"Not a nutritionist or a dietitian or a chef, although I do love to cook.” As a lawyer heading up KHQ Lawyers’ Food and Beverage team, Charles has 13 years’ experience reviewing the recipes and marketing of thousands of products destined for the Australian and New Zealand markets.

Charles Fisher, Principal Solicitor from KHQ Lawyers sure is passionate about cooking. Throughout Charles’ experience, one thing has become very apparent. Innovations in food products – particularly innovations intended to provide nutritional or health benefit – are usually those that trip over regulatory obstacles. At the same time, they often fail to truly take advantage of the marketing opportunities presented by Australia and New Zealand’s food regulatory framework.  

Being able to tell your consumers why your product is healthier without the risk of your business being shut down overnight is vital. While the food industry continues to reel from supply chain disruption and inflationary pressures (which may temporarily change consumer purchasing behaviour), businesses are now well aware of how health-positioning of food products can drive sales. 

Recently, Charles delivered a presentation on this subject at Fine Food Australia 2022 as part of the Talking Shop line-up. Here are the key points that were shared.  

Making food healthier 

Occasionally, a completely new food product takes the market by storm. Most new development of ‘healthier’ products focuses on taking existing products and either removing unhealthy aspects (such as salt) or adding healthier ingredients (such as those ‘packed with antioxidants’). This is of course ignoring aspects of products which are not related to health at all, but consumers associate with ‘being healthier’. 

In both Australia and New Zealand, the key regulation that controls what you can and cannot add to food is the Australia New Zealand Food Standards Code. This doesn’t have a lot of rules around removing unhealthy aspects of food. In terms of regulatory obstacles, there are far more prohibitions against adding substances to food than taking things out. For instance, there are very few barriers to reducing fat content in a product (unlike ice cream whose very regulatory definition includes a minimum fat content) but there are many restrictions on what vitamins and minerals you can add to food. 

The difference between a nutritive substance and a novel food 

Both nutritive substances and novel foods are banned for use in food unless the Food Standards Code expressly approves. So, it’s really important to know whether the substance you want to add to your food to make it healthier is allowed to be in there. 

A nutritive substance is something added to food for nutritional purpose and has been refined, synthesised or concentrated. The Code expressly calls out vitamins, minerals and amino acids (but expressly excludes some prebiotic fibres such as GOS and FOS) as substances that can be used as nutritive substances.  

The trick with determining whether a substance is being ‘used as a nutritive substance’ or not is to know how concentrated is too concentrated. When does something stop being a traditional food ingredient and become a potential nutritive substance? For example, milk components such as caseinates and whey protein are referenced throughout the Code as not being regulated as nutritive substances, despite being refined and often added to foods for nutritional purpose. However, when the Advisory Committee on Novel Foods (ACNF) considered a further refined substance – namely a bovine protein fraction – the ACNF took the view this was like a nutritive substance. 

Then we have the painful example of lactoferrin (find greater detail here), another milk protein that has associated health benefits. The ACNF had previously given industry confidence that it was neither a nutritive substance nor a novel food despite so many companies producing products containing lactoferrin. But then one single company applies to have lactoferrin added to infant formula “as a nutritive substance” and (if this application to change the law is successful) it will have the inadvertent effect of banning lactoferrin in every other category of food. It will suddenly be regulated as a “nutritive substance” and not as a traditional food ingredient. 

Speaking of “traditional food ingredients”, there is no legal definition as to what one is. But there is a definition of a “non-traditional food” which is a food with no history of consumption in Australia or New Zealand as food (not in traditional medicines).  

As soon as you do not have a history of consumption (which most innovative substances will not have), then you risk being a “novel food”. This is a non-traditional food which needs its safety assessed by Food Standards Australia New Zealand (FSANZ) before it can be added to food. In other words, a market pre-approval process is triggered by safety concerns. 

Unlike nutritive substances, novel foods do not have to be concentrated or refined. However, you can take a traditional food and extract from it a substance that could be regulated as a “novel food”. Apple polyphenols were considered by the ACNF to present no safety concerns when added in small quantities to food and thus were a non-traditional but not novel (ie permitted) food. But when those same apple polyphenols were highly concentrated with no evidence as to whether they were safe or not, the ACNF found them to be “novel” and thus prohibited. 

The key takeaway – use traditional food ingredients 

The easiest regulatory path to making food healthier is to add traditional food ingredients. That is: 

• Foods with a history of consumption as food in Australia or New Zealand 

• Foods which are not selectively concentrated or refined 
• Foods which present no concerns regarding public health and safety 

Yes, food ingredients are more expensive than isolated nutritive substances. They can be less technologically consistent. And they can have negative impacts on shelf life. But they are allowed in food. What’s more, traditional food ingredients can often be marketed as ‘natural’ or a ‘superfood’. 

Avoiding risk 

Australia and New Zealand are two of the only countries which allow food companies to self-substantiate health claims on behalf of food products (as opposed to requiring regulatory approval of every claim) so long as the food product in question meets a nutritional profile assessing the product as being “healthy”.  

This flexibility is incredible but does need to be supported by a systematic scientific review and a notification to FSANZ. Therefore – a flexible system to making health claims, but one which requires investment.  

The main regulatory risk to avoid is to make sure your claim (or your product’s presentation) does not result in regulatory scrutiny for being too ‘therapeutic’. While the Food Standards Code definition of ‘therapeutic’ is quite clear, the definition of ‘therapeutic’ claims is much broader in the laws and regulations that empower Australia and New Zealand’s medicine regulators.  

But in my experience, most consumers don’t want food marketed as medicine. They just want food to be better for them. They want “vitality”, “boost”, “bounce” or “chill”; broad wellbeing claims which are unlikely to be therapeutic and might not even be health claims for that matter. 

Even if they are health claims, if you do the systematic review and notify FSANZ, this claim could be the unique selling proposition that sets your product apart in the market. You ought to be able to quantify the sales bump you get from making such a claim and be able to do a return on investment calculation on conducting the systematic review.  

If that investment is not justified or your product does not meet the nutritional profile, there are other categories of health marketing outside of health claims that are permitted. For example, nutrition content claims which mention the presence of a nutrient but make no inference as to what it does – are regulated very differently to health claims. You may be able to make all sorts of claims about the presence of your traditional food ingredients and how nutritious they are without making any claim as to what they do to the human body. 

Whilst Australia and New Zealand are some of the strictest countries in the world when it comes to regulation of food fortification they also have one of the most flexible food-health marketing regimes in the world.