CELEX: 51984PC0703
Language: en
Date: 1984-12-14
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO INFANT FORMULAE AND FOLLOW-UP MILKS

30.1.85                                 Official Journal of the European Communities                            No C 28/3
                                                               II
                                                       (Preparatory Acts)
                                                  COMMISSION
             Proposal for a Council Directive on the approximation of the laws of the Member States
                                       relating to infant formulae and follow-up milks
                                                      COM(84) 703 final
                           (Submitted by the Commission to the Council on 4 January 1985)
                                                         (85/C 28/05)
THE COUNCIL OF THE EUROPEAN                                        cows' milk proteins can already be defined; whereas
COMMUNITIES,                                                       the same is not true for preparations based wholly or
                                                                   partly on other sources of protein; whereas specific
                                                                   rules for such products will therefore have to be
Having regard to the Treaty establishing the
                                                                   adopted at a later date;
European Economic Community, and in particular
Article 100 thereof,
                                                                   Whereas follow-up milks currently sold in the
Having regard to Council Directive 77/94/EEC of 21                 Community are manufactured exclusively from cows'
December 1976 on the approximation of the laws of                  milk; whereas the scope of this Directive should
the Member States relating to foodstuffs for                       therefore be restricted to that type of product for the
particular nutritional uses ( ! ), and in particular Article       time being;
1 (3) thereof,
Having regard to the proposal from the Commission,                 Whereas should follow-up products not or not
                                                                   exclusively based on cows' milk later appear on the
                                                                   market the advisability of adopting common rules for
Having regard to the opinion of the                European        them would have to be examined;
Parliament,
Having regard to the opinion of the Economic and                   Whereas pursuant to Article 5 (1) of Directive
Social Committee,                                                  77/94/EEC the products covered by this Directive
                                                                   are subject to the general rules laid down by Council
                                                                   Directive 79/112/EEC of 18 December 1978 on the
Whereas infant formulae and follow-up milks                        approximation of the laws of the Member States
intended for particular nutritional use by infants in              relating to the labelling, presentation and advertising
good health form a very important group within the                 of foodstuffs for sale to the ultimate consumer (2),
category of foodstuffs for particular nutritional uses;            whereas this Directive need do no more than adopt
                                                                   the additions and exceptions to those general rules;
Whereas a specific Directive within the meaning of
Article 1 (3) of Directive 77/94/EEC should
therefore be adopted for this group of products;                   Whereas, in particular, the nature and destination of
                                                                   the products covered by this Directive require
                                                                   nutritional labelling for the energy value and principal
Whereas the essential composition of the products in               nutrients they contain; whereas on the other hand,
question must satisfy the nutritional requirements of              the method of use must be specified in conformity
infants as established by generally accepted scientific            with Article 3 (1), point 8 and Article 10 (2) of
data;                                                              Directive 79/112/EEC, in order to prevent inappro-
                                                                   priate uses likely to be detrimental to the health of
Whereas on the basis of these data the essential                   infants;
composition of infant formulae manufactured from
C) OJ No L 26, 31. 1. 1977, p. 55.                                 O O J N o L 3 3 , 8.2. 1979, p. 1.
 ---pagebreak---   No C 28/4                            Official Journal of the European Communities                                30.1.85
  Whereas, in application of Article 2 (2) of Directive            marketed only if they conform to the definitions and
  79/112/EEC, and in order to supply objective and                 rules laid down in this Directive.
  scientifically verified information, it is necessary to
  define the conditions under which claims about
  the particular composition of an infant formula are                                      Article 3
  authorized;
                                                                   1.    Infant formulae shall be manufactured from
                                                                   food ingredients whose suitability for particular
 Whereas, in an effort to provide better protection for            nutritional use by infants from birth has been
 the health of infants, the rules of composition and               established by generally accepted scientific data.
 labelling laid down in this Directive should also take
 account of the principles and the aims of the Inter-
 national Code of Marketing of Breast-Milk Sub-                    2.    Follow-up milks shall be manufactured from
 stitutes adopted by the 34th World Health Assembly,              cows' milk and, where appropriate, other food
 bearing in mind the particular legal and factual                 ingredients whose suitability for particular nutritional
 situations existing in the Community;                            use by infants aged over four months has been
                                                                  established by generally accepted scientific data.
