Regulation of novel foods
Novel foods are non-traditional foods that require assessment by FSANZ in order to establish their safety before they are added to the food supply.
In Australia and New Zealand, novel foods and novel food ingredients are regulated under Standard 1.5.1 – Novel Foods in Food Standards Code.
A novel food cannot be sold by way of retail as food or used as a food ingredient unless it is listed in the Standard.
Anyone wanting to sell a novel food or a novel food ingredient must apply to Food Standards Australia New Zealand (FSANZ) to request that the Standard be amended to include the food or ingredient in the list. Novel food applications are subject to a pre-market safety assessment. If the food passes this assessment, it is added to the list in the Standard and the manufacturer can go ahead and sell it, as long as it complies with any specified conditions.
You can find the definitions of ‘non-traditional food’ and ‘novel food’ in clause 1 of the Standard.
How can I determine whether a food is novel?
There are a number of approaches to determining whether a food is novel. You may wish to obtain a view from the relevant food enforcement agency and/or obtain independent legal advice about whether a food is a novel food.
You can also approach the Advisory Committee on Novel Foods (the Committee) to make a recommendation about whether or not a food is novel.
The Committee is made up of representatives from Australian state and territory jurisdictions and the New Zealand Ministry for Primary Industries.
The Committee considers whether particular foods meet the definition of ‘non-traditional food’ in the Standard and, if so, whether a safety assessment needs to be done. It uses a guidance tool to assist it in reaching its view on whether a food is novel or not.
Once the Committee completes its consideration, it provides a recommendation about whether the food in question is a novel food for the purposes of the Standard. The recommendation is published on the FSANZ website along with the reasons for the recommendation .
The Committee recommendations are not legal advice. They are not legally binding. They are also not advice, recommendations, or decisions by FSANZ on whether a food is or is not subject to Standard 1.5.1. The recommendations are provided by the Committee only to help enquirers make their own decision on whether they should submit an application seeking to amend the Standard.
There is no legal requirement to seek a recommendation or opinion from the Committee.
In addition, the Committee recommendation on whether a safety assessment is required is not a pre-market safety assessment. The pre-market safety assessment will be conducted as part of the assessment of an application to amend the Standard.
More information about making an application to FSANZ to amend the Standard can be found in the Application Handbook.
How do I enquire about whether a food is novel?
However, you can also proceed directly to submitting an application seeking to amend the Standard to permit a food which, in your opinion and according to any legal advice you receive, meets the definition of ‘novel food’ in the Standard.
Public health and safety consideration of novel foods
A risk-based assessment process is undertaken to ensure the safety of novel foods before they can be sold in Australia and New Zealand.
The purpose of this assessment is to evaluate its potential impact on public health and safety. When we evaluate the public health and safety of a novel food or novel food ingredient, we consider a variety of toxicological and nutritional issues together with information about its chemistry and how much of it we expect people to eat.
Exclusivity of use for novel foods
The Standard also includes a provision for exclusive permissions for novel foods.
In other words, an applicant may ask FSANZ to grant an exclusive permission for a novel food or novel food ingredient in a specified brand and class of food, subject to any listed conditions. This permission is effective for a period of 15 months. At the end of this period of time, the exclusive permission reverts to a general permission that is not limited to a specific brand.
Exclusivity requests give applicants, who have undertaken the development work in the area, a first-to-market advantage for their brand of novel food product.
The granting of an exclusive permission under the Standard does not preclude others from applying to FSANZ for approval of exclusive permissions of their own brand of the same novel food or novel food ingredient in the same class of food, with the brand being the only differentiating feature.
FSANZ does not enforce the Food Standards Code. This is the responsibility of food enforcement agencies in Australia and New Zealand.