1. www.mpi.govt.nz Julia Edmonds julia.edmonds@mpi.govt.nz Recent changes to food legislation and how this will affect you

2. Outline Brief history and outline of the relevant food legislation Food/ Supplemented food /Dietary supplement interface Standard 1.2.7 – Nutrition, Health and Related Claims overview Supplemented foods and the adoption of Standard 1.2.7 Manuka honey and health claims Time for questions…

3. Brief history of developments in food legislation Food Act 1981 – food safety and suitability Food Regulations 1984 Dietary Supplement Regulations (DSR) 1985 2002 Joint Australia NZ Food Standards Code (the Code) Most of Food Regulations 1984 incorporated into the Code But DSR 1985 retained until permissions available in the Code Provides general food composition and labelling standards Special purpose foods - caffeinated beverages, electrolyte drinks, foods for infants, formulated supplementary foods

4. Brief overview of food legislation 2001 – FSANZ developed proposal P235 - Aimed to incorporate food type dietary supplements under the Code 2000’s – Plans for a trans-Tasman therapeutic products agency - Would encompass dietary supplements as listed complementary medicines (put on hold in 2007) Since 2002 –identified we needed updated regulations - definition broad - pills, powders, liquids and some foods -market growing/changing e.g. orange juice with folic acid, caffeinated energy shots, body building supplements - enabled marketing to young children under 4 years

5. 2010 - Dietary Supplements Regulations split DSR 1985 Therapeutic-type An amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin Sold by itself or in a mixture Sold in a controlled dosage form as a liquid, powder or tablet Intended for ingestion Intended to supplement the amount of amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin normally derived from food Food-type represented as a food has a substance or substances added to it, or has been modified in some way to perform a physiological role beyond the provision of a simple nutritive requirement Supplemented Food Standard Remain in the DSR 1985

6. NZ Food (Supplemented Food) Standard 2010 Came into effect March 2010, revised in 2013 New Zealand only standard Products can be sold in Australia under the trans-Tasman Mutual Recognition Arrangement (TTMRA) Labelling provisions align with the Code ‘Interim regulatory arrangement until appropriate permissions in the Food Standards Code’ Cannot market to children < 4 years

7. Food Act 1981 – relevant legislation Australia New Zealand Food Standards Code 2002 -Developed by FSANZ and enforced by MPI -www.foodstandard.govt.nzwww.foodstandard.govt.nz Dietary Supplement Regulations (DSR) 1985 - Administered by Medsafe: http://www.medsafe.govt.nz/supplements/supplements-landing.asp http://www.medsafe.govt.nz/supplements/supplements-landing.asp New Zealand Food (Supplemented Food) Standard 2013 -Administered and enforced by MPI -http://www.foodsafety.govt.nz/industry/general/labelling- composition/applying-requirements/supplemented.htmhttp://www.foodsafety.govt.nz/industry/general/labelling- composition/applying-requirements/supplemented.htm Food Act 2014 - in force March 2016

8. The Food/Medicine Continuum Dietary Supplements Supplemented foods Medicines Foods

9. Supplemented Food or a Dietary Supplement? Reference: New Zealand Supplemented Food Standard User Guide (pg 7)

10. Supplemented Food/ Dietary Supplement Interface Dietary Supplements Presented in a “therapeutic-type” dose form (e.g. capsule, tablet, controlled dose of powder or liquid) Controlled dosage instructions (1 tablet twice a day) Supplemented foods Food-type presentation (bar, drink or powder) Serving sizes (e.g. 50g) Serving suggestions (e.g. 3 servings per pack) Categorisation decision influenced by product’s form and presentation, use of serving instructions vs dose instructions, and whether traditionally used as a food

11. Supplemented Food/ Dietary Supplement Interface Receive queries from industry Up to manufacturers, importers, sellers to decide which regulations they fit under and meet the relevant requirements Liaise with Medsafe in deciding where a product best sits –i.e. is it a food, supplemented food or dietary supplement? Guidance tools on MPI and Medsafe websites Recommend engage a food consultant or to seek legal guidance

12. Joint Australia New Zealand Food Standards

13. Food Standards Code and Health Claims Standard 1.2.7 – Nutrition, Health and Related Claims –Gazetted in March 2013 –3 year transition period by when industry must comply - January 2016 –Replaces Standard1.1A.2 - Transitional standard for health claims –Covers nutrition content claims, general level and high level health claims – for example: Nutrition content – contains calcium General level – necessary for normal teeth and bone structure (calcium) High level – reduces risk of osteoporosis (calcium and vitamin D) Std 1.2.7 relates to both product labelling AND advertising Cannot make nutrition content or health claim about: –Kava, alcohol>1.15% by volume (energy and carbohydrate only), infant formula

