(1)

Directive 89/398/EEC concerns foodstuffs intended for particular nutritional uses. The specific provisions applicable to certain groups of foods for particular nutritional uses are laid down by specific Directives.

(2)

Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (2) is a specific Directive adopted pursuant to Directive 89/398/EEC. That Directive has been substantially amended several times (3). Since further amendments are to be made, it should be recast in the interests of clarity.

(3)

In the light of discussions in international fora, in particular Codex Alimentarius, in relation to the timing of the introduction of complementary foods into the diet of infants, it is appropriate to amend the current definitions of infant formulae and follow-on formulae and certain provisions on the labelling of follow-on formulae in Directive 91/321/EEC.

(4)

Infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first months of life until the introduction of appropriate complementary feeding. In order to safeguard the health of such infants it is necessary to ensure that the only products marketed as suitable for such use during the period would be infant formulae.

(5)

The essential composition of infant formulae and follow-on formulae must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data.

(6)

The requirements concerning the essential composition of infant formulae and follow-on formulae should include detailed provisions on the protein content. Notwithstanding that traditionally different appropriate conversion factors have been used for the calculation of the protein content from the nitrogen content of different protein sources, recent scientific advice indicates that for the specific purposes of calculating the protein content of infant formulae and follow-on formulae it is appropriate to use a single conversion factor adapted to these products. As infant formulae and follow-on formulae are sophisticated products that are specially formulated for their intended purpose, additional essential requirements on protein, including minimum and maximum levels of protein and minimum levels of certain amino acids, should be established. The protein requirements specified in this Directive should relate to the final products as such, prepared ready for consumption.

(7)

On the basis of such data, the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture, as well as infant formulae based on protein hydrolysates, can already be defined. The same is not true for preparations based wholly or partly on other sources of protein. For this reason specific rules for such products, if necessary, should be adopted at a later date.

(8)

It is important that ingredients used in the manufacture of infant formulae and follow-on formulae are suitable for the particular nutritional use by infants and that their suitability has been demonstrated, when necessary, by appropriate studies. Guidance on the design and conduct of appropriate studies has been published by expert scientific groups such as the Scientific Committee on Food, the UK Committee on the Medical Aspects of Food and Nutrition Policy, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Such guidance should be taken into consideration when ingredients are introduced into infant formulae or follow-on formulae.

(9)

A number of the substances that may be used in the manufacture of infant formulae and follow-on formulae may also be used in foodstuffs as food additives. In that context, purity criteria have already been or are to be adopted at Community level in accordance with Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (4). Those purity criteria should apply to those substances whatever the purpose of their use in foodstuffs.

(10)

Pending the adoption of purity criteria for substances for which such criteria have not yet been adopted at Community level, and in order to ensure a high level of protection for public health, generally acceptable purity criteria recommended by international organisations or agencies, such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) or European Pharmacopoeia (EUP), should apply. In addition, Member States should be permitted to maintain national rules setting stricter purity criteria.

(11)

Given the particular nature of infant formula, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.

(12)

Infant formulae based on protein hydrolysates are distinct from semi-elemental diet products based on high degree hydrolysates used for the dietary management of diagnosed medical conditions, which are not covered by this Directive.

(13)

This Directive reflects current knowledge about the products concerned. Any amendment, to allow innovation based on scientific and technical progress, should be decided by the procedure referred to in Article 13(2) of Directive 89/398/EEC.

(14)

Maximum levels for pesticide residues set out in relevant Community legislation, in particular 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 (5), in Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (6), 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 (7), 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 (8), should apply without prejudice to specific provisions set out in this Directive.

(15)

Taking into account the Community’s international obligations, in cases where the relevant scientific evidence is insufficient, the precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (9) 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.

(16)

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 (ADI) values 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. This very low common limit should be fixed at 0,01 mg/kg which normally is in practice the minimum detectable level.

(17)

Severe limitations on pesticide residues should be required. With careful selection of raw materials, and given that infant formulae and follow-on formulae 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.

(18)

This Directive should establish the principle of the prohibition of the use of these pesticides in the production of agricultural products intended for infant formulae and follow-on formulae. 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.

(19)

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 infant formulae and follow-on formulae by state-of-the-art analytical methods. However, some pesticides degrade slowly and still contaminate the environment. They might be present in infant formulae and follow-on formulae even if they have not been used. For the purposes of control, a harmonised approach should be followed.

(20)

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 (10), 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.

(21)

The Annexes to this Directive dealing with pesticides should be amended following the completion of the review programme being carried out under Directive 91/414/EEC.

(22)

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 (11). This Directive adopts and expands upon the additions and exceptions to those general rules, where it is appropriate, in order to promote and protect breast feeding.

(23)

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(2) of Directive 2000/13/EC, in order to prevent inappropriate uses likely to be detrimental to the health of infants.

(24)

Given the nature of infant formulae and follow-on formulae the detailed rules as to nutrient declaration on the labelling need to be clarified in order to avoid any problems which may arise from the application of other relevant Community legislation.

