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Appendix 3 - FSANZ processes for assessing applications or proposals

Information on these processes can be found on the FSANZ website.

FSANZ's primary role is developing or amending food standards to ensure the safety of food sold in Australia and New Zealand, to ensure the provision of adequate information to consumers and to prevent misleading or deceptive conduct.

FSANZ's work is open for public scrutiny. When developing or changing a food standard, there is generally at least one round of public consultation.

Anyone can make an application to change a current standard or develop a new food standard or code of practice. FSANZ can also initiate the development or review of a standard by preparing a proposal. Both follow the same steps (as set out below). Guidelines on how to make an application are available from our Standards Management Officer or from the FSANZ website.

FSANZ maintains an Application Handbook that includes information to assist potential applicants. FSANZ is able to reject an application on the basis that it has not met the mandatory information requirements set out in Part 3 of the Application Handbook. This ensures that applications contain sufficient information to enable them to be properly assessed, minimising delays in the completion of assessments where further information from an applicant is required to enable an assessment to proceed.

The Application Handbook also includes information covering cost-recovery, confidentiality, application templates and minimum data requirements to complete an assessment. The Application Handbook is updated as required to ensure currency of FSANZ's information needs.

FSANZ continually looks at ways to improve its assessment processes. In recent years, a number of changes have been adopted to improve the format of reports and to place greater emphasis on impact or cost–benefit assessment of regulatory options.

All submissions are uploaded onto our website as soon as possible after acceptance or processing. In relation to applications, the executive summary is made available when the public is notified of its acceptance. The remainder of the application is provided when submissions are called. For access to applications and submissions that were received prior to 1 May 2011 and that are not on the website, or for more information about the detailed matters to do with food standards development, contact FSANZ's Standards Management Officer in Canberra on (02) 6271 2280 or email standards.management@foodstandards.gov.au.

The steps are as follows.

Administrative Assessment

The purpose of this assessment is to determine whether an application includes certain minimum mandatory requirements (as outlined in the Application Handbook) and the procedure by which it should be assessed. Fees are payable after FSANZ has determined whether or not to accept the application, and determined the assessment procedure. FSANZ has 15 working days to complete this process. A report is prepared, which is available to the public. An 'early bird' public notification is subsequently made by FSANZ, advising of the acceptance of the application and its placement on the work plan. Proposals are treated in a similar fashion.

Procedures for the assessment of applications and proposals

General procedure (Default) (9 months to complete assessment)—This procedure is the default process for variations to a food regulatory measure and generally involves one round of public consultation only. Most applications and proposals will be assessed under this procedure, although more can be held as required.

Minor procedure (3 months to complete assessment)—This procedure applies to minor variations to food regulatory measures including, but not limited to, correction of a typographical error or minor editorial changes. It involves one round of limited consultation with government agencies only, and if relevant, affected parties.

Major procedure (12 months to complete assessment)—This procedure applies to the development of a new Standard or a major variation to a food regulatory measure involving such scientific or technical complexity that it is necessary to adopt this procedure in considering it or such a significant change to the scope of the food regulatory measure that it is necessary to adopt this procedure to consider the application. This procedure generally involves two rounds of public consultation, although more can be held as required.

High-level health claims procedure (9 months to complete assessment)—This procedure is used for applications or proposals to make a change to the list of high-level health claims (HLHCs) as permitted in Standard 1.2.7. Once an application has been accepted or proposal prepared, the HLHC expert committee and Food Regulation Steering Committee (FRSC) are formally notified and comments on the application are sought. It involves one round of public consultation only, unless an applicant has requested confidential treatment of their application.

Assessment

The purpose of this assessment is to determine whether to proceed to develop a food regulatory measure. FSANZ will then either prepare a draft food regulatory measure or variation or reject (in whole or part) the application, or abandon the proposal. In this assessment, FSANZ must have regard to the matters listed under Section 29 (applications) or Section 59 (proposals) of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). Paragraphs 29(d) and 59(d) also include the Section 18 objectives of the FSANZ Act (see below). A summary of the assessment and reasons for FSANZ's decision are prepared and publicly released for consultation. Calls for public comment are made via the Food Standards Notification Circular, email alerts to interested stakeholders, media releases and published on our website.

If an application or proposal is being considered under the Major procedure, the assessment is carried out in two parts (first and second call for submissions) with an additional round of consultation between. The second call for submissions includes draft variations to the Australia New Zealand Food Standards Code.

Section 29 matters

  1. In assessing the application, the Authority must have regard to the following matters:
    1. whether costs that would arise from a food regulatory measure developed or varied as a result of the application outweigh the direct and indirect benefits to the community, Government or industry that would arise from the development or variation of the food regulatory measure;
    2. whether other measures (available to the Authority or not) would be more costeffective than a food regulatory measure developed or varied as a result of the application;
    3. any relevant New Zealand standards;
    4. any other relevant matters.

