**Avis juridique important**

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# 31991L0321

**Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae***Official Journal L 175 , 04/07/1991 P. 0035 - 0049 Finnish special edition: Chapter 15 Volume 10 P. 0107  Swedish special edition: Chapter 15 Volume 10 P. 0107*

COMMISSION DIRECTIVE  of 14 May 1991  on infant formulae and follow-on formulae  (91/321/EEC)

 THE COMMISSION OF THE EUROPEAN COMMUNITIES, 

 Having regard to the Treaty establishing the European Economic Community, 

 Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (1), and in particular Article 4 thereof, 

 Whereas the essential composition of the products in question must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data; 

 Whereas on the basis of these data the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture can already be defined; whereas the same is not true for preparations  based wholly or partly on other sources of protein; whereas for this reason specific rules for such products, if necessary, will therefore have to be adopted at a later date; 

 Whereas this Directive reflects current knowledge about these products; whereas any modification, to allow innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC; 

 Whereas because of the persons for which these products are intended it will be necessary to lay down microbiological criteria and maximum levels for contaminants; whereas given the complexity of the subject these will have to be adopted at a later  stage; 

 Whereas infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first four to six months of life; whereas in order to safeguard the health of such infants it is necessary to ensure that  the only products marketed as suitable for such use during the period would be infant formulae; 

 Whereas pursuant to Article 7 (1) of Directive 89/398/EEC the products covered by this Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States  relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (2), as last amended by Directive 89/395/EEC (3); whereas this Directive adopts and expands upon the additions and exceptions to those general rules,  where it is appropriate, in order to promote and protect breast-feeding; 

 Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling for the energy value and principal nutrients they contain; whereas, on the other hand, the method of use must be specified in  conformity with Article 3 (1) (8) and Article 10 (2) of Directive 79/112/EEC, in order to prevent inappropriate uses likely to be detrimental to the health of infants; 

 Whereas, pursuant to Article 2 (2) of Directive 79/112/EEC, and in order to supply objective and scientifically verified information, it is necessary to define the conditions under which claims about the particular composition of an infant formula are  authorized; 

 Whereas, in an effort to provide better protection for the health of infants, the rules of composition, labelling and advertising laid down in this Directive should be in conformity with the principles and the aims of the International Code of Marketing  of Breast-Milk Substitutes adopted by the 34th World Health Assembly, bearing in mind the particular legal and factual situations existing in the Community; 

 Whereas given the important role which information on infant feeding plays in choosing, by pregnant women and mothers of infants, the type of nourishment provided to their children, it is necessary for Member States to take appropriate measures in order  that this information ensures an adequate use of the products in question and is not counter to the promotion of breast-feeding; 

 Whereas this Directive does not concern the conditions of sale of publications specializing in baby care and of scientific publications; 

 Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health; 

 Whereas issues relating to products intended for export to third countries should be dealt with in a coherent and homogeneous manner in a separate measure; 

 Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, 

 HAS ADOPTED THIS DIRECTIVE:  

Article 1 

 1. This Directive is a specific Directive within the meaning of Article 4 of Directive 89/398/EEC and lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health in  the Community. It also provides for Member States to give effect to principles and aims of the International Code of Marketing of Breast-Milk Substitutes dealing with marketing, information and responsibilities of health authorities. 

 2. For the purposes of this Directive, 

 (a) 'infants' means children under the age of 12 months; 

 (b) 'young children' means children aged between one and three years; 

 (c) 'infant formulae' means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons; 

 (d) 'follow-on formulae' means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons.  

Article 2 

 Member States shall ensure that the products referred to in Article 1 (2) (c) and (d) may be marketed within the Community only if they conform to the definitions and rules laid down in this Directive. No product other than infant formula may  be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.  

Article 3 

 1. Infant formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally  accepted scientific data. 

 2. Follow-on formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients as the case may be whose suitability for particular nutritional use by infants aged over four months has been established by generally  accepted scientific data. 

 3. The prohibitions and limitations on the use of food ingredients laid down in Annexes I and II shall be observed.  

Article 4 

 1. Infant formulae must comply with the compositional criteria specified in Annex I. 

 2. Follow-on formulae must comply with the compositional criteria specified in Annex II. 

 3. In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.  

Article 5 

 1. Only the substances listed in Annex III may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on: 

 - mineral substances, 

 - vitamins, 

 - amino acids and other nitrogen compounds, 

 - other substances having a particular nutritional purpose. 

 The purity criteria for these substances shall be stipulated at a later stage. 