 Whereas the adaptation of this Directive to scientific
 and technical progress is an implementing measure                3.     The prohibition and limitations on the use of
 that should be delegated to the Commission; whereas              food ingredients laid down in Annexes I and II shall
 it is nevertheless advisable to allow the Member States          be observed.
 to help find a Community solution by adopting
 temporary measures; whereas the procedure laid
 down in Article 9 of Directive 77/94/EEC is appro-                                        Article 4
 priate for this purpose since it offers close
 cooperation between the Member States and the                     1.    Infant formulae must comply with              the
 Commission,                                                      compositional criteria specified in Annex I.
                                                                  However, the criteria for the compositional criteria
 HAS ADOPTED THIS DIRECTIVE:                                      for infant formulae that are not or not exclusively
                                                                  manufactured from cows' milk proteins shall be
                                                                  specified at a later date in accordance with Article
                          Article 1                               100 of the Treaty.
 1.     This Directive is a specific Directive within the
 meaning of Article 1 (3) of Directive 77/94/EEC. It              2.     Follow-up milks must comply with              the
 shall apply to 'infant formulae' and 'follow-up milks'           compositional criteria specified in Annex II.
 intended for particular nutritional use by infants in
 good health.
                                                                  3.    In order to make infant formulae and follow-up
                                                                  milks ready for use, nothing more, as the case may
 2.     For the purposes of this Directive,
                                                                  be, than the addition of water shall be required.
 (a) 'infant formulae' shall mean foodstuffs intended
      for particular nutritional use by infants during the                                Article 5
      first four to six months of life and satisfying by
      themselves the nutritional requirement of this              Only the substances listed in Annex III may be used
      category of persons;                                        for the enrichment of infant formulae and follow-up
                                                                  milks with:
(b) 'follow-up milks' shall mean foodstuffs intended
      for particular nutritional use by infants aged over        — mineral substances,
      four months and constituting the milk element in
      a progressively diversified diet of this category of
                                                                 — vitamins,
      persons.
                                                                 — amino acids and other nitrogen compounds,
                          Article 2
Member States shall take all necessary steps to ensure           — other substances having a particular nutritional
that the products referred to in Article 1 (2) may be                 purpose.
 ---pagebreak--- 30.1.85                              Official Journal of the European Communities                            No C 28/5
                          Article 6                             Should it be decided pursuant to the preceding
                                                                subparagraph that the national authorization should
For the manufacture of infant formulae and                      be revoked, this decision shall apply simultaneously to
follow-up milks, only the additives listed in Annex IV          any authorizations given by another Member State
may be used, provided the conditions laid down                  for the same subject.
therein are met.
                                                                                        Article 8
                          Article 7
                                                                1.     Infant formulae and follow-up milks     shall not
1.    To take account of scientific or technical                contain any substance in such quantity as to   endanger
developments subsequent to the adoption of this                 the health of infants. The maximum levels of    any such
Directive, a Member State may authorize within its              substances shall be stipulated at a later        date in
territory:                                                      accordance with Article 100 of the Treaty.
— the observance of essential compositional criteria
    that are new or differ from those in Annexes I              2.     Microbiological standards shall be established
    and II,                                                     according to the procedure referred to in paragraph
                                                                1.
— the use of substances not mentioned in Annexes
    III and IV,                                                                         Article 9
— the widening of the conditions of use in Annex                1.     The name under which the products covered by
    IV,                                                         Article 1 are sold shall be, respectively, 'infant
                                                                formula' and 'follow-up milk'.
subject to the following conditions:
(a) the authorization must be limited to a maximum              2.     The labelling of infant formulae and follow-up
     period of three years;                                     milks shall bear, in addition to those foreseen in
                                                                Article 3 of Directive 79/112/EEC, the following
(b) the Member State must carry out an official                 mandatory particulars:
     check of products manufactured in accordance
     with the authorization;                                    (a) in the case of infant formulae generally, a
                                                                     statement to the effect that the product is suitable
(c) products thus manufactured must bear a                           for particular nutritional use by infants from
     distinctive indication which is to be defined in the            birth;
     authorization.
