S.I. No. 41/1972 - Health (Colouring Matter in Food) Regulations, 1972.

S.I. No. 41 of 1972.

HEALTH (COLOURING MATTER IN FOOD) REGULATIONS, 1972.

The Minister for Health in exercise of the powers conferred on him by sections 5 , 54 and 59 of the Health Act, 1947 (No. 28 of 1947), sub-section (3) of section 38 of the Health Act, 1953 (No. 26 of 1953) and section 6 of the Health Act, 1970 (No. 1 of 1970) after consultation with the Minister for Industry and Commerce and the Minister for Agriculture and Fisheries hereby makes the following Regulations:—

PART I. PRELIMINARY AND GENERAL.

1. These Regulations may be cited as the Health (Colouring Matter in Food) Regulations, 1972.

2. These Regulations shall come into operation on the first day of September, 1972.

3. (1) In these Regulations—

"authorised officer" means an authorised officer for the purposes of Part IX of the Health Act, 1947 ;

"British Standard" means a specification published by the British Standards Institution;

"Colour Index" means the 1956 edition of the publication under that title published jointly by the Society of Dyers and Colourists, Dean House, Piccadilly, London and the American Association of Textile Chemists and Colourists, Lowell Technological Institute, Lowell, Massachusetts;

"colouring matter" includes any colouring matter which is an ingredient of any colouring compound or of any colouring and flavouring compound;

"container" includes any form of packaging of food and any wrapper or band;

"food" does not include colouring matter;

"permitted colouring matter" means any colouring matter described in the First Schedule to these Regulations, which complies with the specification in that Schedule in relation to such colouring matter, or any combination of two or more such colouring matters;

"vegetable" includes pulses.

(2) References in these Regulations to percentages shall be construed as references to percentages calculated by weight.

(3) Any reference in these Regulations to a label borne on a container shall be construed as including a reference to any legible marking on the container however effected.

4. Any reference in these Regulations to an owner or to a person in apparent charge or control of food shall in the case of food purchased from an automatic machine be construed as a reference—

(a) where the name and address of the proprietor is stated on the machine and such address is in the State, to the proprietor of the machine;

(b) in other cases, to the occupier of the premises at or on which the machine stands or to which it is affixed.

5. These Regulations shall not apply to any colouring matter, any diluent combined with any colouring matter or any food having any colouring matter in it or on it—

(a) which is intended to be exported or re-exported or

(b) which is sold for the purpose of scientific laboratory testing, if the container of any such colouring matter, diluent or food bears a label stating clearly that such colouring matter, diluent or food, as the case may be, is sold only for such purpose.

6. These Regulations shall be enforced and executed by health boards in their functional areas.

7. (1) Where a sample of any food has been certified under the Health (Sampling of Food) Regulations, 1970 ( S.I. No. 50 of 1970 ) not to comply with these Regulations, an authorised officer may seize, remove and detain such food as being food which is unfit for human consumption.

(2) With the consent in writing of the owner or person in apparent charge or control of such food 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 food in pursuance of the provisions of this article may, on giving notice in writing to the owner or person in apparent charge or control of such food of his intention to do so, apply to a Justice of the District Court for an order directing that such food be destroyed or otherwise disposed of as being food which is unfit for human consumption.

(4) A Justice 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 food 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 food which is unfit for human consumption and an authorised officer shall destroy or dispose of it accordingly.

(5) 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 food and the identity of the person from whom or the place from which any such food has been obtained and the person to whom and the place to which it has been consigned or the manner in which it has otherwise been disposed of.

(6) In this article "food" includes colouring matter.

PART II. SALE ETC. OF COLOURING MATTER AND OF FOOD CONTAINING COLOURING MATTER.

8. (1) Subject to the provisions of these Regulations a person shall not import, distribute, sell or expose for sale any colouring matter, other than a permitted colouring matter, for use in the manufacture or preparation of food.

