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"BCOMMISSION DIRECTIVE
of 14 May 1991
on infant formulae and follow-on formulae
(91/321/EEC)
(OJ L 175, 4.7.1991, p. 35)
Amended by:
Official Journal
No page date
"M1 Commission Directive 96/4/EC of 16 February 1996 L 49 12 28.2.1996
"M2 Commission Directive 1999/50/EC of 25 May 1999 L 139 29 2.6.1999
Amended by:
"A1 Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.19951991L0321 — EN — 22.06.1999 — 002.001 — 1
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 approxi-
mation 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;!B
(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. 17.1991L0321 — EN — 22.06.1999 — 002.001 — 2
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;
(e) ‘pesticide residue’ means the residue in infant formulae and
follow-on formulae of a plant protection product, as defined in
point 1 of Article 2 of Council Directive 91/414/EEC (
1), including
its metabolites and products resulting from its degradation or
reaction.!B
(1) OJ L 230, 19.8.1991, p. 1.!M21991L0321 — EN — 22.06.1999 — 002.001 — 3
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 and young
children. Necessary maximum levels shall be established without delay.
2. Infant formulae and follow-on formulae shall not contain residues of
individual pesticides at levels exceeding 0,01 mg/kg of the product as
proposed ready for consumption or as reconstituted according to the
instructions of the manufacturer.
Analytical methods for determining the levels of pesticide residues shall
be generally acceptable standardised methods.!B
!M21991L0321 — EN — 22.06.1999 — 002.001 — 4
3. Those pesticides listed in Annex IX shall not be used in agricultural
products intended for the production of infant formulae and follow-on
formulae.
4. Microbiological criteria shall be established as necessary.
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:
‘Modermælkserstatning’ and ‘Tilskudsblanding’,
— in German:
‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’,
— in Greek:
‘Παρασκεύασµα για /betatwoρέφη» and ‘ Παρασκεύασµα δεύτερης
/betatwoρεφικής ηλικίας»,
—in Spanish:
‘Preparado para lactantes’ and ‘Preparado de continuación’,
— in French:
‘Préparation pour nourrissons’ and ‘Préparation de suite’,
— in Italian:
‘Alimento per lattanti’ and ‘Alimento di proseguimento’,
— in Dutch:
‘V olledige zuigelingenvoeding’ and ‘Opvolgzuigelingenvoeding’,
— in Portuguese
‘Fórmula para lactentes’ and ‘Fórmula de transição’,
— in Finnish:
‘Äidinmaidonkorvike’ and ‘Vieroitusvalmiste’,
— in Swedish:
‘Modersmjölksersättning’ and ‘Tillskottsnäring’.
However, the name of products manufactured entirely from cows’ milk
proteins, shall be respectively:
— in English:
‘Infant milk’ and ‘follow-on milk’,
— in Danish:
‘Modermælkserstatning udelukkende baseret på mælk’ and ‘Tils-
kudsblanding udelukkende baseret på mælk’,
— in German:
‘Säuglingsmilchnahrung’ and ‘Folgemilch’,
— in Greek:
‘Γάλα για /betatwoρέφη» and ‘ Γάλα δεύτερης /betatwoρεφικής ηλικίας»,
—in Spanish:
‘Leche para lactantes’ and ‘Leche de continuación’,
— in French:
‘Lait pour nourrissons’ and ‘Lait de suite’,
— in Italian:
‘Latte per lattanti’ and ‘Latte di proseguimento’,
— in Dutch:
‘V olledige zuigelingenvoeding op basis van melk’or ‘Zuigelingen-
melk’ and ‘Opvolgmelk’,!M2
!B
!A1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 5
— in Portuguese:
‘Leite para lactentes’ and ‘Leite de transição’,
— in Finnish:
‘Maitopohjainen äidinmaidonkorvike’ and ‘Maitopohjainen vieroi-
tusvalmiste’,
— in Swedish:
‘Modersmjölksersättning uteslutande baserad på mjölk’ and ‘Tills-
kottsnäring uteslutande baserad på mjölk’.
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,
carbohydrates and lipids, expressed in numerical form, 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, carnitine and taurine, expressed in numerical form, 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.
