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 –

substituting –

[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 –

[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 –

[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.

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

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

[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.

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.

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

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.

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. 

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

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

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

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)

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.

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

[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.

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

[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).