Food Quality Magazine
ISSUE 04 | OCTOBER 2015
Self-Substantiation of General Level Health
Claims on Food now Permitted
– and other Changes to the Regulation
of Nutrition and Health Claims
in Australia and New Zealand
Janine Curll, www.foodlabellingmatters.com
Janine Curll BSc (Microbiology)LL.B helps food businesses with their scientific and regulatory food labelling compliance matters at Food Labelling Matters, www.foodlabellingmatters.com. She is an ex-food regulator who was responsible for investigating food safety and health claim compliance in NSW, Australia and was a contributor to the national
development of Standard 1.2.7 - the new health claims system. Janine is a PhD Candidate (Monash University) researching the food regulatory system as it relates to food labelling and specifically, the control of ‘food fraud’.
All effort has been taken to ensure accuracy, but the content is intended only to provide a summary and general
overview of the changes to the regulation of health claims in Australia and New Zealand. It is not intended to be
comprehensive and does not constitute legal advice. You are advised to seek legal or other professional advice before
acting or relying on the content.
Food labelling changes are afoot in
Australia and New Zealand. From
18 January 2016, all foods advertised in those jurisdictions for sale
must comply with a new food standard: Standard 1.2.7 (the new health claims system) in the Australia
New Zealand Food Standards Code
(ANZFSC). The new health claims
standard is the outcome of decade-long policy development, consultation and implementation. It
aims to balance an appropriate level
of regulatory and scientific rigour
to enhance truth in labelling and
decrease false representations or
misleading or deceptive conduct
about the health benefits of foods,
whilst providing avenues for the food
industry to innovate.
A number of fundamental features
describe the new health claims system. Most significant is the concept
of the food (or property of food)/
health relationship (FHR) and the
evidential substantiation requirements to make a claim. The framework requires all health claims
used in the sale of food to be supported by quality scientific evidence, on
a ‘pre-approved’ or ‘self-substantiated’ basis.
There are 212 ‘preapproved’ FHRs
24
listed for application to health claims
according to conditions and permissions. Preapproved FHRs such
as ‘calcium is necessary for normal
teeth and bone structure’ provide
the substantiation requirement in
ensuring health claims subsequently
made are scientifically based; many
of the preapproved FHRs have been
assessed by scientific assessment
bodies in the European Union, the
USA and Canada and adopted in
Australia and New Zealand.
Of particular interest to food businesses marketing health or functional foods is the opportunity to ‘selfsubstantiate’ FHRs. The process summons the high evidence threshold of
a prescribed systematic review (Box
A), and requires food businesses to
notify the national standards body
(FSANZ). Australia and New Zealand
are the first countries to prescribe
a process for the self-substantiation
of general level health claims by
food businesses without pre-market
approval. You, the food business will
hold the dossier of evidence for inspection by a state regulator, if ever
required.
Useful guidance documents have
been published by Australian and
New Zealand government agen-
cies to assist industry navigate the
complex arrangements: Getting Your
Claims Right – A guide to complying with the Nutrition, Health and
Related Claims Standard (2014) and
FSANZ Guidance on establishing
food-health relationships for general level health claims (2013), both
available online (links are provided
below).
Four categories of claims are defined in the new health claims standard and described here: nutrition
content claims (NCC), general level
health claims (pre-approved and
self-substantiated) (GL