EXPOSING EVIDENCE REQUIREMENTS FOR PRODUCTS IN THE FOOD-MEDICINE CONTINUUM Janine Curll BSc LLB MAIFST PhD Candidate (Monash University)Food regulatory consultantjaninecurll@foodlabellingmatters.com

Overview• Standard 1.2.7 – Nutrition, health and related claims on

food (The new health claims standard)• Nutrition content claims• Pre-approved general level health claims• Self-substantiation of general level health claims• High level health claims

• Comparison of claims available for foods and listed medicines

• Foods for Special Medial Purposes (FSMPs)• Permissions for the addition of Vitamins and Minerals to

foods• Food safety standards and Integrity & Purity standards

STANDARD 1.2.7A new food standard to regulate nutrition content claims and health claims on food labels and in advertisements became law on 18 January 2013. Food businesses must comply with 1.2.7 from 18 January 2016.

Types of claims on food

• Nutrition content claims

• General level health claims• Pre-approved food health relationship• Self-substantiated food health relationship

• High level health claims

SEE guidance: Getting your claims right – published by ISFR national working group on implementation of Std 1.2.7 Provides checklists and guides to complete.Available at: http://www.foodstandards.gov.au/publications/Documents/FINAL%20-%20ISFR%20Health%20Claims.pdf

Nutrition content claims on food• Nutrition content claims means a claim about the presence or absence of

• A biologically active substance• Dietary fibre• Energy• Minerals• Potassium• Protein• Carbohydrate• Fat• The components of any one protein, carbohydrate or fat• Salt• Sodium• Vitamins

• Or, a claim about glycaemic index/load

Health claims on food• A ‘health claim’ means a claim which states, suggests or implies

that a food or property of food has, or may have, a health effect.• General level health claim (pre-approved or self substantiated)• High level claim (pre-approved only)

• A ‘health effect’ means an effect on the human body, including an effect on one or more of the following:• A biochemical process or outcome• A physiological process or outcome• A functional process or outcome• Growth and development• Physical performance• Mental performance• A disease, disorder or condition - but not a serious disease (as defined)

Types of claims• General level health claim (preapproved food health relationship)

• ‘means a health claim that is not a health level health claim’• based on a pre-approved food health relationship as listed in 1.2.7

• General level health claim (self-substantiated food health relationship) • Notify FSANZ of the details of a relationship between a food or property of food and

certify a health effect that has been established by a process of systematic review as described in Schedule 6 of 1.2.7

• High level health claims • ‘means a health claim that refers to a serious disease or a biomarker of a serious

disease’• ‘serious disease’ is defined as ‘a disease, disorder or condition which is generally

diagnosed, treated or managed in consultation with or with supervision by a health care professional’

• based on a food-health relationship that has been pre-approved by FSANZ and included in Schedule 1 of 1.2.7

General conditions for the making of health claims

• A food must be ‘healthy’ according to the Nutrient Profile Scoring Criterion (Schedule 5 1.2.7) to carry a health claim (does not apply to NCC)

• Therapeutic claims prohibition A claim must nota) refer to the prevention, diagnosis, cure or alleviation of a

disease, disorder or condition; orb) compare a food with a good that is represented in any way to

be for therapeutic use; or likely to be taken to be for therapeutic use, whether because of the way in which the good is presented or for any other reasons

• The words of claims are not prescribed. Any statement or information required by the Standard may be modified if the modification does not alter or contradict the effect of the required statement or information.

Evidence of the ‘food-health relationship’

• Food businesses making a GLHC can base their claim on a food-health relationship that is either:

• An established food-health relationship, pre-approved by FSANZ as listed in Schedule 3 of Standard 1.2.7; or

• A food-health relationship established in accordance with requirements set out in Schedule 6 of Standard 1.2.7 (Self-substantiation process)

Preapproved food health relationships for GLHC on MINERALSCalcium Necessary for normal teeth and bone structure

Necessary for normal nerve and muscle functionNecessary for normal blood coagulationContributes to normal energy metabolismContributes to the normal function of digestive enzymesContributes to normal cell divisionContributes to normal growth and development

