Advancing food safety risk assessment in China: development of new approach methodologies (NAMs).

Novel techniques and methodologies are being developed to advance food safety risk assessment into the next-generation. Considering the shortcomings of traditional animal testing, new approach methodologies (NAMs) will be the main tools for the next-generation risk assessment (NGRA), using non-animal methodologies such as in vitro and in silico approaches. The United States Environmental Protection Agency and the European Food Safety Authority have established work plans to encourage the development and application of NAMs in NGRA. Currently, NAMs are more commonly used in research than in regulatory risk assessment. China is also developing NAMs for NGRA but without a comprehensive review of the current work. This review summarizes major NAM-related research articles from China and highlights the China National Center for Food Safety Risk Assessment (CFSA) as the primary institution leading the implementation of NAMs in NGRA in China. The projects of CFSA on NAMs such as the Food Toxicology Program and the strategies for implementing NAMs in NGRA are outlined. Key issues and recommendations, such as discipline development and team building, are also presented to promote NAMs development in China and worldwide.

The occurrence and probabilistic risk assessment of 3-MCPDEs and GEs in infant formulas from Chinese market employing Monte Carlo simulation technique.

3-monochloropropane-1,2-diol esters (3-MCPDEs) and glycidyl esters (GEs) are food contaminants and have arisen continuous attention due to their toxicity, especially towards infants. Current risk assessment of these contaminants was mostly employing deterministic approaches, lacking quantitative characterization of the likelihood, incidence, or severity of the risks involved. Herein, 3-MCPDE and GE levels in 46 representative infant formulas (IFs) from Chinese market were determined by GC-MS/MS. Then, combining the occurrence data and consumption data from China National Food Consumption Survey, the Monte Carlo simulation-based probabilistic model for risk assessment of 3-MCPDEs and GEs in IFs from Chinese market was established. The results showed that all P90 (90th percentiles) hazard quotient values were below 1, demonstrating 3-MCPDEs didn't pose health risks to most populations aged 0-36 months old. However, for 0-12 months old groups, P10 (10th percentiles) margin of exposure values were all below 25000, indicating GEs may pose potential risks to 10% of this group. Uncertainty analysis revealed that the probabilistic model had considered uncertainties of model input and distribution, and realized refined assessment. This study is the first report on probabilistic assessment of 3-MCPDEs and GEs in IFs, which also provided references for the formulation of related regulatory limits in China.

Monosodium Glutamate Intake and Risk Assessment in China Nationwide, and a Comparative Analysis Worldwide.

The sixth Total Diet Study (TDS) of China included a countrywide study to assess the health effects of MSG (monosodium glutamate). MSG detection, consumption analysis, and risk assessment were conducted on 168 samples from seven food categories of the most typical Chinese daily diet. The highest value of MSG in the daily diet of the Chinese population was 8.63 g/kg. An MSG intake of 17.63 mg/kg bw/d for the general population of China was obtained from content measurements combined with food consumption, while the data from the apparent consumption survey alone gave 40.20 mg/kg bw/d. The apparent consumption did not consider the loss of MSG during food cooking, resulting in an overestimate. To offer a global perspective, MSG content, food category contributions, and ingestion levels across nations were summarized and thoroughly investigated. A realistic, logical, and precise risk assessment protocol for MSG daily intake was developed in this article.

Risk assessment of eighteen elements leaching from ceramic tableware in China.

Ceramic products are among the most frequently used food contact materials. Health risks associated with ceramic tableware usually arise from the migration of heavy metals. In this study, 767 pieces of ceramic tableware of different shapes and types were collected across China, and the migration levels of 18 elements were determined using inductively coupled plasma mass spectrometry. Migration tests were conducted according to the Chinese National Food Safety Standard - Ceramic Ware (GB 4806.4) with microwaveable and non-microwavable samples under different conditions. The food consumption of consumers via different shapes of ceramic tableware was obtained through a self-reported web-based survey, and the estimated dietary intakes of the studied elements were calculated accordingly. The exposure assessment showed that certain metals leached from the ceramic tableware at levels of concern. In addition, the applicability of the migration experiment conditions for microwaveable ceramic ware in GB 4806.4 needs to be further investigated.

Dietary Exposure Assessment of Rare Earth Elements in the Chinese Population.

