodides calculated as sodium iodide Not more than 0,1% Water insoluble matter Not more than 0,2% Subsidiary colouring matters (except fluorescein) Not more than 4,0% Fluorescein Not more than 20 mg/kg Organic compounds other than colouring matters: Tri-iodoresorcinol Not more than 0,2.% 2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acid Not more than 0,2% Ether extractable matter From a solution of pH from 7 through 8, not more than 0,2% Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/Kg Aluminium Lakes The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5%, for this colour only E 128 RED 2G Synonyms CI Food Red 10, Azogeranine Definition Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 18050 Einecs 223-098-9 Chemical name Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate Chemical formula C18H13N3Na2O8S2 Molecular weight 509,43 Assay Content not less than 80% total colouring matters, calculated as the sodium salt 620 at ca 532 nm in aqueous solution Description Red powder or granules Identification A. Spectrometry Maximum in water at ca 532 nm B. Red solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 2,0% Organic compounds other than colouring matters: 5-acetamido-4-hydroxynaphthalene-2, Total not more than 0,5% 7-disulfonic acid 5-amino-4-hydroxynaphthalene-2,7-disulfonic acid Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/Kg E 129 ALLURA RED AC Synonyms CI Food Red 17 Definition Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted Class Monoazo Colour Index No 16035 Einecs 247-368-0 Chemical name Disodium 2-hydroxy-1-(2-methoxy-5-methy-4-sulfonatophenylazo) naphthalene-6-sulfonate Chemical formula C18H14N2Na2O8S2 Molecular weight 496,42 Assay Content not less than 85% total colouring matters, calculated as the sodium salt 540 at ca 504 nm in aqueous solution at pH 7 Description Dark red powder or granules Identification A. Spectrometry Maximum in water at ca 504 nm B. Red solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 3,0% Organic compounds other than colouring matters: 6-hydroxy-2-naphthalene sulfonic acid, sodium salt Not more than 0,3% 4-amino-5-methoxy-2-methylbenezene sulfonic acid Not more than 0,2% 6,6-oxybis (2-naphthalene sulfonic acid) disodium salt Not more than 1,0% Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter From a solution of pH 7, not more than 0,2% Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/Kg E 131 PATENT BLUE V Synonyms CI Food Blue 5 Definition Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium sulfate as the principal uncoloured components The potassium is also permitted Class Triarylmethane Colour Index No 42051 Einecs 222-573-8 Chemical names The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene),-2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt Chemical formula Calcium compound: C27H31N2O7S2Ca½ Sodium Compound; C27H31N2O7S2Na Molecular weight Calcium compound: 579,72 Sodium compound: 582,67 Assay Content not less than 85% total colouring matters, calculated as the sodium salt 2 000 at ca 638 nm in aqueous solution at pH5 Description Dark-blue powder or granules Identification A. Spectrometry Maximum in water at 638 nm at pH5 B. Blue solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 2,0% Organic compounds other than colouring matters: 3-hydroxy benzaldehyde Total not more than 0,5% 3-hydroxy benzoic acid 3-hydroxy-4-sulfobenzoic acid N,N-diethylamino benzene sulfonic acid Leuco base Not more than 4,0% Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter From a solution of pH 5 not more than 0,2% Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 132 INDIGOTINE, INDIGO CARMINE Synonyms CI Food Blue 1 Definition Indigotine consists essentially of a mixture of disodium 3,3'dioxo-2,2'-bi-indolylidene-5,5'-disulfonate, and disodium 3,3'-dioxo-2,2'-bi-indolylidene-5,7'-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted. Class Indigoid Colour Index No 73015 Einecs 212-728-8 Chemical names Disodium 3,3'-dioxo-2,2'-bi-indolylidene-5,5'-disulfonate Chemical formula C16H8N2Na2O8S2 Molecular weight 466,36 Assay Content not less than 85% total colouring matters, calculated as the sodium salt; disodium 3,3'-dioxo-2,2' bi-indolylidene-5,7'-disulfonate: not more than 18% 480 at ca 610 nm in aqueous solution Description Dark-blue powder or granules Identification A. Spectrometry Maximum in water at ca 610 nm B Blue solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Excluding disodium 3,3'dioxo-2,2'-bi-indolylidene-5,7'-disulfonate: not more than 1,0% Organic compounds other than colouring matters: Isatin-5-sulfonic acid Total not more than 0,5% 5-sulfoanthranilic acid Anthranilic acid Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/Kg E 133 BRILLIANT BLUE FCF Synonyms CI Food Blue 2 Definition Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Class Triarylmethane Colour Index No 42090 Einecs 223-339-8 Chemical names Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl) α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate. Chemical formula C37H34N2 Na2O9 S3 Molecular weight 792,84 Assay Content not less than 85% total colouring matters, calculated as the sodium salt 1 630 at ca 630 nm in aqueous solution Description reddish-blue powder or granules Identification A. Spectrometry Maximum in water at ca 630 nm B. Blue solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 6,0% Organic compounds other than colouring matters; Sum of 2,3-and 4-formyl benzene sulfonic acids Not more than 1,5% 3-((ethyl)(4-sulfophenyl amino)methyl benzene sulfonic acid Not more than 0,3% Leuco base Not more than 5,0% Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2% at pH7 Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 140 (
3. i)CHLOROPHYLLS Synonyms CI Natural Green 3, Magesium Chlorophyll, Magnesium Phaeophytin Definition Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class Porphyrin Colour Index No 75810 Einecs Chlorophylls: 215-800-7, Chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4 Chemical names The major colouring principles are: Phytyl(132-R,17S,18S)-3)(8-ethyl-132- methoxycarbonyl-2,7,12,18-tetramethyl-13'-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl] propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll
4. a)Phytyl (132-R,17S, 18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2, l2, 18-trimethyl-13'-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-
5. yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll
6. b)Chemical formula Chlorophyll a (magnesium complex): C55H72 MgN4O5 Chlorophyll a: C55H74N4O5 Chlorophyll b (magnesium complex): C55H70 MgN4O6 Chlorophyll b: C55H72N4O6 Molecular weight Chlorophyll a (magnesium complex): 893,51 Chlorophyll a: 871,22 Chlorophyll b (magnesium complex): 907,49 Chlorophyll b: 885,20 Assay Content of total combined Chlorophylls and their magnesium complexes is not less than 10% 700 at ca 409 nm in chloroform Description Waxy solid ranging in colour from olive green to dark green depending on the content of coordinated magnesium Identification Spectrometry Maximum in chloroform at ca 409 nm Purity Acetone Not more than 50 mg/kg, singly or in combination Solvent residues Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 140 (
7. ii)CHLOROPHYLLINS Synonyms CI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorphyllin Definition The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class Porphyrin Colour Index No 75815 Einecs 287-483-3 Chemical names The major colouring principles in their acid forms are: —3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-
8. yl)propionate (chlorophyllin
9. a)and —3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-
10. yl)propionate (chlorophyllin
11. b)Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function. Magnesium complexes may also be present. Chemical formula Chlorophyllin a (acid form): C34H34N4O5 Chlorophyllin b (acid form): C34H32N4O6 Molecular weight Chlorophyllin a: 578,68 Chlorophyllin b: 592,66 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved. Assay Content of total chlorophyllins is not less than 95% of the sample dried at ca 100°C for 1 hour. 700 at ca 405 nm in aqueous solution at pH9 140 at ca 653 nm in aqueous solution at pH 9 Description Dark green to blue/black powder Identification Spectrometry Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm E 140 (
12. ii)CHLOROPHYLLINS—contd. Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 141 (
13. i)COPPER COMPLEXES OF CHLOROPHYLLS Synonyms CI Natural Green 3, Copper Chlorophyll, Cooper Phaeophytin Definition Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class Porphyrin Colour Index No 75815 Einecs Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5 Chemical names [Phytyl (132R, 17S, 18S]-3(-8-ethyl-132methoxycarbonyl-2,7,12,18-tetramethyl-13'-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll
14. a)[Phytyl (132R, 17S, 18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,-12,18-trimethyl-13'-oxo-3-vinyl-13113217,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorphyll
15. b)Chemical formula Copper chlorophyll a: C55H72 Cu N4O5 Copper chlorophyll b: C55H70Cu N4O6 Molecular weight Copper chlorophyll a: 932,75 Copper chlorophyll b: 946,73 Content to total copper chlorophylls is not less than 10% Assay 540 at ca 422 nm in chloroform 300 at ca 652 nm in chloroform Description Waxy solid ranging in colour from blue green to dark green depending on the source material Identification Spectrometry Maximum in chloroform at ca 422 nm and at ca 652 nm E 141 (
16. i)COPPER COMPLEXES OF CHLOROPHYLLS—contd. Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl Ethyl ketone Methanol Ehtanol Propan-2-ol Hexane Dichloromethane: Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Copper ions Not more than 200 mg/kg Total copper Not more than 8.0% of the total copper phaeophytins E 141 (
17. ii)COPPER COMPLEXES OF CHLOROPHYLLINS Synonyms Sodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5 Definition The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralised to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Class Porphyrin Colour Index No. 75815 Einecs Chemical names The major colouring principles in their acid forms are 3-(10-Carboxylato-4-4ethyl-1, 3, 5, 8-tetramethyl-9-oxo-2-vinylphorbin-7-
18. yl)propionate, copper complex (Copper chlorophyllin
19. a)and 3-(10-Carboxylato-4-ethyl-3-formyl-1, 5, 8-trimethyl-9-oxo-2-vinylphorbin-7-
20. yl)propionate, copper complex (Copper chlorophyllin
21. b)Chemical formula Copper chlorophyllin a (acid form: C34H32 Cu N4O5 Copper chlorophyllin b (acid form: C34H32 Cu N4O6 Molecular formula Copper chlorophyllin a: 640,20 Copper chlorophyllin b: 654,18 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved. Content of total copper chlorophyllins is not less than 95% of the sample dried at 100°C for 1 hr. Assay 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5 145 at ca 603 nm in aqueous phosphate buffer at pH 7,5 Description Dark green to blue/black powder Identification Spectrometry Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at 630 nm E 141 (
22. ii)COPPER COMPLEXES OF CHLOROPHYLLINS—contd. Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Copper ions Not more than 200 mg/kg Total copper Not more than 8,0% of the total copper chlorophyllins E 142 GREEN S Synonyms CI Food Green 4, Brilliant Green BS Definition Green S consists essentially of sodium N-[4-(dimethylamino) phenyl] 2-hydroxy-3, 6-disulfo-1-naphthalenyl) methylene]-2, 5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds. Green S is described as the sodium salt. The calcium and the potassium salt are also permitted. Class Triarylmethane Colour Index No. 44090 Einecs 221-409-2 Chemical names Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]-2,5-cyclonexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene)benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name). Checial formula C27H25N2Na O7S2 Molecular weight 576,63 Assay Content not less than 80% total matters calculated as the sodium salt 1 720 at ca 632 nm in aqueous solution Description Dark blue or dark green powder or granules Identification A. Spectrometry Maximum in water at ca 632 nm B. Blue or green solution in water Purity Water insoluble matter Not more than 0,2% Subsidiary colouring matters Not more than 1,0% Organic compounds other than colouring matters: 4, 4'-bis(dimethylamino)-benzhydryl alcohol Not more than 0,1% 4, 4'-bis(dimethylamino)-benzophenone Not more than 0,1% 3-hydroxynapthalene-2,7-disulfonic acid Not more than 0,2% Leuco base Not more than 5,0% Unsulfonated primary aromatic amines Not more than 0,01% (calculated as aniline) Ether extractable matter Not more than 0,2% under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/Kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 40 mg/kg E 150a PLAIN CARAMEL Definition Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites. Einecs 232-435-9 Description Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose Not more than 50% Colour bound by phosphoryl cellulose Not more than 50% Colour intensity

