FSANZ Application Handbook – Part 3 – Amendment No. 4 – 2010
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. 4 – 2010.
Commencement
These variations commence on 1 July 2010.
SCHEDULE
[1] Each Part of the Application Handbook in Column 1 of the following table is varied by omitting the corresponding Note in Column 2
Column 1
Part
Column 2
Note
3.2.1
Following D.2.
3.2.3
Preceding A
3.2.5
Following B.3.
3.3.1
Preceding A
Following D.4
3.3.2
Preceding A
Following G.4.
3.3.3
Following D.6
Following H.2.
3.4.1
Preceding A
Following D.2.
Following E.2.
3.4.2
Preceding A
Following E.1.
Following F.2.
3.4.3
Preceding A
3.5.1
Preceding A
2nd Note following D.2.
3.5.2
Following G.2.
3.5.3
Preceding A
3.6.1
Preceding A
Following E.2.
3.6.2
Following E.2.
3.7.1
Preceding A
Following C.1.
3.7.2
Preceding A
Following B.1.
Following C.2.
[2] Each Part of the Application Handbook in Column 1 of the following table is varied by –
[2.1] omitting the heading and related text as indicated in Column 2
Column 1
Part
Column 2
Heading and related text
3.2.1
A
3.3.1
A
3.3.2
A
3.3.3
A
3.4.1
A
3.4.2
A
3.4.3
A
3.5.1
A
3.5.3
A
3.6.1
A
3.6.2
A
3.7.1
A
3.7.2
A
[2.2] renumbering the remaining headings from B onwards, commencing with A
[3] Part 3.1 is varied by –
[3.1] omitting 3.1.4, substituting –
3.1.4 JUSTIFICATION FOR THE APPLICATION
The application must contain a statement or statements regarding the justification for the application. The following general issues should be considered depending on the stated purpose of the application:
(a) the need and/or advantages for the proposed change;
(b) any public health and/or safety issues related to the proposed change e.g. details of target groups and at-risk population groups;
(b) any nutrition issues related to the proposed change e.g. nutritional purpose of adding a nutritive substance to each type of food or composition ;
(c) if for a food additive or processing aid, its technological function or need;
(d) potential impact on trade;
(e) any consumer choice issues related to the proposed change;
(f) any evidence that the food industry generally or other specific companies have an interest in, or support, the proposed change to the Code (this item is mandatory for applications relating to food additives, processing aids, nutritive substances, novel foods, irradiated foods); and
(g) the costs and benefits for industry, consumers and government associated with the proposed change, if available.
Reference may be made to other sections of the application that contain detailed supporting information, where necessary.
Note:
In relation to the costs and benefits associated with the proposed change to the Code, the applicant should provide as much information relating to the impact on industry, consumers and government as is readily available. FSANZ will prepare a Regulatory Impact Statement (see Part 2.2.9) based on information sourced from the applicant and elsewhere.
[3.2] omitting from 3.1.11 –
The Application must contain a completed checklist with regard to information requirement relevant to the application (see Appendix 1).
substituting
The application must contain a completed checklist with regard to format and information requirements relevant to the application (see Appendix 1).
[4] Part 3.3.1 is varied by –
[4.1] omitting B.2., substituting –
2. Information to enable identification of the additive
This part 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 micro-organisms, the source should be provided.
[4.2] omitting B.5., substituting –
5. Manufacturing process
This part includes a description of the method of manufacture of the food additive.
Information is required to address whether the manufacture of the food additive results in carry-over of allergens or gives rise to any food safety issues. This part should cover both the food additive and, if relevant, other substances that are inherently part of the commercial product (for example, antioxidants in additive preparations).
[4.3] 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. 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.
Where the substance, in the form in which it will be present in food, is particulate in nature, the applicant must provide information on particle size, size distribution and morphology in cases where the referenced specification does not include this information.
[4.4] omitting B.8., substituting –
8. Analytical method for detection
This part 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 applicant should provide a suitably robust analytical method suitable for analytical laboratories to determine compliance of any limits prescribed in the Code.
