S.I. No. 459/1994:

EUROPEAN COMMUNITIES (INFANT FORMULAE) REGULATIONS, 1994.

EUROPEAN COMMUNITIES (INFANT FORMULAE) REGULATIONS, 1994.

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) and for the purposes of giving effect to Commission Directive No. 91/321/EEC of the 14th of May, 1991 and Council Directive No. 92/52/EEC of the 18th June, 1992, hereby makes the following Regulations:--

1. These Regulations may be cited as the European Communities (Infant Formulae) Regulations, 1994.

2. These Regulations shall come into operation on the 3rd day of January, 1995.

3. (1) In these Regulations:

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

"export" means to market a product in a country outside the European Community;

"follow-on formulae" means foodstuffs intended for particular nutritional use by infants in good health aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons;

"infant formulae" means foodstuffs intended for particular nutritional use by infants in good health during the first four months of life and satisfying by themselves the nutritional requirements of this category of persons;

"infant milk" and "follow-on milk" means products within the meaning of these regulations manufactured entirely from cows' milk proteins;

"infants" means children under the age of 12 months;

"market" includes supply, offer or expose for sale and have in possession for sale and cognate words shall be construed accordingly;

"Minister" means the Minister for Health;

"Minister" means the Minister for Health;

"product" means infant formulae, follow-on formulae, infant milk and follow-on milk;

"young children" means children aged between one and three years.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto and any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article unless otherwise stated.

4. (1) No product other than infant formulae which comply with these Regulations may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four months of life.

(2) No foodstuffs other than infant formulae referred to in sub-article (1) of this Article may be marketed as suitable for infants aged under four months.

5. (1) Infant formulae shall be manufactured from protein sources defined in the Schedules to these Regulations and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has, in the opinion of the Minister, been established by generally accepted scientific data.

(2) Follow-on formulae shall be manufactured from protein sources defined in the Schedules to these Regulations and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants aged over four months has, in the opinion of the Minister, been established by generally accepted scientific data.

(3) The use of food ingredients is subject to the prohibitions and limitations specified in Schedules I and II to these Regulations.

(4) The Minister may, when forming an opinion in accordance with sub-articles (1) and (2) of this Article, have regard to the views of such persons or authorities as he considers appropriate.

6. (1) Infant formulae shall comply with the compositional criteria specified in Schedule I.

(2) Follow-on formulae shall comply with the compositional criteria specified in Schedule II.

(3) For the purposes of making infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.

(4) No substance other, than a substance specified in Schedule III may be used in the manufacture of infant formulae and follow-on formulae for the purposes of satisfying the requirements on:

--mineral substances,

--vitamins,

--amino acids and other nitrogen compounds,

--other substances having a particular nutritional purpose.

7. (1) The Minister may by order, where he considers it necessary to protect the public health, stipulate the maximum levels of any substance included in infant formulae or follow-on formulae.

(2) The Minister may by order establish such microbiological criteria as he considers appropriate.

8. (1) The labelling of infant formulae shall bear the following particulars in addition to general labelling requirements:

( a ) a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast-fed;

( b ) in the case of infant formulae that do not contain added iron, a statement to the effect that, when the product is given to infants over the age of four months, their total iron requirements must be met from other additional sources;

( c ) the available energy value, expressed in kj and kcal, and the content of proteins, lipids and carbohydrates per 100 ml of the product ready for use;

( d ) the average quantity of each mineral substance and of each vitamin mentioned in Schedule I;

( e ) where applicable, the average quantity of choline, inositol and carnitine, per 100 ml of the product when ready for use;

( f ) instructions for appropriate preparation of the product;

( g ) a warning against the health hazards of inappropriate preparation.

(2) Without prejudice to sub-article (1) the labelling of infant formulae shall also fulfil the following requirements:

( a ) be so designed so as not to discourage breast-feeding;

( b ) avoid the use of the terms "humanised", "maternalised" or similar terms;

( c ) the term "adapted" may only be used in conformity with sub-article (3) paragraph (b) of this Article and Schedule IV, point 1;

( d ) the label shall include the following particulars, preceded by the words "important notice" or their equivalent:

(i) a statement concerning the superiority of breast-feeding,

(ii) a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, midwives, public health nurses, general practitioners or other professionals responsible for maternal and child care;

( e ) the label shall not include:

(i) pictures of infants,

(ii) other pictures or text which may idealise the use of the product.

(3) The labelling of infant formulae may:

( a ) have graphic representations for easy identification of the product and for illustrating methods of preparation;

( b ) bear claims concerning the special composition of an infant formula only in the cases listed in Schedule IV and in accordance with the conditions laid down therein.