14. Food Standards Code and Health Claims Health claim – –means a claim which states, suggests or implies that a food or a property of food has, or may have, a health effect Health effect – –means a health effect on the human body, including an effect on one or more of the following - a) a biochemical process or outcome b) a physiological process or outcome c) a functional process or outcome d) growth and development e) physical performance f) mental performance g) a disease, disorder or condition

15. Health Claims considerations Claims must not be therapeutic in nature (Clause 7) A claim must not – a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition; or b) compare a food with a good that is – i)Represented in any way to be for therapeutic use; or ii)Likely to be taken to be for therapeutic use, whether because of the way in which the good is presented or for any other reason Must not imply slimming effects (Clause 14) – ‘Where a content claims meets the conditions to use the descriptor ‘diet’, must not use another descriptor that directly or indirectly refers to slimming or a synonym for slimming’

16. Health Claims considerations Must meet the nutrient profiling scoring criterion (NPSC) Covered under Schedules 4 and 5 in Std 1.2.7 Foods in Part 2.9 exempt (e.g. Standard 2.9.4 - Formulated supplementary sports foods ) Based on balance of nutrients –favourable - protein, fruit & vegetables, fibre –unfavourable - fat, sugar, sodium NPSC calculator - FSANZ website: http://www.foodstandards.govt.nz/industry/claims/pages/nutrientprofilingcalculator /Default.aspx http://www.foodstandards.govt.nz/industry/claims/pages/nutrientprofilingcalculator /Default.aspx

17. High level health claim : refers to a serious disease or a biomarker of a serious disease* General level health claim: refer to a nutrient or substance in a food and its effect on a health function. Must not refer to a serious disease or to a biomarker of a serious disease. * Serious disease is one that is diagnosed, managed or treated in consultation/supervision by a health care professional Health Claims – high and general level

18. –Conditions for high level health claims listed in Schedule 2 of Standard 1.2.7 –13 pre-approved food-health relationships Calcium, vitamin D, folic acid, saturated fats, sodium, fruits and vegetables, phytosterols Different population groups Must meet conditions required to make claim Must mention specific health effect –FSANZ is considering additional 30+ claims based on EFSA High level health claims

19. High level health claims – pre-approved

20. Pre-approved health relationships –Currently ~200 pre-approved –listed in Schedule 3, Std 1.2.7 –Vitamins, minerals, macronutrients and other foods –Must provide a dietary context statement –Wording not prescribed General level health claims Self-substantiate health claims –relationship between property of the food and a health effect has been established by systematic review –Refer to Schedule 6, Std 1.2.7 –Self-substantiated claims must be notified to CEO of FSANZ –Must provide a dietary context statement –Wording not prescribed Options for businesses

21. General level health claims – pre-approved

22. General level health claims – self substantiated

23. Notifying food-health relationships for food

24. Health claims guidance for food More information on how to make a health claim – ‘Getting it Right’ to be posted on line shortly – www.foodsafety.govt.nz www.foodsafety.govt.nz Application to modify the Standard– contact FSANZ www.foodstandards.gov.au www.foodstandards.gov.au MPI interested in reviewing dossiers for general level self-substantiated food-health relationships

25. New Zealand Food (Supplemented Food) Standard revised in 2013 Part 2 expired and was removed (based on DSR 1985) Updated to include Standard 1.2.7 –Most elements are the same – except refers to 2006 Nutrient Reference Values –Therapeutic claims not permitted through reference to Std 1.2.7 –Must not implying slimming effects through reference to Std 1.2.7 –Health claims can be made on sports-type supplemented foods Must notify MPI if making general level self substantiated health claim –Notification form FA5 - established relationship between a supplemented food/property of supplemented food and health effect: –http://www.foodsafety.govt.nz/industry/general/labelling-composition/applying- requirements/supplemented.htmhttp://www.foodsafety.govt.nz/industry/general/labelling-composition/applying- requirements/supplemented.htm Supplemented food and health claims

26. A food, supplemented food or dietary supplement? Up to manufacturers, importers, sellers to decide which regulations they fit under and meet the relevant requirements Interim labelling guide for manuka honey – developed with industry - http://www.mpi.govt.nz/food/food-safety/manuka-honey http://www.mpi.govt.nz/food/food-safety/manuka-honey Manuka Honey – how is this regulated Categorisation decision influenced by product’s form and presentation, use of serving instructions vs dose instructions, and whether traditionally used as a food

27. Therapeutic claims not permitted –i.e. that the product has an ‘antibacterial effect’ –i.e. ‘non-peroxide activity’, ‘total peroxide activity’, peroxide activity’, ‘total activity’ and ‘active’. Under Food Standards Code and Supplemented Food Standard (based on Std 1.2.7) –Health claims – honey does not meet the NPSC –Need to make an application to FSANZ to seek exemption from NPSC –Currently cannot make nutrition, general level or high level claims Statements must be truthful and not misleading Honey and health claims

28. Questions?