Federal Register of Legislation - Australian Government

Primary content

Food Standards Handbooks as made
This instrument amends the Food Standards Australia New Zealand Act 1991 - Application Handbook - Part 3.
Administered by: Health
Exempt from sunsetting by the Food Standards Australia New Zealand Act 1991 s 23(4)
Registered 05 Jun 2008
Tabling HistoryDate
Tabled HR16-Jun-2008
Tabled Senate16-Jun-2008
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

FSANZ Application Handbook – Part 3 – Amendment No. 1 – 2008

 

Food Standards Australia New Zealand Act 1991

 

Preamble

 

The amendments set forth in the Schedule below are variations to guidelines in the Part 3 of the FSANZ Application Handbook which was originally registered as a legislative instrument on 1 August 2007.

 

These amendments are published pursuant to section 23 of the Food Standards Australia New Zealand Act 1991.

 

Citation

 

These amendments may be collectively known as the FSANZ Application Handbook – Amendment No. 1 – 2008.

 

Commencement

 

These variations commence on the date of the registration of this instrument.

 

SCHEDULE

 

[1]          Part 3.1 is varied by –

 

[1.1]       omitting –

 

MANDATORY INFORMATION REQUIREMENTS

 

The word ‘must’ is used in Part 3 of the Application Handbook to identity information whose provision in an application is mandatory. 

 

substituting –

 

MANDATORY INFORMATION REQUIREMENTS

 

The word ‘must’ is used in Part 3 of the Application Handbook to identify information whose provision in an application is mandatory. 

 

[1.2]       omitting

 

3.1.8      EXCLUSIVE CAPTURABLE COMMERCIAL BENEFIT (ECCB)

 

The applicant must sign a declaration in relation to whether the application is expected to confer an Exclusive Capturable Commercial Benefit. 

 

substituting –

 


3.1.8      EXCLUSIVE CAPTURABLE COMMERCIAL BENEFIT (ECCB)

 

The applicant must indicate whether or not the application is expected to confer an Exclusive Capturable Commercial Benefit and the reasons why (see Part 2.1.4).

 

[2]          Part 3.2.1 is varied by –

 

[2.1]       omitting

 

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.

 

substituting

 

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.

 

[2.2]       omitting B.1, substituting

 

1.           A description of the proposed labelling change

 

This part includes detailed information on the proposed labelling change, and should indicate the Standards and/or clauses which will be affected.

 

[2.3]       omitting the Note following B.2, substituting

 

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.

 

[2.3]       omitting from the Note following C.3

 

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

 

substituting –

 


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]          Part 3.2.5 is varied by omitting the Note following B.3, substituting –

 

Note:

 

For further information on energy factors, see the FSANZ Guidance Document Deriving Energy Factors for Food Ingredients on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/informationforapplicants/additionalfsanzguide3723.cfm.

 

[4]          Part 3.3.1 is varied by omitting B.6, substituting –

 

6.           Specification for identity and purity

 

This part includes a specification from one of the published sources identified in Standard 1.3.4 – Identity and Purity.  If there is no published specification in one of the identified sources, a detailed specification must be provided.

 

This part must include details on the presence of known allergens (See clause 4 of Standard 1.2.3 of the Code) present in the food additive preparation.

 

[5]          Part 3.3.2 is varied by omitting B.5, substituting –

 

5.           Specification for identity and purity

 

This part includes a specification from one of the published sources identified in Standard 1.3.4 – Identity and Purity will be available.  If a published specification is not available, a detailed specification must be provided.    

 

This part must include details on the presence of known allergens (See clause 4 of Standard 1.2.3 of the Code) present in the processing aid preparation.

 

[6]          Part 3.3.3 is varied by –

 

[6.1]       omitting the heading for E, substituting –

 

E.           Information related to the nutritional impact of a nutritive substance other than vitamins and minerals (for vitamins and minerals see Part F)

 

[6.2]       omitting E.1 and the Note following E.1, substituting

 

1.           Information related to the nutritional purpose of adding the nutritive substance to each food

 

This part includes:

 


(a)     data to demonstrate the nutritional role of the nutritive substance consistent with its nutritional purpose and as generally described in Part A.2.(a); and

(b)     data to demonstrate that specific food(s) containing the nutritive substance can contribute to the demonstrated nutritional role in the target population group at the anticipated level of intake; or

(c)     data to demonstrate that the nutritional profile of the specified substitute food[1] can be aligned with the reference food.