Chromium Contributes to normal macronutrient metabolism

Copper Contributes to normal connective tissue structureContributes to normal iron transport and metabolismContributes to cell protection from free radical damageNecessary for normal energy productionNecessary for normal neurological functionNecessary for normal immune system functionNecessary for normal skin and hair colourationContributes to normal growth and development

Fluoride Contributes to the maintenance of tooth mineralisation

Iodine Necessary for normal production of thyroid hormonesNecessary for normal energy productionNecessary for normal neurological functionContributes to normal cognitive functionContributes to the maintenance of normal skinContributes to normal growth and development

Selenium Necessary for normal immune system function  Necessary for the normal utilisation of iodine in the production of thyroid hormones Necessary for cell protection from some types of free radical damageContributes to normal sperm production    Contributes to the maintenance of normal hair and nailsContributes to normal growth and development

Preapproved food health relationships for GLHC on MINERALS (cont.)Iron Necessary for normal oxygen transport

Contributes to normal energy metabolismNecessary for normal immune system functionContributes to normal blood formationNecessary for normal neurological development in the foetusContributes to normal cognitive functionContributes to the reduction of tiredness and fatigueNecessary for normal cell divisionContributes to normal growth and developmentContributes to normal cognitive development

Manganese Contributes to normal bone formationContributes to normal energy metabolismContributes to cell protection from free radical damageContributes to normal connective tissue structureContributes to normal growth and development

Magnesium Contributes to normal energy metabolism    Necessary for normal electrolyte balance    Necessary for normal nerve and muscle function    Necessary for teeth and bone structure    Contributes to a reduction of tiredness and fatigueNecessary for normal protein synthesisContributes to normal psychological function    Necessary for normal cell division    Contributes to normal growth and development

Molybdenum Contributes to normal sulphur amino acid metabolism

Phosporus Necessary for normal teeth and bone structureNecessary for the normal cell membrane structure   Necessary for normal energy metabolismContributes to normal growth and development

Preapproved food health relationships for GLHC on MINERALS (cont.)Zinc

 Necessary for normal immune system functionNecessary for normal cell division    Contributes to normal skin structure and wound healing    Contributes to normal growth and developmentContributes to normal acid-base metabolism    Contributes to normal carbohydrate metabolism    

Contributes to normal cognitive function    Contributes to normal fertility and reproduction    Contributes to normal macronutrient metabolism    

Contributes to normal metabolism of fatty acids   Contributes to normal metabolism of vitamin A    Contributes to normal protein synthesis    Contributes to the maintenance of normal bones    

Contributes to the maintenance of normal hair and nailsContributes to the maintenance of normal testosterone levels in the blood  

Contributes to cell protection from free radicals    Contributes to the maintenance of normal vision

Preapproved food health relationships for GLHC on VITAMINSBiotin Contributes to normal fat metabolism and energy production  

Contributes to normal functioning of the nervous system    Contributes to normal macronutrient metabolism    Contributes to normal psychological function    Contributes to maintenance of normal hairContributes to maintenance of normal skin and mucous membranes

Choline Contributes to normal homocysteine metabolism    Contributes to normal fat metabolism    Contributes to the maintenance of normal liver function

Folate Necessary for normal blood formation    Necessary for normal cell division      Contributes to normal growth and development  Contributes to maternal tissue growth during pregnancy    Contributes to normal amino acid synthesis  Contributes to normal homocysteine metabolism    Contributes to normal psychological function      Contributes to normal immune system function    Contributes to the reduction of tiredness and fatigue

Folic acid (but not folate)

Contributes to normal neural tube structure in the developing foetus

Niacin Necessary for normal neurological function    Necessary for normal energy release from food    Necessary for normal structure and function of skin and mucous membranesContributes to normal growth and developmentContributes to normal psychological function    Contributes to the reduction of tiredness and fatigue

Pantothenic acid Necessary for normal fat metabolism    Contributes to normal growth and developmentContributes to normal energy production    Contributes to normal mental performance    Contributes to normal synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters    Contributes to the reduction of tiredness and fatigue

