
Article 1 

1. This Directive is a ‘specific Directive’ within the meaning of Article 4(1) of Directive 89/398/EEC.
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 to their diet and/or for their progressive adaptation to ordinary food. They comprise:
(a) ‘processed cereal-based foods’ which are divided into the following four categories:
((i)) simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids;
((ii)) cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid;
((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.
3. This Directive does not apply to milks intended for young children.
Article 2 
For the purpose of this Directive, the following definitions shall apply:

((a)) ‘infants’ means children under the age of 12 months;
((b)) ‘young children’ means children aged between one and three years;
((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.
Article 3 
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 manufactured from ingredients whose suitability for particular nutritional use by infants and young children has been established by generally accepted scientific data.
Article 5 

1. Processed cereal-based foods shall comply with the compositional criteria specified in Annex I.
2. Baby foods which are described in Annex II shall comply with the compositional criteria specified therein.
Article 6 
Only the nutritional substances listed in Annex IV may be added in the manufacture of processed cereal-based foods and baby foods.
The purity criteria for those substances shall be laid down at a later stage.
Article 7 

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.
2. Processed cereal-based foods and baby foods shall not contain residues of individual pesticides at levels exceeding 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.
3. The pesticides listed in Annex VII shall not be used in agricultural products intended for the production of processed cereal-based foods and baby foods.However, for the purpose of control:
(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.
4. The levels referred to in paragraphs 2 and 3 shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.
5. For pesticides listed in Annex VI, where a decision 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.
6. Microbiological criteria shall be established as necessary.
Article 8 

1. The labelling of the products concerned shall bear in addition to the particulars provided for in Article 3 of Directive 2000/13/EC, the following mandatory particulars:
(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 independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, advise otherwise;
(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;
(c) the available energy value expressed in kJ and kcal, and the protein, carbohydrate and lipid content, 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;
(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 appropriate, per specified quantity of the product as proposed for consumption;
(e) instructions for appropriate preparation, when necessary, and a statement as to the importance of following those instructions.
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 consumption;
(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, per specified quantity of the product as proposed for 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.
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.
Article 11 
This Directive is addressed to the Member States.
Done at Brussels, 5 December 2006.
For the Commission
The President
José Manuel BARROSO
ANNEX I
The requirements concerning nutrients refer to the products ready for use marketed as such or reconstituted as instructed by the manufacturer.

1. 
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.  2.1. For products mentioned in Article 1(2)(a)(ii) and (iv), the protein content shall not exceed 1,3 g/100 kJ (5,5 g/100 kcal).
 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.  3.1. 

— 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. 

— 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.  4.1. For products mentioned in Article 1(2)(a)(i) and (iv), the lipid content shall not exceed 0,8 g/100 kJ (3,3 g/100 kcal).
 4.2. 

— 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).

5.  5.1. 

— 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.  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. For processed cereal-based foods, the amount of thiamin shall not be less than 25 μg/100 kJ (100 μg/100 kcal).
 6.2. 

 Per 100 kJ Per 100 kcal
Minimum Maximum Minimum Maximum
Vitamin A (μg RE) 14 43 60 180
Vitamin D (μg) 0,25 0,75 1 3



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

7. 
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) 180
Vitamin E (mg α-TE) 3
Vitamin D (μg) 3
Vitamin C (mg) 12,5/25
Thiamin (mg) 0,5
Riboflavin (mg) 0,4
Niacin (mg NE) 4,5
Vitamin B6 (mg) 0,35
Folic acid (μg) 50
Vitamin B12 (μg) 0,35
Pantothenic acid (mg) 1,5
Biotin (μg) 10
Potassium (mg) 160
Calcium (mg) 80/180/100
Magnesium (mg) 40
Iron (mg) 3
Zinc (mg) 2
Copper (μg) 40
Iodine (μg) 35
Manganese (mg) 0,6






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

1.  1.1. 

— 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. 

— 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. 

— 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. 

— 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).
 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. 
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.  3.1. 
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.  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. 
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.

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 shall not be added to baby foods.

6. 
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) 180
Vitamin E (mg α-TE) 3
Vitamin C (mg) 12,5/25/125
Thiamin (mg) 0,25
Riboflavin (mg) 0,4
Niacin (mg NE) 4,5
Vitamin B6 (mg) 0,35
Folic acid (μg) 50
Vitamin B12 (μg) 0,35
Pantothenic acid (mg) 1,5
Biotin (μg) 10
Potassium (mg) 160
Calcium (mg) 80
Magnesium (mg) 40
Iron (mg) 3
Zinc (mg) 2
Copper (μg) 40
Iodine (μg) 35
Manganese (mg) 0,6




