Article 1 This Directive is a "specific Directive" within the meaning of Article 4(1) of Directive 89/398/EEC and lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health in the Community. It also provides for Member States to give effect to principles and aims of the International Code of Marketing of Breast-milk Substitutes dealing with marketing, information and responsibilities of health authorities.

Article 2 For the purposes of this Directive, the definitions of "claim", "nutrition claim", "health claim" and "reduction of disease risk claim" in Article 2(2)(1), (4), (5) and (6) of Regulation (EC) No 1924/2006 shall apply. The following definitions shall also apply: (a)"infants" means children under the age of 12 months; (b)"young children" means children aged between one and three years; (c)"infant formulae" means foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding; (d)"follow-on formulae" means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants; (e)"pesticide residue" means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Directive 91/414/EEC, including its metabolites and products resulting from its degradation or reaction.

Article 3 Infant formulae and follow-on formulae may be marketed within the Community only if they comply with this Directive. No product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first months of life until the introduction of appropriate complementary feeding.

Article 4 Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children.

Article 5 Infant formulae shall be manufactured from protein sources defined in point 2 of Annex I and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data. Such suitability shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.

Article 6 Follow-on formulae shall be manufactured from protein sources defined in point 2 of Annex II and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants aged over six months has been established by generally accepted scientific data. Such suitability shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.

Article 7 1. Infant formulae shall comply with the compositional criteria set out in Annex I taking into account the specifications in Annex V. In the case of infant formulae manufactured from cows’ milk or goats’ milk proteins defined in point 2.1 of Annex I with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. In the case of infant formulae manufactured from protein hydrolysates defined in point 2.2 of Annex I with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in Annex VI. 2. Follow-on formulae shall comply with the compositional criteria set out in Annex II taking into account the specifications set out in Annex V. In the case of follow-on formulae manufactured from protein hydrolysates defined in point 2.2 of Annex II with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal), the suitability of the follow-on formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in Annex VI. 3. In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water. 4. The prohibitions and limitations on the use of food ingredients in infant formulae and follow-on formulae set out in Annexes I and II shall be observed.

Article 8 1. Only the substances listed in Annex III may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on: (a)mineral substances; (b)vitamins; (c)amino acids and other nitrogen compounds; (d)other substances having a particular nutritional purpose. 2. Purity criteria for substances, as provided for in Community legislation concerning the use of substances listed in Annex III, in the manufacture of foodstuffs for purposes other than those covered by this Directive, shall apply. 3. For those substances for which no purity criteria have been provided for in Community legislation, generally acceptable purity criteria recommended by international bodies shall apply until the adoption of such criteria at Community level. However, national rules setting stricter purity criteria than those recommended by international bodies may be maintained.

Article 9 1. To facilitate the efficient official monitoring of infant formulae, when a food business operator places an infant formula on the market he shall notify the competent authority of the Member States where the product is being marketed by forwarding to it a model of the label used for the product. 2. The competent authorities for the purposes of this Article are those referred to in Article 9(4) of Directive 89/398/EEC.

Article 10 1. Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer. Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods. 2. The pesticides listed in Annex VIII shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae. However, for the purpose of controls: (a)pesticides listed in Table 1 of Annex VIII are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level, which is considered to be the limit of quantification of the analytical methods, shall be kept under regular review in the light of technical progress; (b)pesticides listed in Table 2 of Annex VIII are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level shall be kept under regular review in the light of data on environmental contamination. 3. By way of derogation from paragraph 1, for the pesticides listed in Annex IX, the maximum residue levels specified therein shall apply. 4. The levels referred to in paragraphs 2 and 3 shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.

Article 11 Except as provided for in Article 12, the name under which infant formulae and follow-on formulae are sold shall be, respectively: in Bulgarian: "храни за кърмачета" and "преходни храни", in Spanish: "Preparado para lactantes" and "Preparado de continuación", in Czech: "počáteční kojenecká výživa" and "pokračovací kojenecká výživa", in Danish: "Modermælkserstatning" and "Tilskudsblanding", in German: "Säuglingsanfangsnahrung" and "Folgenahrung", in Estonian: "imiku piimasegu" and "jätkupiimasegu", in Greek: "Παρασκεύασμα για βρέφη" and "Παρασκεύασμα δεύτερης βρεφικής ηλικίας", in English: "infant formula" and "follow-on formula", in French: "Préparation pour nourrissons" and "Préparation de suite", in Croatian: "početna hrana za dojenčad" and "prijelazna hrana za dojenčad", in Italian: "Alimento per lattanti" and "Alimento di proseguimento", in Latvian: "Mākslīgais maisījums zīdaiņiem" un "Mākslīgais papildu ēdināšanas maisījums zīdaiņiem", in Lithuanian: "mišinys kūdikiams iki papildomo maitinimo įvedimo" and "mišinys kūdikiams, įvedus papildomą maitinimą", in Hungarian: "anyatej-helyettesítő tápszer" and "anyatej-kiegészítő tápszer", in Maltese: "formula tat-trabi" and "formula tal-prosegwiment", in Dutch: "Volledige zuigelingenvoeding" and "Opvolgzuigelingenvoeding", in Polish: "preparat do początkowego żywienia niemowląt" and "preparat do dalszego żywienia niemowląt", in Portuguese: "Fórmula para lactentes" and "Fórmula de transição", in Romanian: "preparate pentru sugari" and "preparate pentru copii de vârstă mică", in Slovak: "počiatočná dojčenská výživa" and "následná dojčenská výživa". in Slovenian: "začetna formula za dojenčke" and "nadaljevalna formula za dojenčke", in Finnish: "Äidinmaidonkorvike" and "Vieroitusvalmiste", in Swedish: "Modersmjölksersättning" and "Tillskottsnäring".

