Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC Text with EEA relevance
Date: 2006-12-22
Institutions: European Commission
Subjects: early childhood, food safety, food standard, labelling, marketing standard, mother's milk

30.12.2006

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Official Journal of the European Union

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I

(Acts whose publication is obligatory)

COMMISSION DIRECTIVE 2006/141/EC

of 22 December 2006

on infant formulae and follow-on formulae and amending Directive 1999/21/EC

(Text with EEA relevance)

(4)

(5)

(6)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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 intended for particular nutritional uses (1), and in
particular Article 4(1) thereof,

After consulting the European Food Safety Authority (the
Authority),

Whereas:

(1)

(2)

Directive 89/398/EEC concerns foodstuffs intended for
specific provisions
particular nutritional uses. The
applicable to certain groups of foods for particular nu-
tritional uses are laid down by specific Directives.

Commission Directive 91/321/EEC of 14 May 1991 on
infant formulae and follow-on formulae (2) is a specific
Directive adopted pursuant
to Directive 89/398/EEC.
That Directive has been substantially amended several
times (3). Since further amendments are to be made,
it
should be recast in the interests of clarity.

(3)

In the light of discussions in international
in
particular Codex Alimentarius, in relation to the timing
of the introduction of complementary foods into the diet

fora,

(1) OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 175, 4.7.1991, p. 35. Directive as last amended by the 2003

Act of Accession.
(3) See Annex X, Part A.

of infants,
it is appropriate to amend the current defi-
nitions of infant formulae and follow-on formulae and
certain provisions on the labelling of follow-on formulae
in Directive 91/321/EEC.

Infant
formula is the only processed foodstuff which
wholly satisfies the nutritional requirements of infants
during the first months of life until the introduction of
to
appropriate
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.

complementary

feeding.

order

In

The essential composition of infant formulae and follow-
on formulae must satisfy the nutritional requirements of
infants
in good health as established by generally
accepted scientific data.

infant

recent

sources,

scientific

the protein content
protein

The requirements concerning the essential composition
of
formulae and follow-on formulae should
include detailed provisions on the protein content.
Notwithstanding that traditionally different appropriate
conversion factors have been used for the calculation
from the nitrogen content of
of
different
advice
for the specific purposes of calculating
indicates that
the protein content of
infant formulae and follow-on
formulae it is appropriate to use a single conversion
factor adapted to these products. As infant
formulae
and follow-on formulae are sophisticated products that
are specially formulated for their intended purpose, ad-
including
ditional essential
minimum and maximum levels
and
minimum levels of certain amino acids, should be estab-
lished. The protein requirements
specified in this
Directive should relate to the final products as such,
prepared ready for consumption.

requirements on protein,

protein

of

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(7)

(8)

(9)

On the basis of such data, the essential composition of
infant formulae and follow-on formulae manufactured
from cows' milk proteins and soya proteins alone or in
a mixture, as well as infant formulae based on protein
hydrolysates, can already be defined. The same is not true
for preparations based wholly or partly on other sources
of protein. For
such
products, if necessary, should be adopted at a later date.

reason specific rules

this

for

It is important that ingredients used in the manufacture
of infant formulae and follow-on formulae are suitable
for the particular nutritional use by infants and that their
suitability has been demonstrated, when necessary, by
appropriate
studies. Guidance on the design and
conduct of appropriate studies has been published by
expert
Scientific
Committee on Food, the UK Committee on the Medical
Aspects of Food and Nutrition Policy, and the European
Society for Paediatric Gastroenterology, Hepatology and
Nutrition. Such guidance should be taken into con-
sideration when ingredients are introduced into infant
formulae or follow-on formulae.

scientific

groups

such

the

as

A number of the substances that may be used in the
manufacture of infant formulae and follow-on formulae
may also be used in foodstuffs as food additives. In that
context, purity criteria have already been or are to be
adopted at Community
in accordance with
Council Directive 89/107/EEC of 21 December 1988
on the approximation of
the Member
States concerning food additives authorised for use in
foodstuffs intended for human consumption (1). Those
purity
substances
apply
whatever the purpose of their use in foodstuffs.

the laws of

to those

criteria

should

level

(10)

Pending the adoption of purity criteria for substances for
which such criteria have not yet been adopted at
Community level, and in order to ensure a high level
of protection for public health, generally acceptable
purity criteria recommended by international organ-
the Joint FAO/WHO
isations or agencies,
such as
(JECFA) or
Expert Committee on Food Additives
In
should
European Pharmacopoeia
(EUP),
addition, Member
should be permitted to
States
maintain national rules setting stricter purity criteria.

apply.

(11) Given the particular nature of infant formula, additional
means to those usually available to monitoring bodies
should be available in order to facilitate efficient moni-
toring of those products.

(12)

(13)

Infant
formulae based on protein hydrolysates are
distinct
from semi-elemental diet products based on
dietary
high
used
management of diagnosed medical conditions, which
are not covered by this Directive.

hydrolysates

degree

the

for

the
This Directive reflects current knowledge about
to allow inno-
products concerned. Any amendment,
vation based on scientific
and technical progress,
should be decided by the procedure referred to in
Article 13(2) of Directive 89/398/EEC.

and

vegetables (2),

(14) Maximum levels for pesticide residues set out in relevant
Community legislation,
in particular Council Directive
76/895/EEC of 23 November 1976 relating to the
fixing of maximum levels for pesticide residues in and
in Council Directive
on fruit
fixing of
86/362/EEC of 24 July 1986 on the
maximum levels
in and on
cereals (3),
in Council Directive 86/363/EEC of 24 July
1986 on the fixing of maximum levels for pesticide
residues in and on foodstuffs of animal origin (4), and
in Council Directive 90/642/EEC of 27 November
1990 on the fixing of maximum levels for pesticide
residues in and on certain products of plant origin,
veg-
including
etables (5), should apply without prejudice to specific
provisions set out in this Directive.

for pesticide

residues

fruit

and

(15)

laying

Taking into account the Community’s international obli-
gations, in cases where the relevant scientific evidence is
the precautionary principle referred to in
insufficient,
the
Article 7 of Regulation (EC) No 178/2002 of
European Parliament and of the Council of 28 January
down
2002
and
requirements of
food law, establishing the European
Food Safety Authority and laying down procedures in
matters of food safety (6) allows the Community to pro-
visionally adopt measures on the basis of available
pertinent information, pending an additional assessment
of risk and a review of the measure within a reasonable
period of time.

principles

general

the

(2) OJ L 340, 9.12.1976, p. 26. Directive as

last amended by
Commission Directive 2006/92/EC (OJ L 311, 10.11.2006, p. 31).
(3) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Directive

2006/92/EC.

(4) OJ L 221, 7.8.1986, p. 43. Directive as

last amended by

Commission Directive 2006/62/EC (OJ L 206, 27.7.2006, p. 27).
(5) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive

2006/92/EC.