                                                                (b) in the case of infant formulae that do not contain
                                                                     added iron, a statement to the effect that, when
2.    The Member States shall forward to the other
                                                                     the product is given to infants over the age of six
Member States and to the Commission the text of any
authorization drawn up pursuant to paragraph 1 with                  months, their total iron requirements must be met
two months of the date of its taking effect.                         from other additional sources;
                                                                (c) in the case of follow-up milks, a statement to the
3.    Before the expiry of the three-year period                     effect that the product is suitable for particular
provided for in paragraph 1, the Member State may                    nutritional use by infants over the age of four
submit to the Commission a request for the admission                 months and that it should form part of a
in this Directive of the elements that are the subject               diversified diet;
of national authorization in accordance with
paragraph 1. At the same time it shall supply sup-              (d) the available energy value, expressed in kj and
porting documents setting out the grounds on which                   kcal, and the content of proteins, lipids and
it deems such admission justified.                                   carbohydrates per 100 ml of the product ready
                                                                     for use;
Within 18 months of the submission of the request, a
decision shall be taken on the basis of technical data          (e) the average quantity of each mineral substance
and information relating to public health, where                     and of each vitamin mentiond in Annex I and
necessary after consulting the Scientific Committee                  Annex II respectively, and where applicable, of
for Food, and in accordance with the procedure laid                  choline, per 100 ml of the product ready for use;
down in Article 9 of Directive 77/94/EEC as to
whether the elements in question may be admitted in             (f) instructions for appropriate preparation of the
this Directive or whether the national authorization                 product;
should be revoked. By way of derogation from
paragraph 1 (a), the national authorization shall               (g) a statement to the effect that it is important for
remain in force until a decision is taken on the                     the infant's health that these instructions be
request for admission in this Directive.                             followed;
 ---pagebreak--- No C 28/6                            Official Journal of  European Communities                              30.1. 85
(h) information making possible batch identification.                                Article 10
3.     The labelling of infant formulae shall in addition    1.     Where a Member State, as a result of new infor-
bear the following mandatory particulars:                    mation or of a reassessment of existing information
                                                             made since this Directive was adopted, has detailed
(a) a statement concerning the superiority of breast-        grounds for establishing that the use in infant
     feeding;                                                formulae or follow-up milks of one of the substances
                                                             listed in Annexes III and IV or the maximum
(b) a statement recommending that the product be             permissible concentration thereof endangers human
     used only on the advice of persons having               health although it complies with this Directive, that
     qualifications in medicine, nutrition or pharmacy.      Member State may temporarily suspend or restrict
                                                             application of the provisions in question within its
4.     The labelling of infant formulae and follow-up
                                                             territory. It shall immediately inform the other
milks and the methods used must not idealize the use
                                                             Member States and the Commission thereof and give
of the products. The use of the terms 'humanized',           reasons for its decision.
'maternalized', 'adapted' or similar terms shall be
prohibited.                                                  2.     The Commission shall examine as soon as
                                                             possible the grounds given by the Member State
The implementing provisions for this paragraph shall         concerned and consult the Member States within the
be adopted, where necessary, in accordance with the          Standing Committee for Foodstuffs, and shall then
procedure laid down in Article 9 of Directive 77/94/         deliver its opinion forthwith and take the appropriate
EEC.                                                         measures.
