Food Standards Australia New Zealand Act 1991 Application Handbook Part 3 (Cth)
Part 3
Application guidelines
Subsection 22(2) of the Food Standards Australia New Zealand Act 1991 (Cth) (FSANZ Act) provides that an application for the development or variation of a food regulatory measure must, amongst other things:
be in the form specified in the application guidelines; and
include all the information specified by the Application guidelines.
The application guidelines set out at this Part 3 of the Application Handbook are guidelines made by legislative instrument in accordance with subsection 23(1) of the FSANZ Act.
For the purposes of these guidelines, an application includes all documents provided to FSANZ in support of the development or variation of a food regulatory measure.
The guidelines outline requirements related to each of the groups of standards in the following list. Applications to vary the Code will generally, but not exclusively, relate to one or more of the following groups of standards. In many cases, an application may seek a change that means the information requirements of several guidelines must be met:
standards related to labelling and other information requirements
standards related to substances added to food
standards related to contaminants and natural toxins
standards related to new foods
standards related to special purpose foods or standardised foods
standards related to food production
Each of these broad. groups of standards contains a number of individual food standards which relates to specific food matters. For each, there will be different information requirements. Applicants should identify the guidelines that are relevant to their particular application.
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 information requirements for Guidelines 3.1.1 –General requirements, 3.3.3 – Substances used for a nutritive purpose and 3.6.2 – Special purpose food – Infant formula products, would be relevant.
In the case of Chapter 3.2, Applicants should begin with the Guideline on general food labelling, which contains general requirements for an application related to labelling. The other guidelines relate to particular aspects of labelling, which may or may not be relevant to a particular application.
Boxed text such as notes or examples in these application guidelines provide additional information or clarification of requirements outlined in the guidelines only. They do not form part of the guidelines.
Chapter 3.1
General requirements for applications
3.1.1 General requirements
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 [email protected] 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.
Note:
Useful guidelines on undertaking literature searches can be found at 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:
(i) OECD Principles on Good Laboratory Practice
(ii) relevant OECD Guidelines for the Testing of Chemicals
(iii) other recognised test guidelines such as:
US Food and Drug Administration Redbook 2000 Toxicological Principles for the Safety Assessment of Food Ingredients
(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 trials · field trials · individual level · aggregated level (community trials) Observational (non-experimental) studies: · cohort studies · case-control studies · cross-sectional surveys · routine 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 guidelines
(ii) GRADE: Grades of Recommendation, Assessment, Development, and Evaluation
(iii) CONSORT Statement: Consolidated Standards Of Reporting Trials
(iv) PRISMA Statement (formerly QUOROM): Preferred Reporting Items for Systematic Reviews and Meta-Analyses
(v) STARD Statement: Standards for Reporting Studies of Diagnostic Accuracy
(vi) MOOSE Statement: proposal for reporting meta analyses of observational studies in epidemiology
(vii) STARLITE Statement: Standards for Reporting Literature searches
(viii) STROBE Statement (& STREGA): STrengthening the Reporting of OBservational studies in Epidemiology.
|
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 list of current official Codex standards can be found at 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:
1. The information provided in this application fully sets out the matters. required.
2. The information provided in this application is true to the best of my knowledge and belief.
3. 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).
Templates for Australian and New Zealand statutory declarations are provided on the FSANZ website at
Note:
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.
Chapter 3.2
Guidelines for applications for
labellingand other information requirements
3.2.1 General food labelling
An application to vary the Code is required to change the many aspects of food labelling that are detailed in Part 1.2 – Labelling and other information requirements. This includes both the information contained on the label and the way in which this information is presented on the food product, including the conditions that govern such information.
The following information is required to support an application related to food labelling. This information is in addition to that specified in Guideline 3.1.1 – General requirements.
Additional information may be required if the application relates to one or more of the following:
(a) warning and advisory statements
(b) declaration of allergens
(c) labelling for consumer information and choice
(d) nutrition information labelling
(e) nutrition content and health claims.
The additional information requirements relating to the above matters. are outlined in Guidelines 3.2.2–3 2.6.
A General information to support the proposed labelling change
The application must contain the following information:
A.1 A description of the proposed labelling change
This includes detailed information on the proposed labelling change, and should indicate the Standards and clauses which will be affected.
A.2 A list of the foods or food groups likely to be affected by the proposed change
This includes details of the specific foods or food categories affected by the proposed change.
Note:
Specific food categories include packaged or unpackaged food, food intended for restaurants, food intended for catering purposes, food intended for retail sale and food not intended for retail sale. Additional information on likely foods to be exempted from proposed labelling would also be useful.
B Information related to the potential impact on consumer understanding and behaviour
The application must contain the following information:
B.1 Information to demonstrate consumer support of the proposed labelling change
This includes information (possibly consumer research data) to show that the issue(s) underlying the proposed labelling change are significant to consumers. This also includes information on which consumer groups will be affected and the number of consumers. affected.
B.2 Information to demonstrate that the proposed labelling change will be understood and will assist consumers
This includes consumer research information to demonstrate the anticipated consumer response to the proposed change, or data obtained from an overseas market where the proposed labelling is in place.
B.3 Information to demonstrate that the proposed labelling change will not have any adverse health or diet impacts on any population groups (e.g. age or cultural groups)
Note:
The extent of the impact of a food labelling change on consumer understanding and behaviour will vary depending on:
(a) the nature of the labelling change
(b) the foods to which it will apply.
Thus the amount of information necessary to address the impact on consumer understanding and behaviour will depend on the level of impact. Consultation with FSANZ may be necessary to examine the expected level of impact.
Also, there may be situations where consumer impact from the proposed labelling is not required e.g. where there is an identified public health benefit associated with the labelling change, or where the impact is on industry rather than consumers.
3.2.2 Warning and advisory statements
An application to vary the Code is required to include or change the mandatory warning and advisory requirements that are listed in Standard 1.2.3 – Information requirements – warning statements, advisory statements and declarations or Schedule 9 – Mandatory advisory statements.
Note:
Warning statements are generally reserved for well-characterised, potentially life-threatening public health and safety risks where the target population is unaware of the potential risk and a prescribed labelling statement is needed to alert consumers. Advisory statements may be used to advise the general population or a specific target population of potential public health and safety risks associated with a food.
The following additional information is required to support an application to include or change a mandatory warning or advisory statement in relation to a food or food ingredient.
This information is in addition to that specified in Guideline 3.1.1 – General requirements and 3.2.1 – General food labelling. Declaration of allergens is considered under Guideline 3.2.3.
A Additional information related to the safety of the food or food ingredient
The application must contain the following information:
A.1 Data to indicate that the food or food ingredient presents a potential health concern to one or more population groups
This includes one or more of the following types of information:
(a) epidemiology studies on the target population group(s)
(b) clinical studies on individuals from the target population group(s)
(c) case studies of affected individuals
(d) reports adverse food-medicine interactions in individuals
(e) reports of safety studies in experimental animals
Note:
The nature of the target population will vary with the particular potential health concern. Examples of mandatory advisory statements can be found in the Code in the table to section S9—2. Examples of mandatory warning statements and declarations can be found in sections 1.2.3—3, 4 and 5 in the Code.
B Additional information related to consumers’ awareness of a potential public health and safety risk associated with the food
The application must contain the following information:
B.1 Data to indicate that one or more consumer groups are unaware of the public health and safety risk
This includes one or more of the following types of information:
(a) currently available information regarding use and consumption of the food
(b) reports of epidemiology studies or case studies of consumers. being at risk through consumption of the food or food ingredient
(c) data from consumer surveys indicating a potential risk associated with the use of the food or food ingredient.
3.2.3 Declaration of allergens
An application is required to vary the Code to include or change the requirements for mandatory declaration of certain foods or food ingredients, which are listed in Standard 1.2.3 – Information requirements – warning statements, advisory statements and declarations.
A Additional information to support addition of an allergen to the list of declared foods
The following additional information is required to support an application to add an allergenic food on the list of foods in the Standard which are required to be declared on the label. This information is in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.
The application must contain the following information:
A.1 Information to demonstrate the food causes an IgE-mediated allergy
This includes clinical data associating IgE-mediated allergic reactions with the specific food including one or more of the following:
(a) patient history
(b) skin testing
(c) double-blind placebo-controlled food challenges (DBPCFC).
A.2 Information on the incidence in the population of allergic reactions to the food
This includes published data or data derived from allergy clinics on the incidence of allergic reactions to the food in the population.
A.3 Information on the severity of the allergic reaction to the food in relation to the amount of food consumed
This includes clinical reports on the range of symptoms associated with the allergic reaction and an estimate of the amount of food that may provoke these symptoms.
A.4 Information on the extent of use in the food supply and the range of food containing the allergen
This includes information on the quantity of the allergen in the food supply and an indication of the range of foods where it is used. As much as possible, projections for extended use in the immediate and near future should also be included.
B Additional information to support removal of a food derivative from the list of declared foods
The following additional information is required to support an application to exclude a derivative of an allergenic food from the list of foods in the Standard which are required to be declared on the label. This information is in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.
The application must contain the information in sections B.1–4 of this Guideline (3.2.3). Data must also be provided in accordance with subsection B.5 if the information derived from sections B.1–4 is insufficient to conclude that the food derivative should be exempted from declaration on the label.
B.1 Information on the nature of the food derivative
This includes a specification for identity and purity for the food derivative, including data on the level of protein in the derivative.
