Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae
Modified by
Actconcerning 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)
Decision of the Council of the European Unionof 1 January 1995adjusting the instruments concerning the accession of new Member States to the European Union(95/1/EC, Euratom, ECSC), 11994N31995D0001, August 29, 1994
Decision of the Council of the European Unionof 1 January 1995adjusting the instruments concerning the accession of new Member States to the European Union(95/1/EC, Euratom, ECSC), 31995D0001, January 1, 1995
Commission Directive 96/4/ECof 16 February 1996amending Directive 91/321/EEC on infant formulae and follow-on formulae(Text with EEA relevance), 31996L0004, February 28, 1996
Commission Directive 1999/50/ECof 25 May 1999amending Directive 91/321/EEC on infant formulae and follow-on formulae(Text with EEA relevance), 31999L0050, June 2, 1999
Commission Directive 2003/14/ECof 10 February 2003amending Directive 91/321/EEC on infant formulae and follow-on formulae(Text with EEA relevance), 32003L0014, February 14, 2003
Actconcerning 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
Third procès-verbal of rectificationto 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)andthe 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), 12003T12003T0000R(10), September 23, 2003
Commission Directive 2006/82/ECof 23 October 2006adapting 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, 32006L0082, December 20, 2006
Commission Directive 2006/141/ECof 22 December 2006on infant formulae and follow-on formulae and amending Directive 1999/21/EC(Text with EEA relevance), 32006L0141, December 30, 2006
Corrected by
Third procès-verbal of rectification, 12003T0000R(10), February 27, 2007
Commission Directiveof 14 May 1991on infant formulae and follow-on formulae(91/321/EEC)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 usesOJ No L 186, 30. 6. 1989, p. 27., 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 consumerOJ No L 33, 8. 2. 1979, p. 1., as last amended by Directive 89/395/EECOJ No L 186, 30. 6. 1989, p. 17.; 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: