12.11.86 Official Journal of the European Communities No C 285/5 
II 
(Preparatory Acts) 
COMMISSION 
Modified proposal for a Council Directive on the approximation of the laws of the Member 
States relating to infant formulae and follow-up milks (') 
COM(86) 564 final 
(Submitted by the Commission to the Council pursuant to the second paragraph of Article 149 of 
the EEC Treaty on 27 October 1986) 
(86/C 285/07) 
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 paricular 
nutritional uses (2), and in particular Article 1 (3) 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Par­
liament, 
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 in 
those cases in which breastfeeding is not advised, sufficient 
or possible, or the mother chooses not to breastfeed, 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 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 all follow-up milks currently sold in the 
Community are manufactured from cows' milk; 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 (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 breastfeeding; 
Whereas, in particular, the nature and destination of the 
products covered by this Directive required 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 
0) OJ No C 28, 30. 1. 1985, p. 3. 
(2) OJ No L 26, 31. 1. 1977, p. 55. (J) OJNoL33, 8.2. 1979, p. 1. 
No C 285/6 Official Journal of the European Communities 12.11.86 
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 
marketing laid down in this Directive should be in 
conformity with the principles and the aims of the Inter­
national 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 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 appropriate 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 and 
lays down compositional and labelling requirements for 
infant formulae and follow-up milks. It also provides for 
Member States to give effect to those principles and aims of 
the International Code of Marketing of Breast-Milk Sub­
stitutes dealing with marketing, information and 
responsibilities of health authorities. 
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 requirements 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 
1. Member States shall take all necessary steps to 
ensure that the products referred to in Article 1 (2) 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 infants during the first four to 
six months of life. 
2. The provisions of Articles 2 to 9 (5) shall also apply to 
the products referred to in Article 1 (2) which are intended 
for export to third countries, except in so far as precluded 
by provisions applicable in the third country of import. 
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 food 
ingredients 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 com­
positional criteria specified in Annex I. 
However, the compositional criteria for infant formulae 
that are not or not exclusively manufactured from cows' 
milk proteins shall be specified at a later date, but not 
later than 1 July 1988, in accordance with Article 100 of 
the Treaty. 
2. Follow-up milks must comply with the com­
positional 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. 
12. 11.86 Official Journal of the European Communities No C 285/7 
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 auth­
orization; 
(c) products thus manufactured must bear a distinctive 
indication which is to be defined in the authori­
zation. 
2. The Member State shall forward to the other 
Member States and to the Commission the text of any 
authorization drawn up by virtue of paragraph 1 within 
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 autho­
rization in accordance with paragraph 1. At the same 
time it shall supply supporting 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. 
Notwithstanding paragraph 1 (a), the national author­
ization 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 subpara­
graph that the national authorization should be revoked, 
this decision shall apply simultaneously to any authori­
zations 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 provided for 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 in cases in which 
breastfeeding is not advised, sufficient or possible, or 
the mother chooses not to breastfeed; 
(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 only suitable 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 replacement for 
breast milk during the first four months of life; 
(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 mentioned 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 and a warning against the health hazards of 
inappropriate preparation; 
(g) information to enable batch identification. 
3. The labelling of infant formulae shall in addition 
bear the following mandatory particulars, preceded by the 
words 'Important Notice' or their equivalent: 
No C 285/8 Official Journal of the European Communities 12.11.86 
(a) a statement concerning the superiority of 
breastfeeding; 
(b) a statement recommending that the product be used 
only on the advice of persons having qualifications in 
medicine, nutrition or pharmacy; 
(c) a warning concerning the negative effect on 
breastfeeding of introducing partial bottle-feeding; 
(d) a warning concerning the difficulty of reversing a 
decision not to breastfeed. 
4. The labelling of infant formulae and follow-up milks 
shall be designed to provide the necessary information 
about the appropriate use of the products and so as not to 
discourage breastfeeding. The use of the terms 
'humanized', 'maternalized', 'adapted' or similar terms 
shall be prohibited. 
The labelling of infant formulae shall not include pictures 
of infants, nor shall it include other pictures or text which 
may idealize the product. It may, however, have graphics 
for easy identification of the product and for illustrating 
methods of preparation. 
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 requirements, prohibitions and restrictions 
referred to in paragraphs 3, 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. 
Article 10 
The labelling, marketing and advertising of articles for use 
in conjunction with infant formulae, such as teats, feeding-
bottles, bottle-heaters and other specially designed feeding 
equipment, when referring to infant formulae, shall comply 
with the requirements of Article 9, paragraphs 3 and 4. 
