The application must contain the information specified in this Guideline (3.1.1) and as appropriate, the information indicated in Chapters. 3.2–3.7.
Note:
Consultation with FSANZ
Applicants are strongly advised to consult with FSANZ prior to submitting an application to ensure that the application contains all the necessary information relevant to the proposed food regulatory measure or variation to a food regulatory measure. On-going consultation with FSANZ throughout the application process is also encouraged.
Industry and consumer groups are also encouraged to bring to the attention of FSANZ food standards issues which may require attention through means other than via an application.
Mandatory information requirements
The word ‘must’ is used in these guidelines to identify information must be included in an application. Applicants should note that if this information is not provided, the application may be rejected at the administrative assessment stage. Rejection will not preclude an applicant from re-lodging the application at a later date.
Non-mandatory information requirements
The word ‘should’ is used in these Application guidelines to identify information which, though not required to be included in an application, may assist FSANZ in its assessment. Failure to provide this information will not result in rejection of an application at the administrative assessment stage. However, the information may be requested during assessment of the application.
There may be occasions where the information required or recommended for inclusion in an application by these Application guidelines is not sufficient to allow FSANZ to properly assess an application. In such situations, pursuant to section 108 of the FSANZ Act, FSANZ may request additional information from an applicant.
Drafting
It is recommended that applicants not include proposed drafting in their application. It is FSANZ’s responsibility to determine what the appropriate drafting should be for the food regulatory measure in response to an application. To enable FSANZ to prepare appropriate drafting, applicants are expected to outline in general terms the change(s) to the Code that they consider are required to secure the outcomes they want. This can include mentioning the relevant sections of the Code and the matters. that any amended or new provisions need to cover or address. Providing explicit drafting in an application may limit that application’s scope and make its assessment more difficult. If proposed drafting is included in an application, in the absence of an express request in the application to include that drafting in the Code, FSANZ will proceed on the basis that that drafting is not being sought by the applicant, but is provided only as an example of how the Code might be amended.
A Form of the application
A.1 Language
The application must be in English.
Note:
FSANZ will accept supporting information of high relevance to the application in a language other than English that is accompanied by a full English translation.
A.2 Format
The application should contain a table of contents. The table of contents should use the heading titles for the guidelines that are relevant to the application.
The application must contain an executive summary of the application. The executive summary must be provided as an electronic file separate from other parts of the application.
Information contained within the application must clearly identify all parts of the relevant guideline(s) to which they relate.
The application must be numbered sequentially on each page.
A.3 Copies
The application must be submitted electronically. The application must not be sent by facsimile.
The application should be provided on a thumb drive, CD or other device, as an attachment to an email or through the FSANZ website.
Unless these Application guidelines state otherwise, the application must include full electronic copies of all references referred to in the application.
The application should be searchable by word and phrase.
Note:
Before any application is formally lodged, ensure all documents are able to be opened by checking on a different computer to the one which was used to create or burn them on CD. This will help ensure that documents that are corrupted or have other problems which prevent FSANZ access, are not provided.
If under 20 MB, or via a compressed file if larger than 20 MB, the application can be emailed to the Standards Management Officer at applications@foodstandards.gov.au or sent by post or courier to either of the following addresses:
Standards Management Officer
Food Standards Australia New Zealand
PO Box 5423
KINGSTON ACT 2604
AUSTRALIA
Standards Management Officer
Food Standards Australia New Zealand
Ground Floor
Boeing House
55 Blackall Street
BARTON ACT 2600
AUSTRALIA
B Applicant details
The application must contain the following contact details:
(a) applicant (individual or organisation’s) name
(b) name of contact person
(c) address (street and postal)
(d) telephone number
(e) email address
(f) nature of applicant’s business
(g) details of other individuals, companies or organisations associated with the application.
C Purpose of the application
The application must contain a statement regarding the purpose of the application. To the extent possible, the application should identify existing food regulatory measure(s) that need to be varied to achieve the intended purpose of the application. For applications that relate to a matter dealt with under Chapters. 3.2–3.7, the purpose of the application relevant to any particular guidelines must be provided.