(4) The requirements, prohibitions and restrictions referred to in sub-articles (1), (2) and (3) shall also apply to advertising and to the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed.

9. (1) The labelling of follow-on formulae shall bear the following particulars in addition to general labelling requirements:

( a ) a statement which specifies the minimum age of the infant for whom the product is suitable and such minimum age so specified shall be not less than four months;

( b ) that it should form only part of a diversified diet;

( c ) that it is not to be used as a substitute for breast milk during the first four months of life;

( d ) the available energy value, expressed in kj and kcal;

( e ) the content of proteins, lipids and carbohydrates per 100 ml of the product ready for use;

( f ) the average quantity of each mineral substance and of each vitamin mentioned in Schedule II;

( g ) where applicable, the average quantity of choline, inositol and carnitine, per 100 ml of the product ready for use;

( h ) instructions for appropriate preparation of the product;

( i ) a warning against the health hazards of inappropriate preparation.

(2) Without prejudice to sub-article (1) the labelling of follow-on formulae shall also fulfil the following requirements:

( a ) be so designed so as not to discourage breast-feeding;

( b ) avoid the use of the terms "humanised", "maternalised" or similar terms;

( c ) the term "adapted" may only be used in conformity with Article 8. (3) Paragraph (b) and Schedule IV, point 1;

( d ) the packaging at the point of sale shall, to the satisfaction of the Minister, ensure a clear distinction is made between infant formulae and follow-on formulae.

(3) The requirements, prohibitions and restrictions referred to in sub-articles (1) and (2) shall also apply to advertising and to the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed.

10. (1) Advertising of infant formulae shall be restricted to publications specialising in baby care and scientific publications.

(2) The Minister may from time to time by order restrict or prohibit such forms of advertising or promotion, either directly or indirectly, of infant formulae as he considers necessary.

(3) Advertisements for infant formulae shall contain only information which is, in the opinion of the Minister, of a scientific and factual nature; such information shall not imply or create a belief that bottle-feeding is equivalent or superior to breast-feeding.

(4) ( a ) There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formulae directly to the consumer at the retail level;

( b ) Without prejudice to the generality of paragraph (a) of this sub-article the following are prohibited: special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.

(5) The provision of free or low-priced products, samples or any other promotional gifts, either directly or indirectly, via the health care system or health workers by manufacturers, distributors or their associates, is prohibited.

11. (1) The preparation and provision of information on infant and young child feeding intended to reach pregnant women and mothers of infants and young children shall be objective and consistent.

(2) The information referred to in sub-article (1) in relation to infant feeding shall draw attention to:

( a ) the benefits and superiority of breast-feeding;

( b ) the importance of maternal nutrition and the preparation for and maintenance of breast-feeding;

( c ) the possible negative effect on breast-feeding of introducing partial bottle-feeding;

( d ) the difficulty of reversing the decision not to breast-feed;

( e ) where needed, advising on the proper use of infant formulae, whether manufactured industrially or home-prepared.

(3) Any material referred to in sub-article (1) containing information about the use of infant formulae shall include:

( a ) the social and financial implications of its use;

( b ) the health hazards of inappropriate foods or feeding methods;

( c ) the health hazards of improper use of infant formulae.

(4) Donations of informational or educational equipment or materials by manufacturers or distributors or by persons or individuals associated with manufacturers or distributors shall be made only within guidelines approved by the Minister.

(5) Donations or low-price sales of supplies of infant formulae to institutions or organizations, whether for use in the institutions or for distribution outside them, may be made only in accordance with guidelines approved by the Minister.

(6) The guidelines referred to in sub-articles (4) and (5) shall provide that such equipment or materials:

( a ) may bear the donating company's name or logo;

( b ) shall not refer to a proprietary brand of infant formulae;

( c ) be distributed only through the health care system.

(7) The guidelines referred to in sub-article (5) shall ensure that those products referred to in sub-article (6) Paragraph (a) be only used by, or distributed for, infants who have to be fed on infant formulae and only for as long as required by such infants.

12. (1) The Minister may by order approve of such codes of practice which he may consider will assist industry and other affected organisations to comply with the provisions of these Regulations and codes so ordered shall form part of these Regulations.

(2) The Minister may withdraw any approval referred to in sub-article (1) as he sees fit.

13. (1) Infant formulae and follow-on formulae intended for export shall comply with:

( a ) (i) the requirements of Articles 3, 4, 5 and 6 of Commission Directive 91/321/EEC, or

(ii) a standard established by Codex Alimentarius;

( b ) the provisions of Article 7. (2) to (6) of Commission Directive 91/321/EEC;

( c ) the provisions of Directive 89/396/EEC on indications or marks identifying the lot to which the product belongs;

unless otherwise requested or stipulated by provisions established by the importing country.

