30.1.85 Official Journal of the European Communities No C 28/3 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
relating to infant formulae and follow-up milks 
COM(84) 703 final 
(Submitted by the Commission to the Council on 4 January 1985) 
(85/C 28/05) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 100 thereof, 
Having regard to Council Directive 77/94/EEC of 21 
December 1976 on the approximation of the laws of 
the Member States relating to foodstuffs for 
particular nutritional uses (!), and in particular Article 
1 (3) thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas infant formulae and follow-up milks 
intended for particular nutritional use by infants in 
good health form a very important group within the 
category of foodstuffs for particular nutritional uses; 
Whereas a specific Directive within the meaning of 
Article 1 (3) of Directive 77/94/EEC should 
therefore be adopted for this group of products; 
Whereas the essential composition of the products in 
question must satisfy the nutritional requirements of 
infants as established by generally accepted scientific 
data; 
Whereas on the basis of these data the essential 
composition of infant formulae manufactured from cows' milk proteins can already be defined; whereas 
the same is not true for preparations based wholly or 
partly on other sources of protein; whereas specific 
rules for such products will therefore have to be 
adopted at a later date; 
Whereas follow-up milks currently sold in the 
Community are manufactured exclusively from cows' 
milk; whereas the scope of this Directive should 
therefore be restricted to that type of product for the 
time being; 
Whereas should follow-up products not or not 
exclusively based on cows' milk later appear on the 
market the advisability of adopting common rules for 
them would have to be examined; 
Whereas pursuant to Article 5 (1) of Directive 
77/94/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), 
whereas this Directive need do no more than adopt 
the additions and exceptions to those general rules; 
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), point 8 and Article 10 (2) of 
Directive 79/112/EEC, in order to prevent inappro­
priate uses likely to be detrimental to the health of 
infants; 
C) OJ No L 26, 31. 1. 1977, p. 55. O OJNoL33, 8.2. 1979, p. 1. 
No C 28/4 Official Journal of the European Communities 30.1.85 
Whereas, in application of 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 and 
labelling laid down in this Directive should also take 
account of the principles and the aims of the Inter­
national Code of Marketing of Breast-Milk Sub­
stitutes adopted by the 34th World Health Assembly, 
bearing in mind the particular legal and factual 
situations existing in the Community; 
Whereas the adaptation of this Directive to scientific 
and technical progress is an implementing measure 
that should be delegated to the Commission; whereas 
it is nevertheless advisable to allow the Member States 
to help find a Community solution by adopting 
temporary measures; whereas the procedure laid 
down in Article 9 of Directive 77/94/EEC is appro­
priate for this purpose since it offers close 
cooperation between the Member States and the 
Commission, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive is a specific Directive within the 
meaning of Article 1 (3) of Directive 77/94/EEC. It 
shall apply to 'infant formulae' and 'follow-up milks' 
intended for particular nutritional use by infants in 
good health. 
2. For the purposes of this Directive, 
(a) 'infant formulae' shall mean foodstuffs intended 
for particular nutritional use by infants during the 
first four to six months of life and satisfying by 
themselves the nutritional requirement of this 
category of persons; 
(b) 'follow-up milks' shall mean foodstuffs intended 
for particular nutritional use by infants aged over 
four months and constituting the milk element in 
a progressively diversified diet of this category of 
persons. 
Article 2 
Member States shall take all necessary steps to ensure 
that the products referred to in Article 1 (2) may be marketed only if they conform to the definitions and 
rules laid down in this Directive. 
Article 3 
1. Infant formulae shall be manufactured from 
food ingredients whose suitability for particular 
nutritional use by infants from birth has been 
established by generally accepted scientific data. 
2. Follow-up milks shall be manufactured from 
cows' milk and, where appropriate, other food 
ingredients whose suitability for particular nutritional 
use by infants aged over four months has been 
established by generally accepted scientific data. 
3. The prohibition 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. 
However, the criteria for the compositional criteria 
for infant formulae that are not or not exclusively 
manufactured from cows' milk proteins shall be 
specified at a later date in accordance with Article 
100 of the Treaty. 
