S.I. No. 336/1981 - Health (Colouring Agents in Food) (Amendment) Regulations 1981.

The Minister for Health in exercise of the powers conferred on her 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) and after consultation with the Minister for Industry and Energy, the Minister for Trade, Commerce and Tourism and the Minister for Agriculture hereby makes the following Regulations:—

1. These Regulations may be cited as the Health (Colouring Agents in Food) (Amendment) Regulations, 1981.

2. In these Regulations—

“the Principal Regulations” means the Health (Colouring Agents in Food) Regulations, 1973 ( S.I. No. 149 of 1973 ).

3. These Regulations shall come into operation on the 1st day of October, 1981.

4. The Principal Regulations as amended by article 3 of the Health (Colouring Agents in Food) (Amendment) Regulations, 1978 ( S.I. No. 140 of 1978 ) are hereby amended by the substitution for the First Schedule to the Principal Regulations of the Schedule to these Regulations.

5. The Principal Regulations are amended by the addition to Part I of the Second Schedule to the said Regulations of the substances listed hereunder, subject to the restrictions specified on the use of these substances:

Substance	Restrictions on use
Carageenan	For use only with the colours listed in Part I of the Schedule to these Regulations under Serial Numbers E 160 and E 161.
Gum Arabic	For use only with the colours listed in Part I of the Schedule to these Regulations under Serial Numbers E 160 and E 161.

SCHEDULE

“FIRST SCHEDULE

PART I

PERMITTED COLOURING MATTER

In this Schedule the description of the colouring matter shall be taken to include, whether listed or not, the acid form of the colouring matter and its sodium, calcium, potassium and aluminium salts (lakes).

