Regulatory distinctions between a mandatory declaration, an advisory statement or a warning statement

Regulatory distinctions between a mandatory declaration, an advisory statement or a warning statement

By Joe Lederman (FoodLegal Co-Principal) and Samuel Kilpatrick (FoodLegal Consultant)

© Lawmedia Pty Ltd, November 2018

Standard 1.2.3 of the Food Standards Code sets out mandatory information requirements for products that may present safety risks to some consumers. This article discusses the various modes of information delivery contained within Standard 1.2.3, and explores what food businesses can do to achieve compliance and deal with the possibility of cross-contamination.

What are the different types of safety information required under the Food Standards Code?

Standard 1.2.3 of the Australia New Zealand Food Standards Code (Food Standards Code) sets out mandatory information requirements for products that may present safety risks to some consumers. The types of information requirements consist of the following three categories:

1.    Declarations

Section 1.2.3-4 of Standard 1.2.3 contains an exhaustive list of substances which require declarations. Declarations are simple text statements which identify the presence of certain substances in food that are known to potentially cause allergenic reactions. Such a statement is required regardless of whether the substance is used as an ingredient, food additive or processing aid. The list of substances that require a declaration includes:

·         Eggs

·         Cereals containing gluten

·         Fish

·         Crustacea

·         Milk

·         Peanuts

·         Peanuts

·         Soybeans

·         Sulphites

·         Tree nuts

·         Sesame seeds

·         Lupin.

The Food Standards Code creates an obligation to declare the presence of these substances but does not prescribe how this is to be done. Food companies can differ in the way that they make a declaration. Regardless of how the declaration is made, Standard 1.2.1 requires that any statement be ‘set out legibly and prominently such as to afford a distinct contrast to the background’. Even were few detectable traces of allergenic proteins exist (for example because of a high degree of refinement), a producer is still required to declare the presence of the original substance.

An undeclared allergen will usually allow a regulator to pursue a forced recall (which can be used to persuade the company in question to undertake a voluntary recall). Apart from brand reputation damage, other costs and expenses will arise.

2.    Mandatory Advisory Statements

Schedule 9 of the Food Standards Code lists a table of products and substances which, if offered for sale, must bear the corresponding advisory statement in the schedule. Such compounds include bee pollen, cereals, nuts, milks, guarana, unpasteurised egg or milk products. The corresponding warnings vary from ‘containing caffeine’, to ‘unsuitable for children’.

These advisory statements exist to highlight potential safety risks associated with some products or substances. They aim to advise consumers of the presence of a particular substance (such as caffeine) or the potential for negative effects (for example, “the product contains bee pollen which can cause severe allergic reactions”) to allow consumers to be better informed.

3.    Warning Statements

A warning statement is a prescribed set of words that must appear on the packaging of certain products that can be associated with significant safety risks if consumed in certain circumstances. According to Standard 1.2.1, warning statements must be a minimum size font of 3mm (or 1.5 mm minimum for small packages).

Requirements for a product to display a warning statement are contained in various parts of the Food Standards Code. Standard 2.9.4 sets out a warning statement for formulated supplementary sports foods, while Standard 1.9.1 sets out a warning statement for infant formula products. The only mandatory warning statement set out in Standard 1.2.3 is for Royal Jelly, which is also the only ingredient which attracts a blanket warning regardless of which product it is used in. Royal jelly is a product derived from bee hives. Such products must include the statement:

This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers.’

Ensuring compliance with Standard 1.2.3

The following considerations may be useful in determining the information required to be provided in accordance with the Food Standards Code.

1.    Assessing all ingoing ingredients against standard 1.2.3

Components or additives which may not be considered ingredients are still subject to the reporting requirements and should be considered. An often-overlooked requirement in regard to the declaration requirements is the obligation to declare the presence of allergens in food additives. For example, additive 223 contains sulphites and therefore requires an allergen declaration on the final product.

2.    Ensure that mandatory wording is used

This obligation will apply to small-packages as well, and where an inconsistency between packages is present, the fact that the correct warning is applied in one area will not protect a business from liability if anywhere else on the packaging contains statements which are contradictory. For example, a ‘contains milk’ declaration will not be sufficient where a ‘free from milk’ claim is made anywhere else on the packaging.