2. Follow-up milks must comply with the 
compositional criteria specified in Annex II. 
3. In order to make infant formulae and follow-up 
milks ready for use, nothing more, as the case may 
be, than the addition of water shall be required. 
Article 5 
Only the substances listed in Annex III may be used 
for the enrichment of infant formulae and follow-up 
milks with: 
— mineral substances, 
— vitamins, 
— amino acids and other nitrogen compounds, 
— other substances having a particular nutritional 
purpose. 
30.1.85 Official Journal of the European Communities No C 28/5 
Article 6 
For the manufacture of infant formulae and 
follow-up milks, only the additives listed in Annex IV 
may be used, provided the conditions laid down 
therein are met. 
Article 7 
1. To take account of scientific or technical 
developments subsequent to the adoption of this 
Directive, a Member State may authorize within its 
territory: 
— the observance of essential compositional criteria 
that are new or differ from those in Annexes I 
and II, 
— the use of substances not mentioned in Annexes 
III and IV, 
— the widening of the conditions of use in Annex 
IV, 
subject to the following conditions: 
(a) the authorization must be limited to a maximum 
period of three years; 
(b) the Member State must carry out an official 
check of products manufactured in accordance 
with the authorization; 
(c) products thus manufactured must bear a 
distinctive indication which is to be defined in the 
authorization. 
2. The Member States shall forward to the other 
Member States and to the Commission the text of any 
authorization drawn up pursuant to paragraph 1 with 
two months of the date of its taking effect. 
3. Before the expiry of the three-year period 
provided for in paragraph 1, the Member State may 
submit to the Commission a request for the admission 
in this Directive of the elements that are the subject 
of national authorization in accordance with 
paragraph 1. At the same time it shall supply sup­
porting documents setting out the grounds on which 
it deems such admission justified. 
Within 18 months of the submission of the request, a 
decision shall be taken on the basis of technical data 
and information relating to public health, where 
necessary after consulting the Scientific Committee 
for Food, and in accordance with the procedure laid 
down in Article 9 of Directive 77/94/EEC as to 
whether the elements in question may be admitted in 
this Directive or whether the national authorization 
should be revoked. By way of derogation from 
paragraph 1 (a), the national authorization shall 
remain in force until a decision is taken on the 
request for admission in this Directive. Should it be decided pursuant to the preceding 
subparagraph that the national authorization should 
be revoked, this decision shall apply simultaneously to 
any authorizations given by another Member State 
for the same subject. 
Article 8 
1. Infant formulae and follow-up milks shall not 
contain any substance in such quantity as to endanger 
the health of infants. The maximum levels of any such 
substances shall be stipulated at a later date in 
accordance with Article 100 of the Treaty. 
2. Microbiological standards shall be established 
according to the procedure referred to in paragraph 
1. 
Article 9 
1. The name under which the products covered by 
Article 1 are sold shall be, respectively, 'infant 
formula' and 'follow-up milk'. 
2. The labelling of infant formulae and follow-up 
milks shall bear, in addition to those foreseen in 
Article 3 of Directive 79/112/EEC, the following 
mandatory particulars: 
(a) in the case of infant formulae generally, a 
statement to the effect that the product is suitable 
for particular nutritional use by infants from 
birth; 
(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 six 
months, their total iron requirements must be met 
from other additional sources; 
(c) in the case of follow-up milks, a statement to the 
effect that the product is suitable for particular 
nutritional use by infants over the age of four 
months and that it should form part of a 
diversified diet; 
(d) 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) the average quantity of each mineral substance 
and of each vitamin mentiond in Annex I and 
Annex II respectively, and where applicable, of 
choline, per 100 ml of the product ready for use; 
(f) instructions for appropriate preparation of the 
product; 
(g) a statement to the effect that it is important for 
the infant's health that these instructions be 
followed; 
No C 28/6 Official Journal of 
(h) information making possible batch identification. 
3. The labelling of infant formulae shall in addition 
bear the following mandatory particulars: 
(a) a statement concerning the superiority of breast­
feeding; 
(b) a statement recommending that the product be 
used only on the advice of persons having 
qualifications in medicine, nutrition or pharmacy. 
