Government Decree No. 899 validating Sanitary Regulation on the addition of vitamins and minerals, as well as certain other substances, to foodstuffs.

This Government Decree implements Regulation (EC) No. 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods, Regulation (EC) No. 108/2008 of the European Parliament and of the Council amending Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, Commission Regulation (EC) No. 1170/2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements, Commission Regulation (EU) No. 1161/2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No. 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No. 953/2009 as regards the lists of mineral substances that can be added to foods, Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, Commission Regulation (EU) No. 119/2014 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods. This Regulation governs the addition of vitamins and minerals to foodstuffs, as well as the use of certain substances of a different type, which are added to foodstuffs or used in food production, in conditions that lead to the consumption of a higher quantities than are determined for consumption under normal conditions of consumption with a balanced and varied nutrition. This Regulation harmonizes the provisions on the addition of vitamins and minerals to foodstuffs, as well as the use of certain substances of another type to ensure the effective functioning of the internal market, while ensuring a high level of consumer protection. This Regulation applies without prejudice to special provisions, stipulated by national legislation regarding: (a) foodstuffs intended for special purposes of food use, and, in the absence of special provisions, requirements for the composition of these foodstuffs, which became necessary due to the special nutritional needs of persons for whom they are intended; (b) new foodstuffs and new food ingredients; (c) genetically modified foodstuffs; (d) food additives and food flavors; and (e) enological methods and processes. Only vitamins and/or minerals, listed in the Annex 1, in the forms listed in the Annex 2, shall be added to foodstuffs, in compliance with the norms established by this Regulation. Vitamins and minerals shall be added to foodstuffs in the form, biologically accessible to the human body, which allows the body to use them regardless of whether they are contained or not contained in a natural way, taking into account, in particular: (a) deficiency of one or more vitamins and/or minerals in specific groups of the population, which can be confirmed by clinical or subclinical studies of the deficit or found due to low nutrient intake; (b) the possibility of improving the situation regarding the nutrition of the population or specific groups of population groups and/or correcting possible shortcomings in consumption of vitamins or minerals from food caused by changes in nutritional habits; and (c) development of scientific knowledge about the role of vitamins and minerals in nutrition and health consequences.