1991L0321 — EN — 19.03.1996 — 001.001 — 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 14May 1991
on infant formulae and follow-on formulae
(91/321/EEC)
(OJ L 175, 4.7.1991, p. 35)
Amended by:
Official Journal
Nopage date
►M1Commission Directive 96/4/EC of 16 February 1996 L 49 12 28.2.1996
Amended by:
►A1Act 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
1991L0321 — EN — 19.03.1996 — 001.001 — 2
▼B
COMMISSION DIRECTIVE
of 14May 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’ milkproteins 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 andtechnical 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 maximumlevels for contaminants; whereas given the complexity of the subjectthese will have tobe ado pted at a later stage;
Whereas infant formula is the only processed foodstuff which wholly
satisfies the nutritional requirements of infants during the first four tosix months of life; whereas in order to safeguard the health of suchinfants 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 byCouncil Directive 79/112/EEC of 18 December 1978 on the approx-imation of the laws of the Member States relating to the labelling,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 exceptions tothose general rules, where it is appropriate, in order to promote andprotect 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 prevent inap-pro priate uses likely tobe detrimental tothe health o f infants;
Whereas, pursuant toArticle 2 (2) o f Directive 79/112/EEC, and in
order to supply objective and scientifically verified information, it isnecessary to define the conditions under which claims about the partic-ular composition of an infant formula are authorized;
(1) OJ NoL 186, 30. 6. 1989, p. 27.
(2) OJ NoL 33, 8. 2. 1979, p. 1.
(3) OJ NoL 186, 30. 6. 1989, p. 17.
1991L0321 — EN — 19.03.1996 — 001.001 — 3
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Whereas, in an effort to provide better protection for the health ofinfants, the rules of composition, labelling and advertising laid down inthis Directive should be in conformity with the principles and the aimsof the International Code of Marketing of Breast-Milk Substitutesadopted by the 34th World Health Assembly, bearing in mind theparticular 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 informationensures an adequate use of the products in question and is not counter tothe 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 liabletoaffect 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 aseparate 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 labellingrequirements for infant formulae and follow-on formulae intended foruse by infants in good health in the Community. It also provides forMember States togive effect toprinciples and aims o f the Internatio nalCode 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 andsatisfying by themselves the nutritional requirements of thiscategory 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.
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.
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 hasbeen 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
1991L0321 — EN — 19.03.1996 — 001.001 — 4
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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 speci-
fied 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
manufacture of infant formulae and follow-on formulae in order tosatisfy 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.
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Article 6
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.
Microbiological criteria shall also be established as necessary.
▼
B
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:
‘Preparadopara lactantes' and ‘Preparadode co ntinuación',
— in French:
‘Préparation pour nourrissons' and ‘Préparation de suite',
— in Italian:
‘Alimentoper lattanti' and ‘Alimentodi pro seguimento ',
— in Dutch:
‘Volledige zuigelingenvoeding' and ‘Opvolgzuigelingenvoeding',
— in Portuguese
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‘Fórmula para lactentes' and ‘Fórmula de transição',
▼A1
— in Finnish:
‘Äidinmaidonkorvike' and ‘Vieroitusvalmiste',
— in Swedish:
‘Modersmjölksersättning' and ‘Tillskottsnäring'.
▼B
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
‘Tilskudsblanding 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',
▼A1
— in Finnish:
‘Maitopohjainen äidinmaidonkorvike' and ‘Maitopohjainen vieroi-
tusvalmiste',
— in Swedish:
‘Modersmjölksersättning uteslutande baserad på mjölk' and ‘Till-
skottsnäring uteslutande baserad på mjölk'.
▼B
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 frombirth when they are not breast-fed;
(b) in the case of infant formulae that do not contain added iron, a
statement tothe effect that, when the pro duct is given toinfantsover the age of four months, their total iron requirements must bemet 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 diversifieddiet and that it is not to be used as a substitute for breast milkduring the first four months of life;
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(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 mlof 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,
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inositol, carnitine and taurine, expressed in numerical form, per100 ml of the product ready for use;
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B
(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.
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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) ofthis Article, expressed in numerical form, per 100 ml of the productready 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 ofthe product ready for use, provided that the quantities present are atleast equal to15 per cent o f the reference values;
▼
B
3. The labelling of infant formulae and follow-on formulae shall bedesigned to provide the necessary information about the appropriate useof the products so as not to discourage breast-feeding. The use of theterms ‘humanized',‘maternalized',or similar terms shall be prohibited.The term ‘adapted' may only be used in conformity with paragraph 6and 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,nutrition or pharmacy, or other professionals responsible formaternal 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 theuse of the product. It may, however, have graphic representations foreasy identification of the product and for illustrating methods of prepa-ration.
