Patulin

​​​​​Several Australian apple juice products were recalled in 2020 as they were found to have high levels of patulin. In response, FSANZ worked with Australian government and relevant state and territory health authorities to conduct a survey of patulin in apple juice and other apple products. The survey aimed to find out if the level of patulin in these foods posed a risk to Australian consumers.

K​ey points 

  • FSANZ coordinated a survey of patulin in apple juice and other apple products. 
  • The concentration of patulin in most products was low and the amount consumed by Australians was shown to be safe. 
  • FSANZ will work with industry and regulators to make sure patulin in apple juice and other apple products is kept as low as reasonably achievable. 

What is patulin? 

Patulin is a natural toxin produced by certain moulds sometimes found in fruits, vegetables and cereals. The condition of the fruits, vegetables and cereals when they are harvested will affect the likelihood of patulin being present, as will how they are handled and stored after harvesting. Good agricultural and manufacturing practices ensure that levels of patulin in foods is low and safe. 

These moulds grow well on apples so the main way people might be exposed to patulin is by consuming apple juice and other apple products. Consuming high amounts of patulin has been linked to negative health effects in animal studies. 

The Australia New Zealand Food Standards Code does not specifically regulate the amount of patulin allowed in foods, that is, there are no maximum levels set for patulin. However, patulin levels should be kept as low as reasonably achievable1, and foods for sale must be safe and suitable for human consumption. 

Survey of patulin in apple juice and other apple products 

FSANZ coordinated a national survey of apple juice and other apple products to find out how much patulin they contain. The products were purchased from all Australian states and territories in 2021 and 2022. Most of the products sampled were apple juices. The other product types tested were solid apple products for infants, apple puree, apple sauce, canned apple, and dried apple. 

Patulin levels were generally low. For some types of apple juice, patulin concentrations varied between products and over time. 

FSANZ used the results to assess food safety risks for consumers and consider whether to recommend risk management measures. 

Safety of patulin levels in food 

A dietary exposure assessment was carried out using the patulin concentrations found in the survey and the amount of apple juice and apple products Australians typically consume. Estimated dietary exposure to patulin was determined to be low. This was true even for people who consumed large amounts of apple juice. FSANZ concludes that there are no food safety concerns associated with dietary exposure to patulin. 

How is patulin managed by industry? 

Patulin levels in apple juice and other apple products can be kept low by preventing growth and development of mould on the fruit. Quality control and processing techniques during production can also make it less likely that patulin will be present in the final product. 

The Codex Alimentarius Commission has a Code of Practice​ for the prevention and reduction of patulin contamination in apple juice and apple juice ingredients in other beverages. The Code of practice has recommendations for good agricultural and manufacturing practices. 

What other resources are available for industry? 

The European Commission and the United States Food and Drug Administration​ have published guidance for controlling patulin levels in apple juice. 

In Australia, Apple And Pear Australia Limited and the Australian Beverages Council Ltd have information about patulin for businesses involved in producing apple juice. 

The Department of Agriculture, Fisheries and Forestry National Residue Survey (NRS) runs a patulin testing program for pome fruit growers. Growers can contact the NRS​ for a registration form. 

What happens next? 

There are no food safety concerns related to estimated dietary exposure to patulin, and hence no current need to introduce food regulatory measures. 

FSANZ will continue to work with industry and regulators to monitor patulin levels in Australian apple juice to make sure that levels are kept low and safe.