ANNEX III
(g per 100 g of protein)
Arginine 3,7
Cystine 0,3
Histidine 2,9
Isoleucine 5,4
Leucine 9,5
Lysine 8,1
Methionine 2,8
Phenylalanine 5,2
Threonine 4,7
Tryptophan 1,6
Tyrosine 5,8
Valine 6,7
ANNEX IV
1. 
Retinol

Retinyl acetate

Retinyl palmitate

Beta carotene

Vitamin D2 (= ergocalciferol)

Vitamin D3 (= cholecalciferol)

Thiamin hydrochloride

Thiamin mononitrate

Riboflavin

Riboflavin-5'-phosphate, sodium

Nicotinamide

Nicotinic acid

Pyridoxine hydrochloride

Pyridoxine-5-phosphate

Pyridoxine dipalmitate

D-pantothenate, calcium

D-pantothenate, sodium

Dexpanthenol

Folic acid

Cyanocobalamin

Hydroxocobalamin

D-biotin

L-ascorbic acid

Sodium L-ascorbate

Calcium L-ascorbate

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

Potassium ascorbate

Phylloquinone (Phytomenadione)

D-alpha tocopherol

DL-alpha tocopherol

D-alpha tocopherol acetate

DL-alpha tocopherol acetate

2. 

L-arginineL-cystineL-histidineL-isoleucineL-leucineL-lysineL-cysteine and their hydrochlorides

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

3. 
Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

L-carnitine

L-carnitine hydrochloride

4. 
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 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 chloride

Potassium salts of citric acid

Potassium gluconate

Potassium lactate

Potassium glycerophosphate

Ferrous citrate

Ferric ammonium citrate

Ferrous gluconate

Ferrous lactate

Ferrous sulphate

Ferrous fumarate

Ferric diphosphate (ferric pyrophosphate)

Elemental iron (carbonyl + electrolytic + hydrogen-reduced)

Ferric saccharate

Sodium ferric diphosphate

Ferrous carbonate

Copper-lysine complex

Cupric carbonate

Cupric citrate

Cupric gluconate

Cupric sulphate

Zinc acetate

Zinc chloride

Zinc citrate

Zinc lactate

Zinc sulphate

Zinc oxide

Zinc gluconate

Manganese carbonate

Manganese chloride

Manganese citrate

Manganese gluconate

Manganese sulphate

Manganese glycerophosphate

Sodium iodide

Potassium iodide

Potassium iodate

Sodium iodate

ANNEX V
Nutrient Labelling reference value
Vitamin A (μg) 400
Vitamin D (μg) 10
Vitamin C (mg) 25
Thiamin (mg) 0,5
Riboflavin (mg) 0,8
Niacin equivalents (mg) 9
Vitamin B6 (mg) 0,7
Folate (μg) 100
Vitamin B12 (μg) 0,7
Calcium (mg) 400
Iron (mg) 6
Zinc (mg) 4
Iodine (μg) 70
Selenium (μg) 10
Copper (mg) 0,4
ANNEX VI
Chemical name of the substance Maximum residue level(mg/kg)
Cadusafos 0,006
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl) 0,006
Ethoprophos 0,008
Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) 0,004
Propineb/propylenethiourea (sum of propineb and propylenethiourea) 0,006
ANNEX VII
Table 1 
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 
Aldrin and dieldrin, expressed as dieldrin

Endrin

ANNEX VIII

PART A

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

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 30 June 2000 1 July 2002
2003/13/EC 6 March 2004 6 March 2004 6 March 2005

ANNEX IX
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 2(a)
Article 1(4), second indent Article 2(b)
Article 1(4), third indent Article 2(c)
Article 2 Article 3
Article 3 Article 4
Article 4 Article 5
Article 5 Article 6
Article 6(1) 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 7(3)(a)
Article 6(3)(a), first subparagraph, (ii) Article 7(3)(b)
Article 6(3)(a), second subparagraph Article 7(4)
Article 6(3)(b) Article 7(5)
Article 6(4) Article 7(6)
Article 7 Article 8
Article 8 —
— Article 9
Article 9 Article 10
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
Annex I, point 4.1 Annex I, point 4.1
Annex I, point 4.2 Annex I, point 4.2
Annex I, point 4.2(a) Annex I, point 4.2, first indent
Annex I, point 4.2(b) Annex I, point 4.2, second indent
Annex I, point 4.2(c) 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 1.4 Annex II, point 1.5
Annex II, point 1.4a Annex II, point 1.6
Annex II, point 1.4b Annex II, point 1.7
Annex II, point 1.5 Annex II, point 1.8
Annex II, points 2 to 5 Annex II, points 2 to 5
Annex III Annex III
Annex IV Annex IV
Annex V Annex V
Annex VI Annex I, point 7, and Annex II, point 6
Annex VII Annex VI
Annex VIII Annex VII
— Annex VIII
— Annex IX