(25)

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on food (12) establishes the rules and conditions for the use of nutrition and health claims concerning foods. However, Article 1(5) of that Regulation states that it shall apply without prejudice to, in particular, Directive 89/398/EEC and directives adopted relating to foodstuffs for particular nutritional uses.

(26)

It is appropriate to set out specific conditions for the use of nutrition and health claims concerning infant formulae in this Directive. In this respect, it is necessary, in order to supply objective and scientifically verified information, to define the conditions under which nutrition and health claims are authorised, and to establish a list of authorised claims. In accordance with the third subparagraph of Article 4(1) of Directive 89/398/EEC, modification of that list of nutrition and health claims should be adopted, when necessary, after consultation of the Authority.

(27)

In an effort to provide better protection for the health of infants, the rules of composition, labelling and advertising laid down in this Directive should be in conformity with the principles and the aims of the International Code of Marketing of Breast-milk Substitutes adopted by the 34th World Health Assembly, bearing in mind the particular legal and factual situations existing in the Community.

(28)

Given the important role which information on infant feeding plays in choosing, by pregnant women and mothers of infants, the type of nourishment provided to their children, it is necessary for Member States to take appropriate measures in order that this information ensures an adequate use of the products in question and is not counter to the promotion of breast feeding.

(29)

This Directive does not concern the conditions of sale of publications specialising in baby care and of scientific publications.

(30)

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (13) lays down compositional and labelling requirements for dietary foods for special medical purposes. The Annex to that Directive sets out values for minerals in nutritionally complete foods intended for use by infants. There has been new scientific advice as regards the minimum level of manganese in foods intended for infants. Therefore, it is appropriate to amend the levels of manganese in dietary foods for special medical purposes intended for infants set out in that Annex. Directive 1999/21/EC should therefore be amended accordingly.

(31)

Due to the specific nature of dietary foods for special medical purposes intended for infants and to the necessity to assess the new formulation of such products, manufacturers require a longer period to adapt their products to the essential composition that derive from the new requirements set out in this Directive.

(32)

The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.

(33)

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 X, Part B.

(34)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(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.

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in Bulgarian: ‘храни за кърмачета’ and ‘преходни храни’,

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in Spanish: ‘Preparado para lactantes’ and ‘Preparado de continuación’,

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in Czech: ‘počáteční kojenecká výživa’ and ‘pokračovací kojenecká výživa’,

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in Danish: ‘Modermælkserstatning’ and ‘Tilskudsblanding’,

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in German: ‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’,

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in Estonian: ‘imiku piimasegu’ and ‘jätkupiimasegu’,

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in Greek: ‘Παρασκεύασμα για βρέφη’ and ‘Παρασκεύασμα δεύτερης βρεφικής ηλικίας’,

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in English: ‘infant formula’ and ‘follow-on formula’,

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in French: ‘Préparation pour nourrissons’ and ‘Préparation de suite’,

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in Italian: ‘Alimento per lattanti’ and ‘Alimento di proseguimento’,

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in Latvian: ‘Mākslīgais maisījums zīdaiņiem’ un ‘Mākslīgais papildu ēdināšanas maisījums zīdaiņiem’,

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in Lithuanian: ‘mišinys kūdikiams iki papildomo maitinimo įvedimo’ and ‘mišinys kūdikiams, įvedus papildomą maitinimą’,

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in Hungarian: ‘anyatej-helyettesítő tápszer’ and ‘anyatej-kiegészítő tápszer’,

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in Maltese: ‘formula tat-trabi’ and ‘formula tal-prosegwiment’,

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in Dutch: ‘Volledige zuigelingenvoeding’ and ‘Opvolgzuigelingenvoeding’,

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in Polish: ‘preparat do początkowego żywienia niemowląt’ and ‘preparat do dalszego żywienia niemowląt’,

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in Portuguese: ‘Fórmula para lactentes’ and ‘Fórmula de transição’,

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in Romanian: ‘preparate pentru sugari’ and ‘preparate pentru copii de vârstă mică’,

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in Slovak: ‘počiatočná dojčenská výživa’ and ‘následná dojčenská výživa’.

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in Slovenian: ‘začetna formula za dojenčke’ and ‘nadaljevalna formula za dojenčke’,

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in Finnish: ‘Äidinmaidonkorvike’ and ‘Vieroitusvalmiste’,

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in Swedish: ‘Modersmjölksersättning’ and ‘Tillskottsnäring’.

