Are all foods that contain “traces” of allergens now considered unsafe?
Are all foods that contain “traces” of allergens now considered unsafe?
By Charles Fisher (FoodLegal Co-Principal)
© Lawmedia Pty Ltd December 2018
This article details and analyses an actual case study where FoodLegal represented a food manufacturer against enforcement action by the Victorian Department of Health. The client has suggested that it would be beneficial for FoodLegal Bulletin readers to know about this type of scenario. Names and dates have been removed to protect client confidentiality. Should the position taken in this instance become nationwide policy, it would trigger sweeping changes across the food industry in allergen management and labelling in Australia.
Facts of the case
In 2018, a product was sold on the Australian market that declared that it “May contain traces” of a relatively common allergen which can trigger anaphylaxis in consumers with allergies. This company had conducted a HACCP analysis of its use of allergens in its facility, identified that small quantities of the allergen could remain on lines following flushing of those lines, and protected consumers from this risk by declaring the allergen on the label.
In other words, any consumer with an allergy was protected by being notified as to the potential presence of the allergen.
A parent of a young child had been feeding this product to their child knowing that their child had an allergy to the declared allergen. Eventually, that child suffered an anaphylactic reaction to consuming the product.
Prompted by Anaphylaxis Australia, the product was tested by a laboratory that found the product contained 0.06% of the allergen. This laboratory took the view that this presence was more than a “trace”. Following this laboratory testing, the Victorian Department of Health (as the appropriate regulator of any food business registered in Victoria) took the following view:
- That the product contained more than “trace” amounts of the allergen;
- As such, the product label ought to declare that the allergen was actually “present” in the product or that the product actually “contains” the allergen;
- The failure to label this one particular batch as above led to it being considered “unsafe” by the Victorian Department of Health; and
- As a result of the above view, that one batch of the product had to be subject to a consumer-level recall in order to protect public health and safety.
Lack of legal prescription for cross-contact of allergens
As most readers would be aware, Standard 1.2.3 of the Australia New Zealand Food Standards Code (the Food Standards Code) requires the intentional addition or knowing presence of a number of allergens to be declared on food product labels.
Where the Food Standards Code (and all other food-related legislation) is silent is in the circumstance where an allergen may be present in a product unintentionally or unknowingly. The unintentional or unknown presence of an allergen can arise from a number of different factors, but the most common is cross-contact from other manufacturing lines within the manufacturing premises.
Given the lack of prescribed rules around declaring the potential presence of allergens, any labelling requirement arises out of the legal obligation under the Food Act of each State and Territory (as well as the defective good provisions of the Australian Consumer Law) to sell a safe product.
The Australian food industry has tried somewhat to fill the void left by legislation through guidelines and publication of best practices, most notably through the Allergen Bureau’s Voluntary Incidental Trace Allergen Labelling Program (VITAL). Through use of the VITAL Program, a food company will be able to assess whether an allergen is guaranteed to be not present in a food product; will definitely be present (and thus required to be declared in line with Standard 1.2.3); or where the allergen “May Be Present”.
However, industry guides like VITAL are not legally binding. Adherence to these guidelines does not guarantee legal protection should a food regulator – such as the Victorian Department of Health – decide that a product is still unsafe despite the additional steps being taken by food businesses to protect consumers.
The purpose of declaring potential presence of allergens
Therefore, in determining how to voluntarily declare the potential presence of an allergen in a food product, you must answer a relatively simple question: is the label declaration sufficient to guarantee consumer safety?
However, in addition to protecting consumer safety, it is important to acknowledge that voluntary declaration of potential allergen presence has significant impacts on the manufacturing processes involved in any food product. Any product declaration that an allergen may be present has essentially abdicated responsibility to guarantee or verify the absence of the allergen in the product.
In other words: the allergen might be there. It might not be. But by declaring its potential presence, the food company is declaring that the product is still safe because any consumer with an allergy can protect themselves by avoiding the product.
While companies must still engage in best food safety practices and implement manufacturing controls to remove or reduce the presence of any allergen in a product that does not declare its actual presence, they do not have to engage in a costly testing regime to guarantee absence of the allergen to ensure product safety. Any requirement to test and validate the absence of an allergen is triggered by a voluntary claim that the product is “free” of that allergen, not by a statement that the allergen may be present.
“Traces” was not the trigger word
It is worth noting at this juncture that the word “traces” was not the trigger for the regulatory action but definitely reduced the legal arguments available to our client.