 

Note:

 

The scientific evidence for a nutritional purpose is assessed using the following criteria:

 

(a)     The evidence must be based on studies conducted on human subjects.

(b)     The evidence must be based on a food product or food product group containing the nutritive substance rather than the nutritive substance alone.

(c)     The evidence must relate to normal use by the target population group and the food product must contribute to the demonstrated nutritional role relevant to that target population.

 

Refer to Part 3.1.5 for further information regarding data quality.

 

[7]          Part 3.4.2 is varied by omitting the Note following E.1, substituting –

 

Note:

 

For further information on microbiological risk assessment, see the FSANZ Guidance Document Undertaking Microbiological Risk Assessment on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/informationforapplicants/additionalfsanzguide3723.cfm.

 

[8]          Part 3.5.1 is varied by omitting the second Note following D.2, substituting –

 

Note:

 

For further information on the safety assessment of GM foods, see the FSANZ Guidance Document Safety Assessment of Genetically-Modified Foods on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/informationforapplicants/additionalfsanzguide3723.cfm.

 

[9]          Omitting Part 3.5.2, substituting –

 

3.5.2      NOVEL FOODS

 

An application to vary the Code is required to approve the use of a new novel food or novel food ingredient. Permissions for use of novel foods or novel food ingredients are specified in Standard 1.5.1 – Novel Foods.


Note:

 

Standard 1.5.1 contains the following definitions:

 

non-traditional food means –

 

(a)     a food that does not have a history of human consumption in Australia or New Zealand; or

(b)     a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food; or

(c)     any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand.

 

novel food means a non-traditional food and the food requires an assessment of the public health and safety considerations having regard to -

 

(a)          the potential for adverse effects in humans; or

(b)          the composition or structure of the food; or

(c)          the process by which the food has been prepared; or

(d)          the source from which it is derived; or

(e)          patterns and levels of consumption of the food; or

(f)           any other relevant matters.

 

For further information relating to the operation of the Novel Food Standard, particular in relation to whether a particular food would be regarded as novel, refer to the FSANZ website at: http://www.foodstandards.gov.au/foodmatters/novelfoods/index.cfm.

 

The term novel food includes both whole foods and food ingredients – these terms are used either together or separately in this document, depending on the circumstances.  When the novel food is clearly a food ingredient, only this term is used.

 

The following information is required to support an application for a novel food.  This information is in addition to that specified in Section 3.1 – General Requirements. 

 

A.           General information on the application

 

The application must contain the following general information:

 

1.           Purpose of the application

 

This part includes information on the purpose of the proposed change(s) to Standard 1.5.1 – Novel Foods. 

 

2.           Justification for the application

 

This part includes general statements addressing:

 

(a)     the purpose of using the novel food or novel food ingredient, including details of target groups and at-risk population groups;

(b)     the safety of the novel food or food ingredient; and


(c)     the cost and benefits for industry, consumers and government associated with use of the novel food or novel food ingredient.

 

Reference may be made to other sections of the application that contain detailed supporting information, where necessary.

 

3.           Support for the application

 

This part includes information to support that the food industry has an interest in marketing the novel food or novel food ingredient in Australia and New Zealand as a result of the proposed change to the Code, or that food containing the novel food or novel food ingredient may be imported into Australia or New Zealand.

 

4.           Exclusive use of novel foods

 

This part includes a statement as to whether the application is seeking exclusive permission for the novel food.  If exclusive permission is sought, the application must include details of the following:

 

(a)          the specific class of food; and

(b)          the brand of the food.

 

Exclusive permission can only be sought if requested by the applicant at the time the application is received by FSANZ.

 

B.           Technical information on the novel food

 

The application must contain the following information:

 

1.           Information on the type of novel food

 

This part includes a brief description of the novel food, including the name the food will be marketed under (if known), and whether it falls within one of the following major identified categories:

 

(I)           Plants or animals and their components

(II)         Plant or animal extracts

(III)        Herbs (both non-culinary and culinary) including extracts

(IV)        Single chemical entities

(V)         Dietary macro-components

(VI)        Micro-organisms (including probiotics)

(VII)       Food ingredients derived from new sources

(VIII)     Foods produced by a process not previously applied to food.

