The Risk Assessment Of Micronutrient Food Fortification Amend Standards In Applied Research

[Background] The problems of nutritional deficiency and nutritional imbalance coexist in Chinese population:on the one hand, due to the imbalance of dietary structure and economic development, nutrition deficiency diseases still exist in some areas, on the other hand, with the increase of income and standard of living, the structure of food consumption and living style have experienced significant changes, resulting in nutritional imbalance or overnutrition. While encouraged with mass fortification, the market was increasingly filled with fortified food, nutrition formulas, and nutrient supplements, which inevitably increase the chance of micronutrient intake including vitamins and minerals. The concerns on whether or not food fortification will cause overconsumption and nutritional imbalance have urged government authority to initiate the revise of GB14880-1994, national mandatory standard for the use of food fortificants, and adjust the micronutrient fortification levels in various foods, especially for maximum upper level (i.e. the maximum safety level for fortification).[Objectives] To provide scientific suggestions and recommendations on the revise of national standard through the risk assessment on a variety of high-risk class micronutrients, and guarantee that total nutrient intake of the most majority of population is lower than the tolerable upper intake level, UL.[Subject and method] The methodological progress for the risk assessment of micronutrients in some countries and international organizations has been reviewed via literature and regulatory standard retrieval. Based on that, the international and domestic standards for food fortification were compared and a framework for the revise of GB14880 was provided. In accordance with the basic principles of risk assessment, four high-risk class micronutrients including iron, calcium, zinc and vitamin A were fully evaluated:the safety assessment of mass fortification in soybean source, flower, vegetable oil was performed by using EAR-UL cut-point method; the assessment was performed on market-driven food fortifications including biscuit, breakfast cereal, and milk powder by using energy-based MSFL method.[Results] Based on the situation of our country, it is preferable to restrict the regulation on food fortification and clarify the situation and condition where food fortification may be applicable. The monitoring on fortified food production need to be enhanced accordingly, the specific items of inappropriate food fortification carriers should to be deleted. Micronutrients should be classified based on their risk characteristics:specific assessment on the population dietary data is required for class A (UL/RNL<5) nutrient; for class B nutrients (UL/RNI:5～100), it is preferable to regulate the daily intake of the nutrient through fortified foods ranging from 50% NRV to 100%NRV; for class C (UL/RNI>100), it is suggested for food manufactures to design formula based on the nutrition requirements of target population, and in principle, the daily intake through the food should not exceed 100%NRV. It is not necessary to set concrete fortification upper level in mandatory national standards for class C nutrients. The risk assessment results of the 4 class A nutrients were as follows:Iron:maintain the existing requirements on fortified soybean source, while adjust the fortification level to 14-26mg/kg in flours; fortification upper level of formula powder for pregnant women should be set at 100 mg/kg; a little bit decrease the fortification maximum level in breakfast cereals and milk powder;.Calcium:decrease the maximum level of flours to 2.1 mg/kg; maintain the levels for biscuit and cake products; increase the maximum level of milk powder to 8g/kg; combine the limits of all kinds of beverages not based on use level but the level contained in the product while consuming.Vitamin A:maintain the existing requirements on vegetable oil and prohibit the addition in flours; adjust the fortification maximum level in pregnant women formulas powder to 8000μgRE/kg.Zinc:maintain current requirements, and combine the limits of all kinds of beverages not based on use level but the level contained in the product while consuming.It is necessary to enhance the labeling management of fortified foods; the actual levels should be labeled as according to final products, especially for those food specifically for pregnant women and children.[Conclusion] The risk assessment of micronutrients can identify all nutrient intake-related hazards and adverse heath effects. Through scientific evaluation on the dietary nutritional status of individuals and populations, the full-scale and clear risk characterizations of nutrients can be provided for food fortification manager. The inevitable trend that modification and revise of national food fortification regulations, rules and standards need to be based on the risk assessment of micronutrients is also the requirement of food safety law and international trade and reasonable SPS measurements. The EAR-UL cut-point method and energy-based MSFL model follow the basic principles of risk assessment, and provide risk manager the risk characterization based on individual dietary data. This dissertation successfully and productively explored the safety items on mass fortification and determined the fortification maximum levels for market-driven food fortification, the results and conclusions are of significance for the decision maker, and it is advised to incorporate this piece of information in the modification and establishment of fortification standards after comprehensive evaluation.