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Real Decree 72/1998, 23 January, Which Approves The Specific Reglamentación Preparations For Infants And Preparations Continued.

Original Language Title: Real Decreto 72/1998, de 23 de enero, por el que se aprueba la Reglamentación técnico-sanitaria específica de los preparados para lactantes y preparados de continuación.

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TEXT

Royal Decree 2685/1976 of 16 October adopted the Technical and Health Regulations for the elaboration, circulation and trade of food preparations for dietary and/or special regimes, regulations which have been On several occasions, the Royal Decrees 385/1980, of 18 January; 1424/1982 of 18 June; 3140/1982 of 12 November; 2353/1986 of 10 October; 1426/1988 of 25 November, and 1809/1991 of 13 December.

In the Annex to Royal Decree 1809/1991, last amended to the Technical-Health Regulations mentioned above, the relationship of the foodstuffs to be the subject of legislation is established (a) specific, by means of technical and health regulations, including infant formulae and follow-on formulae.

The adoption of Commission Directive 91 /321/EEC of 14 May concerning infant formulae and follow-on formulae has made it necessary to incorporate into the internal legal order of this Directive, Royal Decree 1408/1992 of 20 November 1992 on the specific technical and health regulations of infant formulae and follow-on formulae, which was amended by Royal Decree 46/1996 of 19 December 1996, January.

Given the scientific advances that justify the modifications of the basic composition of infant formulae and follow-on formulae, the Commission of the European Union considered it necessary to adopt the Directive 96 /4/EC of 16 February 2009 implementing the amendment of Directive 91 /321/EEC. It is therefore necessary to incorporate this Directive into our internal legal order, by means of a specific technical-health regulation to take account of these changes.

This Royal Decree is dictated by the provisions of Articles 149.1. 10.a and 16.a, of the Spanish Constitution and in accordance with the provisions of Articles 38, 40.2 and 40.4 of Law 14/1986 of 25 April, General of Health.

In the preparation of this provision, the sectors affected have been heard and the mandatory report has been issued by the Inter-Ministerial Commission for Food Management.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, Agriculture, Fisheries and Food, Economy and Finance, and Industry and Energy, in agreement with the Council of State and after deliberation by the Council of Ministers at their meeting on 23 January 1998,

D I S P O N G O:

Article 1. Object.

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 and advertising and information of the same.

Article 2. Definitions.

For the purposes of this provision:

1. Infants: children aged less than 12 months.

2. Young children: children between one and three years of age.

3. Infant formulae: food products intended for the special feeding of infants from birth to the first four to six months of life, which satisfy themselves the nutritional needs of this category of infants persons.

4. Follow-on formulae: foodstuffs intended for particular nutritional uses of infants over four months of age, constituting the main liquid element of a progressively diversified diet of this category of persons.

Article 3. Elaboration and composition.

1. Infant formulae:

(a) In the case of protein sources defined in the Annexes to this Regulation and other food ingredients the suitability of which for the special feeding of infants from birth, as appropriate, shall be drawn up. has been determined by generally accepted scientific data.

(b) They must comply with the composition criteria specified in Annex I.

2. Follow-on formulae:

(a) The protein sources defined in the Annexes to this Regulation and other food ingredients, which are suitable for the special feeding of infants aged over four, shall be drawn up, as appropriate. months of age has been determined by generally accepted scientific data.

(b) They shall comply with the composition criteria set out in Annex II.

Article 4. Prohibitions and limitations.

1. Infant formulae: no product other than a infant preparation may be marketed or presented as suitable to satisfy itself the nutritional needs of normal, healthy infants during the first four years. six months of life.

2. Infant formulae and follow-on formulae:

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

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

(c) In its preparation only the substances listed in Annex III may be used in order to meet the requirements of:

1.o Mineral substances.

2.Vitamines.

3.o Amino Acids and other nitrogenous compounds.

4.Other substances for special nutritional purposes.

(d) They shall not contain any substance in quantity such as to endanger the health of infants and young children.

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

Article 5. Labelling.

