Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (Codified version)   (Text with EEA relevance)
Date: 2006-12-05
Institutions: European Commission
Subjects: baby food, cereal product, codification of EU law, early childhood, food hygiene, labelling, marketing standard, milk by-product, pesticide

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COMMISSION DIRECTIVE 2006/125/EC

of 5 December 2006

on processed cereal-based foods and baby foods for infants and young children

(Text with EEA relevance)

(Codified version)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

namely processed cereal-based foods and baby foods,
should be laid down.

(6)

(7)

(8)

(9)

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,

Whereas:

(1)

(2)

(3)

(4)

Commission Directive 96/5/EC of 16 February 1996 on
processed cereal-based foods and baby foods for infants
and young children (2) has been substantially amended
several times (3). In the interests of clarity and rationality
the said Directive should be codified.

Processed cereal-based foods and baby foods for infants
and young children are used as part of a diversified diet
and do not constitute the sole source of nourishment of
infants and young children.

There is a great variety of
reflecting the widely varied diet of
weaned and young children owing to social
cultural circumstances existing in the Community.

the products in question
infants being
and

The essential composition of the products in question
must be appropriate for the nutritional requirements of
infants and young children in good health as established
by generally accepted scientific data, account being taken
of the abovementioned factors.

Although, because of
the nature of such products, a
number of mandatory requirements and other restric-
tions as to the level of vitamins, minerals and other
nutrients should be imposed, it should be allowed that
such nutrients are added voluntarily by manufacturers,
provided that they use exclusively certain substances to
be specified by this Directive.

The use of the products to which such nutrients have
been voluntarily added at levels currently observed in the
Community do not appear to result in excessive intakes
those nutrients by infants and young children.
of
Attention should be paid to any future developments
of the situation, and if necessary, appropriate measures
should be taken.

rules on the maximum levels of pesticide
Different
in processed cereal-based foods and baby
residues
foods cause trade barriers between certain Member States.

for pesticide

for pesticide residues

Maximum levels
stipulated in
Council Directive 76/895/EEC of 23 November 1976
relating to the fixing of maximum levels for pesticide
residues in and on fruit and vegetables (4),
in Council
Directive 86/362/EEC of 24 July 1986 on the fixing of
maximum levels
in and on
cereals (5),
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 (6), 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,
including fruit and vegetables (7), are without prejudice
to specific provisions applicable to processed cereal-
based foods and baby foods.

residues

(5)

The essential nutritional requirements for the compo-
sition of the two broad categories of these products,

(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 49, 28.2.1996, p. 17. Directive as last amended by Directive

2003/13/EC (OJ L 41, 14.2.2003, p. 33).

(3) See Annex VIII, Part A.

(4) OJ L 340, 9.12.1976, p. 26. This Directive is repealed by Regulation
(EC) No 396/2005 of the European Parliament and of the Council
(OJ L 70, 16.3.2005, p. 1).

(5) OJ L 221, 7.8.1986, p. 37. This Directive is repealed by Regulation

(EC) No 396/2005.

(6) OJ L 221, 7.8.1986, p. 43. This Directive is repealed by Regulation

(EC) No 396/2005.

(7) OJ L 350, 14.12.1990, p. 71. This Directive is repealed by Regu-

lation (EC) No 396/2005.

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(10)

Taking into account the Community’s international obli-
gations, in cases where the relevant scientific evidence is
insufficient,
the
the precautionary principle
Community to provisionally adopt measures on the
basis of available pertinent information, pending an addi-
tional assessment of risk and a review of the measure
within a reasonable period of time.

allows

(11) 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 values (ADI) 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
is appropriate to
it
young children are concerned,
adopt a very low common limit
for all pesticides
pending case-by-case scientific screening and evaluation
of substances. This very low common limit should be
fixed at 0,01 mg/kg which normally is in practice the
minimum detectable level.

(12)

residues

limitations on pesticide

should be
Severe
required. With careful selection of raw materials, and
given that processed cereal-based foods and baby foods
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.

(13)

This Directive establishes the principle of the prohibition
of the use of these pesticides in the production of agri-
cultural products intended for processed cereal-based
foods and baby foods. However, this prohibition does
not necessarily guarantee that products are free from
such pesticides, since some pesticides contaminate the
environment and their residues may be found in the
products concerned.

