CELEX: 51991FC0321
Language: en
Date: 2006-12-11
Title: Draft Commission Directive ../../EC of […] on infant formulae and follow-on formulae (Codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        C(2004)

                                                                      Draft

                                                          COMMISSION DIRECTIVE ../../EC

                                                                      of […]

                                                    on infant formulae and follow-on formulae

                                                                (Codified version)

                                            ê 91/321/EEC (adapted)

                                                                      Draft

                                                          COMMISSION DIRECTIVE ../../EC

                                                                      of […]

                                                    on infant formulae and follow-on formulae

                                                            (Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive Ö [89/398/EEC] of the European Parliament and of the Council of […] on foodstuffs intended for particular  nutritional
uses Õ[1], and in particular Article 4 Ö (1) Õ thereof,

Whereas:

                                            ê 

(1)   Commission Directive 91/321/EEC of 14 May 1991 on infant  formulae  and  follow-on  formulae[2]  has  been  substantially  amended  several
      times[3]. In the interests of clarity and rationality the said Directive should be codified.

                                            ê 91/321/EEC Recital 1 (adapted)

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

                                            ê 91/321/EEC Recital 2 (adapted)

(3)   On the basis of these data the essential composition of infant formulae and follow-on formulae manufactured from cows'  milk  proteins  and
      soya proteins alone or in a mixture Ö, as well as infant formulae based on protein partial hydrolysates, Õ 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, Ö should Õ therefore be adopted at a later date.

                                            ê 96/4/EC Recital 4 (adapted)

(4)   Ö Infant formulae based on protein partial hydrolysates Õ 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.

                                            ê 91/321/EEC Recital 3 (adapted)

(5)   This Directive reflects current knowledge about the products Ö concerned Õ . Any Ö amendment Õ , to allow innovation  based  on  scientific
      and technical progress, Ö should Õ be decided by the procedure Ö referred to Õ in Article Ö 15(2) Õ of Directive Ö [89/398/EC] Õ.

                                            ê 91/321/EEC Recital 4 (adapted)

(6)   Because of the persons for which the products are intended it will be necessary to lay down microbiological  criteria  and  maximum  levels
      for contaminants. Given the complexity of the subject these Ö should Õ be adopted at a later stage.

                                            ê 1999/50/EC Recital 2 (adapted)

(7)   Different Ö rules Õ on the maximum levels of pesticide residues in Ö the Õ products Ö concerned Õ  cause  trade  barriers  between  certain
      Member States.

                                            ê 1999/50/EC Recital 3 (adapted)

(8)   Maximum levels for pesticide residues stipulated in Council Directive 76/895/EEC of 23 November 1976 relating  to  the  fixing  of  maximum
      levels for pesticide residues in and on fruit and vegetables[4], Ö in Council Directive Õ 86/362/EEC of 24  July  1986  on  the  fixing  of
      maximum levels for pesticide residues in and on cereals[5], Ö in Council Directive Õ 86/363/EEC of 24 July 1986 on the  fixing  of  maximum
      levels for pesticide residues in and on foodstuffs of animal origin[6], and Ö in Council Directive Õ 90/642/EEC of 27 November 1990 on  the
      fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables[7], are  without
      prejudice to specific provisions applicable to infant formulae and follow-on formulae.

                                            ê 1999/50/EC Recital 4

(9)   Taking into account the Community’s international obligations, in cases  where  the  relevant  scientific  evidence  is  insufficient,  the
      precautionary principle allows the Community to provisionally adopt measures on the basis of available pertinent  information,  pending  an
      additional assessment of risk and a review of the measure within a reasonable period of time.

                                            ê 1999/50/EC Recital 5 (adapted)

(10)  On the basis of the two opinions given by the Scientific Committee for Food on 19 September 1997 and 4  June  1998  there  are  at  present
      doubts as to the adequacy of existing acceptable daily intake values (ADI) Ö of pesticides and pesticide residues Õ for the  protection  of
      the health of infants and young children.

                                            ê 1999/50/EC Recital 6 (adapted)

(11)  Therefore, as far as Ö foodstuffs Õ 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.

                                            ê 1999/50/EC Recital 7 (adapted)

(12)  This very low common limit should be fixed at 0.01 mg/kg which Ö normally Õ is in practice the minimum detectable level.

                                            ê 1999/50/EC Recital 8

(13)  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.

                                            ê 2003/14/EC Recital 3 (adapted)

(14)  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 Ö ADI Õ .  This  is  the  case  for  pesticides  or  metabolites  of
      pesticides with an Ö ADI Õ lower than 0.0005 mg/kg body weight.

                                            ê 2003/14/EC Recital 4 (adapted)

(15)  Ö This Directive Õ establishes 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.

                                            ê 2003/14/EC Recital 5

(16)  The health of infants and young children can be better protected by applying additional requirements which  can  be  enforced  by  analysis
      regardless of a product’s origin.

                                            ê 2003/14/EC Recital 6 (adapted)

(17)  Most of the pesticides which have Ö ADI Õ 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 Ö should Õ be followed.

                                            ê 2003/14/EC Recital 7 (adapted)

(18)  Pending Commission Decisions on whether they satisfy the safety requirements of Article 5 of Council Directive 91/414/EEC of 15  July  1991
      concerning the placing of plant protection products on the market[8] the continued use of authorised pesticides should be permitted as long
      as their residues comply with the maximum residue levels established in Ö this Õ Directive. The latter should be  set  at  levels  ensuring
      that their respective Ö ADI Õ values are not exceeded by infants and young children under worst-case intake conditions.

                                            ê 91/321/EEC Recital 5

(19)  Infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first four to  six
      months of life. 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.

                                            ê 91/321/EEC Recital 6 (adapted)

(20)  Pursuant to Article Ö [9] Õ(1) of Directive Ö [89/398/EEC] Õ the products covered by this Directive are subject to the general  rules  laid
      down by Directive Ö 2000/13/EC of the European Parliament and of the Council of 20 March 2000 Õ on the approximation of  the  laws  of  the
      Member States relating to the labelling, presentation and advertising  of  foodstuffs[9].  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.