2a. The labelling may bear:
(a) the average quantity of nutrients mentioned in Annex III when such
declaration is not covered by the provisions of paragraph 2 (e) of this
Article, expressed in numerical form, per 100 ml of the product
ready for use;
(b) for follow-on formulae in addition to numerical information,
information on vitamins and minerals included in Annex VIII,
expressed as a percentage of the reference values given therein, per
100 ml of the product ready for use, provided that the quantities
present are at least equal to 15 per cent of the reference values;
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
!A1
!B
!M1
!B
!M1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 6
(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 manu-
factured industrially or home-prepared.!B1991L0321 — EN — 22.06.1999 — 002.001 — 7
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.!B1991L0321 — EN — 22.06.1999 — 002.001 — 8
ANNEX I
ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECON-
STITUTED 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. Protein
(Protein content = nitrogen content × 6,38) for cows’ milk proteins.
(Protein content = nitrogen content × 6,25) for soya protein isolates and
protein partial hydrolysates.
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 ofeach corresponding amino acid of the reference protein.
2.1. Formulae manufactured from cows’ milk proteins
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);nevertheless, for calculation purposes, the concentration of methionine andcystine may be added together.
2.2. Formulae manufactured from protein partial hydrolysates
Minimum Maximum
0,56 g/100 kJ 0,7 g/100 kJ
(2,25 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);nevertheless, for calculation purposes, the concentration of methionine andcystine may be added together.
The protein efficiency ratio (PER) and the net protein utilization (NPU)
must be at least equal to those of casein.
The taurine content shall be equal to at least 10 µmoles/100 kJ
(42µmoles/100 kcal) and the L-carnitine content shall be equal to at
least 1,8 µmoles/100 kJ (7,5 µmoles/100 kcal).
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 µmoles/100 kJ
(7,5µmoles/100 kcal).!
B
!M1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 9
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
"M1Minimum 3 Maximum
"M11,05 g/100 kJ 3 1,5 g/100 kJ
"M1(4,4 g/100 kcal) 3 (6,5 g/100 kcal)
3.1. The use of the following substances is prohibited:
— sesame seed oil,
— cotton seed oil,
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)
3.5. The alpha-linolenic acid content shall not be less than 12 mg/100 kJ
(50 mg/100 kcal).
The linoleic/alpha-linolenic acid ratio shall not be less than 5 nor greater
than 15.
3.6. The trans fatty acid content shall not exceed 4 % of the total fat content.
3.7. The erucic acid content shall not exceed 1 % of the total fat content.
3.8. Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP)
may be added. In that case their content shall not exceed:
— 1 % of the total fat content for n-3 LCP and— 2 % of the total fat content for n-6 LCP— (1 % of the total fat content for arachidonic acid)
— The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of
docosahexaenoic (22:6 n-3) acid content.
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,!
B
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!B
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!B1991L0321 — EN — 22.06.1999 — 002.001 — 10
— pre-cooked starchgnaturally free of gluten— gelatinized starch
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 gelatinized 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 Minimun Maximum
Sodium (mg) 5 14 20 60
Potassium (mg) 15 35 60 145
Chloride (mg) 12 29 50 125Calcium (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 1,5Copper ( µg) 4,8 19 20 80
Iodine ( µg) 1,2 — 5 —
Selenium (
2)µg — 0,7 — 3
(1)Limit applicable to formulae with added iron.
!M1
(2)Limit applicable to formulae with added selenium.
!B
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 applicable 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!B
!M1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 11
6. Vitamins
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Vitamin A ( µg-RE) (1) 14 43 60 180
Vitamin D ( µg) (2) 0,25 0,65 1 2,5
Thiamin ( µg) 10 — 40 —
Riboflavin ( µg) 14 — 60 —
Niacin (mg-NE) 0,2 — 0,8 —Pantothenic acid ( µg) 70 — 300 —
Vitamin B
6(µg) 9 — 35 —
Biotin ( µg) 0,4 — 1,5 —
Folic Acid ( µg) 1 — 4 —
Vitamin B 12(µg) 0,025 — 0,1 —
Vitamin C ( µg) 1,9 — 8 —
Vitamin K ( µg) 1 — 4 —
Vitamin E (mg α-TE) (3) 0,5/g of poly-
unsaturated fatty
acids expressed
as linoleic acid
but in no case
less than 0,1 mg
per 100 available
kJ— 0,5/g of poly-
unsaturated 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 µg = 400 i.u. of vitamin D.