(14)

The health of infants and young children can be better
protected by applying additional requirements which can
be enforced by analysis regardless of a product’s origin.

detectable in processed cereal-based foods and baby
foods by state of the art analytical methods. However,
some pesticides degrade slowly and still contaminate the
environment. They might be present in processed cereal-
based foods and baby foods even if they have not been
used.
a harmonised
the purposes of
approach should be followed.

control,

For

(16)

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

(17)

The use of novel food ingredients should be dealt with
horizontally for all foodstuffs in a separate measure.

(18)

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

(19)

the persons for whom the products are
In view of
criteria and
intended,
maximum levels for contaminants should be laid down.

the necessary microbiological

(20)

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).

(21)

In this Directive the additions and exceptions to those
general rules should be adopted and expanded upon,
where appropriate.

(15) 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

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation

(EC) No 396/2005.

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

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

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(22)

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 of Directive 2000/13/EC,
in order to
prevent inappropriate uses liable to harm the health of
infants.

(23) Whilst claims not specifically prohibited may generally
be made for the products in question in conformity
with the rules applicable for all foodstuffs, such claims
should, where appropriate, take into account the compo-
sitional criteria specified in this Directive.

(24) On the provisions liable to affect public health,

the
consultation in accordance with Article 4 of Directive
89/398/EEC has taken place.

(iii) pastas which are to be used after cooking in boiling

water or other appropriate liquids;

(iv) rusks and biscuits which are to be used either directly
or, after pulverisation, with the addition of water, milk
or other suitable liquids;

(b) ‘baby foods’ other than processed cereal-based foods.

This Directive does not apply to milks intended for young

3.
children.

Article 2

For the purpose of this Directive, the following definitions shall
apply:

(25)

The measures provided for
accordance with the opinion of
mittee on the Food Chain and Animal Health.

in this Directive are in
the Standing Com-

(a)

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

(26)

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 VIII, Part B,

(b) ‘young children’ means children aged between one and three

years;

HAS ADOPTED THIS DIRECTIVE:

Article 1

(c)

‘pesticide residue’ means the residue in processed cereal-
based foods and baby foods 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.

This Directive is a ‘specific Directive’ within the meaning

1.
of Article 4(1) of Directive 89/398/EEC.

Article 3

2.
This Directive covers foodstuffs for particular nutritional
use fulfilling the particular requirements of infants and young
children in good health in the Community and are intended for
use by infants while they are being weaned, and by young
children as a supplement
their
for
progressive adaptation to ordinary food. They comprise:

to their diet and/or

(a)

‘processed cereal-based foods’ which are divided into the
following four categories:

Member States shall ensure that the products referred to in
Article 1(2) are marketed within the Community only if they
conform to the rules laid down in this Directive.

Article 4

Processed cereal-based foods and baby foods shall be manu-
factured from ingredients whose suitability for particular nutri-
tional use by infants and young children has been established
by generally accepted scientific data.

(i)

simple cereals which are or have to be reconstituted
with milk or other appropriate nutritious liquids;

Article 5

1.
shall
Processed cereal-based foods
compositional criteria specified in Annex I.

comply with the

(ii) cereals with an added high protein food which are or
have to be reconstituted with water or other protein-
free liquid;

Baby foods which are described in Annex II shall comply

2.
with the compositional criteria specified therein.

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Article 6

Only the nutritional substances listed in Annex IV may be
added in the manufacture of processed cereal-based foods and
baby foods.

For pesticides

listed in Annex VI, where a decision
5.
concerning the non-inclusion of an active substance in Annex
I to Directive 91/414/EEC is taken, Annex VI and Annex VII to
this Directive shall be amended accordingly.

The purity criteria for those substances shall be laid down at a
later stage.

6. Microbiological criteria shall be established as necessary.

Article 7

Article 8

1.
Processed cereal-based foods and baby foods shall not
contain any substance in such quantity as to endanger the
health of
infants and young children. Necessary maximum
levels for substances other than those referred to in paragraphs
2 and 3 shall be established.

Processed cereal-based foods and baby foods shall not
2.
individual pesticides at
levels exceeding
contain residues of
0,01 mg/kg, except
for those substances for which specific
levels have been set in Annex VI, in which case these specific
levels shall apply.