1. The products referred to in Article 2 (3) and (4) of this Regulation shall be marketed under the names "infant formulae" and "follow-on formulae", respectively.

However, the name of the food made entirely from the protein derived from cow's milk will be as follows: "breast milk" and "follow-on milk".

2. The labelling of the products referred to in this provision must comply with the provisions of Royal Decree 212/1992 of 6 March 1992 on the general rule on the labelling, presentation and advertising of foodstuffs.

3. The labelling of "infant formulae" and "follow-on formulae" shall also include the following data:

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

(b) The average quantity of each mineral substance and of each vitamin referred to in Annex I and Annex II, respectively, and, where appropriate, of choline, inositol, carnitine and taurine, expressed in numerical form per 100 millilitres of the product ready for consumption.

(c) 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.

1.o The labelling of these products may also include the average quantity of the nutrients referred to in Annex III, if such indication is not governed by the provisions of paragraph 3.b) of this Article, expressed in numerical form per 100 millilitres of the product ready for consumption.

2.o The labelling 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 breast-feeding, the use of the terms being prohibited 'humanised', 'maternised' or similar.

4. The labelling of "infant formulae" shall also include the following data:

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

(b) Where these products are not enriched with iron, an indication that when the product is administered to children over four months of age the total iron needs of these products must be met. by other appropriate sources.

(c) An indication of the superiority of breast-feeding and the recommendation that the product should be used only on the advice of qualified independent persons in medicine, nutrition or pharmacy, or other Professional staff responsible for maternal and child care, preceded by the words "Important notice" or equivalent.

1.o The labelling of these products may also include 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.

2.o The term "adapted" may only be used in accordance with the provisions of paragraph 4.1.o above and in paragraph 1 of Annex IV.

3.o The labelling will not include images of children or other illustrations or texts that can idealise the use of the product. However, they may carry graphic representations that allow easy identification of the product and illustrate the method of preparation.

5. The labelling of the "follow-on formulae" shall also include the following data:

An indication that the product is suitable only for the special feeding of children over four months of age, 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.

The labelling of these products may include, in addition to the numerical information, information on the vitamins and minerals listed in Annex VIII, expressed as a percentage of the reference values indicated therein, by every 100 millilitres of the product ready for consumption, provided that the quantities present are at least equal to 15 per 100 of the reference values.

6. The requirements, prohibitions and restrictions referred to in paragraphs 3.2.; 4.c); 4.1.o, 4.2.o and 4.3.o shall also apply to:

(a) The presentation of the products concerned, in particular their shape, appearance and packaging, the packaging material used, the manner in which they are disposed and the means in which they are exposed.

b) Advertising.

Article 6. Advertising.

1. The advertising of infant formulae shall be limited to publications specialising in child care and scientific publications.

2. Notices of infant formulae shall comply with the conditions laid down in paragraphs 3.2.; 4.c); 4.1.o; 4.2.o, 4.3.o and 6.b) of Article 5 and shall contain only objective information of a scientific nature.

Such information should not imply or suggest that bottle feeding is equivalent to or superior to breastfeeding.

3. Advertising in places of sale, distribution of samples or the use of any other means of propaganda, aimed at promoting sales of infant formulae directly to the consumer in retail establishments, is prohibited. as special exhibits, discount coupons, premiums, special sales, promotional sales or coupled sales.

4. Manufacturers or distributors of infant formulae are prohibited from providing the general public, pregnant women, mothers or members of their families, products below the cost price or by symbolic price, samples or no other promotional gift, whether directly or indirectly through the health services or the health personnel.

Article 7. Information.

1. The health authorities shall ensure that information on the feeding of infants and young children in the field of planning, supply, design and dissemination of information, as well as control, is provided to families and people related to their nutrition, be objective and consistent.

2. The health authorities shall ensure that the information and educational material, written or audiovisual, concerning the feeding of infants and intended for pregnant women and mothers of infants and young children, includes: clear information on the following points:

a) Benefits and superiority of breastfeeding.

b) maternal nutrition and how to prepare for breast-feeding and continuation of breast-feeding.

c) Possible negative effect of partial feeding on breast feeding.

d) Difficulty to rectify the decision not to breastfeed.

e) Where appropriate, the appropriate use of infant formulae, whether industrial or home-made.