B.2 Information on the use of the food derivative and its presence in the final food
This includes information on how the food derivative is used in foods and the range of foods in which it is used.
B.3 Information on the level of dietary intake of the food derivative
This includes information on dietary intake for different population groups.
B.4 Information on the history of safe use of foods containing the food derivative
This includes information on the range of foods containing the food derivative and reports of any allergic reactions to these foods.
B.5 Clinical information on the safety of the food derivative, if applicable
This includes clinical challenge studies where the food derivative is tested in individuals who are sensitised to the source of the food derivative.
3.2.4 Labelling for consumer information and choice
An application is required to vary the Code to include or change the labelling requirements which are in place to provide adequate information and allow consumer choice.
Note:
Certain food labelling is directed towards:
(i) providing adequate information in order to allow consumers. to make to an informed choice; or
(ii) preventing misleading and deceptive conduct by food manufacturers. Such labelling could be in relation to a public health and safety matter or the need for additional information to give consumers. confidence in the food regulatory system. This is sometimes referred to as a ‘market failure’.
In the case of deceptive conduct to mislead. the consumer, this would be dealt with under Australian Consumer Law, rather than through a variation to the Code.
Note:
FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.
For the labelling of GM, irradiated or novel foods, or other foods using new technologies, the relevant Policy Guideline is the Labelling of Foods produced or processed using New Technologies.
FSANZ will have regard to these policy principles during the assessment of applications involving foods produced or processed using new technologies. The Guideline is available at information requirements outlined below take the Policy Guideline into consideration.
The following additional information is required to support an application related to food labelling for consumer information and choice.
This information is in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.
A Additional information related to assisting consumers. to make an informed choice
The application must contain the following information:
A.1 Information to show that the current labelling, or lack of labelling, or information from alternative sources does not allow consumers. to make an informed choice
This includes information to show that consumers. have a limited ability to make an informed choice based on the information provided on the label and that consumers. are unable to source the necessary information from alternative sources.
A.2 Information to show that there are no, or a limited number of, suitable substitute products in all food categories currently available to consumers
A.3 Information to show that the proposed specific labelling change will assist consumers. to make an informed choice or will provide alternative labelling that will not hinder consumers. from making an informed choice
This includes information on the proposed specific labelling change and consumer research data to demonstrate the appropriate consumer response to the proposed change, or data from an overseas market where the proposed labelling is currently used.
A.4 Information to demonstrate that, in the absence of the proposed labelling, alternative measures to address the issue would not be effective
This includes information on one or more of the following alternative measures:
(a) voluntary labelling (e.g. endorsement or product approval programs)
(b) self-regulation (e.g. codes of practice)
(c) other legislative measures (e.g. trade practices)
(d) national manufacturing standards (including those developed by Standards Australia)
Note:
The Code should be read. in conjunction with other applicable laws, such as the Australian Consumer Law (Commonwealth legislation) and the New Zealand and State and Territory Fair Trading Acts. The provisions in these Acts, particularly relating to conduct which is false, misleading or deceptive, apply to the supply of food in trade and commerce.
The prevention of misleading or deceptive conduct is one of the primary subsection 18(1) objectives in the FSANZ Act that must be satisfied by FSANZ in developing or varying a food standard.
The ACCC is responsible for ensuring compliance with the Australian Consumer Law. The substantive provisions of the Australian Consumer Law are expressly limited to activities undertaken by corporations, subject to certain exceptions and qualifications. State and Territory fair trading laws are not subject to these constitutional limitations, and so fill the gaps left by the limited application of the Australian Consumer Law. The Code is usually given legal force through State legislation and is enforced by the States and Territories and by the Australian Government at the border.
3.2.5 Nutrition information labelling
An application is required to vary the Code to change the labelling requirements which are in place to provide nutrition information.
The following additional information is required to support an application related to food labelling for nutrition information.
This information is in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.
A Additional information to support a change to the nutrition information labelling of a food
The following additional information is required to support an application to include or remove nutrition information on a food label or to change the way in which the label currently displays the nutrition information.
The application must contain the following information:
A.1 A description of how the proposed labelling will change the nutrition information labelling of the food
This includes detailed information on the nature and intent of the proposed labelling change, and should indicate the foods or food categories which will be affected.
If applicable, this also includes information on how the proposed labelling of a specific nutrient or energy will affect the declaration of related nutrients.
A.2 Data to demonstrate that the proposed labelling change will assist consumers. to make an informed choice and will not mislead. them
This includes consumer research data or data obtained from an overseas market where the proposed labelling is in place, to demonstrate the anticipated consumer response to the proposed change.
If applicable, this also includes information to show that alternative measures to provide the nutrition information are not, or would not, be effective.
B Additional information to establish or vary an energy factor of a food ingredient
The application must contain the following information to support the establishment of an energy factor for a new food ingredient or to vary an energy factor for an existing food ingredient.
B.1 Information on the nature and composition of the food ingredient
This includes information related to the identity and purity of the food ingredient. If it is a mixture of ingredients, this should identify the relative proportions of each, together with information related to the variability between commercial batches and the batch tested for the various energy measurements.
B.2 Details on the calculation of the energy factor
This includes details on the calculation of the proposed energy factor for a food ingredient. This calculation must follow the following equation. Energy factors. based on other calculation methods will not be considered.
ME = GE - FE - UE - GaE - SE
where
ME means metabolisable energy
GE means gross energy (as measured by bomb calorimetry).
FE means energy lost in faeces.
UE means energy lost in urine.
GaE means the energy lost in gases produced by fermentation in the large intestine.
SE means the energy content of waste products lost from surface areas.
The application must include the following information set out in (a)–(e) relating to the calculation of the food ingredient’s energy factor.
(a) The components and result of the equation (ME, GE, UE, FE, GaE and SE) expressed in kilojoules per gram of food ingredient.
(b) The proportion (as a percentage) of gross energy per gram of original food ingredient lost through each of FE, UE, GaE and SE.
For example: 30% of the food ingredient is lost in faeces, and the GE of the food ingredient is 16 kJ/g, therefore FE = 4.8 kJ/g (0.3 x 16 kJ/g).
(c) A calculation of either the total FE or a sum of its individual components such that
FE = uFE+mFE+oFE. The individual FE components are the energy lost from:
uFE: the proportion of the food ingredient that is excreted unchanged in the faeces
mFE: the excretion of microbial mass in faeces that is produced from the proportion of the food ingredient that reaches the large intestine and is fermented
oFE: the excretion into the faeces of other produced substances from the proportion of the food ingredient that escapes absorption, such as short chain fatty acids or other metabolites.
(d) The proportion of the food ingredient that reaches the large intestine and is fermented, for use in calculations of mFE, oFE or GaE. This amount should be calculated either by:
(i) a direct measurement of the percentage of the food ingredient that reaches the large intestine and is fermented; or
(ii) subtracting measured amounts of the food ingredient that are excreted unchanged in the faeces (uFE) from amounts that are not absorbed in the upper intestine (jejunum and duodenum).
(e) The use or otherwise of default values for one or more of mFE, oFE, GaE or SE. Default values are listed in the following table:
| For ingredients fermented or partly fermented in the large intestine | For ingredients not fermented in the large intestine | |
| mFE (as a % of the ingested food ingredient that is fermented in the large intestine) | 30 | Not applicable |
| oFE (as a % of the ingested food ingredient that is fermented in the large intestine) | 0 | Not applicable |
| GaE (as a % of the ingested food ingredient that is fermented in the large intestine) | 5 | Not applicable |
| SE (as a % of the ingested food ingredient) | 0 | 0 |
If default values are not used for mFE, oFE, GaE of fermented food ingredients, or for SE, then the value for that respective component of the energy factor equation must be substantiated.
B.3 Substantiation of the proposed energy factor of the food ingredient
The application must include specific details on how each of the individual components (GE, UE, FE, GaE, and SE) of ME has been determined, and the scientific evidence and methods used to substantiate these individual values.
