1991L0321 — EN — 01.05.2004 — 004.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION 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
►M3 Commission Directive 2003/14/EC of 10 February 2003 L 41 37 14.2.2003
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 1.1.1995
►A2 Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the Slovak
Republic and the adjustments to the Treaties on which the European
Union is foundedL 236 33 23.9.2003
▼B
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 foodstuffsfor 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 estab-
lished 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 onother sources of protein; whereas for this reason specific rules for suchproducts, 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 inArticle 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 assuitable for such use during the period would be infant formulae;
Whereas pursuant to Article 7 (1) of Directive 89/398/EEC the
products covered by this Directive are subject to the general rules laid
down by Council Directive 79/112/EEC of 18 December 1978 on the
approximation of the laws of the Member States relating to the label-ling, presentation and advertising of foodstuffs for sale to the ultimateconsumer (
2), as last amended by Directive 89/395/EEC (3); whereas
this Directive adopts and expands upon the additions and exceptionsto 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 energyvalue 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 preventinappropriate 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 parti-
cular 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 downin this Directive should be in conformity with the principles and the1991L0321 — EN — 01.05.2004 — 004.001 — 2
(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.
▼B
aims of the International Code of Marketing of Breast-Milk Substitutes
adopted by the 34th World Health Assembly, bearing in mind the parti-cular 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 typeof nourishment provided to their children, it is necessary for MemberStates 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 publi-
cations 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 liableto affect public health;
Whereas issues relating to products intended for export to third coun-
tries 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 alsoprovides for Member States to give effect to principles and aims ofthe International Code of Marketing of Breast-Milk Substitutes dealingwith 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 nutri-
tional use by infants during the first four to six months of life andsatisfying by themselves the nutritional requirements of this cate-gory of persons;
(d) ‘follow-on formulae’ means foodstuffs intended for particular nutri-
tional use by infants aged over four months and constituting theprincipal liquid element in a progressively diversified diet of thiscategory 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 meta-
bolites and products resulting from its degradation or reaction.
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 theyconform to the definitions and rules laid down in this Directive. Noproduct other than infant formula may be marketed or otherwise repre-sented as suitable for satisfying by itself the nutritional requirements ofnormal healthy infants during the first four to six months of life.1991L0321 — EN — 01.05.2004 — 004.001 — 3
(1) OJ L 230, 19.8.1991, p. 1.▼M2
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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 bewhose suitability for particular nutritional use by infants aged over fourmonths 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 theaddition of water.
Article 5
1. Only the substances listed in Annex III may be used in the manu-
facture 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 aCouncil 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 andyoung children. Necessary maximum levels for substances other thanthose referred to in paragraphs 2 and 3 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 productas proposed ready for consumption or as reconstituted according to theinstructions of the manufacturer.
Analytical methods for determining the levels of pesticide residues
shall be generally acceptable standardised methods.
3. (a) Those pesticides listed in Annex IX shall not be used in agricul-
tural products intended for the production of infant formulae andfollow-on formulae. However, for the purpose of control:
(i) pesticides listed in Table 1 of Annex IX are considered not
to have been used if their residues do not exceed a level of0,003 mg/kg. This level which is considered to be the limitof quantification of the analytical methods shall be keptunder regular review in the light of technical progress;1991L0321 — EN — 01.05.2004 — 004.001 — 4
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(ii) pesticides listed in Table 2 of Annex IX are considered not
to have been used if their residues do not exceed a level of0,003 mg/kg. This level shall be kept under regular review
in the light of data on environmental contamination.
(b) By derogation of paragraph 2, for the pesticides listed in Annex
X, the maximum residue levels specified therein shall apply.
For pesticides listed in Annex X, where a decision concerning
the non-inclusion of an active substance in Annex I to Directive91/414/EEC is taken, Annex IX and Annex X to this Directiveshall be amended accordingly.
(c) The levels referred to in subparagraphs (a) and (b) shall apply to
the products as proposed ready for consumption or as reconsti-tuted according to the instructions of the manufacturers.