5.     The labelling may bear claims concerning the          3.     If the Commission considers that amendments
special composition of an infant formula only in the         to this Directive are necessary in order to resolve the
cases listed in Annex V and in accordance with the           difficulties mentioned in paragraph 1 and to ensure
conditions laid down therein.                                the protection of human health, it shall initiate the
                                                             procedure laid down in Article 9 of Directive
Any amendments that have to be made to that Annex            77/94/EEC with a view to adopting those
in line with scientific and technical progress shall be      amendments; in such cases, any Member State which
adopted in accordance with the procedure laid down           has adopted safeguard measures may in that event
in Article 9 of Directive 77/94/EEC.                         retain them until the date on which the amendments
                                                             are to be applied.
6.     The prohibitions and restrictions referred to in
paragraphs 4 and 5 shall also apply to:                                              Article 11
(a) the presentation of infant formulae and follow-up        Member States shall take the necessary measures to
     milks, in particular their shape, appearance or         comply with this Directive. They shall forthwith
     packaging, the packaging materials used, the way        inform the Commission thereof. Those measures shall
     in which they are arranged and the setting in           be applied in such a way as to:
     which they are displayed;                               — permit, by 1 January 1986 at the latest, trade in
                                                                  products complying with this Directive,
(b) advertising.
                                                             — prohibit, on 1 July 1987, trade in products which
7.     This Article shall also apply to infant formulae           do not comply with this Directive.
and follow-up milks for export outside the                                           Article 12
Community, in so far as this is not precluded by
provisions in the importing country.                         This Directive is addressed to the Member States.
 ---pagebreak--- 30. 1. 85                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s          No C 28/7
                                                             ANNEX       I
                               ESSENTIAL COMPOSITION OF INFANT FORMULAE
          NB: The values given refer to the products ready for use.
                                                              PART A
                   FORMULAE       MANUFACTURED              ENTIRELY        FROM COWS'MILK              PROTEINS
          1. Energy
                                      minimum                                               maximum
                                 250 kj                                               315 kj
                                 (60 kcal)/100 ml                                     (75 kcal)/100 ml
          2. Proteins (Protein content == nitrogen content x 6,38)
             2.1 Formulae manufactured from unmodified cows' milk proteins
                                      minimum                                               maximum
                                 0,56g/100kJ                                           0,7g/100kJ
                                 (2,25 g/100 kcal)                                    (3 g/100 kcal)
                 =— The chemical index of the proteins present shall be equal to at least 80 % of that of the
                      reference protein (human milk, as defined in Part I of Annex VI); nevertheless, for calcu-
                      lation purposes, the concentrations of methionine and cystine may be added together;
                 — The 'chemical index' shall mean the lowest of the ratios between the amino acids of the
                      proteins present and the corresponding amino acids of the reference protein.
             2.2 Formulae manufactured from modified cows' milk proteins (alteration of the casein/whey protein
                  ratio)
                                      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
                 (human milk as defined in Part I of Annex VI).
             2.3 In both cases, the addition of amino acids is permitted solely for the purpose of improving the
                 nutritional value of the milk proteins, and only in the proportions necessary for that purpose.
          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 is prohibited
                 — sesame oil,
                 — cotton oil,
                 — fats containing more than 8 % trans isomers of fatty acids.
             3.2 Laurie acid
                                      minimum                                            maximum
                                          —                                       15 % of the total fat content
 ---pagebreak--- N o C 28/8                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                     30. 1. 85
               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)
           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
                   — pre-cooked starch
                                                 naturally free of gluten
                   — gelatinized starch
               4.2 Lactose
                                                                                             maximum
                                   0,85 g/100 kj
                                   (3,5 g/100 kcal)
               4.3 Sucrose
                                        minimum                                              maximum
                                                                                        20 % of the total carbo-
                                                                                        hydrate content
               4.4 Pre-cooked starch and/or gelatinized starch
                                        minimum                                              maximum
                                                                                        2 g/100 ml, and 3 0 % of
                                                                                        the     total         carbohydrate
                                                                                        content
           5. Mineral substances
                                                                       per 100 kj                            per 100 kcal
                                                                minimum            maximum            minimum        maximum
               Sodium (mEq)                                        0,25               0,6                  1              2,6
               Potassium (mEq)                                     0,4                0,9                  1,6            3,8
               Chloride (mEq)                                      0,35               0,8                  M              3,5
               Calcium (mg)                                       12                  —                   50              —
               Phosphorus (mg)                                     6                22                    25            90
               Magnesium (mg)                                      1,2                3,6                  5            15
               Iron (mg) (')                                       0,12               0,36                 0,5            1,5
               Zinc (mg)                                           0,07               —                    0,3            —
               Copper (|i.g)                                       4,8               19                   20            80
               Iodine (ug)                                         1,2                —                    5              —
               The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0.