                                            ê 91/321/EEC Recital 7 (adapted)

(21)  In particular, the nature and destination of the products covered by this Directive require nutritional labelling  Ö showing Õ  the  energy
      value and principal nutrients they contain. On the other hand, the method of use Ö should Õ be specified in Ö accordance Õ with Ö point (9)
      of Õ Article 3(1) and Article Ö 11 Õ(2) of Directive Ö 2000/13/EC Õ , in order to prevent inappropriate uses likely to  be  detrimental  to
      the health of infants. Cf Recital 25 of 96/5.

                                            ê 96/4/EC Recital 1

(22)  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.

                                            ê 91/321/EEC Recital 8 (adapted)

(23)  Pursuant to Article 2(2) of Directive Ö 2000/13/EC Õ , and in order to supply objective and  scientifically  verified  information,  it  is
      necessary to define the conditions under which claims about the particular composition of an infant formula are authorised.

                                            ê 91/321/EEC Recital 9

(24)  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.

                                            ê 91/321/EEC Recital 10

(25)  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.

                                            ê 91/321/EEC Recital 11

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

                                            ê 91/321/EEC Recital 12 (adapted)

(27)  Ö On the provisions liable to affect public health, the consultation in accordance with Article  4  of  Directive  [89/398/EEC]  has  taken
      place. Õ

                                            ê 91/321/EEC Recital 13

(28)  Issues relating to products intended for export to third countries should be dealt with in a coherent and homogeneous manner in a  separate
      measure.

                                            ê 91/321/EEC Recital 14 (adapted)

(29)  The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Ö the  Food  Chain  and  Animal
      Health. Õ

                                            ê 

(30)  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 XI, Part B,

                                            ê 91/321/EEC (adapted)

HAS ADOPTED THIS DIRECTIVE:

                                                                    Article 1

This Directive is a ‘specific Directive’ within the meaning of Article 4 Ö (1) Õ of Directive Ö [89/398/EEC] Õ 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.

                                                                  Ö Article 2 Õ

For the purposes of this Directive, Ö the following definitions shall apply: Õ

(a)   ‘infants’ means children under the age of Ö twelve Õ 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 four  to  six  months  of  life  and
       satisfying by themselves the nutritional requirements of this category of persons;

(d)   ‘follow-on formulae’ means foodstuffs intended for particular nutritional use by  infants  aged  over  four  months  and  constituting  the
       principal liquid element in a progressively diversified diet of this category of persons;

                                            ê 1999/50 Art. 1 pt. 1 (adapted)

(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.

                                            ê 91/321/EEC Art. 2 (adapted)

                                                                    Article 3

Member States shall ensure that the products referred to in Ö points (c) and (d) of Õ Article 2 may be marketed  within  the  Community  only  if
they conform to the definitions and rules laid down in 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 four to  six  months  of
life.

                                            ê 91/321/EEC Art. 3 (adapted)

                                                                    Article 4

1.    Infant formulae shall be manufactured from protein sources defined in Annex Ö I Õ 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.

2.    Follow-on formulae shall be manufactured from protein sources defined in Annex Ö II Õ and other food ingredients as the case may  be  whose
       suitability for particular nutritional use by infants aged over four months has been established by generally accepted scientific data.

3.    The prohibitions and limitations on the use of food ingredients laid down in Annexes I and II shall be observed.

                                            ê 91/321/EEC Art. 4

                                                                    Article 5

1.    Infant formulae must comply with the compositional criteria specified in Annex I.

2.    Follow-on formulae must comply with the compositional criteria specified in Annex II.

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.

                                            ê 91/321/EEC Art. 5 (adapted)

                                                                    Article 6

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:

     – mineral substances,

     – vitamins,

     – amino acids and other nitrogen compounds,

     – other substances having a particular nutritional purpose.

The purity criteria for these substances shall be stipulated at a later stage.

                                            ê 1999/50/EC Art. 1 pt. 2

                                                                    Article 7

                                            ê 2003/14/EC Art. 1 pt. 1 first indent (adapted)

1.    Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the  health  of  infants  and  young
       children. Necessary maximum levels for substances other than those referred to in paragraphs Ö 2, 3 and 4 Õ shall be established.

                                            ê 1999/50/EC Art. 1 pt. 2

2.    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.

                                            ê 2003/14/EC Art. 1 pt. 1 second indent (adapted)

3.    The pesticides listed in Annex IX shall not be used in agricultural products intended for the production of infant formulae  and  follow-on
       formulae.

       However, for the purpose of control:

       Ö (a) Õ    pesticides listed in Table 1 of Annex IX 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;

       Ö (b) Õ    pesticides listed in Table 2 of Annex IX 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.

Ö 4. Õ      By Ö way of Õ derogation Ö from Õ paragraph 2, for the pesticides listed in Annex X, the maximum  residue  levels  specified  therein
       shall apply.

Ö 5.  The levels referred to in paragraphs 3 and 4 shall apply to the products as proposed ready for consumption or  as  reconstituted  according
       to the instructions of the manufacturers. Õ

Ö 6. Õ      For pesticides listed in Annex X, where a Decision concerning the non-inclusion of an  active  substance  in  Annex  I  to  Directive
       91/414/EEC is taken, Annex IX and Annex X to this Directive shall be amended accordingly.

                                            ê 1999/50/EC Art. 1 pt. 2 (adapted)

Ö 7. Õ      Microbiological criteria shall be established as necessary.