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 βρέφη ’ and ‘ Παρασκεύασµα δεύτερης
βρεφικής 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:
‘Volledige zuigelingenvoeding’ and ‘Opvolgzuigelingenvoeding’,
— in Portuguese
‘Fórmula para lactentes’ and ‘Fórmula de transição’,
— in Finnish:
‘Äidinmaidonkorvike’ and ‘Vieroitusvalmiste’,
— in Swedish:
‘Modersmjölksersättning’ and ‘Tillskottsnäring’,
— in Czech:
‘počáteční kojenecká výživa’ and ‘pokra čovací kojenecká výživa’,
— in Estonian:
‘imiku piimasegu’ and ‘jätkupiimasegu’,
— in Latvian:
‘Piena mais ījums z īdaiņiem l īdzčetru m ēnešu vecumam’ and
‘Piena mais ījums z īdaiņiem no četru m ēnešu vecuma’,
— in Lithuanian:
‘mišinys k ūdikiams iki 4 - 6 m ėn’ and ‘mišinys k ūdikiams, vyres-
niems kaip 4 m ėn’,
— in Hungarian:
‘anyatej-helyettesít őtápszer’ and ‘anyatej-kiegészít őtápszer’,
— in Maltese:1991L0321 — EN — 01.05.2004 — 004.001 — 5
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‘formula tat-trabi’ and ‘formula tal-prosegwiment’,
— in Polish:
‘preparat do pocz ątkowego żywienia niemowl ąt’ and ‘preparat do
dalszego żywienia niemowl ąt’,
— in Slovenian:
‘začetna formula za dojen čke’ and ‘nadaljevalna formula za
dojen čke’,
— in Slovak:
‘počiatočná doj čenská výživa’ and ‘následná doj čenská výživa’.
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 βρέφη ’ and ‘ Γάλα δεύτερης βρεφικής 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:
‘Volledige zuigelingenvoeding op basis van melk’or ‘Zuigelingen-
melk’ and ‘Opvolgmelk’,
— 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’,
— in Czech:
‘počáteční mlé čná kojenecká výživa’ and ‘pokra čovací mlé čná
kojenecká výživa’,
— in Estonian:
‘Piimal põhinev imiku piimasegu’ and ‘Piimal põhinev jätkupiima-
segu’,
— in Latvian:
‘Piens z īdaiņiem l īdzčetru m ēnešu vecumam’ and ‘Piens z īdaiņiem
nočetru m ēnešu vecuma’,
— in Lithuanian:
‘pieno mišinys k ūdikiams iki 4-6 m ėn’ and ‘pieno mišinys
kūdikiams, vyresniems kaip 4 m ėn’,
— in Hungarian:
‘tejalapú anyatej-helyettesít ő tápszer’ and ‘tejalapú anyatej-
keigészít őtápszer’,
— in Maltese:
‘ħalib tat-trabi’ and ‘ ħalib tal-prosegwiment’,
— in Polish:
‘mleko pocz ątkowe’ and ‘mleko nast ępne’,1991L0321 — EN — 01.05.2004 — 004.001 — 6
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— in Slovenian:
‘začetno mleko za dojen čke’ and ‘nadaljevalno mleko za dojen čke’,
— in Slovak:
‘počiatočná doj čenská mlie čna výživa’ and ‘následná doj čenská
výživa’.
2. The labelling shall bear, in addition to those provided for in
Article 3 of Directive 79/112/EEC, the following mandatory particu-lars:
(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 infantsover 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 overthe age of four months, that it should form only part of a diversi-fied 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 mentionedin 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 thehealth 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, infor-
mation on vitamins and minerals included in Annex VIII, expressedas 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 appropriateuse of the products so as not to discourage breast-feeding. The use ofthe terms ‘humanized’, ‘maternalized’, or similar terms shall be prohib-
ited. 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 ‘ImportantNotice’ or their equivalent:
(a) a statement concerning the superiority of breast-feeding;
(b) a statement recommending that the product be used only on the
advice of independent persons having qualifications in medicine,1991L0321 — EN — 01.05.2004 — 004.001 — 7
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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 idealizethe 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 accor-dance with the conditions laid down therein.
7. The requirements, prohibitions and restrictions referred to in para-
graphs 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, theway in which they are arranged and the setting in which they aredisplayed;
(b) advertising.
Article 8
1. Advertising of infant formulae shall be restricted to publications
specializing in baby care and scientific publications. Member Statesmay further restrict or prohibit such advertising. Such advertisementsfor infant formulae shall be subject to the conditions laid down inArticle 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 directlyto the consumer at the retail level, such as special displays, discountcoupons, 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 ormembers 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 informa-
tion is provided on infant and young child feeding for use by familiesand those involved in the field of infant and young child nutrition
covering the planning, provision, design and dissemination of informa-
tion and their control.
2. Member States shall ensure that informational and educational
materials, whether written or audiovisual, dealing with the feeding ofinfants and intended to reach pregnant women and mothers of infantsand young children, shall include clear information on all the followingpoints:
(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 manufac-
tured industrially or home-prepared.
