ARCHIVED - Information Document on Health Canada's Proposed Standard (Maximum Level) for the Presence of the Mycotoxin Patulin in Apple Juice and Unfermented Apple Cider


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Health Canada's Bureau of Chemical Safety has completed its risk assessment of patulin, a mycotoxin that can be found in rotting fruit, particularly in apples. Apple-derived products such as apple juice and unfermented apple cider may contain patulin, usually at very low levels. As a result of this assessment, it was concluded that the formalization of a 50 ng/g (ppb) standard (maximum level) for patulin in apple juice, including the apple juice portion of any juice blends or drinks, and unfermented apple cider is the appropriate risk management strategy. The purpose of this document is to provide background information and a summary of the evidence used by Health Canada scientists in support of this proposed maximum level.


Hazard Characterization

Patulin is a toxic fungal metabolite (mycotoxin) that may cause gastrointestinal irritation and kidney dysfunction, as well as immunotoxic, genotoxic and clastogenic effects in many animal species when ingested at sufficiently high doses. Patulin exerts its toxicity through reacting with the sulfhydryl groups (-SH) of the cysteine residues of enzymes, peptides, and chromosomal proteins; these residues are often critical to maintaining the proper form and function of the protein in which they reside. In 1995, the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) recommended a provisional tolerable daily intake (pTDI) of 0.4 µg patulin/kg body weight-day based on long-term exposure to patulin. Health Canada supports the derivation and application of this risk metric.

Exposure Assessment

The main route of human exposure to patulin is through the consumption of apple juice and related products. Health Canada conducted a probabilistic exposure assessment of patulin for all age-sex strata using analytical data on the concentrations of patulin in apple juice and related products available on the Canadian market, assuming the application of no patulin management strategies at the retail level. Because of their low body weight and high consumption of the affected products, young children comprise the age group with the highest potential exposure to patulin.

Risk Characterization

Based on the results of the patulin risk assessment, there were no safety concerns identified for teenagers or adults consuming apple juice and unfermented apple cider. However, young children that are very high consumers of apple juice could potentially exceed Health Canada's tolerable intake level for patulin if the levels of this mycotoxin in apple juice are not adequately controlled.

Risk Management

While the risk of adverse health effects is low, the patulin concentration in apple juice and unfermented apple cider should be maintained within certain low levels in order to protect the health of Canadians, particularly young children who may consume large quantities of apple juice. As such, Health Canada is proposing to implement a formal standard (maximum level) for the presence of patulin in pertinent commodities. The proposed limit of 50 ng patulin/g will apply to apple juice and unfermented apple cider. This standard will be interpreted as also applying to the apple juice portion of any juice blends or drinks (e.g. apple-raspberry, apple-grape, apple drink with 10% real juice) as described in the Canadian Food Inspection Agency's Guide to Food Labelling and Advertising, Section 9.6.1: Beverages or Beverage Mixes Identified with Name of a Fruit.

A maximum level of 50 ng patulin/g has been adopted by the Codex Alimentarius Commission and incorporated as a standard by the United States Food and Drug Administration and the European Commission.

Producers seeking information to aid in meeting this standard can refer to the Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice Ingredients in Other Beverages, adopted by the Codex Alimentarius Commission in 2003, and to the Code of Practice for the Production and Distribution of Unpasteurized Apple and Other Fruit Juice/Cider in Canada, developed in 2001 by Health Canada and the Canadian Food Inspection Agency in consultation with stakeholders. The good agricultural practices (GAP) and good manufacturing practices (GMP) outlined in these documents, such as avoiding the use of fallen or damaged apples and washing, brushing and rinsing fruit prior to processing, can aid in mitigating the potential for patulin contamination. If the Codes of Practice are followed, the standard of 50 ng patulin/g in apple juice or unfermented apple cider should be readily achievable.

Comments on this proposal may be submitted in writing, by regular mail or electronically at the address indicated below. If you are submitting your comments electronically, please use the word "patulin" in the subject box of your e-mail. Submissions must be received by 11:59 p.m. EST on October 4, 2011.

E-mail address:

Mailing address:

Health Canada, Bureau of Chemical Safety
Chemical Health Hazard Assessment Division,
251 Sir Frederick Banting Driveway, PL 2201C
Ottawa, Ontario K1A 0L2
Attention: Chief, CHHAD

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