S.I. No. 148/1973 - Health (Antioxidant in Food) Regulations, 1973.

S.I. No. 148 of 1973.

HEALTH (ANTIOXIDANT IN FOOD) REGULATIONS, 1973.

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 IPRELIMINARY AND GENERAL

1. These Regulations may be cited as the Health (Antioxidant in Food) Regulations, 1973.

2. These Regulations shall come into operation on the first day of July, 1974.

3. (1) The Health (Antioxidant in Food) Regulations, 1972 ( S.I. No. 42 of 1972 ) and the Health (Antioxidant in Food) (Amendment) Regulations, 1972 ( S.I. No. 303 of 1972 ) are hereby revoked.

(2) The provisions of Articles 9 to 12 of the Health (Arsenic and Lead in Food) Regulations, 1972 ( S.I. No. 44 of 1972 ) shall not apply to any permitted antioxidant, any specified antioxidant or any permitted diluent.

4. (1) In these Regulations—

"antioxidant" means any substance which delays, retards or prevents the development in food of rancidity or other deterioration due to oxidation but does not include any substance the use of which is permitted under Regulations, other than these Regulations, for the time being in force under Part V of the Health Act, 1947 ;

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

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

"diluent" means any substance used to dilute or dissolve antioxidant intended for use in food but does not include water;

"ethoxyquin" means 1:2 dihydro-6-ethoxy-2:2:4-trimethylquinoline;

"partial glycerol esters" means any compound formed by incompletely esterifying the hydroxyl groups of glycerol with either—

(a) any single fatty acid or

(b) any mixture of fatty acids or

(c) any mixture of fatty acids with one of the following organic acids—acetic acid, lactic acid, citric acid, tartaric acid, diacetyl tartaric acid or hydroxystearic acid,

in which the proportion of sodium salt, if any, of any fatty acid present does not exceed two per cent of the partial glycerol ester;

"permitted antioxidant" means any antioxidant described in the second column of the First Schedule to these Regulations which complies with the general purity criteria contained in the Third Schedule to these Regulations and, in the case of ethoxyquin, which complies with the specification for that antioxidant in the Fourth Schedule to these Regulations;

"permitted diluent" means any diluent described in the Fifth Schedule to these Regulations which complies with the general purity criteria contained in the Third Schedule to these Regulations;

"pre-packed" means made up in a container for the purpose of retail sale prior to exposure or offer for sale;

"specified antioxidant" means any antioxidant described in the Second Schedule to these Regulations which complies with the restriction on its use specified in the said Schedule and with the general purity criteria contained in the Third Schedule to these Regulations;

"specified food" means any food of a description specified in the first column of the First Schedule to these Regulations.

(2) References in these Regulations to percentages and parts per million shall be construed as references to percentages and parts per million 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.

5. 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.

6. These Regulations shall not apply to any food which is intended to be exported or re-exported.

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

8. (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.

9. 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 in relation 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.

PART IISALE ETC. OF ANTIOXIDANT AND OF FOOD CONTAINING ANTIOXIDANT

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

(a) any antioxidant, other than a specified or a permitted antioxidant, for use in the manufacture or preparation of food;

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

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

(a) any specified food which has in it or on it

(i) an amount exceeding that specified in the third column of Part I and Part II of the First Schedule to these Regulations of an antioxidant described in the second column of the said Parts in relation to such food or

(ii) any other added antioxidant which is not a specified antioxidant;

(b) any food, containing any specified food, which has in it or on it any added antioxidant or an amount of any permitted antioxidant, not permitted by these Regulations for such specified food;

12. Where under the provisions of article 11 a specified food may have in it or on it butylated hydroxyanisole or butylated hydroxytoluene or mixtures thereof within the limits specified for them in Part I of the First Schedule to these Regulations, butylated hydroxyanisole or butylated hydroxytoluene or mixtures thereof may be used in conjunction with propyl gallate or octyl gallate or dodecyl gallate or mixtures thereof within the limits specified for them in Part I of the said Schedule, provided that the total amount of antioxidant shall not exceed, in the case of specified foods in items a and b of the said Part I, 300 parts per million, and in the case of specified foods in item c of the said Part I, 1,000 parts per million.

13. A person shall not import, distribute, sell or expose for sale any food which has in it or on it any added antioxidant which has been diluted or dissolved with a diluent other than water or a permitted diluent.

14. A person shall not import, distribute, sell or expose for sale any food which has in it or on it any added antioxidant other than a specified antioxidant which is recommended in any mark or label on or attached to it or on or attached to its container to be for consumption by babies or infants.

PART IIILABELLING AND ADVERTISING

15. (1) Subject to the provisions of these Regulations a person shall not import, distribute, sell or expose for sale any food mentioned in the first column of Part I or of Part II of the First Schedule to these Regulations which has in it or on it any permitted antioxidant in respect of such food unless it is packed in a container bearing a label which complies with the requirements for such a label specified in the Sixth Schedule to these Regulations or in the case of a retail sale of food which is not pre-packed a notice to the effect that the food contains antioxidant is exhibited in a conspicous place so as to be easily readable by a purchaser of such food.

