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

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

S.I. No. 344/1995:

EUROPEAN COMMUNITIES (GENERAL PROVISIONS ON THE CONTROL OF ADDITIVES, AND IN PARTICULAR COLOURS AND SWEETENERS FOR USE IN FOODSTUFFS) REGULATIONS, 1995.

The Minister for Health in exercise of the powers conferred on him by Section 3 of the European Communities Act, 1972 (No. 27 of 1972) hereby makes the following Regulations for the purpose of giving effect to:

Council Directive 89/107/EEC⁽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, 1995.

2. These Regulations shall come into force on the 31st day of December, 1995.

3. 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).

5. ( 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.

6. 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 ) (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;

(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) (a) (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) (a) (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) (a) to (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

(i) relate to ready-to-eat foodstuffs, prepared according to the instructions for use,

(ii) refer to the quantities of colouring principle contained in the colouring preparation.

(8) For the purpose of health marking as provided in Directive 9¼97/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:

(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;

(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.

19. 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.

20. 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.

22. 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.

23. 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^{(4) (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

Sweeteners for use in Foodstuffs

EC No.	Name	Foodstuffs	Maximum usable dose
E420	Sorbitol	Desserts and similar products	quantum satis
	(i) Sorbital
	(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
	(i) Maltitol	no added sugar
	(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 (i) -- SORBITOL	D-glucitol, D-sorbitol
Definition
Chemical name	D-glucitol
Einics	200-061-5
E number	E 420 (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 (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 n 4 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 (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 (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 (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 (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 (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	(i) Riboflavin
	(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
	(i) Chlorophylls
	(ii) Chlorophyllins
E141	Copper complexes of chlorophylls and chlorophyllins	75815
	(i) Copper complexes of chlorophylls
	(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:
	(i) Mixed carotenes	75130
	(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

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 (i) Riboflavin (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 (i) Riboflavin (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 (i) Riboflavin (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:
	(i) Mixed carotenes
	(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:
	(i) Mixed carotenes
	(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 (i) Riboflavin
	(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	(i) Riboflavin
	(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 (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 (ii) (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-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-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 (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-13^1-13^2-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl] propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a) Phytyl (13²-R,17S, 18S)-3-(8-ethyl-7-formyl-13^2-methoxycarbonyl-2, l2, 18-trimethyl-13'-oxo-3-vinyl-13^1-13²-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl) propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll 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 (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-yl) propionate (chlorophyllin a) and

--3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate (chlorophyllin 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 (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 (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-13^1-13^2-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll 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 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 (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 (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-yl) propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3-formyl-1, 5, 8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin 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 (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 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 both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite)

Einecs

232-435-9

Description

Dark brown to black liquids or solids

Purity

Colour bound by DEAE cellulose

More than 50%

Colour intensity ⁽¹⁾

0,10-0,60

Ammoniacal nitrogen

Not more than 0,6% (²)

Sulphur dioxide

Not more than 0,2% (²)

4-methylimidazole

Not more than 250 mg/kg(²)

Total nitrogen

0,3-1,7% (²)

Total sulphur

0,8-2,5% (²)

Nitrogen/sulphur ratio of alcohol precipitate

0,7--2,7

Absorbance ratio of alcohol precipitate (1)

8--14

Absorbance ratio (A_280/560)

Not more 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/kg1 ² (2) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.2

E 151 BRILLIANT BLACK BN, BLACK PN

Synonyms

CI Food Black 1

Definition

Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.

Class

Bisazo

Colour Index No.