                                            ê 91/321/EEC Art. 7 (adapted)

                                                                    Article 8

1.    The name under which the products Ö defined in points (c) and (d) of Õ Article 2 are sold shall be, respectively:

         – Ö in Spanish: Õ

       Ö ‘Preparado para lactantes’ and ‘Preparado de continuación’, Õ

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Czech:

       ‘počáteční kojenecká výživa’ and ‘pokračovací kojenecká výživa’,

                                            ê 91/321/EEC

         – in Danish:

       ‘Modermælkserstatning’ and ‘Tilskudsblanding’,

         – in German:

       ‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’,

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Estonian:

       ‘imiku piimasegu” and “jätkupiimasegu’,

                                            ê 91/321/EEC (adapted)

         – in Greek:

       ‘Παρασκεύασμα για βρέφη’ and ‘Παρασκεύασμα δεύτερης βρεφικής ηλικίας’,

         – Ö in English: Õ

       Ö ‘infant formula’ and ‘follow-on formula’, Õ

         – in French:

       ‘Préparation pour nourrissons’ and ‘Préparation de suite’,

         – in Italian:

       ‘Alimento per lattanti’ and ‘Alimento di proseguimento’,

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Latvian:

       [‘Piena maisījums zīdaiŋiem līdz četru mēnešu vecumam’ and ‘Piena maisījums zīdaiŋiem no četru mēnešu vecumam’,]

         – in Lithuanian:

       ‘mišinys kūdikiams iki 4 – 6 mėn’ and ‘mišinys kūdikiams, vyresniems kaip 4 mėn’,

         – in Hungarian:

       ‘anyatej-helyettesítő tápszer’ and ‘anyatej-kiegészítő tápszer’,

         – in Maltese:

       ‘formula tat-trabi’ and ‘formula tal-prosegwiment’,

                                            ê 91/321/EEC

         – in Dutch:

       ‘Volledige zuigelingenvoeding’ and ‘Opvolgzuigelingenvoeding’,

                                            ê 2003 Act of Accession , Art. 20 and Annex II, p. 93

         – in Polish:

       ‘preparat do początkowego żywienia niemowląt’ and ‘preparat do dalszego żywienia niemowląt’,

                                            ê 91/321/EEC

         – in Portuguese:

       ‘Fórmula para lactentes’ and ‘Fórmula de transição’,

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Slovak:

       ‘počiatočná dojčenská výživa’ and ‘následná dojčenská výživa’.

         – in Slovenian:

       ‘začetna formula za dojenčke’ and ‘nadaljevalna formula za dojenčke’,

                                            ê Act of Accession of AT, FI and SE Art. 29 and Annex I, p. 212

         – in Finnish:

       ‘Äidinmaidonkorvike’ and ‘Vieroitusvalmiste’,

         – in Swedish:

       ‘Modersmjölksersättning’ and ‘Tillskottsnäring’.

                                            ê 91/321/EEC (adapted)

       However, the name of products manufactured entirely from cows' milk proteins, shall be respectively:

         – Ö in Spanish: Õ

       Ö ‘Leche para lactantes’ and ‘Leche de continuación, Õ

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Czech:

       ‘počáteční mléčná kojenecká výživa’ and ‘pokračovací mléčná kojenecká výživa’,

                                            ê 91/321/EEC

         – in Danish:

       ‘Modermælkserstatning udelukkende baseret på mælk’ and ‘Tilskudsblanding udelukkende baseret på mælk’,

         – in German:

       ‘Säuglingsmilchnahrung’ and ‘Folgemilch’,

                                            ê 2003 Act of Accession , Art. 20 and Annex II, p. 93

         – in Estonian:

       ‘Piimal põhinev imiku piimasegu’ and ‘Piimal põhinev jätkupiimasegu’,

                                            ê 91/321/EEC (adapted)

         – in Greek:

       ‘Γάλα για βρέφη’ and ‘Γάλα δεύτερης βρεφικής ηλικίας’,

         – Ö in English: Õ

       Ö ‘Infant milk’ and ‘follow-on milk’, Õ

         – in French:

       ‘Lait pour nourrissons’ and ‘Lait de suite’,

         – in Italian:

       ‘Latte per lattanti’ and ‘Latte di proseguimento’,

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Latvian:

       [‘Piens zīdaiŋiem līdz četru mēnešu vecumam’ and ‘Piens zīdaiŋiem no četru mēnešu vecumam’,]

         – in Lithuanian:

       ‘pieno mišinys kūdikiams iki 4 – 6 mėn’ and ‘pieno mišinys kūdikiams, vyresniems kaip 4 mėn’,

         – in Hungarian:

       ‘tejalapú anyatej-helyettesítő tápszer’ and ‘tejalapú anyatej-kiegészítő tápszer’,

         – in Maltese:

       ‘ħalib tat-trabi’ and ‘ħalib tal-prosegwiment’,

                                            ê 91/321/EEC

         – in Dutch:

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

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93 (adapted)

         – in Polish:

       ‘mleko początkowe’ and ‘mleko następne’,

                                            ê 91/321/EEC

         – in Portuguese:

       ‘Leite para lactentes’ and ‘Leite de transição’,

                                            ê 2003 Act of Accession, Art. 20 and Annex II, p. 93

         – in Slovak:

       ‘počiatočná dojčenská mliečna výživa’ and ‘následná dojčenská mliečna výživa’,

         – in Slovenian:

       ‘začetno mleko za dojenčke’ and ‘nadaljevalno mleko za dojenčke’,

                                            ê Act of Accession of AT, FI and SE Art. 29 and Annex I, p. 212

         – in Finnish:

       ‘Maitopohjainen äidinmaidonkorvike’ and ‘Maitopohjainen vieroitusvalmiste’,

         – in Swedish:

       ‘Modersmjölksersättning uteslutande baserad på mjölk’ and ‘Tillskottsnäring uteslutande baserad på mjölk’.

                                            ê 91/321/EEC (adapted)

2.    The labelling shall bear, in addition  to  those  provided  for  in  Article  3  of  Directive Ö 2002/13/EC Õ  ,  the  following  mandatory
       particulars:

                                            ê 91/321/EEC

       (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 infant formulae that do not contain added iron, a statement to the effect that, when the product is given  to  infants
           over the age of four months, their total iron requirements must be met from other additional sources;

       (c)  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 four months, that it should form only part of a diversified diet  and  that  it  is  not  to  be  used  as  a
           substitute for breast milk during the first four months of life;

                                            ê 96/4/EC Art. 1 pt. 2(a)

       (d)  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;

       (e)  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, carnitine and taurine, expressed in numerical form,  per
           100 ml of the product ready for use;

                                            ê 91/321/EEC

       (f)  in the case of infant formulae and follow-on formulae, instructions for appropriate preparation of the product and a warning  against
           the health hazards of inappropriate preparation.

