CELEX: 51986PC0564
Language: en
Date: 1986-10-20
Title: MODIFIED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO INFANT FORMULAE AND FOLLOW-UP MILKS

12.11.86                                 Official Journal of the European Communities                                  No C 285/5
                                                                 II
                                                         (Preparatory Acts)
                                                   COMMISSION
               Modified proposal for a Council Directive on the approximation of the laws of the Member
                                    States relating to infant formulae and follow-up milks (')
                                                        COM(86) 564 final
               (Submitted by the Commission to the Council pursuant to the second paragraph of Article 149 of
                                               the EEC Treaty on 27 October 1986)
                                                           (86/C 285/07)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              Whereas on the basis of these data the essential
                                                                      composition of infant formulae manufactured from cows'
Having regard to the Treaty establishing the European                 milk proteins can already be defined; whereas the same
Economic Community, and in particular Article 100                     is not true for preparations based wholly or partly on
thereof,                                                              other sources of protein; whereas specific rules for such
                                                                      products will therefore have to be adopted at a later
Having regard to Council Directive 77/94/EEC of 21                    date;
December 1976 on the approximation of the laws of the
Member States relating to foodstuffs for paricular
nutritional uses (2), and in particular Article 1 (3)                  Whereas infant formula is the only processed foodstuff
thereof,                                                              which wholly satisfies the nutritional requirements of
                                                                      infants during the first four to six months of life; whereas
                                                                      in order to safeguard the health of such infants it is
                                                                      necessary to ensure that the only products marketed as
Having regard to the proposal from the Commission,                    suitable for such use during the period would be infant
                                                                     formulae;
Having regard to the opinion of the European Par-                      Whereas all follow-up           milks currently sold in the
liament,                                                              Community are manufactured from cows' milk; whereas,
                                                                      should follow-up products not or not exclusively based on
                                                                      cows' milk later appear on the market, the advisability of
Having regard to the opinion of the Economic and                      adopting common rules for them would have to be
Social Committee,                                                     examined;
                                                                     Whereas pursuant to Article 5 (1) of Directive
Whereas infant formulae and follow-up milks intended                  77/94/EEC the products covered by this Directive are
for particular nutritional use by infants in good health in           subject to the general rules laid down by Council
those cases in which breastfeeding is not advised, sufficient         Directive 79/112/EEC of 18 December 1978 on the
 or possible, or the mother chooses not to breastfeed, form a         approximation of the laws of the Member States relating
very important group within the category of foodstuffs                to the labelling, presentation and advertising of
for particular nutritional uses;                                      foodstuffs for sale to the ultimate consumer ( 3 ); whereas
                                                                      this Directive adopts and expands upon the additions and
Whereas a specific Directive within the meaning of                    exceptions to those general rules where it is appropriate
Article 1 (3) of Directive 77/94/EEC should therefore                 in order to promote and protect breastfeeding;
be adopted for this group of products;
Whereas the essential composition of the products in                  Whereas, in particular, the nature and destination of the
question must satisfy the nutritional requirements of                 products covered by this Directive required nutritional
infants as established by generally accepted scientific               labelling for the energy value and principal nutrients they
data;                                                                 contain; whereas, on the other hand, the method of use
                                                                      must be specified in conformity with Article 3 (1), point
                                                                      8 and Article 10 (.2) of Directive 79/112/EEC, in order
0) OJ No C 28, 30. 1. 1985, p. 3.
(2) OJ No L 26, 31. 1. 1977, p. 55.                                   (J) O J N o L 3 3 , 8.2. 1979, p. 1.
 ---pagebreak--- N o C 285/6                              Official Journal of the European Communities                                       12.11.86
to prevent inappropriate uses likely to be detrimental to            to the definitions and rules laid down in this Directive.
the health of infants;                                               No product other than infant formula may be marketed or
                                                                     otherwise represented as suitable for satisfying by itself the
                                                                     nutritional requirements of infants during the first four to
Whereas, pursuant to Article 2 (2) of Directive 79/112/
                                                                     six months of life.