 2. The provisions relating to the use of additives in the manufacture of infant formulae and follow-on formulae shall be laid down in a Council directive.   Article 6  1. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants. Where necessary the maximum levels of any such substance shall be stipulated at a later date. 

 2. Microbiological criteria shall be established at a later date.  

Article 7 

 1. The name under which the products covered by Article 1 (2) are sold shall be, respectively: 

 - in English: 

 'infant formula' and 'follow-on formula', 

 - in Danish: 

 'Modermaelkserstatning' and 'Tilskudsblanding', 

 - in German: 

 'Saeuglingsanfangsnahrung' and 'Folgenahrung', 

 - in Greek: 

 'Ðáñáóêaaýáóìá ãéá âñÝoeç » and 'Ðáñáóêaaýáóìá aeaaýôaañçò âñaaoeéêÞò çëéêssáò », 

 - in Spanish: 

 'Preparado para lactentes' and 'Preparado de continuación', 

 - in French: 

 'Préparation pour nourrissons' and 'Préparation de suite', 

 - in Italian: 

 'Alimento per lattanti' and 'Alimento di proseguimento', 

 - in Dutch: 

 'Volledige zuigelingenvoeding' and 'Opvolgzuigelingenvoeding', 

 - in Portuguese: 

 'Fórmula para lactentes' and 'Fórmula de transiçao'. 

 However, the name of products manufactured entirely from cows' milk proteins, shall be respectively: 

 - in English: 

 'Infant milk' and 'follow-on milk', 

 - in Danish: 

 'Modermaelkserstatning udelukkende baseret paa maelk' and 'Tilskudsblanding udelukkende baseret paa maelk', 

 - in German: 

 'Saeuglingsmilchnahrung' and 'Folgemilch', 

 - in Greek: 

 'ÃUEëá ãéá âñÝoeç » and 'ÃUEëá aeaaýôaañçò âñaaoeéêÞò çëéêssáò », 

 - in Spanish: 

 'Leche para lactentes' and 'Leche de continuación', 

 - in French: 

 'Lait pour nourrissons' and 'Lait de suite', 

 - in Italian: 

 'Latte per lattanti' and 'Latte di proseguimento', 

 - in Dutch: 

 'Volledige zuigelingenvoeding op basis van melk' or 'Zuigelingenmelk' and 'Opvolgmelk', 

 - in Portuguese: 

 'Leite para lactentes' and 'Leite de transiçao'. 

 2. The labelling shall bear, in addition to those provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars: 

 (a) in the case of infant formulae, 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) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of four months, that it should form only part of a diversified diet and that it is not to be used  as a substitute for breast milk during the first four months of life; 

 (d) in the case of infant formulae and follow-on formulae, 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; 

 (e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol and carnitine, per 100 ml of the product  ready for use; 

 (f) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation of the product and a warning against the health hazards of inappropriate preparation. 

 3. The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast-feeding. The use of the terms 'humanized', 'maternalized', or  similar terms shall be prohibited. The term 'adapted' may only be used in conformity with paragraph 6 and Annex IV, point 1. 

 4. The labelling of infant formulae shall in addition bear the following mandatory particulars, preceded by the words 'Important Notice' or their equivalent: 

 (a) a statement concerning the superiority of breast-feeding; 

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

 5. The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealize the use of the product. It may, however, have graphic representations for easy identification of the product and  for illustrating methods of preparation. 

 6. The labelling may bear claims concerning the special composition of an infant formula only in the cases listed in Annex IV and in accordance with the conditions laid down therein. 

 7. The requirements, prohibitions and restrictions referred to in paragraphs 3 to 6 shall also apply to: 

 (a) 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; 

 (b) advertising.  

Article 8 

 1. Advertising of infant formulae shall be restricted to publications specializing in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertisements for infant formulae shall be  subject to the conditions laid down in Article 7 (3), (4), (5), (6) and (7) (b) and contain only information 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. 

 2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales,  loss-leaders and tie-in sales. 

 3. Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly  via the health care system or health workers.  

Article 9 

 1. Member States shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition covering the planning, provision,  design and dissemination of information and their control. 

 2. Member States shall ensure that informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear  information on all the following points: 

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

 (b) 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, the proper use of infant formulae, whether manufactured industrially or home-prepared. 

 When such materials contain information about the use of infant formulae, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of  improper use of infant formulae. Such material shall not use any pictures which may idealize the use of infant formulae. 

