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The National Health Commission of the People’s Republic of China and the State Administration for Market Regulation have issued the National Food Safety Standard (GB2762-2022), which delineates the maximum limits (ML) of contaminants in food. This standard will be implemented on June 30, 2023. It currently maintains the ML of cadmium in rice (including unhusked rice, husked rice, polished rice) at 0.2 mg/kg, a value first established 40 years ago in GBn238-1984.
Considering the higher ML of 0.4 mg/kg outlined by the Codex Alimentarius Commission (CAC) and the lower limit of 0.15 mg/kg recommended by the European Food Safety Authority’s (EFSA) Panel on Contaminants in the Food Chain (CONTAM Panel), a review of the Chinese standard was deemed necessary. The primary objective was to determine whether the current provisional tolerable monthly intake (PTMI) of 25 μg/kg body weight (b.w.) for cadmium, as established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), remains appropriate for China.
To reach our recommendation, we considered additional data on the dietary consumption patterns and corresponding biomarkers of exposure for the Chinese population. We also conducted an updated literature review and examined assessments performed by both JECFA and the EFSA CONTAM Panel. Based on these findings, we recommend maintaining the PTMI of cadmium exposure in China at 25 μg/kg b.w. This recommendation provides a scientific foundation for the newly issued ML of cadmium in rice.
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Cadmium is classified as a type I carcinogen by the International Agency for Research on Cancer (IARC) (1), and exposure has been associated with a range of cancers. Long-term exposure to cadmium primarily exerts toxic effects on the kidneys, but also affects the bones (2). Food is the major source of cadmium exposure for the non-smoking general population, contributing up to 90% of the total human cadmium intake (3-4). Rice is more susceptible to cadmium contamination than other crops (5). Furthermore, China is the largest rice-producing and consuming country globally, with rice production accounting for over one-third of the total domestic grain output. Therefore, monitoring cadmium ML in rice is not only a public health measure; it is also part of the nationwide surveillance and control efforts focused on the quality of agricultural products. These practices protect domestic rice traders and contribute to maintaining the safety of food sources in the Chinese mainland.
The ML of cadmium in food was initially established in China in 1984 (GBn238-1984) and has undergone multiple re-evaluations (GB15201-1994, GB2762-2005, GB2762-2012, GB2762-2017), based on the provisional tolerable weekly intake (PTWI) of cadmium set forth by the JECFA (revised to PTMI in 2010). As Table 1 illustrates, the limit values for cadmium in rice range from 0.1 to 0.4 among major rice-trading countries. The ongoing debate regarding the precise allowed level remains unresolved, as evidenced by the current discrepancy between CAC and EFSA guidelines. Given the variability in consumption patterns, cadmium exposure, absorption, and metabolism among diverse populations, a universally accepted standard may not be suitable. As a result, establishing a health-based guidance value (HBGV) for dietary exposure to cadmium in the Chinese mainland is crucial to determine an acceptable cadmium limit in rice for the domestic market.
Nations/regions/
organizationsCadmium limits in rice (mg/kg) Unhusked rice/husked rice Polished rice/rice (flour) China (including Hong Kong SAR) 0.2 0.2 Codex Alimentarius Commission (CAC) −* 0.4 The European Union (EU) −* 0.15 The Republic of Korea −* 0.2 Singapore −* 0.2 Japan 0.4 0.4 Russia −* 0.1 Australia −* 0.1 New Zealand −* 0.1 Thailand −* 0.4 Vietnam −* 0.4 Abbreviation: ML=maximum limits; SAR=Special Administrative Region.
* Data unavailable due to no limit for unhusked/husked rice or undifferentiated limits for rice in those countries or organizations.Table 1. The ML of cadmium in rice in China and other major rice trading countries or organizations.
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The assessment report underwent review and approval during the second meeting of the Sub-Committee on Chemical Hazard, part of the National Food Safety Risk Assessment Expert Committee, on May 27, 2021. The results with comparison to EFSA, JECFA, and similar domestic studies (10) were listed in Table 2.
Phase outcomes for HBVG derivation BMDL5
(EFSA)BMDL5
(JECFA)BMDL5
(current study)BMDL10
(current study)Thresholds derived by generalized additive model BMDL5
(Meta-analysis)BMDL10
(Meta-analysis)BMDL10
(Ke’s study)Reference point of urinary cadmium (μg/g Cr) 4
(1)*5.24
(4.9–5.57)†2.11
(0.88)*4.46
(1.86)*0.85
(0.62–0.98)†1.70
(0.71)*1.95
(0.81)*2.0 (M)§
1.69 (F)§TK model TDI [μg/(kg b.w.·day)] 0.36 1.2
(0.8–1.8) †0.55 1.17 0.54
(0.39–0.62) †0.48 0.52 1.25 (M)
1.06 (F)PTMI [μg/(kg b.w.·month)] 10.8 25 16.5 35.1 16.2
(11.7–18.6) †14.4 15.6 37.5 (M)
31.8 (F)PBTK model TDI [μg/(kg b.w.·day)] −¶ −¶ 0.37 0.95 0.36
(0.23–0.41) †0.30 0.35 1.04 (M)
0.84 (F)PTMI [μg/(kg b.w.·month)] −¶ −¶ 11.1 28.5 10.8
(6.9–12.3) †9.0 10.5 31.2 (M)
25.2 (F)Abbreviations: TDI=tolerable daily intake; PTMI=provisional tolerable monthly intake; EFSA CONTAM Panel=European Food Safety Authority’s Panel on Contaminants in the Food Chain; JECFA=Joint FAO/WHO Expert Committee on Food Additives; HBGV=health based guidance value; BMDL5=benchmark dose lower confidence limit at the benchmark response of 5%; BMDL10=benchmark dose lower confidence limit at the benchmark response of 10%; Cr=creatinine; TK=toxicokinetic; PBTK=physiologically based toxicokinetic.
* Values in brackets have been adjusted for the uncertainty factor.
§ M: Males; F: Females.
† 95% confidence interval.
¶ Data unavailable.Table 2. The estimated TDI and PTMI by the current study, the EFSA CONTAM Panel, the JECFA and other recent studies.
The estimated RPs for urinary cadmium in the Chinese population range from 0.71 to 1.86 μg/g creatinine (Cr), with PTMI values of 14.4 to 35.1 μg/kg b.w. based on TK model and 9.0 to 28.5 μg/kg b.w. based on the PBTK model. When considering the BMDL10 as an RP with high-dose effects alongside the conservative PBTK model, the calculated PTMI equates to 28.5 μg/kg b.w. In contrast, using the BMDL5 result in conjunction with the TK model yields a calculated PTMI of 16.5 μg/kg b.w. Given the current cadmium exposure status in China, the recommended PTMI for cadmium exposure for the Chinese population is 25 μg/kg b.w., aligning with the recommendation proposed by JECFA.
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