           (') Limit applicable to formulae with added iron.
 ---pagebreak--- 30. 1. 85                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                         No C 28/9
          6. Vitamins
                                                                         per 100 kj                           per 100 kcal
                                                                 minimum           maximum             minimum        maximum
              Vitamin A (ug RE) (')                               14                 43                    60            180
              Vitamin D (ug) (2)                                    0,25              0,5                   1              2
              Thiamine (ug)                                       10                  —                    40             —
              Riboflavin (jxg)                                    14                  —                    60             —
              Nicotinamide (ug-NE) (3)                            60                  —                   250             —
              Pantothenic acid (jig)                              70                  —                   300             —
              Vitamin B 6 (ug)                                      9                 —                    35             —
              Biotin (ug)                                          0,4                —                     1,5           —
              Folic acid (ug)                                       1                 —                     4             —
              Vitamin Bi 2 (ug)                                    0,025              —                     0,1           —
              Vitamin C (mg)                                        1,9               —                     8             —
              Vitamin E (mg a-TE) (")                        0,5/g of polyunsaturated                0,5/g of polyunsaturated
                                                             fatty acids expressed as                fatty acids expressed as
                                                             linoleic acid but in no case            linoleic acid but in no case
                                                             less than 0,1 mg/ 100 avail-            less than 0,5 mg/100 avail-
                                                             able kj                                 able kcal
          (') RE =     all trans retinol equivalent.
          (2)  In the form of cholecalciferol, of which 10 ug = 400 i.u. of vitamin D.
          (5)  NE =    Niacin equivalent = mg nicotinic acid + mg tryptophan/60.
          (4)  a-TE   = d-a-tocopherol equivalent.
                                                                 PARTB
          FORMULAE           NOT     OR   NOT     EXCLUSIVELY             MANUFACTURED                   FROM     COWS'      MILK
                                                               PROTEINS
          (To be completed later in accordance with the second paragraph of Article 4(1))
                                                               ANNEX       II
                                  ESSENTIAL COMPOSITION OF FOLLOW-UP MILKS
          NB: The values given refer to the products ready for use.
          1. Energy
                                         minimum                                             maximum
                                   250 kj                                              335 kj
                                   (60 kcal)/100 ml                                    (80 kcal)/100 ml
          2. Proteins (Protein content = nitrogen content x 6,38)
                                         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 85 % of that of the
                  reference protein (casein as defined in Part II of Annex VI).
              — The 'chemical index' shall mean the lowest of the ratios between the amino acids of the
                  proteins present and the corresponding amino acids of the reference protein.
              — Amino acids may be added to follow-up milks for the purpose of improving the nutritional
                  value of the milk proteins, in the proportions necessary for that purpose.
 ---pagebreak--- N o C 28/10                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s             30. 1. 85
            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 is prohibited
                   — sesame oil,
                   — cotton oil,
                   — fats containing more than 8 % trans isomers of fatty acids.
               3.2 Laurie 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 applies only to
                                   follow-up milks containing
                                   vegetable oils
            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 is prohibited.
