No L 49/12 Official Journal of the European Communities 28. 2. 96 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) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European 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 (), and in particular Article 4 thereof, Whereas given the nature of infant formulae and follow-on formulae the detailed rules as to nutrient decla- ration on the labelling need to be clarified in order to avoid any problems which may arise from the application of other relevant Community legislation; Whereas new scientific data justify certain modifications to the mandatory essential composition of infant formulae and follow-on formulae specified in Annexes I and II to Commission Directive 91/321/EEC (), as amended by the Act of Accession of Austria, Finland and Sweden; Whereas nucleotides, being the natural constituents of human milk, have been used to supplement infant formulae and follow-on formulae for many years in Member States and third countries without any negative effects; whereas therefore there is no justification for prohibiting their use in the manufacture of these products; Whereas technological progress has resulted in the production of infant formulae, based on protein partial hydrolysates, which due to their low levels of immuno- reactive proteins may be useful; whereas for this reason a claim as to these particular characteristics should be permitted; whereas these products are distinct from semi- elemental diet products based on high degree hydro- lysates used for the dietary management of diagnosed medical conditions, which are not covered by this Direc- tive; Whereas Directive 91/321/EEC should be amended accordingly; () OJ No L 186, 30. 6. 1989, p. 27. ) OJ No L 175, 4. 7. 1991, p. 35. Whereas the Scientific Committee for Food, in accor- dance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health; Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 91/321/EEC is amended as follows: 1. Article 6 is replaced by the following: ‘Article 6 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 shall be established without delay. Microbiological criteria- shall also be established as necessary.’ 2. Article 7 is amended as follows: (a) Points (d) and (e) of paragraph 2 are replaced by the following: (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 appli- cable of choline, inositol, carnitine and taurine, expressed in numerical form, per 100 ml of the product ready for use; (b) The following is inserted as paragraph 2a: ‘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;