[5] Part 3.3.2 is varied by –
[5.1] omitting B.2., substituting –
2. Information on the identity of the processing aid
This part includes the chemical name (according to both Chemical Abstracts (CA) and the International Union for Pure and Applied Chemistry (IUPAC)); structural formula; common name and synonyms; manufacturers’ code; marketing name; and CAS registry number. For enzymes, this part includes the name and source of the enzyme together with the Enzyme Commission (EC) number. If the enzyme is from a genetically modified microbial source, this part includes both the host and donor organism, including alternative names for the microbial source, if applicable.
For new processing aids, a common name should be proposed. Where relevant, this information should support the evidence that the amounts proposed to be added are consistent with achieving the technological function.
[5.2] omitting B.4., substituting –
4. Manufacturing process
This part includes a description of the method of manufacture of the processing aid.
Information is required to address whether the manufacture of the processing aid results in carry-over of allergens or gives rise to any food safety issues. This part should cover both the processing aid and, if relevant, other substances that are inherently part of the commercial product (for example, preservatives in a processing aid preparation).
For enzymes, detailed information on the manufacturing process must be provided, including any recombinant DNA techniques used to prepare genetically modified organisms used as an enzyme source.
[5.3] 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. Specifications should include information on the name of the processing aid, its chemical and physical properties, its purity, acceptable levels of impurities, the method of preparation, and analytical methods for determining purity.
Where the substance, in the form in which it will be present in food, is particulate in nature, the applicant must provide information on particle size, size distribution and morphology in cases where the referenced specification does not include this information.
This part must include details on the presence of known allergens (See clause 4 of Standard 1.2.3) present in the processing aid preparation.
Where residues from the processing aid are likely to be present in the final food, an analytical method should be provided to quantify the amount of the processing aid remaining in the final food. Such an analytical method should be robust and applicable for analytical laboratories to determine compliance of any limits prescribed in the Code.
[5.4] omitting E.1., substituting –
1. Information on the source micro-organism
The information provided should include the production strain and the strains from which it was originally derived. Information should also be provided on where the wild-type strain is normally found. Any other information on the taxonomy of this strain which would help its characterisation should be provided. It should be stated if the production strain is currently used in food enzyme production.
The information provided should also contain the production method used.
[5.5] omitting E.3., substituting –
3. Information on the genetic stability of the source organism
This part includes information to demonstrate that the strain of the source micro-organism does not undergo strain drift and that the culture conditions can be applied consistently between batches. The steps which are taken to ensure strain stability should be provided, such as tests for morphological, growth and production characteristics of the strain.
[5.6] inserting immediately after the heading for G.2. –
The chemical identity of the residue must be stated.
[6] Part 3.3.3 is varied by –
[6.1] omitting the Note preceding A, substituting –
Note:
If the substance or ingredient intended to be added to food is not a nutritive substance, it may be regarded as a novel food ingredient and considered under Section 3.5.2 – Novel Foods.
[6.2] omitting the Note and paragraph immediately following the Note, after the heading C Information related to the safety of the nutritive substance, substituting–
Note:
FSANZ will undertake an assessment of all available reports of animal and human toxicity studies related to the nutritive substance, where appropriate, and, if possible, establish a safe level of intake, or assess the safety of the nutritive substance at the levels proposed to be used in the food. Where an upper level of safety (UL) has been established, this will be considered. The NHMRC publication Nutrient Reference Values for Australia and New Zealand including Recommended Daily Intakes contains ULs for a range of vitamins and minerals. This publication can be found at http://www.nhmrc.gov.au/publications/synopses/n35syn.htm.
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.
[6.3] omitting C.1., substituting –
1. Information on the toxicokinetics and metabolism of the nutritive substance and, if necessary, its degradation products and major metabolites
For an application for a new nutritive substance, this part includes published reviews or individual study reports on the metabolic fate of the nutritive substance and, if necessary, its degradation products and major metabolites.