EEC, and in order to supply objective and scientifically
verified information, it is necessary to define the
conditions under which claims about the particular                   2.     The provisions of Articles 2 to 9 (5) shall also apply to
composition of an infant formula are authorized;                     the products referred to in Article 1 (2) which are intended
                                                                    for export to third countries, except in so far as precluded
                                                                     by provisions applicable in the third country of import.
Whereas, in an effort to provide better protection for the
health of infants, the rules of composition, labelling and
marketing laid down in this Directive should be in                                              Article 3
conformity with the principles and the aims of the Inter-
national Code of Marketing of Breast-Milk Substitutes                1.    Infant formulae shall be manufactured from food
adopted by the 34th World Health Assembly, bearing in                ingredients whose suitability for particular nutritional use
mind the particular legal and factual situations existing in        by infants from birth has been established by generally
the Community;                                                       accepted scientific data.
Whereas the adaptation of this Directive to scientific and           2.    Follow-up milks shall be manufactured from food
technical progress is an implementing measure that                  ingredients whose suitability for particular nutritional use
should be delegated to the Commission; whereas it is                by infants aged over four months has been established by
nevertheless advisable to allow the Member States to                generally accepted scientific data.
help find a Community solution by adopting temporary
measures; whereas the procedure laid down in Article 9
                                                                    3.     The prohibitions and limitations on the use of food
of Directive 77/94/EEC is appropriate for this purpose
                                                                    ingredients laid down in Annexes I and II shall be
since it offers close cooperation between the Member
                                                                    observed.
States and the Commission,
                                                                                               Article 4
HAS ADOPTED THIS DIRECTIVE:
                                                                     1.    Infant formulae must comply with               the   com-
                                                                    positional criteria specified in Annex I.
                           Article 1
1.     This Directive is a specific Directive within the            However, the compositional criteria for infant formulae
meaning of Article 1 (3) of Directive 77/94/EEC and                 that are not or not exclusively manufactured from cows'
lays down compositional and labelling requirements for              milk proteins shall be specified at a later date, but not
infant formulae and follow-up milks. It also provides for           later than 1 July 1988, in accordance with Article 100 of
Member States to give effect to those principles and aims of        the Treaty.
the International Code of Marketing of Breast-Milk Sub-
stitutes dealing with         marketing,   information    and       2.     Follow-up milks must comply with               the   com-
responsibilities of health authorities.                             positional criteria specified in Annex II.
2.     For the purposes of this Directive,                          3.     In order to make infant formulae and follow-up
                                                                    milks ready for use, nothing more, as the case may be,
(a) 'infant formulae' shall mean foodstuffs intended for            than the addition of water shall be required.
     particular nutritional use by infants during the first
     four to six months of life and satisfying by
     themselves the nutritional requirements of this                                            Article 5
     category of persons;
                                                                    Only the substances listed in Annex III may be used for
                                                                    the enrichment of infant formulae and follow-up milks
(b) 'follow-up milks' shall mean foodstuffs intended for
                                                                    with:
     particular nutritional use by infants aged over four
     months and constituting the milk element in a
     progressively diversified diet of this category of             — mineral substances,
     persons.
                                                                    — vitamins,
                           Article 2                                — amino acids and other nitrogen compounds,
1.     Member States shall take all necessary steps to
ensure that the products referred to in Article 1 (2) may           — other substances        having    a particular      nutritional
be marketed within the Community only if they conform                    purpose.
 ---pagebreak---  12. 11.86                              Official Journal of the European Communities                                No C 285/7
                          Article 6                                                          Article 8
For the manufacture of infant formulae and follow-up               1.    Infant formulae and follow-up milks           shall not
milks, only the additives listed in Annex IV may be used,          contain any substance in such quantity as to         endanger
provided the conditions laid down therein are met.                 the health of infants. The maximum levels of         any such
                                                                   substances shall be stipulated at a later             date in
                                                                   accordance with Article 100 of the Treaty.
                          Article 7
 1.    To take account of scientific or technical
                                                                   2.    Microbiological standards shall be established
developments subsequent to the adoption of this
                                                                   according to the procedure referred to in paragraph 1.
