Royal Decree 2685/1976 of 16 October on the approval of technical and health regulations for the production, circulation and trade of food preparations for dietary and/or special arrangements, as amended by the Royal Decrees 385/1980 of 18 January; 1424/1982 of 18 June; 2353/1986 of 10 October; 1426/1988 of 25 November 1988 and 1809/1991 of 13 December 1991, including the regulation of infant formulae.

The publication by the Commission of the European Communities of Directive 91 /321/EEC of 14 May 1991 on infant formulae and follow-on formulae makes it necessary to issue, in the field of Technical-Health regulations for food preparations for dietetic and/or special regimes, a specific Technical-Health Regulation regulating those prepared.

Since the basic composition of these products must satisfy the nutritional needs of healthy infants, as determined according to generally accepted scientific data, it is considered as a (a) the rules governing the application of the rules of procedure for the protection of the health and safety of workers and the protection of the health of workers and the health and safety of workers; Spanish by Royal Decree 1809/1991 of 13 December.

With regard to the registration of these products in the General Health Register, Directive 91 /321/EEC relating to 89 /398/EEC and Royal Decree 1809/1991 of 13 December 1991 does not lay down the prior to their marketing, therefore, it is not applicable to them as provided by Royal Decree 1712/1991 of 29 November on the General Health Register of Food.

This Royal Decree also includes the recommendations of the Codex Alimentarius in its International Code of Marketing of Maternal Milk Sucedanees, adopted by the 34 World Health Assembly, expressly stating, in In the second paragraph of Article 8 of the Directive which is transposed, the prohibitions on labelling, advertising and information must be applied to products which affect infants and other groups with a view to their use. special nutritional needs.

This Royal Decree is issued pursuant to Article 149.1.16 of the Constitution, with the exception of Article 11, which is issued pursuant to Article 149.1.10. of the Constitution and in accordance with the provisions of Articles 40.2 and 40.4 of Law 14/1986 of 25 April, General of Health.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, Industry, Commerce and Tourism, and Agriculture, Fisheries and Food, the sectors affected, prior to the mandatory report of the Inter-Ministerial Commission for the Food Management, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 20 November 1992,

DISPONGO:

Single item.

The attached Specific Technical-Health Regulations of infant formulae and follow-on formulae are approved.

Single additional disposition.

This Royal Decree is issued pursuant to Article 149.1.16 of the Constitution, with the exception of Article 11, which is issued pursuant to Article 149.1.10. of the Constitution and in accordance with the provisions of Articles 40.2 and 40.4 of Law 14/1986 of 25 April, General of Health.

Single transient arrangement.

infant formulae and post-infant formulae (which respond to the definition of "follow-on formulae" in the Technical-Health Regulations that are approved) prepared in accordance with the provisions of the Technical-Health regulations for food preparations for dietary and/or special arrangements, approved by Royal Decree 2685/1976 of 16 October, may continue to be placed on the market until 1 June 1994.

Final disposition first.

This Royal Decree will enter into force on the day following its publication in the Official Journal of the State.

Final disposition second.

1. The Minister for Health and Consumer Affairs is hereby authorised to take the following matters by means of a ministerial order, following a report by the Inter-Ministerial Committee for Food Management:

1.1. Purity criteria for substances which may be used in the preparation of infant formulae and follow-on formulae listed in Annex III.

1.2 Positive list of authorized additives for use in the manufacture thereof.

1.3 Maximum tolerated limits for polluting substances.

2. The microbiological criteria to be met by infant formulae and follow-on formulae are those laid down in Article 12 of Royal Decree 2685/1976 of 16 October 1976 on the approval of technical and health regulations for the preparation, circulation and trade of food preparations for dietary and/or special arrangements. The abovementioned microbiological criteria may be amended by the Minister for Health and Consumer Affairs by ministerial order, following a report by the Inter-Ministerial Commission for Food Management, in case of further knowledge Scientific or technical advice and to maintain its compliance with the rules of the European Economic Community, being permanently reviewable for reasons of public health.

