| Regulatory authority |
Name: Food Standards Australia New Zealand (FSANZ)
Website:
http://www.foodstandards.gov.au (FSANZ 2011c)
Historical overview:
The first national agency to regulate food in Australia (National Food Authority) was established in June 1991. This became the Australia New Zealand Food Authority in July 1996, and FSANZ was established on 1 July 2002 FSANZ is a statutory authority operating under the Food Standards Australia New Zealand Act 1991 (Commonwealth of Australia 2007). The act provides a focus for cooperation between governments, industry, and the community to establish and maintain uniform food regulation in Australia and New Zealand FSANZ establishes food standards for Australia and New Zealand. There is an agreement (established in July 1996) between the governments of Australia and New Zealand that establishes FSANZ's role in setting joint food standards, i.e. standards that apply in both countries The agreement does not cover some areas, such as maximum residue limits, food hygiene provisions and export requirements relating to third country trade. It also contains provisions that allow New Zealand to opt out of a joint standard for exceptional reasons relating to health, safety, environmental concerns or cultural issues. In such cases, FSANZ may be asked to prepare a variation to a standard to apply only in New Zealand In Australia only, FSANZ develops standards for primary production and processing and for food hygiene, as well as setting residue limits for agricultural and veterinary products. Equivalent New Zealand standards are developed and administered by the New Zealand Ministry for Primary Industries (MPI), formerly MAF. MPI is also responsible for implementation and enforcement of food standards and requirements for exported foods
Role/responsibility:
FSANZ is responsible for developing and administering the Australia New Zealand Food Standards Code (the Code) – see below FSANZ is governed by a Board with a wide range of expertise and experience in food matters, with members drawn from Australia and New Zealand As of February 2001, the Legislative and Governance Forum on Food Regulation (the Forum) is primarily responsible for the development of domestic food regulatory policy and guidelines for setting domestic food standards. The Forum also has the capacity to adopt, amend or reject standards and to request that these be reviewed FSANZ recently implemented the Code Interpretation Service (CIS) on a cost-recovery basis to provide coordinated guidance on Chapters 1 and 2 of the Australia New Zealand Food Standards Code In Australia, enforcing compliance with the Code for all foods is the responsibility of State/Territory Health Departments within Australia. For imported foods, enforcing compliance is the responsibility of the Australian Quarantine Inspection Service (AQIS) In New Zealand, enforcing compliance with the Code for all foods is the responsibility of the New Zealand Ministry for Primary Industries (MPI), formerly MAF
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| Advisory scientific body |
FSANZ Board: The FSANZ Board is selected by the Australian Minister for Health and Aging in Consultation with the Food Regulation Ministerial Council and must include qualified people from a wide range of expertise. Members of the Board have been drawn from specialist areas – public health, food science, human nutrition, consumer affairs, food allergy, medical science, microbiology, food safety, biotechnology, veterinary science, primary food production, the food industry, food processing or retailing, small business, international trade, food regulation, consumer rights and consumer affairs policy, the National Health and Medical Research Council (NHMRC) and government FSANZ Fellows: FSANZ Fellows provide expert advice on applications, proposals and other risk assessment activities of the agency. FSANZ Fellows, within their relevant areas of expertise, also peer review FSANZ work and provide training to FSANZ staff Scientific Advisory Groups (SAG): These ad hoc advisory groups are set up to advise FSANZ on particular scientific issues, e.g. health claims, iodine and folic acid fortification and dairy primary production and processing
Role/responsibility: See above |
| Framework regulations |
Australia New Zealand Standards Code (the Code): The Code regulates all aspects of food including labelling, the addition of food additives, processing aids, nutritive substances, levels of contaminants, approval of new foods (novel foods, genetically modified (GM) foods and irradiated foods), composition of standardised and special purpose foods, and applying in Australia only, food safety programmes and food processing and primary production (http://www.foodstandards.gov.au) (FSANZ 2011a) |
| Part of an overarching international organisation |
Australia and New Zealand are both members of the World Trade Organization since 1995, and they are both members of the Codex Alimentarius Commission |
| Recent and/or pending changes |
No major changes to the regulatory framework anticipated. Refer to the new Science Strategy above |
| Regulatory overview of specific food chemical groups |
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| Food ingredients |
Food ingredients as such are not defined under the Australia New Zealand food regulations. Ingredients are generally considered to be either foods or substances added to food. FSANZ is reviewing the regulation of novel foods and nutritive substances as of March 2012. Due to problems with the definition of these terms a new approach is being considered based on criteria for “eligible foods” (i.e. foods in the wider sense including ingredients, additives and other substances added to food). Any non-eligible foods would be prohibited and will require appropriate safety assessment. Novel foods (including novel food ingredients):
Novel foods are defined as a non-traditional food with no history of safe use and the food requires an assessment of the public health and safety considerations having regard to:
the potential for adverse effects in humans; or the composition or structure of the food; or the process by which the food has been prepared; or the source from which it is derived; oro patterns and levels of consumption of the food; or any other relevant matters.