28440

Einecs

219-746-5

Chemical names

Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo]-1-naphthylazo] naphthalene-1,7-disulfonate

Chemical formula

C₂₈H₁₇N₅ Na₄O₁₄S₄

Molecular weight

867,69

Assay

Content not less than 80% total colouring matters calculated as the sodium salt

530 at ca 570 nm in solution

Description

Black powder or granules

Identification

A. Spectrometry

Maximum in water at ca 570 nm

B. Black-bluish solution in water

Purity

Water insoluble matter

Not more than 0,2%

Subsidiary colouring matters

Not more than 10%(expressed on the dye content)

Organic compounds other than colouring matters:

4-acetamido-5-hydroxynaphthalene-

Total not more than 0,8%

1,7,-disulfonic acid

4-amino-5-hydroxynaphthalene-

1,7-disulfonic acid

8-aminomphthalene-2-sulfonic acid

4,4'-diazoaminodi-(benzenesulfonic 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 153 VEGETABLE CARBON

Synonyms

Vegetable black

Definition

Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonized at high temperatures. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture

Colour Index No

77266

Einecs

215-609-9

Chemical names

Carbon

Chemical formula

Molecular weight

12,01

Content not less than 95% of carbon calculated on an anhydrous and ash-free basis

Assay

Black powder, odourless and tasteless

Description

Identification

A. Solubility

Insoluble in water and organic solvents

B. Burning

What heated to redness it burns slowly without a flame

Purity

Ash (Total)

Not more than 4,0% (ignition temperature: 625°C)

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

Polyaromatic hydrocarbons

The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1,000 ml of 0,01 M sulphuric acid

Loss on drying

Not more than 12% (120°C, 4 hrs)

Alkali soluble matter

The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless

E 154 BROWN FK

Synonyms

CI Food Brown 1

Definition

Brown FK consists essentially of a mixture of:

sodium 4-(2,4-diaminophenylazo) benzenesulfonate

sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate

III

disodium 4,4'-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

disodium 4,4'-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

disodium 4,4'(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)

trisodium 4,4',4"-(2,4-diaminobenzene-1,3,5-trisazo)tri- (benzenesulfonate) and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components

Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted

Class

Azo (a mixture of mono-, bis- and trisazo colours)

Einecs

Chemical names

A mixture of:

sodium 4-(2,4-diaminophenylazo) benzenesulfonate

sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate

III

disodium 4,4-'(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

disodium 4,4'-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

disodium 4,4'-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)

trisodium 4,4',4"-(2,4-diaminobenzene-1.3,5-trisazo)tri-(benzenesulfonate)

Chemical formula

C₁₂H₁₁N₄ NaO₃S

C₁₃H₁₃N₄ NaO₃S

III

C₁₈H₁₄N₆ Na₂O₆S₂

C₁₉H₁₆N₆ Na₂O₆S₂

C₂₄H₁₇N₈ Na₃O₉S₃

Molecular weight

314,30

328,33

III

520,46

534,47

726,59

Assay

Content not less than 70% total colouring matters

Of the total colouring matters present the proportions of the components shall not exceed:

26%

17%

III

17%

16%

20%

16%

Description

Red-brown powder or granules

Identification

Orange to reddish solution

Purity

Water insoluble matter

Not more than 0,2%

Subsidiary colouring matters

Not more than 3,5%

Organic compounds other than colouring matters:

4-aminobenzene-1-sulfonic acid m-phenylenediamine and

Not more than 0,7%

4methyl-m-phenylenediamine

Not more than 0,35%

Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamene

Not more than 0,007% (calculated as aniline)

Ether extractable matter

From a solution of pH7, 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 155 BROWN HT

Synonyms

CI Food Brown 3

Definition

Brown HT consists essentially of disodium 4,4'-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulfate as the principal uncoloured components

Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted

Class

Bisazo

Colour Index No

20285

Einecs

224-924-0

Chemical names

Disodium 4,4'-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-l-sulfonate)

Chemical formula

C₂₇H₁₈N₄ Na₂O₉S₂

Molecular weight

652,57

Assay

Content not less than 70% total colouring matters calculated as the sodium salt

403 at ca 460 nm in aqueous solution at pH 7

Description

Reddish-brown powder or granules

Identification

A. Spectrometry

Maximum in water of pH 7 at ca 460 nm

B. Brown solution in water

Purity

Water insoluble matter

Not more than 0,2%

Subsidiary colouring matters

Not more than 10% (TLC method)

Organic compounds other than colouring matters:

4-aminonaphthalene-1-sulfonic acid

Not more than 0,7%

Unsulfonated primary aromatic amines

Not more than 0,01% (calculated as aniline)

Ether extractable matter

Not more than 0,2% in a solution of pH 7

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 160a (i) MIXED CAROTENES

Synonyms

CI Food Orange 5

Definition

Mixed carotenes are obtained by solvent extraction of natural strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.