                                            ê 96/4/EC Art. 1 pt. 2(b) (adapted)

Ö 3. Õ      The labelling may bear:

       (a)  the average quantity of nutrients mentioned in Annex III when such declaration is not covered by the provisions of paragraph 2(e)  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  VIII,  expressed
           as a percentage of the reference values given therein, per 100 ml of the product ready for use, provided that the quantities  present
           are at least equal to 15 per cent of the reference values.

                                            ê 91/321/EEC (adapted)

Ö 4. Õ      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’, or similar  terms  shall  be
       prohibited. The term ‘adapted’ may only be used in conformity with paragraph Ö 7 Õ and Annex IV, point 1.

Ö 5. Õ      The labelling of infant formulae shall in addition bear the  following  mandatory  particulars,  preceded  by  the  words  ‘Important
       Notice’ or their equivalent:

                                            ê 91/321/EEC

       (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.

                                            ê 91/321/EEC (adapted)

Ö 6. Õ      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.

Ö 7. Õ      The labelling may bear claims concerning the special composition of an infant formula only in the cases listed in  Annex  IV  and  in
       accordance with the conditions laid down therein.

Ö 8. Õ      The requirements, prohibitions and restrictions referred to in paragraphs Ö 4 Õ to Ö 7 Õ shall also apply to:

                                            ê 91/321/EEC

       (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.

                                            ê 91/321/EEC Art. 8 (adapted)

                                                                    Article 9

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 Ö 8(4), (5), (6), (7) and (8) Õ(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.

                                            ê 91/321/EEC

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.

                                            ê 91/321/EEC Art. 9

                                                                    Article 10

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, whether manufactured industrially or home-prepared.

       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.

                                            ê 

                                                                    Article 11

Directive 91/321/EEC, as amended by the Acts listed in Annex XI, Part A, is repealed, without prejudice to the obligations of the  Member  States
relating to the time-limits for transposition into national law of the Directives as set out in Annex XI, 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 XII.

                                                                    Article 12

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

                                            ê 91/321/EEC Art. 11

                                                                    Article 13

This Directive is addressed to the Member States.

Done at Brussels, […]

      For the Commission,
      […]
      Member of the Commission

                                            ê 91/321/EEC

                                                                     ANNEX I

                          ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

NB: The values refer to the product ready for use

                                            ê 91/321/EEC (adapted)

1.    Energy

|Minimum                                                 |Maximum                                                            |
|250 kJ Ö /100 ml Õ                                      |315 kJ Ö /100 ml Õ                                                 |
|(60 kcal/100 ml)                                        |(75 kcal/100 ml)                                                   |

                                            ê 96/4/EC Art. 1 pt. 3 and Annex, pt. 1(a)

2.    Protein

       (Protein content = nitrogen content × 6.38) for cows' milk proteins.

       (Protein content = nitrogen content × 6.25) for soya protein isolates and protein partial hydrolysates.

       The ‘chemical index’ shall mean the lowest of the ratios between the quantity of each essential amino acid of the  test  protein  and  the
       quantity of each corresponding amino acid of the reference protein.

2.1   Formulae manufactured from cows' milk proteins

|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 formula must contain an available quantity of each essential and semi-essential 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.

2.2   Formulae manufactured from protein partial hydrolysates

|Minimum                                                 |Maximum                                                            |
|0.56 g/100 kJ                                           |0.7 g/100 kJ                                                       |
|(2.25 g/100 kcal)                                       |(3 g/100 kcal)                                                     |

       For an equal energy value, the formula must contain an available quantity of each essential and semi-essential 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.

       The protein efficiency ratio (PER) and the net protein utilisation (NPU) must be at least equal to those of casein.

       The taurine content shall be equal to at least 10 μmoles/100 kJ (42 μmoles/100 kcal) and the L-carnitine content  shall  be  equal  to  at
       least 1.8 μmoles/100 kJ (7.5 μmoles/100 kcal).

                                            ê 91/321/EEC (adapted)

2.3   Formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins

|Minimum                                                 |Maximum                                                            |
|0.56 g/100 kJ                                           |0.7 g/100 kJ                                                       |
|(Ö 2.25 Õ g/100 kcal)                                   |(3 g/100 kcal)                                                     |

                                            ê 91/321/EEC (adapted)
                                            è1 96/4 Art. 1, pt. 3 and Annex, pt. 1(b)

       Only soya protein isolates must be used in manufacturing these formulae.

       The chemical index shall be equal to at least 80% of that of the reference protein (breast milk, as defined in Annex VI).

       For an equal energy value the formula must contain an available quantity of methionine at least equal to that contained in  the  reference
       protein (breast milk, as defined in Annex V).

       The L-carnitine content shall be at least equal to 1.8 μmoles/100 kJ (7.5 μmoles/100 kcal).

2.4   In all cases, the addition of amino acids Ö shall be Õ permitted solely  for  the  purpose  of  improving  the  nutritional  value  of  the
       proteins, and only in the proportions necessary for that purpose.

3.    Lipids

|è1 Minimum ç                                            |Maximum                                                            |
|è1 1.05 g/100 kJ ç                                      |1.5 g/100 kJ                                                       |
|è1 (4.4 g/100 kcal) ç                                   |(6.5 g/100 kcal)                                                   |

3.1   The use of the following substances Ö shall be Õ prohibited:

         – sesame seed oil,

         – cotton seed oil.

3.2   Lauric acid

|Minimum                                                 |Maximum                                                            |
|—                                                       |15% of the total fat content                                       |

3.3   Myristic acid

|Minimum                                                 |Maximum                                                            |
|—                                                       |15% of the total fat content                                       |

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

|Minimum                                                 |Maximum                                                            |
|70 mg/100 kJ                                            |285 mg/100 kJ                                                      |
|(300 mg/100 kcal)                                       |(1 200 mg/100 kcal)                                                |

                                            ê 96/4/EC Art. 1 pt. 3 and Annex, pt. 1(d)

3.5   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.

3.6   The trans fatty acid content shall not exceed 4% of the total fat content.

3.7   The erucic acid content shall not exceed 1% of the total fat content.

3.8   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)

       The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.