(2) Where two or more colouring matters any of which contains arsenic, lead or copper are combined or mixed, the amount of arsenic, lead or copper permitted to be contained in such combination or mixture shall be determined by multiplying the amount of arsenic, lead or copper, as the case may be, specified in the First Schedule to these Regulations in relation to each colouring matter present in such combination or mixture, by the proportion of the total amount of such combination or mixture represented by that colouring matter and by adding together the products resulting therefrom.

9. (1) A person shall not import, distribute, sell or expose for sale any diluent combined or mixed with any colouring matter for use in the manufacture or preparation of food where such combination or mixture contains more than the amount of arsenic, lead or copper, as the case may be, specified in the First Schedule to these Regulations in relation to the colouring matter which is combined or mixed with any such diluent.

(2) If any diluent is combined or mixed with two or more colouring matters any of which contains arsenic, lead or copper, the amount of arsenic, lead or copper permitted to be contained in such combination or mixture shall be determined by multiplying the amount of arsenic, lead or copper, as the case may be, specified in the First Schedule to these Regulations in relation to each colouring matter present in such combination or mixture by the proportion of the total amount of colouring matter in such combination or mixture represented by that colouring matter and by adding together the products resulting therefrom.

10. Subject to the provisions of these Regulations a person shall not import, distribute, sell or expose for sale—

(a) any fish, game, meat or poultry which has not been treated or processed otherwise than by boning, cleaning, cutting, grinding, paring or trimming and which has in it or on it, otherwise than for the purpose of marking, any added colouring matter;

(b) processed cheese or cheese spread which has in it or on it any added colouring matter other than a permitted colouring matter within items (1) to (4) in the first column of Part III of the First Schedule to these Regulations;

(c) sage cheese or sage cheese spread which has in it or on it any added colouring matter other than a green permitted colouring matter within item (3) in the first column of Part III of the First Schedule to these Regulations;

(d) hard cheese which has in it or on it (except in or on the rind thereof) or soft cheese or whey cheese which has in it or on it any added colouring matter other than annatto or carotene or both of these substances;

(e) any fruit (except an orange) or vegetable in a raw or unprocessed state which has in it or on it (except on the husk of any nut) any added colouring matter other than a permitted colouring matter which has been added for the purpose of marking;

(f) any orange which has in it or on it any added colouring matter unless the words "colour added" are marked distinctly and legibly on the orange and the added colouring matter is a permitted colouring matter;

(g) any coffee bean, coffee essence, ground coffee, cream, milk, (except a flavoured milk drink), condensed milk, dried milk, or tea (whether in leaf or essence form) which has in it or on it any added colouring matter;

(h) any white bread or soda bread (except any such bread for use by a manufacturer for the purpose of his business) which has in it or on it any added colouring matter;

(i) any bread (other than white bread or soda bread or bread for use by a manufacturer for the purposes of his business) which has in it or on it any added colouring matter other than caramel;

(j) any other food (including the rind of cheese, the husk of any nut, any flavoured milk drink and any bread for use by a manufacturer for the purpose or his business) which has in it or on it, any colouring matter (including colouring matter in any mark however effected) which has been added to the food, other than a permitted colouring matter.

11. For purposes of this Part of the Regulations—

"bread" includes the following, and any part of any of the following, baps, bread rolls, fancy bread, milk bread, malt bread and fruit bread;

"cheese spread" means cheese which has been melted and mixed with milk products other than cheese with or without the addition of emulsifying salts;

"hard cheese" means cheese other than soft cheese, whey cheese, processed cheese or cheese spread;

"processed cheese" means cheese which has been melted and mixed with or without the addition of emulsifying salts;

"soft cheese" means cheese which is readily deformed by moderate pressure but does not include whey cheese, processed cheese or cheese spread, and any reference to soft cheese includes a reference to cream cheese or curd cheese;

"whey cheese" means the product obtained by—

(i) concentrating whey with or without the addition of milk and milk fat and moulding such concentrated whey, or

(ii) coagulating whey with or without the addition of milk and milk fat.

PART III. LABELLING AND ADVERTISING.