For an application to extend the use of a currently permitted form of a nutritive substance, this part need only include the studies conducted since the last safety evaluation by FSANZ. If no previous evaluation by FSANZ is available, this part should include published papers and/or a comprehensive review article on this matter.
[6.4] omitting C.2.(b), substituting –
(b) For an application to extend the use of a currently permitted form of a nutritive substance, this part need only include the original reports of studies conducted since the last safety evaluation by FSANZ. If no previous evaluation by FSANZ is available, this part needs to include published papers and/or a comprehensive review article on this matter.
[6.5] omitting the heading D, and the following Note, substituting –
D. Information on dietary intake of the nutritive substance
Note:
FSANZ will undertake a dietary intake assessment for all nutritive substance applications using a custom-made computer program, DIAMOND, which combines food consumption data from the latest Australian and New Zealand National Nutrition Surveys, together with food nutrient concentration data derived from naturally occurring concentrations, 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.
[6.6] omitting the text immediately after D.4., substituting –
This part includes any consumption information for food groups not included in the 1995 Australian National Nutrition Survey (NNS) or the 1997 New Zealand NNS which relate to this application. Data distinguishing likely consumption levels among target and non-target groups are preferred.
[6.7] omitting the Note following E.1., substituting –
Note:
The scientific evidence for a nutritional purpose must:
(a) be based on studies conducted on human subjects;
(b) be based on foods or food groups containing the nutritive substance rather than the nutritive substance alone; and
(c) relate to normal use by the target population group and the foods must contribute to the demonstrated nutritional role relevant to that target population.
Refer to Part 3.1.5 for further information regarding data quality.
[6.8] omitting the heading for G.1., substituting –
1. Information to demonstrate the level of consumer awareness and understanding of the nutritive substances in the food(s)
[6.9] omitting the heading for G.3., substituting –
3. Information to demonstrate that the consumption of food(s) containing the nutritive substance will not adversely affect any population groups (e.g. particular age or cultural groups).
[7] Part 3.4.1 is varied by –
[7.1] omitting B.1., substituting –
1. Nature of the contaminant or natural toxicant, including chemical and physical properties
This part includes information on the nature of the contaminant or natural toxicant, its chemical and physical properties, the source of the contaminant or natural toxicant, the factors that influence the level of contamination of food, the interaction of the contaminant or natural toxicant with the food, and current control measures and their effectiveness. In cases where particle characteristics may relate to the toxicity of the food contaminant, the applicant must provide information on particle size and morphology.
[7.2] omitting C.1., substituting –
1. Information on the toxicokinetics and metabolism of the contaminant or natural toxicant and, if necessary, its degradation products
This part includes published reviews or individual study reports on the metabolic fate of the contaminant or natural toxicant and, if necessary, its degradation products.
[7.3] omitting D.2., substituting –
2. Surveys on the levels of the contaminant or natural toxicant in foods
This part includes the details of any surveys which have been conducted in Australia or New Zealand on the levels found in foods. If data derived from an analytical survey are used, details of how the survey was conducted and the analytical methods used must be provided.
These details should include the sampling plan, the number of samples, where the samples were collected, whether the analysis was conducted on composite or individual samples, the method of analysis, the limits of detection/quantification/reporting (LOD, LOQ, LOR) for the analytical method used, whether the foods were prepared/cooked before analysis, whether the samples were from the edible portion only, and whether the sampling was targeted or randomly sampled. If applicable, this part must also include details of any surveys conducted in other countries.
[8] Part 3.4.3 is amended by omitting –
An application to vary the Code is required to add, modify or delete an entry in relation to a plant or fungi in Standard 1.4.2 – Prohibited and Restricted Plants and Fungi.
substituting –
An application to vary the Code is required to add, modify or delete an entry in relation to a plant or fungi in Standard 1.4.1 – Prohibited and Restricted Plants and Fungi.
[9] Part 3.5.2 is varied by
[9.1] omitting the Note preceding A, substituting –
Note:
For further information relating to the operation of the Novel Food Standard, particularly in relation to whether a particular food would be regarded as novel, refer to the FSANZ website at http://www.foodstandards.gov.au/consumerinformation/novelfoods/.