Rare earth elements (REEs) are widely found in foods. A high intake of REEs may have associations with adverse effects on human health. This study aimed to investigate the concentrations of REEs in foods in China and to assess the risk of dietary REEs exposure in the Chinese population. The mean concentrations of the total REEs in 27,457 food samples from 11 food categories ranged from 0.04 to 1.41 mg/kg. The daily mean dietary exposure of the total REEs was 1.62 µg/kg BW in the general Chinese population and ranged from 1.61 to 2.80 µg/kg BW in different sex-age groups. The high consumer exposure (95th percentile, P95) was 4.83 µg/kg BW, 9.38% of the temporary ADI (tADI) of REEs (51.5 µg/kg BW). None of the P95 exposure exceeded the tADI in all of the sub-groups. Lanthanum, cerium, and yttrium accounted for approximately 63% of the total exposure of the 16 REEs. The hazard index of 16 REEs was far below 1. Therefore, the health risk of dietary REEs exposure in the general Chinese population was low. No cumulative risk was found for the 16 REEs in China. The results indicate there was no need to stipulate the limits of REEs in foods.

Quantitative probabilistic assessment of caffeine intake from tea in Chinese adult consumers based on nationwide caffeine content determination and tea consumption survey.

Caffeine has known effects on the central nervous and cardiovascular systems. An intake up to 400 mg/day does not give rise to health concerns. Tea, a major source of caffeine, is highly consumed in China. However, the potential health risk of caffeine from tea has not been well evaluated. The present study assessed caffeine intake levels from tea for Chinese adult consumers. We collected 1,398 samples of green, black, dark, jasmine, oolong, white, and yellow tea from 17 provinces. The caffeine content was determined by HPLC. The average contents were 27 (oolong tea) - 43 (yellow tea) mg/g. The leaching rate of caffeine into the water was about 100%. Tea consumption data were from the National Beverage Consumption Survey 2013-2014. Monte Carlo simulations were applied to estimate the distribution of caffeine intake. The average caffeine intake from tea was 180 mg/day of all consumers. Green, dark, and black tea were the primary sources. Males (197 mg/day) consumed more caffeine than females (136 mg/day) on average, but females older than 71 years had the highest intake level (259 mg/day) among all subgroups. Over 90% of Chinese adult tea drinkers have caffeine intake under 400 mg/day.

Risk assessment of rare earth elements in fruits and vegetables from mining areas in China.

Assessment of contaminated food through the dietary intake is essential for human health. To investigate the health risk of rare earth element (REE) exposure to fruits and vegetables in mining areas in China, we collected 288 fruit samples and 942 vegetable samples from four representative mining points (Bayan Obo in Inner Mongolia, Weishan in Shandong, Maoming in Guangdong, Longnan in Jiangxi) and their control areas. The content of REEs was determined by inductively coupled plasma-mass spectrometry (ICP-MS). The total REEs in fruits from mining and control areas were 12.90 µg kg-1 and 11.89 µg kg-1, and in vegetables were 92.90 µg kg-1 and 62.38 µg kg-1, and the difference was statistically significant in vegetables (P = 0.048). The drupes had more REE concentration in fruits (68.41 µg kg-1, 16.90 µg kg-1 in mining and control areas, respectively) (P < 0.01), and the leafy vegetables had more REE concentration in vegetables (245.81 µg kg-1, 123.51 µg kg-1 in mining and control areas, respectively) (P < 0.01). With the enrichment of light rare earth elements (LREE), the REE distribution patterns coincided in mining and control areas and different types of fruits and vegetables. The health risk assessment indicated that the estimated daily intakes (0.02-0.06 µg kg-1 day-1, 0.53-1.22 µg kg-1 day-1 for fruits and vegetables, respectively) were lower than the allowable daily intake value (60.4 µg kg-1 day-1). In mining areas, REEs obtained from fruits and vegetables were insufficient to cause health damage to human beings. However, sustained exposure to low REEs, especially for children, still needs attention.

Occurrence of 3- and 2-monochloropropanediol esters in infant formulas in China and exposure assessment.

The presence of 3-monochloropropane-1,2-diol (3-MCPD) esters and 2-MCPD esters in infant formulas have raised a number of food safety concerns. Here, a dietary exposure assessment was conducted for 3-and 2-MCPD esters in infant formulas available for consumption in Chinese infant and toddlers aged 0-3 years old. This work presents the occurrence data for 3-and 2-MCPD ester in 874 infant formulas purchased in China between 2015 and 2017. The concentrations of 3-MCPD esters ranged from ND to 1.469 mg/kg, with concentrations of 2-MCPD esters ranging from ND to 0.218 mg/kg. The LODs of 3-and 2-MCPD esters were 0.027-0.074 mg/kg. The mean exposures of infants and toddlers to 3-MCPD esters from formulas were lower than the tolerable daily intake (TDI, 2 µg/kg bw/day, established by EFSA), while high exposures (95th percentile) to 3-MCPD esters ranged from 0.907 to 2.520 µg/kg bw/day. On the whole, the health risk of Chinese infant and toddlers exposed to 3-MCPD esters was low, but the health risk of some infants aged 0-6 months with high formula consumption (95th percentile) raises some concern.