4. The labelling of infant formulae and follow-up 
milks and the methods used must not idealize the use 
of the products. The use of the terms 'humanized', 
'maternalized', 'adapted' or similar terms shall be 
prohibited. 
The implementing provisions for this paragraph shall 
be adopted, where necessary, in accordance with the 
procedure laid down in Article 9 of Directive 77/94/ 
EEC. 
5. The labelling may bear claims concerning the 
special composition of an infant formula only in the 
cases listed in Annex V and in accordance with the 
conditions laid down therein. 
Any amendments that have to be made to that Annex 
in line with scientific and technical progress shall be 
adopted in accordance with the procedure laid down 
in Article 9 of Directive 77/94/EEC. 
6. The prohibitions and restrictions referred to in 
paragraphs 4 and 5 shall also apply to: 
(a) the presentation of infant formulae and follow-up 
milks, 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. 
7. This Article shall also apply to infant formulae 
and follow-up milks for export outside the 
Community, in so far as this is not precluded by 
provisions in the importing country. European Communities 30.1. 85 
Article 10 
1. Where a Member State, as a result of new infor­
mation or of a reassessment of existing information 
made since this Directive was adopted, has detailed 
grounds for establishing that the use in infant 
formulae or follow-up milks of one of the substances 
listed in Annexes III and IV or the maximum 
permissible concentration thereof endangers human 
health although it complies with this Directive, that 
Member State may temporarily suspend or restrict 
application of the provisions in question within its 
territory. It shall immediately inform the other 
Member States and the Commission thereof and give 
reasons for its decision. 
2. The Commission shall examine as soon as 
possible the grounds given by the Member State 
concerned and consult the Member States within the 
Standing Committee for Foodstuffs, and shall then 
deliver its opinion forthwith and take the appropriate 
measures. 
3. If the Commission considers that amendments 
to this Directive are necessary in order to resolve the 
difficulties mentioned in paragraph 1 and to ensure 
the protection of human health, it shall initiate the 
procedure laid down in Article 9 of Directive 
77/94/EEC with a view to adopting those 
amendments; in such cases, any Member State which 
has adopted safeguard measures may in that event 
retain them until the date on which the amendments 
are to be applied. 
Article 11 
Member States shall take the necessary measures to 
comply with this Directive. They shall forthwith 
inform the Commission thereof. Those measures shall 
be applied in such a way as to: 
— permit, by 1 January 1986 at the latest, trade in 
products complying with this Directive, 
— prohibit, on 1 July 1987, trade in products which 
do not comply with this Directive. 
Article 12 
This Directive is addressed to the Member States. 
30. 1. 85 Official Journal of the European Communities No C 28/7 
ANNEX I 
ESSENTIAL COMPOSITION OF INFANT FORMULAE 
NB: The values given refer to the products ready for use. 
PART A 
FORMULAE MANUFACTURED ENTIRELY FROM COWS'MILK PROTEINS 
1. Energy 
minimum maximum 
250 kj 315 kj 
(60 kcal)/100 ml (75 kcal)/100 ml 
2. Proteins (Protein content == nitrogen content x 6,38) 
2.1 Formulae manufactured from unmodified cows' milk proteins 
minimum maximum 
0,56g/100kJ 0,7g/100kJ 
(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 (human milk, as defined in Part I of Annex VI); nevertheless, for calcu­
lation purposes, the concentrations of methionine and cystine may be added together; 
— The 'chemical index' shall mean the lowest of the ratios between the amino acids of the 
proteins present and the corresponding amino acids 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 
(human milk as defined in Part I of Annex VI). 
2.3 In both cases, the addition of amino acids is permitted solely for the purpose of improving the 
nutritional value of the milk 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 oil, 
— cotton oil, 
— fats containing more than 8 % trans isomers of fatty acids. 