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

The labelling of

1.
addition to the particulars provided for
Directive 2000/13/EC, the following mandatory particulars:

the products concerned shall bear in
in Article 3 of

(a) a statement as to the appropriate age from which the
product may be used, regard being had to its composition,
texture or other particular properties. The stated age shall
not be less than four months for any product. Products
recommended for use from the age of four months may
indicate that they are suitable from that age unless inde-
pendent persons having qualifications in medicine, nutrition
or pharmacy, or other professionals
for
maternal and child care, advise otherwise;

responsible

The pesticides listed in Annex VII shall not be used in
3.
agricultural products intended for the production of processed
cereal-based foods and baby foods.

(b) information as to the presence or absence of gluten if the
indicated age from which the product may be used is below
six months;

However, for the purpose of control:

(c)

(a) pesticides listed in Table 1 of Annex VII 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 VII 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.

carbohydrate

the available energy value expressed in kJ and kcal, and the
protein,
expressed in
numerical form, per 100 g or 100 ml of the product as
sold and, where appropriate, per specified quantity of the
product as proposed for consumption;

and lipid content,

(d) the average quantity of each mineral substance and of each
vitamin governed by a specific level as specified in Annex I
and Annex II respectively, expressed in numerical form, per
100 g or 100 ml of the product as sold and, where appro-
priate, per specified quantity of the product as proposed for
consumption;

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.

(e)

instructions for appropriate preparation, when necessary,
and a statement as to the importance of following those
instructions.

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2.

The labelling may bear:

(a)

the average quantity of the nutrients set out in Annex IV
when such declaration is not covered by the provisions of
paragraph 1(d), expressed in numerical form, per 100 g or
100 ml of the product as sold and, where appropriate, per
specified quantity of
the product as proposed for con-
sumption;

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 IX.

Article 10

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

(b) in addition to numerical

information,

information on
vitamins and minerals shown in Annex V, expressed as a
percentage of the reference values given therein, per 100 g
or 100 ml of the product as sold, and where appropriate,
the product as proposed for
per specified quantity of
consumption, provided that the quantities present are at
least equal to 15 % of the reference values.

Article 9

Directive 96/5/EC, as amended by the Directives listed in Annex
VIII, Part A, is repealed, without prejudice to the obligations of
the Member States relating to the time-limits for transposition
into national law of the Directives set out in Annex VIII, Part B.

Article 11

This Directive is addressed to the Member States.

Done at Brussels, 5 December 2006.

For the Commission
The President

José Manuel BARROSO

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ANNEX I

ESSENTIAL COMPOSITION OF PROCESSED CEREAL-BASED FOODS FOR INFANTS AND YOUNG
CHILDREN

The requirements concerning nutrients refer to the products ready for use marketed as such or reconstituted as instructed
by the manufacturer.

1.

CEREAL CONTENT

Processed cereal-based foods are prepared primarily from one or more milled cereals and/or starchy root products.

The amount of cereal and/or starchy root shall not be less than 25 % of the final mixture on a dry weight for
weight basis.

2.

PROTEIN

2.1.

For products mentioned in Article 1(2)(a)(ii) and (iv),
(5,5 g/100 kcal).

the protein content shall not exceed 1,3 g/100 kJ

2.2.

For products mentioned in Article 1(2)(a)(ii), the added protein shall not be less than 0,48 g/100 kJ (2 g/100 kcal).

2.3.

For biscuits mentioned in Article 1(2)(a)(iv), made with the addition of a high protein food, and presented as such,
the added protein shall not be less than 0,36 g/100 kJ (1,5 g/100 kcal).

2.4.

The chemical index of the added protein shall be equal to at least 80 % of that of the reference protein (casein as
defined in Annex III), or the protein efficiency ratio (PER) of the protein in the mixture shall be equal to at least
70 % of that of the reference protein. In all cases, the addition of amino acids shall be permitted solely for the
purpose of improving the nutritional value of the protein mixture, and only in the proportions necessary for that
purpose.

3.

CARBOHYDRATES

3.1.

If sucrose, fructose, glucose, glucose syrups or honey are added to products mentioned in Article 1(2)(a)(i) and (iv):

— the amount of added carbohydrates from these sources shall not exceed 1,8 g/100 kJ (7,5 g/100 kcal),

— the amount of added fructose shall not exceed 0,9 g/100 kJ (3,75 g/100 kcal).

3.2.

If sucrose, fructose, glucose syrups or honey are added to products mentioned in Article 1(2)(a)(ii):

— the amount of added carbohydrates from these sources shall not exceed 1,2 g/100 kJ (5 g/100 kcal),

— the amount of added fructose shall not exceed 0,6 g/100 kJ (2,5 g/100 kcal).