6. The labelling may bear claims concerning the special composition
of an infant formula only in the cases listed in Annex IV and inaccordance with the conditions laid down therein.
7. The requirements, prohibitions and restrictions referred to in para-
graphs 3 to6 shall alsoapply to :
(a) the presentation of the products concerned, in particular their shape,
appearance or packaging, the packaging materials used, the way inwhich 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 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 ascientific and factual nature. Such information shall not imply or createa 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.
1991L0321 — EN — 19.03.1996 — 001.001 — 7
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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 anyother promotional gifts, either directly or indirectly via the health caresystem 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 nutritioncovering 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.Such material shall not use any pictures which may idealize the use ofinfant formulae.
3. Member States shall ensure that donations of informational or
educational equipment or materials by manufacturers or distributorsshall 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 healthcare system.
4. Member States shall ensure that donations or low-price sales of
supplies of infant formulae to institutions or organizations, whether foruse in the institutions or for distribution outside them, shall only be usedby or distributed for infants who have to be fed on infant formulae andonly for as long as required by such infants.
Article 10
Member States shall bring into force the laws, regulations and adminis-
trative provisions necessary to comply with this Directive. They shallimmediately inform the Commission thereof. Those provisions shall beapplied 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 atthe time of their official publication. The procedure for such referenceshall be adopted by Member States.
Article 11
This Directive is addressed tothe Member States.
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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)
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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 aminoacid at least equal tothat co ntainedin the reference protein (breast milk, as defined in Annex V); nevertheless,for calculation purposes, the concentration of methionine and cystine maybe 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 aminoacid at least equal tothat co ntainedin the reference protein (breast milk, as defined in Annex V); nevertheless,for calculation purposes, the concentration of methionine and cystine maybe 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
1,8µmoles/100 kJ (7,5 µmoles/100 kcal).
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B
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.
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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 (breastmilk, as defined in Annex V).
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
►M1Minimum ◄ Maximum
►M11,05 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,
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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)
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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 excee d1%oft h et ot a lf a tc o ntent.
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)
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Per 100 kJ Per 100 kcal
Minimum Maximum Minimun Maximum— The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of
docosahexaenoic (22:6 n-3) acid content.
▼B
4.Carbohydrates
Minimum Maximum
1,7 g/100 kJ 3,4 g/100 kJ
(7 g/100 kcal) (14 g/100 kcal)
4.1. Only the following carbohydrates may be used:
— lactose,
— maltose,— sucrose,— malto-dextrins,— glucose syrup or dried glucose syrup,— pre-cooked starch— gelatinized starchnaturally free of gluten
4.2.Lactose
Minimum Maximum
0,85 g/100 kJ —
(3,5 g/100 kcal) —
This provision does not apply to formulae in which soya proteins represent
more than 50 % of the total protein content.
4.3.Sucrose
Minimum Maximum
— 20 % of the total carbohydrate
content
4.4.Pre-cooked starch and/or 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
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 51 5
Iron (mg) (1) 0,12 0,36 0,5 1,5
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Per 100 kJ Per 100 kcal
Minimum Maximum Minimun Maximum
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum MaximumZinc (mg) 0,12 0,36 0,5 1,5
Copper ( µg) 4,8 19 20 80
Iodine ( µg) 1,2 — 5—
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Selenium (2)µg — 0,7 — 3
(1) Limit applicable to formulae with added iron.
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(2) Limit applicable tofo rmulae with added selenium.▼B
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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:
Iron (mg) 0,25 0,5 12
Zinc (mg) 0,18 0,6 0,75 2,4
6.Vitamins
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 —
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Niacin (mg-NE)0,2 — 0,8 —
▼B
Pantothenic acid ( µg)70 — 300 —
Vitamin B6(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 polyun-
saturated fattyacids expressedas linoleic acidbut in nocaseless than 0,1 mgper 100 availablekJ—0,5/g of polyun-
saturated fattyacids expressedas linoleic acidbut in nocaseless than 0,5 mgper 100 availablekcal—
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Maximum (1)
(mg/100 kJ) (mg/100 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.
