Transcript Julia MPI 2014 TAPS presentation

Recent changes to food legislation
and how this will affect you
Julia Edmonds
[email protected]
www.mpi.govt.nz
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…
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)
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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
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
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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
2010 - Dietary Supplements Regulations split
DSR 1985
Therapeutic-type
Food-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
• 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
Remain in the
DSR 1985
Supplemented
Food Standard
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
Food Act 1981 – relevant legislation
• Australia New Zealand Food Standards Code 2002
- Developed by FSANZ and enforced by MPI
- www.foodstandard.govt.nz
• Dietary Supplement Regulations (DSR) 1985
- Administered by Medsafe:
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/labellingcomposition/applying-requirements/supplemented.htm
Food Act 2014 - in force March 2016
The Food/Medicine Continuum
Foods
Supplemented
foods
Dietary
Supplements
Medicines
Supplemented Food or a Dietary Supplement?
Start here
FORM & PRESENTATION
 Is it presented in a traditional food
form such as a bar, drink or a
powder for reconstitution or mixing
with food?
USE
 Are there serving suggestions e.g.
serving size (50g) and servings per
pack (3)?
FORM & PRESENTATION
 Is it a tablet, capsule, lozenge or
pastille, liquid or powder?
USE
 Are there controlled dosage
instructions (e.g take 1 tablet
twice a day)?
No
Yes
Yes
Does it fall under any of the
following?
1. Standard 2.9.3 - Formulated Meal
Replacements and Formulated
Supplementary Foods
2. Standard 2.6.4 - Formulated
Caffeinated Beverages
3. A food intended for infants and
children under four years of age.
It is likely to be a dietary
supplement. Please refer to
Medsafe for further information
Yes
It is a food and must
comply with the Food
Standards Code.
No
Yes
Can it comply with the
Food Standards Code?
No
Your product may be a supplemented food. Refer to the
NZ Supplemented Food Standard to see if your product
complies with the standard.
Reference: New Zealand
Supplemented Food Standard
User Guide (pg 7)
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
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
Joint Australia New Zealand Food Standards
Food Standards Code and Health Claims
• Standard 1.2.7 – Nutrition, Health and Related Claims
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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
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
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)
ii)
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 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’
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
Health Claims – high and general level
• 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
High level health claims
– 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 – pre-approved
General level health claims
Options for businesses
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
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
General level health claims – pre-approved
General level health claims – self
substantiated
Notifying food-health relationships for food
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
• Application to modify the Standard–
contact FSANZ
www.foodstandards.gov.au
• MPI interested in reviewing dossiers
for general level self-substantiated
food-health relationships
Supplemented food and health claims
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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
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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
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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/applyingrequirements/supplemented.htm
Manuka Honey – how is this regulated
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A food, supplemented food or dietary supplement?
Categorisation decision influenced by product’s form and
presentation, use of serving instructions vs dose instructions,
and whether traditionally used as a food
•
Up to manufacturers, importers, sellers to decide which
regulations they fit under and meet the relevant requirements
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Interim labelling guide for manuka honey – developed with
industry - http://www.mpi.govt.nz/food/food-safety/manuka-honey
Honey and health claims
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Therapeutic claims not permitted
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Under Food Standards Code and Supplemented Food Standard
(based on Std 1.2.7)
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i.e. that the product has an ‘antibacterial effect’
i.e. ‘non-peroxide activity’, ‘total peroxide activity’, peroxide activity’,
‘total activity’ and ‘active’.
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
Questions?