D Justification for the application
The application must provide information to indicate why a food regulatory measure is proposed. Such information may, depending on the purpose of the application as outlined according to requirements in section C of this Guideline (3.1.1), include:
(a) the need for the proposed change
(b) the advantages of the proposed change over the status quo, taking into account any disadvantages.
Note:
The following general issues should be considered:
(a) any public health and safety issues related to the proposed change including details of target groups and population groups that may be adversely affected
(b) any consumer choice issues related to the proposed change
(c) any evidence that the food industry generally or other specific companies have an interest in, or support, the proposed change.
The application must also contain details of the status of similar applications made in other countries by the applicant, if applicable.
D.1 Regulatory impact information
The application must include current information and data on the following costs and benefits:
D.1.1 Costs and benefits of the application
This may include:
(a) the cost and benefits to the consumer e.g. health benefits
(b) the costs and benefits to industry and business in general, noting any specific effects on small businesses e.g. savings in production costs
(c) the costs and benefits to government e.g. increased regulatory costs.
Costs and benefits must be quantified in monetary terms wherever possible, or where this is not possible, other quantitative measures and qualitative evidence must be provided.
Reference must be made to other sections of the application that contain detailed supporting information, where necessary.
Note:
If the OBPR makes a decision that a RIS is required, FSANZ must meet the OBPR’s information requirements. In such a case, FSANZ may need to request further information from an applicant before the assessment of the application can continue.
D.1.2 Impact on international trade
This may include information on the impact of the proposed change on international trade.
E Information to support the application
The application must contain sufficient supporting information or data to enable the objectives specified in section 18 of the FSANZ Act to be addressed. This includes all information relevant to the consideration of the safety of a substance.
Note:
Where the application relates to matters. referred to in Chapters. 3.2–3.7, please refer to the relevant guideline for specific information requirements. In some instances more than one guideline may apply.
E.1 Data requirements
Note:
The term ‘data’ in this document refers, among other things, to units of information; facts; observations; or results of an experiment, study or survey.
FSANZ will assess all the available data presented in support of an application.
Wherever the data requirements are mandatory but cannot be met, a reason should be provided.
When a literature search is undertaken, the application must:
(a) list the databases and journals searched (such as MEDLINE, EMBASE, TOXLINE, FSTA, Science Citation Index, BIOSIS, PsycINFO, CINAHL, Cochrane Library, or the Australian Medical Index etc)
(b) provide the criteria used to specify the search, such as the key words, the time period of the search, and any other limiting criteria
(c) list all of the papers. identified in the search
(d) list and provide in full all of the papers. included as the basis of the evidence in the application. Summaries of study findings and papers. are not adequate.
The data underpinning the evidence to support the Application should also:
(a) identify the source, author(s) and year the data was produced
(b) be obtained using validated or standardised methods, where these are available. Standardised methods should be validated for accuracy and reproducibility, and declare the sensitivity and specificity of the method where appropriate
(c) be representative of the Australian and New Zealand populations
(d) be analysed using appropriate statistical techniques.
E.1.1 Data related to safety studies
(a) Studies submitted for safety assessment purposes should be designed and conducted in accordance with the principles and intent of good laboratory practice (GLP). For safety assessments of chemicals, reference should be made to the following:
(b) All studies conducted for a regulatory purpose should be accompanied by evidence of a quality control/assurance program or evidence of independent auditing of the conduct and reporting of the study.
(c) Studies should contain full details of the conduct of the study and its results, including raw data where appropriate.
E.1.2 Data related to surveys on chemicals or other substances in food
(a) The survey design and method should be clearly enunciated along with the findings and the conclusions. Where surveys are designed to be targeted or selective, the basis for doing so should be clearly stated.
(b) The survey should use a design that avoids biasing the results. The target population should be identified, and the sample frame described in terms of the target population. The survey should have a sample size that provides sufficient power to detect an effect. The sampling method used (e.g. simple random sampling, cluster sampling) should be described, and the reason for the method provided. Any deviations from the sampling method should be identified and the reasons for deviation provided. Data analysis and reporting should be consistent with the sampling method. If any observation/case is excluded from data analysis, the reason for exclusion should be defined and reported.