Directive, a Member State may authorize within its
territory:
                                                                                             Article 9
— the observance of essential compositional criteria that
     are new or differ from those in Annexes I and II,             1.    The name under which the products covered by
                                                                   Article 1 are sold shall be, respectively, 'infant formula'
— the use of substances not mentioned in Annexes III               and 'follow-up milk'.
     and IV,
— the widening of the conditions of use in Annex IV,               2.    The labelling of infant formulae and follow-up
                                                                   milks shall bear, in addition to those provided for in
subject to the following conditions:                               Article 3 of Directive 79/112/EEC, the following
                                                                   mandatory particulars:
(a) the authorization must be limited to a maximum
     period of three years;                                        (a) in the case of infant formulae generally, a statement
                                                                       to the effect that the product is suitable for particular
(b) the Member State must carry out an official check of               nutritional use by infants from birth in cases in which
     products manufactured in accordance with the auth-                breastfeeding is not advised, sufficient or possible, or
     orization;                                                        the mother chooses not to breastfeed;
(c) products thus manufactured must bear a distinctive
     indication which is to be defined in the authori-             (b) in the case of infant formulae that do not contain
     zation.                                                           added iron, a statement to the effect that, when the
                                                                       product is given to infants over the age of six
                                                                       months, their total iron requirements must be met
2.     The Member State shall forward to the other
                                                                       from other additional sources;
Member States and to the Commission the text of any
authorization drawn up by virtue of paragraph 1 within
two months of the date of its taking effect.                       (c) in the case of follow-up milks, a statement to the
                                                                       effect that the product is only suitable for particular
3.     Before the expiry of the three-year period provided             nutritional use by infants over the age of four
for in paragraph 1, the Member State may submit to the                 months, that it should form only part of a diversified
Commission a request for the admission in this Directive               diet and that it is not to be used as a replacement for
of the elements that are the subject of national autho-                breast milk during the first four months of life;
rization in accordance with paragraph 1. At the same
time it shall supply supporting documents setting out the          (d) the available energy value, expressed in kj and kcal,
grounds on which it deems such admission justified.                    and the content of proteins, lipids and 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 and
                                                                   (e) the average quantity of each mineral substance and
information relating to public health, where necessary
                                                                       of each vitamin mentioned in Annex I and Annex II
after consulting the Scientific Committee for Food, and
in accordance with the procedure laid down in Article 9                respectively, and where applicable of choline, per
of Directive 77/94/EEC as to whether the elements in                    100 ml of the product ready for use;
question may be admitted in this Directive or whether
the national       authorization    should    be    revoked.       (f) instructions for appropriate preparation of the
Notwithstanding paragraph 1 (a), the national author-                  product and a warning against the health hazards of
ization shall remain in force until a decision is taken on             inappropriate preparation;
the request for admission in this Directive.
                                                                   (g) information to enable batch identification.
Should it be decided pursuant to the preceding subpara-
graph that the national authorization should be revoked,
this decision shall apply simultaneously to any authori-           3.    The labelling of infant formulae shall in addition
zations given by another Member State for the same                 bear the following mandatory particulars, preceded by the
subject.                                                           words 'Important Notice' or their equivalent:
 ---pagebreak---  No C 285/8                               Official Journal of the European Communities                                      12.11.86
 (a) a statement         concerning    the    superiority    of                                   Article 11
      breastfeeding;
                                                                      1.     Advertising of infant formulae shall be restricted to
 (b) a statement recommending that the product be used               publications specializing in baby care.
      only on the advice of persons having qualifications in
      medicine, nutrition or pharmacy;
                                                                      2.     Advertisements for infant formulae shall be subject to
                                                                      the conditions laid down in Article 9, paragraphs 3, 4, 5
 (c) a warning concerning the negative effect               on
                                                                      and 6 (b) and contain only information of a scientific and
      breastfeeding of introducing partial bottle-feeding;
                                                                     factual nature. Such information shall not imply or create a
 (d) a warning concerning the difficulty        of reversing a        belief that bottle-feeding is equivalent or superior to
      decision not to breastfeed.                                     breastfeeding.
 4.     The labelling of infant formulae and follow-up milks          3.     There shall be no point-of-sale advertising, giving of
 shall be designed to provide the necessary information               samples or any other promotional device to induce sales of
 about the appropriate use of the products and so as not to           infant formula directly to the consumer at the retail level,
 discourage breastfeeding. The use of the terms                       such as special displays, discount coupons, premiums, special
 'humanized', 'maternalized', 'adapted' or similar terms              sales, loss-leaders and tie-in sales.
 shall be prohibited.