 3. Member States shall ensure that donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the appropriate national authority or within guidelines  given by that authority for this purpose. Such equipment or materials may bear the donating company's name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system. 

 4. Member States shall ensure that 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, shall only be used by or distributed for infants who  have to be fed on infant formulae and only for as long as required by such infants.  

Article 10 

 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Those provisions shall be applied in such a way as to: 

 - permit trade in products complying with this Directive, by 1 December 1992, 

 - prohibit trade in products which do not comply with this Directive, with effect from 1 June 1994. 

 When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  

Article 11 

 This Directive is addressed to the Member States. Done at Brussels, 14 May 1991. For the Commission 

 Martin BANGEMANN 

 Vice-President  

(1) OJ No L 186, 30. 6. 1989, p. 27. (2) OJ No L 33, 8. 2. 1979, p. 1. (3) OJ No L 186, 30. 6. 1989, p. 17.  

 ANNEX 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    Minimum  Maximum   250 kJ  315 kJ   (60 kcal/100 ml)  (75 kcal/100 ml)  2.  Proteins   (Protein content = nitrogen content × 6,38) for cows' milk proteins.   (Protein content = nitrogen content × 6,25) for soya protein isolates.  2.1.   Formulae manufactured from unmodified cows' milk proteins   Minimum  Maximum   0,56 g/100 kJ  0,7 g/100 kJ   (2,25 g/100 kcal)  (3 g/100 kcal)   The chemical index of the proteins present shall be equal to at least 80 % of that of the reference protein  (breast milk, as defined in Annex 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)   Minimum  Maximum   0,45 g/100 kJ  0,7  g/100 kJ   (1,8 g/100 kcal)  (3 g/100 kcal)   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  Annex V).  2.3.  Formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins   Minimum  Maximum   0,56 g/100 kJ  0,7 g/100 kJ   (2,56 g/100 kcal)  (3 g/100 kcal)   Only soya protein isolates must be used in  manufacturing these formulae.   The chemical index shall be equal to at least 80 % of that of the reference protein (breast milk, as defined in Annex 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 Annex V).   The L-carnitine content shall be at least equal to 1,8 ìmoles/100 kJ (7,5 ìmoles/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   Minimum  Maximum   0,8 g/100 kJ  1,5 g/100 kJ   (3,3 g/100 kcal)  (6,5 g/100 kcal)  3.1.   The use of the following substances is prohibited:   - sesame seed oil,   - cotton seed oil,   - fats containing more than 8 % trans isomers of fatty acids.  3.2.  Lauric acid   Minimum  Maximum   -  15 % of the total fat content  3.3.  Myristic acid     Minimum  Maximum   -  15 % of the total fat content  3.4.  Linoleic acid (in the form of glycerides = linoleates)   Minimum  Maximum   70 mg/100 kJ  285 mg/100 kJ   (300 mg/100 kcal)  (1 200 mg/100 kcal)  4.  Carbohydrates    Minimum  Maximum   1,7  g/100 kJ  3,4 g/100 kJ   (7 g/100 kcal)  (14 g/100 kcal)  4.1.  Only the following carbohydrates may be used:   - lactose,   - maltose,   - sucrose,   - malto-dextrins,   - glucose syrup or dried glucose syrup,   - pre-cooked starch   - gelatinized  starch naturally free of gluten  4.2.  Lactose   Minimum  Maximum   0,85 g/100 kJ  -   (3,5 g/100 kcal)  -   This provision does not apply to formulae in which soya proteins represent more than 50 % of the total protein content.  4.3.  Sucrose   Minimum   Maximum   -  20 % of the total carbohydrate content  4.4  Pre-cooked starch and/or gelatinied starch   Minimum  Maximum   -  2 g/100 ml, and 30 % of the total carbohydrate content  5.  Mineral substances  5.1.  Formulae manufactured from cows' milk  proteins       Per 100 kJ   Per 100 kcal     Minimum  Maximum  Minimum  Maximum        Sodium (mg)  5  14  20  60  Potassium (mg)  15  35  60  145  Chloride (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 (ìg)  4,8  19  20  80  Iodine (ìg)  1,2  -  5  - 

      (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 applicables except those concerning  iron and zinc, which are as follows:       Per 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       Per 100 kJ   Per 100 kcal     Minimum  Maximum   Minimum  Maximum        Vitamin A (ìg-RE) (1)  14  43  60  180  Vitamin D (ìg) (2)  0,25  0,65  1  2,5  Thiamin (ìg)  10  -  40  -  Riboflavin (ìg)  14  -  60  -  Nicotinamide (ìg-EN) (3)   60  -  250  -  Pantothenic acid (ìg)  70  -  300  -  Vitamin B6 (ìg)  9  -  35  -  Biotin (ìg)  0,4  -  1,5  -  Folic acid (ìg)  1  -  4  -  Vitamin B12 (ìg)  0,025  -  0,1  -  Vitamin C  (ìg)  1,9  -  8  -  Vitamin K (ìg)  1  -  4  -  Vitamin E (mg á-TE) (4)  0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ  -  0,5/g of  polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  - 

      (1) RE = all trans retinol equivalent. 