Riboflavin Contributes to normal iron transport and metabolism  Contributes to normal energy release from food    Contributes to normal skin and mucous membrane structure and functionContributes to normal growth and developmentContributes to normal functioning of the nervous system    Contributes to the maintenance of normal red blood cells    Contributes to the maintenance of normal vision    Contributes to the protection of cells from oxidative stress    Contributes to the reduction of tiredness and fatigue

Preapproved food health relationships for GLHC on VITAMINSRiboflavin Contributes to normal iron transport and metabolism  

Contributes to normal energy release from food    Contributes to normal skin and mucous membrane structure and functionContributes to normal growth and developmentContributes to normal functioning of the nervous system    Contributes to the maintenance of normal red blood cells    Contributes to the maintenance of normal vision    Contributes to the protection of cells from oxidative stress    Contributes to the reduction of tiredness and fatigue

Thiamin Necessary for normal carbohydrate metabolism  Necessary for normal neurological and cardiac function  Contributes to normal growth and development Contributes to normal energy production    Contributes to normal psychological function

Vitamin A Necessary for normal vision    Necessary for normal skin and mucous membrane structure and functionNecessary for normal cell differentiation    Contributes to normal growth and developmentContributes to normal iron metabolism    Contributes to normal immune system function

Vitamin B6 Necessary for normal protein metabolism    Necessary for normal iron transport and metabolismContributes to normal growth and developmentContributes to normal cysteine synthesis  Contributes to normal energy metabolism  Contributes to normal functioning of the nervous systemContributes to normal homocysteine metabolism  Contributes to normal glycogen metabolism    Contributes to normal psychological function    Contributes to normal red blood cell formation

Preapproved food health relationships for GLHC on VITAMINSVitamin B6 Contributes to normal immune system function    

Contributes to the reduction of tiredness and fatigue  Contributes to the regulation of hormonal activity

Vitamin B12 Necessary for normal cell division    Contributes to normal blood formation    Necessary for normal neurological structure and function  Contributes to normal growth and developmentContributes to normal energy metabolism    Contributes to normal homocysteine metabolismContributes to normal psychological function    Contributes to normal immune system functionContributes to the reduction of tiredness and fatigue

Vitamin C Contributes to iron absorption from food    Necessary for normal connective tissue structure and functionNecessary for normal blood vessel structure and functionContributes to cell protection from free radical damageNecessary for normal neurological function  Contributes to normal growth and developmentContributes to normal collagen formation for the normal structure of cartilage and bonesContributes to normal collagen formation for the normal function of teeth and gumsContributes to normal collagen formation for the normal function of skinContributes to normal energy metabolism    Contributes to normal psychological function    Contributes to the normal immune system function    Contributes to the reduction of tiredness and fatigue

Vitamin D Necessary for normal absorption and utilisation of calcium and phosphorusContributes to normal cell division    Necessary for normal bone structure    Contributes to normal growth and development  Contributes to normal blood calcium levels    Contributes to the maintenance of normal muscle functionContributes to the maintenance of normal teeth Contributes to the normal function of the immune system

Preapproved food health relationships for GLHC on VITAMINSVitamin E Contributes to cell protection from free radical damage

Contributes to normal growth and development

Vitamin K Necessary for normal blood coagulation  Contributes to normal bone structure    Contributes to normal growth and development

Preapproved food health relationships for GLHC on OTHER PROPERTY OF FOODBeta-glucan Reduces dietary and biliary cholesterol absorption

Carbohydrate Contributes energy for normal metabolismContributes energy for normal metabolism (young children)

Dietary fibre Contributes to regular laxation

Eicosapentaenoic acid (EPA) and Docosa- hexaenoic acid (DHA) (but not Omega-3)

Contributes to heart health

Energy Contributes energy for normal metabolismContributes energy for normal metabolism (young children)Contributes to weight loss or weight maintenance (Diet reduced in energy and including regular exercise; meets conditions for ‘diet’ NCC)

Live yogurt cultures (108 cfu/g (Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus))

Improves lactose digestion

Phytosterols, phytostanols and their esters

Reduces dietary and biliary cholesterol absorptionNOTE - COMPARISON WITH BLOOD CHOLESTOERL HIGH LEVEL CLAIM

Potassium Necessary for normal water and electrolyte balanceContributes to normal growth and developmentContributes to normal functioning of the nervous systemContributes to normal muscle function