The labelling of such articles intended for export to third 
countries shall likewise comply with the requirements of 
Article 9, paragraphs 3 and 4, except in so far as precluded 
by provisions applicable in the third country of import. Article 11 
1. Advertising of infant formulae shall be restricted to 
publications specializing in baby care. 
2. Advertisements for infant formulae shall be subject to 
the conditions laid down in Article 9, paragraphs 3, 4, 5 
and 6 (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 
breastfeeding. 
3. 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. 
4. 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 12 
1. Member States shall take the necessary measures to 
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, provisions, design and 
dissemination of information and their control. 
2. Member States shall take the necessary measures to 
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 infor­
mation on all the following points: 
(a) the benefits and superiority of breastfeeding; 
(b) maternal nutrition and the preparation for and main­
tenance of breastfeeding; 
(c) the negative effect on breastfeeding of introducing 
partial bottle-feeding; 
(d) the difficulty of reversing the decision not to breastfeed; 
(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 
12.11.86 Official Journal of the European Communities No C 285/9 
hazards of unnecessary or improper use of infant formulae. 
Such material shall not use any pictures which may idealize 
the use of infant formulae. 
3. Member States shall take the necessary measures to 
ensure that donations of informational or educational 
equipment or materials by manufacturers or distributors 
shall be made only at the 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 formula and shall be distributed only through the 
health care system. 
4. Member States shall take the necessary measures to 
ensure that donations or low-price sales of infant formula to 
institutions or organizations, whether for use in the 
institutions or for distribution outside them, shall only be 
used by or distributed for infants fed on infant formula and 
only for as long as required by such infants. 
Article 13 
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 14 
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 trade in products complying with this 
Directive, by ... (x), 
— prohibit trade in products which do not comply with 
this Directive, with effect from ... (2). 
Article 15 
This Directive is addressed to the Member States. 
(') 18 months after the notification. 
(2) 36 months after the notification. 
No C 285/10 Official Journal of the European Communities 12. 11. 86 
ANNEX I 
ESSENTIAL COMPOSITION OF INFANT FORMULAE 
NB: The values given refer to the products ready for use. 
1. Energy PART A 
Formulae manufactured entirely from cows' milk proteins 
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 
0,56 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 refer­
ence protein (human milk, as defined in Part I of 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 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 
12. 11. 86 Official Journal of the European Communities No C 285/11 
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 °/o 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 
minimum 
0,85 g/100 kj 
(3,5 g/100 kcal) naturally free of gluten 
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 carbohydrate 
content 
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 (ug) 
Iodine (|i.g) 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 
1,4 
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. 
No C 285/12 Official Journal of the European Communities 12. 11. 86 
6. Vitamins 
Vitamin A (ug RE) (») 
Vitamin D (ug) (2) 
Thiamine (ug) 
Riboflavin (ug) 
Nicotinamide (ug-NE) (') 
Pantothenic acid (jig) 
Vitamin B6 (ug) 
Biotin (ug) 
Folic acid (ug) 
Vitamin Bi2 (ug) 
Vitamin C (mg) 
Vitamin E (mg a-TE) (4) 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 polyunsatui 
fatty acids expressed as . 
leic acid but in no case 
than 0,1 mg/100 avai 
kJ ated 
lino-
less 
lable 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 lino-
leic acid but in no case less 
than 0,5 mg/100 available 
kcal 
(') RE = all trans-retino\ equivalent. 
(2) In the form of cholecalciferol, of which 10 ug = 400 IU of vitamin D. 
(3) NE = Niacin equivalent = mg nicotinic acid + mg tryptophan/60. 
(") 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. 
12. 11. 86 Official Journal of the European Communities No C 285/13 
3. Lipids 
minimum maximum 
0,8 g/100 kj 
(3,3 g/100 kcal) 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 
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) 
4. Carbohydrates minimum 
70 mg/100 kj 
(300 mg/100 kcal); 
this limit applies only to follow-up 
milks containing vegetable oils maximum 
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, . . minimum fructose, 
honey maximum 
3,4 g/100 kj 
(14 g/100 kcal) 
maximum 
maximum 
Separately or as a whole 20 °/o of 
the total carbohydrate content 
5. Mineral substances 
5.1. Iron 
minimum 
0,25 mg/100 kj 
(1 mg/100 kcal) 0,5 mg/100 kj 
(2 mg/100 kcal) 
5.2. Zinc 
0,12 mg/100 kj — 
(0,5 mg/100 kcal) 
5.3. Other The concentrations normally found in cows' milk, reduced, where appropriate, in the 
mineral same ratio as the protein concentration of the follow-up milk to that of cows' milk. 
substances The typical composition of cows' milk is given, for guidance, in Annex VII. 
