Novel foods

How is food regulated in New Zealand?

Regulated foods must comply with relevant food standards before they can be legally sold or exported. Food standards list conditions under which foods must be processed, sold, etc. An application must be made to Food Standards Australia New Zealand (FSANZ) for a new or amended Food Standard if existing ones do not cover the food or food additive.

For foods and food ingredients that have a history of use in New Zealand and Australia the New Zealand Food Safety Authority (NZFSA) checks to see that food producers, processors, and distributors are complying with the rules, and produce information and guidelines for the general public and the food industry.

For foods that have not previously been generally consumed here then a formal pre-market clearance is required before such foods or food products can be used in New Zealand. This requires a safety assessment and inclusion in the relevant food standard.

New Zealand has a joint agreement with Australia to develop standards for food composition and labelling for both countries. This means that, with a few exceptions, foods approved for sale in New Zealand are also able to be sold in Australia, and vice versa. FSANZ is the agency that develops these food standards.

The food standards codes can be found on FSANZ’s website. Their website also has other information about food standards development.

What is regulated?

Food for sale or export, and primary processing of animal products are regulated. Food is anything that is used or represented for use as food or drink for human beings, and includes additives to foods (such as preservatives, colourings, etc).

Any food for sale must comply with the safety and labelling provisions of the relevant Food Standards Code.

If a food claims to have a specific therapeutic benefit (such as “prevents heart disease”) then it is regulated as a medicine.

Most food is normally considered safe if there is a history of safe use in New Zealand and does not need to be approved before it can be sold. However, there are some foods that require pre-market clearance.

In the Regulatory Wayfinder the term “novel food“ is used generally for foods requiring pre-market clearance as defined in Part 1.5 of the Australia New Zealand Food Standards Code. Three types of food require clearance before they can be sold and used. These are what the food standards term novel foods, foods produced using gene technology, and irradiated food. (Note that just because a food has been given pre-market clearance does not mean that the food is currently sold or available in New Zealand). FSANZ has a fact sheet on foods requiring pre-market clearance [2 pages, 73Kb, PDF].

A novel food is a food (or an additive) that has not been widely consumed in New Zealand or Australia before, and for which there is insufficient knowledge in the broad community to enable safe use. Novel foods currently cleared for sale in New Zealand are food additives (chemicals) rather than new fruits, vegetables, or animal products.

An example of a novel food would be an extract from a specific seaweed, which may be added to certain types of processed foods. Novel foods cleared for sale in New Zealand and Australia are listed in Standard 1.5.1.

Foods derived by conventional breeding from another food already eaten in New Zealand are not generally considered "novel" in a regulatory sense and do not require regulatory approval. An example is Gold kiwifruit.

Foods produced using gene technology. This covers foods that are or come from plants, animals, or microbes that have been genetically modified. However, some additives and processing aids derived from gene technology do not need pre-market clearance, although they may need to meet other standards, such as the food additive standard 1.3.1 [6 pages, 109Kb, PDF] or the processing additives standard 1.3.3 [17 pages, 173Kb, PDF].

Some genetically modified foods have already been assessed and approved for sale in New Zealand. These are listed in Standard 1.5.2 [6 pages, 110Kb, PDF] and include various types of modified corn and soybean products. You can find out more about which GM foods or products are able to be sold in New Zealand from the FSANZ website. These foods must be labelled as being genetically modified if there is altered DNA or protein in the final food.

Food that is irradiated also requires special permission to be imported or sold. Currently food irradiation is only permitted for a few types of food where there is a specific requirement for irradiation and alternatives to irradiation are not available. Irradiation is normally used to ensure that certain pests and diseases are not brought into New Zealand.

Irradiated foods that are permitted into New Zealand are listed in Standard 1.5.3 [6 pages, 129Kb, PDF], and include some herbs and spices and some types of tropical fruits (such as mangoes). Specified doses of radiation can only be used on these foods, and they must meet other specified conditions. Irradiated food must be labelled as having been treated with ionising irradiation.

What foods don't need a pre-market clearance?

Foods that are collected, grown, or kept for home consumption and not sold are not regulated. If you are unsure whether a food is or isn't regulated contact FSANZ or the NZFSA.

Why is food regulated?

Foods are regulated to protect human health, to ensure that consumers have adequate information on labels, and to reduce unnecessary trade barriers.

Food Labelling

Are genetically modified foods labelled?

Since 7 December 2002 packaged and bulk food must be labelled if it contains DNA or protein derived from a genetically modified organism, or contains altered characteristics that are due to genetic modification even if no GM material is present in the product (such as oil derived from genetically modified canola).