                                            ê 91/321/EEC (adapted)
                                            è1 96/4/EC Art. 1 pt. 3 and Annex pt. 1(e)

4.    Carbohydrates

|Minimum                                                 |Maximum                                                            |
|1.7 g/100 kJ                                            |3.4 g/100 kJ                                                       |
|(7 g/100 kcal)                                          |(14 g/100 kcal)                                                    |

4.1   Only the following carbohydrates may be used:

         – lactose,

         – maltose,

         – sucrose,

         – malto-dextrins,

         – glucose syrup or dried glucose syrup,

|pre-cooked starch                                                   |naturally free of gluten                                            |
|gelatinised starch                                                  |                                                                    |

4.2   Lactose

|Minimum                                                 |Maximum                                                            |
|0.85 g/100 kJ                                           |—                                                                  |
|(3.5 g/100 kcal)                                        |—                                                                  |

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

4.3   Sucrose

|Minimum                                                 |Maximum                                                            |
|—                                                       |20% of the total carbohydrate content                              |

4.4   Pre-cooked starch and/or gelatinized starch

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

5.    Mineral substances

5.1   Formulae manufactured from cows' milk proteins

|                                   |Per 100 kJ                                |Per 100 kcal                              |
|                                   |Minimum              |Maximum              |Minimum              |Maximum              |
|Sodium (mg)                        |5                    |14                   |20                   |60                   |
|Potassium (mg)                     |15                   |35                   |60                   |145                  |
|Chloride (mg)                      |12                   |29                   |50                   |125                  |
|Calcium (mg)                       |12                   |—                    |50                   |—                    |
|Phosphorus (mg)                    |6                    |22                   |25                   |90                   |
|Magnesium (mg)                     |1.2                  |3.6                  |5                    |15                   |
|Iron (mg)1                         |0.12                 |0.36                 |0.5                  |1.5                  |
|Zinc (mg)                          |0.12                 |0.36                 |0.5                  |1.5                  |
|Copper (μg)                        |4.8                  |19                   |20                   |80                   |
|Iodine (μg)                        |1.2                  |—                    |5                    |—                    |
|è1 Selenium2 (μg) ç                |è1 — ç               |è1 0,7 ç             |è1 — ç               |è1 3 ç               |
|1 Limit applicable to formulae with added iron.                                                                           |
|è1 2 Limit applicable to formulae with added selenium. ç                                                                  |

       The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.

5.2   Formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins

       All requirements of paragraph 5.1 Ö shall be Õ applicable except those concerning iron and zinc, which are as follows:

|                                   |Per 100 kJ                                |Per 100 kcal                              |
|                                   |Minimum              |Maximum              |Minimum              |Maximum              |
|Iron (mg)                          |0.25                 |0.5                  |1                    |2                    |
|Zinc (mg)                          |0.18                 |0.6                  |0.75                 |2.4                  |

                                            ê 91/321/EEC (adapted)
                                            è1 96/4/EC Art. 1 pt. 3 and Annex, pt. 1

6.    Vitamins

|                                   |Per 100 kJ                                 |Per 100 kcal                               |
|                                   |Minimum              |Maximum              |Minimum              |Maximum              |
|Vitamin A (μg-RE)1                 |14                   |43                   |60                   |180                  |
|Vitamin D (μg)2                    |0.25                 |0.65                 |1                    |2.5                  |
|Thiamin (μg)                       |10                   |—                    |40                   |—                    |
|Riboflavin (μg)                    |14                   |—                    |60                   |—                    |
|è1 Niacin (mg-NE) Ö 3 Õ ç          |è1 0.2 ç             |è1 — ç               |è1 0.8 ç             |è1 — ç               |
|Pantothenic acid (μg)              |70                   |—                    |300                  |—                    |
|Vitamin B6 (μg)                    |9                    |—                    |35                   |—                    |
|Biotin (μg)                        |0.4                  |—                    |1.5                  |—                    |
|Folic Acid (μg)                    |1                    |—                    |4                    |—                    |
|Vitamin B12 (μg)                   |0.025                |—                    |0.1                  |—                    |
|Vitamin C ( Ö mg Õ )               |1.9                  |—                    |8                    |—                    |
|Vitamin K (μg)                     |1                    |—                    |4                    |—                    |
|Vitamin E (mg α-TE)4               |0.5/g of             |—                    |0.5/g of             |—                    |
|                                   |polyunsaturated fatty|                     |polyunsaturated fatty|                     |
|                                   |acids expressed as   |                     |acids expressed as   |                     |
|                                   |linoleic acid but in |                     |linoleic acid but in |                     |
|                                   |no case less than    |                     |no case less than    |                     |
|                                   |0.1 mg per 100       |                     |0.5 mg per 100       |                     |
|                                   |available kJ         |                     |available kcal       |                     |
|1 RE = all trans retinol equivalent.                                                                                       |
|2 In the form of cholecalciferol, of which 10 μg = 400 i.u. of vitamin D.                                                  |
|3 NE = Niacin equivalent = mg nicotinic acid + mg tryptophan/60.                                                           |
|4 α-TE = d-α- tocopherol equivalent.                                                                                       |

                                            ê 96/4/EC Art. 1 pt. 3 and Annex, pt. 3 (adapted)

7.    Ö Nucleotides Õ

       The following nucleotides may be added:

|                                                       |Maximum1                                                            |
|                                                       |(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                             |
|1 The total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/100 kcal).                                    |

                                                                   ____________

                                            ê 91/321/EEC (adapted)
                                            è1 96/4/EC Art. 1 pt. 3 and Annex pt. 2(a)

                                                                     ANNEX II

                         ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER

NB: The values refer to the product ready for use

1.    Energy

|Minimum                                                 |Maximum                                                            |
|250 kJ/100 ml                                           |335 kJ/100 ml                                                      |
|(60 kcal/100 ml)                                        |(80 kcal/100 ml)                                                   |

2.    Proteins

       (Protein content = nitrogen content × 6.38) for cows' milk proteins.

       (Protein content = nitrogen content × 6.25) for soya protein isolates.

|Minimum                                                 |Maximum                                                            |
|0.5 g/100 kJ                                            |1 g/100 kJ                                                         |
|(2.25 g/100 kcal)                                       |(4.5 g/100 kcal)                                                   |

       The ‘chemical index’ of the proteins present shall be at least equal to 80% of that of the reference protein (casein è1 or breast milk ças
       defined in Annex VI).