12. (1) Subject to the provisions of these Regulations a person shall not import, distribute, sell or expose for sale any colouring matter or any colouring compound or any colouring and flavouring compound for use as an ingredient in the preparation of food unless such colouring matter or such compound is packed in a container bearing a label in the form specified for such a label in the Second Schedule to these Regulations.

(2) Each label to which sub-article (1) of this article relates shall be securely affixed to or be part of the container and shall be so placed as to be clearly visible and if the container bears a main label shall be placed in close proximity thereto or be part thereof.

13. (1) A person shall not advertise for sale for use in food

(a) any colouring matter other than a permitted colouring matter;

(b) any permitted colouring matter in such a manner as to be likely to lead to its use or sale contrary to these Regulations.

(2) Where a person is charged with a contravention of this article, it shall be a good defence to show that the advertisement was published in such circumstances that he did not know and could not, by the exercise of reasonable care, have known that he was taking part in the publication of such advertisement.

FIRST SCHEDULE.

PERMITTED COLOURING MATTER.

PART I—COAL TAR COLOURS.

Column 1	Column 2	Column 3	Column 4
Common name of colouring matter	Scientific name of colouring matter	Colour Index Number	Specification
British Standard	"Specifications for Identity and Purity of Food Additives." (Vol. II Food Colors) issued by the Food and Agriculture Organisation of the United Nations, Rome, 1963	Other specification or compositional requirement
Amaranth ..	trisodium salt of 1-(4-sulpho-1-naphthy-lazo)-2-naphthol-3 : 6-disulphonic acid.	16185	3341:1961	—	—
Black PN (Brilliant Black BN) ..	tetrasodium salt of 8-acetamido-2-(7-sulpho-4-p-sulphophenylazo-1 -naphthylazo)-1-naphthol-3 : 5-disulphonic acid.	28440	—	Number 41	—
Black 7984 ..	tetrasodium salt of [4 (4-sulpho-1-phenylazo)-7-sulpho-l-naphthylazo]-1-hydroxy-7- amino-naphthalene-3 : 6-disulphonic acid	—	—	—	Compliance with compositional requirements contained in Part II of this Schedule
Brown FK ..	a mixture consisting essentially of the disodium salt of 1 : 3-diamino-4 : 6-di-(p-sulpho-phenylazo) benzene and the sodium salt of 2 : 4-diamino-5-(p-sulpho-phenylazo) toluene.	—	—	—	A standard of purity consistent with good manufacturing practice.
Carmoisine ..	disodium salt of 2-(4-sulpho-l-naphthylazo)-l-naphthol-4-sulphonic acid.	14720	3343 :1961	—	—
Chocolate Brown FB	the product of coupling diazotised naphthionic acid with a mixture (Colour Index Number 1232) of morin and maclurin	—	—	—	A standard of purity consistent with good manufacturing practice
Chocolate Brown HT	disodium salt of 2 : 4-dihydroxy-3 : 5-di- (4-sulpho-l-naphthylazo) benzyl alcohol.	20285	—	—	A standard of purity consistent with good manufacturing practice
Erythrosine BS	disodium or dipotassium salt of 2 : 4 : 5 : 7-tetraiodofluorescein.	45430	—	Number 25	—
Fast Red E ..	disodium salt of l-(4-sulpho-l-naphthylazo)-2-hydroxynaphthalene-6-sulphonic acid	16045	—	Number 20	—
Green S ..	sodium salt of di-(p-dimethylaminophenyl)-2-hydroxy-3:6-disulphonaphthyl-methanol anhydride.	44090	—	—	A standard for purity consistent with good manufacturing practice
Indigo Carmine (Indigotine)	disodium salt of indigotine-5 : 5"-disulphonic acid	73015	—	Number 38	—
Oil Yellow GG	a mixture of 4-phenylazoresorcinol and 4 : 6-di (phenylazo) resorcinol.	11920	—	—	A standard of purity consistent with good manufacturing practice
Oil Yellow XP	3-methyl-1-phenyl-4-(2:4-xylylazo)-5-pyrazolone	12740	—	—v	A standard of purity consistent with good manufacturing practice
Orange G ..	disodium salt of 1-phenylazo-2-naphthol-6 : 8-disulphonic acid	16230	3612 : 1963	—	—
Orange RN ..	sodium salt of 1-phenylazo-2-naphthol-6-sulphonic acid	15970	—	—	A standard of purity consistent with good manufacturing practice
Ponceau 4R ..	trisodium salt of l-(4-sulpho-l-naphthylazo)-2-naphthol-6 : 8-disulphonic acid	16255	3342 : 1961	—	—
Red 2G ..	disodium salt of 8-acetamido-2-phenylazo-1-naphthol-3 : 6-disulphonic acid	18050	3611 : 1963	—	—
Red 6B ..	disodium salt of 8-acetamido-2-pacetamido phenylazo-l-naphthol-3 : 6-disulphonic acid	18055	3780 : 1964	—	—
Red 10B ..	disodium salt of 8-amino-2-phenylazo-1- naphthol-3 : 6-disulphonic acid	17200	3610 : 1963	—	—
Red FB ..	disodium salt of 2-[4-(l-hydroxy-4-sulpho-2-naphthylazo)-3-sulphophenyl]-6-methyl-benzothiazole	14780	—	—	A standard of purity consistent with good manufacturing practice
Sunset Yellow FCF	disodium salt of 1-p-sulphophenylazo-2-naphthol-6-sulphonic acid	15985	3340 : 1961	—	—
Tartrazine ..	trisodium salt of 5-hydroxy-1-p-sulphophenyl-4-p-sulphophenylazopyrazole-3-carboxylic acid	19140	3211 : 1960	—	—
Violet BNP ..	sodium salt of 4 : 4"-di (dimethylamino)-4" -di-(p-sulphobenzylamino) triphenylmethanol anhydride.	—	—	—	A standard of purity consistent with good manufacturing practice
Yellow 2G ..	disodium salt of 1-(2 : 5-dichloro-4-sulphophenyl) -5-hydroxy-3-methyl-4p-sulphophenylazopyrazole	18965	3614 : 1963	—	—

