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.