European Union 'reduction of risk' claims

FSANZ has considered seven 'reduction of disease risk' health claims authorised in the European Union (EU) for possible inclusion as food-health relationships in Standard 1.2.7 - Nutrition, health and related claims.

The first statement of each of the EU-authorised 'reduction of disease risk' claims is currently included in Standard 1.2.7 either as pre-approved general level or high level health claims. The seven EU-authorised claims are:

1.Oat β-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

2.Phytosterols/phytostanols and their esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

3.Plant sterols/plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

4.Plant sterols: sterols extracted from plants, free or esterified with food grade fatty acids have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.

5.Sugar-free chewing gum helps neutralise plaque acids. Plaque acids are a risk factor in the development of dental caries.

6.Sugar-free chewing gum helps reduce tooth demineralisation. Tooth demineralisation is a risk factor in the development of dental caries.

7.Chewing gum sweetened with 100% xylitol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries in children.

Outcome

As the construct of these EU-authorised 'reduction of disease risk' claims does not fit explicitly within the current framework of the Policy Guideline for Nutrition, Health and Related Claims1 (Policy Guideline) and Standard 1.2.7, FSANZ will not be including these claims in Standard 1.2.7 at this time.

Rationale

The Policy Guideline provides the overarching principles for the regulation of health claims in Australia and New Zealand. Standard 1.2.7 was developed having regard to the Policy Guideline. Both the Policy Guideline and Standard 1.2.7 set a framework for substantiating relationships between a food (or a property of food) and a health effect (including risk factors or diseases), but not a relationship between a risk factor and disease. FSANZ has therefore taken a view that the risk factor component does not fit explicitly within the current Australia and New Zealand health claims framework. In forming this view, FSANZ has consulted with the Food Regulation Standing Committee.

Commentary

As we have previously identified, the frameworks for the regulation of claims in the EU differs to that in Australia and New Zealand. These differences can and do result in different outcomes. Our consideration of EU 'reduction of disease risk' claims is a clear example of these differences existing as discussed below.

The EU does not permit claims that make a direct link to disease. The only mechanism available in the EU for mentioning a disease is via a non-disease intermediate followed by a statement that the intermediate is a risk factor for a disease as is the case in the 'reduction of disease risk' claims.

Whereas in contrast, in Australia and New Zealand Standard 1.2.7 only permits claims to be constructed around a link between a food, or property of food and a health effect, including disease i.e. a substantiated food-health relationship.

For example, the following article 14(1)(a)2 EU claim (a 'reduction of disease risk' claim)for calcium and osteoporotic fracture was authorised in 2014:

'Calcium helps to reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor for osteoporotic bone fractures' (over 50yrs) 

whereas FSANZ has approved the following in the Standard 1.2.7:

'Calcium reduces risk of osteoporotic fracture' (over 65yrs).

The European Food Safety Authority (EFSA) released guidance for stakeholders on health claim applications in January 2016. The guidance states that if there is evidence from intervention (dietary or drug) studies that a reduction of the risk factor generally reduces the risk of disease, then evidence that dietary intervention with the food/constituent induces a reduction of the risk factor would be sufficient for the scientific substantiation of the whole 'reduction of disease risk' claim. However the Australian and New Zealand framework requires substantiation of the relationship between the food or property of food and the risk factor or disease (health effect). FSANZ therefore considers that as 'reduction of disease risk' claims do not explicitly fit within the framework it is not appropriate to include the claims in Standard 1.2.7 at this time.

We note the Food Regulation Standing Committee has agreed that the Australian Government Department of Health is to lead consideration of a review of the Policy Guideline, the scope of which is yet to be determined.

We also note that applications to seek an amendment to the Code to permit EU-authorised 'reduction of disease risk' type claims can be submitted to FSANZ. Any application will need to meet the information requirements in the Application Handbook and be assessed in accordance with the FSANZ Act which requires having regard to the Policy Guideline.