DRAFT ASSESSMENT REPORT
(Full Assessment - s. 15)
DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter:
7 AUGUST 2002
Full Report [ pdf 700kb ]
EXECUTIVE SUMMARY
The Australia New Zealand Food Authority (ANZFA) received an application on 28 May 2001 from Surebeam Australia Pty Ltd to amend Standard 1.5.3-Food Irradiation to permit the treatment of specified tropical fruits (breadfruit, carambola, custard apple, litchi, longan, mango, mangosteen, papaya and rambutan) with machine sourced electron beams or x-rays as a phytosanitary measure within the dose range of 150 Gy (minimum) to 1 kGy (maximum). The Applicant stated that approval of irradiation for the above tropical fruits would provide an alternative treatment to existing techniques (such as chemical treatments) and facilitate access to New Zealand markets for Australian tropical fruit growers.
Regulatory Problem
The sale of irradiated foods in Australia and New Zealand (under Standards A17/1.5.3 - Irradiation of Food) is prohibited unless the food is listed in the Table to clause 4 of the Standards. There is currently no permission to irradiate tropical fruits in Standards A17/1.5.3.
Objective
To determine whether the food regulations can be changed to permit the sale of irradiated tropical fruits. Such an amendment needs to be consistent with the section 10 objectives of the ANZFA Act.
Background
This is the second application to ANZFA to amend the Food Standards Code to permit the irradiation of food. ANZFA previously considered an application to irradiate herbs, spices, herbal infusions, peanuts, cashew nuts, almonds and pistachio nuts for food safety and quarantine purposes. Permission was granted by the Australian New Zealand Food Standards Council (ANZFSC) to treat herbs, spices and herbal infusions only.
Seven countries, including the USA and UK, approve the use of irradiation as a phytosanitary treatment for all fruits. In addition, another 8 countries approve the use of irradiation as a phytosanitary treatment for some of the tropical fruits, which are the subject of this application.
Issues considered during assessment of the application
A range of issues were considered during the assessment of the application; namely, the safety, nutritional impact, technological need and the need for labelling of irradiated tropical fruits. Other issues such as the provision of information for consumers about irradiated food, the quality of irradiated food, the benefits to industry, and import and export issues were also addressed.
It was considered that there is a valid technological need to use either electron beams or x-rays to treat the specified tropical fruits for the purpose of pest disinfestation for either the fruit fly or other critical pests that may be of quarantine significance.
The available studies on fruits indicate that there are no safety concerns and there are no new compounds formed following irradiation of tropical fruits that are likely to cause public health and safety concerns. The overall conclusion is that irradiation of tropical fruits up to a maximum of 1 kGy employing Good Manufacturing/Irradiation Practices is safe for Australian and New Zealand consumers.
The nutritional analysis and dietary intake assessment performed established that irradiation would have minimal impact on the nutrient status of the tropical fruits. The tropical fruits proposed to be irradiated are minor contributors to the total dietary intakes of b -carotene, folate vitamin C and Vitamin B1 when considered in the context of the overall diet.
In accordance with Standards A17/1.5.3, irradiated tropical fruits will be required to be labelled to give consumers an informed choices in purchase of these fruits. Some reductions in textural quality of the fruit can occur with increasing doses of irradiation.
There are benefits for both industry and consumers in the approval of irradiation of tropical fruits, although it is recognised that there still needs to be further public education and information programs on the safety and benefits of irradiating food.
Options
ANZFA identified two options, namely:
1. Not to permit the irradiation of tropical fruits; or
2. Permit the irradiation of tropical where there is a technological need and the process does not compromise the safety and nutritional adequacy of the fruits. Prescribed conditions would include adherence to Good Agricultural Practice, Good Radiation Practices and a minimum dose of 150 Gy and a maximum dose of 1kGy
Impact analysis
The impact analysis shows that option 2 satisfies the objectives based on the outcome of the scientific risk assessment and the Regulatory Impact Statement (RIS) taking into account all matters raised following the public consultation period. These matters included an assurance of the safety and wholesomeness of irradiated tropical fruits, the provision of adequate labelling so as to give consumers informed choices for purchases of irradiated tropical fruits, the provision of benefits to industry and Governments, in terms of enhanced market opportunities and trade (under Australia and New Zealand' s requirements under the World Trade Organization), respectively, and in addition, the benefits to consumers in regard to possible greater seasonal availability of fruits.
Any permission in the Food Standards Code would permit irradiated foods to be lawfully sold on the Australian and New Zealand markets. It should be noted, however, that for imported foods, the relevant authorities must assess and approve irradiation as an acceptable phytosanitary measure for quarantine purposes on a case-by-case basis.