(11)0,01-0,12 Total nitrogen Not more than 0,1% Total sulphur Not more than 0,2% Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 25 mg/kg1

(1)E 15Ob CAUSTIC SULPHITE CARAMEL Definition Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used. Einecs 232-435-9 Description Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose More than 50% Colour intensity

(1)0,05—0,13 Total nitrogen Not more than 0,3%

(2)Sulphur dioxide Not more than 0,2%

(2)Total sulphur 0,3—3,5%

(2)Sulphur bound by DEAE cellulose More than 40% Absorbance ratio of colour bound by DEAE 19—34 cellulose Absorbance ratio (A 280/560) Greater than 50 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 25 mg/kg

(1)Colour intensity is defined as the absorbence of a 0,1% (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

(2)Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbence units. E 150c AMMONIA CARAMEL Definition Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used. Einecs 232-435-9 Description Dark brown to black liquids or solids Purity Colour bound by DEAE cellulose More than 50% Colour bound by phosphoryl cellulose More than 50% Colour intensity

(1)0,08-0,36 Ammoniacal nitrogen Not more than 0,3%

(2)4-methylimidazole Not more than 250 mg/kg

(2)2-acetyl-4-tetrahydroxy-butylimidazole Not more than 10 mg/kg

(2)Total sulphur Not more than 0,2%

(2)Total nitrogen 0,7-3,3%

(2)Absorbance ratio of colour bound by phosphoryl cellulose 13-35 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Heavy metals (as Pb) Not more than 25 mg/kg

(1)Colour intensity is defined as the absorbence of a 0,1% (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

(2)Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbence units. E 150d SULPHITE AMMONIA CARAMEL Definition Sulphite ammonia caramel is prepared by