General Information

CAS number: 7440-43-9
Functional Class:
  • Food Contaminant
    • METALS


Evaluation year: 2013
Comments: The Codex Committee on Contaminants in Foods, at its Sixth Session, requested that the Committee conduct an assessment of dietary exposure to cadmium from cocoa and cocoa products. The potential dietary exposures to cadmium for high consumers of products containing cocoa and its derivatives in addition to cadmium derived from other foods were estimated to be 30–69% of the PTMI for adults and 96% of the PTMI for children 0.5–12 years of age. The Committee noted that this total cadmium dietary exposure for high consumers of cocoa and cocoa products was likely to be overestimated and did not consider it to be of concern.
MRL Comment:
Intake: Estimated mean population dietary exposure to cadmium from products containing cocoa and its derivatives, from GEMS data: 0.005 to 0.39 μg/kg bw/month (0.02–1.6% of the PTMI); from national data: 0.001 to 0.46 μg/kg bw/ month (0.004–1.8% of the PTMI).
Tolerable Intake: PTMI: 25 μg/kg bw/month
Meeting: 77
Report: TRS 983 JECFA 77
Tox Monograph: 73rd_2011_cadmium.pdf
Toxicological study
PTMI: 25 µg/kg bw/month

Evaluation year: 2010
Comments: The Committee considered new information that had become available since cadmium was last evaluated. Renal dysfunction is the most sensitive toxicological end-point, and most of the new data involved the use of urinary biomarkers to estimate risk. The Committee considered whether these recent modelled risk estimates for cadmium would support the current PTWI of of 7 μg/kg bw. The Committee noted that the existing health-based guidance value for cadmium was expressed on a weekly basis, but, owing to cadmium’s long half-life of 15 years in human kidneys, considered that a monthly value was more appropriate. The PTWI of 7 μg/kg bw was therefore withdrawn. The Committee noted that a large meta-analysis of studies measuring the dose–response relationship between β2MG and cadmium excretion in urine was available. An analysis of the group mean data relating β2MG excretion to cadmium excretion in urine from individuals who were ≥ 50 years of age, when kidney cadmium levels would be at steady-state, showed that the urinary excretion of less than 5.24 (5th–95th percentiles 4.94–5.57) μg cadmium/gram creatinine was not associated with an increased excretion of β2MG. Using a one-compartment toxicokinetic model, the Committee estimated that a lower bound of the 5th population percentile dietary cadmium exposure of 0.8 μg/kg bw/d or 25 μg/kg bw/ month would result in a urinary cadmium concentration of 5.24 μg cadmium/gram creatinine. The PTMI established was 25 μg/kg bw. The estimates of exposure to cadmium through the diet for all age groups, including consumers with high exposure and subgroups with special dietary habits (e.g. vegetarians), examined by the Committee at this meeting are below the PTMI.
Intake: Adults: 2.2-12 μg/kg bw/month (mean), 6.9-12.1 μg/kg bw/month (high level). Children 0.5–12 years of age: 3.9-20.6 μg/kg bw/ month. Vegetarians: 23.2 μg/kg bw/month.
Tolerable Intake: PTMI: 25 μg/kg bw/ month
Meeting: 73
Report: TRS 960-JECFA 73
Tox Monograph: FAS 64-JECFA 73
Estimated exposure

Best estimate: 2.2-12 µg/kg bw/month

Toxicological study
Pivotal Study: EFSA metaanalysis of several epidemiology studies considering the relationship between urinary ß2MG & urinary cadmium (EFSA, 2009b): Urinary ß2MG level was chosen as the biomarker for the metaanalysis due to wide recognition as a marker for renal pathology and a large amount of available data. A biexponential model characterized the cadmium– ß2MG dose–response relationship; only the high urinary cadmium concentration slope was considered to be indicative of renal pathology. The breakpoint for the second slope for the population = 50 years of age corresponds to 5.24 (5th–95th percentiles 4.94–5.57) µg cadmium/gram creatinine, after which the urinary ß2MG concentration begins to rapidly increase with increasing urinary cadmium level. Toxicodynamic variability was accounted for by incorporating a maximum variability (1 to 3). One-compartment modeling calculated a linear relationship between urinary cadmium concentration and dietary cadmium exposure, after inclusion of a statistical parameter for variation in apparent half-life. A dietary cadmium exposure of 1.2 (5th–95th percentiles 0.8–1.8) µg/kg bw/day at the 5th population percentile corresponded to 5.24 µg cadmium/gram creatinine. This is equivalent to 36 (5th–95th percentiles 24–54) µg/kg bw/month. The Committee decided to use the lower bound of the confidence interval to account for particularly susceptible individuals so that they would remain below the dietary exposure at which renal pathology is indicated.
Animal specie: Human
Effect: Renal pathology indicated by increased urinary excretion of ß2MG
NOAEL: 5.24 µg/g creatinine
PTMI: 25 µg/kg bw/month
Point of departure: Breakpoint for the second slope for the population = 50 years of age: 5.24 µg/g creatinine

Evaluation year: 2005
Comments: The PTWI of 0.007 mg/kg bw that was established at the thirty-third meeting (1988) was not re-evaluated and was maintained at the sixty-fourth meeting (2005). The Committee evaluated the impact of different maximum levels on the overall intake of cadmium and concluded that the effect would be very small. At the proposed Codex maximum levels, mean intake of cadmium would be reduced by approximately 1% of the PTWI. The imposition of maximum levels one level lower would result in potential reductions in intake of cadmium of no more than 6% (wheat, potatoes) of the PTWI. At the proposed Codex maximum levels, no more than 9% of a commodity would be violative (oysters). Maximum levels one level below those proposed would result in approximately 25% of molluscs, potatoes, and other vegetables being violative.
Tolerable Intake: PTWI 0.007 mg/kg bw
Meeting: 41
Report: TRS 930-JECFA 64/26
Tox Monograph: 64th_2006_Cadmium_ML.pdf
2000, TRS 901-JECFA 55/61, FAS 46-JECFA 55/247. THE PTWI OF 0.007 mg/kg