5.4. The calcium/phosphorus ratio shall not exceed 2,0. 
No C 285/14 Official Journal of the European Communities 12. 11. 86 
6. Vitamins 
Vitamin A (ug RE) (*) 
Vitamin D (ug) (2) 
Vitamin C (mg) 
Vitamin E (mg a-TE) (3) per 100 kj 
minimum maximum 
14 43 
0,25 0,5 
1,9 — 
0,5/g of polyunsaturated 
fatty acids expressed as lino-
leic acid but in no case less 
than 0,1 mg/100 available 
kj per 100 kcal 
minimum maximum 
60 180 
1 2 
8 — 
0,5/g of polyunsaturated 
fatty acids expressed as lino-
leic acid but in no case less 
than 0,5 mg/100 available 
kcal 
(') RE = all trans-rei\no\ equivalent. 
(2) In the form of cholecalciferol, of which 10 u.g 
(') a-TE = ^/-a-tocopherol equivalent. 400 IU of vitamin D. 
ANNEX III 
SUBSTANCES WITH A SPECIFIC NUTRITIONAL PURPOSE THAT MAY BE USED IN INFANT 
FORMULAE AND FOLLOW-UP MILKS 
PARTI 
Mineral salts 
Mineral substances 
1. Calcium (Ca) 
2. Phosphorus (P) 
3. Magnesium (Mg) 
4. Iron (Fe) 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 
12. 11. 86 Official Journal of the European Communities No C 285/15 
5. Copper (Cu) 
6. Iodine (I) Cupric citrate 
Cupric gluconate 
Cupric sulphate 
Copper lysine complex 
Copper carbonate 
Potassium iodide 
Sodium iodide 
Potassium iodate 
7. Zinc (Zn) 
8. Manganese (Mn) 
9. Sodium (Na) 
10. Potassium (K) 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 
Vitamins 
Vitamin 
1. Vitamin A 
2. Vitamin D 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). 
No C 285/16 Official Journal of the European Communities 12. 11. 86 
3. Vitamin Bi 
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 
J-Biotin 
L-Ascorbic acid 
Sodium-L-ascorbate 
Calcium-L-ascorbate 
L-ascorbyl-6-palmitate 
Potassium ascorbate 
<£alpha-tocopherol 
*//-alpha-tocopherol 
J-alpha-tocopherol acetate 
^/-alpha-tocopherol acetate 
Vitamin Ki 
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 
Taurine 
PART IV 
Other substances 
Choline (choline chloride) 
12. 11. 86 Official Journal of the European Communities No C 285/17 
ANNEX IV 
ADDITIVES 
NB: The limits given refer to the products ready for use. 
Additives 
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 of fatty acids 
— Carrageenan 
— Locust bean gum 
— Guar gum 
— Citric acid 
— L (+) Lactic acid 
— Cultures producing L (-1-) Lactic acid (E 300) 
(E 301) 
(E 302) 
(E 304) 
(E 306) 
(E 307) 
(E 308) 
(E 309) 
(E 322) 
(E 471) 
(E 407) 
(E 410) 
(E 412) Conditions of use 
In a concentration, taken either separa­
tely 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 formulae and 
follow-up milks (') 
In a concentration of not more than 
0,4 g/100 ml in infant formulae 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 (2) 
In a concentration of not more than 
0,1 g/100 ml in follow-up milks (2) 
(') 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, E 410 and E 412 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. 
No C 285/18 Official Journal of the European Communities 12. 11. 86 
ANNEX VI 
REFERENCE PROTEINS 
PARTI 
Human milk 
Arginine 
Cystine 
Histidine 
Isoleucine 
Leucine 
Lysine 
Methionine 
Phenylalanine 
Threonine 
Tryptophan 
Tyrosine 
Valine 
Arginine 
Cystine 
Histidine 
Isoleucine 
Leucine 
Lysine 
Methionine 
Phenylalanine 
Threonine 
Tryptophan 
Tyrosine 
Valine '100 kj 
16 
6 
11 
17 
37 
29 
7 
15 
19 
7 
14 
19 
PART II 
Casein 
ANNEX VII mg/100 kcal 
69 
24 
45 
72 
156 
122 
29 
62 
80 
30 
59 
80 
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 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 
CONCENTRATIONS OF MINERAL ELEMENTS IN COWS' MILK 
For guidance, the concentrations of mineral elements in cows' milk are as follows: 
per 100 g of fat-free dry matter per 1 g of proteins 
Sodium (mEq) 
Potassium (mEq) 
Chloride (mEq) 
Calcium (mg) 
Phosphorus (mg) 
Magnesium (mg) 
Copper (ug) 
Iodine 24 
43 
30 
1 350 
1 070 
135 
225 
Not specified 0,65 
1,10 
0,80 
35 
28 
3,5 
6 
Not specified