Regulatory Aspects

At present, there are no published toxicological or epidemiological data to indicate whether consumption of patulin is harmful to humans. Products containing patulin have probably been consumed for long periods of time, yet accounts of human toxicity caused by patulin exposure from food do not exist. However, there is a desire to limit patulin levels in apple products since infants and young children are major consumers of these foods and the effects of long-term exposure to patulin are not yet known.

Based on the results of reproductive toxicity and long-term toxicity studies involving animals, the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) established a provisional maximum daily intake for patulin of 0.4 mg/kg body weight [55]. At least ten countries have established action levels of 50 mg/l for patulin in apple juice, and several have established lower limits (25 to 35 mg/l) [3,56]. The FDA has established a 50 mg/l action level for patulin in single strength and reconstituted apple juice [19].

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