Article 12 The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk or goats’ milk proteins are sold shall be respectively: in Bulgarian: "млека за кърмачета" and "преходни млека", in Spanish: "Leche para lactantes" and "Leche de continuación", in Czech: "počáteční mléčná kojenecká výživa" and "pokračovací mléčná kojenecká výživa", in Danish: "Modermælkserstatning udelukkende baseret på mælk" and "Tilskudsblanding udelukkende baseret på mælk", in German: "Säuglingsmilchnahrung" and "Folgemilch", in Estonian: "Piimal põhinev imiku piimasegu" and "Piimal põhinev jätkupiimasegu", in Greek: "Γάλα για βρέφη" and "Γάλα δεύτερης βρεφικής ηλικίας", in English: "infant milk" and "follow-on milk", in French: "Lait pour nourrissons" and "Lait de suite", in Croatian: "početna mliječna hrana za dojenčad" and "prijelazna mliječna hrana za dojenčad", in Italian: "Latte per lattanti" and "Latte di proseguimento", in Latvian: "Mākslīgais piena maisījums zīdaiņiem" un "Mākslīgais papildu ēdināšanas piena maisījums zīdaiņiem", in Lithuanian: "pieno mišinys kūdikiams iki papildomo maitinimo įvedimo" and "pieno mišinys kūdikiams įvedus papildomą maitinimą", in Hungarian: "tejalapú anyatej-helyettesítő tápszer" and "tejalapú anyatej-kiegészítő tápszer", in Maltese: "ħalib tat-trabi" and "ħalib tal-prosegwiment", in Dutch: "Volledige zuigelingenvoeding op basis van melk" or "Zuigelingenmelk" and "Opvolgmelk", in Polish: "mleko początkowe" and "mleko następne", in Portuguese: "Leite para lactentes" and "Leite de transição", in Romanian: "lapte pentru sugari" and "lapte pentru copii de vârstă mică"; in Slovak: "počiatočná dojčenská mliečna výživa" and "následná dojčenská mliečna výživa", in Slovenian: "začetno mleko za dojenčke" and "nadaljevalno mleko za dojenčke", in Finnish: "Maitopohjainen äidinmaidonkorvike" and "Maitopohjainen vieroitusvalmiste", in Swedish: "Modersmjölksersättning uteslutande baserad på mjölk" and "Tillskottsnäring uteslutande baserad på mjölk".

Article 13 1. The labelling shall bear, in addition to those provided for in Article 3(1) of Directive 2000/13/EC, the following mandatory particulars: (a)in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast fed; (b)in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of six months, that it should form only part of a diversified diet, that it is not to be used as a substitute for breast milk during the first six months of life and that the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, based on the individual infant’s specific growth and development needs; (c)in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use; (d)in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol and carnitine, expressed in numerical form, per 100 ml of the product ready for use; (e)in the case of infant formulae and follow-on formulae, instructions for appropriate preparation, storage and disposal of the product and a warning against the health hazards of inappropriate preparation and storage. 2. The labelling may bear the following particulars: (a)for infant formulae and follow-on formulae the average quantity of nutrients mentioned in Annex III when such declaration is not covered by paragraph 1(d) of this Article, expressed in numerical form, per 100 ml of the product ready for use; (b)for follow-on formulae in addition to numerical information, information on vitamins and minerals included in Annex VII, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use. 3. The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast feeding. The use of the terms "humanised", "maternalised", "adapted", or similar terms shall be prohibited. 4. The labelling of infant formulae shall, in addition, bear the following mandatory particulars, preceded by the words "Important Notice" or their equivalent: (a)a statement concerning the superiority of breast feeding; (b)a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care. 5. The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation. 6. The labelling of infant formulae may bear nutrition and health claims only in the cases listed in Annex IV and in accordance with the conditions set out therein. 7. Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between such products so as to avoid any risk of confusion between infant formulae and follow-on formulae. 8. The requirements, prohibitions and restrictions referred to in paragraphs 3 to 7 shall also apply to: (a)the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed; (b)advertising.

