Commission Directive of 14 May 1991 on infant formulae and follow-on formulae (91/321/EEC) (repealed)

Commission Directive

of 14 May 1991

on infant formulae and follow-on formulae

(91/321/EEC) (repealed)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses(1), and in particular Article 4 thereof,

Whereas the essential composition of the products in question must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data;

Whereas on the basis of these data the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture can already be defined; whereas the same is not true for preparations based wholly or partly on other sources of protein; whereas for this reason specific rules for such products, if necessary, will therefore have to be adopted at a later date;

Whereas this Directive reflects current knowledge about these products; whereas any modification, to allow innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;

Whereas because of the persons for which these products are intended it will be necessary to lay down microbiological criteria and maximum levels for contaminants; whereas given the complexity of the subject these will have to be adopted at a later stage;

Whereas infant formula is the only processed foodstuff 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 suitable for such use during the period would be infant formulae;

Whereas pursuant to Article 7 (1) of Directive 89/398/EEC the products covered by this Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer(2), as last amended by Directive 89/395/EEC(3); whereas this Directive adopts and expands upon the additions and exceptions to those general rules, where it is appropriate, in order to promote and protect breast-feeding;

Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling for the energy value and principal nutrients they contain; whereas, on the other hand, the method of use must be specified in conformity with Article 3 (1) (8) and Article 10 (2) of Directive 79/112/EEC, in order to prevent inappropriate uses likely to be detrimental to the health of infants;

Whereas, pursuant to Article 2 (2) of Directive 79/112/EEC, and in order to supply objective and scientifically verified information, it is necessary to define the conditions under which claims about the particular composition of an infant formula are authorized;

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

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

Whereas this Directive does not concern the conditions of sale of publications specializing in baby care and of scientific publications;

Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health;

Whereas issues relating to products intended for export to third countries should be dealt with in a coherent and homogeneous manner in a separate measure;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

(1)

OJ No L 186, 30. 6. 1989, p. 27.

(2)

OJ No L 33, 8. 2. 1979, p. 1.

(3)

OJ No L 186, 30. 6. 1989, p. 17.