(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation

(6) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

(EC) No 1882/2003.

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

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(16) On the basis of the two opinions given by the Scientific
Committee for Food on 19 September 1997 and 4 June
1998, there are at present doubts as to the adequacy of
existing acceptable daily intake (ADI) values of pesticides
and pesticide residues for the protection of the health of
infants and young children. Therefore, as far as foodstuffs
for particular nutritional uses intended for infants and
young children are concerned,
is appropriate to
adopt a very low common limit for all pesticides. This
very low common limit should be fixed at 0,01 mg/kg
which normally is in practice the minimum detectable
level.

it

(17)

(18)

infant

residues

limitations on pesticide

Severe
should be
required. With careful selection of raw materials, and
given that
formulae and follow-on formulae
undergo extensive processing during their manufacture,
it is feasible to produce products containing very low
levels of pesticide residues. However,
in the case of a
small number of pesticides or metabolites of pesticides
even a maximum residue level of 0,01 mg/kg might,
under worst-case intake conditions, allow infants and
young children to exceed the ADI. This is the case for
pesticides or metabolites of pesticides with an ADI lower
than 0,0005 mg/kg body weight.

This Directive should establish the principle of the pro-
hibition of the use of these pesticides in the production
of agricultural products intended for infant formulae and
follow-on formulae. However, this prohibition does not
necessarily guarantee that products are free from such
pesticides, since some pesticides contaminate the en-
vironment and their
residues may be found in the
products concerned.

(21)

(22)

(23)

The Annexes to this Directive dealing with pesticides
should be amended following the completion of
the
review programme being carried out under Directive
91/414/EEC.

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 Directive 2000/13/EC of the
European Parliament and of the Council of 20 March
2000 on the approximation of the laws of the Member
States relating to the labelling, presentation and adver-
tising of foodstuffs (2). 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.

In particular, the nature and destination of the products
covered by this Directive require nutritional
labelling
showing the energy value and principal nutrients they
contain. On the other hand, the method of use should
be specified in accordance with point 9 of Article 3(1)
and Article 11(2) of Directive 2000/13/EC, in order to
prevent inappropriate uses likely to be detrimental to the
health of infants.

(24) Given the nature of

infant

formulae and follow-on
formulae the detailed rules as to nutrient declaration
on the labelling need to be clarified in order to avoid
any problems which may arise from the application of
other relevant Community legislation.

(25)

(26)

(19) Most of the pesticides which have ADI values lower than
0,0005 mg/kg body weight are already prohibited in the
Community. The prohibited pesticides should not be
detectable in infant
formulae and follow-on formulae
by state-of-the-art analytical methods. However, some
pesticides degrade slowly and still contaminate the en-
vironment. They might be present in infant formulae and
follow-on formulae even if they have not been used. For
the purposes of control, a harmonised approach should
be followed.

(20)

Pending Commission decisions on whether they satisfy
the safety requirements of Article 5 of Council Directive
91/414/EEC of 15 July 1991 concerning the placing of
plant protection products on the market (1),
the
continued use of
should be
permitted as long as their residues comply with the
maximum residue levels established in this Directive.
their
The latter should be set at levels ensuring that
respective ADI values are not exceeded by infants and
young children under worst-case intake conditions.

authorised pesticides

Regulation (EC) No 1924/2006 of
the European
Parliament and of the Council of 20 December 2006
on nutrition and health claims made on food (3) estab-
lishes the rules and conditions for the use of nutrition
and health claims concerning foods. However, Article
shall apply
1(5) of
without
Directive
89/398/EEC and directives adopted relating to foodstuffs
for particular nutritional uses.

that Regulation states
prejudice

that
particular,

to,

in

it

It is appropriate to set out specific conditions for the use
of nutrition and health claims concerning infant formulae
in this Directive. In this respect, it is necessary, in order
to supply objective and scientifically verified information,
to define the conditions under which nutrition and
health claims are authorised, and to establish a list of
authorised claims.
In accordance with the third sub-
paragraph of Article 4(1) of Directive 89/398/EEC, modi-
fication of that list of nutrition and health claims should
be adopted, when necessary, after consultation of the
Authority.

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).

2003/89/EC (OJ L 308, 25.11.2003, p. 15) .

(3) OJ L 404, 30.12.2006, p. 9.

(2) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive

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(27)

In an effort to provide better protection for the health of
infants, the rules of composition,
labelling and adver-
tising 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.

(33)

This Directive should be without prejudice to the obli-
gations of the Member States relating to the time limits
for transposition into national law of the Directives set
out in Annex X, Part B.

(34)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

(28) 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.

HAS ADOPTED THIS DIRECTIVE:

Article 1

(29)

This Directive does not concern the conditions of sale of
publications specialising in baby care and of scientific
publications.

(30)

Commission Directive 1999/21/EC of 25 March 1999
on dietary foods for special medical purposes (1)
lays
down compositional and labelling requirements
for
dietary foods for special medical purposes. The Annex
to that Directive sets out values for minerals in nu-
tritionally complete foods intended for use by infants.
There has been new scientific advice as regards the
minimum level of manganese in foods intended for
infants. Therefore, it is appropriate to amend the levels
special medical
of manganese in dietary foods
for
purposes intended for infants set out
in that Annex.
Directive 1999/21/EC should therefore be amended
accordingly.

intended for

(31) Due to the specific nature of dietary foods for special
infants and to the
medical purposes
such
necessity to assess
products, manufacturers
require a longer period to
adapt their products to the essential composition that
in this
derive from the new requirements
Directive.

the new formulation of

set out

This Directive is a ‘specific Directive’ within the meaning of
Article 4(1) of Directive 89/398/EEC and lays down composi-
formulae and
tional and labelling requirements
follow-on formulae intended for use by infants in good health
in the Community.

infant

for

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 responsi-
bilities of health authorities.

Article 2

For the purposes of this Directive, the definitions of ‘claim’,
‘health claim’ and ‘reduction of disease risk
‘nutrition claim’,
claim’
(5) and (6) of Regulation (EC)
No 1924/2006 shall apply.

in Article 2(2)(1),

(4),

The following definitions shall also apply:

(a)

‘infants’ means children under the age of 12 months;

(32)

The obligation to transpose this Directive into national
law should be confined to those provisions which
represent a substantive change as compared with the
the
earlier Directive. The obligation to transpose
provisions which are unchanged arises under the earlier
Directive.

(1) OJ L 91, 7.4.1999, p. 29. Directive as amended by the 2003 Act of

Accession.

(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 months of life
and satisfying by themselves the nutritional requirements
of
the introduction of appropriate
such infants until
complementary feeding;

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(d) ‘follow-on

formulae’ means

foodstuffs

for
particular nutritional use by infants when appropriate
complementary feeding is introduced and constituting the
principal liquid element in a progressively diversified diet of
such infants;

intended

(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 Directive 91/414/EEC, including
its metabolites and products resulting from its degradation
or reaction.

Article 3

Infant
formulae and follow-on formulae may be marketed
within the Community only if they comply with this Directive.

No product other than infant formula may be marketed or
the
otherwise represented as suitable for satisfying by itself
nutritional requirements of normal healthy infants during the
first months of
the introduction of appropriate
complementary feeding.

life until

Article 4

Infant formulae and follow-on formulae shall not contain any
substance in such quantity as to endanger the health of infants
and young children.

Article 5

Infant formulae shall be manufactured from protein sources
defined in point 2 of Annex I 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.

Such suitability shall be demonstrated through a systematic
review of the available data relating to the expected benefits
and to safety considerations as well as, where necessary, appro-
priate studies, performed following generally accepted expert
guidance on the design and conduct of such studies.

priate studies, performed following generally accepted expert
guidance on the design and conduct of such studies.

Article 7

Infant

1.
formulae shall comply with the compositional
criteria set out in Annex I taking into account the specifications
in Annex V.

In the case of infant formulae manufactured from cows’ milk
proteins defined in point 2.1 of Annex I with a protein content
between the minimum and 0,5 g/100 kJ (2 g/100 kcal), the
suitability of the infant formula for the particular nutritional use
by infants shall be demonstrated through appropriate studies,
performed following generally accepted expert guidance on the
design and conduct of such studies.

infant

the suitability of

In the case of
formulae manufactured from protein
hydrolysates defined in point 2.2 of Annex I with a protein
(2,25
content between the minimum and 0,56 g/100 kJ
g/100 kcal),
the
particular nutritional use by infants shall be demonstrated
through appropriate studies, performed following generally
accepted expert guidance on the design and conduct of such
studies and shall be in accordance with the appropriate specifi-
cations set out in Annex VI.

formula for

the infant

Follow-on formulae shall comply with the compositional
2.
criteria set out in Annex II taking into account the specifications
set out in Annex V.

In order to make infant formulae and follow-on formulae
3.
ready for use, nothing more shall be required, as the case may
be, than the addition of water.

4.
The prohibitions and limitations on the use of food in-
gredients in infant formulae and follow-on formulae set out in
Annexes I and II shall be observed.

Article 8

Only the substances listed in Annex III may be used in the
formulae and follow-on formulae in

1.
manufacture of
order to satisfy the requirements on:

infant

Article 6

Follow-on formulae shall be manufactured from protein sources
defined in point 2 of Annex II and other food ingredients, as
the case may be, whose suitability for particular nutritional use
by infants aged over six months has been established by
generally accepted scientific data.

(a) mineral substances;

(b) vitamins;

Such suitability shall be demonstrated through a systematic
review of the available data relating to the expected benefits
and to safety considerations as well as, where necessary, appro-

(d) other substances having a particular nutritional purpose.

(c) amino acids and other nitrogen compounds;

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for

Purity

criteria

in
2.
Community legislation concerning the use of substances listed
in Annex III,
in the manufacture of foodstuffs for purposes
other than those covered by this Directive, shall apply.

as provided for

substances,

For those substances for which no purity criteria have
generally
international
such criteria at

recommended by

shall apply until

the adoption of

in Community

legislation,

criteria

3.
been provided
acceptable purity
bodies
Community level.

for

However, national rules setting stricter purity criteria than those
recommended by international bodies may be maintained.

Article 9

1.
infant
To facilitate the efficient official monitoring of
formulae, when a food business operator places an infant
formula on the market he
competent
authority of the Member States where the product is being
marketed by forwarding to it a model of the label used for
the product.

shall notify the

By way of derogation from paragraph 1, for the pesticides
3.
listed in Annex IX, the maximum residue levels specified therein
shall apply.

4.
The levels referred to in paragraphs 2 and 3 shall apply to
the products as proposed ready for consumption or as recon-
stituted according to the instructions of the manufacturers.

Article 11

Except as provided for in Article 12, the name under which
formulae and follow-on formulae are sold shall be,
infant
respectively:

— in Bulgarian: ‘храни за кърмачета’ and ‘преходни храни’,

— in Spanish:

‘Preparado para lactantes’ and ‘Preparado de

continuación’,

— in Czech:

‘počáteční kojenecká výživa’ and ‘pokračovací

kojenecká výživa’,

2.
The competent authorities for the purposes of this Article
are those referred to in Article 9(4) of Directive 89/398/EEC.

— in Danish: ‘Modermælkserstatning’ and ‘Tilskudsblanding’,

Article 10

1.
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 recon-
stituted according to the instructions of the manufacturer.

— in German: ‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’,

— in Estonian: ‘imiku piimasegu’ and ‘jätkupiimasegu’,

— in Greek:

‘Παρασκεύασμα για βρέφη’ and ‘Παρασκεύασμα

δεύτερης βρεφικής ηλικίας’,

Analytical methods for determining the levels of pesticide
residues shall be generally acceptable standardised methods.

— in English: ‘infant formula’ and ‘follow-on formula’,

The pesticides listed in Annex VIII shall not be used in
infant

2.
agricultural products intended for the production of
formulae and follow-on formulae.

— in French: ‘Préparation pour nourrissons’ and ‘Préparation de

suite’,

However, for the purpose of controls:

— in Italian:
guimento’,

‘Alimento per lattanti’ and ‘Alimento di prose-

(a) pesticides listed in Table 1 of Annex VIII are considered not
to have been used if their residues do not exceed a level of
0,003 mg/kg. This level, which is considered to be the limit
of quantification of the analytical methods, shall be kept
under regular review in the light of technical progress;

(b) pesticides listed in Table 2 of Annex VIII are considered not
to have been used if their residues do not exceed a level of
0,003 mg/kg. This level shall be kept under regular review
in the light of data on environmental contamination.

— in Latvian:

‘Mākslīgais maisījums zīdaiņiem’ un ‘Mākslīgais

papildu ēdināšanas maisījums zīdaiņiem’,

— in Lithuanian:
įvedimo’
and
maitinimą’,

‘mišinys kūdikiams iki papildomo maitinimo
papildomą

kūdikiams,

‘mišinys

įvedus

— in Hungarian:

‘anyatej-helyettesítő tápszer’ and ‘anyatej-

kiegészítő tápszer’,

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— in Maltese: ‘formula tat-trabi’ and ‘formula tal-prosegwiment’,

— in French: ‘Lait pour nourrissons’ and ‘Lait de suite’,

— in Dutch: ‘Volledige zuigelingenvoeding’ and ‘Opvolgzuigelin-

genvoeding’,

— in Italian: ‘Latte per lattanti’ and ‘Latte di proseguimento’,

— in Polish:

‘preparat do początkowego żywienia niemowląt’

and ‘preparat do dalszego żywienia niemowląt’,

— in Latvian:

‘Mākslīgais piena maisījums zīdaiņiem’ un
‘Mākslīgais papildu ēdināšanas piena maisījums zīdaiņiem’,

— in Portuguese:
transição’,

‘Fórmula para lactentes’ and ‘Fórmula de

— in Lithuanian:

‘pieno mišinys kūdikiams
iki papildomo
maitinimo įvedimo’ and ‘pieno mišinys kūdikiams įvedus
papildomą maitinimą’,

— in Romanian: ‘preparate pentru sugari’ and ‘preparate pentru

copii de vârstă mică’,

— in Slovak:

‘počiatočná dojčenská výživa’ and ‘následná

dojčenská výživa’.