When such materials contain information about the use of infant
formulae, they shall include the social and financial implications of itsuse; the health hazards of inappropriate foods or feeding methods, and,in particular, the health hazards of improper use of infant formulae.1991L0321 — EN — 01.05.2004 — 004.001 — 8
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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 theappropriate national authority or within guidelines given by thatauthority for this purpose. Such equipment or materials may bear thedonating company's name or logo, but shall not refer to a proprietarybrand 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, whetherfor use in the institutions or for distribution outside them, shall onlybe used by or distributed for infants who have to be fed on infantformulae and only for as long as required by such infants.
Article 10
Member States shall bring into force the laws, regulations and admin-
istrative 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 refer-
ence shall be adopted by Member States.
Article 11
This Directive is addressed to the Member States.1991L0321 — EN — 01.05.2004 — 004.001 — 9
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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 quan-
tity of each essential amino acid of the test protein and the quantity of each
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 and
cystine 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 and
cystine 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 (42 µmoles/
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).1991L0321 — EN — 01.05.2004 — 004.001 — 10
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The L-carnitine content shall be at least equal to 1,8 µmoles/100 kJ
(7,5 µmoles/100 kcal).
2.4. In all cases , the addition of amino acids is permitted solely for the purpose
of improving the nutritional value of the proteins, and only in the propor-
tions necessary for that purpose.
3. Lipids
►M1 Minimum ◄ Maximum
►M1 1,05 g/100 kJ ◄ 1,5 g/100 kJ
►M1 (4,4 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 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,1991L0321 — EN — 01.05.2004 — 004.001 — 11
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— malto-dextrins,
— glucose syrup or dried glucose syrup,— pre-cooked starchnaturally free of gluten/C27
— 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 50 125
Calcium (mg) 12 — 50 —
Phosphorus (mg) 6 22 25 90
Magnesium (mg) 1,2 3,6 5 15
Iron (mg) (1) 0,12 0,36 0,5 1,5
Zinc (mg) 0,12 0,36 0,5 1,5
Copper ( 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.
(2) Limit applicable to formulae with added selenium.
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:1991L0321 — EN — 01.05.2004 — 004.001 — 12
▼M1
▼B
▼M1
▼B
▼B
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Iron (mg) 0,25 0,5 1 2
Zinc (mg) 0,18 0,6 0,75 2,4
6. Vitamins
Per 100 kJ Per 100 kcal
MinimumMaximu-
mMinimumMaximu-
m
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 B12(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 polyunsa-
turated fatty acids
expressed as lino-
leic acid but in no
case less than0,1 mg per 100
available kJ— 0,5/g of polyunsa-
turated fatty acids
expressed as lino-
leic acid but in no
case less than0,5 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).1991L0321 — EN — 01.05.2004 — 004.001 — 13
▼M1
▼B
▼M1
▼B
ANNEX II
ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN
RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER
NB: The values refer to the product ready for use
1. Energy
Minimum Maximum
250 kJ/100 ml 335 kJ/100 ml
(60 kcal/100 ml) (80 kcal/100 ml)
2. Proteins
(Protein content = nitrogen content × 6,38) for cows' milk proteins.
(Protein content = nitrogen content × 6,25) for soya protein isolates.
Minimum Maximum
0,5 g/100 kJ 1 g/100 kJ
(2,25 g/100 kcal) (4,5 g/100 kcal)
The chemical index of the proteins present shall be at least equal to 80 %
of that of the reference protein (casein ►M1 or breast milk ◄ as
defined in Annex VI).
The ‘chemical index’ shall mean the lowest of the ratios between the
quantity of each essential amino acid of the test protein and the quantity
of each corresponding amino acid of the reference protein.
For follow-on formulae manufactured from soya proteins, alone or in a
mixture with cows' milk proteins, only protein isolates from soya may
be used.
Amino acids may be added to follow-on formulae for the purpose of
improving the nutritional value of the proteins, in the proportions neces-
sary for that purpose.
