14.2.2003 Official Journal of the European Union L 41/37 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) 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 intended for particular nutritional uses (), as last amended by Directive 1999/41/EC of the European Parliament and of the Council (), and in particular Article 4(1) thereof, Having regard to the opinion of the Scientific Committee on Food, Whereas: 1 2 4 () O] () O () O] () O Article 6 of Commission Directive 91/321/EEC (%), as last amended by Directive 1999/50/EC (¥), stipulates that infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. On the basis of opinions given by the Scientific Committee on Food on 19 September 1997 and 4 June 1998, Directive 91/321/EEC established a general maximum residue level of 0,01 mg/kg for any individual pesticide in infant formulae and follow-on formulae. In the case of a small number of pesticides or metabo- lites of pesticides even a maximum residue level of 0,01 mg/kg might, under worst-case intake conditions, allow infants and young children to exceed the accep- table daily intake. This is the case for pesticides or meta- bolites of pesticides with an acceptable daily intake lower than 0,0005 mg/kg body weight. Directive 91/321/EEC establishes the principle of the prohibition of the use of these pesticides in the produc- tion of agricultural products intended for infant formulae and follow-on formulae. The pesticides in question should be listed in Annex IX to Directive 91/321/EEC. However, this prohibition does not necessarily guarantee L 186, 30.6.1989, p. 27. L 172, 8.7.1999, p. 38. L 175, 4.7.1991, p. 35. L 139, 2.6.1999, p. 29. ) 0J that products are free from such pesticides, since some pesticides contaminate the environment and their resi- dues may be found in the products concerned. The health of infants and young children can be better protected by applying additional requirements which can be enforced by analysis regardless of a product's origin. Most of the pesticides which have acceptable daily intake values lower than 0,0005 mg/kg body weight are already prohibited in the Community or will be prohib- ited by July 2003. The prohibited pesticides should not be detectable in infant formulae and follow-on formulae by state of the art analytical methods. However, some pesticides degrade slowly and still contaminate the envir- onment. They might be present in infant formulae and follow-on formulae even if they have not been used. For the purposes of control, a harmonised approach has to be followed. Pending Commission decisions on whether they satisfy the safety requirements of Article 5 of Council Directive 91/414[EEC of 15 July 1991 concerning the placing of plant protection products on the market (), as last amended by Commission Directive 2003/5/EC (°), the continued use of authorised pesticides should be permitted as long as their residues comply with the maximum residue levels established in the present Direc- tive. The latter should be set at levels ensuring that their respective acceptable daily intake values are not exceeded by infants and young children under worst- case intake conditions. Directive 91/321/EEC should be amended accordingly. The measures provided for in this Directive are in accor- dance with the opinion of the Standing Committee on the Food Chain and Animal Health, ’ L 230, 19.8.1991, p. 1. L 8,14.1.2003, p. 7.