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            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)

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,

After consulting the European Food Safety Authority (the Authority),

Whereas:

HAS ADOPTED THIS DIRECTIVE:

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:

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 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.

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:

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:

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:

Article 12

The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk proteins are sold, shall be respectively:

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:

2.   The labelling may bear the following particulars:

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:

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:

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:

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:

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:

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.

Done at Brussels, 22 December 2006.

For the Commission

Markos KYPRIANOU            

Member of the Commission

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(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 175, 4.7.1991, p. 35. Directive as last amended by the 2003 Act of Accession.

(3)  See Annex X, Part A.

(4)OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003.

(5)OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2006/92/EC (OJ L 311, 10.11.2006, p. 31).

(6)OJ L 221, 7.8.1986, p. 37. Directive as last amended by Directive 2006/92/EC.

(7)OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2006/62/EC (OJ L 206, 27.7.2006, p. 27).

(8)OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2006/92/EC.

(9)OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(10)OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/85/EC (OJ L 293, 24.10.2006, p. 3).

(11)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) .

(12)OJ L 404, 30.12.2006, p. 9.

(13)OJ L 91, 7.4.1999, p. 29. Directive as amended by the 2003 Act of Accession.

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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

2.   PROTEINS

(Protein content = nitrogen content × 6,25)

2.1   Infant formulae manufactured from cows’ milk proteins

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.

2.2   Infant formulae manufactured from protein hydrolysates

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 proteins

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

5.   LIPIDS

5.1   The use of the following substances shall be prohibited:

5.2   Lauric acid and myristic acid

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.

5.5   Linoleic acid (in the form of glycerides = linoleates)

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:

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

8.   CARBOHYDRATES

8.1   Only the following carbohydrates may be used:

8.2   Lactose

This provision shall not apply to infant formulae in which soya protein isolates represent more than 50 % of the total protein content.

8.3   Sucrose

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.

8.4   Glucose

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).

8.5   Pre-cooked starch and/or gelatinised starch

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 proteins or protein hydrolysates

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 proteins

All requirements of point 10.1 shall apply, except for those concerning iron and phosphorus, which shall be as follows:

11.   VITAMINS

12.   NUCLEOTIDES

The following nucleotides may be added:

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(1)  Infant formulae manufactured from cows’ 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).

(2)  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).

(3)  RE = all trans retinol equivalent.

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

(5)  Preformed niacin.

(6)  α-TE = d-α-tocopherol equivalent.

(7)  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).

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

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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

2.   PROTEINS

(Protein content = nitrogen content × 6,25)

2.1   Follow-on formulae manufactured from cows' milk proteins

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.

2.2   Follow-on formulae manufactured from protein hydrolysates

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 proteins

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

4.1   The use of the following substances shall be prohibited:

4.2   Lauric acid and myristic acid

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.

4.5   Linoleic acid (in the form of glycerides = linoleates)

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:

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

6.1   The use of ingredients containing gluten shall be prohibited.

6.2   Lactose

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

6.3   Sucrose, fructose, honey

Honey shall be treated to destroy spores of Clostridium botulinum.

6.4   Glucose

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 proteins or protein hydrolysates

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 proteins

All requirements of point 8.1 shall apply, except for those concerning iron, and phosphorus, which shall be as follows:

9.   VITAMINS

10.   NUCLEOTIDES

The following nucleotides may be added:

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(1)  RE = all trans retinol equivalent.

(2)  In the form of cholecalciferol, of which10 μg = 400 i.u. of vitamin D.

(3)  Preformed niacin.

(4)  α-TE = d-α-tocopherol equivalent.

(5)  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).

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

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ANNEX III

NUTRITIONAL SUBSTANCES

1.   Vitamins

2.   Mineral substances

3.   Amino acids and other nitrogen compounds

L-cystine and its hydrochloride

L-histidine and its hydrochloride

L-isoleucine and its hydrochloride

L-leucine and its hydrochloride

L-lysine and its hydrochloride

L-cysteine and its hydrochloride

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

L-carnitine and its hydrochloride

L-carnitine-L-tartrate

Taurine

Cytidine 5′-monophosphate and its sodium salt

Uridine 5′-monophosphate and its sodium salt

Adenosine 5′-monophosphate and its sodium salt

Guanosine 5′-monophosphate and its sodium salt

Inosine 5′-monophosphate and its sodium salt

4.   Other nutritional substances

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

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ANNEX IV

NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A CORRESPONDING CLAIM

1.   NUTRITION CLAIMS

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

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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:

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(1)  1 kJ = 0,239 kcal.

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ANNEX VI

Specification for the protein content and source and the processing of protein used in the manufacture of infant 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

2.   Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:

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.

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ANNEX VII

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

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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 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

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ANNEX IX

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

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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).

PART B

List of time limits for transposition into national law

(referred to in Article 19)

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ANNEX XI

CORRELATION TABLE

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