               4.2 Lactose
                                        minimum                                              maximum
                                   0,45 g/100 kj
                                   (1,8 g/100 kcal)
               4.3 Sucrose, fructose, honey
                                        minimum
                                                                                        Separately or as a whole
                                                                                        20 % of the total carbo-
                                                                                        hydrate content
            5. Mineral substances
               5.1 Iron
                                         minimum
                                   0,25 mg/100 kj                                       0,5 mg/100 kj
                                   (1 mg/100 kcal)                                      (2 mg/100 kcal)
               5.2 Zinc
                                                                                             maximum
                                   0,12 mg/100 kj
                                   (0,5 mg/100 kcal)
               5.3 Other mineral substances
                   The concentrations normally found in cows' milk, reduced, where appropriate, in the same
                   ratio as the protein concentration of the follow-up milk to that of cows' milk. The typical
                   composition of cows' milk is given, for guidance, in Annex VII.
               5.4 The calcium/phosphorus ratio shall not exceed 2,0.
 ---pagebreak--- 30. 1. 85                          Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                         N o C 28/11
          6. Vitamin
                                                                    per 100 kj                             per 100 kcal
                                                             minimum            maximum             minimum        maximum
              Vitamin A (ug RE) (>)                             14                43                   60             180
              Vitamin  D (ug) (2)                                0,25              0,5                   1              2
              Vitamin  C (mg)                                    1,9               —                     8             —
              Vitamin  E (mg a-TE) (J)                    0,5/g of polyunsaturated                0,5/g of polyunsaturated
                                                          fatty acids expressed as                fatty acids expressed as
                                                          linoleic acid but in no case            linoleic acid but in no case
                                                          less than 0,1 mg/100 avail-             less than 0,5 mg/100 avail-
                                                          able kj                                 able kcal
          (') RE = all trans retinol equivalent.
          (2) In the form of cholecalciferol, of which 10 ug = 400 i.u. of vitamin D.
          (3) a-TE = d-a-tocopherol equivalent.
                                                            ANNEX       III
          SUBSTANCES W I T H A SPECIFIC NUTRITIONAL PURPOSE T H A T MAY BE USED IN
                                  INFANT FORMULAE A N D FOLLOW-UP MILKS
                                                              PART I
                                                        MINERAL        SALTS
                        Mineral substances                                           Permitted salts
            1. Calcium (a)                                Calcium    carbonate
                                                          Calcium    chloride
                                                          Calcium    citrate
                                                          Calcium    gluconate
                                                          Calcium    glycerophosphate
                                                          Calcium    lactate
                                                          Calcium    phosphate, monobasic
                                                          Calcium    phosphate, dibasic
                                                          Calcium    phosphate, tribasic
                                                          Calcium    hydroxide
            2. Phosphorus (P)                             Calcium phosphate, monobasic
                                                          Calcium phosphate, dibasic
                                                          Calcium phosphate, tribasic
                                                          Magnesium phosphate, dibasic
                                                          Magnesium phosphate, tribasic
                                                          Potassium phosphate, monobasic
                                                          Potassium phosphate, dibasic
                                                           Sodium phosphate, dibasic
            3. Magnesium (Mg)                              Magnesium      carbonate
                                                           Magnesium      chloride
                                                           Magnesium     oxide
                                                          Magnesium      phosphate, dibasic
                                                          Magnesium      phosphate, tribasic
                                                          Magnesium       sulphate
                                                          Magnesium      gluconate
            4. Iron (Fe)                                  Ferrous citrate
                                                          Ferrous gluconate
                                                          Ferrous lactate
                                                          Ferrous sulphate
                                                          Ferric ammonium citrate
 ---pagebreak--- N o C 28/12                          Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s     30. 1. 85
              5. Copper (Cu)                                Cupric citrate
                                                            Cupric gluconate
                                                            Cupric sulphate
                                                            Copper Lysine Complex
                                                            Copper carbonate
              6. Iodine (I)                                 Potassium iodide
                                                            Sodium iodide
                                                            Potassium iodate
