TABLE 10.

Criteria for epidemiological studies of long‐term effects in humans.

Study design	In	Cross‐sectional studies Cohort studies Case–control studies
Study characteristics	In	Duration of exposure > 6 months. For continuous outcomes > 100 subjects and for discrete outcomes > 5, Exposures to arsenic concentrations < 150 μg/L in drinking water or corresponding exposure level for arsenic biomarkers
Population	In	Any country. Any age groups
Exposure estimate	In	iAs intake per day As in drinking water iAs in urine and its metabolites Total urinary iAs (u‐tiAs), i.e. sum of iAs and metabolites MMA and DMA Other iAs biomarkers that can be transformed into iAs intake
	Out	Intake of total As Total As in urine or blood, unless arsenobetaine could be excluded Studies on inhalation of arsenic Studies with occupational exposure
Outcomes	In	Any long‐term adverse outcomes
Covariates	Out	Lack of age or sex Lack of smoking data for lung and bladder cancer outcome Lack of data on sun exposure or skin sensitivity to UV light for skin cancer Lack of smoking or BMI for T2D outcome Lack of covariates (child characteristics/parents' education or maternal intelligence/socioeconomic status) for neurodevelopment
Language	In	English
	Out	Non‐English
Time period	In	From 1/1/2009 to 18/7/2022 and papers described reviewed by EFSA in 2009
Publication type	In	Peer‐reviewed original research, systematic reviews, meta‐analyses a
	Out	Expert opinions. Editorials. Letters. PhD theses. Conference proceedings. Conference abstracts.

Abbreviations: As, arsenic; BMI, body mass index; DMA, sum of dimethylarsinous acid and dimethylarsinic acid; EFSA, European Food Safety Authority; iAs, inorganic arsenic; MMA, sum of monomethylarsonous acid and monomethylarsonic acid; PhD, Doctor of Philosophy; T2D, type 2 diabetes; u‐tiAs, total urinary iAs (sum of iAs and its methylated metabolites MMA and DMA) ; UV, ultraviolet.

^a Such publications have not been used for risk assessment.