PART II—COMPOSITIONAL REQUIREMENTS FOR THE COLOURING MATTER COMMONLY KNOWN AS BLACK 7984.

The colouring matter commonly known as Black 7984 shall comply with the following requirements:—

Inorganic impurities

1. The colouring matter shall not contain, for every kilogram of pure colouring matter—

(a) more than 1 milligram of arsenic;

(b) more than 10 milligrams of lead;

(c) more than 100 milligrams of any of the following substances, namely antimony, copper, chrome, zinc, or barium sulphate, or more than 200 milligrams of any combination of these substances.

2. The colouring matter shall not contain any detectable quantity of cadmium, mercury, selenium, tellurium, thallium or uranium, any chromate, or any soluble barium compound.

Organic impurities

3. The colouring matter shall not contain—

(a) any 2-naphthylamine, benzidine or 4-amino-diphenyl (or xenylamine), or any derivative of any of these substances;

(b) any aromatic polycyclic hydrocarbon;

(d) synthetic intermediates other than free aromatic amines in excess of 0·5 per cent of the pure colouring matter present;

(e) subsidiary colours such as isomers or homologues in excess of 4 per cent. of the pure colouring matter present;

(f) any substances extractable by diethyl ether in excess of 0·2 per cent. of the pure colouring matter present.

4. The colouring matter shall not contain more matter insoluble in water than 0·2 per cent. of the pure colouring matter present.

PART III—OTHER COLOURS.