3.2 Laurie acid 
minimum maximum 
— 15 % of the total fat content 
No C 28/8 Official Journal of the European Communities 30. 1. 85 
3.3 Myristic acid 
minimum 
3.4 Linoleic acid (in the form of glycerides — linoleates) 
minimum 
70 mg/100 kj 
(300 mg/100 kcal) maximum 
15 % of the total fat content 
maximum 
285 mg/100 kj 
(1 200 mg/100 kcal) 
4. Carbohydrates 
minimum 
1,7 g/100 kj 
(7 g/100 kcal) 
4.1 Only the following carbohydrates may be used 
— lactose 
— maltose 
— sucrose 
— malto-dextrins 
— pre-cooked starch 
— gelatinized starch 
4.2 Lactose naturally free of gluten 
0,85 g/100 kj 
(3,5 g/100 kcal) 
4.3 Sucrose 
minimum 
4.4 Pre-cooked starch and/or gelatinized starch 
minimum maximum 
3,4 g/100 kj 
(14 g/100 kcal) 
maximum 
maximum 
20 % of the total carbo­
hydrate content 
maximum 
2 g/100 ml, and 30% of 
the total carbohydrate 
content 
5. Mineral substances 
Sodium (mEq) 
Potassium (mEq) 
Chloride (mEq) 
Calcium (mg) 
Phosphorus (mg) 
Magnesium (mg) 
Iron (mg) (') 
Zinc (mg) 
Copper (|i.g) 
Iodine (ug) per 
minimum 
0,25 
0,4 
0,35 
12 
6 
1,2 
0,12 
0,07 
4,8 
1,2 100 kj 
maximum 
0,6 
0,9 
0,8 
— 
22 
3,6 
0,36 
— 
19 
— per 
minimum 
1 
1,6 
M 
50 
25 
5 
0,5 
0,3 
20 
5 100 kcal 
maximum 
2,6 
3,8 
3,5 
— 
90 
15 
1,5 
— 
80 
— 
The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0. 
(') Limit applicable to formulae with added iron. 
30. 1. 85 Official Journal of the European Communities No C 28/9 
6. Vitamins 
Vitamin A (ug RE) (') 
Vitamin D (ug) (2) 
Thiamine (ug) 
Riboflavin (jxg) 
Nicotinamide (ug-NE) (3) 
Pantothenic acid (jig) 
Vitamin B6 (ug) 
Biotin (ug) 
Folic acid (ug) 
Vitamin Bi2 (ug) 
Vitamin C (mg) 
Vitamin E (mg a-TE) (") per 
minimum 
14 
0,25 
10 
14 
60 
70 
9 
0,4 
1 
0,025 
1,9 100 kj 
maximum 
43 
0,5 
— 
— 
— 
— 
— 
— 
— 
— 
— 
0,5/g of polyunsaturated 
fatty acids expressed as 
linoleic acid but in no case 
less than 0,1 
able kj mg/ 100 avail-per 
minimum 
60 
1 
40 
60 
250 
300 
35 
1,5 
4 
0,1 
8 100 kcal 
maximum 
180 
2 
— 
— 
— 
— 
— 
— 
— 
— 
— 
0,5/g of polyunsaturated 
fatty acids expressed as 
linoleic acid but in no case 
less than 0,5 mg/100 avail­
able kcal 
(') RE = all trans retinol equivalent. 
(2) In the form of cholecalciferol, of which 10 ug = 400 i.u. of vitamin D. 
(5) NE = Niacin equivalent = mg nicotinic acid + mg tryptophan/60. 
(4) a-TE = d-a-tocopherol equivalent. 
PARTB 
FORMULAE NOT OR NOT EXCLUSIVELY MANUFACTURED FROM COWS' MILK 
PROTEINS 
(To be completed later in accordance with the second paragraph of Article 4(1)) 
ANNEX II 
ESSENTIAL COMPOSITION OF FOLLOW-UP MILKS 
NB: The values given refer to the products ready for use. 