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

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

 (4) á-TE = d-á-tocopherol equivalent.  

 ANNEX 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    Minimum  Maximum   250 kJ/100 ml  335 KJ/100 ml   (60 kcal/100 ml)  (80 kcal/100 ml)  2.  Proteins   (Protein content = nitrogen content × 6,38) for cows' milk proteins.   (Protein content = nitrogen content × 6,25) for soya protein  isolates.   Minimum  Maximum   0,5 g/100 kJ  1 g/100 kJ   (2,25 g/100 kcal)  (4,5 g/100 kcal)   The chemical index of the proteins present shall be at least equal to 80 % of that of the reference protein (casein as defined in Annex 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 forumulae 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    Minimum  Maximum   0,8 g/100 kJ  1,5 g/100 kJ   (3,3 g/100 kcal)  (6,5 g/100 kcal)  3.1.  The use of the following substances is prohibited:   - sesame seed oil,   - cotton seed oil,   - fats containing more than 8 % trans isomers of  fatty acids.  3.2.  Lauric acid    Minimum  Maximum   -  15 % of the total fat content  3.3.  Myristic acid    Minimum  Maximum   -  15 % of the total fat content  3.4.  Linoleic acid (in the form of glycerides = linoleates)   Minimum  Maximum   70  mg/100 kJ  -   (300 mg/100 kcal):    this limit applies only to follow-on formulae containing vegetable oils   4.  Carbohydrates    Minimum  Maximum   1,7 g/100 kJ  3,4 g/100 kJ   (7 g/100 kcal)  (14 g/100 kcal)  4.1.  The use of ingredients containing  gluten is prohibited.  4.2.  Lactose   Minimum  Maximum   0,45 g/100 kJ  -   (1,8 g/100 kcal)    This provision does not apply to follow-on formulae in which soya protein isolates represent more than 50 % of the total protein content.  4.3.  Sucrose,  fructose, honey   Minimum  Maximum   -  separately or as a whole:    20 % of the total carbohydrate content  5.  Mineral substances  5.1.        Per 100 kJ   Per 100 kcal     Minimum  Maximum  Minimum  Maximum             Iron (mg)  0,25  0,5  1  2   Iodine (ìg)  1,2  -  5  -        5.2.  Zinc   5.2.1.  Follow-on formulae manufactured entirely from cows' milk   Minimum  Maximum   0,12 mg/100 kJ  -   (0,5 mg/100 kcal)   5.2.2.  Follow-on formulae containing soya protein isolates, or  mixed with cows' milk   Minimum  Maximum   0,18 mg/100 kJ  -   (0,75 mg/100 kcal)   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 follow-on formulae to that of cows' milk. The typical composition of cows' milk is given, for guidance, in Annex VIII.  5.4.  The calcium/phosphorus ratio shall not exceed 2,0.  6.  Vitamins       Per 100 kJ   Per 100 kcal      Minimum  Maximum  Minimum  Maximum             Vitamin A (ìg-ER) (1)  14  43  60  180  Vitamin D (ìg) (2)  0,25  0,75  1  3  Vitamin C (ìg)  1,9  -  8  -  Vitamin E (mg á-TE) (3)  0,5/g  polyunsaturated fatty acids expressed al linoleic acid but in no case less than 0,1 mg per 100 available kJ  -  0,5/g polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  - 

      (1) RE =  all trans retinol equivalent. 

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

 (3) á-TE = d-á-tocopherol equivalent.  