4.

LIPIDS

4.1.

For products mentioned in Article 1(2)(a)(i) and (iv),
(3,3 g/100 kcal).

the lipid content

shall not exceed 0,8 g/100 kJ

4.2.

For products mentioned in Article 1(2)(a)(ii), the lipid content shall not exceed 1,1 g/100 kJ (4,5 g/100 kcal). If the
lipid content exceeds 0,8 g/100 kJ (3,3 g/100 kcal):

— the amount of lauric acid shall not exceed 15 % of the total lipid content,

— the amount of myristic acid shall not exceed 15 % of the total lipid content,

— the amount of linoleic acid (in the form of glycerides = linoleates) shall not be less than 70 mg/100 kJ

(300 mg/100 kcal) and shall not exceed 285 mg/100 kJ (1 200 mg/100 kcal).

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5.

MINERALS

5.1.

Sodium
— sodium salts may only be added to processed cereal-based foods for technological purposes,

— the sodium content of processed cereal-based foods shall not exceed 25 mg/100 kJ (100 mg/100 kcal).

5.2. Calcium

5.2.1. For products mentioned in Article 1(2)(a)(ii),

the amount of calcium shall not be less than 20 mg/100 kJ

(80 mg/100 kcal).

5.2.2. For products mentioned in Article 1(2)(a)(iv), manufactured with the addition of milk (milk biscuits) and presented

as such, the amount of calcium shall not be less than 12 mg/100 kJ (50 mg/100 kcal).

6.

6.1.

VITAMINS
For processed cereal-based foods, the amount of thiamin shall not be less than 25 μg/100 kJ (100 μg/100 kcal).

6.2.

For products mentioned in Article 1(2)(a)(ii):

Vitamin A (μg RE) (1)

Vitamin D (μg) (2)

Per 100 kJ

Per 100 kcal

Minimum

Maximum

Minimum

Maximum

14

0,25

43

0,75

60

1

180

3

(1) RE = all trans retinol equivalents.
(2)

In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D.

These limits shall also be applicable if vitamins A and D are added to other processed cereal-based foods.

7.

MAXIMUM LIMITS FOR VITAMINS, MINERALS AND TRACE ELEMENTS, IF ADDED

The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as
instructed by the manufacturer, except for potassium and calcium for which the requirements refer to the product
as sold.

Nutrient

Maximum per 100 kcal

Vitamin A (μg RE)

Vitamin E (mg α-TE) (1)

Vitamin D (μg)

Vitamin C (mg)

Thiamin (mg)

Riboflavin (mg)

Niacin (mg NE) (3)

Vitamin B6 (mg)

Folic acid (μg)

Vitamin B12 (μg)

180

3

3

12,5/25 (2)

0,5

0,4

4,5

0,35

50

0,35

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Nutrient

Maximum per 100 kcal

Pantothenic acid (mg)

Biotin (μg)

Potassium (mg)

Calcium (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (μg)

Iodine (μg)

Manganese (mg)

(1) α-TE = d-α-tocopherol equivalent.
(2) Limit applicable to products fortified with iron.
(3) NE = Niacin equivalents = mg nicotinic acid + mg tryptophan/60.
(4) Limit applicable to products mentioned in Article 1(2)(a)(i) and (ii).
(5) Limit applicable to products mentioned in Article 1(2)(a)(iv).

1,5

10

160

80/180 (4)/100 (5)

40

3

2

40

35

0,6

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ANNEX II

ESSENTIAL COMPOSITION OF BABY FOODS FOR INFANTS AND YOUNG CHILDREN

The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed
by the manufacturer.

1.

PROTEIN

1.1. If meat, poultry, fish, offal or other traditional source of protein are the only ingredients mentioned in the name of

the product, then:

— the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than

40 % by weight of the total product,

— each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 %, by

weight, of total named protein sources,

— the total protein from the named sources shall not be less than 1,7 g/100 kJ (7 g/100 kcal).

1.2. If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination, are mentioned first in

the name of the product, whether or not the product is presented as a meal, then:

— the named poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 10 % by

weight of the total product,

— each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 % by

weight, of total named protein sources,

— the protein from the named sources shall not be less than 1 g/100 kJ (4 g/100 kcal).