| Note: It is acceptable to use multiple scientific methods to substantiate the individual components of the energy factor calculation. The following is a list of methods (not exhaustive) that are acceptable for estimating the individual components of ME: (a) bomb calorimetry – GE The GE of food ingredients, metabolites and excreta is determined as the heat of combustion, as measured by adiabatic bomb calorimetry. This is the only acceptable method for determining GE. (b) classical dietary energy balance – FE and UE This method measures the energy excreted in faeces (FE) and urine (UE) following the ingestion of a known amount (and GE) of the food ingredient. The method involves careful measurement and control of intake for at least several days, preceded by a period of habituation, together with collection of urine and faeces for the equivalent period. It is acceptable for this method to use animal or human subjects, although coprophagy must have been eliminated during rat studies. This method is best suited to measurements of food ingredients that are not fermented in the large intestine and which do not produce gas. However, it is acceptable to use this method for food ingredients that are fermented in the large intestine if it is combined with other methods that measure the percentage of the food ingredient that is fermented (or gas production directly). (c) isotopic tracer methods – FE, UE, upper intestinal absorption, large intestinal fermentation These methods involve the use of isotopically labelled substrates (e.g. 13C or 14C) and measure the percentage of the given dose that is recovered in metabolised form (e.g. in CO2 in breath), in unmetabolised (urine) form, or undigested (faeces) form. It is acceptable to combine this method with other techniques to provide adjunct information on intestinal absorption (e.g. analysis of blood glucose fluctuations or other metabolites) and fermentation (breath hydrogen). It is also acceptable to use studies in germ free animals to provide comparative data that calculates the amount of the food ingredient fermented in the large intestine. (d) breath hydrogen test – GaE, large intestinal fermentation The breath hydrogen response is a reflection of the nutrients fermented in the large intestine, and is also suitable for use in estimating GaE. A common form of the test is to measure basal breath H2 obtained after a dose of lactulose compared with the breath H2 after a dose of the test food ingredient. (e) ileal intubation and ileostomy effluent – small intestinal absorption, large intestinal fermentation Ileal intubation involves the insertion of a nasogastric tube and sampling the digestive matter in the terminal ileum. Ileostomy studies involve subjects who have had. their large bowel surgically removed and in whom digestive excreta (from the end of the small bowel) is collected in a plastic bag. The results of these studies may not be quantitatively representative of normal physiologic status, but they are able to provide a direct estimate of upper intestine absorption by measuring small bowel content at the terminal end of the ileum. Combined with faecal excretion, ileal intubation is also able to provide an indirect measure of the proportion of the food ingredient that reaches the large intestine and is fermented. |
B.4 Information on other factors. that affect the calculation of the energy factor
The application must include information on the following matters. where relevant:
(a) justification for and limitations of the evidence and methods used to substantiate the individual components of the energy factor equation
(b) whether the GE of the food ingredient is constant or varies with different proportions of constituent compounds
(c) any variation in the digestion and absorption related to the variation in the composition of the food ingredient
(d) effects of habituation/adaptation to consumption of the food ingredient
(e) dose dependency
(f) the nature of the background diet (e.g. high or low in one or more of fat, fibre or protein)
(g) individual variability.
3.2.6 Nutrition content and health claims
The following information is required to amend Standard 1.2.7 – Nutrition, health and related claims, Schedule 4 – Nutrition, health and related claims, or Schedule 6 –Required elements of a systematic review. This information is required in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.
This Guideline (3.2.6) is divided into two parts. Section A addresses the application requirements for amendments to Standard 1.2.7. Section B is for applications to add a new food-health relationship to the table to section S4—4 (high level health claims) or to the table to section S4—5 (general level health claims) in the Code.
Note:
Applications to make a change in Schedule 4 to the list of high level health claims in section S4—4 and to add a general level health claim to section S4—5 are required to be considered using the high level health claim variation procedure. Other applications seeking to amend Standard 1.2.7 will be assessed using the general, minor or major procedure as applicable. If a single application seeks a high level or general level health claim variation as well another variation, then FSANZ will automatically progress the different variations under separate applications, each using the relevant procedure.
A Amendments to Standard 1.2.7 or Schedule 4, other than adding new food-health relationships to the tables to sections S4—4 and 5
A.1 Information related to nutrition content claims in the table to section S4—3
If the application relates to nutrition content claims in the table to section S4—3, the following information must be provided:
(a) consideration of the following in relation to any proposed changes to the claim conditions related to the property of food and each descriptor:
(i) the nutrient composition of foods likely to carry the nutrition content claim as described in response to subsection A.2 in Guideline 3.2.1
(ii) any relevant reference values pertaining to the property of food
(iii) whether the conditions are achievable in the Australian and New Zealand food supply.
If the application is for new claim conditions for a property of food not already mentioned in Schedule 4, the application must include a robust analytical method suitable for analytical laboratories to use for detecting and quantifying the property of food in a food.
A.2 Information related to the amendment of an existing high level or general level health claim in the table to S4—4 or the table to S4—5
If the application seeks to vary the food, property of food or the health effect of an existing high level or general level health claim, the application must meet the requirements in Section 2 of this Guideline. If the application seeks to delete an existing high level or general level health claim from the tables to S4—4 or S4—5, then it must contain sufficient detail to justify why the relationship should not be regarded as causal.
If the application seeks to vary the conditions in Column 5 of the tables to sections S4—4 or S4—5 relating to the food or property of food that is the subject of the food-health relationship, then it must contain sufficient detail about the relationship to allow an effective amount of the food or property of food to be determined. Information about the likely dietary intake of the food or property of food by the target group (if there is one) or by the whole population must also be provided.
A.3 Information related to the amendment of the nutrient profiling scoring criterion or method in Schedules 4 or 5 of Standard 1.2.7
If the application seeks to vary the nutrient profiling scoring criterion or method in Schedules 4 or 5, the following information must be provided:
(a) a description of the variation(s) to Schedules 4 or 5, including any food category and other definitions that are to be introduced
(b) a detailed analysis of the impact of the proposed variation on the food eligibility that would occur if the proposed variation was implemented. The analysis must include a range of different types of foods illustrative of those in the market in Australia and New Zealand, not solely the foods of interest to the applicant. It must include:
(i) a description of how the applicant selected the range of foods examined, including how their nutrient and other relevant compositional characteristics were determined
(ii) a description of how the eligibility status of the range of foods tested was affected when evaluated under the current requirements and under the proposed variation.
FSANZ may request the applicant to supply the dataset containing the range of foods analysed in a form that enables FSANZ to review the data referred to in paragraph A.3(b) of this Guideline (3.2.6).
A.4 Information related to variation of the required elements of a systematic review in Schedule 6
If the application seeks to vary any of the required elements of a systematic review as described in Schedule 6, the application must provide sufficient information to support the proposed variation, including an indication about how the proposed variation will deliver an equivalent level of rigour in evaluating the scientific information.
B Amendments to add food-health relationships to the tables to sectionsS4—4 or S4—5
If the application seeks to add a new food-health-relationship to either the tables to sections S4—4 or S4—5, the application must include suitable data, as described below, to assess the nominated food-health relationship and to permit determination of appropriate conditions for a claim based on the relationship.
If the application seeks to vary a food-health relationship already listed in the Code (Columns 1 and 2 in the tables to sections S4—4 or S4—5), then this is equivalent to a new relationship and appropriately suitable data must be provided, as outlined below.
B.1 The scope of the food-health relationship
B.1.1 A clear description of the food or property of food in the food-health relationship
The application must clearly characterise the food group, the food (e.g. genus, species, variety) or property of food that is the subject of the proposed health effect.
Note:
The food or property of food (see for example, Column 1 in the tables to sections S4—4 or S4—5) may include:
a food group (e.g. fruit)
a single ingredient food (e.g. banana)
a food with more than one ingredient (e.g. chewing gum, bread)
a property of food that may either be added or inherent (e.g. a nutrient, ingredient, a component of an ingredient, such as dietary fibre, or other substance or feature of food).
If the food or property of food is a substance or a novel food, a permission to add the substance to food or introduce a novel food must be present in the Code. If there is no permission in the Code for the substance or novel food, a simultaneous application may be required because the processes to amend the relevant standards are different.
There can be concurrent, but separate, applications for both a new substance or novel food and a new food-health relationship.
If a property of food is the subject of the food-health relationship, the application must also include:
(a) a summary of the source and specifications of the property of food
(b) if permission to add the property of food to food is already in the Code, evidence to confirm that the property of food under consideration is the same as already in the Code
(c) a description of the relative bioequivalence of the property of food when consumed in different food matrices, or of a relevant aspect of bioequivalence such as bioavailability or bioconversion
(d) a robust analytical method suitable for analytical laboratories to use for detecting and quantifying the property of food in the foods in which it is present.
B.1.2 A clear description of the health effect in the food-health relationship
The application must detail the health effect of the food or property of food and how it is measured.
B.1.3 A clear description of the proposed food-health relationship
The application must contain a summary of the food-health relationship including the amount of food or property of food required to achieve the health effect, the nature and extent of the health effect, including its direction, and the target population group.
B.2 Identifying and filtering literature for the proposed food-health relationship
The application must contain the information in either subsections B.2.1 or B.2.2 of this Guideline (3.2.6), whichever applies. Only original literature involving humans can be used as a basis to establish a food-health relationship or update an existing systematic review.
B.2.1 A clear description of the search strategy used for food-health relationships examined using original literature only
If the proposed food-health relationship is being examined using the original literature, the application must contain a clear description of the search strategy used to capture the scientific evidence. This includes:
(a) identification of the electronic databases (e.g. Medline, CINAHL, Cochrane Library, Embase and PsycINFO etc.) used for the search
(b) the search parameters. including search terms, time period and languages
(c) justification for excluding the use of any closely related ant search terms
(d) reasons for choosing a specified time period
(e) other restrictions placed on the search (e.g. language and study design)
(f) a description of any manual (non-electronic) search techniques employed, including hand-searching, and the strategy used to identify any unpublished studies
(g) a list of inclusion and exclusion criteria used to filter the literature
(h) the number of studies identified from the search strategy, and number of studies excluded at each stage (Title filter, abstract filter and full-text filter) of filtering
(i) a list of the publications (includes author, reference and publication details) excluded at the full text screening stage, and for each excluded publication, the reason(s) why it was considered not relevant (e.g. the inclusion criteria that were not met).
Note:
If a completed literature search yields a very large number of articles (e.g. 500) it is suggested using the inclusion and exclusion criteria to filter studies by reading the titles, then read. the abstracts to screen those left, and then finally screen with full-text reading.
The following data sources are not suitable:
articles published in newspapers, magazines, or newsletters.
books or book chapters. for consumers. or the general public
information intended for the general public on the internet, such as Wikipedia.
A relationship between a food or property of food and a health effect cannot be established from animal and in vitro studies alone. However, animal and in vitro studies may be provided in support of a relationship.
