Directive 2006/141 / EC

The production, sale and requirements for milk formula for feeding infants in the EU market began to be regulated in 1989. Certain provisions of Directive 89/398 / EEC of May 3, 1989 on the approximation of the laws of the Member States in relation to foods intended for special dietary purposes also referred to baby food ^[1] .

Subsequently, the European legislator developed a more specific legislative framework for the regulation of controversial issues regarding the requirements for milk formula for feeding infants. Such a document was the European Commission Directive 91/321 / EEC “On milk formula for feeding infants and subsequent mixtures for feeding young children”. Subsequently, changes and innovations in the baby food industry led to the adoption of an updated act, which became - Directive of the European Commission 2006/141 / EC of December 22, 2006 ^{[2] [3]} .

Structure

• Preamble (Whereas, consists of n ^[4] .1-34);
• Art. 1-21 (Articles 1-21);
• Appendix I. Essential composition of infant formula reconstituted in accordance with the manufacturer's instructions (Annex I Essential composition of infant formulae when reconstituted as instructed by the manufacturer);
• Appendix II The basic composition of the subsequent infant formula reconstituted according to the manufacturer’s instructions (Annex II Essential composition of follow-on formulae when reconstituted as instructed by the manufacturer);
• Appendix III. Nutrients (Annex III Nutritional substances);
• Appendix IV Statements of nutritional value and health benefits and conditions guaranteeing these statements (Annex IV Nutrition and health claims for infant formulae and conditions warranting a corresponding claim);
• Appendix V. Indispensable and conditionally indispensable amino acids in breast milk;
• Appendix VI. Specification for protein content and source, and protein processing in the manufacture of infant formulas with a protein content of less than 0.56 g / 100 kJ (2.25 g / 100 kcal) produced from whey hydrolysates derived from cow's milk protein (Annex VI Specification for the protein content and source and the processing of protein used in the manufacture of infant formulae with a protein content less than 0.56 g / 100 kj (2.25 g / 100 kcal) manufactured from hydrolysates of whey proteins derived from cows' milk protein);
• Appendix VII. Reference values ​​for nutrition labeling for foods intended for infants and young children;
• Appendix VIII. Pesticides, the use of which is prohibited in the agricultural production of products used for the production of mixtures for the nutrition of infants and young children (Annex VIII Pesticides which shall not be used in agricultural production intended for the production of infant formulae and follow on formulae);
• Appendix IX. Special level of maximum residue of pesticides or metabolites of pesticides in infant formula and formula for subsequent feeding (Annex IX Specific maximum residue levels of pesticides or metabolites of pesticides in infant formulae and follow-on formulae);
• Appendix X (Annex X);
• Appendix XI. Correlation table (Annex XI Correlation table) ^{[5] [6]} .

Tasks

The main objective of Directive 2006/141 / EC was to provide guarantees for the protection of the health of infants while feeding them adapted infant formula, which contains only ingredients that are allowed to be consumed during the first months of life before the introduction of appropriate complementary foods. A secondary objective was the systematization and adoption of common criteria at the EU level in order to ensure the protection of public health recommended by international organizations such as the Joint Expert Commission on Food Additives ( JECFA ), the World Health Organization ( WHO ) and the United Nations Food and Agriculture Organization (FAO), as well as the criteria enshrined in the European Pharmacopoeia (EUP) ^[5] .