Single repeal provision.

It is repealed from the Technical-Health Regulations for the elaboration, circulation and trade of food preparations for dietary and/or special regimes, approved by Royal Decree 2685/1976 of 16 October, and as amended by the Royal Decrees 385/1980 of 18 January; 1424/1982 of 18 June; 2353/1986 of 10 October; 1426/1988 of 25 November and 1809/1991 of 13 December 1991:

(a) Article 3 (1) (1) (1).

(b) Article 3 (1) (1) (2), in respect of products which comply with the definition of follow-on formulae set out in the Technical-Health Regulations to be adopted.

(c) Paragraphs 5.2 and 5.6 of Article 5.

(d) Article 14 (1), (2), (2) and (3), except under heading 14.3.1, in respect of post-infant foods other than follow-on formulae.

(e) Article 14 (4), in respect of postlactating preparations which meet the definition of follow-on formulae contained in the Technical-Health Regulations to be adopted.

(f) Article 15.

(g) The first indent of Article 20 (20) (1).

As well as how many provisions of equal or lower rank are opposed to the provisions of this Royal Decree and the Technical-Health Regulations that it approves.

Given in Madrid on 20 November 1992.

JOHN CARLOS R.

The Minister of Relations with the Courts and the Government Secretariat,

VIRGILIO ZAPATERO GOMEZ

SPECIFIC TECHNICAL-HEALTH REGULATIONS FOR INFANT FORMULAE AND FOLLOW-ON FORMULAE

Chapter I

Scope

Article 1. Scope of application.

The purpose of this Regulation is to define what is meant by infant formulae and follow-on formulae intended for healthy children and to lay down the requirements for composition, labelling, advertising and information of the same.

Chapter II

Definitions

Article 2. Definitions.

For the purposes of this provision:

2.1 : Children who are less than twelve months old.

2.2

: Children between one and three years of age.

2.3 : Food products intended for the special feeding of infants from birth to the first four to six months of life, which satisfy themselves the needs nutritional status of this category of persons.

2.4

: Food products intended for the special feeding of infants over four months of age which constitute the main liquid element of a progressively diversified diet of this category of people.

Chapter III

Elaboration and Composition

Article 3. Infant formulae.

3.1 As the case may be, the protein sources defined in the Annexes to this Regulation and other food ingredients, which are suitable for the special feeding of infants from the birth has been determined by generally accepted scientific data.

3.2 They must comply with the composition criteria specified in Annex I.

Article 4. Follow-on formulae.

4.1 As the case may be, the protein sources defined in the Annexes to this Regulation and other food ingredients, which are suitable for the special feeding of infants over four years of age, shall be drawn up. months of age, has been determined by generally accepted scientific data.

4.2 They must comply with the composition criteria set out in Annex II.

Article 5. Prohibitions and limitations.

5.1 Infant preparations.

No product other than a infant formula may be marketed or presented as suitable to meet the nutritional needs of normal, healthy infants for the first four to six years. months of life.

5.2 Infants prepared for infants and follow-on formulae.

5.2.1 They may be marketed only if they comply with the definitions and rules laid down in this Regulation.

5.2.2 The prohibitions and limitations on the use of food ingredients laid down in Annexes I and II shall be respected in their preparation and composition.

5.2.3 Only the substances in Annex III may be used in their preparation, in order to meet the needs of:

a) Mineral substances.

b) Vitamins.

c) Amino acids and other nitrogenous compounds.

d) Other substances for special nutritional purposes.

5.2.4 They shall not contain any substance in such quantity as to endanger the health of the infants to whom they are intended.

5.2.5 The preparation of the product ready for consumption should only require, where appropriate, the addition of water.

Chapter IV

Labelling, advertising, and information

Article 6. Labelling.

The labelling and labelling of the packaging must comply with the General Standard of Labelling, Presentation and Advertising of the Food Products, approved by Royal Decree 212/1992, of March 6, with the following requirements, restrictions and prohibitions:

6.1 Name of the product.

The products referred to in Article 2 (2.3) and (2.4) of this Regulation shall be marketed under the names and , respectively.

However, the name of the food made entirely from the proteins from cow's milk will be as follows: and .

6.2 The following mandatory data must also be included:

6.2.1 In infant formulae:

6.2.1.1 An indication that the product is suitable for the special feeding of infants from birth, when they are not breastfed.

6.2.1.2 If these products are not enriched with iron, an indication that when the product is administered to children over four months the total iron needs of these products should be be satisfied by other appropriate sources.

6.2.2 In the follow-on formulae:

An indication that the product is suitable only for the special feeding of children older than four months, which should only be part of a diversified diet and should not be used as a substitute for milk for the first four months of life.

6.2.3 In the case of infant formulae and follow-on formulae:

6.2.3.1 The available energy value, expressed in kilojulios and kilocalories, and the content of carbohydrates, proteins and fats per 100 millilitres of the product, ready for consumption.

6.2.3.2 The average quantity of each mineral substance and each vitamin mentioned in Annex I and Annex II respectively and, where applicable, of choline, inositol and carnitine per 100 millilitres of the product ready for use consumption.

6.2.3.3 Instructions regarding the correct preparation of the product and a warning about health risks in the case of inadequate preparation. The use of graphic representations illustrating the method of preparation is permitted.

6.2.4 The labelling of infant formulae and follow-on formulae must be designed in such a way as to provide the necessary information on the proper use of the products and not to disadvantage the use of the breastfeeding. The use of the terms , , or similar is prohibited. The term may be used only in accordance with paragraph 6.2.6 and paragraph 1 of Annex IV.

Not included in the labelling of infant formulae images of children or other illustrations or texts that can idealize the use of the product. However, they may carry graphic representations that allow easy identification of the product and illustrate the method of preparation.

6.2.5 The labelling of infant formulae must also bear the following mandatory indications preceded by the words or other equivalent:

6.2.5.1 An indication of the superiority of breastfeeding.

6.2.5.2 An indication that the product is to be used only on the advice of qualified independent persons in medicine, nutrition or pharmacy or other professionals in charge of care mother and child.

6.2.6 In infant formulae, the labelling may bear an indication of the special composition of the product, only in the cases referred to in Annex IV and in accordance with the conditions laid down therein.

6.2.7 The requirements, prohibitions and restrictions referred to in paragraphs 6.2.4, 6.2.5 and 6.2.6 shall also apply to:

6.2.7.1 The presentation of the products concerned, in particular their shape, appearance and packaging, the packaging material used, the way in which they are disposed and the means in which they are exposed.

6.2.7.2 Advertising.

Article 7. Advertising.

7.1 The advertising of infant formulae will be limited to publications specializing in child care and scientific publications.

7.2 The notices of infant formulae shall comply with the conditions set out in paragraphs 6.2.4, 6.2.5, 6.2.6 and 6.2.7.2 of Article 6 and shall contain only objective information of a scientific nature. Such information should not imply or imply that feeding with bottle is equivalent or superior to breastfeeding.

7.3 Advertising in the sales, distribution of samples or the use of any other means of propaganda aimed at encouraging sales of infant formula directly to the consumer is prohibited. retail establishments, such as special exhibitions, discount coupons, premiums, special sales, promotion sales and coupled sales.

7.4 Manufacturers or distributors of infant formulae are prohibited from providing the general public, pregnant women, mothers or members of their families, free or low-priced products, samples or any other gift of promotion, whether directly or indirectly through health services or health care personnel.

Article 8. Information.

8.1 The Sanitary Administrations will ensure that information on feeding infants and young children, in the field of planning, supply, conception and dissemination of information, as well as control, which is Provide families and people related to their nutrition to be objective and consistent.