B.2.2 Food-health relationships based on updating existing systematic reviews
Where the proposed food-health relationship is based on an existing systematic review, the application must:
(a) demonstrate that the food-health relationship described in the existing systematic review is based on the same, or is within the scope of, the proposed food-health relationship
(b) demonstrate that the existing review includes all relevant data from human studies (i.e. evidence in favour, equivocal evidence and evidence that is not in favour of the food-health relationship) given the time period and search criteria that it used
(c) include a full copy of the existing systematic review
(d) describe how the existing systematic review was updated.
Note:
The comparability with the methods of the existing systematic review could be demonstrated by showing that the updating search was done using the same criteria (i.e. points in paragraphs B.2.1 (a)–(f) and B.2.2(a)–(b) above) that were described by the authors. of an existing review. It is important to include the time period covered by an existing review and show how the updated review complements the existing review.
B.3 Summarising literature for the proposed food-health relationship
The application must summarise the studies in humans for the proposed food-health relationship in tabular form, including objectives, sample size, participant characteristics, measurement methods, control for confounding, results and any adverse effects. If an existing systematic review is being updated, the tabulation must include studies from the existing systematic review as well as additional literature identified in the update. If the tabulation in the existing review covers. all the items, then it is acceptable to reproduce the table(s) from the existing review, or to expand them if one or more items are missing.
Each study must be assessed for quality. A description of the quality assessment method used must be provided.
Note:
Presentation of data from human studies
Relevant data from each of the included studies should be presented in tabulated form. Original studies (i.e. not reviews or pooled/meta-analyses) should be organised according to study design (e.g. intervention/experimental studies, observational studies) into one or more tables. Tables should include the following information for each study:
(a) the study reference: reference by author/date for each study
(b) the study design: e.g. randomised controlled trial, cohort study, nested case-control study
(c) the objectives or hypothesis
(d) the sample size in the study groups: including the numbers. in each group who were recruited, randomised, completed the study, and included in the analyses, and any power calculations. Include loss to follow up or non-response
(e) the participants characteristics: including age, sex, setting, health status, background diets (including use of supplements if relevant) and other relevant aspects of lifestyle
(f) the method used to measure the food or property of food including amount consumed: including additional dietary intake (including methodology for this), method and frequency of consumption, form of substance including the food matrix (where applicable), amount consumed per day, duration of intervention (or study) and period of follow-up
(g) confounders. measured and method used to control for confounding
(h) the method used to measure the health effect
(i) the study results, including effect size and statistical significance
(j) any adverse effects.
Where an application is based on an existing systematic review, data from the studies included in the existing review and the additional studies that update the review should be organised in one or more tables and provide the information listed under a-j above.
Updates of existing reviews should include commentary about how the update affects the conclusions drawn by the authors. of the existing reviews.
Empirical analysis of the data
A meta-analysis of the data can be undertaken. This may add to the weight of evidence in support of the food-health relationship.
B.4 Assessment of the data from human studies
The application must include a scientific assessment about how the studies reviewed demonstrate, with a high degree of certainty, that a causal relationship exists between the food or property of food and the health effect.
Note:
Whether a causal relationship is likely to be established depends on the totality and weight of evidence that supports the proposed food-health relationship under investigation. The evidence would include consideration of a consistent association across all high quality studies that are independent of other factors, inclusion of well-conducted trials temporality and biological plausibility. It may be useful to consider if the relationship could be reversed by at least one additional high quality study.
B.5 Information for setting conditions
The application must contain sufficient detail about the relationship to allow the amount of the food or property of food that is necessary to achieve the health effect, to be determined. Information about the likely dietary intake by the target population group (if there is one) or the whole population of the food or property of food must also be provided.
If the proposed food-health relationship covers. a wider target population group than the groups studied (for example, a wider age-sex range than covered by the included studies), the application must include justification of the validity of the extrapolation.”
Chapter 3.3
Guidelines for applications for
substancesadded to food
3.3.1 Food additives
An application to vary the Code is required to approve the use of a new food additive in the food supply or to change the permissions for a currently used food additive. Permissions for use of food additives are specified in Schedule 15 – Substances that may be used as food additives.
The substance or preparation assessed should be representative of the commercial product for which approval is sought. A statement to that effect must be made in the application. If this situation is not the case for any of the relevant studies then a justification and explanation is required.
The following information is required to support an application for a new permissions to use a food additive or to change the permissions for a currently used food additive. This information is in addition to that specified in Guideline 3.1.1 – General requirements.
A Technical information on the food additive
The application must contain the following technical information:
Note:
FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.
For food additives, the relevant Guideline is the Addition to Food of Substances other than Vitamins and Minerals. Since food additives perform a technological purpose in food the specific order policy principles relevant for food additives are the five listed under Technological Function within this Guideline.
FSANZ will have regard to these policy principles during the assessment of the application. The Guideline is available at information requirements outlined below take the Policy Guideline into consideration.
A.1 Nature and technological purpose of the additive
This includes information related to the technological purpose of the food additive and includes the following specific information:
(a) each of the technological purposes listed in Schedule 14 – Technological purposes performed by substances used as food additives that the additive fulfils
(b) the reason why the food additive is needed to fulfil these purposes in each of the foods in which it is proposed to be used
(c) evidence that the amounts proposed to be added are consistent with achieving the technological purpose
(d) if the food additive is a preservative, data to demonstrate its effectiveness in each of the food groups in which it is proposed to be used
(e) information is required on how the food additive is incorporated homogenously and stably into the different food matrices to which it is proposed to be added.
Data should also be provided to address losses of the substance from the foods during normal shelf life conditions.
A.2 Information to enable identification of the additive
This includes the chemical name (according to both Chemical Abstracts (CA) and the International Union of Pure and Applied Chemistry (IUPAC)); structural formula; common name and synonyms; manufacturers’ code; marketing name; and Chemical Abstract Service (CAS) registry number. For new food additives, a common name should be proposed.
For additives that are not single chemicals, the name should describe the additive as completely as possible. The sources of the additive should be provided, together with either sufficient compositional data to accurately identify the additive, or reference to its common name in other publications used by regulatory agencies. For additives that are derived from animals, plants or microorganisms, the source should be provided.
A.3 Information on the chemical and physical properties of the additive
This includes sufficiently detailed information to enable the technological properties of the additive in a food matrix to be characterised, such as how it may interact with different foods, as well as providing general information on the likely metabolic fate of the additive following consumption.
In cases where particle size is important to achieving the technological purpose or may relate to a difference in toxicity, the application must include information on particle size, size distribution, and morphology, as well as any size-dependent properties.
A.4 Information on the impurity profile
This includes details on the nature and amounts (by weight) of all impurities, including isomers. and manufacturing by-products, present in the additive preparation. Where possible, impurities should be identified by their CA or IUPAC names.
A.5 Manufacturing process
This includes a description of the method of manufacture of the food additive.
A.6 Specification for identity and purity
This includes a specification from one of the published sources identified in Schedule 3 – Identity and purity. If there is no published specification in one of the identified sources, a detailed specification must be provided. Specifications should include information on the name of the food additive, its chemical and physical properties, its purity, acceptable levels of impurities, the method of preparation, and analytical methods of determining purity.
Information is also required for the presence of known allergens (see section 1.2.3—4 in the Code) in the commercial product.
A.7 Information for food labelling
This includes information on the class of the food additive and, if available, the code number for the additive.
A.8 Analytical method for detection
An analytical method must be provided for detecting and quantifying the additive, or its degradation products, in the foods in which it will be used.
This includes information on available methodology for detecting and quantifying the additive, or its degradation products, in the foods in which it will be used. The application must include a robust analytical method suitable for analytical laboratories to determine compliance of any limits prescribed in the Code.
A.9Potential additional purposes of the food additive when added to food
This includes a brief description about any additional purposes, such as a nutritive or health-related purpose, of the food additive at the levels proposed to be added.
B Information related to the safety of the food additive
Note:
FSANZ will undertake a safety assessment using the detailed study reports, where possible, of all animal and human toxicity studies related to the food additive and, if applicable, establish an acceptable daily intake (ADI) for the food additive, if the studies are suitable for this purpose.
An application for a food additive must contain the following information:
B.1 Information on the toxicokinetics and metabolism of the food additive and, if necessary, its degradation products or major metabolites
(a) For an application for a new food additive, this includes detailed reports of all studies conducted in animals or humans to examine the metabolic fate of the food additive and, if necessary, its degradation products or major metabolites.
(b) For an application to extend the use of a currently permitted food additive, reports of the studies conducted since the last safety evaluation by FSANZ should be included. If no previous evaluation by FSANZ is available, published papers. or a comprehensive review article on this matter should be included.
B.2 Information on the toxicity of the food additive and, if necessary, its degradation products and major metabolites
(a) For an application for a new food additive, this includes reports of all in vitro and in vivo studies conducted in animals or humans to examine the toxicity of the food additive and, if necessary, its metabolites or degradation products.
The application should address the following categories of studies:
(a) acute toxicity
(b) short-term toxicity
(c) long-term toxicity and carcinogenicity
(d) reproductive toxicity
(e) developmental toxicity
(f) genotoxicity
(g) special studies, such as neurotoxicity or immunotoxicity
Where data are not available or are not considered relevant to the safety assessment of the additive, an explanatory statement must be provided.
(b) For an application to extend the use of a currently permitted food additive, this need only include the detailed reports of studies conducted since the last safety evaluation by FSANZ.