(2) The provisions of this article shall not apply to

(a) a sale in the course of a catering business of any specified food for immediate consumption, or

(b) a sale by retail of apples and pears which have in them or on them ethoxyquin.

16. A person shall not import, distribute, sell or expose for sale any substance for use as an antioxidant in food unless such substance is packed in a container bearing a label which complies with the requirements for such a label specified in the Sixth Schedule to these Regulations.

17. (1) A person shall not advertise for sale—

(a) any antioxidant for use in food other than an antioxidant which is a specified or permitted antioxidant in respect of such food,

(b) any food containing a permitted antioxidant in such a manner as to indicate or imply that the food is intended mainly for consumption by babies or infants,

(c) any specified or permitted antioxidant for use in food or any food containing a specified or permitted antioxidant 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.

SPECIFIED FOODS AND PERMITTED ANTIOXIDANTS.

PART I.

Column 1	Column 2	Column 3
Specified food	Description of antioxidant and Serial Number	Amount expressed in parts per million
(a) Anhydrous edible oils and fats, whether hardened or not, and vitamin oils and concentrates other than preparations containing more than 30 mg retinol per gram	Propyl gallate or E311 Octyl gallate or E312 Dodecyl gallate or any mixture thereof or	100
	E320 Butylated hydroxyanisole
	(B.H.A.) or	200
	E321 Butylated hydroxytoluene
	(B.H.T.) or	200
any mixture of B.H.A. and B.H.T.	200
(b) Partial glycerol esters	Propyl gallate or E311 Octyl gallate or E312 Dodecyl gallate or any mixture thereof or	100
	E320 Butylated hydroxyanisole (B.H.A.) or
		200
	E321 Butylated hydroxytoluene
	(B.H.T.) or	200
any mixture of B.H.A. and B.H.T.	200
(c) Essential oils and isolates from concentrates of essential oils	Propyl gallate or E311 Octyl gallate or E312 Dodecyl gallate or any mixture thereof or	1,000
	E320 Butylated hydroxyanisole
	(B.H.A.) or	1,000
	E321 Butylated hydroxytoluene
	(B.H.T.) or	1,000
any mixture of B.H.A. and B.H.T.	1,000
(d) Potato Flakes	E320 Butylated hydroxyanisole
	(B.H.A.) or	25
	E321 Butylated hydroxytoluene
	(B.H.T.) or	25
any mixture of B.H.A. and B.H.T.	25
(e) Apples and pears	Ethoxyquin	3

PART II.

Column 1	Column 2	Column 3
Specified food	Description of antioxidant and Serial Number	Amount expressed in parts per million for each 300 micro grammes retinol per gram
Preparations containing more than 30 mg retinol per gram	E320 Butylated hydroxyanisole
	(B.H.A.)	10
	or
	E321 Butylated hydroxytoluene
	(B.H.T.)	10
	or
any mixture of B.H.A. and B.H.T.	10

SECOND SCHEDULE.

SPECIFIED ANTIOXIDANTS.

Serial Number	Description of Substance
E 300	L—Ascorbic acid
E 301	Sodium L—Ascorbate (Sodium salt of L—Ascorbic Acid)
E 302	Calcium L—Ascorbate (Calcium salt of L—Ascorbic Acid)
E 303	Diacetyl 5, 6—L Ascorbic Acid (Ascorbyle diacetate)
E 304	Palmityl 6—L Ascorbic Acid (Ascorbyle palmitate)
E 306	Extracts of natural origin rich in tocopherol
E 307	Alpha—tocopherol by synthesis
E 308	Gamma—tocopherol by synthesis
E 309	Delta—tocopherol by synthesis
E 322	Lecithin
E 325	Sodium Lactate (sodium salt of lactic acid)
E 326	Potassium lactate (potassium salt of lactic acid)
E 327	Calcium lactate (calcium salt of lactic acid)
E 330	Citric acid
E 331	Sodium citrates (sodium salts of citric acid)
E 332	Potassium citrates (potassium salts of citric acid)
E 333	Calcium citrates (calcium salts of citric acid)
E 334	Tartaric acid
E 335	Sodium tartrates (sodium salts of tartaric acid)
E 336	Potassium tartrates (potassium salts of tartaric acid)
E 337	Sodium potassium tartrate
E 338	Orthophosphoric acid
E 339	Sodium orthophosphates (sodium salts of orthophosphoric acid)
E 340	Potassium orthophosphates (potassium salts of orthophosphoric acid)
E 341	Calcium orthophosphates (calcium salts of orthophosphoric acid)
E 372c	Citric ester of mono—and diglycerides of alimentary fatty acids
E 450	Sodium acid salt of pyrophosphoric acid
E 450	Sodium pyrophosphate
E 450	Potassium pyrophosphate
—	Calcium pyrophosphate
E 450	Sodium tripolyphosphate
—	Potassium polymetaphosphate
—	Sodium metaphosphate

Restriction on use:

restricted to the use of an amount not in excess of that required in accordance with good manufacturing practice.