The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. α-, ¾-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.

Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane, dichloromethane and carbon dioxide

Class

Carotenoid

Colour Index No

75130

Einecs

230-636-6

Chemical names

Chemical formula

ß-Carotene: C₄₀H₅₆

Molecular weight

ß-Carotene: 536,88

Assay

Content of carotenes (calculated as ß-carotene) is not less than 5%. For products obtained by extraction of vegetables oils: not less than 0,2% in edible fats

2 500 at ca 440-457 nm in cyclohexane

Identification

Spectrometry

Maximum in cyclohexane at 440-457 nm and 470 nm-486 nm

Purity

Solvent residues

Acetone

Not more than 50 mg/kg, singly or in combination

Methylethylketone

Methanol

Propan-2-ol

Hexane

Ethanol

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 160a (ii) BETA-CAROTENE

Synonyms

CI Food Orange 5

Definition

These specifications apply predominantly to all trans isomer of ß-carotene together with minor amounts of other carotenoids. Diluted and stabilized preparations may have different cis/trans isomer ratios

Class

Carotenoid

Colour Index No

40800

Einecs

230-636-6

Chemical names

ß-Carotene, ß,ß-Carotene

Chemical formula

C₄₀H₅₆

Molecular weight

536,88

Assay

Not less than 96% total colouring matters (expressed as ß-carotene)

2 500 at ca 453-456 nm in cyclohexane

Description

Red to brownish-red crystals or crystalline powder

Identification

Spectrometry

Maximum in cyclohexane at ca 453-456 nm

Purity

Sulphated ash

Not more than 0,2%

Subsidiary colouring matters

Carotenoids other than ß-carotene: not more than 3,0% of total colouring matters

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 160b ANNATTO, BIXIN, NORBIXIN

Synonyms

CI Natural Orange 4

Definition

Class

Carotenoid

Colour Index No

75120

Einecs

Annatto:

215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7

Chemical names

Bixin:

6'-Methylhydrogen-9'-cis-6,6'-diapocarotene-6,6-dioate

6'-Methylhydrogen-9'-trans-6,6-diapocarotene-6,6'-dioate

Norbixin:

9'Cis-6,6'-diapocarotene-6,6'-dioic acid

9'-Trans-6,6-'diapocarotene-6-6'-dioic acid

Chemical formula

Bixin:

C₂₅H₃₀O₄

Norbixin:

C₂₄H₂₈O₄

Molecular weight

Bixin:

394,51

Norbixin:

380,48

Description

Reddish-brown powder, suspension or solution

Identification

Spectrometry

Bixin: maximum in chloroform at ca 502 nm

Norbixin: maximum in dilute KOH solution at ca 482 nm

E 160b ANNATTO, BIXIN, NORBIXIN--contd.

(i) SOLVENT EXTRACTED BIXIN AND NORBIXIN

Definition

Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent

Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin Bixin and norbixin may contain other materials extracted from the annatto seed.

The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.

The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present

Assay

Content of bixin powders not less than 75% total carotenoids calculated as bixin

Content of norbixin powders not less than 25% total carotenoids calculated as norbixin

Bixin: 2 870 at ca 502 nm in chloroform

Norbixin: 2 870 at ca 482 nm in KOH solution

Purity

Solvent residues

Acetone

Not more than 50 mg/kg, singly or in combination

Methanol

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 160b ANNATTO, BIXIN, NORBIXIN--contd.

(ii) ALKALI EXTRACTED ANATTO

Definition

Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L) Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present

Assay

Contains not less than 0,1% of total carotenoids expressed as norbixin

Norbixin: 2 870 at ca 482 nm in KOH solution

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 160b ANNATTO, BIXIN, NORBIXIN--contd.