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

Article 8. Donations.

1. The health authorities shall ensure that donations of equipment or information or educational material by manufacturers or distributors are only made at the request of the general public and after written approval by those authorities. Such equipment or materials may bear the name or distinctive name of the donor undertaking, but must not make any reference to a specific brand of infant formula and shall be distributed only through health services.

2. The health authorities shall ensure that donations or sales at low prices, of consignments of infant formulae to institutions or organisations, for use in or for distribution outside them, are intended only for: distribute to infants who need to be fed with these preparations and only during the period that the infants require.

Article 9. Distribution and marketing.

Infant formulae and follow-on formulae, referred to in this Specific Technical-Health Regulation, shall be distributed and marketed throughout the national territory, in their packaging of origin, to through the offices of pharmacy and the channels of the food retail trade.

Article 10. General Food Health Record.

Products regulated by this Regulation shall not apply to them the provisions of Articles 4 and 5 of Royal Decree 1712/1991 of 29 November on the General Health Register of Food.

Article 11. Products from third countries.

The products referred to in this provision and which come from third countries must comply with their marketing in Spain, the requirements set out in this Royal Decree.

Article 12. Sanctioning regime.

1. Without prejudice to any other legislation which may be applicable, the offences committed against the provisions of this Royal Decree shall be subject to administrative penalties, subject to the instruction of the appropriate administrative file, in accordance with The provisions of Chapter VI of Title I of Law 14/1986 of 25 April, General of Health.

2. In accordance with Article 35 (B) 1 1 of Law 14/1986, General Health, failure to comply with the rules on the labelling, information and advertising of products covered by this Regulation shall be deemed to be serious. Health-technical.

3. In addition, in accordance with Article 35 (C), 1 or 1 of Law 14/1986, General Health, the marketing of products subject to regulation by this Royal Decree which does not meet the criteria of the composition specified in Annexes I, II and III.

Additional disposition first. Competence title.

The provisions of this Royal Decree, which shall apply throughout the national territory, are hereby issued pursuant to Article 149.1.16.a of the Spanish Constitution and pursuant to the provisions of Article 40.2 and 4 of Law 14/1986, of 25 April, General of Health, with the exception of Article 11, which is issued in accordance with the provisions of Article 149.1.10.a of the Spanish Constitution and Article 38 of Law 14/1986 of 25 April, General de Health, which enshrine the exclusive powers of the State in matters of trade and external health.

Additional provision second. Microbiological criteria.

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 2000 approving the Technical-health regulations for the production, circulation and trade of food preparations for dietary and/or special arrangements.

Single transient arrangement. Extension of marketing.

The foodstuffs referred to in this Royal Decree, which do not comply with the provisions of this Regulation, but which comply with the provisions of the legislation in force on the date of its entry into force, may be marketed. until 31 March 1999.

Single repeal provision. Provisions to be repealed.

The Royal Decrees 1408/1992 of 20 November 1992 and 46/96 of 19 January 1996, for which the specific technical-health regulations for infant and infant formulae are approved and amended, are hereby repealed. The following are prepared as follows, as well as how many provisions of equal or lower rank are opposed to the provisions of this Royal Decree.

Final disposition first. Technical update.

The Minister for Health and Consumer Affairs is empowered to amend or update the microbiological criteria referred to in the provision by Order and on the basis of a report from the Inter-Ministerial Commission for Food Management. Second and the Annexes to this Royal Decree, in order to bring them into line with the rules of the European Community.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Dado en Madrid a 23 de enero de 1998.

JOHN CARLOS R.

The First Vice President of the Government

and Minister of the Presidency,

FRANCISCO ALVEZ-HELMETS FERNANDEZ

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 isolated soy proteins and for partial protein hydrolysates.

The "chemical index" 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.

(a) Prepared from cow's milk protein:

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 (such as breast milk and as defined in Annex V). However, concentrations of methionine and cystine may be added for the purpose of the calculation.