1. Energy 
minimum 
250 kj 
(60 kcal)/100 ml 
2. Proteins (Protein content = nitrogen content x 6,38) 
minimum 
0,5 g/100 kj 
(2,25 g/100 kcal) maximum 
335 kj 
(80 kcal)/100 ml 
maximum 
1 g/100 kj 
(4,5 g/100 kcal) 
—- The chemical index of the proteins present shall be at least equal to 85 % of that of the 
reference protein (casein as defined in Part II of Annex VI). 
— The 'chemical index' shall mean the lowest of the ratios between the amino acids of the 
proteins present and the corresponding amino acids of the reference protein. 
— Amino acids may be added to follow-up milks for the purpose of improving the nutritional 
value of the milk proteins, in the proportions necessary for that purpose. 
No C 28/10 Official Journal of the European Communities 30. 1. 85 
3. Lipids 
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 
— sesame oil, 
— cotton oil, 
— fats containing more than 8 % trans isomers of fatty acids. 
3.2 Laurie acid: 
3.3 Myristic acid: minimum 
minimum 
3.4 Linoleic acid (in the form of glycerides = linoleates) 
minimum 
70 mg/100 kj 
(300 mg/100 kcal); 
this limit applies only to 
follow-up milks containing 
vegetable oils maximum 
15 % of the total fat content 
maximum 
15 % of the total fat content 
maximum 
4. Carbohydrates 
minimum 
1,7 g/100 kj 
(7 g/100 kcal) 
4.1 The use of ingredients containing gluten is prohibited. 
4.2 Lactose 
minimum 
0,45 g/100 kj 
(1,8 g/100 kcal) 
4.3 Sucrose, fructose, honey 
minimum maximum 
3,4 g/100 kj 
(14 g/100 kcal) 
maximum 
Separately or as a whole 
20 % of the total carbo­
hydrate content 
5. Mineral substances 
5.1 Iron 
5.2 Zinc minimum 
0,25 mg/100 kj 
(1 mg/100 kcal) 
0,12 mg/100 kj 
(0,5 mg/100 kcal) 0,5 mg/100 kj 
(2 mg/100 kcal) 
maximum 
5.3 Other mineral substances 
The concentrations normally found in cows' milk, reduced, where appropriate, in the same 
ratio as the protein concentration of the follow-up milk to that of cows' milk. The typical 
composition of cows' milk is given, for guidance, in Annex VII. 
5.4 The calcium/phosphorus ratio shall not exceed 2,0. 
30. 1. 85 Official Journal of the European Communities No C 28/11 
6. Vitamin 
Vitamin A (ug RE) (>) 
Vitamin D (ug) (2) 
Vitamin C (mg) 
Vitamin E (mg a-TE) (J) per 100 kj 
minimum maximum 
14 43 
0,25 0,5 
1,9 — 
0,5/g of polyunsaturated 
fatty acids expressed as 
linoleic acid but in no case 
less than 0,1 mg/100 avail­
able kj per 100 kcal 
minimum maximum 
60 180 
1 2 
8 — 
0,5/g of polyunsaturated 
fatty acids expressed as 
linoleic acid but in no case 
less than 0,5 mg/100 avail­
able kcal 
(') RE = all trans retinol equivalent. 
(2) In the form of cholecalciferol, of which 10 ug = 400 i.u. of vitamin D. 
(3) a-TE = d-a-tocopherol equivalent. 