  The labelling of infant formulae shall not include pictures         4.     Manufacturers and distributors of infant formulae
 of infants, nor shall it include other pictures or text which        shall not provide, to the general public or to pregnant
 may idealize the product. It may, however, have graphics             women, mothers or members of their families, free or low-
for easy identification of the product and for illustrating          priced products, samples or any other promotional gifts,
 methods of preparation.                                              either directly or indirectly via the health care system or
                                                                      health workers.
The implementing provisions for this paragraph shall be
 adopted, where necessary, in accordance with the
 procedure laid down in Article 9 of Directive 77/94/                                             Article 12
 EEC.
                                                                      1.     Member States shall take the necessary measures to
 5.    The labelling may bear claims concerning the                   ensure that objective and consistent information is provided
 special composition of an infant formula only in the                 on infant and young child feeding for use by families and
 cases listed in Annex V and in accordance with the                   those involved in the field of infant and young child
 conditions laid down therein.                                        nutrition covering the planning, provisions, design and
                                                                      dissemination of information and their control.
 Any amendments that have to be made to that Annex in
 line with scientific and technical progress shall be
                                                                      2.     Member States shall take the necessary measures to
 adopted in accordance with the procedure laid down in
                                                                      ensure that informational and educational materials,
Article 9 of Directive 77/94/EEC.
                                                                      whether written or audiovisual, dealing with the feeding of
                                                                      infants and intended to reach pregnant women and mothers
 6.     The requirements, prohibitions        and restrictions        of infants and young children, shall include clear infor-
 referred to in paragraphs 3, 4 and 5 shall also apply to:            mation on all the following points:
 (a) the presentation of infant formulae and follow-up
      milks, in particular their shape, appearance or                 (a) the benefits and superiority of breastfeeding;
      packaging, the packaging materials used, the way in
      which they are arranged and the setting in which                (b) maternal nutrition and the preparation for and main-
      they are displayed;                                                  tenance of breastfeeding;
 (b) advertising.
                                                                      (c) the negative effect on breastfeeding of         introducing
                                                                          partial bottle-feeding;
                            Article 10
  The labelling, marketing and advertising of articles for use        (d) the difficulty of reversing the decision not to breastfeed;
 in conjunction with infant formulae, such as teats, feeding-
 bottles, bottle-heaters and other specially designed feeding
 equipment, when referring to infant formulae, shall comply           (e) where needed, the proper use of infant formulae,
 with the requirements of Article 9, paragraphs 3 and 4.                   whether manufactured industrially or home-prepared.
  The labelling of such articles intended for export to third         When such materials contain information about the use of
 countries shall likewise comply with the requirements of             infant formulae, they shall include the social and financial
Article 9, paragraphs 3 and 4, except in so far as precluded          implications of its use; the health hazards of inappropriate
 by provisions applicable in the third country of import.            foods or feeding methods; and, in particular, the health
 ---pagebreak---  12.11.86                                 Official Journal of the European Communities                               No C 285/9
 hazards of unnecessary or improper use of infant formulae.           provisions in question within its territory. It shall
 Such material shall not use any pictures which may idealize          immediately inform the other Member States and the
 the use of infant formulae.                                          Commission thereof and give reasons for its decision.
 3.     Member States shall take the necessary measures to            2.    The Commission shall examine as soon as possible
 ensure that donations of informational or educational               the grounds given by the Member State concerned and
 equipment or materials by manufacturers or distributors              consult the Member States within the Standing
 shall be made only at the request and with the written               Committee for Foodstuffs, and shall then deliver its
 approval of the appropriate national authority or within             opinion forthwith and take the appropriate measures.
guidelines given by that authority for this purpose. Such             3.    If the Commission considers that amendments to
 equipment or materials may bear the donating company's              this Directive are necessary in order to resolve the
 name or logo, but shall not refer to a proprietary brand of         difficulties mentioned in paragraph 1 and to ensure the
 infant formula and shall be distributed only through the            protection of human health, it shall initiate the procedure
health care system.                                                  laid down in Article 9 of Directive 77/94/EEC with a
                                                                     view to adopting those amendments; in such cases, any
 4.     Member States shall take the necessary measures to           Member State which has adopted safeguard measures
 ensure that donations or low-price sales of infant formula to       may in that event retain them until the date on which the
 institutions or organizations, whether for use in the               amendments are to be applied.
 institutions or for distribution outside them, shall only be
used by or distributed for infants fed on infant formula and                                      Article 14
only for as long as required by such infants.