— in Slovenian: ‘začetna formula za dojenčke’ and ‘nadaljevalna

formula za dojenčke’,

— in Finnish: ‘Äidinmaidonkorvike’ and ‘Vieroitusvalmiste’,

— in Swedish: ‘Modersmjölksersättning’ and ‘Tillskottsnäring’.

Article 12

The name under which infant formulae and follow-on formulae
manufactured entirely from cows’ milk proteins are sold, shall
be respectively:

— in Bulgarian: ‘млека за кърмачета’ and ‘преходни млека’,

— in Spanish: ‘Leche para lactantes’ and ‘Leche de continuación’,

— in Czech:

‘počáteční mléčná kojenecká výživa’ and ‘pokra-

čovací mléčná kojenecká výživa’,

— in Danish:

‘Modermælkserstatning udelukkende baseret på
mælk’ and ‘Tilskudsblanding udelukkende baseret på mælk’,

— in German: ‘Säuglingsmilchnahrung’ and ‘Folgemilch’,

— in Estonian:

‘Piimal põhinev imiku piimasegu’ and ‘Piimal

põhinev jätkupiimasegu’,

— in Hungarian:

‘tejalapú anyatej-helyettesítő tápszer’

‘tejalapú anyatej-kiegészítő tápszer’,

and

— in Maltese: ‘ħalib tat-trabi’ and ‘ħalib tal-prosegwiment’,

— in Dutch:

‘Volledige zuigelingenvoeding op basis van melk’

or ‘Zuigelingenmelk’ and ‘Opvolgmelk’,

— in Polish: ‘mleko początkowe’ and ‘mleko następne’,

— in Portuguese:

‘Leite para lactentes’ and ‘Leite de transição’,

— in Romanian: ‘lapte pentru sugari’ and ‘lapte pentru copii de

vârstă mică’;

— in Slovak:

‘počiatočná dojčenská mliečna

výživa’

and

‘následná dojčenská mliečna výživa’,

— in Slovenian:

‘začetno mleko za dojenčke’ and ‘nadaljevalno

mleko za dojenčke’,

— in Finnish: ‘Maitopohjainen äidinmaidonkorvike’ and ‘Maito-

pohjainen vieroitusvalmiste’,

— in Swedish:

‘Modersmjölksersättning uteslutande baserad på
mjölk’ and ‘Tillskottsnäring uteslutande baserad på mjölk’.

Article 13

The labelling shall bear, in addition to those provided for
following

1.
in Article 3(1) of Directive 2000/13/EC,
mandatory particulars:

the

— in Greek:
ηλικίας’,

‘Γάλα για βρέφη’ and ‘Γάλα δεύτερης βρεφικής

— in English: ‘infant milk’ and ‘follow-on milk’,

(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;

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(b) 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 six months, that it should
form only part of a diversified diet, that it is not to be used
as a substitute for breast milk during the first six months of
life and that the decision to begin complementary feeding,
including any exception to six months of age, should be
made only on the advice of independent persons having
qualifications in medicine, nutrition or pharmacy, or other
professionals responsible for maternal and child care, based
on the individual infant’s specific growth and development
needs;

(c)

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;

(d) 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
and carnitine,
choline,
expressed in numerical form, per 100 ml of the product
ready for use;

applicable of

inositol

(e)

infant

formulae and follow-on formulae,
in the case of
and
for
instructions
disposal of the product and a warning against the health
hazards of inappropriate preparation and storage.

appropriate preparation,

storage

2.

The labelling may bear the following particulars:

(a)

formulae and follow-on formulae the average
for infant
quantity of nutrients mentioned in Annex III when such
declaration is not covered by paragraph 1(d) of
this
Article, expressed in numerical form, per 100 ml of the
product ready for use;

The labelling of infant formulae shall, in addition, bear the
4.
following mandatory particulars, preceded by the words
‘Important Notice’ 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 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
idealise 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 of infant formulae may bear nutrition and
health claims only in the cases listed in Annex IV and in
accordance with the conditions set out therein.

Infant formulae and follow-on formulae shall be labelled
7.
in such a way that
it enables consumers to make a clear
distinction between such products so as to avoid any risk of
confusion between infant formulae and follow-on formulae.

The requirements, prohibitions and restrictions referred to

8.
in paragraphs 3 to 7 shall also apply to:

(a)

shape,

in particular
the presentation of the products concerned,
their
the packaging
appearance or packaging,
materials used, the way in which they are arranged and
the setting in which they are displayed;

(b) for follow-on formulae in addition to numerical

infor-
mation, information on vitamins and minerals included in
Annex VII, expressed as a percentage of the reference values
given therein, per 100 ml of the product ready for use.

(b) advertising.

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 ‘humanised’,
similar terms shall be prohibited.

‘maternalised’,

‘adapted’, or

Article 14

1.
Advertising of infant formulae shall be restricted to publi-
cations specialising 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 13(3) to (7) and Article 13(8)(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.

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There shall be no point-of-sale advertising, giving of
2.
samples or any other promotional device to induce sales of
infant
level,
such as special displays, discount coupons, premiums, special
sales, loss-leaders and tie-in sales.

formula directly to the consumer at

the retail

infant formulae shall
3. Manufacturers and distributors of
to the general public or to pregnant women,
not provide,
low-priced
families,
mothers or members of
products,
samples or any other promotional gifts, either
directly or indirectly via the health care system or health
workers.

free or

their

Article 15

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 edu-
cational 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.

When such materials contain information about
the use of
infant formulae, they shall include the social and financial impli-
cations of its use, the health hazards of inappropriate foods or
feeding methods, and,
the health hazards of
in particular,
improper use of infant formulae. Such material shall not use
any pictures which may idealise the use of infant formulae.

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 organ-
isations, 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 16

In the Annex to Directive 1999/21/EC, the row relating to
manganese set out in the second part of Table I concerning
minerals, is replaced by the following:

‘Manganese (μg)

0,25

25

1

100’

Article 17

The new requirements set out in Article 7(1) and (2) of this
Directive shall not apply mandatorily to dietary foods for special
medical purposes intended specifically for infants, as referred to
the Annex to Directive 1999/21/EC, until
in point 4 of
1 January 2012.