A non-traditional food is defined as:
a food that does not have a history of human consumption in Australia/New Zealand; or a substance derived from a food where that substance does not have a history of human consumption in Australia/New Zealand other than as a component of that food; or 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/New Zealand.
Categories of novel foods may include but are not limited to:
plants or animals and their components; plant or animal extracts; herbs, including extracts; dietary macro-components; single chemical entities; microorganisms, including probiotics; and foods produced from new sources, or by a process not previously applied to food. Foods produced using gene technology or irradiated foods are regulated separately from novel foods and will be not discussed further within this report
Regulation:
Novel foods and novel food ingredients are regulated under Food Standard 1.5.1. This standard prohibits the sale of these foods unless they are listed in the table to Clause 2 under Food Standard 1.5.1 and comply with any special conditions of use in that table Food Standard 1.3.4 describes standards for the identity and purity of novel food ingredients
Guidance document: Application Handbook (http://www.foodstandards.gov.au):
Approval process for a new substances: An application to vary the code is required to approve the use of a novel food ingredient or a novel food. All application forms must conform to the general requirements (under Section 3.1 of the Application Handbook). Section 3.5.2 Novel Foods (within the handbook) lists additional requirements specificto novel foods. A summary of the requirements are listed below:
Indicate whether the applicant is requesting for exclusive permission for the novel food (if applicable):
Technical information on novel food:
Description of novel food (if it falls under one of the major categories listed below) Physical and chemical properties Impurity profile Manufacturing process Specification for identity and purity Analytical method for detection
Safety information of novel food:
Depending on which major category that novel foods falls below (plants or animals and their components; plant or animal extracts; herbs (both non-culinary and culinary) including extracts; single chemical entities; dietary macro-components; microorganisms (including probiotics); food ingredients derived from new sources; or foods produced by a process not previously applied to food), different requirements are specified (see Section 3.5.2 of handbook)
Dietary exposure to novel food:
List of the foods or food groups proposed to contain the novel food Proposed use level of novel food for each food or food group Percentage of the food group in which the novel food is proposed to be used or the percentage of the market likely to use the novel food ingredient Data to indicate 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) Information regarding the use of the novel food/novel food ingredient in other countries (if applicable)
Nutritional impact of the novel food Information related to potential impact on consumer understanding and behaviour Information related to impact on the food industry (industry applicants only)
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| Nutritive substances |
Definition: Nutritive substance means a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides
Regulation: Nutritive substances cannot be added to certain special purpose foods without express permission. These are:
Standard 2.9.1 Infant Formula Products Standard 2.9.2 Food for Infants Standard 2.9.3 Formulated Meal Replacements and formulated supplementary foods Vitamins and minerals are regulated under Standard 1.3.2
Guidance document: Application Handbook:
Approval process for a new substances: An application to vary the code is required to approve the use of a nutritive substance or to change the permissions of a currently used nutritive substance. All application forms must conform to the general requirements (under Section 3.1 of the Application Handbook). A summary of the requirements are listed below:
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| Direct food additives |
Definition:
Direct food additive is not a term used in Australia/New Zealand A food additive is any substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which is intentionally added to a food to achieve one or more of the technological functions specified in Schedule 5. It or its by-products may remain in the food. Food additives are distinguishable from processing aids and vitamins and minerals added to food for nutritional purposes
Regulation:
Food additives may only be added to food where expressly permitted in Food Standard 1.3.1. Additives can only be added to food in order to achieve an identified technological function according to good manufacturing practice (GMP). Some additives have specific permissions and maximum use levels allowed in food and other additives are limited to GMP (see Schedules 1–5 below). Specific flavourings, sweeteners and colouring agents are regulated as food additives Schedule 1 of Standard 1.3.1 contains information on the permitted uses of food additives (including sweeteners) by food type Schedule 2 of Standard 1.3.1 contains miscellaneous food additives permitted according to GMP in processed foods specified in Schedule 1 Schedules 3 and 4 of Standard 1.3.1 contain colouring agents permitted to GMP and to specified levels in processed foods specified in Schedule 1 Schedule 5 lists the technological functions that may be performed by food additives Standard 1.3.4 describes standards for the identity and purity of food additivesGuidance document: Application Handbook: General application requirements are provided in Sections 2 and 3.1 Specific requirements for food additives are provided in Section 3.3.1