Article 14 1. Advertising of infant formulae shall be restricted to publications specialising in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertisements for infant formulae shall be subject to the conditions laid down in Article 13(3) to (7) and Article 13(8)(b) and contain only information of a scientific and factual nature. Such information shall not imply or create a belief that bottle-feeding is equivalent or superior to breast feeding. 2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales. 3. Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers.

Article 15 1. Member States shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition covering the planning, provision, design and dissemination of information and their control. 2. Member States shall ensure that informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear information on all the following points: (a)the benefits and superiority of breast feeding; (b)maternal nutrition and the preparation for and maintenance of breast feeding; (c)the possible negative effect on breast feeding of introducing partial bottle feeding; (d)the difficulty of reversing the decision not to breast feed; (e)where needed, the proper use of infant formulae. When such materials contain information about the use of infant formulae, they shall include the social and financial implications of its use, the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of improper use of infant formulae. Such material shall not use any pictures which may idealise the use of infant formulae. 3. Member States shall ensure that donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the appropriate national authority or within guidelines given by that authority for this purpose. Such equipment or materials may bear the donating company’s name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system. 4. Member States shall ensure that donations or low-price sales of supplies of infant formulae to institutions or organisations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formulae and only for as long as required by such infants.

Article 16 In the Annex to Directive 1999/21/EC, the row relating to manganese set out in the second part of Table I concerning minerals, is replaced by the following:

"Manganese (μg)

0,25

100"

Article 17 The new requirements set out in Article 7(1) and (2) of this Directive shall not apply mandatorily to dietary foods for special medical purposes intended specifically for infants, as referred to in point 4 of the Annex to Directive 1999/21/EC, until 1 January 2012.

Article 18 1. Member States shall adopt and publish, by 31 December 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with Articles 2, 3 and 5 to 17 and Annexes I to VII. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions in such a way as to: permit trade in products complying with this Directive by 1 January 2008 at the latest, without prejudice to Article 17, prohibit, with effect from 31 December 2009 trade in products which do not comply with this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 19 Directive 91/321/EEC, as amended by the Directives listed in Annex X, Part A, is repealed with effect from 1 January 2008, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives listed in Annex X, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XI.

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

Article 21 This Directive is addressed to the Member States.

null ANNEX I ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER The values set out in this Annex refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. 1.ENERGY

Minimum	Maximum
250 kJ/100 ml	295 kJ/100 ml
(60 kcal/100 ml)	(70 kcal/100 ml)

2.PROTEINS (Protein content = nitrogen content × 6,25) 2.1.Infant formulae manufactured from cows’ milk or goats’ milk proteins

Infant formulae manufactured from cows’ milk or goats’ milk protein with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(1).

Minimum	Maximum
0,45 g/100 kJ	0,7 g/100 kJ
(1,8 g/100 kcal)	(3 g/100 kcal)

For an equal energy value, the infant formula must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V). Nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies. 2.2Infant formulae manufactured from protein hydrolysates

Infant formulae manufactured from protein hydrolysates with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal) shall be in accordance with the third subparagraph of Article 7(1).

Minimum	Maximum
0,45 g/100 kJ	0,7 g/100 kJ
(1,8 g/100 kcal)	(3 g/100 kcal)

For an equal energy value, the infant formula must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V). Nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal). 2.3.Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins

Minimum	Maximum
0,56 g/100 kJ	0,7 g/100 kJ
(2,25 g/100 kcal)	(3 g/100 kcal)

Only protein isolates from soya shall be used in manufacturing these infant formulae.For an equal energy value the infant formula must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V). Nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together if the methionine:cystine ratio is not greater than 2, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. The ratio of methionine:cystine may be greater than 2 but shall not be greater than 3 provided that the suitability of the product for the particular nutritional use by infants is demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.The L-carnitine content shall be at least equal to 0,3 mg/100 kJ (1,2 mg/100 kcal). 2.4 In all cases, amino acids may be added to infant formulae solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose. 3.TAURINE If added to infant formulae, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal). 4.CHOLINE

Minimum	Maximum
1,7 mg/100 kJ	12 mg/100 kJ
(7 mg/100 kcal)	(50 mg/100 kcal)

5.LIPIDS

Minimum	Maximum
1,05 g/100 kJ	1,4 g/100 kJ
(4,4 g/100 kcal)	(6,0 g/100 kcal)

5.1 The use of the following substances shall be prohibited: sesame seed oil, cotton seed oil. 5.2Lauric acid and myristic acid

Minimum	Maximum
—	separately or as a whole:20 % of the total fat content

5.3 The trans fatty acid content shall not exceed 3 % of the total fat content. 5.4 The erucic acid content shall not exceed 1 % of the total fat content. 5.5Linoleic acid (in the form of glycerides = linoleates)