(iii) OIL EXTRACTED ANNATTO

Definition

Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and trans-forms. Thermal degradation products of bixin may also be present

Assay

Contains not less than 0,1% of total carotenoids expressed as bixin

Bixin: 2 870 at ca 502 nm in chloroform

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 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN

Synonyms

Paprika Oleoresin

Definition

Paprika extract is obtained by solvent extraction of the natural strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.

Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate and carbon dioxide

Class

Carotenoid

Einecs

Capsanthin: 207-364-1, capsorubin: 207-425-2

Chemical names

Capsanthin: (3R, 3'S, 5'R)-3,3',-dihydroxy-ß,k-carotene-6--one

Capsorubin: (3S, 3'S, 5R, 5R')3,3'dihydroxy-k,k-carotene-6,6'-dione

Chemical formula

Capsanthin: C₄₀H₅₆O₃

Capsorubin: C₄₀H₅₆O₄

Molecular weight

Capsanthin: 584,85

Capsorubin: 600,85

Assay

Paprika extract: content not less than 7,0% carotenoids

Capsanthin/capsorubin: not less than 30% of total carotenoids

2 100 at ca 462 nm in acetone

Description

Dark-red viscous liquid

Identification

A. Spectrometry

Maximum in acetone at ca 462 nm

B. Colour reaction

A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform

E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN--contd.

Purity

Ethyl acetate

Not more than 50 mg/kg, singly or in combination

Solvent residues

Methanol

Ethanol

Acetone

Hexane

Dichloromethane: Not more than 10 mg/kg

Capsaicin

Not more than 250 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 160d LYCOPENE

Synonyms

Natural Yellow 27

Definition

Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes.

Class

Carotenoid

Colour Index No

75125

Chemical names

Lycopene, ψ,ψ-carotene

Chemical formula

C₄₀H₅₆

Molecular weight

536,85

Assay

Content not less than 5% total colouring matters

3 450 at ca 472 nm in hexane

Description

Dark red viscous liquid

Identification

Spectrometry

Maximum in hexane at ca 472 nm

Purity

Solvent residues

Ethyl acetate

Not more than 50 mg/kg, singly or in combination

Methanol

Ethanol

Acetone

Hexane

Propan-2-ol

Dichloromethane: Not more than 10 mg/kg

Sulphated ash

Not more than 0,1%

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 160e BETA-APO-8'-CAROTENAL (C30)

Synonyms

CI Food Orange 6

Definition

These specifications apply to predominantly all trans isomer of ß-apo-8'-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from ß-apo-8'-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8' carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

Class

Carotenoid

Colour Index No

40820

Einecs

214-171-6

Chemical names

ß-P-Apo-8'-carotenal, Trans-ß-apo-8' carotene-aldehyde

Chemical formula

C₃₀H₄₀O

Molecular weight

416,65

Assay

Not less than 96% of total colouring matters

2 640 at 460--462 nm in cyclohexane

Description

Dark violet crystals with metallic lustre or crystalline powder

Identification

Spectrometry

Maximum in cyclohexane at 460-462 nm

Purity

Sulphated ash

Not more than 0,1%

Subsidiary colouring matters

Carotenoids other than ßapo8'-carotenal: not more than 3,0% of total colouring matters

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 10 mg/kg

E 160f ETHYL ESTER OF BETA -APO-8'-CAROTENOIC ACID (C30)

Synonyms

CI Food Orange 7, ß-apo-8'-carotenoic ester

Definition

These specifications apply to predominantly all trans isomer of ß-apo-8'-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from ß-apo-8'-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of ß-apo-8'-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

Class

Carotenoid

Colour Index No

40825

Einecs

214-173-7

Chemical names

ß-Apo-8'-carotenoic acid ethyl ester, ethyl 8'-apo-ß-caroten-8'-oate

Chemical formula

C₃₂H₄₄O₂

Molecular weight

460,70

Assay

Not less than 96% of total colouring matters

2 550 at ca 449 nm in cyclohexane

Description

Red to violet-red crystals or crystalline powder

Identification

Spectrometry

Maximum in cyclohexane at ca 449 nm

Purity

Sulphated ash

Not more than 0,1%

Subsidiary colouring matters

Carotenoids other than ß-apo-8'-carotenoic acid ethyl ester: not more than 3,0% of total colouring matters