(b) Prepared from partial protein hydrolysates:

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

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

For an equivalent energy value, preparations shall contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (such as breast milk). and as defined in Annex V). However, concentrations of methionine and cystine may be added for the purpose of the calculation.

The protein efficacy coefficient (CEP) and the net protein utilization (UPN) must be at least equal to that of casein.

The taurine content shall be at least equivalent to 10 mmoles/100 kJ (42 mmoles/100 kcal) and the L-carnitine content shall be at least equal to 1,8 mmoles/100 kJ (7,5 mmoles/100 kcal).

(c) 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 at least 80 per 100 of the reference protein (breast milk, as defined in Annex VI).

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

The L-carnitine content shall be at least 1,8 mmoles/100 kJ (7,5 mmoles/100 kcal).

d) 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. Lipids:

Minimum: 1.05 g/100 kJ (4.4 g/100 kcal).

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

(a) The use of the following substances shall be prohibited: sesame oil, cotton oil.

b) Lauric acid:

Minimum:-.

Maximum: 15 per 100 of the total fat content.

c) Myristic acid:

Minimum:-.

Maximum: 15 per 100 of the total fat content.

d) 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).

e) The alpha-linolenic acid content shall not be less than 12 mg/100 kJ (50 mg/100 kcal).

The ratio between linoleic and alpha-linolenic acids shall not be less than 5 and not more than 15.

f) The content of trans fatty acids shall not exceed 4 per 100 of the total fat content.

g) The erucic acid content shall not exceed 1 per 100 of the total fat content.

h) Long chain polyunsaturated fatty acids (20 and 22 carbon atoms) (PCL) may be added. In such a case, their content shall not exceed: 1 per 100 of the total fat content for PCL n-3, and 2 per 100 of the total fat content for PCL n-6 (1 per 100 of the total fat content for arachidonic acid).

The content of eicosapentaenoic acid (20: 5 n-3) will not exceed the docosahexaenoic acid content (22: 6 n-3).

4. Carbohydrates:

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

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

(a) Only the following carbohydrates may be used: lactose, maltose, sucrose, maltodextrin, glucose syrup or dehydrated glucose syrup, pre-roasted starch originating without gluten, gelatinised starch originally gluten-free.

b) 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.

c) Sucrose:

Minimum:-.

Maximum: 20 per 100 of the total carbohydrate content.

d) Pre-roasted starch or gelatinized starch:

Minimum:-.

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

5. Mineral substances:

(a) Preparations made from the proteins obtained from cow's milk:

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

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

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

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

Selenium (mg) (2)/-/0.7/-/3

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

(2) Limit applicable to those prepared for which selenium has been added. The calcium/phosphorus ratio shall not be less than 1,2 and not more than 2,0.

(b) Prepared prepared from soy proteins or consisting of a mixture thereof with the protein of the cow's milk.

All requirements of paragraph 5.a shall apply, except those relating to iron and zinc, which shall be as follows:

By 100 kJ/Per 100 kcal

/Minimum/Maximum/Minimum/Maximum

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

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

6. Vitamins:

By 100 kJ/Per 100 kcal

/Minimum/Maximum/Minimum/Maximum

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

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

Tiamine (mg)/10/-/40/-

Riboflavin (mg)/14/-/60/-

Niacin (mg-EN) (3)/0.2/-/0.8/-

Pantothenic acid (mg). /70/-/300/-

Vitamin B (mg)/9/-/35/-

Biotin (mg)/0.4/-/1.5/-

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

Vitamin B (mg)/0.025/-/0.1/-

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

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

Vitamin E (mg alpha-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 kJ available.

(1) ER = All trans retinol equivalent.

(2) In the form of colecalciferol, of which 10 mg = 400 IU of vitamin D.

(3) EN = Niacin equivalent = mg of nicotinic acid + mg tryptophan/60.

(4) alpha-TE = Equivalent of d-alpha-tocopherol.