3.    Risk management for other unprescribed food products

No section of the Food Standards Code prohibits businesses disclosing additional information. However, the list of substances which require declarations, statements and warnings is written as an exhaustive list. Therefore, it is not a breach of the Standard 1.2.3 to not declare the presence of a substance that is not listed. However, under the Food Acts of each State and Territory it is a statutory offence to sell unsafe foods. Where a food business becomes aware that an allergen which is not listed in the standard poses a risk to health, they may be then under an obligation to provide that information.

Balancing commercial interests make it difficult to determine to what extent risks and allergens should be labelled since overt warnings of risks discourages purchase. However, failure to provide safety information can result in liability, particularly in cases where a product is one that may cause harm to vulnerable groups. This was the case for milk analogues fed to infants, which prompted the legislators to impose a mandatory advisory statement “not suitable as a complete milk replacement for children”. Where a company becomes aware of a risk to safety, it must take immediate action.

How do declarations and the possibility of cross contamination interact?

The consequences of ‘failing to declare’ highlights the significant issue cross contamination creates for food businesses. There is a danger that a substance that is not actually in the product formulation (and therefore does not have to be declared), may be present as a result of cross contamination during manufacturing. Declaration requirements obligate a manufacturer to declare an allergen, but where such a possibility is minimal how can a brand ensure their label complies with Standard 1.2.3, but will not deter consumers?

As a precautionary measure to limit legal liability, producers are increasingly branding their products with phrases such as ‘may contain’. Both the indirect and direct costs of recalls, as well as consumer action means manufacturers are understandably hesitant to expose themselves to liability by failing to provide such a statement. The unfortunate effect of such precautions is that the very people whom the statements are designed to help, allergy sufferers, are left uncertain as to what products are actually at risk of contamination. Such precautionary warnings have become commonplace as a legal protective mechanism in relation to packaged processed foods sold in Australian supermarkets.

VITAL as a precautionary alternative

One way in which the food industry seeks to eliminate unnecessary warnings has involved better regulation and identification of the risk of contamination. The NSW Food Authority and the Allergen Bureau have worked to create such a risk assessment process – the Voluntary Incidental Trace Allergen Labelling (VITAL) program. VITAL assesses the risk of contamination in a factory and can effectively determine when a product will be safe for 90% of allergy sufferers. Accordingly, the ‘may be present’ warning will only be placed on products where the risk is substantial.

Once the risk has been established, food producers can either adopt measures to reduce the risk, or alternatively proceed with the ‘may be present’ labelling. At very least, consumers can be assured that where such a label is affixed, it constitutes a real risk. Further, adhering to best practice guidelines, in accordance with VITAL, may protect a company from negligence claims if an allergen is found but not declared. Combining VITAL risk assessment, with genuine efforts to limit contamination could limit manufacturers liability in some circumstances whilst simultaneously improving consumer choice and confidence.

The distinction between ‘may contain’ and ‘may contain traces’

There is dispute about what indemnity such statements bring to products, with health authorities distinguishing between ‘may contain’ and ‘may contain traces’. Where a product claim only refers to traces, and substantial amounts of an allergen can be found, the regulator may see this as under declaring, conduct which may amount to the sale of unsafe food. This is because the true risk to consumers was not adequately disclosed. For similar reasons, ‘may contain’ statements will not satisfy a producer’s obligations where a product is being used as an ingredient, additive or processing aid.

Future Regulatory Change

Given the success of VITAL, the optional labelling scheme will remain widespread a way of labelling in compliance with declaration requirements. Given that FSANZ rarely incorporates external standards wholesale into the Food Standards Code and many parts of the industry have already adopted the scheme, it seems unlikely that the Food Standards Code would be varied to mandate the anti-contamination measures as required for certain riskier products such as poultry under the Food Safety Plans regime.

However, the list of allergens requiring declaration under the Standard 1.2.3 will continue to be assessed and updated by FSANZ. For example, in May 2017, Lupin was introduced as an allergen requiring declaration, following research conducted by FSANZ. This provides a balance for consumers and manufacturers by assessing the risk of allergic reactions in the context of the potential effect of such information on commercial interests.


This is general information rather than legal advice and is current as of 12 Dec 2023. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.