Serial Number	Name of Colour		Colour Index Number	Scientific Name or Description
E 100	Curcumin		75300	1, 7-Bis-(4-hydroxy-3-methoxyphenyl) hepta-1, 6-diene-3,5-dione
E 101	Riboflavin or		—	6,7-Dimethy1-9-(D-1¹-ribityl) isoalloxazine.
—	Riboflavin-5'-phosphate		—	Phosphate ester of Riboflavin.
E 102	Tartrazine		19140	Trisodium salt of 5-hydroxy-1-p-sulphophenyl-4-p-sulphophenyl-azopyrazole-3-carboxylic acid.
E 104	Quinoline Yellow		47005	Sodium salt of a mixture of the mono- and disulphonic acids (mainly the latter) of quinophthalone or 2-quinolylindanedione.
—	Yellow 2G		18965	Disodium salt of 1-(2,5-dichloro-4-sulphophenyl-5-hydroxy-3-methyl-4-p sulphophenylazopyrazole.
E 110	Sunset Yellow FCF or Orange Yellow S		15985	Disodium slat of 1-p-sulphophenylazo-2-naphthol-6-sulphonic acid.
E 120	Cochineal or Carminic		75470	extract of Coccus Cacti (ammonium salts are included)
E 122	Carmoisine or Azorubine		14720	Disodium salt of 2-(4-sulphol-1-naphthylazo)-1-naphthol-4-sulphonic acid.
E 123	Amaranth		16185	Trisodium salt of 1-(4-sulpho-1-naphthylazo)-2-naphthol-6,8-disulphonic acid.
E 124	Ponceau 4R or Cochin-		16255	Trisodium salt of 1-(4-sulpho-1-naphthylazo)-2-naphthol-6,8-disulphonic acid.
E 127	Erythrosine		45430	Disodium salt of 2, 4, 5, 7-tetraiodofluorscein.
—	Red 2G		18050	Disodium salt of 5-acetamido-4-hydroxy-3-phenylazonaphthalene-2,7-disulphonic acid.
E 131	Patent Blue V		42051	Calcium salt of the disulphonic acid of m-hydroxytetraethyl diaminotriphenyl-carbinol anhydride
E 132	Indigo Carmine or Indigotine		73015	Disodium salt of indigotin-5,5'-disulphonic acid.
—	Brilliant Blue FCF		42090	Disodium salt of 4', 4”-di-(N-ethyl-3-sulphon-atobenzylamino) triphenyl-methylium-2-sulphonic acid.
E 140	Chlorophylls		75810	Chlorophyll a: Magnesium complex of 1, 3, 5, 8-tetramethyl-4-ethyl-2-vinyl-9-oxo-10-methoxycarbonylphorbin-7-propionic acid phytyl ester.
				Chlorophyll b: Maggnesium complex of 1, 5, 8-trimethyl-4-ethyl-2-vinyl-3-formyl-9-oxo-10-methoxycarbonylph-orbin-7-propionic acid phytyl ester.
E 141	Copper complexes of chlorophyll and chlorophyllins		75810	Copper chlorophyll complex and copper chlorophyllin complex.
E 142	Green S or Acid Brilliant Green BS, or Lissamine Green		44090	Sodium salt of 4, 4-bis (dimethyl-amino) diphenyl-methylene-2-naphthol-3, 6-sulphonic acid.
—	Brown FK		—	mixture of: Sodium 2', 4'-diaminoazobenzene-4-sulphonate (I) Sodium 2', 4'-diamino-5'-methylazobenzene-4-sulphonate (II) Disodium 4,4'-(4,6-diamino-1,3-phenyl-enebisazo) dibenzene-sulphonate (III). Disodium 4.4'-(2,4-diamino-1,3-phenyl-enebisazo) dibenzene-sulphonate (IV). Disodium 4,4' -(2,4- diamino-5-methyl- 1,3-phenylenebisazo dibenzenesulphonate (V). Trisodium 4,4',4” -(2,4-diaminobenzene-1,3,5-triazo) tribenzenesulphonate (VI).
—	Chocolate Brown HT		20285	Disodium 4,4-(2,4-dihydroxy-5-hydroxy-methyl-1, 3-phenylene-bisazo) di (naphthalene-1-sulphonate).
E 150	Caramel		—	products obtained exclusively by heating sucrose or other edible sugars; or water soluble amorphous products, of a brown colour, obtained by the controlled action of heat on edible sugars in the presence of one or more of the following chemical compounds:
				— acetic acid, citric acid, phosphoric acid, sulphuric acid, sulphorous acid or sulphur dioxide.
				— Ammonium-, sodium-,potassium hydroxide or gaseous ammonia.
				— Ammonium-, sodium-, potassium carbonates, phosphates, sulphates or sulphites.
E 151	Black PN or Brilliant Blue BN		28440	Tetrasodium salt of 8-acetamido-2-(7-sulpho- 4-p-sulphophenylazo-1-naphthylazo)-1-naphthol-3,5-disulphonic acid.
E 153	Vegetable carbon or Carbo medicinalis vegetalis			Vegetable charcoal having the same properties as medicinal charcoal.
E 160	Carotenoids
	(a) alpha-, beta- and gamma-carotene		75130	products predominantly in the trans form.
	(b) Annatto, Bixin, Norbixin		75120	Bixin is the principal colouring of oil extracts of Annatto and Norbixin the alkaline salt of which is the principal colouring of aqueous extracts of Annatto
	(c) capsanthin or capsorbin		—	Paprika extract.
	(d) lycopene		75125	Products predominantly in the trans form.
	(e) Beta-apo-8'-carotenal (C30)		40820	Products predominantly in the trans form.
	(f) Ethyl ester of beta-apo-8'-carotenoic acid (C30)		40825	Products predominantly in the trans form.
E 161	Xanthophylls:			The ketonic and/or hydroxylic derivatives of carotenes.
	(a) Flavoxanthin
	(b) Lutein
	(c) Kryptoxanthin
	(d) Rubixanthin		75135
	(e) Violaxanthin
	(f) Rhodoxanthin
	(g) Canthaxanthin		40850
E 162	Beetroot red or Betanin		—	Aqueous extract of red beetroots.
E 163	Anthocyanins		—	Anthocyanins are glycosides of 2-phenyl-benzo-pyrylium salts, most are hydroxyl-derivatives. They include the following: non-glyconated anthocyanidins; pelargonidin; cyanidin; peonidin; delphinidin; petunidin; malvidin. The anthocyanins may be obtained only from edible fruit or vegetables such as strawberries, mulberries, cherries, plums, raspberries, blackberries, black currants, red currants, red cabbage, red onions, cranberries, myrtles, aubergines, grapes and elderberries.
	The following natural substances having a secondary colouring effect:
	(a) paprika		—
	(b) turmeric		75300
	(c) saffron		75100
	(d) sandalwood
	(e) the pure colouring principle of any of the colouring matters listed under (a) to (d) above.
E 170	Calcium carbonate		77220
E 171	Titanium Dioxide		77891
E 172	Iron oxides and hydroxides		77489
			77491
			77492
			77499
E 173 E 174 E 175	Aluminium Silver Gold	(restricted for use only in colouring the surface of dragees and for the decoration of sugar-coated flour confectionery)	77000 — 77480
E 180	Pigment Rubine (lithol rubine BK) (restricted for use only in colouring rinds of hard cheese).		15850	only the calcium and aluminium salts of 3- hydroxy-4-(2-sulpho-p-tolylazo)-2-naphthoic acid.
—	Methyl Violet (restricted for use only in marking citrus fruit and raw and unprocessed meat)		42535	Mixture of the hydrochlorides of the more highly methylated pararosanilines containing principally the N-tetra-, penta-, and hexa methyl derivatives.

