6.12.2006 EN Official Journal of the European Union L 339/16 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, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4(1) thereof, Whereas: (1) 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. (2) 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. (3) There is a great variety of the products in question reflecting the widely varied diet of infants being weaned and young children owing to social and cultural circumstances existing in the Community. (4) 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. (5) The essential nutritional requirements for the composition of the two broad categories of these products, namely processed cereal-based foods and baby foods, should be laid down. (6) Although, because of the nature of such products, a number of mandatory requirements and other restrictions 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. (7) 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 of those nutrients by infants and young children. Attention should be paid to any future developments of the situation, and if necessary, appropriate measures should be taken. (8) Different rules on the maximum levels of pesticide residues in processed cereal-based foods and baby foods cause trade barriers between certain Member States. (9) Maximum levels for pesticide residues 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 for pesticide residues 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. (10) Taking into account the Community’s international obligations, in cases where the relevant scientific evidence is insufficient, the precautionary principle allows the Community to provisionally 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. (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 young children are concerned, it is appropriate to 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) Severe limitations on pesticide residues should be 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 agricultural 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. (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 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. For the purposes of control, a harmonised approach should be followed. (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 (8), the continued use of authorised pesticides should be permitted as long as their residues comply with the maximum residue levels established in this Directive. The latter should be set at levels ensuring that their respective ADI values are not exceeded by infants and young children under worst-case intake conditions. (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 innovation based on scientific and technical progress, should be decided by the procedure referred to in Article 13(2) of Directive 89/398/EEC. (19) In view of the persons for whom the products are intended, the necessary microbiological criteria and maximum levels for contaminants should be laid down. (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 advertising of foodstuffs (9). (21) In this Directive the additions and exceptions to those general rules should be adopted and expanded upon, where appropriate. (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 compositional 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. (25) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. (26) This Directive should be 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, HAS ADOPTED THIS DIRECTIVE: 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 (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 Regulation (EC) No 396/2005. (8) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005. (9) 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). 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), 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) (1) 14 43 60 180 Vitamin D (μg) (2) 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. 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) (3) 3 Vitamin D (μg) 3 Vitamin C (mg) 12,5/25 (4) Thiamin (mg) 0,5 Riboflavin (mg) 0,4 Niacin (mg NE) (5) 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 (6)/100 (7) Magnesium (mg) 40 Iron (mg) 3 Zinc (mg) 2 Copper (μg) 40 Iodine (μg) 35 Manganese (mg) 0,6 (1) RE = all trans retinol equivalents. (2) In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D. (3) α-TE = d-α-tocopherol equivalent. (4) Limit applicable to products fortified with iron. (5) NE = Niacin equivalents = mg nicotinic acid + mg tryptophan/60. (6) Limit applicable to products mentioned in Article 1(2)(a)(i) and (ii). (7) Limit applicable to products mentioned in Article 1(2)(a)(iv). 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). 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) 180 (1) Vitamin E (mg α-TE) 3 Vitamin C (mg) 12,5/25 (2)/125 (3) 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 (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. ANNEX III AMINO ACID COMPOSITION OF CASEIN (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 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 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 REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN 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 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 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 PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF PROCESSED CEREAL-BASED FOODS AND BABY FOODS 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 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 30 June 2000 1 July 2002 2003/13/EC 6 March 2004 6 March 2004 6 March 2005 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 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

Summary: Processed cereal-based foods and baby foods for infants and young children Processed cereal-based foods and baby foods for infants and young children SUMMARY OF: Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children WHAT IS THE AIM OF THE DIRECTIVE? It lays down harmonised rules for the composition and labelling of processed cereal-based foods and baby foods for infants* and young children*. These products are carefully monitored since they may contain pesticide residues* which may endanger the health of this sensitive population group. Pesticide residues are prohibited or controlled on the basis of maximum permissible quantities which may not exceed the acceptable daily intake values. It is a specific directive within the meaning of Directive 89/398/EEC, a directive which has since been replaced by Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (see summary). It codifies previous directives (96/5/EC, 98/36/EC, 1999/39/EC and 2003/13/EC). KEY POINTS Scope This directive covers foodstuffs for particular nutritional use that fulfil the nutritional requirements of infants and young children in good health 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: processed cereal-based foods, which are divided into the following 4 categories: simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids;cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid;pastas which are to be used after cooking in boiling water or other appropriate liquids;rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids; baby foods other than processed cereal-based foods. This directive does not apply to milks intended for young children. General obligation EU countries must ensure that only products which comply with this directive are sold. Composition Only ingredients suitable for particular nutritional use for infants and young children (supported by scientific data) may be used in the manufacture of the foods concerned. Processed cereal-based foods must comply with the compositional criteria specified in Annex I. Baby foods which are described in Annex II must comply with the compositional criteria specified therein. Only the nutritional substances listed in Annex IV may be added in the manufacture of processed cereal-based foods and baby foods within the maximum limits laid down by the directive. The purity criteria for those substances must be laid down at a later stage. Processed cereal-based foods and baby foods may not contain any substance in such quantity as to endanger the health of infants and young children (see Regulation (EC) No 1881/2006) (see summary). Labelling In addition to the mandatory particulars stipulated by Regulation (EU) No 1169/2011 (see summary), labelling must bear the following information: the age from which the product may be used, which must not be less than 4 months. Products recommended for use from the age of 4 months may indicate that they are suitable from that age unless persons having qualifications in medicine, nutrition etc. advise otherwise; the presence or absence of gluten if the indicated age from which the product may be used is below 6 months; the available energy value (in kJ and kcal) and the protein, carbohydrate and lipid content (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; the average quantity of each mineral substance and of each vitamin governed by a specific level 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; instructions for appropriate preparation, when necessary, and a statement as to the importance of following those instructions. The labelling may include non-mandatory particulars: the average quantity of the nutrients set out in Annex IV (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; information on vitamins and minerals shown in Annex V (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. Maximum pesticide levels This directive sets the maximum permissible level of pesticide residues in processed cereal-based foods and baby foods at 0.01 mg/kg, except for certain substances whose limit is laid down in Annex VI. Standardised analytical methods must be used for determining the presence of pesticide residues. Prohibited pesticides This directive prohibits the use of certain pesticides in agricultural products intended for baby foods (list in Annex VII). For pesticides or pesticide metabolites in this list, the maximum level of 0.01 mg/kg may be excessive for infants and young children. This is the case for pesticides or metabolites of pesticides with an acceptable daily intake lower than 0.0005 mg/kg body weight. The limit of quantification of the analytical methods is 0.003 mg/kg. At this level, pesticides are considered not to have been used. This limit may be altered in the light of technical progress or data on environmental contamination. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 26 December 2006. BACKGROUND For more information, see: Food for infants and young children (European Commission). KEY TERMS Infants: children under the age of 12 months. Young children: children aged between 1 and 3 years. Pesticide residues: residues of a plant protection product in processed cereal-based foods and baby foods, including its metabolites (intermediate products created during cell metabolism) and products resulting from its degradation or reaction. MAIN DOCUMENT Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (Codified version) (OJ L 339, 6.12.2006, pp. 16-35) RELATED DOCUMENTS Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35-56) Successive amendments to Regulation (EU) No 609/2013 have been incorporated into the original text. This consolidated version is of documentary value only. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, pp. 5-24) See consolidated version. Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1-16) See consolidated version. last update 12.06.2020