1.3. If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination are mentioned, but

not first, in the name of the product, whether or not the product is presented as a meal, then:

— the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 8 %

by weight of the total product,

— each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 %, by

weight, of total named protein sources,

— the protein from the named sources shall not be less than 0,5 g/100 kJ (2,2 g/100 kcal),

— the total protein in the product from all sources shall not be less than 0,7 g/100 kJ (3 g/100 kcal).

1.4. If cheese is mentioned together with other ingredients in the name of a savoury product, whether or not the product

is presented as a meal, then:

— the protein from the dairy sources shall not be less than 0,5 g/100 kJ (2,2 g/100 kcal),

— the total protein in the product from all sources shall not be less than 0,7 g/100 kJ (3 g/100 kcal).

1.5. If the product is designated on the label as a meal, but does not mention meat, poultry, fish, offal or other
traditional source of protein in the name of the product, the total protein in the product from all sources shall
not be less than 0,7 g/100 kJ (3 g/100 kcal).

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1.6. Sauces presented as an accompaniment to a meal shall be exempt from the requirements of points 1.1 to 1.5

inclusive.

1.7. Sweet dishes that mention dairy products as the first or only ingredient in the name shall contain not less than 2,2 g

dairy protein/100 kcal. All other sweet dishes shall be exempt from the requirements in 1.1 to 1.5.

1.8. The addition of amino acids shall be permitted solely for the purpose of improving the nutritional value of the

protein present, and only in the proportions necessary for that purpose.

2.

CARBOHYDRATES

The quantities of total carbohydrates present in fruit and vegetable juices and nectars, fruit-only dishes, and desserts
or puddings shall not exceed:

— 10 g/100 ml for vegetable juices and drinks based on them,

— 15 g/100 ml for fruit juices and nectars and drinks based on them,

— 20 g/100 g for fruit-only dishes,

— 25 g/100 g for desserts and puddings,

— 5 g/100 g for other non-milk-based drinks.

3.

FAT

3.1. For products referred to in point 1.1:

If meat or cheese are the only ingredients or are mentioned first in the name of a product, the total fat in the
product from all sources shall not exceed 1,4 g/100 kJ (6 g/100 kcal).

3.2. For all other products, the total fat in the product from all sources shall not exceed 1,1 g/100 kJ (4,5 g/100 kcal).

4.

SODIUM

4.1. The final sodium content in the product shall be either not more than 48 mg/100 kJ (200 mg/100 kcal) or not more
than 200 mg per 100 g. However if cheese is the only ingredient mentioned in the name of the product, the final
sodium content in the product shall not be more than 70 mg/100 kJ (300 mg/100 kcal).

4.2. Sodium salts may not be added to products based on fruit, nor to desserts, puddings except for technological

purposes.

5.

VITAMINS

Vitamin C

In a fruit juice, nectar, or vegetable juice the final content of vitamin C in the product shall be either not less than
6 mg/100 kJ (25 mg/100 kcal) or not less than 25 mg per 100 g.

Vitamin A
In vegetable juices, the final content of vitamin A in the product shall be not less than 25 μg RE/100 kJ (100 μg
RE/100 kcal).

Vitamin A shall not be added to other baby foods.

Vitamin D

Vitamin D shall not be added to baby foods.

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6. MAXIMUM LIMITS FOR VITAMINS, MINERALS AND TRACE ELEMENTS, IF ADDED

The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as
instructed by the manufacturer, except for potassium and calcium for which the requirements refer to the
product as sold.

Nutrient

Maximum per 100 kcal

Vitamin A (μg RE)

Vitamin E (mg α-TE)

Vitamin C (mg)

Thiamin (mg)

Riboflavin (mg)

Niacin (mg NE)

Vitamin B6 (mg)

Folic acid (μg)

Vitamin B12 (μg)

Pantothenic acid (mg)

Biotin (μg)

Potassium (mg)

Calcium (mg)

Magnesium (mg)

Iron (mg)

Zinc (mg)

Copper (μg)

Iodine (μg)

Manganese (mg)

(1)
In accordance with the provisions of point 5.
(2) Limit applicable to products fortified with iron.
(3) Limit applicable to fruit-based dishes, fruit juices, nectars and vegetable juices.