       The ‘chemical index’ shall mean the lowest of the ratios between the quantity of each essential amino acid of the  test  protein  and  the
       quantity of each corresponding amino acid of the reference protein.

       For follow-on formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins, only protein  isolates  from  soya
       may be used.

       Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of  the  proteins,  in  the  proportions
       necessary for that purpose.

       è1 For an equal energy value, these formulae must contain an available quantity of methionine at least equal to that contained  in  breast
       milk as defined in Annex V. ç

3.    Lipids

|Minimum                                                 |Maximum                                                            |
|0.8 g/100 kJ                                            |1.5 g/100 kJ                                                       |
|(3.3 g/100 kcal)                                        |(6.5 g/100 kcal)                                                   |

3.1   The use of the following substances Ö shall be Õ prohibited:

         – sesame seed oil,

         – cotton seed oil.

3.2   Lauric acid

|Minimum                                                 |Maximum                                                            |
|—                                                       |15% of the total fat content                                       |

3.3   Myristic acid

|Minimum                                                 |Maximum                                                            |
|—                                                       |15% of the total fat content                                       |

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

|Minimum                                                 |Maximum                                                             |
|70 mg/100 kJ                                            |—                                                                   |
|(300 mg/100 kcal):                                      |                                                                    |
|this limit Ö shall apply Õ only to follow-on formulae   |                                                                    |
|containing vegetable oils                               |                                                                    |

                                            ê 96/4/EC Art. 1 pt. 3 and Annex, pt. 2(c)

3.5   The trans fatty acid content shall not exceed 4% of the total fat content.

3.6   The erucic acid content shall not exceed 1% of the total fat content.

                                            ê 91/321/EEC (adapted)

4.    Carbohydrates

|Minimum                                                 |Maximum                                                            |
|1.7 g/100 kJ                                            |3.4 g/100 kJ                                                       |
|(7 g/100 kcal)                                          |(14 g/100 kcal)                                                    |

4.1   The use of ingredients containing gluten Ö shall be Õ prohibited.

4.2   Lactose

|Minimum                                                 |Maximum                                                            |
|0.45 g/100 kJ                                           |—                                                                  |
|(1.8 g/100 kcal)                                        |                                                                   |

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

4.3   Sucrose, fructose, honey

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

5.    Mineral substances

5.1

|                                     |Per 100 kJ                               |Per 100 kcal                             |
|                                     |Minimum             |Maximum             |Minimum             |Maximum             |
|Iron (mg)                            |0.25                |0.5                 |1                   |2                   |
|Iodine (μg)                          |1.2                 |—                   |5                   |—                   |

5.2   Zinc

5.2.1 Follow-on formulae manufactured entirely from cows' milk

|Minimum                                                 |Maximum                                                            |
|0.12 mg/100 kJ                                          |—                                                                  |
|(0.5 mg/100 kcal)                                       |                                                                   |

5.2.2 Follow-on formulae containing soya protein isolates, or mixed with cows' milk

|Minimum                                                 |Maximum                                                            |
|0.18 mg/100 kJ                                          |—                                                                  |
|(0.75 mg/100 kcal)                                      |                                                                   |

5.3   Other mineral substances

                                            ê 91/321/EEC (adapted)

       The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the  protein
       concentration of the follow-on formulae to that of cows’ milk. The typical composition of cows’ milk is given, for guidance, in Annex VII.

                                            ê 91/321/EEC

5.4   The calcium/phosphorus ratio shall not exceed 2.0.

                                            ê 91/321/EEC (adapted)

6.    Vitamins

|                                     |Per 100 kJ                                |Per 100 kcal                              |
|                                     |Minimum              |Maximum              |Minimum              |Maximum              |
|Vitamin A (μg-RE)1                   |14                   |43                   |60                   |180                  |
|Vitamin D (μg)2                      |0.25                 |0.75                 |1                    |3                    |
|Vitamin C (Ö mg Õ )                  |1.9                  |—                    |8                    |—                    |
|Vitamin E (mg α-TE)3                 |0.5/g polyunsaturated|—                    |0.5/g polyunsaturated|—                    |
|                                     |fatty acids expressed|                     |fatty acids expressed|                     |
|                                     |as linoleic acid but |                     |as linoleic acid but |                     |
|                                     |in no case less than |                     |in no case less than |                     |
|                                     |0.1 mg per 100       |                     |0.5 mg per 100       |                     |
|                                     |available kJ         |                     |available kcal       |                     |
|1 RE = all trans retinol equivalent.                                                                                       |
|2 In the form of cholecalciferol, of which10 μg = 400 i.u. of vitamin D.                                                   |
|3 α-TE = d-α-tocopherol equivalent.                                                                                        |

                                            ê 96/4/EC Art. 1 pt. 3 and Annex pt. 3 (adapted)

7.    Ö Nucleotides Õ

       Ö The following nucleotides may be added: Õ

|                                                    |Maximum1                                                             |
|                                                    |(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                              |
|1 The total concentration of nucleotides shall not exceed 1.2 mg/100 kJ (5 mg/100 kcal).                                  |

                                                                   ____________

                                            ê 91/321/EEC (adapted)