Column 1	Column 2
	Specification
Common name or description of colouring matter	British Standard	"Specifications for Identity and Purity of Food Additives". (Vol. II. Food Colors) issued by Food and Agriculture Organisation of the United Nations, Rome, 1963.	Other specification or compositional requirement
1. Caramel .. .. .. .. .. ..	3874 : 1965	—	—
2. Carmine (the colouring matter prepared from cochineal)	3916 : 1965	—	—
3. The following colouring matters of vegetable (including pulses) origin:—
(a) any colouring matter natural to edible fruit or vegetables (including pulses) ..	—	—	A standard of purity consistent with good manufacturing practice.
(b) Alkanet .. .. .. .. ..	—	Number 5	—
(c) Annatto .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(d) Carotene .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(e) Chlorophyll .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(f) Flavine .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice
(g) Indigo .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(h) Orchil .. .. .. .. ..	—	Number 17	—
(i) Osage orange .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(j) Persian Berry .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(k) Safflower .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(l) Saffron .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(m) Sandalwood .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
(n) Turmeric .. .. .. .. ..	—	Number 14	—
(o) The pure colouring principle of any of the colouring matters mentioned in the preceding paragraphs (a) to (n) inclusive, whether isolated from such colouring matters or produced synthetically.	—	—	A standard of purity consistent with good manufacturing practice.
4. ß-apo-8"-Carotenal and the ethyl ester of ß-apo-8"-Carotenoic acid .. .. .	—	—	A standard of purity consistent with good manufacturing practice.
5. Canthaxanthin .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
6. Bole or iron oxide .. .. .. ..	—	Number 2	—
7. Carbon black .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
8. Charcoal .. .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
9. Titanium dioxide .. .. .. ..	—	—	A standard of purity consistent with good manufacturing practice.
10. Ultramarine .. .. .. .. ..	—	Number 4	—
11. Silver gold or aluminium in leaf or powder form for use solely for the external colouring of dragees and the decoration of sugar coated flour confectionery.	—	—	A standard of purity consistent with good manufacturing practice.
12. The aluminium and calcium salts (lakes) of any water-soluble colour mentioned in this Schedule.	—	—	A standard of purity consistent with good manufacturing practice.

SECOND SCHEDULE.

LABELLING OF COLOURING MATTER AND COLOURING AND FLAVOURING COMPOUNDS.

1. The label to which article 12 relates shall be in the following form or in a form substantially to the like effect:—

(a) in the case of any colouring matter alone—

FOOD COLOUR

CONTAINS

(X)

(Y)

(b) in the base of any compound substance containing colouring matter or a combination of colouring and flavouring matter—

COMPOUND CONTAINING FOOD

COLOUR

(X)

(Y)

The declaration shall in each case be completed by inserting at (X) the common name of the colouring matter present, solely or as an ingredient of any common compound substance, in the container and at (Y) a correct description of any other substance present in the preparation in the container.

2. Two or more substances declared at (Y), pursuant to paragraph 1 of this Schedule, shall appear in the order of the proportion by weight which such substances bear respectively to the total contents of the container at the time of sale by the manufacturer, the substance present in the greatest proportion by weight being specified first.

3. The label prescribed in this Schedule shall be printed distinctly and legibly in dark type upon a light-coloured ground or in light type upon a dark-coloured ground. The type used for labels on containers of quantities of not less than 4 ounces or 4 fluid ounces, as the case may be, shall be not less than one-eight of an inch in height, and the type used for labels on containers of quantities of less than 4 ounces or 4 fluid ounces, as the case may be, shall be not less than one-sixteenth of an inch in height. Every letter of every word shall be of uniform size and colour provided that the initial letter in any word may be larger than the other letters in that word.

GIVEN under the Official Seal of the Minister for Health this

17th day of February, 1972.

ERSKINE H. CHILDERS,

Minister for Health.

EXPLANATORY NOTE.

These Regulations which come into operation on 1st September, 1972, prescribe the colouring matters which may be added to food which is imported, distributed, sold or exposed for sale and limit the use of such colouring matters in or on certain named foods. They regulate the amount of arsenic, lead and copper which may be contained in permitted colouring matters and in diluents combined with such colouring matters. They also prescribe labelling requirements for colouring matters.

The Regulations provide that where a sample of food has been certified not to comply with the Regulations, an authorised officer may seize, remove and detain such food as being food which is unfit for human consumption and, in certain circumstances, destroy it.

The provisions relating to colouring matter in the Public Health (Saorstát Éireann) (Preservatives, etc., in Food) Regulations, 1928 are being revoked on 1st September, 1972 under S.I. No. 46 of 1972 .