Navigating supplemented food regulations
The rise in popularity of supplemented foods is undeniable. From gut friendly ingredients to protein to vitamins galore – what you can do with foods is endless. Or is it?
This article explores how supplemented foods are regulated in New Zealand, and how this differs to Australia - perhaps creating more opportunities and flexibility for health food businesses who can manufacture ‘across the ditch’.
Background New Zealand Law
Most foods sold in New Zealand are regulated by the joint Australia New Zealand Food Standards Code (Food Code). Prior to New Zealand adopting the Food Code, certain food products were classified as dietary supplements and were regulated under the NZ Dietary Supplement Regulations 1985 (DSRs) which was enacted under the Food Act 1981 (at the time).
As the Food Code did not extend to these food-type dietary supplements, they continued to be regulated under the DSRs. This was until 2010 when partial reform occurred with the introduction of the New Zealand Food (Supplemented Food) Standard (SF Standard). The intention behind the SF Standard was to provide updated regulation for food-type dietary supplements and to align them as closely as possible with the Food Code requirements. Practically speaking, this meant that regulation of dietary supplements was split into two categories:
food-type dietary supplements under the SF Standard; and
therapeutic-type supplements under the DSRs.[1]
What are Supplemented Foods?
The SF Standard defines the term ‘supplemented food’ as follows:
A supplemented food is a product that is represented as a food that has a substance or substances added to it, or that has been modified in some way, to perform a physiological role beyond the provision of a simple nutritive requirement.
The SF Standard also makes it clear that some products are NOT supplemented foods. This includes a:
dietary supplement (as defined under the DSRs);
medicine (as defined under the NZ Medicines Act 1981);
controlled drug or restricted substance (as defined under the NZ Misuse of Drugs Act 1975); or
formulated meal replacement, formulated supplementary food or formulated caffeinated beverage (as defined under the Food Code).
This means that where a product falls within the definition of any of the above listed products, it cannot be a supplemented food under the SF Standard. However, for all other foods and where there are not appropriate ingredient permissions in the Food Code, it is possible that the food may meet the SF Standard requirements and be regulated as a supplemented food. By way of example, a yoghurt product with added folic acid would not be permitted under the Food Code as the Food Code does not permit the addition of folic acid to yoghurt. However, under the SF Standard folic acid can be added to yoghurt (at restricted levels) and the product could otherwise be a supplemented food.
What compositional requirements apply to Supplemented Foods?
A key benefit of the SF Standard is that ingredient composition requirements are less restrictive than under the Food Code. In particular:
The SF Standard does not provide a complete list of vitamins, minerals, botanical and bio-active substances that can be added to supplemented foods. Unless it is specifically restricted or prohibited under the SF Standard, any of these substances (which can be nutritive substances) can be added provided it is safe and suitable for the purpose that it is being added. For example, a food business must still ensure that the substance, when eaten as intended, is unlikely to cause or lead to illness or injury to humans or public health. Ensuring food is ‘safe and suitable’ is a primary duty of all persons who trade in food and is required under section 14 of the Food Act 2014.
The SF Standard is less restrictive than the Food Code on the use of novel foods. Under the Food Code, a novel food can only be added to a food if it is expressly permitted. However, under the SF Standard, an ingredient that can be considered novel may be used in a supplemented food so long as it is safe and suitable (as required by the Food Act).
What labelling requirements apply to Supplemented Foods?
The SF Standard incorporates much of the same labelling and claims requirements as set out under the Food Code. This means that the Food Code labelling requirements relevant to ingredient statements, allergens, nutrition information panels will also apply to supplemented foods, as will the requirements for nutrition and health claims.
Can Supplemented Foods be sold in Australia?
Australia does not currently have an equivalent to the SF Standard in New Zealand. This means that consumables are regulated in Australia as either “foods” pursuant to the Food Code or as “therapeutic goods” pursuant to the Therapeutic Goods Act 1989 (Cth) and associated regulations. This binary approach to regulation continues to present significant challenges and uncertainty for Australian health food businesses who wish to operate at the food/therapeutic good interface.
While the SF Standard is a New Zealand specific standard and therefore applies to New Zealand only, it is possible in certain situations for supplemented foods to be imported and sold in Australia with no changes to the labels or formulations pursuant to the Trans-Tasman Mutual Recognition Arrangement (TTMRA). Under the TTMRA, Australia and New Zealand have agreed that, subject to limited exceptions, food produced or imported in one country that meets that country’s food standards, may be legally sold in the other country.
In theory, this means it is possible that a food may be non-compliant with the ingredient composition requirements under the Food Code (eg where it contains a novel food), but be permitted to be sold in New Zealand as a ‘supplemented food’ under the SF Standard. In addition, and in reliance on the TTMRA, it is also possible for this product to be legally sold in Australia as a ‘supplemented food’ without any changes to its composition or label so long as it is compliant with the SF Standard.
There are some important restrictions on the extent to which the TTMRA may be relied upon to import supplemented foods from New Zealand. In particular, it is not possible to rely on the TTMRA to import a supplemented food from New Zealand if it is a “therapeutic good” as defined in Australia’s therapeutic goods legislation. Given the breadth of the definition of “therapeutic good” this needs to be carefully considered before seeking to rely on the TTMRA.
What next for Supplemented Food regulation?
It remains to be seen whether Australia’s food regulatory system will be reformed to provide further flexibility like that under the SF Standard in New Zealand. In the meantime, Australian food businesses that find the novel food or nutritive substance restrictions under the Food Code overly restrictive may wish to explore whether their foods can comply with the SF Standard and rely on the TTMRA to be imported and sold in Australia. While not without complexity, this remains an avenue worth considering for food businesses with trans-tasman manufacturing capabilities.
[1] It is worth noting that the DSRs currently remain in force but the intention is for these regulations to be replaced by the Natural Health Products Bill which is currently before Parliament.
Authors: Julie Cox and Ciska De Rijk