Protein Necessary for tissue building and repairNecessary for normal growth and development of boneContributes to the growth of muscle mass Contributes to the maintenance of muscle massContributes to the maintenance of normal bonesNecessary for normal growth and development

Preapproved food health relationships for GLHC on FOODFruits and vegetables Contributes to heart heart (Food NOT a fruit juice, standardised

food. Must contain no less than 90% fruit or vegetable by weight)

Sugar or sugars (confectionary or chewing gum with composition conditions)

Contributes to dental health (Good oral hygiene)

Chewing gum Contributes to the maintenance of tooth mineralisation Contributes to the neutralisation of plaque acidsContributes to the reduction of oral dryness

Permitted High Level Health Claims – Schedule 2 of Standard 1.2.7

Food/property Specific health effectA high intake of fruit and vege Reduces risk of coronary health disease

Beta-glucan Reduces blood cholesterol (3g per day)Calcium Reduces risk of osteoporosis

Enhances bone mineral densityReduces risk of osteoporotic fracture

Calcium and Vit D Reduces risk of osteoporosisReduces risk of osteoporotic fracture

Folic Acid Reduces risk of foetal neural tube defects (>65 years)Increased intake of fruit and vegetables

Reduces risk of coronary heart disease (Diet containing an increased amount of both fruit and vegetables)

Phytosterols, phytostanols and their esters

Reduces Blood Cholesterol (Diet w 2g sterols/stanols per day)

Saturated fatty acids Reduces total blood cholesterol or blood LDL cholesterol (Diet low in saturated fatty acids)

Saturated and trans fatty acids Reduces total blood cholesterol or blood LDL cholesterol (Diet low in saturated/ trans fatty acid)

Sodium or salt Reduces blood pressure (Diet low in salt)

Self-substantiation of GLHC

• Systematic review must be conducted in accordance with Schedule 6 of Standard 1.2.7

• Scientific best practice for the systematic review is outlined in the FSANZ guidance document:

Guidance on establishing food-health relationships for general level health claims (September 2013)

A systematic review must include the following elements (Schedule 6 Std 1.2.7)

1             A description of the food or property of food, the health effect and the proposed relationship between the food or property of food and the health effect. 2             A description of the search strategy used to capture the scientific evidence relevant to the proposed relationship between the food or property of food and the health effect, including the inclusion and exclusion criteria. 3             A final list of studies based on the inclusion and exclusion criteria. Studies in humans are essential. A relationship between a food or property of food and the health effect cannot be established from animal and in vitro studies alone. 4             A table with key information from each included study. This must include information on – (a)          the study reference(b)          the study design(c)          the objectives(d)          the sample size in the study groups and loss to follow-up or non-response(e)          the participant characteristics(f)           the method used to measure the food or property of food including amount consumed(g)          confounders measured(h)          the method used to measure the health effect(i)           the study results, including effect size and statistical significance(j)           any adverse effects.

Systematic review (Cont..)5 An assessment of the quality of each included study based on consideration of, as a minimum – (a)          a clearly stated hypothesis(b)          minimisation of bias(c)          adequate control for confounding(d)          the study participants’ background diets and other relevant lifestyle factors(e)          study duration and follow-up adequate to demonstrate the health effect(f)           the statistical power to test the hypothesis. 6             An assessment of the results of the studies as a group by considering whether (a)          there is a consistent association between the food or property of food and the health effect across all high quality studies(b)          there is a causal association between the consumption of the food or property of food and the health effect that is independent of other factors (with most weight given to well-designed experimental studies in humans)(c)          the proposed relationship between the food or property of food and the health effect is biologically plausible(d)          the amount of the food or property of food to achieve the health effect can be consumed as part of a normal diet of the Australian and New Zealand populations. 

Systematic review (Cont..)7             A conclusion based on the results of the studies that includes – (a)          whether a causal relationship has been established between the food or property of food and the health effect based on the totality and weight of evidence; and(b)          where there is a causal relationship between the food or property of food and the health effect:

(i)            the amount of the food or property of food required to achieve the health effect

(ii)           whether the amount of the food or property of food to achieve the health effect is likely to be consumed in the diet of the Australian and New Zealand populations or by the target population group, where relevant.