Minimum	Maximum
70 mg/100 kJ	285 mg/100 kJ
(300 mg/100 kcal)	(1200 mg/100 kcal)

5.6 The alpha-linolenic acid content shall not be less than 12 mg/100 kJ (50 mg/100 kcal).The linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15. 5.7 Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) may be added. In that case their content shall not exceed: 1 % of the total fat content for n-3 LCP, and 2 % of the total fat content for n-6 LCP (1 % of the total fat content for arachidonic acid (20:4 n-6)) The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.The docosahexaenoic acid (22:6 n-3) content shall not exceed that of n-6 LCP. 6.PHOSPHOLIPIDS The amount of phospholipids in infant formulae shall not be greater than 2 g/l. 7.INOSITOL

Minimum	Maximum
1 mg/100 kJ	10 mg/100 kJ
(4 mg/100 kcal)	(40 mg/100 kcal)

8.CARBOHYDRATES

Minimum	Maximum
2,2 g/100 kJ	3,4 g/100 kJ
(9 g/100 kcal)	(14 g/100 kcal)

8.1 Only the following carbohydrates may be used:

—lactose,
—maltose,
—sucrose,
—glucose,
—malto-dextrins,
—glucose syrup or dried glucose syrup,
—pre-cooked starch	naturally free of gluten.
—gelatinised starch

8.2Lactose

Minimum	Maximum
1,1 g/100 kJ	—
(4,5 g/100 kcal)	—

This provision shall not apply to infant formulae in which soya protein isolates represent more than 50 % of the total protein content. 8.3Sucrose Sucrose may only be added to infant formulae manufactured from protein hydrolysates. If added, the sucrose content shall not exceed 20 % of the total carbohydrate content. 8.4Glucose Glucose may only be added to infant formulae manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal). 8.5Pre-cooked starch and/or gelatinised starch

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

9.FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES Fructo-oligosaccharides and galacto-oligosaccharides may be added to infant formulae. In that case their content shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight oligofructosyl-saccharose.Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with Article 5. 10.MINERAL SUBSTANCES 10.1.Infant formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Sodium (mg)	5	14	20	60
Potassium (mg)	15	38	60	160
Chloride (mg)	12	38	50	160
Calcium (mg)	12	33	50	140
Phosphorus (mg)	6	22	25	90
Magnesium (mg)	1,2	3,6	5	15
Iron (mg)	0,07	0,3	0,3	1,3
Zinc (mg)	0,12	0,36	0,5	1,5
Copper (μg)	8,4	25	35	100
Iodine (μg)	2,5	12	10	50
Selenium (μg)	0,25	2,2	1	9
Manganese (μg)	0,25	25	1	100
Fluoride (μg)	—	25	—	100

The calcium:phosphorus ratio shall not be less than 1 nor greater than 2. 10.2.Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins All requirements of point 10.1 shall apply, except for those concerning iron and phosphorus, which shall be as follows:

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Iron (mg)	0,12	0,5	0,45	2
Phosphorus (mg)	7,5	25	30	100

11.VITAMINS

RE = all trans retinol equivalent. In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D. Preformed niacin. α-TE = d-α-tocopherol equivalent. 0,5 mg α-TE/1 g linoleic acid (18:2 n-6); 0,75 mg α-TE/1 g α-linolenic acid (18:3 n-3); 1,0 mg α-TE/1 g arachidonic acid (20:4 n-6); 1,25 mg α-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Vitamin A (μg-RE)	14	43	60	180
Vitamin D (μg)	0,25	0,65	1	2,5
Thiamin (μg)	14	72	60	300
Riboflavin (μg)	19	95	80	400
Niacin (μg)	72	375	300	1500
Pantothenic acid (μg)	95	475	400	2000
Vitamin B6 (μg)	9	42	35	175
Biotin (μg)	0,4	1,8	1,5	7,5
Folic Acid (μg)	2,5	12	10	50
Vitamin B12 (μg)	0,025	0,12	0,1	0,5
Vitamin C (mg)	2,5	7,5	10	30
Vitamin K (μg)	1	6	4	25
Vitamin E (mg α-TE)	0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds but in no case less than 0,1 mg per 100 available kJ	1,2	0,5/g of polyunsaturated fatty acids expressed as linoleic acid as corrected for the double bonds but in no case less than 0,5 mg per 100 available kcal	5

12.NUCLEOTIDES The following nucleotides may be added:

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

	Maximum
	(mg/100 kJ)	(mg/100 kcal)
cytidine 5′-monophosphate	0,60	2,50
uridine 5′-monophosphate	0,42	1,75
adenosine 5′-monophosphate	0,36	1,50
guanosine 5′-monophosphate	0,12	0,50
inosine 5′-monophosphate	0,24	1,00

ANNEX II ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER The values set out in this Annex refer to the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer. 1.ENERGY

Minimum	Maximum
250 kJ/100 ml	295 kJ/100 ml
(60 kcal/100 ml)	(70 kcal/100 ml)

2.PROTEINS (Protein content = nitrogen content × 6,25) 2.1.Follow-on formulae manufactured from cows’ milk or goats’ milk proteins

Minimum	Maximum
0,45 g/100 kJ	0,8 g/100 kJ
(1,8 g/100 kcal)	(3,5 g/100 kcal)

For an equal energy value, the follow-on formula must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V). Nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. 2.2Follow-on formulae manufactured from protein hydrolysates

Follow-on formulae manufactured from protein hydrolysates with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(2).