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 161b LUTEIN

Synonyms

Mixed Carotenoids, Xanthophylls

Definition

Lutein is obtained by solvent extraction of the natural strains of edible fruits and plants, grass, lucerne (alfalfa) and tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material

Only the following solvents may be used for the extraction: methanol, ethanol, propan-2--ol, hexane, acetone, methyl ethyl ketone, dichloromethane and carbon dioxide

Class

Carotenoid

Einecs

204-840-0

Chemical names

3,3'-dihydroxy-d-carotene

Chemical formula

C₄₀H₅₆O₂

Molecular weight

568,88

Assay

Content of total colouring matter not less than 4% calculated as lutein

2 550 at ca 445 nm in chloroform/ethanol (10+90) or in hexane/ethanol/acetone (80 + 10 + 10)

Description

Dark, yellowish brown liquid

Identification

Spectrometry

Maximum in chloroform/ethanol (10 + 90) at ca 445 nm

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 161g CANTHAXANTHIN

Synonyms

CI Food Orange 8

Definition

These specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

Class

Carotenoid

Colour Index No

40850

Einecs

208-187-2

Chemical names

ß-Carotene-4,4'-dione, canthaxanthin, 4,4'--dioxo-ß-carotene

Chemical formula

C₄₀H₅₂O₂

Molecular weight

564,86

Assay

Not less than 96% of total colouring matters (expressed as canthaxanthin)

2 200 at ca 485 nm in chloroform

at 468--472 nm in cyclohexane

at 464--467 nm in petroleum ether

Description

Deep violet crystals or crystalline powder

Identification

Spectrometry

Maximum in chloroform at ca 485 nm

Maximum in cyclohexane at 468--472 nm

Maximum in petroleum ether at 464---467 nm

Purity

Sulphated ash

Not more than 0,1%

Subsidiary colouring matters

Carotenoids other than canthaxanthin: Not more than 5,0% of total colouring matters

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 162 BEETROOT RED, BETANIN

Synonyms

Beet Red

Definition

Beet red is obtained from the roots of natural strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75--95%. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.

Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins

Class

Betalaine

Einecs

231-628-5

Chemical names

(S-(R',R')-4-(2-(2-Carboxy-5-(ß-D-glycilolsglucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-l-yl)-ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-ß-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate

Chemical formula

Betanin: C₂₄H₂₆N₂O₁₃

Molecular weight

550,48

Assay

Content of red colour (expressed as betanine) is not less than 0,4%

1 120 at ca 535 nm in aqueous solution at pH 5

Description

Red or dark red liquid, paste, powder or solid

Identification

Spectrometry

Maximum in water of pH 5 at ca 535 nm

Purity

Nitrate

Not more than 2 g nitrate anion/g of red colour (as calculated from assay)

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 163 ANTHOCYANINS

Definition

Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals, etc., but not necessarily in the same proportions as found in the source material

Class

Anthocyanin

Einecs

208-438-6 (cyanidin); 205-125-6 (peonidin); 208-4-370 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)

Chemical names

3,3',4',5,7- Pentahydroxy-flavylium chloride (cyanidin)

3,4',5,7-Tetrahydroxy-3'-methoxyflavylium chloride (peonidin)

3,4',5,7,-Tetrahydroxy-3',5'-dimethoxyflavylium chloride (malvidin)

3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)--1-benzopyrylium chloride (delphinidin)

3,3'4',5,7 Pentanydroxy-5'-methoxyflavylium chloride (petunidin)

3,5,7-Trihydroxy-2-(4-hydroxyphenyl)--1-benzopyrilium chloride (pelargonidin)

Chemical formula

Cyanidin: C₁₅H₁₁O₆C₁

Peonidin: C₁₆H₁₃O₆C₁

Malvidin: C₁₇H₁₅O₇C₁

Delphinidin: C₁₅ H ₁₁O₇C₁

Petunidin: C₁₆H₁₃O₇C₁

Pelargonidin: C₁₅H₁₁O₅C₁

Molecular weight

Cyanidin: 322,6

Peonidin: 336,7

Malvidin: 366,7

Delphinidin: 340,6

Petunidin: 352,7

Pelargonidin: 306,7

Assay

300 for the pure pigment at 515--535 nm at pH3,0

E 163 ANTHOCYANINS--contd.