Article 18

the latest,

1. Member States shall adopt and publish, by 31 December
2007 at
the laws, regulations and administrative
provisions necessary to comply with Articles 2, 3 and 5 to
17 and Annexes I to VII. They shall forthwith communicate
to the Commission the text of those provisions and a corre-
lation table between those provisions and this Directive.

They shall apply those provisions in such a way as to:

— permit trade in products complying with this Directive by 1

January 2008 at the latest,

3. Member States
infor-
mational or educational equipment or materials by manufac-
turers or distributors shall be made only on request and with

shall ensure that donations of

— without prejudice to Article 17, prohibit, with effect from
31 December 2009 trade in products which do not comply
with this Directive.

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When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. They
shall also include a statement that references in existing laws,
to the Directive
regulations and administrative provisions
repealed by this Directive shall be construed as references to
shall determine how such
this Directive. Member States
reference is to be made and how that statement
is to be
formulated.

References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex XI.

Article 20

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 21

This Directive is addressed to the Member States.

Article 19

Done at Brussels, 22 December 2006.

Directive 91/321/EEC, as amended by the Directives listed in
Annex X, Part A, is repealed with effect from 1 January 2008,
without prejudice to the obligations of
the Member States
relating to the time limits for transposition into national law
of the Directives listed in Annex X, Part B.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE
MANUFACTURER

The values set out in this Annex refer to the final product ready for use, marketed as such or reconstituted as instructed
by the manufacturer.

1.

ENERGY

Minimum

250 kJ/100 ml

(60 kcal/100 ml)

Maximum

295 kJ/100 ml

(70 kcal/100 ml)

2.

PROTEINS

(Protein content = nitrogen content × 6,25)

2.1

Infant formulae manufactured from cows’ milk proteins

Minimum (1)

0,45 g/100 kJ

(1,8 g/100 kcal)

Maximum

0,7 g/100 kJ

(3 g/100 kcal)

(1) Infant formulae manufactured from cows’ milk protein with a protein content between the minimum and 0,5 g/100 kJ

(2 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(1).

For an equal energy value, the infant formula must contain an available quantity of each indispensable and
conditionally indispensable 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 if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and
tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methioni-
ne:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the
particular nutritional use by infants is demonstrated through appropriate studies, performed following generally
accepted expert guidance on the design and conduct of such studies.

2.2

Infant formulae manufactured from protein hydrolysates

Minimum (1)

0,45 g/100 kJ

(1,8 g/100 kcal)

Maximum

0,7 g/100 kJ

(3 g/100 kcal)

(1) Infant formulae manufactured from protein hydrolysates with a protein content between the minimum and 0,56 g/100 kJ

(2,25 g/100 kcal) shall be in accordance with the third subparagraph of Article 7(1).

For an equal energy value, the infant formula must contain an available quantity of each indispensable and
conditionally indispensable 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 if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and
tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methioni-
ne:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the
particular nutritional use by infants is demonstrated through appropriate studies, performed following generally
accepted expert guidance on the design and conduct of such studies.

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

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2.3

Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk proteins

Minimum

0,56 g/100 kJ

(2,25 g/100 kcal)

Maximum

0,7 g/100 kJ

(3 g/100 kcal)

Only protein isolates from soya shall be used in manufacturing these infant formulae.

For an equal energy value the infant formula must contain an available quantity of each indispensable and
conditionally indispensable 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 if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and
tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methioni-
ne:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the
particular nutritional use by infants is demonstrated through appropriate studies, performed following generally
accepted expert guidance on the design and conduct of such studies.

The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal).

2.4

In all cases, amino acids may be added to infant formulae solely for the purpose of improving the nutritional value
of the proteins, and only in the proportions necessary for that purpose.

3.

TAURINE

If added to infant formulae, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal).

4.

CHOLINE

5.

LIPIDS

Minimum

1,7 mg/100 kJ

(7 mg/100 kcal)

Minimum

1,05 g/100 kJ

(4,4 g/100 kcal)

Maximum

12 mg/100 kJ

(50 mg/100 kcal)

Maximum

1,4 g/100 kJ

(6,0 g/100 kcal)

5.1

The use of the following substances shall be prohibited:

— sesame seed oil,

— cotton seed oil.

5.2

Lauric acid and myristic acid

Minimum

—

Maximum

separately or as a whole:

20 % of the total fat content

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5.3

The trans fatty acid content shall not exceed 3 % of the total fat content.

5.4

The erucic acid content shall not exceed 1 % of the total fat content.

5.5

Linoleic acid (in the form of glycerides = linoleates)

Minimum

70 mg/100 kJ

(300 mg/100 kcal)

Maximum

285 mg/100 kJ

(1 200 mg/100 kcal)

5.6

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.

5.7

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 (20:4 n-6))

The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.

The docosahexaenoic acid (22:6 n-3) content shall not exceed that of n-6 LCP.

6.

PHOSPHOLIPIDS

The amount of phospholipids in infant formulae shall not be greater than 2 g/l.

7.

INOSITOL

Maximum

10 mg/100 kJ

(40 mg/100 kcal)

Maximum

3,4 g/100 kJ

(14 g/100 kcal)

8.

CARBOHYDRATES

Minimum

1 mg/100 kJ

(4 mg/100 kcal)

Minimum

2,2 g/100 kJ

(9 g/100 kcal)

8.1 Only the following carbohydrates may be used:

— lactose,

— maltose,

— sucrose,

— glucose,

— malto-dextrins,

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— glucose syrup or dried glucose syrup,

— pre-cooked starch

— gelatinised starch

9
=

;

naturally free of gluten.

8.2

Lactose

Minimum

1,1 g/100 kJ

(4,5 g/100 kcal)

Maximum

—

—

This provision shall not apply to infant formulae in which soya protein isolates represent more than 50 % of the
total protein content.

8.3

Sucrose

Sucrose may only be added to infant formulae manufactured from protein hydrolysates. If added, the sucrose
content shall not exceed 20 % of the total carbohydrate content.

8.4 Glucose

Glucose may only be added to infant formulae manufactured from protein hydrolysates. If added, the glucose
content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).

8.5

Pre-cooked starch and/or gelatinised starch

Minimum

—

Maximum

2 g/100 ml, and 30 % of the total carbohydrate content

9.

FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES

Fructo-oligosaccharides and galacto-oligosaccharides may be added to infant formulae. In that case their content
shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight
oligofructosyl-saccharose.

Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in
accordance with Article 5.