                                                                    ANNEX III

                                                              NUTRITIONAL SUBSTANCES

                                                                   1. Vitamins

|Vitamin                           |Vitamin formulation                                                                                   |
|Vitamin A                         |Retinyl acetate                                                                                       |
|                                  |Retinyl palmitate                                                                                     |
|                                  |Beta-carotene                                                                                         |
|                                  |Retinol                                                                                               |
|Vitamin D                         |Vitamin D2 (ergocalciferol)                                                                           |
|                                  |Vitamin D3 (cholecalciferol)                                                                          |
|Vitamin B1                        |Ö Thiamin Õ hydrochloride                                                                             |
|                                  |Ö Thiamin Õ mononitrate                                                                               |
|Vitamin B2                        |Riboflavin                                                                                            |
|                                  |Riboflavin-5′-phosphate, sodium                                                                       |
|Niacin                            |Nicotinamide                                                                                          |
|                                  |Nicotinic acid                                                                                        |
|Vitamin B6                        |Pyridoxine hydrochloride                                                                              |
|                                  |Pyridoxine-5′-phosphate                                                                               |
|Folate                            |Folic acid                                                                                            |
|Pantothenic acid                  |D-pantothenate, calcium                                                                               |
|                                  |D-pantothenate, sodium                                                                                |
|                                  |Dexpanthenol                                                                                          |
|Vitamin B12                       |Cyanocobalamin                                                                                        |
|                                  |Hydroxocobalamin                                                                                      |
|Biotin                            |D-biotin                                                                                              |
|Vitamin C                         |L-ascorbic acid                                                                                       |
|                                  |Sodium L-ascorbate                                                                                    |
|                                  |Calcium L-ascorbate                                                                                   |
|                                  |6-palmityl-L-ascorbic acid (ascorbyl palmitate)                                                       |
|                                  |Potassium ascorbate                                                                                   |
|Vitamin E                         |D-alpha tocopherol                                                                                    |
|                                  |DL-alpha tocopherol                                                                                   |
|                                  |D-alpha tocopherol acetate                                                                            |
|                                  |DL-alpha tocopherol acetate                                                                           |
|Vitamin K                         |Phylloquinone (Phytomenadione)                                                                        |

                                            ê 91/321/EEC (adapted)
                                            è1 96/4/EC Art. 1 pt. 3 and Annex pt. 4(a)

                                                              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)                                                             |
|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                                                                                   |
|è1 Selenium ç                     |è1 Sodium selenate                                                                                    |
|Ö (Se) Õ                          |Sodium selenite ç                                                                                     |

                                                   3. Amino acids and other nitrogen compounds

L-arginine and its hydrochloride

L-cystine and its hydrochloride

L-histidine and its hydrochloride

L-isoleucine and its hydrochloride

L-leucine and its hydrochloride

                                            ê 91/321/EEC (adapted)

L- Ö lysine Õ and its hydrochloride

                                            ê 91/321/EEC

L-cysteine and its hydrochloride

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

L-carnitine and its hydrochloride

Taurine

                                            ê 96/4/EC Art. 1 pt. 3 and Annex, pt. 4(b)

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

                                            ê 91/321/EEC

                                                                    4. Others

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

                                                                   ____________

                                            ê 91/321/EEC (adapted)
                                            è1 96/4/EC Art. 1 pt. 3 and Annex pt. 5

                                                                     ANNEX IV

                                   COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM

|Claim related to                             |Conditions warranting the claim                                                            |
|1. Adapted protein                           |The protein content is lower than 0.6 g/100 kJ (2.5 g/100 kcal) and the whey protein/casein|
|                                             |ratio is not less than 1.0.                                                                |
|2. Low sodium                                |The sodium content is lower than 9 mg/100 kJ (39 mg/100 kcal).                             |
|3. Sucrose free                              |No sucrose is present.                                                                     |
|4. Lactose only                              |Lactose is the only carbohydrate present.                                                  |
|5. Lactose free                              |No lactose is present1.                                                                    |
|6. Iron enriched                             |Iron is added.                                                                             |
|è1 7. Reduction of risk to allergy to milk   |è1 (a) The formulae shall satisfy the provisions laid down in Section 2.2 of Annex I and   |
|proteins. This claim may include terms       |the amount of immunoreactive protein measured with methods gererally acceptable as         |
|referring to reduced allergen Ö or Õ reduced |appropriate shall be less than 1% of nitrogen containing substances in the formulae;       |
|antigen properties. ç                        |(b) The label shall indicate that the product must not be consumed by infants allergic to  |
|                                             |the intact proteins from which it is made unless generally accepted clinical tests provide |
|                                             |proof of the formulae's tolerance in more than 90% of infants (confidence interval 95%)    |
|                                             |hypersensitive to proteins from which the hydrolysate is made;                             |
|                                             |(c) The formulae administered orally should not induce sensitization, in animals, to the   |
|                                             |intact proteins from which the formulae are derived;                                       |
|                                             |(d) Objective and scientifically verified data as proof to the claimed properties must be  |
|                                             |available. ç                                                                               |
|1 When determined by a method the detection limits of which will be established at a later stage.                                        |

                                                                   ____________

                                            ê 91/321/EEC (adapted)

                                                                     ANNEX V

                                             ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK

For the purpose of this Ö Directive Õ , the essential and semi-essential amino acids in breast milk, expressed in mg  per  100 kJ  and  100 kcal,
Ö shall be Õ the following:

|                                                |Per 100 kJ1                               |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                                        |
|1 1 kJ = 0.239 kcal.                                                                                                                  |

                                                                   ____________

                                                                     ANNEX VI

                                             AMINO ACID COMPOSITION OF CASEIN AND BREAST MILK PROTEIN

                                          The amino acid composition of casein and breast milk protein:

|(g/100 g of protein)                                                                                                                  |
|                                                |Casein1                                   |Breast milk1                              |
|Arginine                                        |3.7                                       |3.8                                       |
|Cystine                                         |0.3                                       |1.3                                       |
|Histidine                                       |2.9                                       |2.5                                       |
|Isoleucine                                      |54                                        |4.0                                       |
|Leucine                                         |9.5                                       |8.5                                       |
|Lysine                                          |8.1                                       |6.7                                       |
|Methionine                                      |2.8                                       |1.6                                       |
|Phenylalanine                                   |5.2                                       |3.4                                       |
|Threonine                                       |4.7                                       |4.4                                       |
|Tryptophan                                      |1.6                                       |1.7                                       |
|Tyrosine                                        |5.8                                       |3.2                                       |
|Valine                                          |6.7                                       |4.5                                       |
|1 Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383.           |