 ANNEX III 

NUTRITIONAL SUBSTANCES 

 1. Vitamins  

 Vitamin  Vitamin formulation     Vitamin A  Retinyl acetate   Retinyl palmitate   Beta-carotene   Retinol  Vitamin D  Vitamin D2 (ergocalciferol)   Vitamin D3 (cholecalciferol)  Vitamin B1  Thalmin hydrochloride   Thalmin mononitrate  Vitamin B2   Riboflavin   Riboflavin-5-phosphate, sodium  Niacin  Nictotinamide   Nicotinic acid  Vitamin B6  Pyridoxine hydrochloride   Pyridoxine-5-phosphate  Folate  Folic acid  Pantothenic acid  D-pantothenate, calcium   D-pantothenate, sodium   Dexpanthenol   Vitamin B12  Cyanocobalamin   Hydroxocobalamin  Biotin  D-biotin  Vitamin C  L-ascorbic acid   Sodium L-ascorbate   Calcium L-ascorbate   6-palmityl-L-ascorbic acid (ascorbyl palmitate)   Potassium ascorbate  Vitamin E  D-alpha tocopherol   DL-alpha  tocopherol   D-alpha tocopherol acetate   DL-alpha tocopherol acetate  Vitamin K  Phylloquinone (Phytomenadione) 

   2. Mineral substances  

 Mineral substances  Permitted salts       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 salts of orthophosphoric acid   Magnesium sulphate   Magnesium gluconate   Magnesium hydroxide   Magnesium salts of citric acid  Iron (Fe)  Ferrous citrate    Ferrous gluconate   Ferrous lactate   Ferrous sulphate   Ferric ammonium citrate   Ferrous fumarate   Ferric diphosphate (Ferric pyrophosphate)  Copper (Cu)  Cupric citrate   Cupric gluconate   Cupric sulphate   Copper-lysine complex   Cupric  carbonate  Iodine (I)  Potassium iodide   Sodium iodide   Potassium iodate  Zinc (Zn)  Zinc acetate   Zinc chloride   Zinc lactate   Zinc sulphate   Zinc citrate   Zinc gluconate   Zinc oxide  Manganese (Mn)  Manganese carbonate   Manganese chloride    Manganese citrate   Manganese sulphate   Manganese gluconate  Sodium (Na)  Sodium bicarbonate   Sodium chloride   Sodium citrate   Sodium gluconate   Sodium carbonate   Sodium lactate   Sodium salts of orthophosphoric acid   Sodium hydroxide   Potassium (K)  Potassium bicarbonate   Potassium carbonate   Potassium chloride   Potassium salts of citric acid   Potassium gluconate   Potassium lactate   Potassium salts of orthophosphoric acid   Potassium hydroxide 

   3. Amino acids and other  nitrogen 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-cysteine 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. Others 

 Choline 

 Choline chloride 

 Choline citrate 

 Choline bitartrate 

 Inositol  

 ANNEX IV 

COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM  

 Claim related to  Conditions warranting the claim     1. Adapted protein  The protein content is lower than 0,6 g/100 kJ (2,5 g/100 kcal) and the whey protein/casein ratio is not less than 1,0.  2. Low sodium  The sodium content is lower than 9  mg/100 kJ (39 mg/100 kcal).  3. Sucrose free  No sucrose is present.  4. Lactose only  Lactose is the only carbohydrate present.  5. Lactose free  No lactose is present (1).  6. Iron enriched  Iron is added. 

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

 ANNEX 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:  

  Per 100 kJ (1)  Per 100 kcal      Arginine  16  69  Cystine  6  24  Histidine  11  45  Isoleucine  17  72  Leucine  37  156  Lysine  29  122  Methionine  7  29  Phenylalanine  15  62  Threonine  19  80  Tryptophan  7  30  Tyrosine  14  59  Valine   19  80 

    (1) 1 kJ = 0,239 kcal.  

 ANNEX VI 

Amino acid composition of casein and breast milk protein 

 The amino acid composition of casein and breast milk protein: 

 (g/100 g of protein)  

  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  Lysine  8,1  6,7  Methionine  2,8  1,6  Phenylalanine  5,2  3,4  Threonine  4,7  4,4  Tryptophan  1,6  1,7   Tyrosine  5,8  3,2  Valine  6,7  4,5 

    (1) Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383.  

 ANNEX 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:  

  Per 100 g SNF (1)  Per g of proteins      Sodium (mg)  550  15  Potassium (mg)  1 680  43  Chloride (mg)  1 050  28  Calcium (mg)  1 350  35  Phosphorus (mg)  1 070  28  Magnesium (mg)  135  3,5  Copper (ìg)  225  6  Iodine  NS (2)   NS 

    (1) SNF: 'solids-no fats'. 

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

_  

1.2,3 //  

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

4.3 .  