8             An existing systematic review may be used if it is updated to include  (a)          the required elements 1 to 6 above for any relevant scientific data not included in the existing systematic review(b)          the required element 7 above incorporating the new relevant scientific data with the conclusions of the existing systematic review. 

Notified self-substantiated food-health relationships

• FSANZ does not consider the merits of notified food health relationships

• FSANZ administers the listing online of FHR notified to it

• If requested by a state food regulator, food businesses must provide records demonstrating that a systematic review was conducted in accordance with Schedule 6 of 1.2.7 certifying that the notified relationship is a reasonable conclusion of the systematic review.

Notified food health relationships1. Food or property of food: Apple Cider Vinegar (Capitano Honey Pty Limited)Health effect: Adding apple cider vinegar to meals contributes to / helps carbohydrate Health effect: Apple Cider Vinegar has a prebiotic effectHealth effect: Adding apple cider vinegar to a meal can help to improve satiety / reduce

appetite.Health effect: 15mL of Apple Cider Vinegar daily contributes to weight lossHealth effect: 15mL of Apple Cider Vinegar daily can help adults reduce body fat / loose

weightHealth effect: Daily intake of 15mL of apple cider vinegar can help reduce body weight and

body fat in overweight adults

2. Food or property of food: Wheat bran fibre (Kellogg (Aust) Pty Limited)Health effect: increases stool weight; and reduces intestinal transit time

3. Food or property of food: Zespri green kiwifruit (Actinidia deliciosa cv. 'Hayward’) (Zespri Int. Ltd)Health effect: Can contribute to normal bowel function

4. Food or property of food: Green Tea Catechins (GCTs) with caffeineHealth effect: Contribute to modest weight loss in overweight and obese adults

5. Food or property of food: Combination of ingredients in Aspire drink: citric acid; sodium citrate; taurine; extract mixture: green tea, guarana, ginger; vitamin mixture: vitamin C, niacinamide, panthothenic acid, vitamin B6, biotin, vitamin B12; L-carnitine (Speedifitness P/L)

Health effect: Thermogenic effect (physiological process it triggers is of thermogenic nature – calorie burning effect

CLAIMS COMPAREDA selection of claims permitted in the therapeutics and food spaces compared.

Examples of permissible claims for listed medicines and foods

FOOD HEALTH RELATIONSHIP CONDITION CLAIM FOR A LISTED THERAPEUTIC GOOD

Dietary fibre contributes to regular laxation Constipation XX Aids or assists in the relief/treatment/management of constipation

Chewing gum contributes to the maintenance of tooth mineralisation/ contributes to the neutralisation of plaque acids/ contributes to the reduction of oral dryness

Dental XX May help prevent dental caries

Live yogurt cultures (108 cfu/g (Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus) improves lactose digestion

Digestion XX Helps maintain healthy digestive function[many claims permitted]

Beta-glucan reduces dietary and biliary cholesterol absorption (General level claim)

Cholesterol absorption Not permitted

Phytosterols, phytostanols and their esters reduces dietary and biliary cholesterol absorption (General level claim)

Cholesterol absorption

Not permitted

Beta-glucan reduces blood cholesterol (High Level Claim)

Blood cholesterol reduction

Not permitted

Phytosterols, phytostanols and their esters Reduces Blood Cholesterol

Blood cholesterol Not permitted

Calcium reduces risk of osteoporosis/ enhances bone mineral density/ reduces risk of osteoporotic fracture (High level claim)

Bone health XX is a source of calcium. A calcium supplement formulated to strength bone and tissue in growing and mature users or source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone

No pre-approved general level or high level health claim

Arthritis May help reduce joint inflammation/swelling/pain associated with arthritis

No pre-approved general level or high level claim [Some vitamins and minerals have FHR established: necessary for normal immune system function]

Common cold Relief of the symptoms of colds/ May help reduce the severity of the symptoms of colds/May reduce the severity and duration of colds

FOODS FOR SPECIAL MEDICAL PURPOSESThis Standard regulates the sale, composition and labelling of foods specially formulated for the dietary management of individuals with certain diseases, disorders or medical conditions. Food regulated by this Standard is intended to be used under medical supervision.