B.3 Safety assessment reports prepared by international agencies or other national government agencies, if available
This includes safety assessment reports prepared by JECFA (unless provided under subsection B.2 of this Guideline (3.3.1)) or by other national or supranational agencies responsible for food safety.
C Information related to the dietary exposure to the food additive
Note:
FSANZ may undertake a dietary exposure assessment for all food additive applications requesting changes to permissions in Schedule 15 using a custom-made computer program, HARVEST, which combines food consumption data from the latest Australian and New Zealand National Nutrition Surveys, together with food chemical concentration data derived from either the proposed levels of use, the current permissions for use specified in the Code, analytical data derived from surveys or data on use provided by the manufacturers. The information required to undertake this assessment will be derived from different sources, including the application.
The application must contain the following information:
C.1 A list of the food groups or foods proposed to contain the food additive, or changes to currently permitted foods
The food list should be based on the food group descriptions in the table to S15—5.
C.2 The maximum proposed level or the concentration range of the food additive for each food group or food, or the proposed changes to the currently permitted levels
C3 For foods or food groups not currently listed in the most recent Australian or New Zealand National Nutrition Surveys (NNSs), information on the likely level of consumption
This includes any consumption information for food groups not included in the most recent Australian or New Zealand NNSs which relate to this application. Data distinguishing likely consumption levels among target and non-target groups are preferred.
Note:
Information on likely consumption can be based on proposed levels of consumption (grams per day) or on consumption data for these foods from a similar market in another country. The most recent NNSs are the 2011–12 National Nutrition and Physical Activity Survey (NNPAS) component of the 2011–13 Australian Health Survey (2 years. and above), the 2008–09 New Zealand NNS (15 years. and above) and the 2002 New Zealand Children’s NNS (5–14 years).
The application should contain the following information:
C.4 The percentage of the food group in which the food additive is proposed to be used or the percentage of the market likely to use the food additive
This includes information based on projected uptake or market share data for foods likely to contain the food additive. This can be based on a similar market in another country.
C.5 Information relating to the use of the food additive in other countries, if applicable
This includes information on the foods or food groups in which it is used and the use levels.
C.6 For foods where consumption has changed in recent years, information on likely current food consumption
This includes any consumption information for foods where there has been a significant change in consumption since the most recent Australian and New Zealand NNSs which relate to the application. This can be based on market share data, or sales data, or on a similar market in another country.
3.3.2 Processing aids
An application to vary the Code is required to approve the use of a new processing aid or to change the permissions for a currently used processing aid. Permissions for use of processing aids are specified in Schedule 18 – Processing aids.
The substance or preparation assessed should be representative of the commercial product on which approval is sought. A statement to that effect must be made in the application. If this situation is not the case for any of the relevant studies then a justification and explanation is required.
The following information is required to support an application for a new processing aid or to change the permissions for a currently used processing aid. This information is in addition to that specified in Guideline 3.1.1 – General requirements.
Note:
FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.
For processing aids, the relevant Guideline is the Addition to Food of Substances other than Vitamins and Minerals. Since processing aids perform a technological function during the manufacture of food the specific order policy principles relevant for processing aids are the five listed under Technological Function within this Guideline.
FSANZ will have regard to these policy principles during the assessment of the application. The Policy Guideline is available at Human infant studies must include a control group (i.e. an infant formula-fed group that is not exposed to the proposed compositional change), an exposure group (i.e. a formula-fed group that is exposed to the proposed compositional change, plus a breastfed reference group. If a breastfed reference group is not included, a rationale for its omission is required.
(iv) Information on the quality and strength of the evidence must include descriptions of the study design, methodology and characteristics of the study population and study limitations (refer to subsection 3.1.5.A of Guideline 3.1.1) for guidance).
(v) Evidence to demonstrate there is no risk of nutrient imbalances as a result of infants fed the infant formula product containing the proposed compositional change must be provided. If this evidence is not applicable, a rationale for its omission is required.
(c) Efficacy of the proposed compositional change
Any nutritive substance (including energy or macronutrient), novel food or novel food ingredient must meet the respective requirements of Guideline 3.3.3 (sections D or E) or Guideline 3.5.2 (section E). In addition, for a compositional change to infant formula products, efficacy and potential beneficial effect(s) of consumption of the substance at the proposed level must be described and supported by evidence as outlined below:
(i) Description and measures of the physiological, biochemical or functional effect(s) of the substance.
(ii) Description and measures of a health outcome. If no health outcome is specified, a rationale must be provided for its omission.
(iii) Study designs must align with the requirements for nutritional safety and tolerance outlined in paragraph A.3.1(b) of this Guideline (3.6.2).
Note:
The beneficial role of substances in infant formula products may be determined by the measurement of physiological, biochemical or functional effects and health outcome. Examples of these effects include enzyme pathways, blood levels, microbiological composition and counts, liver, kidney, gastrointestinal or other organ functions. An example of a possible health outcome may be reduced incidence of diarrhoea or ear infection.
Evidence from non-human studies will add weight to the determination of a substance’s role, particularly in understanding the mode of action.
A.3.2 For a food additive or processing aid
Compositional changes involving a food additive or processing aid must meet the respective safety requirements of Guidelines 3.3.1 and 3.3.2. In addition, the following must be provided:
(a) Tolerance of the proposed compositional change
Evidence to support tolerance must include appropriate human studies. This includes an explanation of the way in which this evidence relates to infants.
(b) Efficacy of the proposed compositional change
If the food additive also provides a nutritive or health-related function, the information requirements listed in component (I) for efficacy of proposed change must be met. If the function is purely technological, there are no further requirements in this section.
B Information related to the dietary intake or dietary exposure
B.1 Data to enable the dietary intake or exposure of the target population to be estimated
The application must meet the information requirements for the dietary exposure of a food additive, processing aid, novel food or novel food ingredient, or dietary intake of a nutritive substance (including energy or macronutrient), as outlined in these application guidelines. The information provided must have a focus on infants.
B.2 Data on the recommended level of formula consumption for the target population
The application must contain the following information:
(i) the capacity of the product scoop (in grams of product)
(ii) the number of scoops required per feed
(iii) the volume of water required per feed
(iv) total volume of the made-up feed
(v) recommended number of feeds per day relevant to each age group in the relevant target population.
B.3 Information relating to the substance
The application should also contain information or references on the levels (naturally occurring or naturally occurring and added) of the proposed substance in other foods that infants are likely to consume.
C Information related to labelling requirements under Part 2.9 of the Code
C.1 Information related to safety or nutritional impact of the proposed labelling change
The application must include information to support the proposed labelling change. For example, the inclusion of (or change to) a warning or advisory statement, directions for use, or conditions.
C.2 Information to demonstrate that the proposed labelling change will be understood and will assist consumers
This should include consumer research information to demonstrate the anticipated consumer response to the proposed change, or data obtained from an overseas market where the proposed labelling is already in place.
Note:
The extent of the impact of a labelling change on consumer understanding and behaviour will vary depending on:
(a) the nature of the labelling change; and
(b) the foods to which it will apply.
Thus the amount of information necessary to address the impact on consumer understanding and behaviour will depend on the level of impact. Consultation with FSANZ may be necessary to examine the expected level of impact.
D Information related to internationally recognised standards, codes of practice, recommendations AND guidelines
The application must include information demonstrating the level of consistency with internationally recognised standards, codes of practices, recommendations or guidelines such as Codex and the WHO, relating to the manufacture and labelling of infant formula products.
Note:
Examples of relevant standards, codes of practice, recommendations and guidelines are:
(a) Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants at Codex Standard for Follow-up Formula at
(c) Codex Code of Hygienic Practice for Powdered Formulae for Infants and Young Children at
(d) Marketing in Australia of Infant Formulas: Manufacturers. and Importers. Agreement 1992 at
(e) The Infant Nutrition Council Code of Practice for the Marketing of Infant Formula in New Zealand at
(f) the WHO International Code of Marketing of Breast-milk Substitutes at Special purpose foods – Other foods
An application to vary the Code is required to change the compositional or labelling requirements for Special Purpose Foods contained in Part 2.9 of the Code and the Schedules. Currently, these are:
Standard 2.9.2 – Foods for infants
Standard 2.9.3 – Formulated meal replacements and formulated supplementary foods
Standard 2.9.4 – Formulated supplementary sports foods.
Standard 2.9.5 – Food for special medical purposes.
Standard 2.9.6 –Transitional Standard for special purpose foods (including amino acid modified foods)
Schedule 29 – Special purpose foods (sections S29—11 to S29—21 and parts of section S29—7 (as determined by Standard 2.9.2
Note:
FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum. The relevant Policy Guideline for special purpose foods is the Intent of Part 2.9 – Special Purpose Foods (approved in 2009).
The Policy Guideline is available at
The following information is required to change the compositional or labelling requirements of a special purpose food under Part 2.9 of the Code. The information requirements outlined below are in addition to that specified in Guideline 3.1.1 – General requirements and in other relevant Guidelines in this Handbook.
The relevance of other guidelines is dependent on the proposed variation to the Code; possible Guidelines include:
3.3.1.1 for a food additive
3.3.2 for a processing aid
3.3.3 for a nutritive substance (including an increase or decrease in energy content or macronutrient amount)
3.4.2 microbiological limits
3.5.2. for a novel food or novel food ingredient
3.2.1 for general food labelling
3.2.3 for food allergens
3.2.4 for labelling for consumer information and choice
3.2.5 for nutrition information labelling.