PART II

GENERAL PURITY CRITERIA

Unless otherwise provided in the specific criteria in Part III of this Schedule the colouring matters referred to in Part I of this Schedule shall comply with the following criteria of purity:-

1. Inorganic Impurities:

(a) They shall not contain more than 5 mg per kg of arsenic and not more than 20 mg per kg of lead.

(b) They shall not contain more than 100 mg per kg of any one of the following substances: antimony, copper, chromium, zinc or barium sulphate or more than 200 mg per kg of any combination of these substances.

(c) They shall not contain cadmium, mercury, selenium, tellerium, thallium, uranium or chromates or soluble barium compounds in detectable quantities.

2. Organic Impurities:

(a) They shall not contain 2-naphthylamine, benzidine, 4-aminodiph-enyl (or xenylamine) or their derivatives.

(b) they shall not contain polycyclic aromatic hydrocarbons.

(d) Synthetic organic colouring matters shall not contain more than 0.5% of synthetic intermediates other than free aromatic amines.

(e) Synthetic organic colouring matters shall not contain more than 4% of subsidiary colours (isomers, homologues, etc.).

(f) Sulphonated organic colouring matters shall not contain more than 0.2% of substances extractable by diethyl ether.

PART III

SPECIFIC PURITY CRITERIA

E 101 Riboflavin (Lactoflavin):

Lumiflavin: Prepare ethanol-free chloroform as follows: Shake 20 ml of cholroform with 20 ml of water gently but carefully for 3 minutes and allow time to separate. Draw off the cholorform layer and repeat the extraction twice using 20 ml each time. Finally, filter the cholroform through dry filter paper, shake the filtrate well for 5 minutes with 5g of powdered anhydrous sodium sulphate, leave the mixture to stand for 2 hours and decant or filter the clear chloroform. Shake 25 mg of riboflavin with 10 ml of the ethanol-free cholorform for 5 minutes and filter. The colour of the filtrate shall not be more intense than that of an aqueous solution obtained by diluting 3 ml of O.IN potassium dichromate to 1,000 ml.

Riboflavin-5' -phosphate Chemical description	Riboflavin-5'-phosphate (riboflavin 5'- (sodium phosphate)) consists primarily of the monosodium salt of the 5'-monoph- osphate ester of riboflavin. It also contains small amounts of unesterified riboflavin, other riboflavin phosphate esters and the disodium salt of riboflavin 5'-monophos- phate ester.
Description	Orange-yellow powder, practically odourless and with a less bitter taste in solution than unesterified riboflavin.
Content	Not less than 70% and not more than 75% of total (free and esterified) riboflavin, caluclated as riboflavin, determined by fluorescence at 460 nm.
Free riboflavin	Not more than 6.0%.
Specific rotation, [α] 20°C D of material dried at 100°C for 5 hours in vacuo over phosphorus pentoxide.	Not less than + 38° and not more than + 42° using a 1.5% weight/volume solution in 20% weight/volume hydrochloric acid.
Volatile matter	Not more than 8.0% after drying at 100°C for 5 hours in vacuo over phosphorus pentoxide.
Inorganic phosphate	Not more than 1.0% caluclated as PO₄, on a volatile matter-free basis.
Sulphated Ash	Not more than 25%.
pH of a 1 % weight/volume solution	Not less than 5.0 and not more than 6.5
Lumiflavin	Not more than 250 mg per kg.

E 102 Tartrazine:

Water-insoluble matter: not more than 0.2%.

Subsidiary colours: not more than 1%.

E 104 Quinoline Yellow:

Water-insoluble matter: not more than 0.2%.

— Yellow 2G:

Water-insoluble matter: not more than 0.1%.

Subsidiary colours: not more than 2%.

E 110 Sunset Yellow FCF (Orange Yellow S):

Water-insoluble matter: not more than 0.2%.

E 120 Cochineal or Carminic Acid:

Paper chromatography: with a solution of 2 g of trisodium citrate in 100 ml of a 5% solution of ammonium hydroxide (ammonium solution), cochineal shall give only a single spot in the alkaline zone.

E 122 Carmoisine or Azorubine:

Water-insoluble matter: not more than 0.2%.