(3)α-TE = d- α-tocopherol equivalent.
7. The following nucleotides may be added:
Maximum (1)
(mg/100 kJ) (mg/100 kcal)
cytidine 5 ’-monophosphate 0,60 2,50
uridine 5 ’-monophosphate 0,42 1,75
adenosine 5 ’-monophosphate 0,36 1,50
guanosine 5 ’-monophosphate 0,12 0,50
inosine 5 ’-monophosphate 0,24 1,00
(1)The total concentration of nucleotides shall not exeed 1,2 mg/100 kJ
(5 mg/100 kcal).!B
!M1
!B
!M11991L0321 — EN — 22.06.1999 — 002.001 — 12
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 Maximum0,5 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 "
M1or breast milk 3as 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 formulae manufactured from soya proteins, alone or in a
mixture with cows’ milk proteins, only protein isolates from soya may beused.
Amino acids may be added to follow-on formulae for the purpose of
improving the nutritional value of the proteins, in the proportionsnecessary for that purpose.
"
M1For an equal energy value, these formulae must contain an
available quantity of methionine at least equal to that contained in breast
milk as defined in Annex V . 3
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,
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 —!B
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!B1991L0321 — EN — 22.06.1999 — 002.001 — 13
Minimum Maximum
(300 mg/100 kcal):
this limit applies only to follow-on
formulae containing vegetable oils
3.5. The trans fatty acid content shall not exceed 4 % of the total fat content.
3.6. The eruic acid content shal not exceed 1 % of the total fat content.
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 ( µg) 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 proteinconcentration of the follow-on formulae to that of cows’ milk. The typicalcomposition of cows’ milk is given, for guidance, in Annex VIII.
5.4. The calcium/phosphorus ratio shall not exceed 2,0.!
B
!M1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 14
6. Vitamins
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Vitamin A ( µg-ER) (1) 14 43 60 180
Vitamin D ( µg) (2) 0,25 0,75 1 3
Vitamin C ( µg) 1,9 — 8 —
Vitamin E (mg α-TE) (3) 0,5/g polyunsatu-
rated fatty acids
expressed as li-
noleic acid but in
no case less than
0,1 mg per 100
available kJ— 0,5/g polyunsatu-
rated fatty acids
expressed as li-
noleic 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 which10 µg = 400 u.i. of vitamin D.
(3)α-TE = d- α-tocopherol equivalent.
7. The following nucleotides may be added:
Maximum (1)
(mg/100 kJ) (mg/100 kcal)
cytidine 5 ’-monophosphate 0,60 2,50
uridine 5 ’-monophosphate 0,42 1,75
adenosine 5 ’-monophosphate 0,36 1,50
guanosine 5 ’-monophosphate 0,12 0,50
inosine 5 ’-monophosphate 0,24 1,00
(1)The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ
(5 mg/100 kcal).!B
!M11991L0321 — EN — 22.06.1999 — 002.001 — 15
ANNEX III
NUTRITIONAL SUBSTANCES
1.Vitamins
Vitamin Vitamin formulation
Vitamin A Retinyl acetate
Retinyl palmitate
Beta-carotene
Retinol
Vitamin D Vitamin D 2(ergocalciferol)
Vitamin D 3(cholecalciferol)
Vitamin B 1 Thalmin hydrochloride
Thalmin mononitrate
Vitamin B 2 Riboflavin
Riboflavin-5 ’-phosphate, sodium
Niacin Nicotinamide
Nicotinic acid
Vitamin B 6 Pyridoxine hydrochloride
Pyridoxine-5 ’-phosphate
Folate Folic acidPantothenic acid D-pantothenate, calcium
D-pantothenate, sodium
Dexpanthenol
Vitamin B
12 Cyanocobalamin
Hydroxocobalamin
Biotin D-biotinVitamin 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!B1991L0321 — EN — 22.06.1999 — 002.001 — 16
Mineral substances Permitted salts
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
Selenium Sodium selenate
Sodium selenite
3.Amino acids and other nitrogen compounds
L-arginine and its hydrochloride
L-cystine and its hydrochlorideL-histidine and its hydrochlorideL-isoleucine and its hydrochlorideL-leucine and its hydrochloride
L-cysteine and its hydrochloride
L-cysteine and its hydrochlorideL-methionineL-phenylalanineL-threonine!