Standard 2.9.4Standard 2.9.4 provides a food is a FSMP if the food is,  (1) Subject to subclause (2), a food is a food for special medical purposes if the food is -

Specially formulated for the dietary management of individuals-by way of exclusive or partial feeding, who have special medically determined

nutrient requirements or whose capacity is limited or impaired to take, digest, absorb, metabolism or excrete ordinary food or certain nutrients in ordinary food; and

whose dietary management cannot be completely achieved without the use of the food; and

Intended to be used under medical supervision; andRepresented as being a food for special medical purposes or for the dietary

management of a disease, disorder or medical condition.

(2) A food is not a food for special medical purposes if the food is – a) Formulated and represented as being for the dietary management of obesity or overweight; or b) An infant formula product as defined in Standard 2.9.1.

Regulatory control – restriction on sale

FSMPs must not be sold to a consumer, other than by, • a medical practitioner or dietitian• a medical practice, pharmacy or responsible institution; or• a majority seller of that food for special medical purposes.

Prohibitions on other foods, do not apply to FSMPs

The general prohibition (cl 9 Std 1.1.1) on the addition of nutritive substances to foods without permission does not apply to FSMPs

The Nutrition, health and related claims Standard 1.2.7 - Claims can be made outside of the 1.2.7 framework. - Must not be misleading or deceptive or likely to mislead or deceive

The vitamins and minerals standard (Std 1.3.2) for foods (for commencement on 18 January 2016) does not apply to FSMPs

The novel food standard (Std 1.5.1) (for commencement on 18 January 2016) does not apply, novel foods can be added to FSMPs

Prohibition on therapeutic claimsClaims on FSMPs must not

refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition;or compare the food with a good that is represented in any way to be for therapeutic use;or likely to be taken to be for therapeutic use, whether because of the way in which the good is presented of for any other reason

The Macquarie dictionary provide definitions for these concepts:• Prevention is ‘the act of preventing; effectual hindrance. Prevent: to keep from occurring;

hinder’• Cure ‘is a method or course of remedial treatment, as for disease.’• Alleviation is the ‘act of alleviating. Alleviate: to make easier to be endured; lessen;

mitigate’• Mitigate is ‘to lessen in force or intensity (wrath, grief, harshness, pain, etc); to moderate

the severity of (anything distressing)’• Disease is ‘a morbid condition of the body, or of some organ or part; illness, sickness;

ailment’• Disorder is ‘a derangement of physical or mental health or functions’

ADDITION OF VITS AND MINS TO FOODVitamins and minerals can only be added to food if permissions exist in the Food Standards Code.

Voluntary fortificationGeneral permissions • Standard 1.3.2 – Vitamins and Minerals, most vitamin and mineral

permissions for addition to foods are detailed

Product standards may also permit vitamin and mineral addition to specific food types

• Standard 2.6.4 – Formulated Caffeinated Beverages, permits manufacturers to add certain vitamins to formulated caffeinated beverages

• Standard 2.6.2 – Non alcoholic Beverages and brewed soft drinks permits the addition of fluoride to bottled water

• Standard 2.10.3 – Chewing gum gives permission to add calcium to chewing gum

• Standard 2.10.2 – Salt and salt products permit the addition of iodine

Compositional requirementsPart 2.9 Food Standards Code – Special Purpose Foods• Meal replacements• Supplementary foods• Infant formula

Mandatory fortification standards

Standard 2.1.1 – Cereals and Cereal Products requires the addition of thiamin and folic acid to wheat flour for making bread (Australia only) and the replacement of iodised sale in breadStandard 2.4.2 – Edible Oils spreads requires the addition of vitamin D to margarines and spreads (Australia only)

MANUFACTURING QUALITY AND SAFETY STANDARDS FOR FOODSThe Australian food regulatory system operates a risk-based approach to licensing food manufacturing activities, audits & inspections and enforcement.