Subsidiary colours: not more than 1%.

E 123 Amaranth:

Water-insoluble matter: not more than 0.2%.

E 124 Ponceau 4R or Cochineal Red:

Water-insoluble matter: not more than 0.2%.

E 127 Erythrosine:

Water-insoluble matter: not more than 0.2%.

Mineral iodides: not more than 1,000 mg/kg (evaluated as sodium iodide).

Subsidiary colours: not more than 3%.

Fluorescein: no detectable trace.

— Red 2G:

Water-insoluble material: not more than 0.1%.

Subsidiary colours: not more than 2%.

E 131 Patent Blue V:

Water-insoluble matter: not more than 0.5%.

Chromium (expressed as Cr): not more than 20 mg per kg.

Subsidiary colours: not more than 1%.

E 132 Indigo Carmine Indigotine:

Water-insoluble matter: not more than 0.2%.

Subsidiary colours: not more than 1%.

Isatin sulphonic aicd: not more than 1%.

Disodium salt of indigotin -5,5' -disulphonic acid: Not more than 20%.

— Brilliant Blue FCF:

Water-insoluble matter: not more than 0.2%.

Subsidiary colours: not more than 7%.

Leuco base: not more than 6%.

Free aromatic amines: not more than 0.35%.

Synthetic intermediates (other than free aromatic amines): not more than 2%.

Diethyl ether extract: not more than 0.4%.

E 141 Copper complexes of chlorophyll and chlorophyllins.

A 1% solution of copper-chlorophyll complex in turpentine shall not be turbid and shall not give a sediment.

Copper (free ionisable Cu): not more than 200 mg per kg.

E 142 Green S or Acid Brilliant Green BS or Lissamine Green:

Water-insoluble matter: not more than 0.2%.

Subsidiary colours: not more than 1%.

— Brown FK:

Water-insoluble matter: not more than 0.2%.

Subsidiary colours: not more than 5%.

Free aromatic amines (calculated as 1, 3 phenylenediamine): not more than 0.5%.

Synthetic intermediates (other than free aromatic amines): not more than 1.0%.

Component I:	Not more than 26%	The components are as identified in Part I of the First Schedule.
Component II:	not more than 17%
Component III:	not more than 17%
Component IV:	not more than 16%
Component V:	not more than 20%
Component VI:	not more than 16%

— Chocolate Brown HT:

Water-insoluble matter: not more than 0.2%.

Subsidiary colour (which shall consist principally of the monosodium salt of 4-(a, 2,4-Trihydroxy-m-tolylazo) naphthalene-1-sulphonic acid).

Synthetic intermediates (other than free aromatic amines): not more than 1.0%.

E 150 Caramel:

Phosphates: not more than 0.5% expressed as P₂O₅.

Ammoniacal nitrogen: not more than 0.5% determined according to the Tillmans-Mildner method as follows:

Mix 5-10 g of the colouring matter with 300 ml of water and 1-2 g of MgO, and distil. (To avoid foaming, a few drops of octyl alcohol, silicone, or a few drops of paraffin oil, or small pieces of paraffin, are added.) The duration of the distillation should be 35 minutes, of which 10 minutes is required for heating up and 25 minutes for the distillation. Absorb the volatile nitrogen compounds which are liberated in excess of O.1 N sulphuric acid. After back titration of the excess, the amount of nitrogen can be calculated using the following formula:

1 ml O.1 N sulphuric acid = 1.4 mg nitrogen

sulphur dioxide: not more than 0.1% determined according to the Monier-Williams E.W. Method^*

pH: not less than 1.8.

E 151 Black PN or Brilliant Black BN:

Water insoluble matter: not more than 0.2%.

Subsidiary colours (which shall consist principally of the diacetyl compound): not more than 15%.

Synthetic intermediates: not more than 1%.

E 153 Vegetable Carbon or carbon medicinalis vegetalis:

Higher aromatic hydrocarbons: Extract 1 g of the colouring matter with 10g of pure cyclohexane for 2 hours. The extract shall not show any colour. In ultraviolet light it shall give practically no fluorescence. There shall be no residue on evaporation.

Tar products: Boil 2g of the colouring matter with 20 ml of N sodium hydroxide and filter. The filtrate shall be colourless.

E 160a Beta-Carotene

Using chromatography, by absorption on alumina or silica gel, pure beta-carotene shall give only one zone.

