Commission Directive of 14 May 1991 on infant formulae and follow-on formulae (91/321/EEC) (repealed)

Article 1 U.K.

1. This Directive is a specific Directive within the meaning of Article 4 of Directive 89/398/EEC and lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health in the Community. It also provides for Member States to give effect to principles and aims of the International Code of Marketing of Breast-Milk Substitutes dealing with marketing, information and responsibilities of health authorities.

2. For the purposes of this Directive,

(a) ‘infants’ means children under the age of 12 months;

(b) ‘young children’ means children aged between one and three years;

(c) ‘infant formulae’ means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons;

(d) ‘follow-on formulae’ means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons[F1 ;]

[F2 (e) ‘pesticide residue’ means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC (1) , including its metabolites and products resulting from its degradation or reaction.]

Textual Amendments

F1 Substituted by Commission Directive 1999/50/EC of 25 May 1999 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

F2 Inserted by Commission Directive 1999/50/EC of 25 May 1999 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

Article 2 U.K.

Member States shall ensure that the products referred to in Article 1 (2) (c) and (d) may be marketed within the Community only if they conform to the definitions and rules laid down in this Directive. No product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.

Article 3 U.K.

1. Infant formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data.

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

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

Article 4 U.K.

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

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

3. In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.

Article 5 U.K.

1. Only the substances listed in Annex III may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on:

• mineral substances,

• vitamins,

• amino acids and other nitrogen compounds,

• other substances having a particular nutritional purpose.

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

2. The provisions relating to the use of additives in the manufacture of infant formulae and follow-on formulae shall be laid down in a Council directive.

[F1 Article 6 U.K.

[F3 1. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels for substances other than those referred to in paragraphs 2 and 3 shall be established without delay.]

2. Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.

Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.

[F3 3. (a) Those pesticides listed in Annex IX shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae. However, for the purpose of control:

(i)

pesticides listed in Table 1 of Annex IX are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level which is considered to be the limit of quantification of the analytical methods shall be kept under regular review in the light of technical progress;

(ii)

pesticides listed in Table 2 of Annex IX are considered not to have been used if their residues do not exceed a level of 0,003 mg/kg. This level shall be kept under regular review in the light of data on environmental contamination.

(b) By derogation of paragraph 2, for the pesticides listed in Annex X, the maximum residue levels specified therein shall apply.

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

(c) The levels referred to in subparagraphs (a) and (b) shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.]

4. Microbiological criteria shall be established as necessary.]

Textual Amendments

F1 Substituted by Commission Directive 1999/50/EC of 25 May 1999 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

F3 Substituted by Commission Directive 2003/14/EC of 10 February 2003 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

Article 7 U.K.

1. The name under which the products covered by Article 1 (2) are sold shall be, respectively:

• in English:

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

• in Danish:

  ‘Modermælkserstatning’ and ‘Tilskudsblanding’,

• in German:

  ‘Säuglingsanfangsnahrung’ and ‘Folgenahrung’,

• in Greek:

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

• in Spanish:

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

• in French:

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

• in Italian:

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

• in Dutch:

  ‘Volledige zuigelingenvoeding’ and ‘Opvolgzuigelingenvoeding’,

• in Portuguese

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

• [F4 [F5 in Finnish:

  ‘ Äidinmaidonkorvike ’ and ‘ Vieroitusvalmiste ’ ,

• in Swedish:

  ‘ Modersmjölksersättning ’ and ‘ Tillskottsnäring ’ [F6 ,] ] ]

• [F7 in Czech:

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

• in Estonian:

  ‘ imiku piimasegu ’ and ‘ jätkupiimasegu ’,

• [X1 in Latvian:

  ‘ Maisījums zīdaiņiem līdz četru-sešu mēnešu vecumam ’ and ‘ Maisījums zīdaiņiem no četru mēnešu vecuma ’ ,]

• in Lithuanian:

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

• in Hungarian:

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

• in Maltese:

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

• in Polish:

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

• in Slovenian:

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

• in Slovak:

  ‘ počiatočná dojčenská výživa ’ and ‘ následná dojčenská výživa ’ [F8 ,] ]

• [F9 in Bulgarian:

  ‘ храни за кърмачета ’ and ‘ преходни храни ’,

• in Romanian:

  ‘ preparate pentru sugari ’ and ‘ pentru copii de vârstă mică ’.]