Food Safety Standards• All food businesses must only sell safe and suitable food. Food is not safe if it would be likely to cause physical harm to a person who might later consume it, assuming it was:a) After that time and before being consumed by the person, properly subjected to

all processes (if any) that are relevant to its reasonable intended use; andb) Consumed by the person according to its reasonable intended use (Meaning of

safe and suitable food – Standard 3.1.1)

• Risk-based regulatory system where the high risk activities are licensed and audited. Operators must design, implement and comply with a food safety program which is audited on a frequency also determined by risk assessments.

– meat, poultry, seafood, plant products, eggs and egg products and vulnerable population (aged care etc.)- Australian Standards are adopted in state based food regulations for compliance

Food Safety Standards (Cont..)• Standard 3.2.2 Food Safety Practices and General

Requirements-The specific requirements for food businesses and food handlers to comply with to ensure food does not become unsafe or unsuitable and sets standards for:

food handling (skills and knowledge); notification as a food business; food receipt; food storage; food processing; food display; food packaging; food transportation; food disposal; food recall; health of food handlers; hygiene of food handlers; health of persons who handle food (duties of food business); hygiene of food handlers; general duties of food businesses; cleanliness; cleaning and sanitising of specific equipment; maintenance; temperature measuring devices; single use items; animals and pests and alternative methods of compliance.

Food Safety Standards (Cont.)• Standard 3.2.3 Food Premises and Equipment

- This mandatory standard sets out requirements for food premises and equipment that if complied with will facilitate compliance by food businesses with the food safety requirements of Standard 3.2.2.

It sets standards for the design and construction of food premises, floors, walls and ceilings, fixtures, fittings and equipment, hand washing facilities, storage facilities, toilet facilities and food transport vehicles.

Standard 1.3.4 – Identity and Purity• This standard operates to ensure that food additives,

processing aids, novel food substances, vitamins and minerals and nutritive substances added to food in accordance with the Food Standards Code meet appropriate specifications for identity and purity.

• Generally, the specifications are internationally accepted.

Compliance with monographsA substance must comply with a relevant monograph published in one of the following –

(a)          the Schedule to Standard (contains specifications of identity and purity for substances added to food where there are no references in the monographs); or(b)          Combined Compendium of Food Additive Specifications, FAO JECFA Monograph 1 (2005) as superseded by specifications published in FAO JECFA Monographs 3 (2006) and FAO JECFA Monographs 4 (2007) and FAO JECFA Monographs 5 (2008) and FAO JECFA Monographs 7 (2009) and FAO JECFA Monographs 10 (2010), Food and Agriculture Organisation of the United Nations. Rome; or(c)          Food Chemicals Codex (7th Edition) published by United States Pharmacopoeia (2010).

Compliance with Monographs (Cont.)If there is no monograph applying to a substance, the substance must comply with a relevant monograph published in one of the following – (a)          the British Pharmacopoeia 2010, TSO, Norwich (2010); or(b)          the United States Pharmacopeia, 34th Revision and The National Formulary, 29th Edition (2010); or(c)          the Pharmaceutical Codex, 12th Edition, Council of the Pharmaceutical Society of Great Britain.  The Pharmaceutical Press, London (1994); or(d)          Martindale; The Complete Drug Reference. The Pharmaceutical Press London (2009); or(e)          the European Pharmacopoeia 6th Edition, Council of Europe, Strasbourg (2007); or(f)           the International Pharmacopoeia 4th Edition, World Health Organization, Geneva (2006 and 2008 supplement); or(g)          the Merck Index, 14th Edition, (2006); or(h)          the Code of Federal Regulations; or(i)           the Specifications and Standards for Food Additives, 7th Edition (2000), Ministry of Health and Welfare (Japan); or(j)           the International Oenological Codex (2010 supplementary edition), Organisation Internationale de la Vigne et du Vin (OIV).

No Monograph?Where no monograph applies to a substance by virtue of clauses 2 or 3, or where a monograph contains no specifications for identity and purity of a substance relating to arsenic or heavy metals, the substance must not contain on a dry weight basis more than –

(a)          2 mg/kg of lead;(b)          1 mg/kg of arsenic;(c)          1 mg/kg of cadmium;(d)          1 mg/kg of mercury.

THANK YOU AND QUESTIONS?Janine Curll BSc LLB MAIFST

PhD Candidate (Monash) janinecurll@foodlabellingmatters.com

0410577315