E 160b Annatto, Bixin, Norbixin

1. Annatto shall be identified according to the following method and criteria:

(a) Dissolve a sufficient quantity of annatto in benzene or sufficiently dilute a benzene solution of annatto to obtain a solution of the same colour as 0.1 per cent. potassium dichromate solution. Pour 3 ml of the solution on the top of an alumina column: elute slowly. Wash the column three times with benzene. Bixin is very strongly adsorbed on the surface of the aiumina, forming a brilliant orange-red zone (which distinguishes it from crocetin). A very pale yellow zone usually moves very quickly down the column, even with pure crystalline bixin. The bixin cannot be eluted with benzene, petroleum either, chloroform, acetone, ethanol or methanol, but ethanol and methanol cause the orange colour to turn into an orange-yellow.

(b) Proceed as described in the preceding sub-paragraph, then remove the benzene from the column by washing three times with chloroform previously dried with potassium carbonate. After elution of the last, chloroform washing add 5 ml of Carr-Price reagent (antimony trichloride — a saturated solution in chloroform) at the top of the column. The bixin zone immediately turns blue/green (which distinguishes it from crocetin). This is knows as the Carr-Price reaction.

2. Bixin shall be identified according to the following method and criteria:

Dissolve 1-2 mg of crystalline bixin in 20 ml of chloroform. Add 5 ml of this solution to the top of a suitable alumina column. Rinse the solution with chloroform previously dried with sodium carbonate. After elution of the last chloroform washing add 5 ml of Carr-Price reagent at the top of the column. The bixin zone immediately turns blue/green.

3. Alkaline solution of norbixin shall be identified according to the following method and criteria:

Place 2 ml of an aqueous annatto solution in a 50 ml separating funnel. Add a sufficient quantity of 2N sulphuric acid to obtain a strongly acid reaction. Norbixin separates as a red precipitate. Add 50 ml of benzene and shake vigorously. After separation, discard the aqueous layer and wash the benzene solution with 100 ml of water until the solution is no longer acid. Centrifuge the solution (usually emulsified) of norbixin in benzene for 10 minutes at 2,500 revolutions per minute. Decant the clear norbixin solution and dry with anhydrous sodium sulphate. Add 3-5 ml of this solution to the top of an alumina column. Norbixin, like bixin, forms an orange/red zone at the surface of the alumina. Treated by the elutants benzene, petroleum ether, chloroform, acetone, ethanol or methanol it behaves like bixin and also gives the Carr-Price reaction described in sub-paragraph (b) of paragraph 1 above.

E 162 Beetroot Red or Betanin:

Paper chromatography: With butanol saturated with 2N hydrochloric acid as solvent (ascending chromatography) betainin shall give a single red spot with a brownish trail and little migration.

E 171 Titanium Dioxide:

Substances soluble in hydrochloric acid: Suspend 5 g of titanium dioxide in 100 ml of 0.5N hydrochloric acid and heat for 30 minutes on a water bath, shaking occasionally. Filter through a Gooch crucible containing a three-layer filter bed — the first, coarse asbestos; the second, filter paper reduced to a pulp; and the third, fine asbestos. Wash with three successive 10 ml portions of 0.5N hydrochloric acid. Evaporate the filtrate to dryness in a platinum evaporating dish and heat to a dull red until the weight of the residue is constant.

Weight of residue	not more than 0.0175 g.
Antimony:	not more than 100 mg/kg.
Zinc:	not more than 50 mg/kg.
Soluble barium compounds:	not more than 5 mg/kg.

E 172 Iron oxides and hydroxides:

Selenium:	not more than 1 mg per kg.
Mercury:	not more than 1 mg per kg.”

	GIVEN under the Official Seal of the Minister for Health this 21st day of September, 1981.
	EILEEN DESMOND,
	Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Regulations and does not purport to be a legal interpretation).

The Regulations amend the Health (Colouring Agents in Food) Regulations, 1973 ( S.I. No. 149 of 1973 ) by

(i) the addition of Riboflavin-5'-phosphate to Part I of the First Schedule;

(ii) the addition of specific purity criteria for this colour to Part III of the First Schedule;

(iii) the deletion of Orange G, Violet 6B and Chocolate Brown FB from Part I of the First Schedule;

(iv) the deletion of the specific purity criteria in respect of these three colours from Part III of the First Schedule; and

(v) the addition of Carageenan and Gum Arabic to the list of diluents permitted in Part I of the Second Schedule to the Health (Colouring Agents in Food) Regulations, 1973.

The Regulations implement Directives No. 78/144/EEC of 30 January, 1978 and 81/20/EEC of 20 January 1981.

The Regulations come into operation on 1 October, 1981.