Non-targeted analysis and risk assessment of non-volatile compounds in polyamide food contact materials.

Small molecules in food contact materials may migrate into food during their contact. To extensively analyze the migrants, non-targeted screening is needed to detect the migrants. The migrants' detection is difficult because of the complexity and the trace amount of the migrants. In this work, the dissolution precipitation method was used to extract small molecules in Polyamide (PA) kitchenware. The extract solutions were screened by ultra-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry (UPLC-QTOF-MS) for non-targeted analysis and 64 different small molecules in materials were identified through the screening of a self-built database. Then, migration tests were performed to analyze migrants in food simulants. It suggests that the abundance of PA oligomers was the highest in migrants. The risk assessment of migrants revealed that the exposure of most migrants was at a safer level unlike the exposure of PA oligomers that exceeded their threshold of toxicological concern (TTC).

Dietary cadmium exposure assessment among the Chinese population.

Cadmium, a toxic heavy metal, is widely present in food. It has been reported that chronic cadmium exposure is associated with kidney disease, osteoporosis, cardiovascular disease and cancer. The aim of this study was to assess the dietary cadmium exposure and potential health risk in different age-sex groups of the Chinese population (children aged 4-11 years, young people aged 12-17 years and adults aged over 18 years), and in the southern and northern population using a semi-probabilistic method. Cadmium was detected in 228,687 food samples from 32 food categrories by graphite furnace atomic absorption spectrometry. The dietary cadmium exposures were estimated by combining the cadmium concentration data with food consumption data derived from the China National Nutrient and Health Survey 2002, and evaluated against the Provisional Tolerable Monthly Intake (PTMI) of 25 µg/kg BW/month established by the Joint FAO/WHO expert committee on food additives (JECFA). The mean dietary cadmium exposure of the general Chinese population (15.3 µg/kg BW/month) was below the PTMI. The high consumer exposures (95th percentile, P95) for the general population and different sub-groups were higher than the PTMI. The dietary cadmium exposure of the southern population was apparently higher than that of the northern population. Rice was the most important contributor to cadmium exposure for Chinese people, especially those living in the southern areas of China. These findings indicated that the health risk from dietary cadmium exposure of the general Chinese people was low, but the health risk of cadmium exposure of certain sub-groups should be of concern.

[Dietary intake and risk assessment of diisononyl phthalate (DINP) in Chinese population].

OBJECTIVE: To study DINP concentration level in the main food, evaluate DINP dietary intake level in Chinese population and its potential health risks. METHODS: Based on the deterministic assessment model, using concentration level of 25 kinds of food in 2011 - 2013 and Chinese national nutrition and health survey data in 2002, to calculate dietary intake of DINP in Chinese population. RESULTS: The average DINP concentration level in 24 kinds of foods was 0. 24 mg/kg, and the maximum value was 9. 55 mg/kg. In whole population, average dietary intake of DINP was 4. 39 µg/kg bw per day, only 2. 93% of TDI. The dietary intake of DINP in children aged 2 to 6 years old was highest, with an average of 8. 91 µg/kg bw per day, 5. 94% of the TDI. The dietary intake of DINP in children aged 7 to 12 years old was lower than 2 to 6 years old children, with an average of 6.53 µg/kg bw per day, 4. 35% of TDI. The dietary intake of DINP in high consumer(P97. 5) in all population was 8. 35 µg/kg bw per day, 5. 57% of the TDI. The range of dietary intake of DINP in high consumer (P97. 5) in each group (grouping by gender and age) was from 13. 84 to 5.44 µg/kg bw per day, which were all lower than the TDI. CONCLUSION: The dietary intake of DINP in different populations is considerably below the TDI and any health risk that would be expected to occur at this intake level is negligible.

[Dietary intake and risk assessment of diethylhexyl phthalate in Chinese populations].