 

Note:

 

These categories are provided as a guide based on previous experience and knowledge of the nature of products from enquiries received by FSANZ.  It is anticipated that most novel foods will fall under one of these categories, however, this may not always be the case and the categories listed are not intended to be exhaustive. 


The term dietary macro-component generally refers to those dietary components which constitute a significant proportion of the food, such as fats, sugars, proteins and polysaccharides.  Novel macro-components are used to replace the naturally-occurring components, either for a functional purpose or to reduce the energy value of the food.  Examples include olestra, tagatose, cyclodextrin, salatrim, diacylglycerol oil, trehalose, resistant starches.

 

The term single chemical entity generally refers to a substance, however derived, that is added to food but not consumed as food in its own right.  It is intended for addition to food at levels consistent with use as a food ingredient.  For the purposes of the Novel Food Standard, a single chemical entity does not include a substance used for a technological purpose.

 

2.           Information on the physical and chemical properties of the novel food or novel food ingredient

 

This part includes detailed information on the physical and chemical properties of the novel food or novel food ingredient including, where relevant, chemical name, CAS registry number, empirical and structural formula, molecular weight, chemical stability, thermal stability, solubility in water and melting point. 

 

3.           Information on the impurity profile for a typical preparation

 

This part includes details on the nature and amounts (by weight) of all impurities, including isomers and manufacturing by-products, present in the novel food ingredient preparation.  Impurities should be identified by their Chemical Abstract (CA) or International Union of Pure and Applied Chemists (IUPAC) names.

 

4.           Manufacturing process for a novel food ingredient

 

This part includes a comprehensive outline of the method of manufacture of the novel food ingredient.

 

5.           Specification for identity and purity for a novel food ingredient

 

This part includes a specification from one of the published sources identified in Standard 1.3.4 – Identity and Purity.  If a published specification is not available, a detailed specification must be provided.

 

6.           Analytical method for detection

 

The application should contain the following information:

 

This part includes a method for detection of the novel food ingredient or its degradation products (where relevant) in the foods in which it will be used.

 


C.           Information on the safety of the novel food

 

Note:

 

FSANZ will undertake an assessment of all available reports of animal and human studies which provide information related to the toxicity of the novel food or novel food ingredient.  The safety of the novel food will be assessed at the proposed levels of use, using both the technical information provided in section A and the information specified in this section.

For a novel food ingredient, a safe level of intake will be established, if possible, from the available studies.

 

There are a number of categories of novel foods.  The data required for a safety assessment will therefore vary depending on the nature of the novel foods.  Factors to consider in a safety assessment will include:

 

(a)          the history of use as a food in other countries

(b)     the composition of the novel food, particularly the levels of anti-nutrients and naturally-occurring toxins

(c)     the method of preparation and specifications of a novel food ingredient

(d)     potential for allergenicity of the novel food

(e)     metabolism/toxicokinetic studies on the novel food ingredient

(f)      animal toxicity studies on the novel food ingredient

(g)     human toleration studies on the novel food ingredient

 

The nature of the information on the safety of the novel food to be submitted will depend on the category of the novel food as identified in Part B1.

 

(I)          Plants or animals (or their components)

 

An application for a novel food which is a plant or animal (or their components) must contain the following information:

 

1.           Information on the composition of the novel food

 

This part includes information on the levels of anti-nutrients and naturally-occurring toxins in the plant or animal (or their components).

 

2.           Information on the effects of food processing or preparation

 

This part includes information on methods of reducing the levels of anti-nutrients or naturally-occurring toxins during food processing or food preparation.

 

3.           Information on the current use of this food or food component in population sub-groups or in other countries

 

This part includes information on the extent and history of use of the food in other countries; any particular preparation, processing or cooking practices normally used; and the level and purpose of consumption (e.g. staple food, ceremonial use).

 


4.           Information regarding the potential adverse effects associated with the food or its ingredients

 

This part includes published or unpublished reports of allergenicity or other adverse effects in humans associated with the food.  If available, this part also includes any reports of toxicity studies conducted in animals or toleration studies conducted in humans.

 

(II)         Plant or animal extracts

 

An application for a novel food which is a plant or animal extract must contain all of the information in I. Plants or Animals (or their Components) above as well the following additional information:

 

1.           Information on the method of extraction and the composition of the concentrated extract

 

This part includes the methodology used to prepare the extract and the composition of the extract.  This must include information on the levels of potential contaminants from the extraction process.  