Approval process for a new substances: Application to vary the code is required to approve the use of a new food additive or to change the permissions of a currently used food additive. The following information are required:
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Technical information on food additive:
Nature and technological function Identification of food additive Chemical and physical properties of food additive Impurity profile Manufacturing process Specification for identity and purity Food labelling information Analytical method for detection
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Safety information of food additive:
Toxicokinetics and metabolism of food additive and if applicable, its degradation products and/or major metabolites Information on the toxicity of food additive and if applicable, its degradation products and major metabolites Safety assessment reports prepared by international agencies or other national government agencies, if available
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Dietary exposure to food additive:
List of food groups or foods proposed to contain food additive, or changes to currently permitted foods Maximum proposed level or concentration range of food additive for each food group or food, or proposed changes to the currently permitted levels 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 Information regarding the use of the food additive in other countries (if applicable)
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| Food contact substances (e.g. components of packaging materials) |
Definition:
Food contact substances are defined as any materials in contact with food, including packaging material, which may include materials such as moisture absorbers, mould inhibitors, oxygen absorbers, promotional materials, writing or other graphics Food contact substances may be placed in contact with food, provided such articles or materials, if taken into the mouth, are not capable of being swallowed or of obstructing any alimentary or respiratory passage and are not otherwise likely to cause bodily harm, distress or discomfort
Regulation:
Food Standard 1.4.3 Food Standard 1.4.1
Guidance document:
Food Standard 1.4.3 deals with food contact materials in general terms, and does not specify individual packaging materials for food contact or how they should be produced or used. However, with respect to plastic packaging products, the standard refers to the Australian Standard for Plastic Materials for Food Contact Use, AS 2070-1999. This Standard provides a guide to industry about the production of plastic materials for food contact use. AS 2070, in turn, refers to regulations of the United States and European Economic Community directives relevant to the manufacture and use of plastics Standard 1.4.1 – Contaminants and Natural Toxicants of the Food Standard Code regulates the levels of these substances that can be present in food from any source, including as a result of contact with food packaging materials. Even if a specific contaminant or toxicant is not listed in the standards, it sets out an expectation that all other contaminants and toxicants be kept to levels as low as reasonably achievable
Approval process for a new substances:
Applications for food packaging materials are generally unnecessary if there is approval in the European Union or United States. At present it is voluntary that plastic materials for food contact use comply with the Australian Standard AS 2070-1999 FSANZ has been considering its approach to chemicals that migrate from packaging into food for several years now, and it is envisaged that their approach may change to become more prescriptive and mandatory. Thus, in future, it may become mandatory to comply with either EU or US regulations under the Standard Code pending discussions with stakeholders
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| Flavouring agents |
Definition:
Flavouring agents, as such, are not defined in the Food Standards Code Flavourings are defined as intense preparations which are added to foods to impart taste and/or odour, which are used in small amounts and are not intended to be consumed alone, but do not include herbs, spices and substances which have an exclusively sweet, sour or salt taste Some flavourings are listed on the approved list of food additives with limitations -
“Permitted flavouring substances are those which are either: a) listed in at least one of the following publications:
Food Technology, A Publication of the Institute of Food Technologists, Generally Recognized as Safe (GRAS) lists of flavoring substances published by the Flavor and Extract Manufacturers” Association of the United States from 1960 to August 2007; or Chemically defined flavoring substances, Council of Europe, November 2000; or United States Code of Federal Regulations, 2007, 21 CFR Part 172.515;
or (b) a substance that is a single chemical entity obtained by physical, microbiological, enzymatic, synthetic or chemical processes, from material of vegetable or animal origin either in its raw state or after processing by traditional preparation process including drying, roasting, and fermentation”