(c) Surveys should include evidence of quality control/assurance systems. Information on limits of reporting should also be included.
E.1.3 Data related to epidemiological/intervention studies in humans
(a) Epidemiological/intervention studies should include comprehensive detail about:
(i) the study design e.g. randomised controlled trial, cohort study, nested case-control study
(ii) the objectives or hypothesis
(iii) the sample size in the study groups including the numbers. in each group that were recruited, randomised, completed the study, and included in the analyses, and any power calculations
(iv) the participants’ characteristics including age, sex, setting, health status
(v) the methodology including duration of intervention (or study) and period of follow-up, measurement of outcomes and confounders, statistical analysis
(vi) the study results including effect size and statistical significance, any adverse effects.
(b) The studies should have a sample size that provides sufficient power to detect an intended effect.
Note:Examples of the main types of intervention and epidemiological study designs include:Intervention (experimental) studies:clinical trialsfield trialsindividual levelaggregated level (community trials)Observational (non-experimental) studies:cohort studiescase-control studiescross-sectional surveysroutine data-based studies:– individual level data– aggregated level data (ecological studies)
Note:A number of resources exist which provide guidance on how to report research methods and findings. These resources specify a minimum set of items required for a clear and transparent account of what was done and what was found in a research study, reflecting in particular, issues that might introduce bias into the research. Most widely recognised guidelines are based on the available evidence and reflect consensus opinion of experts in a particular field, including research methodologists and journal editors. These resources are all available online. A list of links to useful resources is provided below:(i) Equator Network: overview of reporting guidelineshttp://www.equator-network.org/index.aspx?o=1032(ii) GRADE: Grades of Recommendation, Assessment, Development, and Evaluationhttp://www.jclinepi.com/content/jce-GRADE-Series(iii) CONSORT Statement: Consolidated Standards Of Reporting Trialshttp://www.consort-statement.org/(iv) PRISMA Statement (formerly QUOROM): Preferred Reporting Items for Systematic Reviews and Meta-Analyseshttp://www.prisma-statement.org/(v) STARD Statement: Standards for Reporting Studies of Diagnostic Accuracyhttp://www.consort-statement.org/resources/downloads/other-instruments/(vi) MOOSE Statement: proposal for reporting meta analyses of observational studies in epidemiologyhttp://www.consort-statement.org/index.aspx?o=1347(vii) STARLITE Statement: Standards for Reporting Literature searcheshttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1629442/pdf/i1536-5050-094-04-0421.pdf(viii) STROBE Statement (& STREGA): STrengthening the Reporting of OBservational studies in Epidemiology.http://www.strobe-statement.org/
F Assessment procedure
If related to a variation to the Code, the application must provide details as to what an applicant considers. is the appropriate procedure to be adopted in assessing the application i.e. general, minor, major or high level health claim variation. This is a requirement under paragraph 22(2)(e) of the FSANZ Act. As a matter of practice, FSANZ has regard to the applicant’s suggestion, but makes its own determination on the process to be adopted. The process to be adopted by FSANZ will be communicated to FSANZ in accordance with section 27(c) of the FSANZ Act.
Note:
FSANZ makes the final determination on the appropriate procedure and cost recovery level (based on the number of hours. estimated for the assessment) during the administrative assessment, taking account of the purpose and complexity of the application.
G Confidential commercial information (CCI)
Any information that the applicant considers. to be CCI must be identified as CCI. This information must be separated from the other parts of the application (both electronically and in hard copy).
The application must be accompanied by a written explanation of why and how that identified information is CCI. That is, how that information satisfies the definition of CCI in section 4 of the FSANZ Act.
The application must be accompanied by provide a non-confidential general summary of any information that they consider to CCI. That summary must be sufficiently detailed for it to be useful for assessment. This allows FSANZ to address the information in general terms as part of the assessment.