                                                                     Member States shall take the necessary measures to
                            Article 13                               comply with this Directive. They shall forthwith inform
                                                                     the Commission thereof. Those measures shall be applied
 1.     Where a Member State, as a result of new infor-              in such a way as to:
mation or of a reassessment of existing information made             — permit trade in products complying with this
since this Directive was adopted, has detailed grounds                   Directive, by . . . (x),
for establishing that the use in infant formulae or
                                                                     — prohibit trade in products which do not comply with
follow-up milks of one of the substances listed in
                                                                         this Directive, with effect from . . . (2).
Annexes III and IV or the maximum permissible
concentration thereof endangers human health although
                                                                                                  Article 15
it complies with this Directive, that Member State may
temporarily suspend or restrict application of the                   This Directive is addressed to the Member States.
                                                                     (') 18 months after the notification.
                                                                     (2) 36 months after the notification.
 ---pagebreak--- N o C 285/10                              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             12. 11. 86
                                                                   ANNEX       I
                                      ESSENTIAL COMPOSITION O F 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
                                   0,56 g/100 kj                                       0,7 g/100 kj
                                   (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 refer-
                        ence protein (human milk, as defined in Part I of Annex VI); nevertheless, for calculation
                        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--- 12. 11. 86                                 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 285/11
               3.3. Myristic acid
                                          minimum                                               maximum
                                                                                          15 °/o 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
                                          minimum                                               maximum
                                     0,85 g/100 kj
                                     (3,5 g/100 kcal)
               4.3. Sucrose
                                          minimum                                               maximum
                                                                                         20 % of the total carbohydrate
                                                                                         content
               4.4. Pre-cooked starch and/or gelatinized starch
                                          minimum
                                                                                         2 g/100 ml, and 30 % 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                         1,4            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 (ug)                                           4,8              19                         20             80
               Iodine (|i.g)                                         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--- N o C 285/12                                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                              12. 11. 86
            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 (ug)                                      14                  —                            60             —
               Nicotinamide (ug-NE) (')                             60                  —                          250              —
               Pantothenic acid (jig)                               70                  —                          300              —
               Vitamin B6 (ug)                                       9                  —                            35             —
               Biotin (ug)                                           0,4                —                             1,5           —
               Folic acid (ug)                                       1                  —                             4             —
               Vitamin Bi2 (ug)                                      0,025              —                             0,1           —•
               Vitamin C (mg)                                        1,9                —                             8             —
               Vitamin E (mg a-TE) (4)                         0,5/g of polyunsatui ated                      0,5/g of polyunsaturated
                                                               fatty acids expressed as .lino-                fatty acids expressed as lino-
                                                               leic acid but in no case less                  leic acid but in no case less
                                                               than 0,1 mg/100 avai lable                     than 0,5 mg/100 available
                                                               kJ                                             kcal
           (') RE = all trans-retino\ equivalent.
           (2) In the form of cholecalciferol, of which 10 ug = 400 IU of vitamin D.
           (3) NE = Niacin equivalent = mg nicotinic acid + mg tryptophan/60.
           (") 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 C O M P O S I T I O N 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--- 12. 11. 86                               Official Journal of the European Communities                                No C 285/13
           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
                                                                                    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,               . .                                       maximum
                                        minimum
                   fructose,                                                 Separately or as a whole 20 °/o of
                    honey                                                    the total carbohydrate 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
                                  0,12 mg/100 kj                                       —
                                  (0,5 mg/100 kcal)
              5.3. Other          The concentrations normally found in cows' milk, reduced, where appropriate, in the
                    mineral       same ratio as the protein concentration of the follow-up milk to that of cows' milk.
                    substances    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--- No C 285/14                                Official Journal of the European Communities                                           12. 11. 86
          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
              Vitamin   C (mg)                                     1,9             —                        8              —
              Vitamin   E (mg a-TE) (3)                     0,5/g of polyunsaturated               0,5/g of polyunsaturated
                                                            fatty acids expressed as lino-         fatty acids expressed as lino-
                                                            leic acid but in no case less          leic acid but in no case less
                                                            than 0,1 mg/100 available              than 0,5 mg/100 available
                                                            kj                                     kcal
          (') RE = all trans-rei\no\ equivalent.