Section 59 matters

  1. In assessing the proposal, the Authority must have regard to the following matters:
    1. whether costs that would arise from a food regulatory measure developed or varied as a result of the proposal outweigh the direct and indirect benefits to the community, Government or industry that would arise from the development or variation of the food regulatory measure;
    2. whether other measures (available to the Authority or not) would be more cost-effective than a food regulatory measure developed or varied as a result of the proposal;
    3. any relevant New Zealand standards;
    4. any other relevant matters.

Section 18 objectives

In descending order of priority:

  1. The protection of public health and safety; and
  2. the provision of adequate information relating to food to enable consumers to make informed choices and
  3. the prevention of misleading or deceptive conduct.

In developing or reviewing food standards, the Authority is also required to have regard to the following.

  1. The need for standards to be based on risk analysis using the best scientific evidence.
  2. The promotion of consistency between domestic and international food standards.
  3. The desirability of an efficient and internationally competitive food industry.
  4. The promotion of fair trading in food.
  5. Any written policy guidelines formulated by the Ministerial Council and notified to FSANZ.

Approval

After the submission period, FSANZ must either approve, approve subject to amendment, or reject the draft standard or variation. FSANZ must have regard to all submissions made during the submission period/s. A report is prepared containing the decision, reasons, summary of issues raised in submissions and how these have been addressed, Regulation Impact Statement (if prepared) and if approved, the food regulatory measure or variation.

The report is publicly released following the notification of the decision to ministers. Advice on approvals is made via the Food Standards Notification Circular, email alerts to interested stakeholders and on our website, as well as in the newspapers. The newspaper notices appear nationally in The Australian and in New Zealand, The New Zealand Herald.

High-level health claims

Applications or proposals seeking a variation whose only effect is to change this list are assessed as a high-level health claim variation. All other applications to amend Standard 1.2.7 are assessed under the General, Minor or Major procedure.

An application or proposal for a high-level health claim variation must only deal with a change to the list in Standard 1.2.7. For example, if the claim related to an unapproved novel food, a separate application or proposal seeking approval for the novel food would be required. FSANZ would then progress both applications or proposals in parallel.

Applicants can also choose to have their application considered confidentially. In this case, no public comment is called and no information is released to the public about the application until after gazettal has occurred.

When assessing an application FSANZ will need to be satisfied that any draft variation will meet the following objectives:

  • the protection of public health and safety
  • the provision of adequate information relating to food to enable consumers to make informed choices
  • the prevention of misleading or deceptive conduct

FSANZ will assess any draft variation against the criteria set out in Standard 1.2.7 in relation to high level health claims, taking into account any recommendations made by the HLHC committee and any submission made on behalf of a jurisdiction represented on FRSC.

If public submissions are to be called for, the same process is followed as for other applications. If not, FSANZ will proceed to consider approval of the draft variation as for other applications.

Ministers consideration of approved food standards

Decisions on food standards, once approved by the FSANZ Board, are notified to the Council of Australian Governments Legislative and Governance Forum on Food Regulation (formerly known as the Australia and New Zealand Food Regulation Ministerial Council) (Food Regulation Forum). Within 60 days of this notification, a majority of jurisdictions on the Food Regulation Forum may ask FSANZ to conduct a review of its decision.

Alternatively, the Food Regulation Forum may inform FSANZ that it does not intend to request a review. In the latter case, the standards are gazetted in Australia and New Zealand and registered as legislative instruments and become law at the date specified.

If the Food Regulation Forum requests a review, FSANZ must conduct the review within three months (or a longer period if allowed by the Food Regulation Forum) and either re-affirm the decision, with or without amendments to the standard, or withdraw its approval of the standard.

That decision is then notified to the Food Regulation Forum. The Food Regulation Forum, by a majority decision, may then, within 60 days, approve, amend or reject the draft variation.

If the Food Regulation Forum amends or does not amend the draft variation, the amendment is gazetted in Australia and New Zealand and registered as a legislative instrument and becomes law at the date specified.

Advice on gazettals is made via the Food Standards Notification Circular, email alerts to interested stakeholders and on our website, as well as in the newspapers. The newspaper notices appear nationally in The Australian and in New Zealand, The New Zealand Herald.

Once the amendment becomes law, it is the responsibility of state and territory governments and the New Zealand Ministry for Primary Industries to enforce the standard. The Australian Government Department of Agriculture, Fisheries and Forestry is responsible for enforcing standards relating to imported food.

Criteria for requesting a review

Under the 2008 Inter-Governmental Food Regulation Agreement, ministers can only request reviews of FSANZ decisions based on one or more of the following criteria:

  1. it is not consistent with existing policy guidelines set by the Ministerial Council11
  2. it is not consistent with the objectives of the legislation that establishes FSANZ
  3. it does not protect public health and safety
  4. it does not promote consistency between domestic and international food standards where these are at variance
  5. it does not provide adequate information to enable informed choice
  6. it is difficult to enforce or comply with in both practical or resource terms
  7. it places an unreasonable cost burden on industry or consumers.

One request for a review was received in 2012–13. The request for a review on a decision relating to the approval of low tetrahydrocannabinol hemp in food was based on criteria (iii) and (vi).

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