Both the laboratory conducting the testing and the Victorian Department of Health decided that the quantity present in the precise batch of product was “more than a trace”. Neither party had any evidence or guidance as to what would be acceptable for a “trace” amount of the allergen.
If the company had followed VITAL labelling practices as opposed to using its own wording, the label would have stated that the allergen “May be present”, without any references to “traces”. Whether or not there is evidence to support this view, the Victorian Department of Health took the view that there may be consumers for whom “traces” of an allergen are safe, whereas higher quantities are not.
However, even if our client had declared “May be present” as opposed to “May contain traces”, the Victorian Department of Health took the frustrating view that the only appropriate labelling for a product tested to contain 0.06% of an allergen was a statement that the allergen was actually present or that the product actually contained the allergen. This view of course ignores the fact that these circumstances will differ batch to batch and that a “May be present” statement specifically exists to protect consumer safety whilst avoiding the need to test every single batch or product.
Were the products “unsafe” from a legal perspective?
FoodLegal advised the client and maintains the view that the products were absolutely safe with a “May contain traces of” statement. The allergen was declared on the label. The allergen in question can trigger anaphylaxis at very low levels. Any consumer with an allergy could and should have avoided consuming the product.
Whether the labelling declaration or the manufacturing controls could have been improved is a separate point. The Department of Health took the view that this batch was unsafe and were prepared to use their emergency powers to force a mandatory recall, claiming that this product was a threat to public health and safety.
If this is the case, a very large proportion of food products on the Australian market present a risk to public health and safety.
While FoodLegal absolutely rejects the view taken by the Victorian Department of Health in this instance, the key legal question was whether a judge – with no background in food manufacturing – would ever find against a Department of Health arguing that a product was a risk to public health and safety.
What are the industry ramifications of this decision?
In our negotiations with the Victorian Department of Health, it became apparent that they were under significant pressure to act, especially in light of recent deaths due to undeclared allergens. In contrast to those past situations, the allergens had been declared in this instance. But despite offers of a number of different remedial actions short of consumer-level recall, the Department felt that they could not accept any action less than a consumer-level recall and be seen to be acting appropriately.
While FoodLegal did notify the Department of Health as to the significant impact on the food industry their interpretation could have, these arguments did not sway the Department.
To recap: the Department of Health took the view that a product being found to contain a certain level of an allergen was unsafe if that product label only declared its potential presence.
Here are the potential ramifications of such a policy becoming widely adopted:
- Any product declaring that they contain or may contain “traces” of an allergen will have to determine what level is a “trace” (without any current regulatory guidance) and test every single batch of product to make sure that the product contains less than that level;
- Any product fully compliant with VITAL declaring that an allergen “may be present” and found to actually contain that allergen could be found to be unsafe and subjected to product recall; and
- Consumers with allergies will arguably be relieved of any responsibility to avoid food products labelled with potential allergenic presence.
It will become a natural consequence of the above for companies that do not wish to implement expensive testing regimes to simply declare that all of their food products contain all common allergens, whether there is any risk of them being present or not. This would further and unnecessarily limit food products that consumers with allergies could safely consume.
A key jurisdictional distinction
FoodLegal acknowledges that this is only a single enforcement action. However, the policy positions and legal interpretations taken by the Victorian Department of Health are consistent with their ongoing approach to allergen management, particularly where there has been an anaphylactic reaction.
This highly contentious, conservative and potentially damaging policy view has been taken only by the Victorian Department of Health, so far. The Victorian Department of Health only has jurisdiction over food businesses that are registered in Victoria, due to the Home Jurisdiction Rule. Whether a product is sold in Victoria or not is irrelevant; the key issue is where a food business is registered. The pressure to recall would likely not have been placed on our client if their business had been registered in another State or Territory, even if the anaphylactic reaction had occurred in Victoria.
Given the rise of allergies and the lack of responsibility being placed on consumers to manage their own allergies, food companies are likely to be forced to over-declare allergens to avoid costly (albeit unnecessary) consumer-level recalls.
Whenever there is an anaphylactic reaction, there will be considerable pressure on companies to recall unless the actual (and not potential) presence of the allergen is declared on the product label.
Any company should avoid use of the term “traces” (and instead use the VITAL “may be present” declaration) in their allergen declarations unless they are prepared to implement a testing regime. Even when prepared to implement a testing regime, companies should seek regulatory guidance as to what level they consider to be a “trace”.
This is general information rather than legal advice and is current as of 10 Dec 2018. 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.