Minimum	Maximum
0,45 g/100 kJ(1,8 g/100 kcal)	0,8 g/100 kJ(3,5 g/100 kcal)

For an equal energy value, the follow-on formula must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V). Nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. 2.3.Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins

Minimum	Maximum
0,56 g/100 kJ	0,8 g/100 kJ
(2,25 g/100 kcal)	(3,5 g/100 kcal)

Only protein isolates from soya shall be used in manufacturing these formulae.For an equal energy value the follow-on formula must contain an available quantity of each indispensable and conditionally indispensable amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V). Nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together if the methionine:cystine ratio is not greater than 3, and the concentration of phenylalanine and tyrosine may be added together if the tyrosine:phenylalanine ratio is not greater than 2. 2.4 In all cases, amino acids may be added to follow-on formulae solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose. 3.TAURINE If added to follow-on formulae, the amount of taurine shall not be greater than 2,9 mg/100 kJ (12 mg/100 kcal). 4.LIPIDS

Minimum	Maximum
0,96 g/100 kJ	1,4 g/100 kJ
(4,0 g/100 kcal)	(6,0 g/100 kcal)

4.1 The use of the following substances shall be prohibited: sesame seed oil, cotton seed oil. 4.2Lauric acid and myristic acid

Minimum	Maximum
—	separately or as a whole:20 % of the total fat content

4.3. The trans fatty acid content shall not exceed 3 % of the total fat content. 4.4 The erucic acid content shall not exceed 1 % of the total fat content. 4.5Linoleic acid (in the form of glycerides = linoleates)

Minimum	Maximum
70 mg/100 kJ	285 mg/100 kJ
(300 mg/100 kcal)	(1200 mg/100 kcal)

4.6 The alpha-linolenic acid content shall not be less than 12 mg/100 kJ (50 mg/100 kcal).The linoleic:alpha-linolenic acid ratio shall not be less than 5 nor greater than 15. 4.7 Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) may be added. In that case their content shall not exceed: 1 % of the total fat content for n-3 LCP, and 2 % of the total fat content for n-6 LCP (1 % of the total fat content for arachidonic acid (20:4 n-6)) The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.The docosahexaenoic (22:6 n-3) acid content shall not exceed that of n-6 LCP. 5.PHOSPHOLIPIDS The amount of phospholipids in follow-on formulae shall not be greater than 2 g/l. 6.CARBOHYDRATES

Minimum	Maximum
2,2 g/100 kJ	3,4 g/100 kJ
(9 g/100 kcal)	(14 g/100 kcal)

6.1 The use of ingredients containing gluten shall be prohibited. 6.2Lactose

Minimum	Maximum
1,1 g/100 kJ	—
(4,5 g/100 kcal)

This provision shall not apply to follow-on formulae in which soya protein isolates represent more than 50 % of the total protein content. 6.3Sucrose, fructose, honey

Minimum	Maximum
—	separately or as a whole:20 % of the total carbohydrate content

Honey shall be treated to destroy spores of Clostridium botulinum. 6.4Glucose Glucose may only be added to follow-on formulae manufactured from protein hydrolysates. If added, the glucose content shall not exceed 0,5 g/100 kJ (2 g/100 kcal). 7.FRUCTO-OLIGOSACCHARIDES AND GALACTO-OLIGOSACCHARIDES Fructo-oligosaccharides and galacto-oligosaccharides may be added to follow-on formulae. In that case their content shall not exceed: 0,8 g/100 ml in a combination of 90 % oligogalactosyl-lactose and 10 % high molecular weight oligofructosyl-saccharose.Other combinations and maximum levels of fructo-oligosaccharides and galacto-oligosaccharides may be used in accordance with Article 6. 8.MINERAL SUBSTANCES 8.1.Follow-on formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Sodium (mg)	5	14	20	60
Potassium (mg)	15	38	60	160
Chloride (mg)	12	38	50	160
Calcium (mg)	12	33	50	140
Phosphorus (mg)	6	22	25	90
Magnesium (mg)	1,2	3,6	5	15
Iron (mg)	0,14	0,5	0,6	2
Zinc (mg)	0,12	0,36	0,5	1,5
Copper (μg)	8,4	25	35	100
Iodine (μg)	2,5	12	10	50
Selenium (μg)	0,25	2,2	1	9
Manganese (μg)	0,25	25	1	100
Fluoride (μg)	—	25	—	100