8.2 The Sanitary Administrations shall ensure that information and educational material, written or audiovisual, concerning the feeding of infants and intended for pregnant women and mothers of infants and children Please include clear information on the following points:

8.2.1 Advantages and superiority of breastfeeding:

8.2.2 Maternal nutrition and how to prepare for breast-feeding and continuation of breast-feeding.

8.2.3 Possible negative effect of partial feeding with bottle on breast-feeding.

8.2.4 Difficulty of rectifying the decision not to breastfeed.

8.2.5 Where appropriate, the appropriate use of infant formulae, whether industrial manufacturing or home preparation.

Where such materials contain information on the use of infant formulae, they shall include the social and financial consequences of their use; health risks arising from inadequate food or methods In particular, the health risks arising from the inadequate use of infant formula are the health risks. Such materials shall not use any image that may idealize the use of infant formulae.

Chapter V

Donations

Article 9. Donations.

9.1 The Sanitary Administrations shall ensure that donations of equipment or information or educational material by manufacturers or distributors are only made at the request and after written approval of the aforementioned Administrations. Such equipment or materials may bear the name or flag of the donor undertaking, but must not make any specific reference to a specific brand of infant preparation and shall be distributed only through health services.

9.2 Sanitary Administrations shall ensure that donations or low-priced sales of infant formulae to institutions or organizations, for use in or for distribution outside the institutions or organizations, are intended or distributed only to infants who have to be fed with such preparations and only during the period which those infants require.

Chapter VI

General Food Health Record

Article 10. General Food Health Record.

To those prepared by the present Technical-Health Regulations, the provisions of Articles 4 and 5 of Royal Decree 1712/1991 of 29 November on the General Health Register of Food shall not apply to them.

Chapter VII

Exporting and importing

Article 11. Export and import.

11.1 The products covered by this Regulation which are to be drawn up for export to non-EEC countries and do not comply with the provisions of this provision shall be printed on their packaging. . In addition, your label must bear the word , or any other sign that is regulated and that allows you to identify it unequivocally to prevent the product from being marketed and consumed in Spain.

11.2 Imported products from countries outside the European Economic Community must meet the requirements set out in this provision.

Chapter VIII

Responsibilities and sanctioning regime

Article 12. Responsibilities and sanctioning regime.

The responsibilities as well as the penalties to be imposed for the infringements to be committed shall be governed by the provisions of Royal Decree 1945/1983 of 22 June 1983 governing infringements and penalties in respect of consumer protection and agri-food production, and the provisions of Law 14/1986 of 25 April, General of Health.

ANNEX I

Basic composition of infant formula when reconstituted according to the manufacturer's instructions

The indicated values refer to products ready for consumption.

1. Energy:

Minimum: 250 kJ (60 kcal/100 ml)

Maximum: 315 kJ (75 kcal/100 ml)

2. Protein:

(Protein content = nitrogen content x 6.38) for protein from cow's milk.

(Protein content = nitrogen content x 6.25) for protein from soy.

2.1 Preparations made from proteins contained in unmodified cow's milk:

Minimum: 0.56 g/100 kJ (2.25 g/100 kcal)

Maximum: 0.7 g/100 kJ (3 g/100 kcal)

The chemical index of the proteins present shall be equivalent to at least 80 per 100 of that of the reference protein (human milk, as defined in Annex VI); however, for the purposes of calculation, concentrations Methionine and cystine may be added together.

The will be the lowest ratio between the amount of each of the essential amino acids of the test protein and the amount of each of the corresponding amino acids of the reference protein.

2.2 Preparations made from the proteins contained in the modified cow's milk (alteration of the protein ratio of serum/casein):

Minimum: 0.45 g/100 kJ (1.8 g/100 kcal)

Maximum: 0.7 g/100 kJ (3 g/100 kcal)

For an equivalent energy value, the preparation shall contain an available quantity of each of the essential and semi-essential amino acids equal at least to that contained in the reference protein (human milk, as is defined in Annex V).

2.3 Preparations made from soya proteins alone or from a mixture with cow's milk protein:

Minimum: 0.56 g/100 kJ (2.25 g/100 kcal)

Maximum: 0.7 g/100 kJ (3 g/100 kcal)

Only soy proteins will be used in the preparation of these preparations.