Sucrose  

1.2.3 //  

Minimum  

Maximum   //  

_  

20 % of the total carbohydrate content  

1.2,34.4  

Pre-cooked starch and/or gelatinied starch  

1.2.3 //  

Minimum  

Maximum   //  

_  

2 g/100 ml, and 30 % of the total carbohydrate content  

1.2,35 .  

Mineral substances  

5.1 .  

Formulae manufactured from cows' milk proteins  

1.2,3.4,5 //   //  //  //  

Per 100 kJ  

Per 100 kcal  

1.2.3.4.5Minimum  

Maximum  

Minimum  

Maximum   //   //  //  //  //  

Sodium ( mg )  

5  

14  

20  

60  

Potassium ( mg )  

15  

35  

60  

145  

Chloride ( 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 (* g )  

4,8  

19  

20  

80  

Iodine (* g )  

1,2  

_  

5  

_   //   //  //  //  //  

( 1 ) Limit applicable to formulae with added iron .  

1.2The 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 applicables except those concerning iron and zinc, which are as follows :  

1.2,3.4,5 //   //  //  //  

Per 100 kJ  

Per 100 kcal  

1.2.3.4.5Minimum  

Maximum  

Minimum  

Maximum   //   //  //  //  //  

Iron ( mg )  

0,25  

0,5  

1  

2  

Zinc ( mg )  

0,18  

0,6  

0,75  

2,4   //   //  //  //  //  

1.26 .  

Vitamins  

1.2,3.4,5 //   //  //  //  

Per 100 kJ  

Per 100 kcal  

1.2.3.4.5Minimum  

Maximum  

Minimum  

Maximum   //   //  //  //  //  

Vitamin A (* g-RE ) ( 1 )  

14  

43  

60  

180  

Vitamin D (* g ) ( 2 )  

0,25  

0,65  

1  

2,5  

Thiamin (* g )  

10  

_  

40  

_  

Riboflavin (* g )  

14  

_  

60  

_  

Nicotinamide (* g-EN ) ( 3 )  

60  

_  

250  

_  

Pantothenic acid (* g )  

70  

_  

300  

_  

Vitamin B6 (* g )  

9  

_  

35  

_  

Biotin (* g )  

0,4  

_  

1,5  

_  

Folic acid (* g )  

1  

_  

4  

_  

Vitamin B12 (* g )  

0,025  

_  

0,1  

_  

Vitamin C (* g )  

1,9  

_  

8  

_  

Vitamin K (* g )  

1  

_  

4  

_  

Vitamin E ( mg *-TE ) ( 4 )  

0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ  

_  

0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  

_   //   //  //  //  //  

( 1 ) RE = all trans retinol equivalent .  

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

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

( 4 ) *-TE = d-*-tocopherol equivalent .  

ANNEX II  

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

NB : The values refer to the product ready for use  

1.2.31 .  

Energy   //  //  

Minimum  

Maximum   //  

250 kJ/100 ml  

335 KJ/100 ml   //  

( 60 kcal/100 ml )  

( 80 kcal/100 ml )  

1.2,32 .  

Proteins   //  

( Protein content = nitrogen content x 6,38 ) for cows' milk proteins .   //  

( Protein content = nitrogen content x 6,25 ) for soya protein isolates .  

1.2.3 //  

Minimum  

Maximum   //  

0,5 g/100 kJ  

1 g/100 kJ   //  

( 2,25 g/100 kcal )  

( 4,5 g/100 kcal )  

1.2,3 //  

The chemical index of the proteins present shall be at least equal to 80 % of that of the reference protein ( casein as defined in Annex 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 forumulae 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 .  

1.2.33 .  

Lipids   //  //  

Minimum  

Maximum   //  

0,8 g/100 kJ  

1,5 g/100 kJ   //  

( 3,3 g/100 kcal )  

( 6,5 g/100 kcal )  

1.2,33.1 .  

The use of the following substances is prohibited :   //  

_ sesame seed oil,   //  

_ cotton seed oil,   //  

_ fats containing more than 8 % trans isomers of fatty acids .  

1.2.33.2 .  

Lauric acid   //  //  

Minimum  

Maximum   //  

_  

15 % of the total fat content  

3.3 .  

Myristic acid   //  //  

Minimum  

Maximum   //  

_  

15 % of the total fat content  

1.2,33.4 .  

Linoleic acid ( in the form of glycerides = linoleates )  

1.2.3 //  

Minimum  

Maximum   //  

70 mg/100 kJ  

_   //  

( 300 mg/100 kcal ):   //  //  

this limit applies only to follow-on formulae containing vegetable oils   //  

4 .  