Description

Purplish-red liquid, powder or paste, having a slight characteristic odour

Identification

Spectrometry

Maximum in methanol with 0,01% conc. HC1

Cyanidin: 535 nm

Peonidin: 532 nm

Malvidin: 542 nm

Delphinidin: 546 nm

Petunidin: 543 nm

Pelargonidin: 530 nm

Purity

Solvent residues

Methanol

Not more than 50 mg/kg, singly or in combination

Ethanol

Sulphur dioxide

Not more than 1 000 mg/kg per percent pigment

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 170 CALCIUM CARBONATE

Synonyms

CI Pigment White 18, Chalk

Definition

Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.

Class

Inorganic

Colour Index No.

77220

Einecs

Calcium carbonate: 207-439-9

Limestone: 215-279-6

Chemical names

Calcium carbonate

Chemical formula

CaCO₃

Molecular weight

100,1

Assay

Content not less than 98% on the anhydrous basis

Description

White Crystalline or amorphous, odourless and tasteless powder

Identification

Solubility

Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solution, after boiling, give positive tests for calcium.

Purity

Loss on drying

Not more than 2,0% (200°C, 4 hours)

Acid-insoluble substances

Not more than 0,2%

Magnesium and alkali salts

Not more than 1,5%

Flouride

Not more than 50 mg/kg

Antimony (as Sb)

Not more than 100 mg/kg, singly or in combination

Copper (as Cu)

Chromium (as Cr)

Zinc (as Zn)

Barium (as Ba)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Cadmium

Not more than 1 mg/kg

E 171 TITANIUM DIOXIDE

Synonyms

CI Pigment White 6

Definition

Titanium Dioxide consists essentially of pure anatase titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.

Class

Inorganic

Colour Index No.

77891

Einecs

236-675-5

Chemical names

Titanium dioxide

Chemical formula

TiO₂

Molecular weight

79,88

Assay

Content not less than 99% on an alumina and silica-free basis

Description

Amorphous white powder

Identification

Solubility

Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid.

Purity

Loss on drying

Not more than 0,5% (105°C, 3 hours)

Loss on ignition

Not more than 1,0% on a volatile matter free basis (800°C)

Aluminium oxide and/or silicon dioxide

Total not more than 2,0%

Matter soluble in 0,5N HCI

Not more than 0,5% on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5% on the basis of the product as sold.

Water soluble matter

Not more than 0,5%

Cadmium

Not more than 1 mg/kg

Antimony

Not more than 50 mg/kg by total dissolution

Arsenic

Not more than 3 mg/kg by total dissolution

Lead

Not more than 10 mg/kg by total dissolution

Mercury

Not more than 1 mg/kg by total dissolution

Zinc

Not more than 50 mg/kg by total dissolution

E 172 IRON OXIDES AND IRON HYDROXIDES

Synonyms

Iron Oxide Yellow: CI Pigment Yellow 42 and 43

Iron Oxide Red: CI Pigment Red

101 and 102

Iron Oxide Black: CI Pigment

Black 11

Definition

Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.

Class

Inorganic

Colour Index No.

Iron Oxide Yellow: 77492

Iron Oxide Red: 77491

Iron Oxide Black: 77499

Einecs

Iron Oxide Yellow: 257-098-5

Iron Oxide Red: 215-168-2

Iron Oxide Black: 235-442-5

Chemical names

Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide

Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide

Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide

Chemical formula

Iron Oxide Yellow: FeO(OH)·xH₂O

Iron Oxide Red: Fe₂O₃

Iron Oxide Black: FeO.Fe₂O₃

Molecular weight

88,85: FeO (OH)

159,70: Fe₂O₃

231,55: FeO. FeO₃

Assay

Yellow not less than 60%, red and black not less than 68% total iron, expressed as iron