(2) The packaging of infant formulae and follow-on formulae intended for export shall be in an appropriate language and ensure that a clear distinction is made between infant formulae and follow-on formulae.

(3) The provisions of sub-article (2) shall not prevent such information from being indicated in more than one language.

(4) The stipulations, prohibitions and restrictions laid down in Article 7. (2) to (6) of Commission Directive 91/321/EEC shall also apply to the presentation of the products concerned intended for export and in particular their form, aspect or packaging and the packaging material used.

14. (1) These Regulations shall be enforced and executed by each health board in its functional area.

(2) An offence under these Regulations, subject to the provisions of sub-article (3), may be prosecuted by the health boards.

(3) Legal proceedings other than proceedings under Article 15 shall be initiated by the health board only with the consent of the Minister for Health.

15. (1) Where a sample of any foodstuff has been certified under the provisions of the Health (Official Control of Food) Regulations, 1991 not to comply with these Regulations, an authorised officer may seize, remove and detain such foodstuff as being a foodstuff which is unfit for human consumption.

(2) With the consent in writing of the owner or person responsible for such foodstuff, 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 in pursuance of the provisions of this article may, on giving notice in writing to the owner or person responsible for such foodstuff of his intention to do so, apply to a Judge of the District Court for an order directing that such food be destroyed or otherwise disposed of as being a foodstuff 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) may, if satisfied that such foodstuff 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 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 foodstuff and the identity of the person from whom or the place from which any such foodstuff 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.

16. (1) A person shall not manufacture, prepare, import, distribute or sell any product or promotional material which does not comply with these Regulations.

(2) Any person who fails to comply with Articles 4, 5, 6, 8, 9, 10, 11, 13, 15 or 16 of these Regulations shall be guilty of an offence and on conviction thereof is liable to a fine not exceeding £1,000 for such offence.

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

18. These Regulations shall not apply to any food manufactured, packaged or labelled before the date specified in Article 2.

19. In any proceedings for an offence under these Regulations, it shall be a defence to the alleged offence for the person charged to show that the product in respect of which the offence is alleged to have been committed was intended for export and complied with:

(i) the food legislation of the importing country,

or

(ii) where appropriate, other requirements specified for the product by the Government of the importing country, where such specifications are not inconsistent with the provisions of these Regulations.

SCHEDULE I.

ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER.

NB: the values refer to the product ready for use.

1. Energy.

2. Proteins.

(protein content = nitrogen content x 6.38) for cows' milk proteins.

(protein content = nitrogen content x 6.25) for Soya protein isolates.

2.1. Formulae manufactured from unmodified cows' milk proteins.

The Chemical Index of the proteins present shall be equal to at least 80 per cent of that of the reference protein (breast milk, as defined in Schedule VI); nevertheless, for calculation purposes, the concentrations of methionine and cystine may be added together.

The Chemical Index shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein.

2.2. Formulae manufactured from modified cows' milk proteins (alteration of the casein/whey protein ratio).

For an equal energy value, the formula must contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in Schedule V).

2.3. Formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins.

Only soya protein isolates must be used in manufacturing these formulae.

The Chemical Index shall be equal to at least 80 per cent of that of the reference protein (breast milk, as defined in Schedule VI).

For an equal energy value the formula must contain an available quantity of methionine at least equal to that contained in the reference protein (breast milk, as defined in Schedule V).

The l-carnitine content shall be at least equal to 1.8 µmoles/100 kj (7.5 µmoles/100 kcal).

2.4. In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.

3. Lipids.

3.1. The use of the following substances is prohibited:

--sesame seed oil,

--cotton seed oil,

--fats containing more than 8 per cent trans isomers of fatty acids.

3.2. Lauric Acid.

3.3. Myristic Acid.

3.4. Linoleic Acid (in the form of glycerides = linoleates).

4. Carbohydrates.

4.1. Only the following carbohydrates may be used:

--lactose,

--maltose,

--sucrose,

--malto-dextrins,

--glucose syrup or dried glucose syrup,

--pre-cooked starch naturally free of gluten,

--gelatinized starch naturally free of gluten.

4.2. Lactose.

This provision does not apply to formulae in which soya proteins represent more than 50 per cent of the total protein content.

4.3. Sucrose.

4.4. Pre-cooked starch and/or gelatinized starch.

5. Mineral substances.

5.1. Formulae manufactured from cows' milk proteins.

⁽¹⁾Limit applicable to formulae with added iron.

The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.

