Self-substantiation of health claims
Find out more about how self-substantiation gives you flexibility to develop food products that can carry general level health claims and capture 'first mover advantage' in a competitive food innovation market.
For a new general level health claim (a claim that doesn't relate to diseases or serious illnesses) you can self-substantiate, or provide evidence, for the food health relationship of your food product.
This provides an opportunity for you to develop new food products that can carry a health claim, and for that health claim to be exclusively used by you, as the holder of the validated scientific evidence base used to support it.
Self-substantiation has been developed to encourage innovation and investment in product development to capture 'first mover advantage' in a competitive market.
To self-substantiate your health claim, you need to:
- carry out base research into the food-health relationship
- undertake a systematic review of the scientific evidence base and prepare a systematic review dossier.
MPI has produced a guidance document:
- Systematic review of a food health relationship: Guidance on how to self-substantiate a food-health relationship in order to make a new general level health claim [PDF, 413 KB]
This guide has been developed to explain the process for undertaking a systematic review of the scientific evidence and developing a systematic review dossier to self-substantiate a general level health claim.
MPI's support of self-substantiation
MPI is committed to assisting you along the way to self-substantiation. MPI is available to support the industry by providing regulatory and technical advice on the development of a dossier of validated scientific evidence.
MPI has prepared scientific and technical advice for preparing a dossier to self-substantiate a health claim. Refer to MPI's Systematic review of a food health relationship guidance document.
The robust scientific evaluation of evidence dossiers for a claim notified in New Zealand is led by MPI and carried out confidentially with input from networks of national and international subject matter experts.
If MPI's evaluation concludes that the evidence presented for the health claim is consistent in supporting the food-health relationship, this builds confidence towards international market acceptability of the health claim.
MPI has produced a resource to illustrate the steps and approximate timeframes involved in our formal evaluation of notified self-substantiated food health relationships:
- What to expect from MPI when notifying a self-substantiated food health relationship to FSANZ: A step-by-step guide for food businesses [PDF, 191 KB]
MPI is initially providing evaluation for all self-substantiated health claims generated in New Zealand to determine whether the food-health relationship aligns to regulatory requirements and are a reasonable conclusion of the evidence provided through validated science.
MPI is working with key international science assessment authorities to reinforce the integrity of the scientific evaluation of the evidence base provided for the food-health relationship. MPI has developed agreements for technical scientific liason with international regulatory authorities such as the European Food Safety Authority, Health Canada, US Food and Drug Administration, and FSANZ. MPI also seeks to broaden these agreements to other relevant regulatory authorities. There is a commitment to work internationally on the scientific assessments underpinning health claims. This helps to reinforce the integrity of MPI's scientific evaluation of the food-health relationship evidence base, and build international market acceptability of health claims.
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