10. MINERAL SUBSTANCES
10.1 Infant formulae manufactured from cows’ milk proteins or protein hydrolysates

Sodium (mg)

Potassium (mg)

Chloride (mg)

Calcium (mg)

Phosphorus (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)
Copper (μg)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

5

15

12

12

6

1,2

0,07

0,12

8,4

14

38

38

33

22

3,6

0,3

0,36

25

20

60

50

50

25

5

0,3

0,5

35

60

160

160

140

90

15

1,3

1,5

100

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Iodine (μg)
Selenium (μg)
Manganese (μg)
Fluoride (μg)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

2,5

0,25

0,25

—

12

2,2

25

25

10

1

1

—

50

9

100

100

The calcium:phosphorus ratio shall not be less than 1 nor greater than 2.

10.2 Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk proteins

All requirements of point 10.1 shall apply, except for those concerning iron and phosphorus, which shall be as
follows:

Iron (mg)

Phosphorus (mg)

11.

VITAMINS

Vitamin A (μg-RE) (1)
Vitamin D (μg) (2)
Thiamin (μg)
Riboflavin (μg)
Niacin (μg) (3)
Pantothenic acid (μg)
Vitamin B6 (μg)
Biotin (μg)
Folic Acid (μg)
Vitamin B12 (μg)

Vitamin C (mg)
Vitamin K (μg)
Vitamin E (mg α-TE) (4)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

0,12

7,5

0,5

25

0,45

30

2

100

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

43

0,65

72

95

375

475

42

1,8

12

0,12

7,5

6

1,2

14

0,25

14

19

72

95

9

0,4

2,5

0,025

2,5

1

0,5/g of polyunsa-
turated fatty acids
expressed as linoleic
acid as corrected for
the double bonds (5)
but in no case less
than 0,1 mg per 100
available kJ

60

1

60

80

300

400

35

1,5

10

0,1

10

4

0,5/g of polyunsa-
turated fatty acids
expressed as linoleic
acid as corrected for
the double bonds (5)
but in no case less
than 0,5 mg per 100
available kcal

180

2,5

300

400

1 500

2 000

175

7,5

50

0,5

30

25

5

(1) RE = all trans retinol equivalent.
(2) In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D.
(3) Preformed niacin.
(4) α-TE = d-α-tocopherol equivalent.
(5) 0,5 mg α-TE/1 g linoleic acid (18:2 n-6); 0,75 mg α-TE/1 g α-linolenic acid (18:3 n-3); 1,0 mg α-TE/1 g arachidonic acid (20:4

n-6); 1,25 mg α-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).

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12. NUCLEOTIDES

The following nucleotides may be added:

cytidine 5′-monophosphate
uridine 5′-monophosphate
adenosine 5′-monophosphate
guanosine 5′-monophosphate
inosine 5′-monophosphate

(1) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).

Maximum (1)

(mg/100 kJ)

(mg/100 kcal)

0,60

0,42

0,36

0,12

0,24

2,50

1,75

1,50

0,50

1,00

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ANNEX II

ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY
THE MANUFACTURER

The values set out in this Annex refer to the final product ready for use, marketed as such or reconstituted as instructed
by the manufacturer.

1.

ENERGY

Minimum

250 kJ/100 ml

(60 kcal/100 ml)

Maximum

295 kJ/100 ml

(70 kcal/100 ml)

2.

PROTEINS

(Protein content = nitrogen content × 6,25)

2.1

Follow-on formulae manufactured from cows' milk proteins

Minimum

0,45 g/100 kJ

(1,8 g/100 kcal)

Maximum

0,8 g/100 kJ

(3,5 g/100 kcal)

For an equal energy value, the follow-on formula must contain an available quantity of each indispensable and
conditionally indispensable 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 if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and
tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2.

2.2

Follow-on formulae manufactured from protein hydrolysates

Minimum

0,56 g/100 kJ

(2,25 g/100 kcal)

Maximum

0,8 g/100 kJ

(3,5 g/100 kcal)

For an equal energy value, the follow-on formula must contain an available quantity of each indispensable and
conditionally indispensable 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 if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and
tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2.

2.3

Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk
proteins

Minimum

0,56 g/100 kJ

(2,25 g/100 kcal)

Maximum

0,8 g/100 kJ

(3,5 g/100 kcal)

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Only protein isolates from soya shall be used in manufacturing these formulae.

For an equal energy value the follow-on formula must contain an available quantity of each indispensable and
conditionally indispensable 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 if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and
tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2.

2.4

In all cases, amino acids may be added to follow-on formulae solely for the purpose of improving the nutritional
value of the proteins, and only in the proportions necessary for that purpose.

3.

TAURINE

If added to follow-on formulae, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal).

4.

LIPIDS

Minimum

0,96 g/100 kJ

(4,0 g/100 kcal)

Maximum

1,4 g/100 kJ

(6,0 g/100 kcal)

4.1

The use of the following substances shall be prohibited:

— sesame seed oil,

— cotton seed oil.

4.2

Lauric acid and myristic acid

Minimum

—

Maximum

separately or as a whole:

20 % of the total fat content

4.3. The trans fatty acid content shall not exceed 3 % of the total fat content.

4.4

The erucic acid content shall not exceed 1% of the total fat content.

4.5

Linoleic acid (in the form of glycerides = linoleates)

Minimum

70 mg/100 kJ

(300 mg/100 kcal)

Maximum

285 mg/100 kJ

(1 200 mg/100 kcal)

4.6

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.

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4.7

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 (20:4 n-6))

The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.

The docosahexaenoic (22:6 n-3) acid content shall not exceed that of n-6 LCP.

5.

PHOSPHOLIPIDS

The amount of phospholipids in follow-on formulae shall not be greater than 2 g/l.

6.

CARBOHYDRATES

Minimum

2,2 g/100 kJ

(9 g/100 kcal)

6.1

The use of ingredients containing gluten shall be prohibited.

6.2

Lactose

Minimum

1,1 g/100 kJ

(4,5 g/100 kcal)

Maximum

3,4 g/100 kJ

(14 g/100 kcal)

Maximum

—

This provision shall not apply to follow-on formulae in which soya protein isolates represent more than 50 % of
the total protein content.

6.3

Sucrose, fructose, honey

Minimum

—

Maximum

separately or as a whole:

20 % of the total carbohydrate content

Honey shall be treated to destroy spores of Clostridium botulinum.

6.4 Glucose

Glucose may only be added to follow-on formulae manufactured from protein hydrolysates. If added, the glucose
content shall not exceed 0,5 g/100 kJ (2 g/100 kcal).

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Official Journal of the European Union

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7.

FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES

Fructo-oligosaccharides and galacto-oligosaccharides may be added to follow-on formulae. In that case their content
shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight
oligofructosyl-saccharose.

Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in
accordance with Article 6.

8.

