Novel Food Application in Australia and New Zealand

Background

Food ingredients permitted for use in Australia and New Zealand must be included in Annexes to the Australia New Zealand Food Standards Code (the Code).

Therefore, if businesses intend to use or sell new food ingredients, food processing aids, food additives, or other substances not yet approved in Australia and New Zealand, they must apply to change the Code with the Food Standards Australia New Zealand (FSANZ), based on the characteristics of the proposed substances.

Note: While both Australia, New Zealand, and the EU have the regulatory classification for Novel Food (NF), the criteria for identifying NF substances in Australia and New Zealand are distinct from those in the EU. For instance, HMOs are not managed as NF in Australia and New Zealand. Instead, corresponding standards in the Code are revised based on the primary functions of HMOs to ensure their compliant use in the Australian and New Zealand markets.

Regulatory revision procedures

Applications for revisions to the Code are subject to an administrative assessment by FSANZ to determine whether the application meet the requirements. If deemed compliant, applications will then be assessed by FSANZ under appropriate procedures.

At present, the assessment procedures in Australia and New Zealand are mainly categorized into three types: minor, general, and major procedures, each follows distinct process and timeframe.

Procedures and timeframe

• Dossier submission;
• Administrative assessment: An administrative assessment of an application is made by FSANZ within 15 business days after an application is given to FSANZ;
• Technical assessment: Depending on different procedures, the timeframe from assessment to approval is approximately 9-12 months (including a 6-week period for public comment, excluding time for additional information submission);
• If an applicant doesn’t elect to have the consideration of the application expedited, FSANZ typically begins the assessment approximately 9 months after receiving the application;
• If an applicant chooses to have the consideration of the application expedited, payment must be made the within 20 business days of FSANZ’s acceptance of the application. FSANZ will then initiate the assessment process;
• Notification of approval of draft food regulatory measure to the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum): 10 business days;
• Forum opinion: The Forum must respond to FSANZ within 60 calendar days of notification from FSANZ;
• If review not requested, public notification is made; and
• If review requested, amend or reject the draft (approximately 3 months)

Fees

FSANZ doesn’t charge a fee for assessing an application unless:

• An applicant applies for 15-month exclusive capturable commercial benefit (ECCB) ; and/or
• An applicant wants work to start on the assessment immediately, rather than according to the anticipated timeframes established as part of the Administrative Assessment. In such cases, payment must be made according to assessment procedures, ranging from 60,000 to 200,000 Australian dollars or more.

Materials requirements

Applications for revisions to the Code are subject to an administrative assessment by FSANZ to determine whether the application meet the requirements. If deemed compliant, applications will then be assessed by FSANZ under appropriate procedures. The general requirements are as follows:

• Applicant details: Applicant name, name of contact person, address, telephone number, email address, etc;
• Supporting information;
• All electronic literature (searchable) shall be submitted;
• The data should be representative of the Australian and New Zealand populations;
• The safety tests must be conducted in GLP labs;
• The test data submitted should be detailed and complete, including original data;
• Any confidential commercial information (CCI) must be be separated from non-confidential information, and a publicly disclosable description of the CCI should be included in the public available version; and
• Overview of regulatory situations in other countries

Note: Given that Australia and New Zealand have different requirements for each food category, the specific material requirements are subject to actual substance information.

Our service

Novel food application service in Australia and New Zealand

Our strength

The Food Business Division at CIRS Group boasts a professional technical team specializing in the field of “Three New Foods”. With extensive experience, we have made a track record of successful cases in the regulatory application and filing of new food raw materials, new food additives and new food contact materials. Currently, CIRS Group has carried out the application of dozens of GMM new food raw materials and additives on behalf of our clients, positioning us at the forefront of the industry. We warmly welcome inquiries or visits for a more in-depth insight into our technological capabilities.