7. The following nucleotides may be added:

Maximum (1)/mg/100 kJ/mg/100 kcal

Citidine 5 '-monophosphate/0.60/2.50

Uridine 5 '-monophosphate/0.42/1.75

Adenosine 5 '-monophosphate/0.36/1.50

Guanosine 5 '-monophosphate/0.12/0.50

Inosine 5 '-monophosphate/0.24/1.00

(1) The total nucleotide concentration shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).

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 protein from cow's milk.

Protein content = nitrogen content x 6.25 for soy 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 80 per 100 of that of the reference protein (casein or breast milk as defined in Annex VI).

The "chemical index" will consist of the smaller proportion of those obtained 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.

For an equivalent energy value, these preparations shall contain an available amount of methionine, at least equivalent to that contained in the breast milk, as defined in Annex V.

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 in the proportion necessary for this purpose.

3. Lipids:

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

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

(a) The use of the following substances shall be prohibited: sesame oil, cotton oil.

b) Lauric acid:

Minimum:-.

Maximum: 15 per 100 of the total fat content.

c) Myristic acid:

Minimum:-.

Maximum: 15 per 100 of the total fat content.

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

Minimum: 70 mg/100 kJ (300 mg/100 kcal). This limit is only applied to follow-on formulae containing vegetable oils.

Maximum:-.

e) The content of trans fatty acids shall not exceed 4 per 100 of the total fat content.

f) The erucic acid content shall not exceed 1 per 100 of the total fat content.

4. Carbohydrates:

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

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

(a) The use of gluten-containing ingredients is prohibited.

b) 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.

c) Sucrose, fructose, honey:

Minimum:-.

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

5. Mineral substances:

a)

By 100 kJ/Per 100 kcal

/Minimum/Maximum/Minimum/Maximum

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

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

b) Zinc:

1.o Continuation preparations made entirely from cow's milk:

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

Maximum:-.

2.o 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:-.

(c) Other mineral substances: concentrations must be at least equivalent to those normally found in cow's milk, lowered, where appropriate, in the same proportion as the concentration of the protein in the preparation of the following preparation in respect of cow's milk. The typical composition of cow's milk is given in Annex VII for guidance.

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

6. Vitamins:

By 100 kJ/Per 100 kcal

/Minimum/Maximum/Minimum/Maximum

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

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

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

Vitamin E (mg alpha-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 equivalent in trans retinol.

(2) In the form of colecalciferol, of which 10 mg = 400 IU of vitamin D.

(3) alpha-TE = Equivalent of d-alpha-tocopherol.

7. The following nucleotides may be added:

Maximum (1)/mg/100 kJ/mg/100 kcal

Citidine 5 '-monophosphate/0.60/2.50

Uridine 5 '-monophosphate/0.42/1.75

Adenosine 5 '-monophosphate/0.36/1.50

Guanosine 5 '-monophosphate/0.12/0.50

Inosine 5 '-monophosphate/0.24/1.00

(1) The total nucleotide concentration shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).

ANNEX III

Vitamins, minerals, amino acids, and others

composites

1. Vitamins

Vitamins/Permitted Substances

Vitamin A./Retinol Acetate.

Retinol palmitate.

Beta-Carotene.

Retinol.

Vitamin D./Vitamin D (ergocalciferol).

Vitamin D (colecalciferol).

Vitamin B./Thiamine Hydrochloride.

thiamine mononitrate.

Vitamin B./Riboflavin.

Riboflavin-5 '-sodium phosphate.

Niacin. /Nicotinamide.

Nicotinic acid.

Vitamin B./Pyridoxine Hydrochloride.

pyridine-5 '-phosphate.

Folate. /Folic acid.

Pantothenic acid. /D-calcium pantothenate.

D-pantothenate sodium.

Dexpantenol.

Vitamin B./Cyanocobalamin.

hydroxycobalamin.

Biotin. /D-Biotin.

Vitamin C./L-ascorbic acid.

L-ascorbate sodium.

L-calcium ascorbate.

6-palmitil-L-ascorbic acid (ascorbilyl palmitate).

potassium ascorbate.

Vitamin E./D-alpha tocopherol.

DL-alpha tocopherol.

D-alpha-tocopherol acetate.

DL-alpha acetate of tocopherol.

Vitamin K./quinone (Fitomenadione).