5.2. Formulae manufactured from soya proteins alone or in a mixture with cows' milk proteins.

All requirements of paragraph 5.1. are applicable except those concerning iron and zinc, which are as follows:

6. Vitamins.

⁽¹⁾RE = all trans retinol equivalent.

⁽²⁾ In the form of cholecalciferol, of which 10µg = 400 i.u. of vitamin D.

⁽³⁾ NE = niacin equivalent = mg nicotinic acid + mg tryptophan/60.

⁽⁴⁾ α-TE = d-α-tocopherol equivalent.

SCHEDULE II.

ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER.

NB: the values refer to the product ready for use.

1. Energy.

2. Proteins.

(protein content = nitrogen content x 6.38) for cows' milk proteins.

(protein content = nitrogen content x 6.25) for soya protein isolates.

The Chemical Index of the proteins present shall be at least equal to 80 per cent of that of the reference protein (casein as defined in Schedule VI).

The Chemical Index shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein.

For follow-on formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins, only protein isolates from soya may be used.

Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of the proteins, in the proportions necessary for that purpose.

3. Lipids.

3.1. The use of the following substances is prohibited:

--sesame seed oil,

--cotton seed oil,

--fats containing more than 8 per cent trans isomers of fatty acids.

3.2. Lauric acid.

3.3. Myristic acid.

3.4. Linoleic Acid (in the form of glycerides = linoleates).

4. Carbohydrates.

4.1. Gluten.

The use of ingredients containing gluten is prohibited.

4.2. Lactose.

This provision does not apply to follow-on formulae in which soya protein isolates represent more than 50 per cent of the total protein content.

4.3. Sucrose, Fructose, Honey.

5. Mineral Substances.

5.1.

5.2. Zinc.

5.2.1. Follow-on formulae manufactured entirely from cows' milk.

5.2.2. Follow-on formulae containing soya protein isolates, or mixed with cows' milk

5.3. Other mineral substances.

The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the protein concentration of the following formulae to that of cows' milk. The typical composition of cows' milk is given, for guidance, in Schedule VIII.

5.4. Calcium/phosphorus ratio.The calcium/phosphorus ratio shall not exceed 2.0.

6. Vitamins.

⁽¹⁾ ER = all trans retinol equivalent.

⁽²⁾ in the form of cholecalciferol, of which 10 µg = 400 u.i. of vitamin D.

⁽³⁾ a-TE = d-a-tocopherol equivalent.

SCHEDULE III.

NUTRITIONAL SUBSTANCES.

1. Vitamins.

2. Mineral substances.

3. Amino acids and other nitrogen compounds.

1-arginine and its hydrochloride

1-cystine and its hydrochloride

1-histidine and its hydrochloride

1-isoleucine and its hydrochloride

1-leucine and its hydrochloride

1-cysteine and its hydrochloride

1-cysteine and its hydrochloride

1-methionine

1-phenylalanine

1-threonine

1-tryptophan

1-tyrosine

1-valine

1-carnitine and its hydrochloride taurine

4. others.

choline

choline chloride

choline citrate

choline bitartrate

inositol

SCHEDULE IV.

COMPOSITIONAL CRITERIA FOR INFANT FORMULAE WARRANTING A CORRESPONDING CLAIM.

⁽¹⁾when determined by a method the detection limits of which will be established at a later stage.

SCHEDULE V.

ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK.

For the purpose of this report, the essential and semi-essential amino acids in breast milk, expressed in mg per 100 kj and 100 kcal are the following:

⁽¹⁾1kj .= 0.239 kcal.

SCHEDULE VI.

AMINO ACID COMPOSITION OF CASEIN AND BREAST MILK PROTEIN.

The amino acid composition of casein and breast milk protein: (g/100g of protein).

⁽¹⁾ amino acid content of foods and biological data on protein. FAO nutritional studies, no 24, Rome 1970, items 375 and 383.

SCHEDULE VII.

THE MINERAL ELEMENTS IN COWS' MILK.

As a reference, the contents of mineral elements in cows' milk expressed per 100 g of solids-non-fat and per g of proteins are the following:

⁽¹⁾ snf: 'solids-no-fats'.

⁽²⁾ ns: non-specified, varies widely according to season and stock farming conditions

GIVEN under the Official Seal of the Minister for Health, this 30th

day of December, 1994.

MICHAEL NOONAN,

Minister for Health

EXPLANATORY NOTE.

These Regulations give effect to Commission Directive (91/321/EEC) of 14 May 1991 and Council Directive (92/52/EEC) of 18 June 1992 on compositional, labelling and marketing requirements for infant formulae and follow-on formulae intended for infants in good health.

These Regulations come into effect on 3 January 1995.