Going beyond an ACNF opinion that an ingredient is a “novel food”
By Jenny Awad (FoodLegal
Co-Principal)
© Lawmedia Pty Ltd, August
2024
An opinion by the Advisory Committee on Novel
Foods (ACNF) that an ingredient is a “novel food” does not automatically
mean it is prohibited. This article corrects the growing amount of
misinformation regarding the use of novel foods based on FoodLegal’s extensive
experience in supporting startups through to multinational brands in bringing
innovative ideas to life whilst overcoming unwarranted misunderstandings or
unnecessary scrutiny.
In recent years, there has been a tendency for
food or food ingredient companies to have a mistaken understanding about the
legal effect of using an ingredient that the Advisory Committee on Novel Foods
(ACNF) has previously viewed as a “novel food”. For businesses seeking
to bring innovative food products to the Australian and New Zealand market, the
impact of this confusion has led to commercial decisions that unwittingly might
have confined a startup business from exercising choices that could have been
legitimately made.
What is a “novel food”?
Under Standard 1.5.1 of the Australia New
Zealand Food Standards Code (Food Standards Code), a “novel food” is
a non-traditional food (i.e. does not have a history of consumption as a food
in Australia and New Zealand) that requires an assessment by Food Standards
Australia New Zealand (FSANZ) to establish its safety before it can be
added to food that is imported and supplied in Australia or New
Zealand. In other words, if there is strong evidence of consumption to
show an ingredient does not present a safety risk, it cannot be a
“novel food”.
An ingredient which is classified as a “novel
food” is prohibited in most food categories, except where it is expressly
permitted in Schedule 25 of the Food Standards Code. An ingredient can only be
added to Schedule 25 by making an application to amend the Food Standards Code,
which can be a costly and time-consuming process.
How to determine if an ingredient is a “novel
food”?
There are two main ways to determine whether an ingredient is a “novel food”:
(1)
Seek independent legal advice
– this is the approach which FoodLegal recommends in the first instance as it
allows you to make informed commercial decisions, including about whether to
make an application to the ACNF; or
(2) Make an application to the ACNF for a non-legally binding recommendation about whether an ingredient is novel – this approach involves completing the ACNF Questionnaire covering the form of the ingredient, how it will be used (including levels and end-product categories), history of use, and safety. There is no mandatory obligation to approach the ACNF for its recommendation. The main commercial consideration in deciding whether to do so is the risk of a negative ACNF recommendation (i.e. that the ingredient is a novel food), because this can be persuasive in the eyes of food regulatory authorities enforcing the Food Standards Code.
What is the ACNF and how does it work?
The ACNF is a
committee comprised of representatives from FSANZ and State food regulatory
bodies, and the role of the ACNF is to assist any business in reviewing whether
an application to amend the Food Standards Code is required. However, the ACNF’s
recommendations are not legally equivalent to a decision made by FSANZ, as
clearly stated on FSANZ’s website:
The ACNF
recommendations are not legal advice and are not legally binding. They are also
not advice, recommendations, or decisions by FSANZ on whether a food is or is
not a novel food. The recommendations provided by the ACNF are only to help
enquirers make their own decision on whether they should submit an application
seeking to amend the Code.
There is no legal
requirement to seek a recommendation or opinion from the ACNF.
In addition, the
ACNF recommendation on whether a safety assessment is required is not a
pre-market safety assessment, rather it is preliminary hazard identification
step in the context of the risk analysis framework. The pre-market safety
assessment is part of FSANZ's assessment of an application to amend the
Code.
The ACNF makes its decisions based
on the information that is provided by the person or business requesting the recommendation.
The identity of the applicant and the data which they provide in their
applicable is not publicly available. Moreover, the ACNF is not bound by its
previous decisions, meaning it may provide a different opinion on a substance
if it is given updated data. Two examples of this are:
-
Apple polyphenol
extract – viewed by the ACNF as not novel prior to March 2008, but a more
refined version of the extract was viewed as novel in 2011.
-
White kidney bean
extract – viewed by the ACNF as novel prior to March 2008, but then considered to
be not novel in 2012.
Does a negative ACNF recommendation mean an
ingredient is prohibited?
There could be many reasons why the ACNF makes
a negative recommendation, including insufficient data being provided in the
application as submitted for review by the ACNF. As it is not legally binding,
a negative ACNF recommendation does not automatically mean an ingredient
is prohibited.
How can you make informed commercial decisions
that go beyond a negative ACNF recommendation?
If you wish to use an ingredient which has been
the subject of a previous ACNF recommendation that was negative, or if you are
considering approaching the ACNF for its review of a new ingredient, we
strongly recommend that you first seek independent legal advice.
FoodLegal frequently provides key advice at this preliminary stage, having regard to our experience in considering all relevant legal, regulatory, scientific and commercial factors identifiable in discussions with our client. This can involve:
- advising you on whether your product category is subject to novel food restrictions and other pathways to market which you can consider;
- advising you on whether your ingredient is novel, considering how it will be used in your product and relevant scientific evidence;
- preparing and reviewing an ACNF submission;
-
negotiating on your behalf about
the regulatory status and trends, scientific viewpoints and innovation trends
concerning the merits or attributes of an ingredient; and
-
preparing an application to
amend the Food Standards Code if the ingredient is in fact a novel food.
This is general information rather than legal advice and is current as of 5 Aug 2024. We recommend you seek legal advice for your specific circumstances before making any commercial decisions.