ANNEX IESSENTIAL 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), 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.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), the lipid content shall not exceed 0,8 g/100 kJ (3,3 g/100 kcal).
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).
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.VITAMINS
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.For products mentioned in Article 1(2)(a)(ii):
Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | |
Vitamin A (μg RE)10 | 14 | 43 | 60 | 180 |
Vitamin D (μg)11 | 0,25 | 0,75 | 1 | 3 |
RE = all trans retinol equivalents. | ||||
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) | 180 |
Vitamin E (mg α-TE)12 | 3 |
Vitamin D (μg) | 3 |
Vitamin C (mg) | 12,5/2513 |
Thiamin (mg) | 0,5 |
Riboflavin (mg) | 0,4 |
Niacin (mg NE)14 | 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) | |
Magnesium (mg) | 40 |
Iron (mg) | 3 |
Zinc (mg) | 2 |
Copper (μg) | 40 |
Iodine (μg) | 35 |
Manganese (mg) | 0,6 |
α-TE = d-α-tocopherol equivalent. | |
Limit applicable to products fortified with iron. | |
NE = Niacin equivalents = mg nicotinic acid + mg tryptophan/60. | |
Limit applicable to products mentioned in Article 1(2)(a)(i) and (ii). | |
Limit applicable to products mentioned in Article 1(2)(a)(iv). | |
ANNEX IIESSENTIAL 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).
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.
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) | 18017 |
Vitamin E (mg α-TE) | 3 |
Vitamin C (mg) | |
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 |
In accordance with the provisions of point 5. | |
Limit applicable to products fortified with iron. | |
Limit applicable to fruit-based dishes, fruit juices, nectars and vegetable juices. | |
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 IVNUTRITIONAL 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
2.AMINO ACIDS
L-arginine L-cystine L-histidine L-isoleucine L-leucine L-lysine L-cysteine | and their hydrochlorides |
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
4.SALTS OF MINERALS AND TRACE ELEMENTS
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
Ferrous fumarate
Ferric diphosphate (ferric pyrophosphate)
Elemental iron (carbonyl + electrolytic + hydrogen-reduced)
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
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 VIIPESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF PROCESSED CEREAL-BASED FOODS AND BABY FOODS
Table 1Chemical 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 2Chemical name of the substance
Aldrin and dieldrin, expressed as dieldrin
Endrin
ANNEX VIII
PART A
Commission Directive 96/5/EC | |
Commission Directive 98/36/EC | |
Commission Directive 1999/39/EC | |
Commission Directive 2003/13/EC |
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 |