OBJECTIVE: To assess dietary exposure of diethylhexyl phthalate(DEHP) among Chinese population, including general population, children aged 2-6 years, adolescent aged 7-12, young people aged 13-17, adults aged 18-59 years old as well as older people aged 60 and above and its health risk. METHODS: A total of 6 650 food samples were collected during 2011 to 2013 from 140 local markets of 14 provinces in China, which covered major foods in China. Samples were detected by GC-MS and categorized into 22 food groups. Food consumption data were taken from China National Nutrition and Health Survey performed in 2002 including 68 959 subjects. Mean concentrations of DEHP in food were combined with individual food consumption data to estimate dietary exposure, and food contributors to dietary DEHP intake were also calculated. Then, the exposure was compared with the tolerable daily intake (TDI, 50 µg·kg(-1)-d(-1)) of DEHP. RESULTS: DEHP level in foods (n = 6 650) was in the range of not detected to 43.80 mg/kg. Mean dietary intakes of DEHP in general population was 2.07 (95% CI: 0.06-4.09) µg·kg(-1)·d(-1), accounting for 4.14 percent of TDI (50 µg·kg(-1)·d(-1)). Mean dietary intake for population aged 2-6, 7-12, 13-17, 18-59 as well as elderly aged 60 and above were 3.92 (95% CI: 0.83-7.01), 3.02 (95% CI: 0.69-5.36), 2.17 (95% CI: 0.54-3.81), 1.83 (95% CI: 0.46-3.21) and 1.66 (95% CI: 0.38-2.94) µg·kg(-1)·d(-1) respectively. The 97.5 percentile intakes in the general populations was 4.73 µg·kg(-1)·d(-1), accounting for 9.46% of TDI. Main food sources of DEHP were rice (28.4% (0.59/2.07)), melon solanaceous vegetables (14.7% (0.30/2.07)) and flour (13.2% (0.27/2.07)) for the general population. CONCLUSION: The results suggested that dietary exposure to DEHP among Chinese population was lower than tolerable daily intake of DEHP and there were no health concerns based on generally accepted exposure limits. Rice, melon solanaceous vegetables and flour were main food contributors of DEHP dietary intake for Chinese populations.

[Applicability of thresholds of toxicological concern in the chronic dietary risk assessment of transformation products of pesticide active substance].

OBJECTIVE: To establish the threshold of toxicological concern(TTC) approach and to apply it in the risk assessment of metabolites, degradation and reaction products of pirimicarb. METHODS: TTC decision tree approach based on Cramer classification was established and Lazar software was used to predict the genotoxicity of the seven transformation products of pirimicarb, namely, R34836, R34885, R35140, R31805, R34865, R16210 and R16192. Dietary exposure in general population as well as in six age population groups was estimated by using data from the Chinese National Nutrition and Health Survey and pirimicarb residue data from national chemical surveillance data in 2011. TTC decision tree approach was used for risk assessment and the exposure was compared with the corresponding TTC values. RESULTS: Of the seven transformations of pirimicarb active substance, namely, R34836, R34885, R35140, R31805, R34865, R16210 and R16192, the maximum dietary exposure of mean and large portion(P 97.5) were all belong to 2-6 age group. The mean exposures of the seven transformation products for 2-6 age group,were 0.0290, 0.0207, 0.0015, 0.0320, 0.0005, 0.6918 and 0.1274 µg/kg,respectively, and the corresponding P 97.5 exposures were 0.0817,0.0581,0.0042,0.0900,0.0014, 1.9459 and 0.3585 µg/kg. Besides, the mean and P 97.5 exposure of R16210 for 2-6 age group was the largest,which were 0.6918 and 1.9459 µg/kg, accounting for 46.12% and 129.73% of the TTC threshold,respectively. CONCLUSION: TTC decision tree approach is a useful tool for prior screening and primary risk assessment of the transformation products of pesticide active substance.

[Assessment of dietary iodine intake of population in non-high-iodine areas in China].

OBJECTIVE: To assess the potential risk of dietary iodine insufficiency of population in non-high-iodine areas (water iodine < 150 microg/L) in China. METHOD: The dietary iodine intake of 13 age-sex population groups were estimated by combining the data of iodine intake from food, table salt and drinking water. Two conditions were considered: consuming iodized salt or non-iodized salt. The data of food and table salt consumption were derived from the Chinese National Nutrition and Health Survey in 2002. Water consumption was calculated as the recommended water intake. Iodine contents of food, table salt and water were calculated from China Food Composition Table and iodine surveillance data. RESULTS: Under the condition of consuming iodized salt, the average iodine intake of all population groups was higher than the Recommended Nutrient Intake (RNI), while the iodine intakes of individuals above Upper Limits (UL) and below RNI were 5.8% and 13.4% respectively, and the iodine intake of individuals lower than the Estimated Average Requirement (EAR) was 9.4% in adults above 18 years of age (including pregnant and lactating women). If non-iodized salt was consumed, the average iodine intake of most sex-age population groups was higher than RNI, but the iodine intake of 97.6% of individuals would be lower than RNI, while the iodine intake of 97.4% of adults would be lower than EAR. The contribution of iodine from table salt was much higher than that from drinking water and food in the condition of consuming iodized salt, while food was the predominant contributor of dietary iodine in the condition of consuming non-iodized salt. CONCLUSION: The health risk of iodine deficiency was higher than that of iodine excess in areas where water iodine was < 150 p.g/L in China, and the risk of iodine insufficiency was much higher if non-iodized salt was consumed. Iodized salt should be the main sources of dietary iodine intake for population in areas where water iodine was < 150 microg/L in China.