FSANZ administers the notification of self-substantiated food-health relationships. FSANZ does not consider the merits of notified food-health relationships, and publication of a notification by FSANZ does not indicate acceptance, approval or validation of the relationship.
FSANZ recommends that food businesses contact their local enforcement agency before notifying a self-substantiated food-health relationship. See contact details for enforcement authorities.
See also for further information about health claims relating to food:
By law, if you are asked by an enforcement authority you will need to provide records demonstrating that a systematic review was conducted in accordance with Schedule 6 of the Australia New Zealand Food Standards Code and that the notified food-health relationship is a reasonable conclusion of the systematic review.
Documentation relating to the systematic review (as set out in Schedule 6) should not be provided to FSANZ.
When do I have to notify FSANZ about a food-health relationship?
A self-substantiated food-health relationship must be notified to FSANZ before it can be used as the basis of a general level health claim made about a food.
The food-health relationship must be established in accordance with the requirements of Standard 1.2.7, which include that the food-health relationship has been established by a process of systematic review.
The person responsible for making the self-substantiated general level health claim must:
- notify the FSANZ Chief Executive Officer of the details of an established food-health relationship and provide the name and address of the person making the notification
- certify that the food-health relationship has been established by a process of systematic review as described in Schedule 6 of the Code
- consent to the publication by FSANZ of the name and address of the person notifying FSANZ and the details of the established food-health relationship.
A general level health claim is not able to be made based on a food-health relationship that has been notified by another person or business. If you want to make a general level health claim based on a food-health relationship that is already on the list of notified food-health relationships, you must also notify FSANZ and certify that the food-health relationship has been established by a process of systematic review as described in Schedule 6 of the Code.
Food-health relationships relating to therapeutic goods
Does the food-health relationship being notified refer or relate to a therapeutic good, including products declared to be a therapeutic good by the Therapeutic Goods (Declared Goods) Order 2019?
The Order, for example, declares the following to be therapeutic goods: ‘goods that are labelled or promoted for cosmetic purposes, when used, advertised or presented for supply for oral consumption’.
The Code – including the provisions of Standard 1.2.7 providing for notification of food-health relationships – does not apply to products that are a therapeutic good.
It is recommended that you obtain advice from your local food enforcement agency and/or your own legal advice about whether the food-health relationship you wish to notify will relate or refer to a therapeutic good.
Food-health relationships relating to novel foods
Does the food-health relationship being notified refer or relate to a novel food that will be: a food for retail sale; or an ingredient or a component of a food for retail sale? A novel food may only be a food for retail sale, or an ingredient or a component of a food for retail sale, if and when expressly permitted by the Code.
It is recommended that you obtain advice from your local food enforcement agency and/or your own legal advice about whether the food-health relationship you wish to notify will relate or refer to a novel food that requires an express permission in the Code. You can also approach the Advisory Committee on Novel Foods (ACNF) to seek its view about whether the food in question is novel.
Food-health relationships relating to other excluded products
The Code provides that Standard 1.2.7 does not apply to any of the following foods:
- food that is intended for further processing, packaging or labelling prior to retail sale; or
- food that is delivered to a vulnerable person by a delivered meal organisation; or
- food, other than food in a package, that is provided to a patient in a hospital or a medical institution (see section 1.2.7—5).
This means the provisions of Standard 1.2.7 providing for notification of food-health relationship do not apply to these foods.
Food-health relationships relating to an excluded claim
The Code provides that a health claim must not be therapeutic in nature (section 1.2.7—8).
The Code also provides that a notified food-health relationship can only be used as the basis of a self-substantiated general level health claim and not a high-level health claim.
How do I notify FSANZ?
Food-health relationships can be notified via email. To do this, please complete this FHR notification form (PDF 234KB) and email it to us at FHR@foodstandards.gov.au, together with the required certificate/s.
On the form you will be asked to provide the:
- name and address of the person or business making the notification
- details of the food-health relationship established between a food or property of food and a health effect
- a copy of the certificate that states that the food-health relationship has been established by a process of systematic review as described in Schedule 6 of the Code.
As per the requirement of section 1.2.7—18 of the Code, you will be asked to give consent to the publication by FSANZ of the name and address of the person or business making the notification and the details of the established food-health relationship.
What details about the food-health relationship do I need to provide?