The calcium:phosphorus ratio in follow-on formulae shall not be less than 1,0 nor greater than 2,0. 8.2.Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins All requirements of point 8.1 shall apply, except for those concerning iron, and phosphorus, which shall be as follows:

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Iron (mg)	0,22	0,65	0,9	2,5
Phosphorus (mg)	7,5	25	30	100

9.VITAMINS

RE = all trans retinol equivalent. In the form of cholecalciferol, of which10 μg = 400 i.u. of vitamin D. Preformed niacin. α-TE = d-α-tocopherol equivalent. 0,5 mg α-TE/1 g linoleic acid (18:2 n-6); 0,75 mg α-TE/1 g α-linolenic acid (18:3 n-3); 1,0 mg α-TE/1 g arachidonic acid (20:4 n-6); 1,25 mg α-TE/1 g eicosapentaenoic acid (20:5 n-3); 1,5 mg α-TE/1 g docosahexaenoic acid (22:6 n-3).

	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
Thiamin (μg)	14	72	60	300
Riboflavin (μg)	19	95	80	400
Niacin (μg)	72	375	300	1500
Pantothenic acid (μg)	95	475	400	2000
Vitamin B6 (μg)	9	42	35	175
Biotin (μg)	0,4	1,8	1,5	7,5
Folic Acid (μg)	2,5	12	10	50
Vitamin B12 (μg)	0,025	0,12	0,1	0,5
Vitamin C (mg)	2,5	7,5	10	30
Vitamin K (μg)	1	6	4	25
Vitamin E (mg α-TE)	0,5/g poly-unsaturated fatty acids expressed as linoleic acid as corrected for the double bonds but in no case less than 0,1 mg per 100 available kJ	1,2	0,5/g poly-unsaturated fatty acids expressed as linoleic acid as corrected for the double bonds but in no case less than 0,5 mg per 100 available kcal	5

10.NUCLEOTIDES The following nucleotides may be added:

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

	Maximum
	(mg/100 kJ)	(mg/100 kcal)
cytidine 5′-monophosphate	0,60	2,50
uridine 5′-monophosphate	0,42	1,75
adenosine 5′-monophosphate	0,36	1,50
guanosine 5′-monophosphate	0,12	0,50
inosine 5′-monophosphate	0,24	1,00

ANNEX III NUTRITIONAL SUBSTANCES 1.Vitamins

Vitamin	Vitamin formulation
Vitamin A	Retinyl acetate
	Retinyl palmitate
	Retinol
Vitamin D	Vitamin D2 (ergocalciferol)
Vitamin D	Vitamin D3 (cholecalciferol)
Vitamin B1	Thiamin hydrochloride
Vitamin B1	Thiamin mononitrate
Vitamin B2	Riboflavin
Vitamin B2	Riboflavin-5′-phosphate, sodium
Niacin	Nicotinamide
Niacin	Nicotinic acid
Vitamin B6	Pyridoxine hydrochloride
Vitamin B6	Pyridoxine-5′-phosphate
Folate	Folic acid
Pantothenic acid	D-pantothenate, calcium
	D-pantothenate, sodium
	Dexpanthenol
Vitamin B12	Cyanocobalamin
Vitamin B12	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 E	D-alpha tocopherol
	DL-alpha tocopherol
	D-alpha tocopherol acetate
	DL-alpha tocopherol acetate
Vitamin K	Phylloquinone (Phytomenadione)

2.Mineral substances

Mineral substances	Permitted salts
Calcium (Ca)	Calcium carbonate
	Calcium chloride
	Calcium salts of citric acid
	Calcium gluconate
	Calcium glycerophosphate
	Calcium lactate
	Calcium salts of orthophosphoric acid
	Calcium hydroxide
Magnesium (Mg)	Magnesium carbonate
	Magnesium chloride
	Magnesium oxide
	Magnesium salts of orthophosphoric acid
	Magnesium sulphate
	Magnesium gluconate
	Magnesium hydroxide
	Magnesium salts of citric acid
Iron (Fe)	Ferrous citrate
	Ferrous gluconate
	Ferrous lactate
	Ferrous sulphate
	Ferric ammonium citrate
	Ferrous fumarate
	Ferric diphosphate (Ferric pyrophosphate)
	Ferrous bisglycinate
Copper (Cu)	Cupric citrate
	Cupric gluconate
	Cupric sulphate
	Copper-lysine complex
	Cupric carbonate
Iodine (I)	Potassium iodide
	Sodium iodide
	Potassium iodate
Zinc (Zn)	Zinc acetate
	Zinc chloride
	Zinc lactate
	Zinc sulphate
	Zinc citrate
	Zinc gluconate
	Zinc oxide
Manganese (Mn)	Manganese carbonate
	Manganese chloride
	Manganese citrate
	Manganese sulphate
	Manganese gluconate
Sodium (Na)	Sodium bicarbonate
	Sodium chloride
	Sodium citrate
	Sodium gluconate
	Sodium carbonate
	Sodium lactate
	Sodium salts of orthophosphoric acid
	Sodium hydroxide
Potassium (K)	Potassium bicarbonate
	Potassium carbonate
	Potassium chloride
	Potassium salts of citric acid
	Potassium gluconate
	Potassium lactate
	Potassium salts of orthophosphoric acid
	Potassium hydroxide
Selenium (Se)	Sodium selenate
Selenium (Se)	Sodium selenite