              7. Zinc (Zn)                                  Zinc  acetate
                                                            Zinc  chloride
                                                            Zinc  lactate
                                                            Zinc  sulphate
                                                            Zinc  citrate
              8. Manganese (Mn)                             Manganese      carbonate
                                                            Manganese      chloride
                                                            Manganese      citrate
                                                            Manganese     sulphate
                                                            Manganese      gluconate
              9. Sodium (Na)                                Sodium    bicarbonate
                                                            Sodium    chloride
                                                            Sodium    citrate
                                                            Sodium    gluconate
                                                            Sodium    carbonate
                                                            Sodium    lactate
                                                            Sodium    phosphate, monobasic
                                                            Sodium    phosphate, dibasic
                                                            Sodium    phosphate, tribasic
                                                            Sodium    hydroxide
            10. Potassium (K)                               Potassium    bicarbonate
                                                            Potassium    carbonate
                                                            Potassium    chloride
                                                            Potassium    citrate
                                                            Potassium    gluconate
                                                            Potassium    lactate
                                                            Potassium    phosphate, monobasic
                                                            Potassium    phosphate, dibasic
                                                            Potassium    phosphate, tribasic
                                                            Potassium    hydroxide
                                                               PART II
                                                              VITAMINS
                              Vitamin                                             Vitamin formulation    (')
              1. Vitamin A                                  Vitamin A acetate
                                                            Vitamin A palmitate
                                                            Beta-carotene (Provitamin A)
              2. Vitamin D                                  Vitamin D 2 (Ergocalciferol)
                                                            Vitamin D3 (Cholecalciferol)
                                                            Vitamin D3-Cholesterol
            (') The following substances may be added to vitamin formulations, for technological reasons:
                — edible substances,
                — gelatine,
                — the additives listed in Annex IV,
                — gum arabic,
                — silicon dioxide (maximum concentration: 10 g/kg).
 ---pagebreak--- 30. 1. 85                          Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s No C 28/13
           3. Vitamin Bj                                  Thiamine hydrochloride
                                                          Thiamine mononitrate
           4. Vitamin B 2                                  Riboflavin
                                                           Riboflavin 5'-phosphate sodium
           5. Nicotinamide                                 Niacinamide
                                                           Nicotinic acid (niacin)
           6. Vitamin B 6                                  Pyridoxine hydrochloride
                                                           Pyridoxal-5'-phosphate
           7. Folic acid                                   Folic acid
           8. Pantothenic acid                             D-calcium pantothenate
                                                           D-sodium pantothenate
                                                           D-panthenol
           9. Vitamin B 12                                 Cyanocobalamin
                                                           Hydroxocobalamin
          10. Vitamin H                                    d-Biotin
          11. Vitamin C                                    1-ascorbic acid
                                                           Sodium-1-ascorbate
                                                           Calcium-1-ascorbate
                                                           l-ascorbyl-6-palmitate
                                                           Potassium ascorbate
          12. Vitamin E                                    d-alpha-tocopherol
                                                          dl-alpha-tocopherol
                                                           d-alpha-tocopherol acetate
                                                          dl-alpha-tocopherol acetate
          13. Vitamin K                                   Vitamin Kj
                                                              PART III
                             AMINO ACIDS AND OTHER NITROGEN                            COMPOUNDS
                         L-arginine and its hydrochloride
                         L-cystine and its hydrochloride
                         L-histidine and its hydrochloride
                         L-isoleucine
                         L-leucine
                         L-lysine
                         L- and DL-methionine
                         L-phenylalanine
                         L-threonine
                         L-tryptophan
                         L-tyrosine
                         L-valine
                                                              PART IV
                                                    OTHER         SUBSTANCES
                         Choline (choline chloride)
 ---pagebreak--- N o C 28/14                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                   30. 1. 85
                                                               ANNEX      IV
                                                              ADDITIVES
            NB: The limits given refer to the products ready for use.