B
!M1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 17
L-tryptophan
L-tyrosine
L-valine
L-carnitine and its hydrochlorideTaurine
cytidine 5 ’- monophosphate and its sodium salt
uridine 5 ’- monophosphate and its sodium salt
adenosine 5 ’- monophosphate and its sodium salt
guanosine 5 ’- monophosphate and its sodium salt
inosine 5 ’- monophosphate and its sodium salt.
4.Others
Choline
Choline chlorideCholine citrate
Choline bitartrate
Inositol!
B
!M1
!B1991L0321 — EN — 22.06.1999 — 002.001 — 18
ANNEX IV
COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, W ARRANT-
ING 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 isnot 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.
7. Reduction of risk to
allergy to milk pro-
teins. This claim mayinclude terms refer-ring to reduced al-
lergen of reduced
antigen properties.(a) The formulae shall satisfy the provisions laid
down in Section 2.2 of Annex I and the amount
of immunoreactive protein measured withmethods gererally acceptable as appropriateshall be less than 1 % of nitrogen containing
substances in the formulae;
(b) The label shall indicate that the product must
not be consumed by infants allergic to the intact
proteins from which it is made unless generally
accepted clinical tests provide proof of theformulae’s tolerance in more than 90 % ofinfants (confidence interval 95 %) hypersensi-
tive to proteins from which the hydrolysate is
made;
(c) The formulae administered orally should not
induce sensitization, in animals, to the intact
proteins from which the formulae are derived;
(d) Objective and scientifically verified data as
proof to the claimed properties must be avail-
able.
(
1)When determined by a method the detection limits of which will be established at a later
stage.!B
!M11991L0321 — EN — 22.06.1999 — 002.001 — 19
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 45Isoleucine 17 72Leucine 37 156
Lysine 29 122
Methionine 7 29Phenylalanine 15 62Threonine 19 80
Tryptophan 7 30
Tyrosine 14 59Valine 19 80
(
1)1 kJ = 0,239 kcal.!B1991L0321 — EN — 22.06.1999 — 002.001 — 20
ANNEX VI
Amino acid composition of casein and breast milk protein
The amino acid composition of casein and breast milk protein:
Casein (1) Breast milk (1)
Arginine 3,7 3,8
Cystine 0,3 1,3Histidine 2,9 2,5Isoleucine 5,4 4,0
Leucine 9,5 8,5
Lysine 8,1 6,7Methionine 2,8 1,6Phenylalanine 5,2 3,4
Threonine 4,7 4,4
Tryptophan 1,6 1,7Tyrosine 5,8 3,2Valine 6,7 4,5
(
1)Amino acid content of foods and biological data on protein. F AO Nutritional Studies, No
24, Rome 1970, items 375 and 383 .!B1991L0321 — EN — 22.06.1999 — 002.001 — 21
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 de SNF (1) Per g of proteins
Sodium (mg) 550 15
Potassium (mg) 1 680 43
Chloride (mg) 1 050 28Calcium (mg) 1 350 35Phosphorus (mg) 1 070 28
Magnesium (mg) 135 3,5
Copper ( µg) 225 6
Iodine NS (
2)N S
(1)SNF : ‘solids no fats’.
(2)NS : non-specified, varies widely according to season and stock farming conditions.!B1991L0321 — EN — 22.06.1999 — 002.001 — 22
ANNEX VIII
REFERENCE V ALUES FOR NUTRITION LABELLING FOR FOODS
INTENDED FOR INFANTS AND YOUNG CHILDREN
Nutrient Labelling reference value
Vitamin A ( µg) 400
Vitamin D ( µg) 10
Vitamin C (mg) 25
Thiamin (mg) 0,5Riboflavin (mg) 0,8Niacin equivalents (mg) 9
Vitamin B6 (mg) 0,7
Folate ( µg) 100
Vitamin B12 ( µg) 0,7
Calcium (mg) 400
Iron (mg) 6
Zinc (mg) 4Iodine ( µg) 70
Selenium ( µg) 10
Copper (mg) 0,4!
M11991L0321 — EN — 22.06.1999 — 002.001 — 23
ANNEX IX
Pesticides which shall not be used in agricultural products intended for the
production of infant formulae and follow-on formulae
Chemical name of the substance
…!M21991L0321 — EN — 22.06.1999 — 002.001 — 24