►M1 For an equal energy value, these formulae must contain an avail-
able quantity of methionine at least equal to that contained in breast milk
as defined in Annex V. ◄
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 content1991L0321 — EN — 01.05.2004 — 004.001 — 14
▼M1
▼B
▼B
3.4. Linoleic acid (in the form of glycerides = linoleates)
Minimum Maximum
70 mg/100 kJ —
(300 mg/100 kcal):
this limit applies only to follow-on
formulae containing vegetable oils
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. F o l l o w - o n f o r m u l a e m a n u f a c t u r e d e n t i r e l y f r o m c o w s ' m i l k
Minimum Maximum
0,12 mg/100 kJ —
(0,5 mg/100 kcal)
5.2.2. F o l l o w - o n f o r m u l a e c o n t a i n i n g s o y a p r o t e i n i s o l a t e s , o r
m i x e dw i t hc o w s 'm i l k
Minimum Maximum
0,18 mg/100 kJ —
(0,75 mg/100 kcal)1991L0321 — EN — 01.05.2004 — 004.001 — 15
▼M1
▼B
▼B
5.3. Other mineral substances
The concentrations are at least equal to those normally found in cows'
milk, reduced, where appropriate, in the same ratio as the protein concen-
tration of the follow-on formulae to that of cows' milk. The typical
composition of cows' milk is given, for guidance, in Annex VIII.
5.4. The calcium/phosphorus ratio shall not exceed 2,0.
6. Vitamins
Per 100 kJ Per 100 kcal
MinimumMaximu-
mMinimumMaximu-
m
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
linoleic acid but
in no case less
than 0,1 mg per
100 available kJ— 0,5/g polyunsatu-
rated 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 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).1991L0321 — EN — 01.05.2004 — 004.001 — 16
▼M1
▼B
ANNEX III
NUTRITIONAL SUBSTANCES
1.Vitamins
Vitamin Vitamin formulation
Vitamin A Retinyl acetate
Retinyl palmitate
Beta-caroteneRetinol
Vitamin D Vitamin D
2(ergocalciferol)
Vitamin D3(cholecalciferol)
Vitamin B1Thalmin hydrochloride
Thalmin mononitrate
Vitamin B2Riboflavin
Riboflavin-5 ′-phosphate, sodium
Niacin Nicotinamide
Nicotinic acid
Vitamin B6Pyridoxine hydrochloride
Pyridoxine-5 ′-phosphate
Folate Folic acidPantothenic acid D-pantothenate, calcium
D-pantothenate, sodium
Dexpanthenol
Vitamin B
12Cyanocobalamin
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 acetateDL-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 gluconateCalcium glycerophosphate
Calcium lactate
Calcium salts of orthophosphoric acid1991L0321 — EN — 01.05.2004 — 004.001 — 17
▼B
Mineral substances Permitted salts
Calcium hydroxide
Magnesium (Mg) Magnesium carbonate
Magnesium chlorideMagnesium oxideMagnesium salts of orthophosphoric acid
Magnesium sulphate
Magnesium gluconateMagnesium hydroxideMagnesium salts of citric acid
Iron (Fe) Ferrous citrate
Ferrous gluconateFerrous lactate
Ferrous sulphate
Ferric ammonium citrateFerrous fumarateFerric diphosphate (Ferric pyrophosphate)
Copper (Cu) Cupric citrate
Cupric gluconateCupric sulphate
Copper-lysine complex
Cupric carbonate
Iodine (I) Potassium iodide
Sodium iodide
Potassium iodate
Zinc (Zn) Zinc acetate
Zinc chloride
Zinc lactate
Zinc sulphateZinc citrateZinc gluconate
Zinc oxide
Manganese (Mn) Manganese carbonate
Manganese chloride
Manganese citrate
Manganese sulphateManganese gluconate
Sodium (Na) Sodium bicarbonate
Sodium chlorideSodium citrateSodium gluconate
Sodium carbonate
Sodium lactateSodium salts of orthophosphoric acidSodium hydroxide
Potassium (K) Potassium bicarbonate
Potassium carbonatePotassium chloride
Potassium salts of citric acid
Potassium gluconate1991L0321 — EN — 01.05.2004 — 004.001 — 18
▼B
Mineral substances Permitted salts
Potassium lactate
Potassium salts of orthophosphoric acidPotassium hydroxide
Selenium Sodium selenate
Sodium selenite
3.Amino acids and other nitrogen compounds
L-arginine and its hydrochloride
L-cystine and its hydrochloride
L-histidine and its hydrochloride
L-isoleucine and its hydrochlorideL-leucine and its hydrochloride
L-cysteine and its hydrochloride
L-cysteine and its hydrochlorideL-methionineL-phenylalanine
L-threonine
L-tryptophanL-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 chloride
Choline citrateCholine bitartrate
Inositol1991L0321 — EN — 01.05.2004 — 004.001 — 19
▼M1
▼B
▼M1
▼B
▼B
ANNEX IV
COMPOSITIONAL CRITERIA FOR INFANT FORMULAE,
WARRANTING A CORRESPONDING CLAIM
Claim related to Conditions warranting the claim
1. Adapted protein The protein content is lower than
0,6 g/100 kJ (2,5 g/100 kcal) and the
whey protein/casein ratio is not less
than 1,0.
