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A443 FAR exec summary

Breadfruit, Carambola, Custard Apple, Litchi, Longan, Mango, Mangosteen, Papaya and Rambutan

18 December 2002

FINAL ASSESSMENT REPORT

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EXECUTIVE SUMMARY

Food Standards Australia New Zealand (FSANZ) 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 [1] within the dose range of 150 Gy (minimum) to 1 kGy (maximum). It is expected that approval of irradiation for the above tropical fruits would provide an alternative treatment to existing techniques (such as chemical treatments). It would also facilitate access to New Zealand markets for Australian tropical fruit growers.

Regulatory Problem

The sale of irradiated foods in Australia and New Zealand (Standard 1.5.3 –Food Irradiation) is prohibited unless the food is listed in the Table to clause 4 of the Standard. There is currently no permission to irradiate tropical fruits in Standard 1.5.3.

Objective

To determine whether the food standards should be changed to permit the sale of irradiated tropical fruits. Such an amendment would need to be consistent with the section 10 objectives of theFood Standards Australia New Zealand Act 1991.

Background

This is the second application to FSANZ to amend the Food Standards Code to permit the irradiation of food. FSANZ previously considered an application to irradiate herbs, spices, nuts, oilseeds and teas. Permission was granted by the former Australia New Zealand Food Standards Council (ANZFSC) to treat herbs, spices and herbal infusions only.

Seven countries, including the USA and UK, currently permit the use of irradiation as a disinfestation or quarantine measure for all fruits. However, it should be noted that disinfestation treatments may be also be carried out for non-quarantine purposes (for example to destroy non-quarantine pests that may affect the quality of the fruit) and would be classified as sanitary treatments.

Issues considered during assessment of the Application

A range of issues were considered during the assessment of the application; namely, 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, packaging, approval of irradiation facilities, methods of detection, quality of irradiated food and the benefits to industry were also addressed.

It was considered that there is a technological need [2] to use either electron beams or x-rays to treat the specified tropical fruits for the purpose of pest disinfestation [3] 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 concluded 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 Standard 1.5.3, irradiated tropical fruits will be required to be labelled or information otherwise provided in connection with the fruit, to give consumers an informed choice in the purchase of these fruits.

FSANZ has undertaken various communication activities to assist consumer, industry and government understanding about irradiation of tropical fruits in general and has detailed the results of recent consumer and industry perception surveys on irradiated foods.

Food to be processed by irradiation, and the packages and packing materials used must be of suitable quality appropriate for food irradiation, and there are various standards which cover this requirement.

Although theFood Standard Codedoes not address the approval of irradiation facilities, FSANZ notes that there are many irradiation facilities that are licensed and regulated by authorities in Australia and New Zealand, which will ensure that irradiation facilities are appropriately licensed to perform irradiation of tropical fruits.

There are methods of detection available for irradiated foods. However, these are still in the developmental stage and the specific method applicable to tropical fruits has not been verified internationally. Therefore, control of dose is managed by accurate dosimetry and maintenance of records under the requirements of Standard 1.5.3.

Although 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. It is recognised that there still needs to be further public education and information programs about irradiated food.

Options

FSANZ identified two options, namely:

1. Not to permit the irradiation of tropical fruits; or
2. Permit the irradiation of tropical fruits in accordance with Standard 1.5.3, that is, where there is a technological need or it is necessary for a food hygiene purpose.

Impact analysis

The impact analysis shows that option 2 satisfies the objectives of the FSANZ Act 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) 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, or foods subject to interstate trade within Australia, or trade between Australia and New Zealand, the relevant authorities in Australia and New Zealand must assess and approve irradiation as an acceptable phytosanitary measure for quarantine purposes on a case-by-case basis.

Consultation

There are many parties affected by the application and FSANZ has consulted widely on the advantages and disadvantages to specific stakeholders should permission be granted to irradiate the specific tropical fruits. Furthermore, FSANZ has evaluated the costs and benefits to consumers, the Government and industry.

STATEMENT OF REASONS

FSANZ approved a draft variation of a standard pursuant to Application A443 for the following reasons:

  • there is no evidence of any public health and safety concern associated with consumption of irradiated tropical fruits and there are no significant nutritional losses of vitamins and minerals in the context of total dietary intakes from irradiated fruits at a dose of up to 1 kGy;
  • a specific technological need (pest disinfestation) as required by Standard 1.5.3 has been shown to exist and a minimum dose of 150 Gy and a maximum dose of 1 kGy is considered to be an appropriate dose range to control the range of pests of likely concern. This has been confirmed by quarantine officials in Australia and New Zealand;
  • mandatory labelling statements will be required to ensure that consumers are informed that the food has been irradiated;
  • the proposed changes to Volume 2 of the Food Standards Code are consistent with the section 10 objectives of the Food Standards Australia New Zealand Act1991. In particular, public health and safety, adequate information being available to consumers to make informed choices and prevention of misleading and deceptive conduct have all been considered in detail; and
  • as part of the analysis of the costs and benefits required for the Regulatory Impact Statement, it was determined that, for the preferred option, namely, to approve the use of irradiation on tropical fruits, the benefits of the proposed amendment outweigh the costs.


[1] A Phytosanitary measure is any legislation, regulation or official procedure having the purpose to prevent the introduction and/or spread of quarantine pests.

[2] Technological need, in relation to irradiation of food, refers to the minimum dose of ionising irradiation required to ensure the safety or quality of food, provided the process is performed in accordance with good manufacturing practice, and includes the extension of shelf life, the destruction of certain bacteriological contamination or pest disinfestation (Standard 1.5.3, Clause 1, Definitions).

[3] Pest disinfestation only pertains to a phytosanitary measure in this Application and does not include treatments carried out for non-quarantine purposes.

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