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

• in English:

  ‘Infant milk’ and ‘follow-on milk’,

• in Danish:

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

• in German:

  ‘Säuglingsmilchnahrung’ and ‘Folgemilch’,

• in Greek:

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

• in Spanish:

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

• in French:

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

• in Italian:

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

• in Dutch:

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

• in Portuguese:

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

• [F4 [F5 in Finnish:

  ‘ Maitopohjainen äidinmaidonkorvike ’ and ‘ Maitopohjainen vieroitusvalmiste ’ ,

• in Swedish:

  ‘ Modersmjölksersättning uteslutande baserad på mjölk ’ and ‘ Tillskottsnäring uteslutande baserad på mjölk ’ [F6 ,] ] ]

• [F7 in Czech:

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

• in Estonian:

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

• [X1 in Latvian:

  ‘ Piens zīdaiņiem līdz četru-sešu mēnešu vecumam ’ and ‘ Piens zīdaiņiem no četru mēnešu vecuma ’ ,]

• in Lithuanian:

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

• in Hungarian:

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

• in Maltese:

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

• in Polish:

  ‘ mleko początkowe ’ and ‘ mleko następne ’,

• in Slovenian:

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

• in Slovak:

  ‘ počiatočná dojčenská mliečna výživa ’ and ‘ následná dojčenská mliečna výživa ’ [F8 ,] ]

• [F9 in Bulgarian:

  ‘ млека за кърмачета ’ and ‘ преходни млека ’,

• in Romanian:

  ‘ lapte pentru sugari ’ and ‘ pentru copii de vârstă mică ’.]

2. The labelling shall bear, in addition to those provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars:

(a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast-fed;

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

(c) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of four months, that it should form only part of a diversified diet and that it is not to be used as a substitute for breast milk during the first four months of life;

[F10 (d) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use;

(e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol, carnitine and taurine, expressed in numerical form, per 100 ml of the product ready for use;]

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

[F11 2a. The labelling may bear:

(a) the average quantity of nutrients mentioned in Annex III when such declaration is not covered by the provisions of paragraph 2 (e) of this Article, expressed in numerical form, per 100 ml of the product ready for use;

(b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in Annex VIII, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use, provided that the quantities present are at least equal to 15 per cent of the reference values;]

3. The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast-feeding. The use of the terms ‘humanized’, ‘maternalized’, or similar terms shall be prohibited. The term ‘adapted’ may only be used in conformity with paragraph 6 and Annex IV, point 1.

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

(a) a statement concerning the superiority of breast-feeding;

(b) a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care.

5. The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealize the use of the product. It may, however, have graphic representations for easy identification of the product and for illustrating methods of preparation.

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

7. The requirements, prohibitions and restrictions referred to in paragraphs 3 to 6 shall also apply to:

(a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;

(b) advertising.

Editorial Information

X1 Substituted by Third procès-verbal of rectification to the Treaty between the Kingdom of Belgium, the Kingdom of Denmark, the Federal Republic of Germany, the Hellenic Republic, the Kingdom of Spain, the French Republic, Ireland, the Italian Republic, the Grand Duchy of Luxembourg, the Kingdom of the Netherlands, the Republic of Austria, the Portuguese Republic, the Republic of Finland, the Kingdom of Sweden, the United Kingdom of Great Britain and Northern Ireland (Member States of the European Union) and the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia, the Slovak Republic, concerning the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union (Official Journal of the European Union L 236 of 23 September 2003).

Textual Amendments

F4 Inserted by Act concerning the conditions of accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded (94/C 241/08).

F5 Substituted by Decision of the Council of the European Union of 1 January 1995 adjusting the instruments concerning the accession of new Member States to the European Union (95/1/EC, Euratom, ECSC).

F6 Substituted by Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded.

F7 Inserted by Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded.

F8 Substituted by Commission Directive 2006/82/EC of 23 October 2006 adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania.

F9 Inserted by Commission Directive 2006/82/EC of 23 October 2006 adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania.

F10 Substituted by Commission Directive 96/4/EC of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

F11 Inserted by Commission Directive 96/4/EC of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance).

Article 8 U.K.

1. Advertising of infant formulae shall be restricted to publications specializing in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertisements for infant formulae shall be subject to the conditions laid down in Article 7 (3), (4), (5), (6) and (7) (b) and contain only information of a scientific and factual nature. Such information shall not imply or create a belief that bottle-feeding is equivalent or superior to breast-feeding.

2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales.

3. Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly via the health care system or health workers.

Article 9 U.K.

1. Member States shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition covering the planning, provision, design and dissemination of information and their control.

2. Member States shall ensure that informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear information on all the following points:

(a) the benefits and superiority of breast-feeding;

(b) maternal nutrition and the preparation for and maintenance of breast-feeding;

(c) the possible negative effect on breast-feeding of introducing partial bottle-feeding;

(d) the difficulty of reversing the decision not to breast-feed;

(e) where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.

When such materials contain information about the use of infant formulae, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of improper use of infant formulae. Such material shall not use any pictures which may idealize the use of infant formulae.

3. Member States shall ensure that donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the appropriate national authority or within guidelines given by that authority for this purpose. Such equipment or materials may bear the donating company's name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system.

4. Member States shall ensure that donations or low-price sales of supplies of infant formulae to institutions or organizations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who have to be fed on infant formulae and only for as long as required by such infants.

Article 10 U.K.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Those provisions shall be applied in such a way as to:

• permit trade in products complying with this Directive, by 1 December 1992,

• prohibit trade in products which do not comply with this Directive, with effect from 1 June 1994.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 11 U.K.

This Directive is addressed to the Member States.