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The current study is based on the AFM1 contamination of milk determined from April 2013 to December 2018 in the framework of a self-control plan of six milk processing plants in Italy. These data – together with the consumption data of milk consumers – were evaluated and used for the calculation of the Estimated Daily Intake (EDI), the Hazard Index (HI), and the fraction of hepatocarcinoma cases (HCC) due to AFM1 exposure in different population groups. Altogether a total of 31,702 milk samples were analyzed, representing 556,413 tons of milk, which is an outstanding amount compared to published studies. The results indicate the monthly fluctuation of AFM1 levels through a period of nearly 6 years. The EDI of AFM1 in different population groups was in the range of 0.025–0.328 ng kg−1 body weight (bw) per day, based on the average consumption levels and weighted mean contamination of the milk in the study period. Considering average consumptions, in the groups of infants and toddlers, the HI calculation resulted in 1.64 and 1.4, respectively, while for older age groups, it was <1. The estimated fractions of HCC incidences attributable to the AFM1 intakes were 0.005 and 0.004 cases per 100,000 individuals in the 0–0.9 and 1–2.9-year age groups, respectively, and below 0.004 cases in the other age categories. The monthly average AFM1 contamination of tested milk consignments ranged between 7.19 and 22.53 ng kg−1. Although the results of this extensive investigation showed a low risk of HCC, the variability of climatic conditions throughout years that influence AFB1 contamination of feed and consequently AFM1 contamination of milk justifies their continuous monitoring and update of the risk assessment. [ABSTRACT FROM AUTHOR]

Aflatoxin M1(AFM1) contamination in 21 969 milk samples taken in Italy during 2005–08 and 2010 provided the basis for designing an early warning self-control plan. Additionally, 4148 AFM1 data points from the mycotoxin crisis (2003–04) represented the worst case. No parametric function provided a good fit for the skewed and scattered AFM1 concentrations. The acceptable reference values, reflecting the combined uncertainty of AFM1 measured in consignments consisting of milk from one to six farms, ranged from 40 to 16.7 ng kg−1, respectively. Asymmetric control charts with these reference values, 40 and 50 ng kg−1warning and action limits are recommended to assess immediately the distribution of AFM1 concentration in incoming consignments. The moving window method, presented as a worked example including 5 days with five samples/day, enabled verification of compliance of production with the legal limit in 98% of the consignments at a 94% probability level. The sampling plan developed assumes consecutive analyses of samples taken from individual farms, which makes early detection of contamination possible and also immediate corrective actions if the AFM1 concentration in a consignment exceeds the reference value. In the latter case different control plans with increased sampling frequency should be applied depending on the level and frequency of contamination. As aflatoxin B1increases in feed at about the same time, therefore a coordinated sampling programme performed by the milk processing plants operating in a confined geographic area is more effective and economical then the individual ones. The applicability of the sample size calculation based on binomial theorem and the fast response rate resulting from the recommended sampling plan were verified by taking 1000–10 000 random samples with replacement from the experimental databases representing the normal, moderately and highly contaminated periods. The efficiency of the control plan could be substantially enhanced if the dairy farms used feed with a tolerable level of AFB1. [ABSTRACT FROM AUTHOR]

The presence of aflatoxin M1(AFM1) in milk was assessed in Italy in the framework of designing a monitoring plan actuated by the milk industry in the period 2005–10. Overall, 21 969 samples were taken from tankers collecting milk from 690 dairy farms. The milk samples were representative of the consignments of co-mingled milk received from multiple (two to six) farms. Systematic, biweekly sampling of consignments involved each of the 121 districts (70 in the North, 17 in the Central and 34 in the South regions of Italy). AFM1 concentration was measured using an enzyme-linked immunoassay method (validated within the range of 5–100 ng kg−1) whereas an HPLC method was used for the quantification of levels in the samples that had concentrations higher than 100 ng kg−1. Process control charts using data collected in three processing plants illustrate, as an example, the seasonal variation of the contamination. The mean concentration of AFM1 was in the range between 11 and 19 ng kg−1. The 90th and 99th percentile values were 19–34 and 41–91 ng kg−1, respectively, and values as high as 280 ng kg−1were reached in 2008. The number of non-compliant consignments (those with an AFM1 concentration above the statutory limit of 50 ng kg−1) varied between 0.3% and 3.1% per year, with peaks in September, after the maize harvest season. The variability between different regions was not significant. The results show that controlling the aflatoxins in feed at farm level was inadequate, consequently screening of raw milk prior to processing was needed. The evaluation of the AFM1 contamination level observed during a long-term period can provide useful data for defining the frequency of sampling. [ABSTRACT FROM AUTHOR]