Vengono descritti, con esempi, i criteri scientifici comunemente utilizzati per il riconoscimento di specifiche sostanze o miscele capaci di produrre tumori nella specie umana. Si presentano inoltre i limiti e le potenzialità dei comuni strumenti della ricerca epidemiologica (studi-caso controllo e di coorte) per la dimostrazione della cancerogenicità di specifiche sostanze. Vengono elencate le condizioni necessarie affinché - sul piano del rigore scientifico - le ricerche epidemiologiche siano in grado di portare alla dimostrazione della cancerogenicità per l'uomo di uno specifico composto. La difficoltà della realizzazione di tali condizioni spiega la modestia del numero di sostanze riconosciute cancerogene per l'uomo. Pertanto, la predizione del rischio di cancerogenicità di un composto deve spesso appoggiarsi soltanto sui risultati di ricerche sperimentali.
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