A Information related to general compositional requirements
The application must contain the following information if it relates to a change to the general compositional requirements:
A.1 Information on the identity and physical and physiological need of the target population
The application must include a description of the target population for the special purpose food. It must also include a description of the physical and physiological need of specific life stages e.g. infancy, physical disease, disorder and disability of the target population; or physical and physiological need of the target population that require altered energy or nutrient intake.
A.2 Purpose of the compositional change
The application must include a brief description of all of the nutritive or health-related function(s) of the substance at the proposed level in the relevant food product(s). Where an added substance or compositional change has multiple purposes or functions, then these must be specified.
A.3 Information related to the safety of the proposed compositional change
The application must include information related to the safety of a food additive, processing aid, novel food or novel food ingredient, or nutritive substance for the target population (Information to demonstrate safety is also requested elsewhere in Part 3).
A.4 Information related to the nutritional impact or performance impact of the proposed compositional change
This demonstrates how the compositional change would contribute to achieving the intended purpose of the special purpose food.
The application must include clinical studies that examine the nutritional suitability of the food, for the target population.
This also includes information on the performance goals of sports people, if it relates to the addition of a nutritive substance or novel food ingredient to foods regulated under Standard 2.9.4 – Formulated Supplementary Sports Foods and Schedule 29 (sections S29—16 to S29—19).
Note:
With regard to performance goals of sports people, this should include, as a minimum, the results of a literature search on the potential for the nutritive substance or novel food ingredient to achieve specific nutritional or performance goals.
B Information related to the dietary intake or dietary exposure
The application must contain the following information if it relates to a change to the general compositional requirements:
B.1 Data to enable the dietary exposure of the target population to be estimated
This includes information on the dietary exposure of a food additive, processing aid, novel food or novel food ingredient, or dietary intake of a nutritive substance (as indicated elsewhere in these Applications guidelines for the target population.
B.2 Data on the recommended level of consumption of the special purpose food for the target population
Information relating to the recommended number of serves per day and the size of each recommended serve should be provided for relevant special purpose foods for the target population.
C Information related to labelling requirements under Part 2.9 of the Code
The application must contain the following information if it relates to a change to labelling requirements:
C.1 Information related to safety or nutritional impact of the proposed labelling change
This includes information to support the proposed labelling change e.g. the inclusion of (or change to) a warning or advisory statement, directions for use, or claim conditions.
C.2 Information to demonstrate that the proposed labelling change will be understood and will assist consumers, if applicable
This includes consumer research information to demonstrate the anticipated consumer response to the proposed change, or data obtained from an overseas market where the proposed labelling is in place.
For example, information to demonstrate how the proposed label change will assist consumer understanding of the specific nature of the food, the intended population group or the intended special purpose of the food;
Note:
A proposed labelling change will only be relevant to consumers. for those special purpose foods which are available for retail sale.
D Information related to internationally recognised codes of practice and guidelines
The application must contain information demonstrating the extent to which the application is consistent with internationally recognised standards and codes of practices. These include Codex and the WHO recommendations and guidelines, relating to the composition and labelling of special purpose foods.
Note:
Examples of relevant standards, codes of practice, recommendations and guidelines are:
Codex Guidelines for Formulated Supplementary Foods for Older Infants and Young Children at Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses Intended for Infants and Young Children
Code of Hygienic Practice for Powdered Formulae for Infants and Young Children
Standard for Processed Cereal-Based Foods for Infants and Young Children
Standard for Formula Foods for Use in Weight Control Diets
Standard for Labelling of and Claims for Foods for Special Medical Purposes at
Codex Standard for the Labelling of and Claims for Pre-packaged Foods for Special Dietary Uses
align="center">Chapter 3.7
Guidelines for applications for food production
3.7.1 Food safety standards
An application to vary the Code is required to change the requirements for standards in Chapter 3 of the Code. The Chapter 3 standards apply in Australia only. Currently, these are:
Standard 3.1.1 – Interpretation and Application
Standard 3.2 1 – Food Safety Programs
Standard 3.2.2 – Food Safety Practices and General Requirements
Standard 3.2.3 – Food Premises and Equipment
Standard 3.3.1 – Food Safety Programs for Food Service to Vulnerable Persons.
The following information is required to support an application to amend these Standards. This information is in addition to that specified in Guideline 3.1.1 – General requirements.
A Information related to food safety
The application must contain the following information:
A.1 Data to show that the proposed change will protect public health and safety
This includes:
(a) survey data, if applicable, to demonstrate that the proposed change will have result in protection of public health and safety equivalent to the current Standard
(b) information from other countries on current practices that relate to the proposed change.
3.7.2 Food processing and primary production
An application to vary the Code is required to change the food processing requirements specified in Standard 1.6.2 – Processing requirements for meat, or the primary production requirements specified in Chapter 4 – Primary Production Standards. These Standards apply in Australia only.
The following information is required to support an application to amend these Standards. This information is in addition to that specified in Guideline 3.1.1 – General requirements.
A Information related to food safety
The application must contain the following information:
A.1 Data to show that the proposed change will protect public health and safety
This includes:
(a) data to demonstrate that the proposed change will have result in protection of public health and safety equivalent to the current Standard
(b) information from other countries on current practices that relate to the proposed change.
Appendix 1
Checklists
Checklist for General requirements
This Checklist will assist you in determining if you have met the mandatory format and information requirements as detailed in Guideline 3.1.1 – General requirements. All applications must include this Checklist.
| General requirements (3.1.1) | ||
| Check | Page No. | Mandatory requirements |
| £ | A Form of application £ Application in English £ All references provided | |
| £ | B Applicant details | |
| £ | C Purpose of the application | |
| £ | D Justification for the application £ Regulatory impact information £ Impact on international trade | |
| £ | E Information to support the application £ Data requirements | |
| £ | F Assessment procedure £ General £ High level health claim variation | |
| £ | G Confidential commercial information £ CCI material separated from other application material £ Non-confidential summary provided | |
| £ | H Other confidential information £ Confidential material separated from other application material £ Formal request including reasons | |
| £ | I Exclusive Capturable Commercial Benefit £ Justification provided | |
| £ | J International and other national standards £ International standards £ Other national standards | |
| £ | K Statutory Declaration | |
| £ | L Checklist/s provided with application £ 3.1.1 Checklist £ Any other relevant checklists for Chapters. 3.2–3.7 | |
Checklist for applications for labelling and other information requirements
This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Guideline 3.2.1 – General food labelling which is mandatory for all labelling applications. If your application relates to Guidelines 3.2.2–3.2.6, then the information required is in addition to 3.2.1.
| General food labelling (3.2.1) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Proposed labelling change | ||
| £ | A.2 Foods or food groups potentially affected | ||
| £ | B.1 Demonstrated consumer support for change | ||
| £ | B.2 Proposed labelling to be understood and assist consumers | ||
| £ | B.3 Any adverse health or diet impacts | ||
| Warning and advisory statements (3.2.2) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Data on potential health concern | ||
| £ | B.1 Data on lack of consumer awareness of health and safety risk | ||
| Declaration of allergens (3.2.3) | |||
| Check | Page No. | Mandatory requirements | |
| A Addition of allergen to list of declared foods | |||
| £ | A.1 Demonstration that the food causes IgE-mediated allergy | ||
| £ | A.2 Incidence of allergic reaction | ||
| £ | A.3 Severity of allergic reaction | ||
| £ | A.4 Extent of use of allergen in foods | ||
| B Removal of food derivative from the list of declared foods | |||
| £ | B.1 Nature of food derivative | ||
| £ | B.2 Use of food derivative and presence in final food | ||
| £ | B.3 Dietary intake information | ||
| £ | B.4 History of safe use | ||
| £ | B.5 Clinical information on safety of food derivative | ||
| Labelling for consumer information and choice (3.2.4) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Current labelling or alternative information inadequacies | ||
| £ | A.2 Information on lack of suitable alternatives available to consumers. | ||
| £ | A.3 How proposed labelling change will assist consumers | ||
| £ | A.4 Information to demonstrate alternate measures in absence of labelling would not be effective | ||
| Nutrition information labelling (3.2.5) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Proposed change and how it will change nutrition information labelling | ||
| £ | A.2 Data to demonstrate labelling will assist consumers | ||
| £ | B.1 Nature and composition of the ingredient | ||
| £ | B.2 Calculation of energy factor | ||
| £ | B.3.1 Substantiation of energy factor – Bomb calorimetry | ||
| £ | B.3.2 Substantiation of energy factor – Classical dietary energy balance | ||
| £ | B.3.3 Substantiation of energy factor – Isometric tracer methods | ||
| £ | B.3.4 Substantiation of energy factor – Breath hydrogen test | ||
| £ | B.3.5 Substantiation of energy factor – Ileal intubation and ileostomy effluent | ||
| £ | B.4 Other factors | ||
| Nutrition content and health claims (3.2.6) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Nutrition content claims | ||
| £ | A.2 Amendment to existing high level or general level claim | ||
| £ | A.3 Amendment to nutrient profiling scoring criterion or method | ||
| £ | A.4 Variation of required elements of systematic review in Schedule 6 | ||
| £ | B.1.1 Description of food or property of food in food-health relationship | ||
| £ | B.1.2 Description of health effect in food-health relationship | ||
| £ | B.1.3 Description of food-health relationship | ||
| £ | B.2.1 Description of search strategy for relationships (original literature only) | ||
| £ | B.2.2 Food-health relationship based on updating systematic reviews | ||
| £ | B.3 Summarising literature for proposed food-health relationship | ||
| £ | B.4 Assessment of data from human studies | ||
| £ | B.5 Information for setting conditions | ||
Checklist for applications for substances added to food
This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Guidelines 3.3.1–3.3.3.