The label should identify what ingredients are genetically modified (eg corn meal (genetically modified)), but labels will not identify what the actual genetic modification is. You can contact the manufacturer of the food to obtain more information. The NZFSA has information for consumers on labelling of GM foods

Labelling exemptions

Under certain conditions foods containing ingredients derived from genetic modification are exempt from the labelling requirements.

For more information on food labelling see the FSANZ website or the NZFSA website.

Regulatory Process

To receive approval for a novel or irradiated food, or one derived using gene technology to be sold in New Zealand requires the food to be included in the approved table in the relevant food standard. This requires an application to be made to FSANZ. The FSANZ website has information for industry on codes, user guides, and other sources of information that should be consulted when considering whether regulatory approval is required. They also provide information for applicants.

The FSANZ decision-making framework builds on the accepted risk analysis practices of the international food standards body, the Codex Alimentarius Commission.

An application requires:

FSANZ will then undertake an assessment of the application which will include two rounds of public comment. The first round follows FSANZ's initial assessment of an application. The initial assessment is intended to stimulate useful input from stakeholders by raising issues and asking questions.

Following these submissions a draft assessment of the application is made, which takes account of the public submissions and undertakes a scientific risk assessment. The FSANZ Board considers the Draft Assessment Report and, if endorsed, it is released as a public document for public comment. If the Board concludes that a new standard or an amendment to a standard is warranted the Draft Assessment Report includes a draft of a proposed standard.

After considering any further public submissions FSANZ produce and publish a Final Assessment Report.

Ministerial Clearance

The FSANZ Board makes a final decision on a standard and makes a recommendation to the Ministerial Council which is responsible for deciding whether an amendment should become law. If the Australia and New Zealand Food Regulation Ministerial Council does not seek a review, the standard is Gazetted (ie officially published) and the food is able to be sold if it meets the Food Standard requirements.

The Ministerial Council consists of the State and Territory Ministers responsible for food in Australia, and the New Zealand Minister of Food Safety.

Once a food is approved for sale, processing, or export, the NZFSA monitors that conditions for sale, processing, import and export are met, and undertakes investigations of food safety issues.

Other approvals

New organisms

The food regulators only give approval to sell or process foods. They do not give clearance to grow such new foods in New Zealand. To grow or raise a food that is “new” to New Zealand may also require an approval from a different agency, the Environmental Risk Management Authority of New Zealand (ERMA NZ), which assesses the human, environmental and other risks of having the plant, animal or microbe in the country. “New” in this context means an organism that has not been grown or been present here previously, or is a genetically modified organism.

If the food to be imported was not able to develop into the complete plant, animal or microbe (because it was processed or was only part of a plant or animal and unable to grow back into a whole plant or animal - such as leaves or crocodile steaks) then it would not require approval from ERMA NZ.

If the food is genetically modified or a species new to New Zealand, and is to be grown in New Zealand then an approval for conditional release or full release from ERMA NZ will also be required before the food can be imported, planted or taken out of containment. A conditional or full release approval requires a detailed risk assessment of potential risks to humans (and so require similar information as presented to FSANZ) and the environment, and would involve public notification and probably a public hearing before a decision is made. See the New organisms section on this site for more information.

Genetically modified foods would most probably be given conditional approval, so that controls can be imposed that state where, when and how the food may be grown, harvested or slaughtered. Other types of controls may also be imposed depending on the nature of the organism.

Importation of a new food (such as a variety of genetically modified maize) may also require an appropriate Import Health Standard before it can be imported. Bisoecurity New Zealand (which is part of the Ministry of Agriculture & Forestry) is reposnsible for developing Import Health Standards and issues Permits to Import. The Biosecurity New Zealand website has information on import health standards for plants and plant products and import health standards for animals and animal products.

Making a submission on a proposal to change or create a new food standard

Public submissions are invited through notices in newspapers, Food Standards News, circulars to interested stakeholders and on the FSANZ website.

How can I find out about decisions?

Regulatory updates are provided on FSANZ's website. You can also register on the website to receive e-mails advising you of new regulatory information and decisions.

Time and Cost

The cost for pre-market clearance depends on how complex the issue is. Some may not cost anything if they are added to FSANZ's work plan. Where prompt action is required a very simple application can cost several thousand New Zealand dollars, while a highly complex application (such as approving a GM food) can cost tens of thousands of dollars. More information of costs of applications can be found on FSANZ's information for applicants web page.

FSANZ must make a recommendation to the Ministerial Council within 12 months of an initial assessment, and the Council must make a decision within 60 working days.

Additional time and application charges will be associated with an ERMA NZ application if one is required. ERMA NZ will provide an indicative cost for the application upon request. Processing of a release application takes 100 working days.

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