This Regulation prescribes the set of conditions aimed for infant food formulas and follow-on formulas for infants and young children (composition, labelling, advertising). The initial formulas must be in accordance with the composition criteria set out in Annex I, taking into account Annex V to this Regulation (article 7).
These rules are in accordance with the provisions of the Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC; and Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae; Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (see article 1 for the complete list of reference documents).
The list of Annexes is here as follows: Annex I: Basic composition of infant formulas prepared according to the manufacturer's instructions; Annex II: Basic composition of follow-on formulas for infants and young children prepared according to the manufacturer's instructions; Annex III: Nutrients; Annex IV: Nutrition and health claims for infant formulas and conditions justifying the appropriateness of the claims; Annex V: Indispensable and conditionally essential amino acids in breast milk; Annex VI: Specification for protein content, protein source and protein processing used for the production of infant formulas and follow-on formulas; Annex VII: Reference values for nutrition labeling of foods intended for infants and young children; Annex VIII: Pesticides not to be used in agricultural products intended for the production of infant formulas and follow-on formulas; Annex IX: Specific maximum levels for pesticide residues and pesticide metabolites in infant formulas and follow-on formulas.