Carbohydrates   //  //  

Minimum  

Maximum   //  

1,7 g/100 kJ  

3,4 g/100 kJ   //  

( 7 g/100 kcal )  

( 14 g/100 kcal )  

1.2,34.1 .  

The use of ingredients containing gluten is prohibited .  

4.2 .  

Lactose  

1.2.3 //

Minimum  

Maximum   //  

0,45 g/100 kJ  

_   //  

( 1,8 g/100 kcal )   //  

1.2,3 //  

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

4.3 .  

Sucrose, fructose, honey  

1.2.3 //  

Minimum  

Maximum   //  

_  

separately or as a whole :   //  //  

20 % of the total carbohydrate content  

1.2,35 .  

Mineral substances  

5.1 .   //  

1.2,3.4,5 //   //  //  //  

Per 100 kJ  

Per 100 kcal  

1.2.3.4.5Minimum  

Maximum  

Minimum  

Maximum   //   //  //  //  //  //  //  //  //  //  

Iron ( mg )  

0,25  

0,5  

1  

2  

Iodine (* g )  

1,2  

_  

5  

_   //   //  //  //  //  

1.2.35.2 .  

Zinc   //  

1.2,35.2.1 .  

Follow-on formulae manufactured entirely from cows' milk  

1.2.3Minimum  

Maximum   //  

0,12 mg/100 kJ  

_   //  

( 0,5 mg/100 kcal )   //  

1.2,35.2.2 .  

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

1.2.3Minimum  

Maximum   //  

0,18 mg/100 kJ  

_   //  

( 0,75 mg/100 kcal )   //  

1.2,35.3 .  

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 follow-on formulae to that of cows' milk . The typical composition of cows' milk is given, for guidance, in Annex VIII .  

5.4 .  

The calcium/phosphorus ratio shall not exceed 2,0 .  

6 .  

Vitamins  

1.2,3.4,5 //   //  //  //  

Per 100 kJ  

Per 100 kcal  

1.2.3.4.5Minimum  

Maximum  

Minimum  

Maximum   //   //  //  //  //  //  //  //  //  //  

Vitamin A (* g-ER ) ( 1 )  

14  

43  

60  

180  

Vitamin D (* g ) ( 2 )  

0,25  

0,75  

1  

3  

Vitamin C (* g )  

1,9  

_  

8  

_  

Vitamin E ( mg *-TE ) ( 3 )  

0,5/g polyunsaturated fatty acids expressed al linoleic acid but in no case less than 0,1 mg per 100 available kJ  

_  

0,5/g polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  

_   //   //  //  //  //  

( 1 ) RE = all trans retinol equivalent .  

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

( 3 ) *-TE = d-*-tocopherol equivalent .  

ANNEX III  

NUTRITIONAL SUBSTANCES  

1 . Vitamins  

1.2Vitamin  

Vitamin formulation  

Vitamin A  

Retinyl acetate   //  

Retinyl palmitate   //  

Beta-carotene   //  

Retinol  

Vitamin D  

Vitamin D2 ( ergocalciferol )   //  

Vitamin D3 ( cholecalciferol )  

Vitamin B1  

Thalmin hydrochloride   //  

Thalmin mononitrate  

Vitamin B2  

Riboflavin   //  

Riboflavin-5-phosphate, sodium  

Niacin  

Nictotinamide   //  

Nicotinic acid  

Vitamin B6  

Pyridoxine hydrochloride   //  

Pyridoxine-5-phosphate  

Folate  

Folic acid  

Pantothenic acid  

D-pantothenate, calcium   //  

D-pantothenate, sodium   //  

Dexpanthenol  

Vitamin B12  

Cyanocobalamin   //  

Hydroxocobalamin  

Biotin  

D-biotin  

Vitamin C  

L-ascorbic acid   //  

Sodium L-ascorbate   //  

Calcium L-ascorbate   //  

6-palmityl-L-ascorbic acid ( ascorbyl palmitate )   //  

Potassium ascorbate  

Vitamin E  

D-alpha tocopherol   //  

DL-alpha tocopherol   //  

D-alpha tocopherol acetate   //  

DL-alpha tocopherol acetate  

Vitamin K  

Phylloquinone ( Phytomenadione )   //   //  

2 . Mineral substances  

1.2Mineral substances  

Permitted salts  

Calcium ( Ca )  

Calcium carbonate   //  

Calcium chloride   //  

Calcium salts of citric acid   //  

Calcium gluconate   //  

Calcium glycerophosphate   //  

Calcium lactate   //  

Calcium salts of orthophosphoric acid   //  

Calcium hydroxide  

Mineral substances  

Permitted salts  

Magnesium ( Mg )  