          (2) In the form of cholecalciferol, of which 10 u.g   400 IU of vitamin D.
          (') a-TE = ^/-a-tocopherol equivalent.
                                                                 ANNEX III
          SUBSTANCES WITH A SPECIFIC NUTRITIONAL PURPOSE THAT MAY BE USED IN INFANT
                                                FORMULAE AND FOLLOW-UP MILKS
                                                                    PARTI
                                                                 Mineral salts
                            Mineral substances                                              Permitted salts
            1. Calcium (Ca)                                          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--- 12. 11. 86                                  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 285/15
              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 D2 (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--- N o C 285/16                             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 12. 1 1 . 86
             3. Vitamin Bi                                          Thiamine hydrochloride
                                                                    Thiamine mononitrate
             4. Vitamin B2                                          Riboflavin
                                                                    Riboflavin 5'-phosphate sodium
             5. Nicotinamide                                        Niacinamide
                                                                    Nicotinic acid (niacin)
             6. Vitamin B6                                          Pyridoxine hydrochloride
                                                                    Pyridoxal 5'-phosphate
             7. Folic acid                                          Folic acid
             8. Pantothenic acid                                    D-Calcium pantothenate
                                                                    D-Sodium pantothenate
                                                                    D-Panthenol
             9. Vitamin B12                                         Cyanocobalamin
                                                                    Hydroxocobalamin
           10. Vitamin H                                            J-Biotin
           11. Vitamin C                                            L-Ascorbic acid
                                                                    Sodium-L-ascorbate
                                                                    Calcium-L-ascorbate
                                                                    L-ascorbyl-6-palmitate
                                                                    Potassium ascorbate
           12. Vitamin E                                            <£alpha-tocopherol
                                                                    *//-alpha-tocopherol
                                                                    J-alpha-tocopherol acetate
                                                                    ^/-alpha-tocopherol acetate
           13. Vitamin K                                            Vitamin Ki
                                                                  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
                           Taurine
                                                                  PART IV
                                                               Other substances
                           Choline (choline chloride)
 ---pagebreak--- 12. 11. 86                                 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 285/17
                                                                   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                                        (E  301)
                Calcium-L-ascorbate                                       (E  302)
                Ascorbyl palmitate                                        (E  304)          In a concentration, taken either separa-
                                                                                            tely or together, of not more than
                Tocopherol-rich extracts
                                                                                             1 mg/100 ml in infant formulae and
                of natural origin                                         (E 306)           follow-up milks
                Synthetic alpha-tocopherol                                (E 307)
                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 formulae and
                                                                                            follow-up milks (')
           — Mono- and diglycerides of fatty acids                        (E 471)           In a concentration of not more than
                                                                                            0,4 g/100 ml in infant formulae 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                                              (E 410)           In a concentration of not more than
                                                                                            0,1 g/100 ml in follow-up milks (2)
           — Guar gum                                                     (E 412)           In a concentration of not more than
                                                                                            0,1 g/100 ml in follow-up milks (2)
           — Citric acid
           — L ( + ) Lactic acid
           — Cultures producing L (-1-) 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, E 410 and E 412 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                                            N o sucrose is present.
               Lactose                                            Lactose is the only carbohydrate used.
               Iron                                               The iron is added.
 ---pagebreak--- N o C 285/18                            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                     12. 11. 86
                                                                  ANNEX     VI
                                                       REFERENCE PROTEINS
                                                                    PARTI
                                                                 Human milk
                                                              '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
                                Methionine                                                     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 OF 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 matter      per 1 g of proteins
           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 (ug)                                                                  225                         6
           Iodine                                                                Not specified                Not specified