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.
Key takeaways
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.