THIRD SCHEDULE.

GENERAL PURITY CRITERIA.

The antioxidants referred to in the First Schedule and the substances referred to in the Second and Fifth Schedules to these Regulations shall comply with the following criteria of purity:—

1. They must not contain more than 3 mg. per kg. of arsenic or more than 10 mg. per kg. of lead.

2. They must not contain more than 50 mg. per kg. of copper and zinc taken together, the zinc content, however, not to be higher than 25 mg. per kg.

3. They must not contain any measurable trace of other toxic elements, in particular other heavy metals.

FOURTH SCHEDULE.

SPECIFICATION FOR ETHOXYQUIN.

Empirical Formula	Structural Formula	Molecular Weight	Description	Purity	Boiling Point	Refractive Index	Solubility
C₁₄H₁₉NC		217.3	Light amber oil when freshly prepared. Tendency to polymerise on exposure to light and oxygen with darkening in colour	Not less than 92 per cent by weight of the monomer. Remainder consists of the dimer and higher polymers.	125°C at 1-2 mm mercury	1.569 to 1.572 at 25°C	Insoluble in water. Soluble in organic solvents and oils and fats.

FIFTH SCHEDULE.

PERMITTED DILUENTS.

1. Edible oils.

2. Edible fats.

3. Ethyl alcohol.

4. Glycerol.

5. Sorbitol.

6. Propylene Glycol (1.2 Propanediol).

SIXTH SCHEDULE.

1. The label to which sub-article (1) of article 15 relates shall have printed on it a statement in one of the following forms or in a form substantially to the like effect:—

CONTAINS ANTIOXIDANT

CONTAINS PERMITTED ANTIOXIDANT.

2. The label to which article 16 relates shall have printed on it a true statement of:

(a) the serial number, if any, and the name as described in the First Second and Fifth Schedules to these Regulations of each specified and permitted antioxidant and permitted diluent present;

(b) the description, in the case of a mixture of substances, of each constituent present;

(d) the words "for foodstuffs (limited use)".

3. Any statement required by paragraphs 1 and 2 of this Schedule:

(a) shall be clear and legible;

(b) shall be in a conspicuous position on the label which shall be marked on, or securely attached to, the container in such a manner that it will be readily discernible and easily read by an intending purchaser or consumer under normal conditions of purchase or use;

(c) shall not be in any way hidden or obscured or reduced in conspicuousness by any other matter, whether pictorial or not, appearing on the label.

4. The letters and figures in every word in any statement to which paragraph 3 above applies:

(a) shall be in characters of uniform colour and size (being in the case of a label to which article 16 relates not less than 1.5 millimetres in height for labels on containers of which the greatest dimension does not exceed 12 centimetres, and not less than 3 millimetres in height for labels on containers of which the greatest dimension exceeds 12 centimetres and being in all other cases not less than 1.5 millimetres in height) provided that the initial letter of any word may be taller than any other letter in the word;

(b) shall appear on a contrasting ground, so however that where there is no ground other than such as is provided by a transparent container and the contents of that container are visible behind the letters, those contents shall be taken to be the ground for the purposes of this paragraph.

5. A container referred to in article 16 shall have on it the name and address of the person importing or the person selling or exposing for sale the antioxidant packed in the container or if the antioxidant is manufactured within the State, the name of the manufacturer of the antioxidant.

6. For the purposes of this Schedule:

(a) the height of any lower case letter shall be taken to be the height thereof, disregarding any ascender or descender thereof;

(b) any requirement that letters or figures shall be of uniform height, colour or size, shall be construed as being subject to the saver that any inconsiderable variation in height, colour or size, as the case may be, may be disregarded.

GIVEN under the Official Seal of the Minister for Health this 11th day of June, 1973.

BRENDAN CORISH,

Minister for Health.

EXPLANATORY NOTE.

These Regulations, which come into operation on 1st July, 1974, prohibit the importation, distribution, sale or exposure for sale for use in food of any antioxidant other than a specified or permitted antioxidant as described in the Regulations or any such antioxidant in such a manner as to be likely to lead to its use contrary to the Regulations. The Regulations also provide that food being imported, distributed, sold or exposed for sale shall not have in it or on it antioxidant, as defined, except as provided for in the Regulations and prescribe the foods which may contain certain antioxidants and the amounts of such antioxidants that may be contained in them.

The Regulations provide that a person shall not import, distribute, sell or expose for sale any food which has in it or on it any added antioxidant which has been diluted or dissolved with a diluent other than water or certain permitted diluents. The marking, labelling or advertising of any food as food intended for babies or infants is prohibited if the food has any permitted antioxidant in or on it. The Regulations also provide for the labelling of specified foods containing antioxidants and of antioxidants.

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 Health (Antioxidant in Food) Regulations, 1972 ( S.I. No. 42 of 1972 ) and the Health (Antioxidant in Food) (Amendment) Regulations, 1972 ( S.I. No. 303 of 1972 ) are being revoked on the 1st July, 1974.