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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 transparent. 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 which includes information to help potential applicants. FSANZ can reject an application if it has not met the mandatory information requirements set out in Part 3 of the Application Handbook. This ensures that applications contain enough information to enable them to be properly assessed. It also minimises delays in completing assessments by avoiding the need to ask for further information from an applicant so an assessment can proceed.

The Application Handbook also includes information covering cost-recovery, confidentiality and assessment processes. The handbook is updated as required to ensure information about FSANZ's needs is current.

FSANZ continually looks at ways to improve its assessment processes and the documents it produces as part of those processes.

All submissions are placed on 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 received before 1 May 2011 and which 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 +61 2 6271 2280 or email standards.management@foodstandards.gov.au.

The steps relating to the assessment of applications and proposals 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 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. 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 FRSC are formally notified and comments on the application are sought. No public consultation on applications occurs, unless the applicant has asked for it.

Assessment (general, minor or major procedures)

The purpose of the 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 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 through the Food Standards Notification Circular, email alerts to interested stakeholders, media releases, the website and social media.

If an application or proposal is being considered under the major procedure, the assessment is carried out in two parts (1st and 2nd call for submissions) with an additional round of consultation between. The 2nd call for submissions includes draft variations to the Code.

Section 29 matters

(2) In assessing the application, the Authority must have regard to the following matters:

(a) 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;

(b) 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 application;

(c) any relevant New Zealand standards;

 

(d) any other relevant matters.​

 

Section 59 matters

(2) In assessing the proposal, the Authority must have regard to the following matters:

(a) 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;

(b) 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;

(c) any relevant New Zealand standards;

(d) any other relevant matters.

Section 18 objectives​

In descending order of priority:

(a) The protection of public health and safety; and

(b) the provision of adequate information relating to food to enable consumers to make informed choices; and

(c) the prevention of misleading or deceptive conduct.

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

(a) The need for standards to be based on risk analysis using the best scientific evidence.

(b) The promotion of consistency between domestic and international food standards.

(c) The desirability of an efficient and internationally competitive food industry.

(d) The promotion of fair trading in food.

 

(e) 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 for the decision, summary of issues raised in submissions and how these have been addressed, a Regulation Impact Statement (if prepared) and, if approved, the food regulatory measure or variation.

The report is publicly released following 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 newspaper and in New Zealand, The New Zealand Herald.

Assessment (high level health claim (HLHC) variation procedure)

Assessment under the HLHC variation procedure applies to applications or proposals seeking to make a change to the list of high level health claims in Schedule 2 of Standard 1.2.7 or to add a general level health claim to Schedule 3 of Standard 1.2.7. All other applications and proposals to amend Standard 1.2.7 are assessed under the general, minor or major procedure. In addition, if the claim relates to an unapproved novel food, FSANZ must treat that part of the request as a separate application. FSANZ would then progress both applications in parallel. The same approach would be applied to proposals.

Public submissions are not called for on these applications, unless the applicant has advised FSANZ that this can occur. If public submissions are not called for, no documentation will be placed on the internet and minimal information will be placed in the FSANZ Work Plan.

FSANZ is also required to seek advice from an expert committee and FRSC as part of the assessment process.

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 also has to assess any draft variation against the criteria set out in Standard 1.2.7 in relation to HLHCs, 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, a similar process is followed as for the general procedure. If not, FSANZ proceeds to consider approval of the draft variation in the same way as other applications or proposals.

Ministers consider approved draft food standards

Decisions on draft food standards, once approved by the FSANZ Board, are notified to the Australia and New Zealand Ministerial Forum for Food Regulation. Within 60 days of this notification, a majority of jurisdictions on the Forum may ask FSANZ to conduct a review of its decision.

Alternatively, the Forum may inform FSANZ that it does not intend to request a review. If there is no request for review standards are gazetted in Australia and New Zealand and registered as legislative instruments, becoming law at the date specified.

If the Forum requests a review, FSANZ must conduct the review within three months (or a longer period if allowed by the 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 Forum. The Forum, by a majority decision, may then, within 60 days, approve, amend or reject the draft variation.

If the 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. If the variation is rejected by the Forum, the Forum is required to publish its reasons for the decision.

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 newspaper and in New Zealand, The New Zealand Herald.

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

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