The chemical index > shall be equal to at least 80 per 100 of that of the reference protein (breast milk, as defined in Annex VI).

For an equivalent energy value, the preparation shall contain an available amount of methionine equivalent at least to that contained in the reference protein (breast milk, as defined in Annex V).

The content of L-carnitine will be at least equivalent to 1.8 micromoles/100 kJ (7.5 micromoles/100 kcal).

2.4 In all cases, the addition of amino acids will be permitted only to improve the nutritional value of the proteins and, only, in the proportion necessary for this purpose.

3. Fats:

Minimum: 0.8 g/100 kJ (3.3 g/100 kcal)

Maximum: 1.5 g/100 kJ (6.5 g/100 kcal)

3.1 The use of the following substances is prohibited:

a) sesame oil.

b) Cotton oil.

c) Fats containing more than 8 per 100 of trans isomers of fatty acids.

3.2 Lauric acid:

Minimum:-

Maximum: 15 per 100 of the total fat content.

3.3 Myristic Acid:

Minimum:-

Maximum: 15 per 100 of the total fat content.

3.4 Linoleic acid (in the form of glycerides = linoleates):

Minimum: 70 mg/100 kJ (300 mg/100 kcal)

Maximum: 285 mg/100 kJ (1,200 mg/100 kcal)

4. Carbohydrates:

Minimum: 1.7 g/100 kJ (7 g/100 kcal)

Maximum: 3.4 g/100 kJ (14 g/100 kcal)

4.1 Only the following carbohydrates may be used:

1. Lactose.

2. Maltose.

3. Sucrose.

4. Malto-dextrin.

5. Glucose syrup or dehydrated glucose syrup.

6. Pre-roasted starch originating without gluten.

7. Gelatinized starch originating without gluten.

4.2 Lactose:

Minimum: 0.85 g/100 kJ (3.5 g/100 kcal)

Maximum:--

This provision shall not apply to preparations in which soya protein is more than 50 per 100 of the total protein content.

4.3 Sucrose:

Minimum:-

Maximum: 20 per 100 of the total carbohydrate content.

4.4 Pre-roasted starch or gelatinized starch:

Minimum:-

Maximum: 2 g/100 ml and 30 per 100 of the total carbohydrate content.

5. Mineral substances:

5.1 Prepared from the proteins obtained from cow's milk:

/Per 100 kJ: Minimum/Maximum/Per 100 kcal: Minimum/Maximum/

Sodium (mg)/5/14/20/60/

Potassium (mg)/15/35/60/145/

Chlorine (mg)/12/29/50/125/

Calcium (mg)/12/-/50/-/

Phosphorus (mg)/6/22/25/90/

Magnesium (mg)/1.2/3.6/5/15/

Iron (mg) (1)/0.12/0.36/0.5/1.5/

Cinc (mg)/0.12/0.36/0.5/1.5/

Copper (microg)/4.8/19/20/80/

Iodine (microg)/1,2//5/-/

(1) Limit applicable to those prepared for which iron has been added.

The calcium/phosphorus ratio shall not be less than 1,2 and not more than 2,0.

5.2 Preparations made from soy proteins or consisting of a mixture of soy proteins with the protein of cow's milk.

All requirements of paragraph 5.1 shall apply except those relating to iron and zinc which shall be as follows:

/Per 100 kJ: Minimum/Maximum/Per 100 kcal: Minimum/Maximum/

Iron (mg)/0.25/0.5/1/2/

Cinc (mg)/0.18/0.6/0.75/2.4/

6. Vitamins:

/Per 100 kJ/Minimum/Maximum/Per 100 kcal/Minimum/Maximum/

Vitamin A (micro-ER) (1)/14/43/60/180/

Vitamin D (microg) (2)/0.25/0.65/1/2.5/

Vitamin B1 (microg)/10/-/40/-/

Vitamin B2 (microg)/14/-/60/-/

Niacin (micro-EN) (3)/60/-/250/-/

Pantothenic acid (microg)/70/-/300/-/

Vitamin B6 (microg)/9/-/35/-/

Biotin (microg)/0.4/-/1.5/-/

Folic acid (microg)/1/-/4/-/

Vitamin B12 (microg)/0.025/-/0.1//

Vitamin C (mg)/1.9/-/8/-/

Vitamin K (microg)/1/-/4/-/

Vitamin E (mgalfa-ET) (4)/0 ,5/g of polyunsaturated fatty acids expressed as linoleic acid, in no case less than 0.1 mg per 100 kJ available. /-/0 ,5/g of polyunsaturated fatty acids expressed as linoleic acid, in no case less than 0,5 mg per 100 kcal available. /-/

(1) ER = All trasn equivalent retinol.

(2) In the form of colecalciferol of which 10 microg = 400 U.I. of vitamin D.

(3) EN = Equivalent of niacin = mg nicotinic acid + mg tryptophan/60.

(4) alpha-ET = Equivalent of d-alpha-Tocoferol.

ANNEX II

Basic composition of the follow-on formulae when they are reconstituted according to the manufacturer's instructions

The indicated values refer to the product ready for consumption.

1. Energy:

Minimum: 250 kJ/100 ml (60 kcal/100 ml)

Maximum: 335 kJ/100 ml (80 kcal/100 ml)

2. Protein:

(Protein content = nitrogen content x 6.38) for cow's milk proteins. (Protein content = nitrogen content x 6.25) for soya proteins.

Minimum: 0.5 g/100 kJ (2.25 g/100 kcal)

Maximum: 1 g/100 kJ (4.5 g/100 kcal)

The chemical index of the proteins present shall be at least equivalent to 80 per 100 of that of the reference protein (casein, as defined in Annex VI).

The chemical index > will consist of the lower ratio of the existing ones between the amount of each of the essential amino acids of the test protein and the amount of each of the corresponding amino acids of the protein. reference.

In the case of follow-on formulae made from soya proteins or from a mixture of soya proteins with the protein of cow's milk, only protein isolates from soya will be used.

amino acids may be added to the follow-on formulae in order to increase the nutritional value of the proteins and always to the extent necessary for this purpose.

3. Fats:

Minimum: 0.8 g/100 kJ (3.3 g/100 kcal)

Maximum: 1.5 g/100 kJ (6.5 g/100 kcal)

3.1 The use of the following substances is prohibited:

a) sesame oil.

b) Cotton oil.

c) Fats containing more than 8 per 100 of trans isomers of fatty acids.

3.2 Lauric acid:

Minimum:-

Maximum: 15 per 100 of the total fat content.

3.3 Myristic Acid:

Minimum:-

Maximum: 15 per 100 of the total fat content.

3.4 Linoleic acid (in the form of glycerides = linoleates):

Minimum: 70 mg/100 kJ (300 mg/100 kcal)

Maximum:-

This limit is only applied to follow-on formulae containing vegetable oils.

4. Carbohydrates:

Minimum: 1.7 g/100 kJ (7 g/100 kcal)

Maximum: 3.4 g/100 kJ (14 g/100 kcal)

4.1 The use of gluten-containing ingredients is prohibited:

4.2 Lactose:

Minimum: 0.45 g/100 kJ (1.8 g/100 kcal)

Maximum:--

This provision is not applicable to the follow-on formulae in which soya proteins assume more than 50 per 100 of the total protein content.

4.3 Sucrose, fructose, honey:

Minimum:-

Maximum: Separately or in aggregate: 20 per 100 of the total carbohydrate content.

5. Mineral substances:

5.1

/Per 100 kJ: Minimum/Maximum/Per 100 kcal: Minimum/Maximum/

Iron (mg)/0.25/0.5/1/2/

Iodine (microg)/1,2/-/5/-/

5.2 Cinc:

5.2.1 Continuation preparations made entirely from the

cow's milk:

Minimum: 0.12 mg/100 kJ (0.5 mg/100 kcal)

Maximum:-

5.2.2 Continuation preparations containing soy protein or a mixture of soy proteins with cow's milk:

Minimum: 0.18 mg/100 kJ (0.75 mg/100 kcal)

Maximum:-

5.3 Other mineral substances:

The concentrations shall be at least equivalent to those normally found in cow's milk, lowered, where appropriate in the same ratio as the protein concentration of the follow-on preparation with respect to milk of cow. The typical composition of cow's milk is included in Annex VII as a guideline.