                                                                   ____________

                                                                    ANNEX VII

                                                        THE MINERAL ELEMENTS IN COWS’ MILK

   As a reference, the contents of mineral elements in cows' milk expressed per 100 g of solids-non-fat and per g of proteins Ö shall be Õ the
                                                                    following:

|                                                |Per 100 g SNF1                            |Per g of proteins                         |
|Sodium (mg)                                     |550                                       |15                                        |
|Potassium (mg)                                  |1680                                      |43                                        |
|Chloride (mg)                                   |1050                                      |28                                        |
|Calcium (mg)                                    |1350                                      |35                                        |
|Phosphorus (mg)                                 |1070                                      |28                                        |
|Magnesium (mg)                                  |135                                       |3.5                                       |
|Copper (μg)                                     |225                                       |6                                         |
|Iodine                                          |NS2                                       |NS                                        |
|1 SNF: ‘solids no fats’.                                                                                                              |
|2 NS: non-specified, varies widely according to season and stock farming conditions.                                                  |

                                                                   ____________

                                            ê 96/4/EC Art. 1 pt. 3 and Annex, pt. 6

                                                                    ANNEX VIII

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

|Nutrient                                                           |Labelling reference value                                          |
|Vitamin A                                                          |(μg) 400                                                           |
|Vitamin D                                                          |(μg) 10                                                            |
|Vitamin C                                                          |(mg) 25                                                            |
|Thiamin                                                            |(mg) 0.5                                                           |
|Riboflavin                                                         |(mg) 0.8                                                           |
|Niacin equivalents                                                 |(mg) 9                                                             |
|Vitamin B6                                                         |(mg) 0.7                                                           |
|Folate                                                             |(μg) 100                                                           |
|Vitamin B12                                                        |(μg) 0.7                                                           |
|Calcium                                                            |(mg) 400                                                           |
|Iron                                                               |(mg) 6                                                             |
|Zinc                                                               |(mg) 4                                                             |
|Iodine                                                             |(μg) 70                                                            |
|Selenium                                                           |(μg) 10                                                            |
|Copper                                                             |(mg) 0.4                                                           |

                                                                   ____________

                                            ê 2003/14/EC Art. 1 pt. 2 (adapted)

                                                                     ANNEX IX

       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                                                                                                                                  |

                                                                   ____________

                                            ê 2003/14/EC Art. 1 pt. 3 (adapted)

                                                                     ANNEX X

               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,  |0.006                                            |
|expressed as demeton-S-methyl)                                                          |                                                 |
|Ethoprophos                                                                             |0.008                                            |
|Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)               |0.004                                            |
|Propineb/propylenethiourea (sum of propineb and propylenethiourea)                      |0.006                                            |

                                                                   ____________

                                            é

                                                                     ANNEX XI

                                                                      Part A

                                                Repealed Directive, with its successive amendments
                                                           (referred to in Article 11)

|Commission Directive 91/321/EEC[10]                                          |(OJ L 175, 4.7.1991, p. 35)                                 |
|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)                          |

                                                                      Part B

                                             List of time limits for transposition into national law
                                                           (referred to in Article 11)

|Directive                         |Time limit for transposition      |Permission of trade in products   |Prohibition of trade in products  |
|                                  |                                  |complying with this Directive     |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 XII

                                                                Correlation Table

|Directive 91/321/EEC                                                |This Directive                                                      |
|Article 1(1)                                                        |Article 1                                                           |
|Article 1(2)                                                        |Article 2                                                           |
|Article 2                                                           |Article 3                                                           |
|Article 3                                                           |Article 4                                                           |
|Article 4                                                           |Article 5                                                           |
|Article 5(1)                                                        |Article 6                                                           |
|Article 5(2)                                                        |—                                                                   |
|Article 6(1) and (2)                                                |Article 7(1) and (2)                                                |
|Article 6(3)(a), introductory phrase                                |Article 7(3), introductory phrase                                   |
|Article 6(3)(a)(i)                                                  |Article 7(3)(a)                                                     |
|Article 6(3)(a)(ii)                                                 |Article 7(3)(b)                                                     |
|Article 6(3)(b), first subparagraph                                 |Article 7(4)                                                        |
|Article 6(3)(b), second subparagraph                                |Article 7(6)                                                        |
|Article 6(3)(c)                                                     |Article 7(5)                                                        |
|Article 6(4)                                                        |Article 7(7)                                                        |
|Article 7(1) and (2)                                                |Article 8(1) and (2)                                                |
|Article 7(2a)                                                       |Article 8(3)                                                        |
|Article 7(3)                                                        |Article 8(4)                                                        |
|Article 7(4)                                                        |Article 8(5)                                                        |
|Article 7(5)                                                        |Article 8(6)                                                        |
|Article 7(6)                                                        |Article 8(7)                                                        |
|Article 7(7)                                                        |Article 8(8)                                                        |
|Article 8                                                           |Article 9                                                           |
|Article 9                                                           |Article 10                                                          |
|Article 10                                                          |—                                                                   |
|—                                                                   |Article 11                                                          |
|—                                                                   |Article 12                                                          |
|Article 11                                                          |Article 13                                                          |
|Annexes I to X                                                      |Annexes I to X                                                      |
|—                                                                   |Annex XI                                                            |
|—                                                                   |Annex XII                                                           |

                                                                   ____________

                                                             -----------------------
[1]   Ö OJ L […], […], p. […] Õ.
[2]   OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).
[3]   See Annex XI, Part A.
[4]   OJ L 340, 9.12.1976, p. 26. Ö Directive as last amended by Commission Directive 2003/118/EC (OJ L 327, 16.12.2003, p. 25). Õ
[5]   OJ L 221, 7.8.1986, p. 37. Ö Directive as last amended by Commission Directive 2004/2/EC (OJ L 14, 21.1.2004, p. 10). Õ
[6]   OJ L 221, 7.8.1986, p. 43. Ö Directive as last amended by Directive 2004/2/EC. Õ
[7]   OJ L 350, 14.12.1990, p. 71. Ö Directive as last amended by Directive 2004/2/EC. Õ
[8]   OJ L 230, 19.8.1991, p. 1. Ö Directive as last amended by Commission Directive 2003/119/EC (OJ L 325, 12.12.2003, p. 41). Õ
[9]   Ö 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) Õ.
[10]  Directive 91/321/EEC was also amended by the following non-repealed Acts:
      - Act of Accession of Austria, Finland and Sweden;
      - 2003 Act of Accession.