8.1

MINERAL SUBSTANCES
Follow-on formulae manufactured from cows’ milk proteins or protein hydrolysates

Sodium (mg)

Potassium (mg)

Chloride (mg)

Calcium (mg)

Phosphorus (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (μg)

Iodine (μg)

Selenium (μg)

Manganese (μg)

Fluoride (μg)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

5

15

12

12

6

1,2

0,14

0,12

8,4

2,5

0,25

0,25

—

14

38

38

33

22

3,6

0,5

0,36

25

12

2,2

25

25

20

60

50

50

25

5

0,6

0,5

35

10

1

1

—

60

160

160

140

90

15

2

1,5

100

50

9

100

100

The calcium:phosphorus ratio in follow-on formulae shall not be less than 1,0 nor greater than 2,0.

8.2

Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk
proteins

All requirements of point 8.1 shall apply, except for those concerning iron, and phosphorus, which shall be as
follows:

Iron (mg)

Phosphorus (mg)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

0,22

7,5

0,65

25

0,9

30

2,5

100

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9.

VITAMINS

Vitamin A (μg-RE) (1)
Vitamin D (μg) (2)
Thiamin (μg)
Riboflavin (μg)
Niacin (μg) (3)
Pantothenic acid (μg)
Vitamin B6 (μg)
Biotin (μg)
Folic Acid (μg)
Vitamin B12 (μg)

Vitamin C (mg)
Vitamin K (μg)
Vitamin E (mg α-TE) (4)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

180

3

300

400

1 500

2 000

175

7,5

50

0,5

30

25

5

43

0,75

72

95

375

475

42

1,8

12

0,12

7,5

6

1,2

14

0,25

14

19

72

95

9

0,4

2,5

0,025

2,5

1

0,5/g poly-
unsaturated fatty
acids expressed as
linoleic acid as
corrected for the
double bonds (5) but
in no case less than
0,1 mg per 100
available kJ

60

1

60

80

300

400

35

1,5

10

0,1

10

4

0,5/g poly-
unsaturated fatty
acids expressed as
linoleic acid as
corrected for the
double bonds (5) 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 i.u. of vitamin D.
(3) Preformed niacin.
(4) α-TE = d-α-tocopherol equivalent.
(5) 0,5 mg α-TE/1 g linoleic acid (18:2 n-6); 0,75 mg α-TE/1 g α-linolenic acid (18:3 n-3); 1,0 mg α-TE/1 g arachidonic acid (20:4

n-6); 1,25 mg α-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).

10. NUCLEOTIDES

The following nucleotides may be added:

cytidine 5′-monophosphate
uridine 5′-monophosphate
adenosine 5′-monophosphate
guanosine 5′-monophosphate
inosine 5′-monophosphate

(1) The total concentration of nucleotides shall not exceed 1,2 mg/100 kJ (5 mg/100 kcal).

Maximum (1)

(mg/100 kJ)

(mg/100 kcal)

0,60

0,42

0,36

0,12

0,24

2,50

1,75

1,50

0,50

1,00

L 401/22

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Official Journal of the European Union

30.12.2006

ANNEX III

NUTRITIONAL SUBSTANCES

1. Vitamins

Vitamin

Vitamin formulation

Vitamin A

Vitamin D

Vitamin B1

Retinyl acetate

Retinyl palmitate

Retinol

Vitamin D2 (ergocalciferol)

Vitamin D3 (cholecalciferol)

Thiamin hydrochloride

Thiamin mononitrate

Vitamin B2

Riboflavin

Niacin

Vitamin B6

Riboflavin-5′-phosphate, sodium

Nicotinamide

Nicotinic acid

Pyridoxine hydrochloride

Pyridoxine-5′-phosphate

Folate

Folic acid

Pantothenic acid

D-pantothenate, calcium

Vitamin B12

Biotin

Vitamin C

Vitamin E

D-pantothenate, sodium

Dexpanthenol

Cyanocobalamin

Hydroxocobalamin

D-biotin

L-ascorbic acid

Sodium L-ascorbate

Calcium L-ascorbate

6-palmityl-L-ascorbic acid (ascorbyl palmitate)

Potassium ascorbate

D-alpha tocopherol

DL-alpha tocopherol

D-alpha tocopherol acetate

DL-alpha tocopherol acetate

Vitamin K

Phylloquinone (Phytomenadione)

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L 401/23

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

Iron (Fe)

Copper (Cu)

Iodine (I)

Zinc (Zn)

Magnesium chloride

Magnesium oxide

Magnesium salts of orthophosphoric acid

Magnesium sulphate

Magnesium gluconate

Magnesium hydroxide

Magnesium salts of citric acid

Ferrous citrate

Ferrous gluconate

Ferrous lactate

Ferrous sulphate

Ferric ammonium citrate

Ferrous fumarate

Ferric diphosphate (Ferric pyrophosphate)

Ferrous bisglycinate

Cupric citrate

Cupric gluconate

Cupric sulphate

Copper-lysine complex

Cupric carbonate

Potassium iodide

Sodium iodide

Potassium iodate

Zinc acetate

Zinc chloride

Zinc lactate

Zinc sulphate

Zinc citrate

Zinc gluconate

Zinc oxide

L 401/24

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Official Journal of the European Union

30.12.2006

Mineral substances

Permitted salts

Manganese (Mn)

Manganese carbonate

Sodium (Na)

Manganese chloride

Manganese citrate

Manganese sulphate

Manganese gluconate

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

Sodium selenate

Sodium selenite

3. Amino acids and other nitrogen compounds

Selenium (Se)

L-cystine and its hydrochloride

L-histidine and its hydrochloride

L-isoleucine and its hydrochloride

L-leucine and its hydrochloride

L-lysine and its hydrochloride

L-cysteine and its hydrochloride

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

L-carnitine and its hydrochloride

L-carnitine-L-tartrate

Taurine

30.12.2006

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L 401/25

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. Other nutritional substances

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

L 401/26

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Official Journal of the European Union

30.12.2006

ANNEX IV

NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A
CORRESPONDING CLAIM

1. NUTRITION CLAIMS

Nutrition claim related to

Conditions warranting the nutrition claim

1.1

Lactose only

1.2

Lactose free

Lactose is the only carbohydrate present.

Lactose content is not greater than 2,5 mg/100 kJ (10 mg/
100 kcal).

1.3 Added LCP or an equivalent nutrition claim

related to the addition of docosahexaenoic acid

The docosahexaenoic acid content is not less than 0,2 % of
the total fatty acid content.

1.4 Nutrition claims on the addition of the following

optional ingredients:

1.4.1 taurine

1.4.2 fructo-oligosaccharides

and

galacto-oligosac-

charides

1.4.3 nucleotides

9

>>>>>>=
>>>>>>;

Voluntarily added at a level that would be appropriate
for
the intended particular use by infants and in
accordance with the conditions set out in Annex I.

2. HEALTH CLAIMS (INCLUDING REDUCTION OF DISEASE RISK CLAIMS)

Nutrition claim related to

Conditions warranting the health claim

2.1 Reduction of risk to allergy to milk proteins. This
health claim may include terms referring to reduced
allergen or reduced antigen properties.