3.Amino acids and other nitrogen compounds L-arginine and its hydrochloride L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred to in the third subparagraph of Article 7(1) and follow-on formulae referred to in the second subparagraph of Article 7(2). L-cystine and its hydrochlorideL-histidine and its hydrochlorideL-isoleucine and its hydrochlorideL-leucine and its hydrochlorideL-lysine and its hydrochlorideL-cysteine and its hydrochlorideL-methionineL-phenylalanineL-threonineL-tryptophanL-tyrosineL-valineL-carnitine and its hydrochlorideL-carnitine-L-tartrateTaurineCytidine 5′-monophosphate and its sodium saltUridine 5′-monophosphate and its sodium saltAdenosine 5′-monophosphate and its sodium saltGuanosine 5′-monophosphate and its sodium saltInosine 5′-monophosphate and its sodium salt 4.Other nutritional substances CholineCholine chlorideCholine citrateCholine bitartrateInositol ANNEX IV NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A CORRESPONDING CLAIM

1.NUTRITION CLAIMS1.4Nutrition claims on the addition of the following optional ingredients:

Nutrition claim related to	Conditions warranting the nutrition claim
1.1Lactose only	Lactose is the only carbohydrate present.
1.2Lactose free	Lactose content is not greater than 2,5 mg/100 kJ (10 mg/100 kcal).
1.3Added LCP or an equivalent nutrition claim related to the addition of docosahexaenoic acid	The docosahexaenoic acid content is not less than 0,2 % of the total fatty acid content.
1.4.1taurine	Voluntarily added at a level that would be appropriate for the intended particular use by infants and in accordance with the conditions set out in Annex I.
1.4.2fructo-oligosaccharides and galacto-oligosaccharides
1.4.3nucleotides

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

Nutrition claim related to	Conditions warranting the health claim
2.1Reduction of risk to allergy to milk proteins. This health claim may include terms referring to reduced allergen or reduced antigen properties.	(a)Objective and scientifically verified data as proof to the claimed properties must be available; (b)The infant formulae shall satisfy the provisions set out in point 2.2 of Annex I and the amount of immunoreactive protein measured with methods generally acceptable as appropriate shall be less than 1 % of nitrogen containing substances in the formulae; (c)The label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is manufactured unless generally accepted clinical tests provide proof of the infant formulae’s tolerance in more than 90 % of infants (confidence interval 95 %) hypersensitive to proteins from which the hydrolysate is manufactured; (d)The infant formulae administered orally must not induce sensitisation, in animals, to the intact proteins from which the infant formulae are manufactured.

Nutrition claim related to

Conditions warranting the health claim

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

(a)Objective and scientifically verified data as proof to the claimed properties must be available; (b)The infant formulae shall satisfy the provisions set out in point 2.2 of Annex I and the amount of immunoreactive protein measured with methods generally acceptable as appropriate shall be less than 1 % of nitrogen containing substances in the formulae; (c)The label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is manufactured unless generally accepted clinical tests provide proof of the infant formulae’s tolerance in more than 90 % of infants (confidence interval 95 %) hypersensitive to proteins from which the hydrolysate is manufactured; (d)The infant formulae administered orally must not induce sensitisation, in animals, to the intact proteins from which the infant formulae are manufactured.

ANNEX V INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK For the purpose of this Directive, the indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:

1 kJ = 0,239 kcal.

	Per 100 kJ	Per 100 kcal
Cystine	9	38
Histidine	10	40
Isoleucine	22	90
Leucine	40	166
Lysine	27	113
Methionine	5	23
Phenylalanine	20	83
Threonine	18	77
Tryptophan	8	32
Tyrosine	18	76
Valine	21	88

ANNEX VI Specification for the protein content and source and the processing of protein used in the manufacture of infant formulae and follow-on formulae with a protein content less than 0,56 g/100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of whey proteins derived from cows’ milk protein 1.Protein content Protein content = nitrogen content × 6,25

Minimum	Maximum
0,44 g/100 kJ	0,7 g/100 kJ
(1,86 g/100 kcal)	(3 g/100 kcal)

2.Protein source Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of: (a)63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and (b)37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %. 3.Protein processing Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps. 4.Protein quality The indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:

1 kJ = 0,239 kcal.

