It has been almost 20 years when my professional career took a 180-degree turn and I moved from the small molecule world of mycotoxins to the large and complex compound world of food allergens and gluten. If found that new start was challenging given the number of unknowns and questions that needed answers. But most of all, I found food allergens an exciting field to contribute to.
At that time, beginning of the 21st century, we lived with the Big 8 food allergens defined by Codex and with the 200 ppm of gluten threshold for labeling products as gluten-free. Today, many jurisdictions have enacted food allergen labeling regulations, most of them based on the Codex Big 8 (USA), many have expanded this list over time (EU, Canada, Australia), and some have deviated from Codex and adjusted the regulated food allergen labeling considering the local food allergy prevalence (Japan).
Back then we could only find a handful of ELISA assays in the market for a few food allergens, mainly peanuts, milk, egg and gluten. Now, it is difficult to keep track of all allergen assays available in the market. We have more analytical technologies available, not only immunoassays but also PCR and mass spectrometry, which allow us to detect all mandated food allergens, although with some question marks in some instances, e.g. the ability to detect all fish and crustacea species. All analytical technologies have their particularities, pros and cons, they all share common challenges as there are also technology-specific challenges. They all have their own place in the testing market and in many cases, they have complementary roles.
In all these years we have learned that food processing activities have an important effect on food allergens, their extraction from samples and further detection by the different analytical applications. We know that not all food processes have the same impact on the food allergens and that not all food allergens are affected equally. And for these reasons food matrices determine our analytical strategies, including sample extraction methods and choice of analytical method.
I have never counted how many hours I’ve spent attending food allergen conferences, committees, working groups, task forces… quite a few. In those events, colleagues have shared information on research, new analytical developments, regulatory novelties, projects, industry initiatives, etc., but I have also heard the same questions over and over, like an echo that goes from meeting to meeting. I have selected 3 of those almost eternal questions/needs, that now (caution: spoiler) seem to get answers. Are those answers the ones we wanted to hear?
The first question was about the availability of confirmatory methods. The need was to find analytical technologies different than the existing immunoassays. This need found a first solution some years ago, with the application of DNA-based methods. However, this option has not been accepted as valid analytical option by some countries, e.g. United States and Australia/New Zealand, Canada, since they do not target the proteins (food allergens), which are the actual triggers of food allergies. More recently, new improvements in the mass spectrometry (MS) technology led to the development of applications for food allergen detection. Since then, I have not seen a single presentation asking for new confirmatory methods.
The second question is related to the need for reference materials for calibration, validation, quality control and to facilitate the comparison of analytical results given by different analytical methods. After many years of inactivity in this field, excluding the prolamin working group (PWG) gliadin, where the material is of limited availability, there has not been globally accepted reference materials for either food allergens or gluten testing. This has been the case until 4 or 5 years ago, when the MoniQA Association gathered stakeholders and started an initiative to identify, select, characterize and produce materials to be used across platforms (immunoassays, DNA-based assays and mass spectrometry). Milk is already available, and gluten will be shortly in the market. More recently, there are also new activities in this field, one in Europe sponsored by the Food Standard Agency in the UK and also in the US by the National Institute of Standards and Technology, and an additional one which is not yet in the public domain. So, it seems that soon we will have more materials available. And then the question needs to be asked: are these materials equal or are some more equal than others?
The third point is the need for threshold levels. After the enactment of food allergen labeling regulations, we have seen an increase in the number of recalls due to presence or potential presence of food allergens. Many have pointed out that a possible reason is that the lack of regulated or recommended official threshold levels for food allergens pushes industry to manage allergens with zero-tolerance. This results in very costly controls that do not seem to bring additional protection or benefit for the consumer. Moreover, the lack of official threshold levels creates inconsistency across the industry in the manner they assess risk and control food allergens. If having threshold levels will contribute to the reduction in the number of recalls due to food allergens remains to be seen. Looking at recalls due to gluten (in the context of gluten-free labeling for celiac sufferers), where there is a threshold of 20 ppm gluten in most countries, the number of recalls remains high.
A first initiative to address allergen levels was led by the food industry in Australia, which is known as VITAL. This system is a risk assessment tool for the industry with associated reference doses for the mandated food allergens and used for labeling purposes. The establishment of these allergen levels has been based on the evaluation of scientific and clinical information. Such levels have been suggested to government regulatory agencies, none has yet adopted them or made any recommendations. However, in the last couple of years there have been some activities in governments of 3 central European countries: Germany, Belgium and the Netherlands (Food Allergen Community Newsletter 2018, vol 9, issue 1). Although it seems a move forward, the levels are significantly different in the three countries. While in Germany, the values established have their base in findings from enforcement activities by control authorities, the Belgian values are based on VITAL and the Dutch values, the lowest of the 3 countries, are based on an own assessment. As we have seen in other areas, having diverse threshold/tolerance levels does not only create compliance complexity but is also unhelpful for affected consumers.
Although many efforts are driven to involve different stakeholders and provide consensus agreements positions and recommendations, not all activities have converged. The need to find practical solutions to chronic needs, e.g. reference materials and threshold levels, and the lack of a clear lead in these areas is steering some efforts in different directions. Given the proliferation of reference materials produced to different specifications, thresholds and action levels…. Do we need to start thinking about harmonization? Will it be the next hot topic that we will hear in all the meetings?
