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Notifying a self-substantiated food-health relationship

(November 2017)

FSANZ does not consider the merits of notified food-health relationships. While FSANZ administers the notification process, 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:

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 of the Code and that the notified relationship is a reasonable conclusion of the systematic review.

Because we do not evaluate or approve notified relationships, 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?

You have to notify FSANZ before making a general level health claim based on a self-substantiated food-health relationship.

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 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.

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 of the relationship and certify that the food-health relationship has been established by a process of systematic review as described in Schedule 6 of the Code.

How do I notify FSANZ?

Go to the notification portal to provide the required information.

You will need 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.

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.

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 then state:

I certify that this notified relationship between the food or property of food and health effect has been established by a process of systematic review that is described in Schedule 6 of the Code.

No other information is required.

As per the requirement of section 1.2.7—18 of the Code, you will be asked to give consent (via a ‘tick the box’) 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 happens after I have notified FSANZ?

FSANZ will email you to acknowledge receipt of your notification and attached certificate. FSANZ will then 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 standards.management@foodstandards.gov.au.

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 FSANZ to remove the notified food-health relationship from the list.

How do I remove 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 standards.management@foodstandards.gov.au.

The statutory declaration must 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.

Further information

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