| Food additives (3.3.1) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Nature and technological purpose information | ||
| £ | A.2 Identification information | ||
| £ | A.3 Chemical and physical properties | ||
| £ | A.4 Impurity profile | ||
| £ | A.5 Manufacturing process | ||
| £ | A.6 Specifications | ||
| £ | A.7 Food labelling | ||
| £ | A.8 Analytical detection method | ||
| £ | A.9 Additional functions | ||
| £ | B.1 Toxicokinetics and metabolism information | ||
| £ | B.2 Toxicity information | ||
| £ | B.3 Safety assessments from international agencies | ||
| £ | C.1 List of foods likely to contain the food additive | ||
| £ | C.2 Proposed levels in foods | ||
| £ | C.3 Likely level of consumption | ||
| £ | C.4 Percentage of food group to contain the food additive | ||
| £ | C.5 Use in other countries (if applicable) | ||
| £ | C.6 Where consumption has changed, information on likely consumption | ||
| Processing aids (3.3.2) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Type of processing aid | ||
| £ | A.2 Identification information | ||
| £ | A.3 Chemical and physical properties | ||
| £ | A.4 Manufacturing process | ||
| £ | A.5 Specification information | ||
| £ | A.6 Analytical method for detection | ||
| £ | B.1 Industrial use information (chemical only) | ||
| £ | B.2 Information on use in other countries (chemical only) | ||
| £ | B.3 Toxicokinetics and metabolism information (chemical only) | ||
| £ | B.4 Toxicity information (chemical only) | ||
| £ | B.5 Safety assessments from international agencies (chemical only) | ||
| £ | C.1 Information on enzyme use on other countries (enzyme only) | ||
| £ | C.2 Toxicity information of enzyme (enzyme only) | ||
| £ | C.3. Allergenicity information of enzyme (enzyme only) | ||
| £ | C.4. Overseas safety Assessment Reports | ||
| £ | D.1 Information on source organism (enzyme from microorganism only) | ||
| £ | D.2 Pathogenicity and toxicity of source microorganism (enzyme from microorganism only) | ||
| £ | D.3 Genetic stability of source organism (enzyme from microorganism only) | ||
| £ | E.1 Nature of genetic modification of source organism (enzyme from GM source microorganism) | ||
| £ | F.1 List of foods likely to contain the processing aid | ||
| £ | F.2 Anticipated residue levels in foods | ||
| £ | F.3 Information on likely level of consumption | ||
| £ | F.4 Percentage of food group to use processing aid | ||
| £ | F.5 Information on residues in foods in other countries (if available) | ||
| £ | F.6 Where consumption has changed, information on likely consumption | ||
| Substances used of a nutritive purpose (3.3.3) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Purpose of the use of the substance | ||
| £ | A.2 General data requirements for supporting evidence | ||
| £ | B.1 Identification | ||
| £ | B.2 Chemical and physical properties | ||
| £ | B.3 Impurity profile | ||
| £ | B.4 manufacturing process | ||
| £ | B.5 Specification for identity and purity | ||
| £ | B.6 Analytical method for detection | ||
| £ | B.7 Proposed food label | ||
| £ | C.1 Toxicokinetics and metabolism, degradation products and major metabolites | ||
| £ | C.2 Animal or human studies | ||
| £ | C.3 International safety assessments | ||
| £ | D.1 List of food groups or foods likely to contain the nutritive substance | ||
| £ | D.2 Proposed maximum levels in food groups or foods | ||
| £ | D.3 Likely level of consumption | ||
| £ | D.4 Percentage of food group to use nutritive substance | ||
| £ | D.5 Use in other countries (if available) | ||
| £ | D.6 Where consumption has changed, information on likely consumption | ||
| £ | E.1 Need to permit addition of vitamin or mineral | ||
| £ | E.2 Demonstrated potential to address deficit or health benefit | ||
| £ | F.1 Nutritional purpose (other than vitamins and minerals) | ||
| £ | G.1 Consumer awareness and understanding | ||
| £ | G.2 Actual or potential behaviour of consumers | ||
| £ | H.3 Demonstration of no adverse effects on any population groups | ||
| £ | H.3 Demonstration of no adverse effects on any population groups | ||
Checklist for applications for contaminants and
natural toxicants
This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Guidelines 3.4.1–3.4.3.
| Chemical contaminant and natural toxicant maximum levels (3.4.1) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Nature of contaminant or natural toxicant | ||
| £ | A.2 Analytical detection method | ||
| £ | B.1 Toxicokinetics & metabolism information | ||
| £ | B.2 Toxicity studies | ||
| £ | B.3 Human studies relevant to safety | ||
| £ | C.1 List of foods where maximum level is proposed | ||
| £ | C.2 Survey data on contaminant or toxicant levels in foods | ||
| £ | C.3 Information on levels of consumption | ||
| £ | C.4 Where consumption has changed, information on likely consumption | ||
| Microbiological limits (3.4.2) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Raw inputs, production and manufacturing process | ||
| £ | A.2 Food technology | ||
| £ | B.1 Nature of the microbiological hazard | ||
| £ | B.2 Source & prevalence of contamination | ||
| £ | B.3 Consumer handling and use | ||
| £ | C.1 Nutritional impact | ||
| £ | D.1 Dietary exposure | ||
| Prohibited and restricted plants and fungi (3.4.3) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Nature of plant or fungi | ||
| £ | A.2 Identity and levels of natural toxicants | ||
| £ | B.1 Toxicity studies | ||
| £ | B.2 Human toxicity case studies | ||
| £ | B.3 Use in other countries | ||
Checklist for applications for new foods
This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Guidelines 3.5.1–3.5.3.
| Foods produced using gene technology (3.5.1) | ||
| Check | Page No. | Mandatory requirements |
| £ | A.1 Nature and identity | |
| £ | A.2 History of use of host and donor organisms | |
| £ | A.3 Nature of genetic modification | |
| £ | B.1 Characterisation and safety assessment | |
| £ | B.2 New proteins | |
| £ | B.3 Other (non-protein) new substances | |
| £ | B.4 Novel herbicide metabolites in GM herbicide-tolerant plants | |
| £ | B.5 Compositional analyses | |
| £ | C Nutritional impact of GM food | |
| £ | D Other information | |
| Novel foods (3.5.2) | ||
| Check | Page No. | Mandatory requirements |
| £ | A. Exclusive use | |
| £ | B.1 Type of novel food | |
| £ | B.2 Information on potential beneficial outcomes | |
| £ | B.3 Chemical and physical properties | |
| £ | B.4 Impurity profile | |
| £ | B.5 Manufacturing process | |
| £ | B.6 Specification for identity and purity | |
| £ | B.7 Analytical detection method | |
| C.1 Plant or animal extracts | ||
| £ | C.1.1 Extraction and composition | |
| £ | C.1.2 Effects of food processing or preparation | |
| £ | C.1.3 Current use | |
| £ | C.1.4 Potential adverse effects | |
| C.2 Plant and animal extracts | ||
| £ | C.2.1 Method or extraction and composition of extract | |
| £ | C.2.2 Use as a food in other countries | |
| £ | C.2.3 Toxicity studies | |
| £ | C.2.4 Safety assessments from other agencies | |
| C.3 Herbs (both non-culinary and culinary) including extracts | ||
| £ | C.3.1.1 History of use | |
| £ | C.3.2 Composition | |
| £ | C.3.3 Method of extraction and composition of extract | |
| £ | C.3.4 Use in other countries | |
| £ | C.3.5 Potential allergenicity | |
| £ | C.3.6 Toxicity studies | |
| £ | C.3.7 Safety assessments from other agencies | |
| C.4 Single chemical entities & dietary macrocomponents | ||
| £ | C.4.1 Toxicokinetics and metabolism | |
| £ | C.4.2 Toxicity studies | |
| £ | C.4.3 Safety assessments from other agencies | |
| C.5 Microorganisms (including probiotics) | ||
| £ | C.5.1 Potential pathogenicity | |
| £ | C.5.2 Effects on gut microflora | |
| £ | C.5.3 Use as a food in other countries | |
| £ | C.5.4 Human toleration studies | |
| C.6 Food ingredients derived from a new source | ||
| £ | C.6.1 Safety of the source organism, including allergen statement | |
| £ | C.6.2 Composition | |
| £ | C.6.3 Toxicity studies | |
| £ | C.6.4 Overseas safety reports | |
| C.7 Foods produced by a process not previously applied to food | ||
| £ | C.7.1 Details of the new process | |
| £ | C.7.2 Toxicity studies | |
| £ | C.7.3 Overseas safety reports | |
| £ | D.1 List of foods likely to contain the novel food or novel food ingredient | |
| £ | D.2 Proposed levels in foods | |
| £ | D.3 Information on levels of consumption | |
| £ | D.4 Percentage of food group or market | |
| £ | D.5 Where consumption has changed, information on likely consumption | |
| £ | D.6 Information to show whether the food or ingredient will replace another food | |
| £ | D.7 Use in other countries | |
| £ | E.1 Nutritional impact information | |
| £ | E.2 Public health impact | |
| £ | F.1 Demonstrated consumer awareness and understanding | |
| £ | F.2 Potential behaviour in response to foods | |
| £ | F.3 Demonstration of no adverse effects on any population groups | |
| Irradiated foods (3.5.3) | ||
| Check | Page No. | Mandatory requirements |
| £ | A.1 Nature of the food or food ingredient to be irradiated | |
| £ | A.2 Technological need | |
| £ | A.3 Food products likely to contain irradiated food | |
| £ | B Safety information | |
| £ | C Nutritional impact | |
Checklist for applications for special purpose foods and
standardised foods
This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Guidelines 3.6.1–3.6.3.