When describing the food or property of food it is important to consider whether the subject of the established relationship is a food group (e.g. vegetables or fruit); a single ingredient food (e.g. banana); a food with more than one ingredient (e.g. chewing gum, bread); or a property of food that is either naturally present or added (e.g. a component, an ingredient, a constituent, or other feature of food) and therefore to provide the appropriate description. For example, if you have established a relationship between calcium and a health effect, calcium should be listed as the food or property of food and not the name of the product that carries the health claim.
For each food-health relationship, a specific health effect should be described.
Each health effect attributable to a food and intended to underpin separate general level health claims must be notified accordingly.
It is important to note that your notification should include the specific food-health relationship that has been established, and not the actual health claim/s that will be made in relation to the sale of your food, which the food-health relationship underpins.
You should also include information about whether changing (e.g. increasing) the intake of a food or property of food may increase, decrease or maintain the level of the health effect.
What do I need to include in the certificate?
The person making the notification must certify that the food-health relationship has been established by a process of systematic review in accordance with Schedule 6 of the Code.
This certification should be provided on company letterhead.
If the person is a body corporate, the certificate must be signed by a senior officer of the body corporate.
The certificate should include the description of the notified relationship between the food or property of food and health effect and state:
No other information is required.
You can certify more than one food-health relationship in a certificate. However, you will still need to notify each food-health relationship individually and attach the certificate in each instance.
FSANZ recommends using the template below as it contains the information that FSANZ requires to be included.
Information to include in certification that a food-health relationship has been established by a process of systematic review in accordance with Schedule 6 of the Code.
|Food or property of food
|e.g. necessary for normal teeth and bone structure
*duplicate rows as required.
What happens after I have notified FSANZ?
FSANZ will check that all necessary details have been provided and add this information to the list of notified food-health relationships on the FSANZ website within 5 working days.
You will receive an email when your notified information has been added to the list. The information will then remain on this list, until you ask FSANZ to remove it.
Following the initial notification, if there are any changes to the information provided, you should notify FSANZ of the changes by emailing FHR@foodstandards.gov.au. Depending on the nature of the changes required, a new notification, a statutory declaration or advice via email may be required. You will be advised accordingly via return email.
If I update a systematic review, do I need to notify FSANZ of the update?
If you update a systematic review of a relationship between a food or property of food and health effect that you have previously notified to FSANZ, and the conclusion is consistent with the previous review, you do not need to notify FSANZ again.
However, if the conclusion no longer meets the requirements of Standard 1.2.7 you should ask to withdraw the notified food-health relationship from the list.
If the conclusion meets the requirements of Standard 1.2.7 but differs from the previous conclusion you should ask to withdraw the existing notified food-health relationship from the list, and notify the new food-health relationship that has been established.
How do I withdraw my notified food-health relationship from the list?
The person responsible for the notified food-health relationship must write to FSANZ to ask it to remove the relationship from the list. The written request should include the words:
‘I request that the notified food-health relationship[s] [state the food-health relationship[s]] be removed from the list and hereby rescind the notification and consent given earlier to FSANZ in relation to [that/those] relationship[s].’
This written request must be accompanied by a statutory declaration. If a body corporate is responsible, the statutory declaration must be signed by a senior officer of that body corporate. The written request and statutory declaration should be sent by email to FHR@foodstandards.gov.au.
The statutory declaration should include:
- the words 'I have requested Food Standards Australia New Zealand (FSANZ) to remove the following food-health relationship[s] from the list of notified self-substantiated food-health relationships'.
- a description of the notified relationship between the food or property of food and the health effect
- a sufficient explanation of who the person is (name, place of residence, occupation, organisation/employer, position title) making the statutory declaration
- a statement that they are authorised or have the authority to request the removal of the notified relationship from the list.
FSANZ recommends using the forms at the links below to request removal of a notified food-health relationship. Each contains the information that FSANZ requires to be included
Read more about Commonwealth statutory declarations in Australia
Read more about statutory declarations in New Zealand
If you are not in Australia or New Zealand you should use the Australian Commonwealth statutory declaration form. A Commonwealth statutory declaration can be made outside Australia, provided that it is witnessed by a person on the list of authorised witnesses who holds an official, administrative connection to Australia. More information about how to complete a Commonwealth statutory declaration outside of Australia.