Magnesium carbonate   //  

Magnesium chloride   //  

Magnesium oxide   //  

Magnesium salts of orthophosphoric acid   //  

Magnesium sulphate   //  

Magnesium gluconate   //  

Magnesium hydroxide   //  

Magnesium salts of citric acid  

Iron ( Fe )  

Ferrous citrate   //  

Ferrous gluconate   //  

Ferrous lactate   //  

Ferrous sulphate   //  

Ferric ammonium citrate   //  

Ferrous fumarate   //  

Ferric diphosphate ( Ferric pyrophosphate )  

Copper ( Cu )  

Cupric citrate   //  

Cupric gluconate   //  

Cupric sulphate   //  

Copper-lysine complex   //  

Cupric carbonate  

Iodine ( I )  

Potassium iodide   //  

Sodium iodide   //  

Potassium iodate  

Zinc ( Zn )  

Zinc acetate   //  

Zinc chloride   //  

Zinc lactate   //  

Zinc sulphate   //  

Zinc citrate   //  

Zinc gluconate   //  

Zinc oxide  

Manganese ( Mn )  

Manganese carbonate   //  

Manganese chloride   //  

Manganese citrate   //  

Manganese sulphate   //  

Manganese gluconate  

Sodium ( Na )  

Sodium bicarbonate   //  

Sodium chloride   //  

Sodium citrate   //  

Sodium gluconate   //  

Sodium carbonate   //  

Sodium lactate   //  

Sodium salts of orthophosphoric acid   //  

Sodium hydroxide  

Potassium ( K )  

Potassium bicarbonate   //  

Potassium carbonate   //  

Potassium chloride   //  

Potassium salts of citric acid   //  

Potassium gluconate   //  

Potassium lactate   //  

Potassium salts of orthophosphoric acid   //  

Potassium hydroxide   //   //  

3 . Amino acids and other nitrogen 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-cysteine 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 . Others  

Choline  

Choline chloride  

Choline citrate  

Choline bitartrate  

Inositol  

ANNEX IV  

COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM  

1.2Claim related to  

Conditions warranting the claim  

1 . Adapted protein  

The protein content is lower than 0,6 g/100 kJ ( 2,5 g/100 kcal ) and the whey protein/casein ratio is not less than 1,0 .  

2 . Low sodium  

The sodium content is lower than 9 mg/100 kJ ( 39 mg/100 kcal ).  

3 . Sucrose free  

No sucrose is present .  

4 . Lactose only  

Lactose is the only carbohydrate present .  

5 . Lactose free  

No lactose is present ( 1 ).  

6 . Iron enriched  

Iron is added .   //   //  

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

ANNEX 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 :

1.2.3Per 100 kJ ( 1 )  

Per 100 kcal   //   //  //  

Arginine  

16  

69  

Cystine  

6  

24  

Histidine  

11  

45  

Isoleucine  

17  

72  

Leucine  

37  

156  

Lysine  

29  

122  

Methionine  

7  

29  

Phenylalanine  

15  

62  

Threonine  

19  

80  

Tryptophan  

7  

30  

Tyrosine  

14  

59  

Valine  

19  

80   //   //  //  

( 1 ) 1 kJ = 0,239 kcal .  

ANNEX VI  

Amino acid composition of casein and breast milk protein  

The amino acid composition of casein and breast milk protein :  

( g/100 g of protein )  

1.2.3Casein ( 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  

Lysine  

8,1  

6,7  

Methionine  

2,8  

1,6  

Phenylalanine  

5,2  

3,4  

Threonine  

4,7  

4,4  

Tryptophan  

1,6  

1,7  

Tyrosine  

5,8  

3,2  

Valine  

6,7  

4,5   //   //  //  

( 1 ) Amino acid content of foods and biological data on protein . FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383 .  

ANNEX 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 :  

1.2.3Per 100 g SNF ( 1 )  

Per g of proteins   //   //  //  

Sodium ( mg )  

550  

15  

Potassium ( mg )  

1 680  

43  

Chloride ( mg )  

1 050  

28  

Calcium ( mg )  

1 350  

35  

Phosphorus ( mg )  

1 070  

28  

Magnesium ( mg )  

135  

3,5  

Copper (* g )  

225  

6  

Iodine  

NS ( 2 )  

NS   //   //  //  

( 1 ) SNF : "solids-no fats '.  

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