| Standardised foods (3.6.1) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Proposed compositional change | ||
| £ | A.2 List of foods likely to be affected | ||
| £ | B.1 Nutritional content | ||
| £ | C.1 Demonstrated consumer understanding of proposed change | ||
| £ | C.2 Potential adverse health or diet impacts | ||
| Special purpose foods – Infant formula products (3.6.2) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Purpose of compositional change | ||
| £ | A.2 Data for supporting evidence | ||
| £ | A.3 Specific information requirements £ Characterisation of proposed substance in breast milk £ Tolerance of proposed compositional change | ||
| £ | B.1 Dietary intake or exposure of target population | ||
| £ | B.2 Level of consumption | ||
| £ | B.3 Information relating to the substance | ||
| £ | C.1 Safety or nutritional impact of labelling change | ||
| £ | C.2 Demonstrated consumer understanding of labelling change | ||
| £ | D Internationally recognised codes of practice and guidelines on labelling | ||
| Special purpose foods – Other foods (3.6.3) | |||
| Check | Page No. | Mandatory requirements | |
| £ | A.1 Identity and need of target population | ||
| £ | A.2 Purpose of compositional change | ||
| £ | A.3 Safety of proposed compositional change | ||
| £ | A.4 Nutritional or performance impact | ||
| £ | B.1 Dietary exposure data | ||
| £ | B.2 Level of consumption | ||
| £ | C.1 Safety and nutritional impact of labelling change | ||
| £ | C.2 Demonstrated consumer understanding of labelling change | ||
| £ | D Internationally recognised codes of practice and guidelines | ||
Checklist for applications for food production
This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Sections 3.7.1–3.7.2.
| Food safety standards (3.7.1) | ||
| Check | Page No. | Mandatory requirements |
| £ | A.1 Public health and safety data | |
| £ | B.1 Projected costs to food industry | |
| Food processing and primary production (3.7.2) | ||
| Check | Page No. | Mandatory requirements |
| £ | A.1 Public health and safety data | |
Amendment history
Note 1
Part 3 of the FSANZ Application Handbook (in force under section 23 of the Food Standards Australia New Zealand Act 1991) as shown in this compilation is amended as indicated in the Tables below.
This is a compilation of Part 3 as in force on 1 March 2016 (up to Amendment No. 7 – 2016).
Prepared by Food Standards Australia New Zealand on 5 January 2016.
Table of instruments
| Title | Date of FRLI Registration | Date of Commencement | Application, Saving or Transitional Provisions |
| FSANZ Application Handbook – Part 3 | 1 August 2007 (F2007L02114). | 2 August 2007 | |
| FSANZ Application Handbook – Part 3 – Amendment No. 1 – 2008 | 5 June 2008 (F2008L01697) | 5 June 2008 | - |
| FSANZ Application Handbook – Part 3 – Amendment No. 2 – 2008 | 9 December 2008 (F2008L04594) | 9 December 2008 | - |
| FSANZ Application Handbook – Part 3 – Amendment No. 3 – 2009 | 25 August 2009 (F2009L03244) | 25 August 2009 | - |
| FSANZ Application Handbook – Part 3 – Amendment No. 4 – 2010 | 2 June 2010 (F2010L01483) | 1 July 2010 | - |
| FSANZ Application Handbook – Part 3 – Amendment No. 5 – 2011 | 7 July 2011 (F2011L01439) | 1 August 2011 | - |
| FSANZ Application Handbook – Part 3 – Amendment No. 6 – 2013 | 19 August 2013 (F2013L01586) | 1 September 2013 | - |
| FSANZ Application Handbook – Part 3 – Amendment No. 7 – 2016 | 5 January 2016 (F2016L00022) | 1 March 2016 | - |
Table of amendments
| ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
| Provision affected | How affected |
| Part 3 cover page | am. No. 5 – 2011, rs. No. 7 – 2016 |
| Part 3.1 | am. No. 1 – 2008, am. No. 5 – 2011, rep No. 7 – 2016 |
| 3.1.1 | am. No. 3 – 2009, am. No. 5 – 2011, am. No. 6 – 2013, rep. No. 7 – 2016 |
| 3.1.2 | am. No. 5 – 2011, rep. No. 7 – 2016 |
| 3.1.3 | rs. No. 5 – 2011, rep. No. 7 – 2016 |
| 3.1.4 | rs. No. 4 – 2010, rs. No. 5 – 2011, rep. No. 7 – 2016 |
| 3.1.5 | am. No. 3 – 2009, rs. No. 5 – 2011, am. No. 6 – 2013, rep. No. 7 – 2016 |
| 3.1.6 | am. No. 5 – 2011, rs. No. 6 – 2013, rep. No. 7 – 2016 |
| 3.1.7 | am. No. 5 – 2011, rep. No. 7 – 2016 |
| 3.1.8 | am. No. 1 – 2008, am. No. 3 – 2009, rs. No. 6 – 2013, rep. No. 7 – 2016 |
| 3.1.9 | am. No. 6 – 2013, rep. No. 7 – 2016 |
| 3.1.11 | am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, rep. No. 7 – 2016 |
| Chapter 3.1 | |
| Cover page | ad. No. 7 – 2016 |
| 3.1.1 | ad. No. 7 – 2016 |
| Chapter 3.2 | |
| Cover page | rs. No. 7 – 2016 |
| 3.2.1 | am. No. 1 – 2008, am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, rs. No. 7 – 2016 |
| 3.2.3 | am. No. 4 – 2010, rs. No. 7 – 2016 |
| 3.2.4 | am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.2.5 | am. No. 1 – 2008, am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, rs. No. 7 – 2016 |
| 3.2.6 | ad. No. 6 – 2013, rs. No. 7 – 2016 |
| Chapter 3.3 | |
| Cover page | rs. No. 7 – 2016 |
| 3.3.1 | am. No. 1 – 2008, am. No. 2 – 2008, am. No. 3 – 2009, am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, am. No. 6 – 2013, rs. No. 7 – 2016 |
| 3.3.2 | am. No. 1 – 2008, am. No. 2 – 2008, am. No. 3 – 2009, am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.3.3 | am. No. 1 – 2008, am. No. 2 – 2008, am. No. 3 – 2009, am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, rs. No. 7 – 2016 |
| Chapter 3.4 | |
| Cover page | rs. No. 7 – 2016 |
| 3.4.1 | am. No. 2 – 2008, am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.4.2 | am. No. 1 – 2008, am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.4.3 | am. No. 4 – 2010, am. No. 6 – 2013, rs. No. 7 – 2016 |
| Chapter 3.5 | |
| Cover page | rs. No. 7 – 2016 |
| 3.5.1 | am. No. 1 – 2008, am. No. 3 – 2009, am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.5.2 | am. No. 2 – 2008, am. No. 3 – 2009, am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, rs. No. 7 – 2016 |
| 3.5.3 | rs. No. 1 – 2008, am. No. 3 – 2009, am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| Chapter 3.6 | |
| Cover page | rs. No. 6 – 2013, rs. No. 7 – 2016 |
| 3.6.1 | am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.6.2 | am. No. 4 – 2010, rs. No. 5 – 2011, rs. No. 6 – 2013, rs. No. 7 – 2016 |
| 3.6.3 | ad. No. 6 – 2013, rs. No. 7 – 2016 |
| Chapter 3.7 | |
| Cover page | rs. No. 7 – 2016 |
| 3.7.1 | am. No. 4 – 2010, am. No. 5 – 2011, rs. No. 7 – 2016 |
| 3.7.2 | am. No. 1 – 2008, am. No. 4 – 2010, am. No. 5 – 2011, am. No. 6 – 2013, rs. No. 7 – 2016 |
| Appendix 1 | |
| Checklist for General requirements | am. No. 4 – 2010, rs. No. 5 – 2011, rs. No. 6 – 2013, rs. No. 7 – 2016 |
| Checklist for Standards related to labelling and other information requirements | am. No. 4 – 2010, rs. No. 5 – 2011, s. No. 6 – 2013, rs. No. 7 – 2016 |
| Checklist for Standards related to substances added to food | am. No. 4 – 2010, rs. No. 5 – 2011, rs. No. 7 – 2016 |
| Checklist for Standards related to contaminants and natural toxicants | rs. No. 5 – 2011, rs. No. 7 – 2016 |
| Checklist for Standards related to new foods | am. No. 1 – 2008, am. No. 4 – 2010, rs. No. 5 – 2011, rs. No. 7 – 2016 |
| Checklist for Standards related to the composition of food products | rs. No. 5 – 2011, rep. No. 6 – 2013, rs. No. 7 – 2016 |
| Checklist for Standards related to special purpose foods and standardised foods | ad. No. 6 – 2013, rs. No. 7 – 2016 |
| Checklist for Standards related to food production | rs. No. 5 – 2011, rs. No. 7 – 2016 |
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