 

2.           Information on the use of this plant or animal extract as a food in other countries

 

This part includes information on the extent and history of use of the extract in other countries, together with reports of any adverse health effects.

 

Note: 

 

Use of the plant or animal extract as a dietary supplement, natural medicine or complementary medicine in other countries should be provided.  In some countries, this is regarded as food use rather than medicinal use.  If adverse effects are reported, the nature of the adverse event reporting scheme should be provided, if known.

 

3.           Information on the toxicity of the extract obtained from studies conducted in animals or humans

 

This part includes reports of toxicity studies conducted in animals.  It must also include any reports of toleration studies conducted in humans.

 

4.           Safety assessment reports prepared by international agencies or other national government agencies

 

This part includes published safety assessment reports prepared by other agencies.

 

(III)       Herbs (both non-culinary and culinary) including extracts

 

An application for a novel food which is a herb (both non-culinary and culinary) including extracts must contain the following information:

 


1.           Information on the history of use of the herb

 

This part includes information on the use of the herb as a complementary medicine in Australia or as a dietary supplement in New Zealand, or as a food or medicine in other countries.  The plant part(s) used must also be specified.

 

2.           Information on the composition of the herb

 

This part includes information on the levels of active constituents in the herbs or herbal extracts, and information on their potential adverse effects.

 

3.           For a herbal extract, information on the method of extraction and the composition of the concentrated extract

 

This part includes detailed information on the plant part(s) used to prepare the extract, the method used to prepare the extract and the composition of the extract.  This must include information on the levels of potential contaminants from the extraction process.  

 

4.           Information on the use of this herbal extract as a food in other countries

 

This part includes information on the extent and history of use of the herbal extract in other countries, together with reports of any adverse health effects.  The nature of the adverse event reporting scheme in that country should be detailed, if available.

 

5.           Information regarding the potential allergenicity of the herb or herbal extract

 

This part includes reports of allergenicity associated with the herb or herbal extract.

 

6.           Information on the toxicity of the herb, or herbal extract, or any key constituents  obtained from studies conducted in animals or humans

 

This part includes reports of toxicity studies conducted in animals.  It must also include any reports of toleration studies conducted in humans.

 

7.           Safety assessment reports prepared by international agencies or other national government agencies

 

This part includes published safety assessment reports prepared by other agencies. 

 

(IV & V)              Single chemical entities and Dietary macro-components

 

An application for a novel food which is a single chemical entity or a dietary macro-component must contain the following information:

 

1.           Information on the toxicokinetics and metabolism of the single chemical entity and, where appropriate, its degradation products and major metabolites

 

This part includes reports of all studies conducted in animals or humans to examine the metabolic fate of the single chemical entity or dietary macrocomponent and, where necessary, its degradation products and major metabolites. 


2.           Information from studies in animals or humans that is relevant to the toxicity of the single chemical entity and, where appropriate, its degradation products and major metabolites

 

This part includes detailed reports of all in vitro and in vivo toxicity studies conducted in animals or humans to examine the toxicity of the single chemical entity or dietary macro-component and, where necessary, its metabolites or degradation products. 

 

Note:

 

The application should address the following categories of animal studies:

 

(a)          Acute toxicity studies

(b)          Short-term toxicity

(c)          Long-term toxicity studies and  carcinogenicity studies

(d)          Reproductive toxicity studies

(e)          Developmental toxicity studies

(f)           Genotoxicity studies

(g)          Special studies such as neurotoxicity or immunotoxicity

 

Where data are not available or is not considered relevant to the safety assessment of the single chemical entity, an explanatory statement should be provided.

 

3.           Safety assessment reports prepared by international agencies or other national government agencies

 

This part includes safety assessment reports prepared by WHO or by other national or supranational agencies responsible for food safety or public health.

 

(VI)        Micro-organisms (including probiotics)

 

An application for a novel food which is a micro-organism (including probiotics) must contain the following information:

 
1.           Information on potential pathogenicity

 

This part includes information related to the potential pathogenicity of the micro-organism and related micro-organisms.

 

2.           Information on the effects of the micro-organism on gut microflora

 

This part includes studies to demonstrate that the micro-organism does not have adverse effects on the gut microflora.