Description

Powder; yellow, red, brown or black in hue

Identification

Solubility

Insoluble in water and in organic solvents

Soluble in concentrated mineral acids

Purity

Water soluble matter

Not more than 1,0%

By total dissolution

Arsenic

Not more than 5 mg/kg

Barium

Not more than 50 mg/kg

Cadmium

Not more than 5 mg/kg

Chromium

Not more than 100 mg/kg

Copper

Not more than 50 mg/kg

Lead

Not more than 20 mg/kg

Mercury

Not more than 1 mg/kg

Nickel

Not more than 200 mg/kg

Zinc

Not more than 100 mg/kg

E 173 ALUMINIUM

Synonyms

CI Pigment Metal, AI

Definition

Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.

Colour Index No.

77000

Einecs

231-072-3

Chemical names

Aluminium

Chemical formula

Atomic weight

26,98

Assay

Not less than 99% calculated as AI on an oil-free basis

Description

A silvery grey powder or tiny sheets

Identification

Solubility

Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium

Purity

Loss on drying

Not more than 0,5% (105°C, to constant weight)

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 174 SILVER

Synonyms

Argentum, Ag

Class

Inorganic

Colour Index No.

77820

Einecs

231-131-3

Chemical name

Silver

Chemical formula

Atomic weight

107,87

Assay

Content not less than 99,5% Ag

Description

Silver-coloured powder or tiny sheets

E 175 GOLD

Synonyms

Pigment Metal 3, Aurum, Au

Class

Inorganic

Colour Index No.

77480

Einecs

231-165-9

Chemical name

Gold

Chemical formula

Atomic weight

197,0

Assay

Content not less than 90% Au

Description

Gold-coloured powder or tiny sheets

Purity

Silver

Not more than 7%

After complete dissolution

Copper

Not more than 4%

E 180 LITHOLRUBINE BK

Synonyms

CI Pigment Red 57, Rubinpigment, carmine 6B

Definition

Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulfate as the principal uncoloured components.

Class

Monoazo

Colour Index No.

15850:1

Einecs

226-109-5

Chemical names

Calcium 3-hydroxy-4-)4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate

Chemical formula

C₁₈H₁₂ CaN₂O₆S

Molecular weight

424,45

Assay

Content not less than 90% total colouring matters

200 at ca 442 nm in dimethylformamide

Description

Red powder

Identification

A. Spectrometry

Maximum in dimethylformamide at ca 442 nm

Purity

Subsidiary colouring matters

Not more than 0,5%

Organic compounds other than colouring matters:

2 Amino-5-methylbenzene-sulfonic acid, calcium salt

Not more than 0,2%

3-hydroxy-2-naphthalenecar-boxylic acid, calcium salt

Not more than 0,4%

Unsulfonated primary aromatic amines

Not more than 0,01% (expressed 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

GIVEN under the Official Seal of the Minister for Health, this 19th day of December, 1995.

MICHAEL NOONAN,

Minister for Health.

EXPLANATORY NOTE

These Regulations implement the Directives on food additives generally and on colours and sweeteners in particular, which are listed below.

Council Directive 89/107/EEC⁽¹⁾ on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption.

⁽¹⁾OJ No. L40, 11.2.89, pp 27-33

European Parliament and Council Directive 94/35/EC⁽²⁾on sweeteners for use in foodstuffs.

⁽²⁾OJ No. L237, 10.9.94, pp 3-12

European Parliament and Council Directive 94/36/EC⁽³⁾ on colours for use in foodstuffs.

⁽³⁾OJ 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⁾OJ 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⁾OJ No. L226 22.9.95, pp 1-45

All food additives must comply with the provisions in Part I of the Regulations while, in addition, sweeteners and colours used as food additives must comply with the provisions in Parts II and III respectively.

These Regulations, cited as the European Communities (General Provisions on the Control of Additives, and in particular Colours and Sweeteners for use in Foodstuffs) Regulations, 1995 come into effect on 31st December 1995.

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

(1) Absorbance ratio of alcohol precipitate is defuned as the absorbance of the precipitate at 280 nm dividend by the absorbance at 560 nm (1 cm cell).

Irish Statutory Instruments

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