ANNEX III 
SUBSTANCES WITH A SPECIFIC NUTRITIONAL PURPOSE THAT MAY BE USED IN 
INFANT FORMULAE AND FOLLOW-UP MILKS 
Mineral substances 
1. Calcium (a) 
2. Phosphorus (P) 
3. Magnesium (Mg) 
4. Iron (Fe) PART I 
MINERAL SALTS 
Permitted salts 
Calcium carbonate 
Calcium chloride 
Calcium citrate 
Calcium gluconate 
Calcium glycerophosphate 
Calcium lactate 
Calcium phosphate, monobasic 
Calcium phosphate, dibasic 
Calcium phosphate, tribasic 
Calcium hydroxide 
Calcium phosphate, monobasic 
Calcium phosphate, dibasic 
Calcium phosphate, tribasic 
Magnesium phosphate, dibasic 
Magnesium phosphate, tribasic 
Potassium phosphate, monobasic 
Potassium phosphate, dibasic 
Sodium phosphate, dibasic 
Magnesium carbonate 
Magnesium chloride 
Magnesium oxide 
Magnesium phosphate, dibasic 
Magnesium phosphate, tribasic 
Magnesium sulphate 
Magnesium gluconate 
Ferrous citrate 
Ferrous gluconate 
Ferrous lactate 
Ferrous sulphate 
Ferric ammonium citrate 
No C 28/12 Official Journal of the European Communities 30. 1. 85 
5. Copper (Cu) 
6. Iodine (I) 
7. Zinc (Zn) 
8. Manganese (Mn) 
9. Sodium (Na) 
10. Potassium (K) Cupric citrate 
Cupric gluconate 
Cupric sulphate 
Copper Lysine Complex 
Copper carbonate 
Potassium iodide 
Sodium iodide 
Potassium iodate 
Zinc acetate 
Zinc chloride 
Zinc lactate 
Zinc sulphate 
Zinc citrate 
Manganese carbonate 
Manganese chloride 
Manganese citrate 
Manganese sulphate 
Manganese gluconate 
Sodium bicarbonate 
Sodium chloride 
Sodium citrate 
Sodium gluconate 
Sodium carbonate 
Sodium lactate 
Sodium phosphate, monobasic 
Sodium phosphate, dibasic 
Sodium phosphate, tribasic 
Sodium hydroxide 
Potassium bicarbonate 
Potassium carbonate 
Potassium chloride 
Potassium citrate 
Potassium gluconate 
Potassium lactate 
Potassium phosphate, monobasic 
Potassium phosphate, dibasic 
Potassium phosphate, tribasic 
Potassium hydroxide 
PART II 
Vitamin 
1. Vitamin A 
2. Vitamin D VITAMINS 
Vitamin formulation (') 
Vitamin A acetate 
Vitamin A palmitate 
Beta-carotene (Provitamin A) 
Vitamin D2 (Ergocalciferol) 
Vitamin D3 (Cholecalciferol) 
Vitamin D3-Cholesterol 
(') The following substances may be added to vitamin formulations, for technological reasons: 
— edible substances, 
— gelatine, 
— the additives listed in Annex IV, 
— gum arabic, 
— silicon dioxide (maximum concentration: 10 g/kg). 
30. 1. 85 Official Journal of the European Communities No C 28/13 
3. Vitamin Bj 
4. Vitamin B2 
5. Nicotinamide 
6. Vitamin B6 
7. Folic acid 
8. Pantothenic acid 
9. Vitamin B12 
10. Vitamin H 
11. Vitamin C 
12. Vitamin E 
13. Vitamin K Thiamine hydrochloride 
Thiamine mononitrate 
Riboflavin 
Riboflavin 5'-phosphate sodium 
Niacinamide 
Nicotinic acid (niacin) 
Pyridoxine hydrochloride 
Pyridoxal-5'-phosphate 
Folic acid 
D-calcium pantothenate 
D-sodium pantothenate 
D-panthenol 
Cyanocobalamin 
Hydroxocobalamin 
d-Biotin 
1-ascorbic acid 
Sodium-1-ascorbate 
Calcium-1-ascorbate 
l-ascorbyl-6-palmitate 
Potassium ascorbate 
d-alpha-tocopherol 
dl-alpha-tocopherol 
d-alpha-tocopherol acetate 
dl-alpha-tocopherol acetate 
Vitamin Kj 
PART III 
AMINO ACIDS AND OTHER NITROGEN COMPOUNDS 
L-arginine and its hydrochloride 
L-cystine and its hydrochloride 
L-histidine and its hydrochloride 
L-isoleucine 
L-leucine 
L-lysine 
L- and DL-methionine 
L-phenylalanine 
L-threonine 
L-tryptophan 
L-tyrosine 
L-valine 
PART IV 
OTHER SUBSTANCES 
Choline (choline chloride) 
No C 28/14 Official Journal of the European Communities 30. 1. 85 
ANNEX IV 
ADDITIVES 
NB: The limits given refer to the products ready for use. 