5.4 The calcium/phosphorus ratio must not exceed 2,0.

6. Vitamins:

/Per 100 kJ: Minimum/Maximum/Per 100 kcal: Minimum/Maximum/

Vitamin A (micro-ER) (1)/14/43/60/180/

Vitamin D (microg) (2)/0.25/0.75/1/3/

Vitamin C (mg)/1.9/-/8/-/

Vitamin E (mgalfa-ET) (3)/0 ,5/g of polyunsaturated fatty acids expressed as linoleic acid, in no case less than 0.1 mg per 100 kJ available. /-/0 ,5/g of polyunsaturated fatty acids expressed as linoleic acid, in no case less than 0,5 mg per 100 kcal available. /-/

(1) ER = All trans retinol equivalent.

(2) In the form of colecalciferol, of which 10 microg = 400 U.I. vitamin D.

(3) alpha-ET = D-alpha-tocopherol equivalent.

ANNEX III

Nutritional substances

1. Vitamins:

Vitamin/Substance allowed/

Vitamin A/Retinol (INN).

Retinol acetate.

Retinol palmitate.

Beta-Carotene.

Vitamin D/Vitamin D2 (ergocalciferol) (INN).

Vitamin D3 (ergocalciferol) (INN). /

Vitamin B1/Tiamine hydrochloride (INN).

Tiamine mononitrate (INN). /

Vitamin B2/Riboflavin (INN).

Riboflavin-5 '-sodium phosphate. /

Niacin/Nicotinamide.

Nicotinic acid (INN). /

Vitamin B6/Pyridoxine Hydrochloride (INN).

Pirodoxine-5 '-phosphate. /

Folic acid/Folates. /

Pantothenic acid/D-calcium pantothenate.

D-pantothenate sodium.

Dexpantenol. /

Vitamin B12/Cyanocobalamin.

hydroxycobalamin. /

Biotin/D-Biotin. /

Vitamin C/L-ascorbic acid.

L-ascorbate sodium.

L-calcium ascorbate.

Acid 6 palmitil-L-ascorbic acid (ascorbilo palmito).

potassium ascorbate. /

Vitamin E/D-alpha tocopherol.

DL-alpha tocopherol.

D-alpha-tocopherol acetate.

DL-alpha acetate of tocopherol. /

Vitamin K/Fitomenadione (INN) (quinone). /

INN: International Non-proprietary Name.

2. Mineral substances:

Mineral Substances/Sales Allowed/

Calcium (Ca)/Calcium Carbonate.

Calcium chloride.

calcium salts of citric acid.

Calcium gluconate.

Calcium glycerophosphate.

Calcium lactate.

calcium salts of orthophosphoric acid.

Calcium hydroxide. /

Magnesium (Mg)/Magnesium Carbonate.

Magnesium chloride.

Magnesium oxide.

Magnesium orthophosphates.

Magnesium sulfate.

Magnesium gluconate.

Magnesium hydroxide.

Magnesium citrates. /

Iron (Fe)/ferrous Citrate.

Ferrous gluconate.

ferrous lactate.

Ferrous sulfate.

Ferric ammonium citrate.

Ferrous fumarate.

Ferric diphosphate. /

Copper (Cu)/Copric Citrate.

Cupric Gluconate.

Cupric Sulfate.

Cobre-lysine complex.

Cupric Carbonate. /

Iodine (I)/potassium iodide.

Sodium iodide.

Potassium iodate. /

Zinc (Zn)/Zinc Acetate.

Zinc chloride.

zinc lactate.

Zinc Sulfate.

zinc citrate.

Zinc gluconate.

Zinc Oxide. /

Manganese (Mn)/Manganese Carbonate.