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in Bulgarian: ‘млека за кърмачета’ and ‘преходни млека’,

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in Spanish: ‘Leche para lactantes’ and ‘Leche de continuación’,

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in Czech: ‘počáteční mléčná kojenecká výživa’ and ‘pokračovací mléčná kojenecká výživa’,

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in Danish: ‘Modermælkserstatning udelukkende baseret på mælk’ and ‘Tilskudsblanding udelukkende baseret på mælk’,

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in German: ‘Säuglingsmilchnahrung’ and ‘Folgemilch’,

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in Estonian: ‘Piimal põhinev imiku piimasegu’ and ‘Piimal põhinev jätkupiimasegu’,

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in Greek: ‘Γάλα για βρέφη’ and ‘Γάλα δεύτερης βρεφικής ηλικίας’,

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in English: ‘infant milk’ and ‘follow-on milk’,

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in French: ‘Lait pour nourrissons’ and ‘Lait de suite’,

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in Italian: ‘Latte per lattanti’ and ‘Latte di proseguimento’,

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in Latvian: ‘Mākslīgais piena maisījums zīdaiņiem’ un ‘Mākslīgais papildu ēdināšanas piena maisījums zīdaiņiem’,

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in Lithuanian: ‘pieno mišinys kūdikiams iki papildomo maitinimo įvedimo’ and ‘pieno mišinys kūdikiams įvedus papildomą maitinimą’,

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in Hungarian: ‘tejalapú anyatej-helyettesítő tápszer’ and ‘tejalapú anyatej-kiegészítő tápszer’,

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in Maltese: ‘ħalib tat-trabi’ and ‘ħalib tal-prosegwiment’,

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in Dutch: ‘Volledige zuigelingenvoeding op basis van melk’ or ‘Zuigelingenmelk’ and ‘Opvolgmelk’,

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in Polish: ‘mleko początkowe’ and ‘mleko następne’,

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in Portuguese: ‘Leite para lactentes’ and ‘Leite de transição’,

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in Romanian: ‘lapte pentru sugari’ and ‘lapte pentru copii de vârstă mică’;

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in Slovak: ‘počiatočná dojčenská mliečna výživa’ and ‘následná dojčenská mliečna výživa’,

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in Slovenian: ‘začetno mleko za dojenčke’ and ‘nadaljevalno mleko za dojenčke’,

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in Finnish: ‘Maitopohjainen äidinmaidonkorvike’ and ‘Maitopohjainen vieroitusvalmiste’,

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in Swedish: ‘Modersmjölksersättning uteslutande baserad på mjölk’ and ‘Tillskottsnäring uteslutande baserad på mjölk’.

(1)

Regulation (EC) No 21/2004 provides that each Member State is to establish a system for the identification and registration of ovine and caprine animals in accordance with that Regulation.

(2)

Regulation (EC) No 21/2004 also provides that all animals on a holding born after 9 July 2005 are to be identified by two means of identification. The first means of identification are eartags and the second means of identification are set out in point 4 of Section A of the Annex to that Regulation. One of the second means of identification is an electronic transponder. In addition, Article 9 of Regulation (EC) No 21/2004 provides that, as from 1 January 2008 or another date that may be fixed by the Council, electronic identification as a second means of identification is to be obligatory for all animals.

(3)

Regulation (EC) No 21/2004 provides for the adoption by the Commission of guidelines and procedures for the implementation of the electronic identification in order to improve its implementation. Those guidelines and procedures should be applied for those animals for which electronic identification is already used as the second means of identification and for all animals as from the date provided for in Article 9(3) of that Regulation.

(4)

In order to ensure that the identifiers to be applied to ovine and caprine animals for the purpose of Regulation (EC) No 21/2004 are readable in all Member States, minimum requirements concerning certain conformance and performance tests should be laid down in this Decision for the approval of identifiers.

(5)

In order to provide guidance to the Member States as regards readers, minimum requirements concerning certain conformance and performance tests should be laid down in this Decision taking into account that Regulation (EC) No 21/2004 does not foresee that every operator must possess a reader.

(6)

Due to the different geographic conditions and husbandry systems under which ovine and caprine animals are kept in the Community, the Member States should have the possibility to require additional performance tests taking into account their specific national conditions.

(7)

The International Organization for Standardization (ISO) has published standards dealing with aspects of radio frequency identification (RFID) of animals. In addition, the International Committee on Animal Recording (ICAR) has developed procedures aimed to verify the compliance of certain RFID characteristics with ISO standards. Those procedures have been published in the International Agreement on Recording Practices in the version as approved by the ICAR General Assembly, June 2004. The ISO standards are accepted and used internationally and should therefore be taken into account in this Decision.

(8)

The Joint Research Centre (JRC) of the Commission has developed Technical Guidelines specifying tests for assessing the performance and reliability of RFID devices that are published on the JRC website as JRC technical standards. The essential elements of those guidelines should be taken into account in this Decision.

(9)

The European Committee for Standardisation (CEN) has published technical standards dealing with the accreditation of test laboratories. Those standards (EN standards) are accepted and used internationally and should therefore be taken into account in this Decision.

(10)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

for the second means of identification, as provided for in Article 4(2)(b) of Regulation (EC) No 21/2004 and referred to in the fourth indent of point 4 of Section A of the Annex to that Regulation; and

(b)

provided for in the first subparagraph of Article 9(3) of Regulation (EC) No 21/2004.