 

3.           Information on the use of this micro-organism as a food in other countries

 

This part includes information on the extent and history of use of this micro-organism or related micro-organisms in other countries, together with reports of any adverse health effects. The nature of any adverse event reporting system in that country should be detailed, if available.


4.           Information on human toleration studies

 

This part includes any published or unpublished reports of toleration studies conducted in humans.

 

(VII)      Food ingredients derived from a new source

 

An application for a novel food which is a food ingredient derived from a new source must contain the following information:

 

1.           Information on the safety of the source organism

 

This part includes information on whether the source organism of the novel ingredient has a history of safe use as a food.  If the source organism is microbial, this part must include information on any potential pathogenicity.  This part must also include information on potential naturally-occurring toxins, if applicable.

 

2.           Information on the composition of the novel food ingredient derived from a new source

 

This part includes information on the levels of major components and nutrients in the final food.

 

3.           Information on the toxicity of the novel food ingredient derived from the new source

 

This part includes any published or unpublished reports of toxicity studies conducted in animals.  It must also include any reports of toleration studies conducted in humans.

 

4.           Safety assessment reports prepared by international agencies or other national government agencies

 

This part includes safety assessment reports prepared by WHO or by other national or supranational agencies responsible for food safety or public health.

 

(VIII)     Foods produced or by a process not previously applied to food

 

An application for a novel food which is produced by a process not previously applied to food must contain the following information:

 

1.           Details of the process not previously applied to food

 

This part includes details of the new food processing technology and its impact on the composition of the food.

 


2.           Information on the toxicity of the novel food produced by a process not previously applied to food

 

This part includes any published or unpublished reports of toxicity studies conducted in animals.  It must also include any reports of toleration studies conducted in humans.  The nature of the toxicity or toleration studies to be submitted will depend on the category of the novel food as set out in Part B1.

 

3.           Safety assessment reports prepared by international agencies or other national government agencies

 

This part includes safety assessment reports prepared by WHO or by other national or supranational agencies responsible for food safety or public health.

 

D.          Information on dietary exposure to the novel food

 

Note:

 

FSANZ will undertake a dietary exposure assessment for all novel foods applications.  The type of dietary exposure assessment will vary depending on the nature of the novel food.  For novel foods which are either the final food or a major component of the final food, the dietary exposure assessment may be based on the projected market share data, or data from markets in other countries.

 

For novel foods which are minor components of the final food, the dietary exposure assessment will use a custom-made computer program, DIAMOND, which combines food consumption data from the latest Australian and New Zealand National Nutrition Surveys together with food chemical concentration data derived from the proposed levels of use provided by the applicant. 

 

The application must contain the following information:

 

1.           A list of the foods or food groups proposed to contain the novel food ingredient

 

2.           The proposed level of the novel food ingredient for each food or food group

 

The application should contain the following information:

 

3.           The percentage of the food group in which the novel food ingredient is proposed to be used or the percentage of the market likely to use the novel food ingredient

 

This part includes information based on projected uptake or market share data for foods likely to contain the novel food or novel food ingredient.  This could be based on a similar market in another country.

 


4.           Data to show whether the food, or the food in which the novel food ingredient is used, is likely to replace another food from the diet, if applicable

 

This part includes information on projected consumption levels for the novel food or food(s) containing the novel food ingredient, and frequency of consumption.  This could include market research data or data from other international markets.

 

5.           Information relating to the use of the novel food or novel food ingredient in other countries, if applicable

 

This part includes information on the food groups and/or foods in which is it used and the use levels.

 

E.           Information on the nutritional impact of the novel food

 

Note:

 

Some of the information derived from Section C – Information on the safety of the novel food, will be used also to assess the nutritional impact of the novel food.  The information below is in addition to this information.  Information in relation to the safety, dietary exposure and nutritional impact will be considered in characterising the risk of the novel food or novel food ingredient.

 

The application must contain the following information:

 

1.           Information to demonstrate that the use of the novel food or novel food ingredient will not cause a nutritional imbalance in the diet

 

This part includes:

 

(a)     information relating to the nutritional properties of the novel food or novel food ingredient, its effect on the bioavailability of other nutrients, and its impact on the overall diet (particularly dietary macro-components); and

(b)     data on the macro- and micro-nutrient profile of the novel food or food(s) containing the novel food ingredient.