Manganese chloride.

manganese citrate.

Manganese sulfate.

Manganese gluconate. /

Sodium (Na)/Sodium bicarbonate.

Sodium chloride.

Sodium citrate.

Sodium gluconate.

Sodium carbonate.

Sodium lactate.

Monobasic sodium phosphate.

Dibasic Sodium Phosphate.

Sodium tribasic phosphate.

Sodium hydroxide. /

Potassium (K)/Potassium bicarbonate.

Potassium carbonate.

Potassium chloride.

Potassium citrates.

Potassium gluconate.

Potassium lactate.

Potassium orthophosphates.

Potassium hydroxide. /

3. Amino acids and other nitrogenous compounds:

L-arginine and its hydrochloride.

L-cystine and its hydrochloride.

L-histidine and its hydrochloride.

L-isoleucine and its hydrochloride.

L-leucine and its hydrochloride.

L-lysine and its hydrochloride.

L-cysteine and its hydrochloride.

L-methionine.

L-phenylalanine.

L-threonine.

L-tryptophan.

L-tyrosine.

L-valine.

L-carnitine and its hydrochloride.

Taurine.

4. Other:

Hill.

Choline Chloride.

Hill citrate.

Hill Bitartrate.

Inositol.

ANNEX IV

Composition criteria for infant formulae that authorize the corresponding declaration

Statement on/Conditions authorizing the declaration/

1. Adapted proteins/The protein content is less than 0.6 g/100 kJ (2.5 g/100 kcal) and the ratio of serum/casein proteins is not less than 1.0. /

2. Low sodium content/The sodium content is less than 9 mg/100 kJ (939 mg/100 kcal). /

3. Absence of sucrose/No sucrose. /

4. Only lactose/lactose is the only carbon hydrate present. /

5. Absence of lactose/No lactose (1). /

6. Enrichment with iron/With addition of iron. /

(1) When determined by a method whose detection limits will be set later.

ANNEX V

Essential and semi-essential amino acids in breast milk

For the purposes of this Regulation, the essential and semi-essential amino acids of breast milk, expressed in milligrams per 100 kJ and 100 kcal, are as follows:

/By 100 kJ (1)/By 100 kcal/

Arginine/16/69/

Cystine/6/24/

Histidine/11/45/

Isoleucine/17/72/

Leucine/37/156/

Lisina/29/122/

Metionine/7/29/

Phenylalanine/15/62/

Treonin/19/80/

Tryptophan/7/30/

Tirosin/14/59/

Valina/19/80/

(1) 1 kJ = 0.239 kcal.

ANNEX VI

Composition of amino acids from breast milk casein

The amino acid composition of casein and protein derived from breast milk (g/100 g of protein) is as follows:

/Casein (1)/Breast milk (1)/

Arginine/3.7/3.8/

Cystine/0.3/1.3/Histidine/2.9/2.5/

Isoleucine/5.4/4.0/

Leucine/9.5/8.5/

Lisina/8.1/6.7/

Methionine/2.8/1.6/

Phenylalanine/5.2/3.4/

Treonine/4.7/4.4/

Tryptophan/1.6/1.7/

Tirosin/5.8/3.2/

Valina/6.7/4.5/

(1) Content in amino acids of food and biological data on proteins. FAO nutritional studies, number 24, Rome 1970, points 375 and 383.

ANNEX VII

Mineral substances from cow's milk

As a guideline, the content of mineral substances in cow's milk expressed per 100 g of non-fatty solids and per gram of protein is as follows:

/By 100 g SNG (1)/Per g of protein/

Sodium (mg)/550/15/

Potassium (mg)/1,680/43/

Chlorine (mg)/1,050/28/

Calcium (mg)/1,350/35/

Phosphorus (mg)/1,070/28/

Magnesium (mg)/135/3.5/

Copper (microg)/225/6/

Iodo/NE (2)/NE (2)/

(1) SNG:

.

(2) NE: Not specified, varies depending on season and livestock breeding conditions.