2. Mineral substances

Permitted Mineral/Sales Substances

Calcium (Ca). /Calcium Carbonate.

Calcium chloride.

Citric acid calcium salts.

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). /cuprico citrate.

Cupric Gluconate.

Cupric Sulfate.

Cobre-lysine complex.

Cupric Carbonate.

Iodine (I). /iodide potassium.

Iodide sodium.

potassium iodate.

Zinc (Zn). /Zinc Acetate.

Zinc chloride.

Zinc lactate.

Zinc Sulfate.

Zinc Citrate.

Zinc gluconate.

Zinc Oxide.

Manganese (Mn). /Manganese carbonate.

Manganese chloride.

Citrate of Mananganese.

Manganese Sulfate.

Manganese gluconate.

Sodium (Na). /Sodium bicarbonate.

Sodium Chloride.

Sodium citrate.

Sodium gluconate.

Sodium Carbonate.

Sodium lactate.

Sodium monobasic phosphate.

Sodium dibasic phosphate.

Sodium tribasic phosphate.

Sodium Hydroxide.

Potassium (K). /potassium bicarbonate.

Potassium carbonate.

Potassium chloride.

Potassium Citrates.

Potassium gluconate.

Potassium lactate.

Potassium orthophosphates.

Potassium hydroxide.

Selenium (Se). /Sodium seleniate.

Selenito sodium.

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.

Citidine 5 '-monophosphate and its sodium salt.

Uridine 5 '-monophosphate and its sodium salt.

Adenosine 5 '-monophosphate and its sodium salt.

Guanosine 5 '-monophosphate and its sodium salt.

Inosine 5 '-monophosphate and its sodium salt.

4. Other

Hill.

Choline Chloride.

Hill citrate.

Hill Bitartrate.

Inositol.

ANNEX IV

Composition criteria for infant formulae that authorize the corresponding declaration

Statement Regarding/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 infe rior at 9 mg/100 kJ (39 mg/100 kcal).

3. /Absence of sucrose. /Does not contain sucrose.

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

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

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

7. /Reduction of the risk of allergy to milk proteins. This statement may be accompanied by terms referring to reduced or reduced antigenic allergenic property. /(a) The preparations comply with the requirements laid down in Annex I (2) (b) and the quantity of immuno-reactive protein, measured by generally accepted methods, is less than 1 per 100 of the nitrogenous substances in the preparation.

b) It is indicated on the label that the product should not be consumed by lactating infants to the intact proteins from which it is appropriate, unless it is established, by generally accepted clinical trials, that the preparation is tolerated. by more than 90 per 100 of the infants (95 per 100 confidence interval) who are hypersensitive to the protein from which the hydrolysate is derived.

(c) Orally administered preparations do not induce sensitisation in animals against the intact proteins from which the preparation comes.

d) objective and scientifically verified data are available as evidence of declared properties.

(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, ex-

given in milligrams per 100 kJ and 100 kcal, are as follows:

Per 100 kJ */Per 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 kJ = 0.239 kcal.

ANNEX VI

Composition of amino acids from casein

and breast milk proteins

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

Casein */Breast milk *

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

Treonin/4.7/4.4

Tryptophan/1.6/1.7

Tyrosine/5.8/3.2

Valina/6.7/4.5

* 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:

Per 100 g SNG */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 (mg)/225/6

Iodine/NE **/NE

* SNG: Non-fatty solids.

** NE: Not specified, varies depending on season and livestock breeding conditions.

ANNEX VIII

Reference values for the labelling of nutritional properties of foods for infants and young children

Reference value

for tagging/Nutrient

Vitamin A (mg)/400

Vitamin D (mg)/10

Vitamin C (mg)/25

Tiamine (mg)/0.5

Riboflavin (mg)/0.8

Niacin Equivalents (mg)/9

Vitamin B (mg)/0.7

Folate (mg)/100

Vitamin B (mg)/0.7

Calcium (mg)/400

Iron (mg)/6

Zinc (mg)/4

Iodine (mg)/70

Selenium (mg)/10

Copper (mg)/0.4