 

F.           Information related to potential impact on consumer understanding and behaviour

 

Note:

 

Some of the information derived from Section D – Information on dietary exposure to the novel food, will be used also to assess the impact on consumers of the novel food.  The information below is in addition to this information.

 

The application should contain the following information:

 


1.           Information to demonstrate consumer awareness and understanding of the novel food or novel food ingredient

 

2.           Information on the actual and/or potential behaviour of consumers in response to the novel food or novel food ingredient

 

This part includes information such as changes in consumption behaviour and changes in health and diet behaviour.

 

3.           Information to demonstrate that the food(s) containing the novel food ingredient will not adversely affect any population groups (e.g. particular age or cultural groups)

 

Note:

 

Consumption behaviour changes include substitution, addition or avoidance.  Health and diet behaviour changes relate to the potential impacts of the food in the context of not promoting patterns inconsistent with nutrition and physical activity policies and/or guidelines for Australia and New Zealand.

 

Novel foods or novel food ingredients can be used in food products for different purposes, not all of which may impact on consumer behaviour in relation to food products (e.g. cyclodextrins).  The amount of information necessary to address the impact on consumer behaviour will depend on the nature of the novel food or ingredient, its extent of use, and the nature of the claims associated with the food.

 

G.          Information related to impact on the food industry (industry applicants only)

 

The application must contain the following information:

 

1.           Data on the projected impact on the food industry of the proposed novel food or novel food ingredient

 

This part includes information on the costs of foods containing the novel food or novel food ingredient, and, if applicable, the impact of the new foods on the sale of similar existing products.

 

2.           Impact on international trade

 

This part includes information, if available, on the impact of the proposed change on foods imported into Australia/New Zealand.

 

Note:

 

The applicant should provide as much readily available information as is possible on the impact of the proposed novel food on the food industry.  FSANZ will use this information together with information from other sources to prepare a Regulatory Impact Statement (see Section 2.2.9).

 

[10]        Part 3.7.2  is varied by omitting the Note following B.1, substituting –

Note:

 

For further information on the use of equivalence, see the FSANZ Guidance Document Determining the Equivalence of Food Safety Measures on the FSANZ website at http://www.foodstandards.gov.au/standardsdevelopment/informationforapplicants/additionalfsanzguide3723.cfm..

 

[11]        The Appendix  is varied by –

 

[11.1]     omitting the General Requirements Checklist under Standards related to New Foods, substituting –

 

Checklist for Standards related to New Foods

 

This checklist will assist you in determining if you have met the information requirements as detailed in the Application Handbook.  Section 3.1 – General Requirements is mandatory for all applications.  Sections 3.5.1-3.5.3 are related to the specifics of your application and the information required is in addition to section 3.1.

 


General Requirements (3.1)

 

£

Form of application

 

£

Assessment procedure

£

Applicant details

 

£

Confidential Commercial Information

£

Purpose of the application

 

£

Exclusive Capturable Commercial Benefit

£

Justification for the application

 

£

International standards

£

Information to support the application

 

£

Statutory Declaration

 

[11.1]     omitting the Checklist for Novel Foods (3.5.2), substituting –

 

Novel Foods (3.5.2)

 

£

Support for the application

£

Percentage of food group anticipated to contain novel food or novel food ingredient

 

£

Exclusive use

£

Predicted consumption (replacement)

 

£

Type of novel food

 

£

Details of target or at risk population groups

£

Chemical and physical properties

 

£

Use in other countries

£

Impurity profile 

 

£

Nutritional impact information

£

Manufacturing process

 

£

Demonstrated consumer awareness and understanding

 

£

Specification and identity

£

Potential behaviour in response to foods

 

£

Analytical detection method

 

£

Demonstration of no adverse affects to any population groups

 

£

Safety information for specified section I-VIII

*(see below)

 

£

Impact on food industry

£

List of foods likely to contain the novel food or novel food ingredient

 

£

Impact on trade

£

Proposed levels in foods

 

 

 

 

 



[1] Based on the definition of a substitute food in the Codex General Principles, FSANZ defines a substitute food as a food which is designed to resemble a common food in appearance and texture and is intended to be used as a complete or partial replacement for the food it resembles (i.e. reference food).