Additives Conditions of use 
L-ascorbic acid 
Sodium-L-ascorbate 
Calcium-L-ascorbate 
Ascorbyl palmitate 
Tocopherol-rich extracts of natural origin 
Synthetic Alpha-tocopherol 
Synthetic Gamma-tocopherol 
Synthetic Delta-tocopherol 
Lecithin 
Mono- and diglycerides 
Carrageenan 
Locust bean gum 
Guar gum of fatty acids (E 300) 
(E301) 
(E 302) 
(E 304) 
(E 306) 
(E 307) 
(E 308) 
(E 309) 
(E 322) 
(E471) 
(E 407) 
(E410) 
(E412) In a concentration, taken either 
separately or together, of not more 
than 1 mg/100 ml in infant 
formulae and follow-up milks 
In a concentration of not more 
than 0,5 g/100 ml in infant for­
mulae and follow-up milks (') 
In a concentration of not more 
than 0,4 g/100 ml in infant for­
mulae and follow-up milks (') 
In a concentration of not more 
• than 0,03 g/100 ml in follow-up 
milks (2) 
In a concentration of not more 
than 0,1 g/100 ml in follow-up 
milks O 
In a concentration of not more 
than 0,1 g/100 ml in follow-up 
milks (2) 
Citric acid 
L (-I-) lactic acid 
Cultures producing L (+) lactic acid 
(') Where substances E 322 and E 471 are used together, the amount of each of them actually used 
shall represent only part of the maximum concentration and shall be such that the sum of the 
two fractions does not exceed one. 
(2) Where substances E 407, E410 and E412 are used together, the amount of each of them 
actually used shall represent only part of the maximum concentration and shall be such that the 
sum of the fractions does not exceed one. 
ANNEX V 
CLAIMS CONCERNING A SPECIFIC COMPOSITIONAL CRITERION FOR INFANT 
FORMULAE 
Compositional criterion 
— Proteins 
— Sodium 
— Sucrose 
— Lactose 
— Iron Conditions warranting a claim 
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. 
The sodium content is lower than 0,4 mEq/100 kj 
(1,7 mEq/100 kcal). 
No sucrose is present. 
Lactose is the only carbohydrate used. 
The iron is added. 
30. 1. 85 Official Journal of the European Communities No C 28/15 
ANNEX VI 
REFERENCE PROTEINS 
PARTI 
Arginine 
Cystine 
Histidine 
Isoleucine 
Leucine 
Lysine 
Methionine 
Phenylalanine 
Threonine 
Tryptophan 
Tyrosine 
Valine HUMANMILK 
mg/100 kj 
16 
6 
11 
17 
37 
29 
7 
15 
19 
7 
14 
19 mg/100 kcal 
69 
24 
45 
72 
156 
122 
29 
62 
80 
30 
59 
80 g/100 g of protein 
3,8 
1,3 
2,5 
4,0 
8,5 
6,7 
1,6 
3,4 
4,4 
1,7 
3,2 
4,5 
PART II 
CASEIN 
Arginine 
Cystine 
Histidine 
Isoleucine 
Leucine 
Lysine 
Menthionine 
Phenylalanine 
Threonine 
Tryptophan 
Tyrosine 
Valine g/100 g of protein 
3,7 
0,3 
2,9 
5,4 
9,5 
8,1 
2,8 
5,2 
4,7 
1,6 
5,8 
6,7 
ANNEX VII 
CONCENTRATIONS OF MINERAL ELEMENTS IN COWS' MILK 
For guidance, the concentrations of mineral elements in cows' milk are as follows: 
Sodium (mEq) 
Potassium (mEq) 
Chloride (mEq) 
Calcium (mg) 
Phosphorus (mg) 
Magnesium (mg) 
Copper (ng) 
Iodine per 100 g of fat-free 
matter 
24 
43 
30 
1 350 
1 070 
135 
225 
Not specified dry per 1 g of proteins 
0,65 
1,10 
0,80 
35 
28 
3,5 
6 
Not specified