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7. The following nucleotides may be added:
cytidine 5 /prime1-monophosphate 0,60 2,50
uridine 5 /prime1-monophosphate 0,42 1,75
adenosine 5 /prime1-monophosphate 0,36 1,50
guanosine 5 /prime1-monophosphate 0,12 0,50
inosine 5 /prime1-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 — 19.03.1996 — 001.001 — 13
Minimum Maximum
Minimum Maximum
Minimum Maximum
Minimum Maximum▼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
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.
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 ►
M1or 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 corre-sponding 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 necessary for thatpurpose.
►
M1For an equal energy value, these formulae must contain an available
quantity of methionine at least equal to that contained in breast milk as definedin Annex V. ◄
3.Lipids
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,
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3.2.Lauric acid
— 15 % of the total fat content
3.3.Myristic acid
1991L0321 — EN — 19.03.1996 — 001.001 — 14
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Minimum Maximum
Minimum Maximum
Minimum Maximum
Minimum Maximum
Minimum Maximum
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum— 15 % of the total fat content
3.4.Linoleic acid (in the form of glycerides = linoleates)
70 mg/100 kJ —
(300 mg/100 kcal):this limit applies only to follow-on
formulae containing vegetable oils
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3.5. The trans fatty acid content shall not exceed 4 % of the total fat content.
3.6. The eruic acid content shal not excee d1%oft h et ot a lf a tc o ntent.
▼B
4.Carbohydrates
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
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
— separately or as a whole:
20 % of the total carbohydrate
content
5.Mineral substances
5.1.
Iron (mg) 0,25 0,5 12
Iodine ( µg) 1,2 — 5 —
5.2.Zinc
5.2.1. Follow-on formulae manufactured entirely from cows’ milk
1991L0321 — EN — 19.03.1996 — 001.001 — 15
▼B
Minimum Maximum
Minimum Maximum
Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Maximum (1)
(mg/100 kJ) (mg/100 kcal)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
0,18 mg/100 kJ —
(0,75 mg/100 kcal)
5.3.Other mineral substances
The concentrations are at least equal to those normally found in cows’
milk, reduced, where appropriate, in the same ratio as the protein concen-tration 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.
6.Vitamins
Vitamin A ( µg-ER) (1) 14 43 60 180
Vitamin D ( µg) (2) 0,25 0,75 13
Vitamin C ( µg) 1,9 — 8—
Vitamin E (mg α-TE)(3) 0,5/g polyunsat-
urated fattyacids expressedas linoleic acidbut in nocaseless than0,1 mg per 100available kJ—0,5/g polyunsat-urated fattyacids expressedas linoleic acidbut in nocaseless than0,5 mg per 100available 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.
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7. The following nucleotides may be added:
cytidine 5 /prime1-monophosphate 0,60 2,50
uridine 5 /prime1-monophosphate 0,42 1,75
adenosine 5 /prime1-monophosphate 0,36 1,50
guanosine 5 /prime1-monophosphate 0,12 0,50
inosine 5 /prime1-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 — 19.03.1996 — 001.001 — 16
Vitamin Vitamin formulation
Mineral substances Permitted salts▼B
ANNEX III
NUTRITIONAL SUBSTANCES
1.Vitamins
Vitamin A Retinyl acetate
Retinyl palmitateBeta-caroteneRetinol
Vitamin D Vitamin D2(ergocalciferol)
Vitamin D3(cholecalciferol)
Vitamin B1 Thalmin hydrochlorideThalmin mononitrate
Vitamin B2 RiboflavinRiboflavin-5 /prime1-phosphate, sodium
Niacin Nicotinamide
Nicotinic acid
Vitamin B6 Pyridoxine hydrochloridePyridoxine-5 /prime1-phosphate
Folate Folic acid
Pantothenic acid D-pantothenate, calcium
D-pantothenate, sodiumDexpanthenol
Vitamin B12 CyanocobalaminHydroxocobalamin
Biotin D-biotin
Vitamin C L-ascorbic acid
Sodium L-ascorbateCalcium L-ascorbate6-palmityl-L-ascorbic acid (ascorbyl palmitate)Potassium ascorbate
Vitamin E D-alpha tocopherol
DL-alpha tocopherolD-alpha tocopherol acetateDL-alpha tocopherol acetate
Vitamin K Phylloquinone (Phytomenadione)
2.Mineral substances
Calcium (Ca) Calcium carbonate
Calcium chlorideCalcium salts of citric acidCalcium gluconateCalcium glycerophosphateCalcium lactateCalcium salts of orthophosphoric acidCalcium hydroxide
