Going beyond an ACNF opinion that an ingredient is a “novel food”

By Jenny Awad (FoodLegal Co-Principal)

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 therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.

FoodLegal