(a) Objective and scientifically verified data as proof to the

claimed properties must be available;

(b) The infant formulae shall satisfy the provisions set out
in point 2.2 of Annex I and the amount of immuno-
reactive protein measured with methods generally
acceptable as appropriate shall be less than 1 % of
nitrogen containing substances in the formulae;

(c) The label shall indicate that the product must not be
consumed by infants allergic to the intact proteins
is manufactured unless generally
from which it
the infant
accepted clinical
tests provide proof of
formulae’s tolerance in more than 90 % of
infants
(confidence interval 95 %) hypersensitive to proteins
from which the hydrolysate is manufactured;

(d) The infant

formulae administered orally must not
induce sensitisation, in animals, to the intact proteins
from which the infant formulae are manufactured.

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Official Journal of the European Union

L 401/27

ANNEX V

INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK

For the purpose of this Directive, the indispensable and conditionally indispensable amino acids in breast milk, expressed
in mg per 100 kJ and 100 kcal, are the following:

Per 100 kJ (1)

Per 100 kcal

Cystine

Histidine

Isoleucine

Leucine

Lysine

Methionine

Phenylalanine

Threonine

Tryptophan

Tyrosine

Valine

(1) 1 kJ = 0,239 kcal.

9

10

22

40

27

5

20

18

8

18

21

38

40

90

166

113

23

83

77

32

76

88

L 401/28

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Official Journal of the European Union

30.12.2006

ANNEX VI

Specification for the protein content and source and the processing of protein used in the manufacture of infant
formulae with a protein content less than 0,56 g/100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of
whey proteins derived from cows’ milk protein

1. Protein content

Protein content = nitrogen content × 6,25

Minimum

Maximum

0,7 g/100 kJ

(3 g/100 kcal)

0,44 g/100 kJ

(1,86 g/100 kcal)

2. Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin,
consisting of:

(a) 63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter

and protein denaturation of less than 70 % and a maximum ash content of 3 %; and

(b) 37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein

denaturation of less than 70 % and a maximum ash content of 3,5 %.

3. Protein processing

Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to
100 °C) between the two hydrolysis steps.

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L 401/29

REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG
CHILDREN

ANNEX VII

Nutrient

Labelling reference value

Vitamin A

Vitamin D

Vitamin E

Vitamin K

Vitamin C

Thiamin

Riboflavin

Niacin

Vitamin B6

Folate

Vitamin B12

Pantothenic acid

Biotin

Calcium

Phosphorus

Potassium

Sodium

Chloride

Iron

Zinc

Iodine

Selenium

Copper

Magnesium

Manganese

(μg) 400

(μg) 7

(mg TE) 5

(μg) 12

(mg) 45

(mg) 0,5

(mg) 0,7

(mg) 7

(mg) 0,7

(μg) 125

(μg) 0,8

(mg) 3

(μg) 10

(mg) 550

(mg) 550

(mg) 1 000

(mg) 400

(mg) 500

(mg) 8

(mg) 5

(μg) 80

(μg) 20

(mg) 0,5

(mg) 80

(mg) 1,2

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Official Journal of the European Union

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ANNEX VIII

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)

Aldrin and dieldrin, expressed as dieldrin

Endrin

Table 2

Chemical name of the substance

ANNEX IX

SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN INFANT
FORMULAE AND FOLLOW-ON FORMULAE

Chemical name of the substance

Maximum residue level
(mg/kg)

Cadusafos

Demeton-S-methyl/demeton-S-methyl
sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl)

Ethoprophos

Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)

Propineb/propylenethiourea (sum of propineb and propylenethiourea)

0,006

0,006

0,008

0,004

0,006

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ANNEX X

PART A

Repealed Directive, with list of its successive amendments

(referred to in Article 19)

Commission Directive 91/321/EEC (OJ L 175, 4.7.1991, p. 35).

Point XI.C.IX.5 of Annex I to the 1994 Act of Accession, p. 212.

Commission Directive 96/4/EC (OJ L 49, 28.2.1996, p. 12).

Commission Directive 1999/50/EC (OJ L 139, 2.6.1999, p. 29).

Commission Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

Point 1.J.3 of Annex II to the 2003 Act of Accession, p. 93.

PART B

List of time limits for transposition into national law

(referred to in Article 19)

Directive

Time limit for transposition

Permission of trade in products
complying with this Directive

Prohibition of trade in products
not complying with this
Directive

91/321/EEC

96/4/EC

1999/50/EC

2003/14/EC

1 December 1992

1 June 1994

31 March 1997

1 April 1997

31 March 1999

30 June 2000

30 June 2000

1 July 2002

6 March 2004

6 March 2004

6 March 2005

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ANNEX XI

CORRELATION TABLE

Directive 91/321/EEC

This Directive

Article 1(1)

Article 1(2)

Article 2

Article 3(1)

Article 3(2)

Article 3(3)

Article 4

Article 1

Article 2

Article 3

Article 5

Article 6

Article 7(4)

Article 7(1) to (3)

Article 5(1), first subparagraph

Article 8(1)

Article 5(1), second subparagraph

Article 8(2) and (3)

Article 5(2)

—

Article 6(1), first sentence

Article 6(1), second sentence

—

Article 9

Article 4

—

Article 6(2)

Article 10(1)

Article 6(3)(a), introductory phrase

Article 10(2), introductory phrase

Article 6(3)(a)(i)

Article 6(3)(a)(ii)

Article 10(2)(a)

Article 10(2)(b)

Article 6(3)(b), first subparagraph

Article 10(3)

Article 6(3)(b), second subparagraph

Article 6(3)(c)

Article 6(4)

Article 7(1), first subparagraph

Article 7(1), second subparagraph

Article 7(2)(a)

Article 7(2)(b)

Article 7(2)(c)

Article 7(2)(d)

—

Article 10(4)

—

Article 11

Article 12

Article 13(1)(a)

—

Article 13(1)(b)

Article 13(1)(c)

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Directive 91/321/EEC

This Directive

Article 7(2)(e)

Article 7(2)(f)

Article 7(2a)

Article 7(3)

Article 7(4)

Article 7(5)

Article 7(6)

—

Article 7(7)

Article 8

Article 9

Article 10

—

—

—

—

—

Article 11

Annexes I to V

Annex VI

Annex VII

—

Annexes VIII to X

—

—

Article 13(1)(d)

Article 13(1)(e)

Article 13(2)

Article 13(3)

Article 13(4)

Article 13(5)

Article 13(6)

Article 13(7)

Article 13(8)

Article 14

Article 15

—

Article 16

Article 17

Article 18

Article 19

Article 20

Article 21

Annexes I to V

—

—

Annex VI

Annexes VII to IX

Annex X

Annex XI