Magnesium (Mg) Magnesium carbonate
Magnesium chlorideMagnesium oxideMagnesium salts of orthophosphoric acidMagnesium sulphate
1991L0321 — EN — 19.03.1996 — 001.001 — 17
▼B
Mineral substances Permitted salts
Magnesium gluconate
Magnesium hydroxideMagnesium salts of citric acid
Iron (Fe) Ferrous citrate
Ferrous gluconate
Ferrous lactateFerrous sulphateFerric ammonium citrateFerrous fumarateFerric diphosphate (Ferric pyrophosphate)
Copper (Cu) Cupric citrate
Cupric gluconate
Cupric sulphateCopper-lysine complexCupric carbonate
Iodine (I) Potassium iodide
Sodium iodide
Potassium iodate
Zinc (Zn) Zinc acetate
Zinc chloride
Zinc lactateZinc sulphateZinc citrateZinc gluconateZinc oxide
Manganese (Mn) Manganese carbonate
Manganese chloride
Manganese citrateManganese sulphateManganese gluconate
Sodium (Na) Sodium bicarbonate
Sodium chloride
Sodium citrateSodium gluconateSodium carbonateSodium lactateSodium salts of orthophosphoric acidSodium hydroxide
Potassium (K) Potassium bicarbonate
Potassium carbonate
Potassium chloridePotassium salts of citric acidPotassium gluconatePotassium lactatePotassium salts of orthophosphoric acidPotassium hydroxide
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SeleniumSodium selenate
Sodium selenite
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3.Amino acids and other nitrogen compounds
L-arginine and its hydrochloride
L-cystine and its hydrochlorideL-histidine and its hydrochlorideL-isoleucine and its hydrochloride
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L-leucine and its hydrochloride
L-cysteine and its hydrochlorideL-cysteine and its hydrochlorideL-methionineL-phenylalanineL-threonineL-tryptophanL-tyrosineL-valineL-carnitine and its hydrochlorideTaurine
►
M1cytidine 5 /prime1- monophosphate and its sodium salt
uridine 5 /prime1- monophosphate and its sodium salt
adenosine 5 /prime1- monophosphate and its sodium salt
guanosine 5 /prime1- monophosphate and its sodium salt
inosine 5 /prime1- monophosphate and its sodium salt. ◄
4.Others
Choline
Choline chlorideCholine citrateCholine bitartrateInositol
1991L0321 — EN — 19.03.1996 — 001.001 — 19
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Claim related to Conditions warranting the claimANNEX IV
COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRE-
SPONDING 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.
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7. Reduction of risk to
allergy tomilkproteins. This claimmay include termsreferring toreducedallergen of reducedantigen properties.(a) The formulae shall satisfy the provisions laid down in Section 2.2
of Annex I and the amount of immunoreactive protein measuredwith methods gererally acceptable as appropriate shall be less than1 % 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 unlessgenerally accepted clinical tests provide proof of the formulae’stolerance 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 verified 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.
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Per 100 kJ (1) Per 100 kcal▼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:
Arginine 16 69
Cystine 6 24
Histidine 11 45
Isoleucine 17 72
Leucine 37 156
Lysine 29 122
Methionine 7 29
Phenylalanine 15 62
Threonine 19 80
Tryptophan 7 30
Tyrosine 14 59
Valine 19 80
(1) 1 kJ=0,239 kcal.
1991L0321 — EN — 19.03.1996 — 001.001 — 21
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(g/100 g of protein)
Casein (1) Breast milk(1)ANNEX VI
Amino acid composition of casein and breast milk protein
The amino acid composition of casein and breast milk protein:
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 — 19.03.1996 — 001.001 — 22
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Per 100 g de SNF (1) Per g of proteinsANNEX 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:
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) NS
(1) SNF: ‘solids no fats'.
(2) NS: non-specified, varies widely according to season and stock farming conditions.
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Nutrient Labelling reference value▼M1
ANNEX VIII
REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR
INFANTS AND YOUNG CHILDREN
Vitamin A ( µg) 400
Vitamin D ( µg) 10
Vitamin C (mg) 25
Thiamin (mg) 0,5
Riboflavin (mg) 0,8
Niacin 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) 0,4