A method for establishing risk control values of perchlorate in infant formula raw materials based on a probabilistic model

ObjectiveTo establish a method for determining reasonable control levels of perchlorate in raw materials for infant formula by applying a probabilistic model.MethodsBased on the levels of perchlorate in the raw materials of infant formula and the constituent ratio of ingredients， a probabilistic model between raw materials and final products was established using Monte Carlo simulation and the key influencing raw materials were identified through sensitivity analysis. The content threshold of perchlorate in the key raw material， which is the reasonable control level， was found by using step-back method according to the limit of perchlorate in infant formula.ResultsAt the initial levels of perchlorate contamination in raw milk， milk powder， lactose， whey protein powder and other ingredients collected in this study， the probability that the perchlorate level in the final product exceeded the limit value set by the European Union， which is 1.6% when a certain formula is used to manufacture infant formula. Sensitivity analysis showed that raw milk was the ingredient that has the greatest impact on the perchlorate content in the final product. Given that the perchlorate in other raw materials remains the current level， the perchlorate content in raw milk should be controlled below 43.6 µg/kg， to ensure a probability exceeding 99.9% that the perchlorate content in infant formula powder remains below the regulatory limit value. When taking this value as the risk control level for perchlorate in raw milk， the current ratio of raw milk samples exceeding this level was approximately 3.5%.ConclusionThe method established in this study can effectively simulate the probability distributions of stable chemical contaminants when transferring from raw materials to the final product and identify the most influential ingredient. By applying this method， the reasonable control level of perchlorate in raw materials of infant formula can be proposed， providing a scientific basis for infant formula enterprises to prevent and control risks associated with raw materials.