What is behind a “may contain” label? Romer Labs senior research scientist Adrian Rogers explains a new initiative to provide realistic risk assessment that food producers can use to help their consumers make scientifically informed decisions. This story was first published in Food & Drink Business May/June 2020.
Anyone who buys pre-packed food cannot help but notice what seems to be a proliferation of “may contain” statements on ingredients labels these days.
Such precautionary allergen labelling (PAL) is voluntary on the part of the food manufacturers and grocery stores and aims to guide an allergenic consumer as to the risk of potential contamination of the food from one or more food allergens during production and handling.
But what’s behind a “may contain” label? Is it an honest, science-based assessment of risk designed to inform the consumer, or is it a legalistic overreaction designed to immunise a food producer from possible lawsuits?
A growing concern among the allergy community is that “may contain” statements are descending into mere alibi labelling, whereby food producers and retailers are listing all allergens to protect themselves against any possible litigation.
This is an issue of real consequence: millions of consumers around the world suffer both from the risk of allergic reactions to certain food and the limits that this risk imposes on their choice of food at the store and in a restaurant.
Such precautionary labelling can severely and unnecessarily limit the choices of food safe to eat for an allergenic consumer.
So, what can be done to make the use of PAL, a scientific, risk-based assessment rather then something that seems
only to protect manufacturers and retailers?
This is the quandary the Australian and New Zealand-based Allergen Bureau faced.
The Allergen Bureau was established in 2005 as a non-profit industry organisation in partnership with national and multinational food manufacturing and marketing companies, suppliers, importers, exporters, retailers and consumer groups.
Its overall aim is to share information and experience within the food industry on the management of food allergens to ensure that consumers receive relevant, consistent and comprehensible information on food allergens.
Greater precision
In consultation with experts, the Allergen Bureau manages the Voluntary Incidental Trace Allergen Labelling (VITAL) Program. While continuing to invest in VITAL and other allergen management resources, the Bureau engages in a range of food allergen management initiatives on behalf of its stakeholders.
It aims to make sure that manufactured food is safe to eat for the vast majority of food allergic consumers by providing consistent precautionary labelling criteria to allow allergic consumers and those who care for them to avoid buying food that may present a risk to the individual. In this way, they work to preserve the value of precautionary labelling as a risk management tool.
VITAL provides a common approach to due diligence for identification, reduction and control of cross-contact allergens and the process that can determine the appropriate use of precautionary allergen labelling.
Prior to any implementation of VITAL, a robust allergen management plan must already be in place. It stipulates that the allergen status be assessed product-by-product rather than by factory or line. Each ingredient and processing line are assessed for potential cross-contact allergens so that such cross-contact can be reduced to a minimum level.
Creating allergens reference doses
To base its work on sound and robust science, in 2011 the Allergen Bureau invited scientists from around the world specialising in allergen management, food allergy and risk assessment to form the VITAL Scientific Expert Panel (VSEP). The objective of the panel was to review the underpinning science around food allergen thresholds.
The VSEP reviewed the data from clinical (low-dose oral) food challenges from both published and unpublished studies. The papers were sourced from Australia, the United States and the European Union and over 3400 clinical data points were collated.
The data included in the review was required to meet defined quality criteria to ensure that resulting allergen thresholds were statistically sound. The data set was analysed by applying a new Stacked Model Averaging program for each allergenic food.
The Stacked Model Averaging program produces a single curve for each allergen from which Eliciting Doses may be derived. The VSEP identified the ED01 (which is the dose of the total allergen protein that is predicted to produce objective symptoms in one per cent of the allergic population) which were adopted as the Reference Doses for VITAL 3.0.
The role of analysis
Allergen analysis plays a significant role in the application of VITAL. However, it is only one part of the overall process of risk assessment. It is intended to provide additional information to help inform the assessment rather than to be used as a stand-alone tool.
Analysis is complex and thus needs to be matrix-and allergen-specific. It is important to consider the nature of the food or surface under analysis and the processes to which it has been exposed to ensure that the method applied is appropriate.
When comparing analytical test results with concentrations calculated from a VITAL risk assessment, it is important to ensure that the units of measurement are comparable. Methods used should be robust, reliable, reproducible, sensitive, and specific; and an appropriate sampling plan is crucial.
Through the continued adoption of the VITAL Program and the use of other science-based allergen risk assessment processes by the food industry, we hope that the confusion and misunderstanding currently surrounding precautionary allergen labelling can begin to be resolved.
Rather than benefiting the manufacturers and retailers, PAL should become a trusted method that empowers allergic consumers. Then they can make safer food choices to stop preventable fatalities while not artificially limiting their choices as consumers.