Regulation: Food Standard 1.3.1 Section 11
Guidance document: An application is generally not required for flavourings and therefore no guidance is provided in the Application Handbook
Approval process for a new substances: Flavourings are regarded as food additives. An application is generally not required for flavourings |
| Enzymes |
Definition:
Enzymes, as such, are not specifically defined in the Food Standards Code Enzymes are considered to be processing aids. They may be used in the course of manufacture of any food, provided the enzyme is derived from the corresponding source or sources specified in the tables of Sections 15, 16, and 17 of Food Standard 1.3.3. Refer to processing aids (below)
Regulation: Enzymes are regulated as processing aids (below)Guidance document: Refer to processing aids (below)
Approval process for a new substances: Refer to processing aids (below) |
| Processing aids |
Definition: Processing aid means a substance listed in clauses 3–19 [of Standard 1.3.3] where:
the substances used in the processing of raw materials, foods or ingredients, to fulfila technological purpose relating to treatment or processing but does not perform a technological function in the final food; and the substance is used in the course of manufacture of a food at the lowest level necessary to achieve a function in the processing of that food, irrespective of any maximum permitted level specified
Regulation: Food Standard 1.3.3 – Processing aids
Guidance document:
Refer to the Application Handbook General application guidelines are provided in Sections 2 and 3.1 Specific requirements for processing aids are provided in Section 3.3.2
Approval process for a new substances: Application to vary the code is required to approve the use of a new processing aid or to change the permissions of a currently used processing aid. The following information are required in the application:
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Technical information on processing aid:
Information on the type of processing aid Identification of processing aid Chemical and physical properties of processing aid Manufacturing process Specification for identity and purity Analytical method for detection
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Safety information of a chemical processing aid:
General information on the industrial use of the chemical General information on the use of the chemical as a food processing aid in other countries Toxicokinetic and metabolism data on the processing aid, and if necessary its metabolites Information on the toxicity of the processing aid, and if necessary its major metabolites Safety assessment reports prepared by international agencies or other national government agencies, if available
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Safety information of an enzyme processing aid:
General information on the use of the enzyme as a food processing aid in other countries Toxicity information of the enzyme processing aid Information on the potential allergenicity of the enzyme processing aid Safety assessment reports prepared by international agencies or other national government agencies, if available
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Additional information related to the safety of an enzyme processing aid derived from a microorganism:
Information regarding the source microorganism Information regarding the pathogenicity and toxicity of the source microorganism Information on the genetic stability of the source organism
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Additional information related to the safety of a processing aid derived from a genetically modified microorganism:
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Dietary exposure to the processing aid:
List of foods or food groups likely to contain the processing aid or its metabolites Levels of residues of the processing aid or its metabolites for each food or food group Percentage of the food group in which the processing aid is likely to be present or the percentage of the market likely to use the processing aid Information relating to the levels of residues in foods in other countries
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| Nanoscale materials |
Definition: The term “nanotechnology” is usually applied to the process of controlling the size and shape of materials at the atomic and molecular scale. Generally, the term is defined as deliberately engineered matter less than 100 nm in size in one dimension (http://www.foodstandards.gov.au/consumerinformation/nanotechnologyandfoo4542.cfm)
Regulation: No authoritative statement found for food applications
Guidance document: No specific guidance document found for food applications
Approval process for a new substances:
Any new food substances that are manufactured using nanotechnologies that may present safety concerns will have to undergo a comprehensive scientific safety assessment under the appropriate standard before they can be legally supplied in Australia (http://www.foodstandards.gov.au/consumerinformation/nanotechnologyandfoo4542.cfm) Applications for food additives, processing aids, novel foods and nutritive substances must include particle size, size distribution and morphology, where the substance(s) is particulate in nature and will remain so in the final food
Efforts towards developing standards and regulations (Locascio et al. 2011): National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (http://www.nicnas.gov.au):
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