180 (1)

3

12,5/25 (2)/125 (3)

0,25

0,4

4,5

0,35

50

0,35

1,5

10

160

80

40

3

2

40

35

0,6

6.12.2006

EN

Official Journal of the European Union

L 339/27

ANNEX III

AMINO ACID COMPOSITION OF CASEIN

(g per 100 g of protein)

Arginine

Cystine

Histidine

Isoleucine

Leucine

Lysine

Methionine

Phenylalanine

Threonine

Tryptophan

Tyrosine

Valine

3,7

0,3

2,9

5,4

9,5

8,1

2,8

5,2

4,7

1,6

5,8

6,7

L 339/28

EN

Official Journal of the European Union

6.12.2006

ANNEX IV

NUTRITIONAL SUBSTANCES

1. VITAMINS

Vitamin A

Retinol

Retinyl acetate

Retinyl palmitate

Beta carotene

Vitamin D

Vitamin D2 (= ergocalciferol)

Vitamin D3 (= cholecalciferol)

Vitamin B1

Thiamin hydrochloride

Thiamin mononitrate

Vitamin B2

Riboflavin

Riboflavin-5'-phosphate, sodium

Niacin

Nicotinamide

Nicotinic acid

Vitamin B6

Pyridoxine hydrochloride

Pyridoxine-5-phosphate

Pyridoxine dipalmitate

Pantothenic Acid

D-pantothenate, calcium

D-pantothenate, sodium

Dexpanthenol

Folate

Folic acid

Vitamin B12

Cyanocobalamin

Hydroxocobalamin

Biotin

D-biotin

Vitamin C

L-ascorbic acid

Sodium L-ascorbate

Calcium L-ascorbate

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

Potassium ascorbate

Vitamin K

Phylloquinone (Phytomenadione)

Vitamin E

D-alpha tocopherol

DL-alpha tocopherol

D-alpha tocopherol acetate

DL-alpha tocopherol acetate

and their hydrochlorides

2. AMINO ACIDS

9

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

L-arginine
L-cystine
L-histidine
L-isoleucine
L-leucine
L-lysine
L-cysteine

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

3. OTHERS

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

L-carnitine

L-carnitine hydrochloride

6.12.2006

EN

Official Journal of the European Union

L 339/29

4. SALTS OF MINERALS AND TRACE ELEMENTS

Ferrous fumarate

Calcium

Calcium carbonate

Calcium chloride

Calcium salts of citric acid

Calcium gluconate

Calcium glycerophosphate

Calcium lactate

Calcium oxide

Calcium hydroxide

Calcium salts of orthophosphoric acid

Magnesium

Magnesium carbonate

Magnesium chloride

Magnesium salts of citric acid

Magnesium gluconate

Magnesium oxide

Magnesium hydroxide

Magnesium salts of orthophosphoric acid

Magnesium sulphate

Magnesium lactate

Magnesium glycerophosphate

Potassium

Potassium chloride

Potassium salts of citric acid

Potassium gluconate

Potassium lactate

Potassium glycerophosphate

Iron

Ferrous citrate

Ferric ammonium citrate

Ferrous gluconate

Ferrous lactate

Ferrous sulphate

Ferric diphosphate (ferric pyrophosphate)

Elemental
reduced)

iron (carbonyl + electrolytic + hydrogen-

Ferric saccharate

Sodium ferric diphosphate

Ferrous carbonate

Copper

Copper-lysine complex

Cupric carbonate

Cupric citrate

Cupric gluconate

Cupric sulphate

Zinc

Zinc acetate

Zinc chloride

Zinc citrate

Zinc lactate

Zinc sulphate

Zinc oxide

Zinc gluconate

Manganese

Manganese carbonate

Manganese chloride

Manganese citrate

Manganese gluconate

Manganese sulphate

Manganese glycerophosphate

Iodine

Sodium iodide

Potassium iodide

Potassium iodate

Sodium iodate

L 339/30

EN

Official Journal of the European Union

6.12.2006

ANNEX V

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

Nutrient

Labelling reference value

Vitamin A

Vitamin D

Vitamin C

Thiamin

Riboflavin

Niacin equivalents

Vitamin B6

Folate

Vitamin B12

Calcium

Iron

Zinc

Iodine

Selenium

Copper

(μg) 400

(μg) 10

(mg) 25

(mg) 0,5

(mg) 0,8

(mg) 9

(mg) 0,7

(μg) 100

(μg) 0,7

(mg) 400

(mg) 6

(mg) 4

(μg) 70

(μg) 10

(mg) 0,4

6.12.2006

EN

Official Journal of the European Union

L 339/31

ANNEX VI

SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN PROCESSED
CEREAL-BASED FOODS AND BABY FOODS

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

L 339/32

EN

Official Journal of the European Union

6.12.2006

PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE
PRODUCTION OF PROCESSED CEREAL-BASED FOODS AND BABY FOODS

ANNEX VII

Table 1

Chemical name of the substance (residue definition)

Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton)

Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion)

Fentin, expressed as triphenyltin cation

Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop)

Heptachlor and trans-heptachlor epoxide, expressed as heptachlor

Hexachlorobenzene

Nitrofen

Omethoate

Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)

Table 2

Chemical name of the substance

Aldrin and dieldrin, expressed as dieldrin

Endrin

6.12.2006

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Official Journal of the European Union

L 339/33

ANNEX VIII

PART A

Repealed Directive with its successive amendments

(referred to in Article 9)

Commission Directive 96/5/EC

(OJ L 49, 28.2.1996, p. 17)

Commission Directive 98/36/EC

(OJ L 167, 12.6.1998, p. 23)

Commission Directive 1999/39/EC

(OJ L 124, 18.5.1999, p. 8)

Commission Directive 2003/13/EC

(OJ L 41, 14.2.2003, p. 33)

PART B

List of time-limits for transposition into national law

(referred to in Article 9)

Directive

Time-limit for transposition

Permission of trade in products
complying with this Directive

Prohibition of trade in products not
complying with this Directive

96/5/EC

30 September 1997

1 October 1997

31 March 1999

98/36/EC

31 December 1998

1 January 1999

1 January 2000

1999/39/EC

30 June 2000

2003/13/EC

6 March 2004

30 June 2000

6 March 2004

1 July 2002

6 March 2005

L 339/34

EN

Official Journal of the European Union

6.12.2006

ANNEX IX

CORRELATION TABLE

Directive 96/5/EC

This Directive

Article 1(1), (2) and (3)

Article 1(1), (2) and (3)

Article 1(4), introductory phrase

Article 2, introductory phrase

Article 1(4), first indent

Article 1(4), second indent

Article 1(4), third indent

Article 2

Article 3

Article 4

Article 5

Article 6(1)

Article 2(a)

Article 2(b)

Article 2(c)

Article 3

Article 4

Article 5

Article 6

Article 7(1)

Article 6(2), first subparagraph

Article 7(2), first subparagraph

Article 6(2), second subparagraph

Article 7(4)

Article 6(2), third subparagraph

Article 7(2) second subparagraph

Article 6(3)(a), first subparagraph, introductory phrase

Article 7(3), introductory phrase

Article 6(3)(a), first subparagraph, (i)

Article 6(3)(a), first subparagraph, (ii)

Article 6(3)(a), second subparagraph

Article 6(3)(b)

Article 6(4)

Article 7

Article 8

—

Article 9

Article 10

Article 7(3)(a)

Article 7(3)(b)

Article 7(4)

Article 7(5)

Article 7(6)

Article 8

—

Article 9

Article 10

Article 11

Annex I, introductory phrase

Annex I, introductory phrase

Annex I, points 1, 2 and 3

Annex I, points 1, 2 and 3

Annex I, point 4

Annex I, point 4.1

Annex I, point 4.2

Annex I, point 4

Annex I, point 4.1

Annex I, point 4.2

Annex I, point 4.2(a)

Annex I, point 4.2, first indent

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Official Journal of the European Union

L 339/35

Annex I, point 4.2(b)

Annex I, point 4.2(c)

Annex I, point 4.2, second indent

Annex I, point 4.2, third indent

Annex I, points 5 and 6

Annex I, points 5 and 6

Annex II, introductory phrase

Annex II, introductory phrase

Annex II, point 1

Annex II, point 1

Annex II, points 1.1-1.3

Annex II, points 1.1-1.3

Annex II, point 1.3a

Annex II, point 1.4

Annex II, point 1.4a

Annex II, point 1.4b

Annex II, point 1.5

Annex II, point 1.4

Annex II, point 1.5

Annex II, point 1.6

Annex II, point 1.7

Annex II, point 1.8

Annex II, points 2 to 5

Annex II, points 2 to 5

Annex III

Annex IV

Annex V

Annex VI

Annex VII

Annex VIII

—

—

Annex III

Annex IV

Annex V

Annex I, point 7, and Annex II, point 6

Annex VI

Annex VII

Annex VIII

Annex IX