                                      Additives                                                       Conditions of use
                L-ascorbic acid                                     (E 300)
                Sodium-L-ascorbate                                  (E301)
                Calcium-L-ascorbate                                 (E 302)            In a concentration, taken either
                Ascorbyl palmitate                                  (E 304)            separately or together, of not more
                Tocopherol-rich extracts of natural origin          (E 306)            than 1 mg/100 ml in infant
                Synthetic Alpha-tocopherol                          (E 307)            formulae and follow-up milks
                Synthetic Gamma-tocopherol                          (E 308)
                Synthetic Delta-tocopherol                          (E 309)
                Lecithin                                            (E 322)            In a concentration of not more
                                                                                       than 0,5 g/100 ml in infant for-
                                                                                       mulae and follow-up milks (')
                Mono- and diglycerides of fatty acids               (E471)             In a concentration of not more
                                                                                       than 0,4 g/100 ml in infant for-
                                                                                       mulae and follow-up milks (')
                Carrageenan                                         (E 407)            In a concentration of not more
                                                                                    • than 0,03 g/100 ml in follow-up
                                                                                       milks (2)
                Locust bean gum                                     (E410)             In a concentration of not more
                                                                                       than 0,1 g/100 ml in follow-up
                                                                                       milks O
                Guar gum                                            (E412)             In a concentration of not more
                                                                                       than 0,1 g/100 ml in follow-up
                                                                                       milks (2)
                Citric acid
                L (-I-) lactic acid
                Cultures producing L ( + ) lactic acid
            (') Where substances E 322 and E 471 are used together, the amount of each of them actually used
                shall represent only part of the maximum concentration and shall be such that the sum of the
                two fractions does not exceed one.
            (2) Where substances E 407, E410 and E412 are used together, the amount of each of them
                actually used shall represent only part of the maximum concentration and shall be such that the
                sum of the fractions does not exceed one.
                                                               ANNEX      V
                CLAIMS C O N C E R N I N G A SPECIFIC COMPOSITIONAL CRITERION FOR INFANT
                                                              FORMULAE
                        Compositional criterion                               Conditions warranting a claim
            — Proteins                                       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.
            — Sodium                                         The sodium content is lower than 0,4 mEq/100                kj
                                                             (1,7 mEq/100 kcal).
            — Sucrose                                        No sucrose is present.
            — Lactose                                        Lactose is the only carbohydrate used.
            — Iron                                           The iron is added.
 ---pagebreak--- 30. 1. 85                          Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                      N o C 28/15
                                                            ANNEX      VI
                                                  REFERENCE PROTEINS
                                                              PARTI
                                                          HUMANMILK
                                              mg/100 kj                     mg/100 kcal                  g/100 g of protein
          Arginine                                 16                             69                             3,8
          Cystine                                   6                             24                             1,3
          Histidine                                11                             45                             2,5
          Isoleucine                               17                             72                             4,0
          Leucine                                 37                             156                             8,5
          Lysine                                  29                             122                             6,7
          Methionine                                7                             29                             1,6
          Phenylalanine                            15                             62                             3,4
          Threonine                                19                             80                             4,4
          Tryptophan                                7                             30                             1,7
          Tyrosine                                 14                             59                             3,2
          Valine                                   19                             80                             4,5
                                                             PART II
                                                              CASEIN
                                                                               g/100 g of protein
                         Arginine                                                      3,7
                         Cystine                                                      0,3
                         Histidine                                                    2,9
                         Isoleucine                                                    5,4
                         Leucine                                                      9,5
                         Lysine                                                        8,1
                         Menthionine                                                  2,8
                         Phenylalanine                                                 5,2
                         Threonine                                                     4,7
                         Tryptophan                                                    1,6
                         Tyrosine                                                      5,8
                         Valine                                                        6,7
                                                           ANNEX       VII
                        C O N C E N T R A T I O N S O F MINERAL ELEMENTS IN COWS' MILK
                    For guidance, the concentrations of mineral elements in cows' milk are as follows:
                                                              per 100 g of fat-free dry                per 1 g of proteins
                                                                        matter
          Sodium (mEq)                                                       24                                0,65
          Potassium (mEq)                                                    43                                1,10
          Chloride (mEq)                                                     30                                0,80
          Calcium (mg)                                                  1 350                                 35
          Phosphorus (mg)                                               1 070                                28
          Magnesium (mg)                                                   135                                 3,5
          Copper (ng)                                                      225                                 6
          Iodine                                                   Not specified                         Not specified