2. Low sodium The sodium content is lower than
9 mg/100 kJ (39 mg/100 kcal).
3. Sucrose free No sucrose is present.
4. Lactose only Lactose is the only carbohydrate
present.
5. Lactose free No lactose is present (1).
6. Iron enriched Iron is added.
7. Reduction of risk to allergy to
milk proteins. This claim may
include terms referring to reduced
allergen of reduced antigen proper-
ties.(a) The formulae shall satisfy the
provisions laid down in Section
2.2 of Annex I and the amount of
immunoreactive protein measured
with methods gererally acceptable
as appropriate shall 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 the formu-
lae's tolerance in more than 90 %
of infants (confidence interval
95 %) hypersensitive 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 veri-
fied data as proof to the claimed
properties must be available.
(1) When determined by a method the detection limits of which will be established at a
later stage.1991L0321 — EN — 01.05.2004 — 004.001 — 20
▼M1
▼B
▼B
ANNEX V
ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK
For the purpose of this report, the essential and semi-essential amino acids in
breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:
Per 100 kJ (1) Per 100 kcal
Arginine 16 69
Cystine 6 24
Histidine 11 45
Isoleucine 17 72
Leucine 37 156
Lysine 29 122
Methionine 7 29
Phenylalanine 15 62
Threonine 19 80
Tryptophan 7 30Tyrosine 14 59
Valine 19 80
(1) 1 kJ = 0,239 kcal.1991L0321 — EN — 01.05.2004 — 004.001 — 21
▼B
ANNEX VI
Amino acid composition of casein and breast milk protein
The amino acid composition of casein and breast milk protein:
(g/100 g of protein)
Casein (1) Breast milk (1)
Arginine 3,7 3,8
Cystine 0,3 1,3
Histidine 2,9 2,5
Isoleucine 5,4 4,0
Leucine 9,5 8,5
Lysine 8,1 6,7
Methionine 2,8 1,6
Phenylalanine 5,2 3,4
Threonine 4,7 4,4
Tryptophan 1,6 1,7
Tyrosine 5,8 3,2
Valine 6,7 4,5
(1) Amino acid content of foods and biological data on protein. FAO Nutritional Studies,
No 24, Rome 1970, items 375 and 383 .1991L0321 — EN — 01.05.2004 — 004.001 — 22
▼B
ANNEX VII
The mineral elements in cows' milk
As a reference, the contents of mineral elements in cows' milk expressed per
100 g of solids-non-fat and per g of proteins are the following:
Per 100 g SNF (1) Per g of proteins
Sodium (mg) 550 15
Potassium (mg) 1 680 43
Chloride (mg) 1 050 28
Calcium (mg) 1 350 35
Phosphorus (mg) 1 070 28
Magnesium (mg) 135 3,5
Copper ( 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.1991L0321 — EN — 01.05.2004 — 004.001 — 23
▼M1
ANNEX VIII
REFERENCE VALUES 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) 0,5
Riboflavin (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) 4
Iodine ( µg) 70
Selenium ( µg) 10
Copper (mg) 0,41991L0321 — EN — 01.05.2004 — 004.001 — 24
▼M3
ANNEX IX
Pesticides which shall not be used in agricultural production intended for
the production of infant formulae and follow-on formulae
Table 1
Chemical name of the substance (residue definition)
Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone
expressed as disulfoton)
Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones,expressed as fensulfothion)
Fentin, expressed as triphenyltin cation
Haloxyfop (sum of haloxyfop, its salts and esters including conjugates,expressed as haloxyfop)
Heptachlor and trans -heptachlor epoxide, expressed as heptachlor
Hexachlorobenzene
Nitrofen
Omethoate
Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)
Table 2
Chemical name of the substance
Aldrin and dieldrin, expressed as dieldrin
Endrin1991L0321 — EN — 01.05.2004 — 004.001 — 25
▼M3
ANNEX X
Specific maximum residue levels of pesticides or metabolites of pesticides in
infant formulae and follow-on formulae
Chemical name of the substanceMaximum residue level
(mg/kg)
Cadusafos 0,006
Demeton-S-methyl/demeton-S-methyl sulfone/
oxydemeton-methyl (individually or combined,
expressed as demeton-S-methyl)0,006
Ethoprophos 0,008
Fipronil (sum of fipronil and fipronil-desulfinyl,
expressed as fipronil)0,004
Propineb/propylenethiourea (sum of propineb and
propylenethiourea)0,0061991L0321 — EN — 01.05.2004 — 004.001 — 26