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.
[9.2] deleting A, substituting –
A. 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.
[9.3] inserting at the end of the Note following B.1. –
A novel food may fit under more than one category above. In this case, all applicable requirements for each category should be addressed.
[9.4] omitting B.6., substituting –
6. Analytical method for detection
The application should contain the following information:
This part includes a method for detection and quantification of the novel food ingredient or its degradation products (where relevant) in the foods in which it will be used. Such analytical methods need to be robust and applicable for analytical laboratories to determine compliance of any limits prescribed in the Code.
[9.5] omitting C.(I)2. and C.(I)3., substituting –
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, if relevant.
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). This evidence of safe use should include the frequency of consumption, the extent of the population using the food, and the period of use.
[9.6] omitting C.(VI)4., substituting –
4. Information on human toleration studies
This part includes any published or unpublished reports of toleration studies conducted in humans. Clinical evaluation of potential probiotics must use double blind, placebo-controlled human trials, with detailed reporting of adverse side effects, which can be used to confirm the results observed in animal tests or in vitro studies.
[9.7] omitting C.(VII)1., substituting –
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 and toxicity. This part must also include information on potential naturally-occurring toxins, if applicable.
This part must include details on the presence of known allergens (see clause 4 of Standard 1.2.3).
[9.8] omitting the heading for C.(VIII), substituting –
(VIII) Foods produced by a process not previously applied to food
[9.9] omitting C.(VIII)2., substituting –
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.
This part must include details on the presence of known allergens (see clause 4 of Standard 1.2.3).
[9.10] inserting immediately after the heading for D.2. –
Data that must be provided are the proposed levels of use (or concentration) of the novel food ingredient, for each of the foods or food groups identified as well as any naturally occurring levels. The application should indicate whether these use levels are the maximum levels that will be used or are the likely actual use level.
[10] Appendix 1 is amended by –
[10.1] omitting the Checklist for General Requirements (3.1), wherever occurring, substituting –
General Requirements (3.1)
£
Form of application
£ Executive Summary
£ Relevant sections of part 3 identified
£ Pages sequentially numbered
£ Hard copies capable of being laid flat
£ Electronic and hard copies identical
£
Assessment procedure
£
Applicant details
£
Confidential Commercial Information
£ Confidential material separated in both electronic and hard copy
£
Purpose of the application
£
Exclusive Capturable Commercial Benefit
£
Justification for the application
£
International standards
£
Information to support the application
£
Statutory Declaration
[10.2] omitting Support for the application wherever occurring
[10.3] omitting the Checklist for Nutritive Substances (3.3.3), substituting –
£
Identification information
£
Proposed maximum levels in food groups or foods
£
Information on chemical and physical properties
£
Percentage of food group anticipated to contain nutritive substance
£
Impurity profile information
£
Food consumption data for new foods
£
Manufacturing process information
£
Nutritional purpose
£
Specification information
£
Need for nutritive substance in food
£
Analytical detection method
£
Demonstrated potential deficit or health benefit
£
Proposed food label
£
Consumer awareness and understanding
£
Statement that the product being assessed is representative of the commercial product
£
Actual or potential behaviour of consumers
£
Toxicokinetics and metabolism information
£
Demonstration of no adverse affects to any population groups
£
Animal or human toxicity studies
£
Impact on food industry
£
Safety assessments from international agencies
£
Impact on trade
£
List of food groups or foods likely to contain the nutritive substance
[10.4] omitting from the Checklist for Chemical Contaminant and Natural Toxicant Maximum Levels (3.4.1) –
£
Survey data on contaminant levels in foods
substituting
£
Survey data on contaminant or toxicant levels in foods
[10.5] inserting in (VII) Food ingredients derived from a new source in the Checklist for *Novel Foods – safety information –
£
Allergen statement
[10.6] inserting in (VIII) Foods produced by a process not previously applied to foods in the Checklist for *Novel Foods – safety information –
£
Allergen statement
£
Human toleration studies