Note:
FSANZ may not accept an applicant’s claim that information is CCI. In such a case, if FSANZ is satisfied that the information is not CCI, FSANZ will advise the applicant that it does not consider that the material is protected by section 114 of the FSANZ Act.
FSANZ will deal with CCI in accordance with section 114 of the FSANZ Act. Applicants should note that section 114 allows CCI to be disclosed to third parties in certain circumstances.
FSANZ will provide CCI to advisory committees or groups established by FSANZ to provide it with expert advice and analysis on an as needs basis, for example, information relating to analytical methods. The members. of such advisory committees and groups are subject to the same confidentiality requirements of the FSANZ Act as FSANZ staff.
H Other confidential information
Applications must identify all non-CCI information that the applicant wishes to be treated as confidential.
That information must be separated from other material provided to FSANZ and be marked ‘Confidential’. It must be accompanied by a written statement detailing the reasons as to why the applicant wishes that information to be treated as confidential. For example, disclosure of the information would be detrimental to the applicant or the information is not publicly available and known only to a limited number of people.
Applicants who provide unpublished manuscripts must indicate whether or not the author is aware that the manuscript has been provided to FSANZ.
Note:
The fact that FSANZ agrees to accept information on a confidential basis does not mean that that information cannot be made public or disclosed to others. FSANZ can be required by law, Parliament and the courts to disclose information provided to it on a confidential basis.
If applicants have concerns about personal information contained in an application being published by FSANZ on its website, they may wish to provide a redacted version of the application, in addition to the required complete electronic version of that application. FSANZ will then decide whether to publish the redacted version instead. of the complete version.
I Exclusive capturable commercial benefit (ECCB)
The applicant should indicate whether or not the application is expected to confer an exclusive capturable commercial benefit. The applicant should provide a justification for their assertion to assist FSANZ in making a decision.
Note:
Consideration of the circumstances surrounding the application, including the following factors, may help in determining whether or not an ECCB is conferred:
Why are you making this application? What are you hoping to get out its approval?
How will you benefit from the approval of your application?
Who besides you, will benefit from the approval of your application? How and why will they benefit?
If your application is approved, whose permission will be required before anyone can derive a benefit from that approval?
Who holds the intellectual property in the subject matter of your application?
J International and other national standards
J.1 International Standards
The application must contain details of any Codex Alimentarius Commission (Codex) Standards relevant to the application.
Note:
This information is required since one of the five additional objectives to which FSANZ must have regard is the promotion of consistency between domestic and international standards.
Codex standards are regarded as the international standards related to food by the World Trade Organization (WTO). Information on Codex Alimentarius can be found at http://www.fao.org/docrep/w9114e/w9114e00.htm.
Both Australia and New Zealand, as members. of the WTO, must comply with the Technical Barriers. to Trade (TBT) and Sanitary and Phytosanitary (SPS) Agreements of the WTO.
J.2 Other national standards or regulations
The application should contain details of relevant standards or regulations in other countries with comparable regulatory processes, where available.
K Statutory declaration
The application must contain a signed statutory declaration that includes the following statements:
The information provided in this application fully sets out the matters. required.
The information provided in this application is true to the best of my knowledge and belief.
No information has been withheld that might prejudice this application, to the best of my knowledge and belief.
A statutory declaration provided on behalf of a body corporate must be made by a senior officer of that body corporate who is authorised to make the declaration on its behalf. The senior officer must state their name and source of knowledge and authority in making the statutory declaration and include a sufficient explanation of who they are (name, address, organisation/employer, position).
For overseas applicants, FSANZ will accept signed equivalent documents from other countries (in English).
L Checklist
More than one guideline may apply to an application. The application must contain completed checklists for all relevant guidelines with regard to format and information requirements relevant to the application (see Appendix 1).
Page numbers. must be included with the checklist as indicated in the Appendix.
Note:
An example of when more than one guideline might apply is where an application involves adding a nutritive substance to infant formula. In this case, the checklists for Guidelines 3.1.1 – General requirements, 3.3.3 – Substances used for a nutritive purpose and 3.6.3 – Special purpose foods – Other foods, would be relevant.