	Per 100 kJ	Per 100 kcal
Arginine	16	69
Cystine	6	24
Histidine	11	45
Isoleucine	17	72
Leucine	37	156
Lysine	29	122
Methionine	7	29
Phenylalanine	15	62
Threonine	19	80
Tryptophan	7	30
Tyrosine	14	59
Valine	19	80

ANNEX VII

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

Nutrient	Labelling reference value
Vitamin A	(μg) 400
Vitamin D	(μg) 7
Vitamin E	(mg TE) 5
Vitamin K	(μg) 12
Vitamin C	(mg) 45
Thiamin	(mg) 0,5
Riboflavin	(mg) 0,7
Niacin	(mg) 7
Vitamin B6	(mg) 0,7
Folate	(μg) 125
Vitamin B12	(μg) 0,8
Pantothenic acid	(mg) 3
Biotin	(μg) 10
Calcium	(mg) 550
Phosphorus	(mg) 550
Potassium	(mg) 1000
Sodium	(mg) 400
Chloride	(mg) 500
Iron	(mg) 8
Zinc	(mg) 5
Iodine	(μg) 80
Selenium	(μg) 20
Copper	(mg) 0,5
Magnesium	(mg) 80
Manganese	(mg) 1,2

ANNEX VIII PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF INFANT FORMULAE AND FOLLOW ON FORMULAE Table 1 Chemical name of the substance (residue definition) Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton)Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion)Fentin, expressed as triphenyltin cationHaloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop)Heptachlor and trans-heptachlor epoxide, expressed as heptachlorHexachlorobenzeneNitrofenOmethoateTerbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos) Table 2 Chemical name of the substance Aldrin and dieldrin, expressed as dieldrinEndrin ANNEX IX

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

Chemical name of the substance	Maximum residue level(mg/kg)
Cadusafos	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 X PART A Repealed Directive, with list of its successive amendments(referred to in Article 19) Commission Directive 91/321/EEC (OJ L 175, 4.7.1991, p. 35). Point XI.C.IX.5 of Annex I to the 1994 Act of Accession, p. 212. Commission Directive 96/4/EC (OJ L 49, 28.2.1996, p. 12). Commission Directive 1999/50/EC (OJ L 139, 2.6.1999, p. 29). Commission Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37). Point 1.J.3 of Annex II to the 2003 Act of Accession, p. 93. PART B List of time limits for transposition into national law(referred to in Article 19)

Directive	Time limit for transposition	Permission of trade in products complying with this Directive	Prohibition of trade in products not complying with this Directive
91/321/EEC		1 December 1992	1 June 1994
96/4/EC	31 March 1997	1 April 1997	31 March 1999
1999/50/EC	30 June 2000	30 June 2000	1 July 2002
2003/14/EC	6 March 2004	6 March 2004	6 March 2005

ANNEX XI

CORRELATION TABLE

Directive 91/321/EEC	This Directive
Article 1(1)	Article 1
Article 1(2)	Article 2
Article 2	Article 3
Article 3(1)	Article 5
Article 3(2)	Article 6
Article 3(3)	Article 7(4)
Article 4	Article 7(1) to (3)
Article 5(1), first subparagraph	Article 8(1)
Article 5(1), second subparagraph	Article 8(2) and (3)
Article 5(2)	—
—	Article 9
Article 6(1), first sentence	Article 4
Article 6(1), second sentence	—
Article 6(2)	Article 10(1)
Article 6(3)(a), introductory phrase	Article 10(2), introductory phrase
Article 6(3)(a)(i)	Article 10(2)(a)
Article 6(3)(a)(ii)	Article 10(2)(b)
Article 6(3)(b), first subparagraph	Article 10(3)
Article 6(3)(b), second subparagraph	—
Article 6(3)(c)	Article 10(4)
Article 6(4)	—
Article 7(1), first subparagraph	Article 11
Article 7(1), second subparagraph	Article 12
Article 7(2)(a)	Article 13(1)(a)
Article 7(2)(b)	—
Article 7(2)(c)	Article 13(1)(b)
Article 7(2)(d)	Article 13(1)(c)
Article 7(2)(e)	Article 13(1)(d)
Article 7(2)(f)	Article 13(1)(e)
Article 7(2a)	Article 13(2)
Article 7(3)	Article 13(3)
Article 7(4)	Article 13(4)
Article 7(5)	Article 13(5)
Article 7(6)	Article 13(6)
—	Article 13(7)
Article 7(7)	Article 13(8)
Article 8	Article 14
Article 9	Article 15
Article 10	—
—	Article 16
—	Article 17
—	Article 18
—	Article 19
—	Article 20
Article 11	Article 21
Annexes I to V	Annexes I to V
Annex VI	—
Annex VII	—
—	Annex VI
Annexes VIII to X	Annexes VII to IX
—	Annex X
—	Annex XI

October 28, 2008	annex 3	Amendment
October 28, 2008	annex 6	Amendment

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC Text with EEA relevance

Modified by

Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (Text with EEA relevance)