International food safety experts are moving ahead on recommendations to define and standardize allergen “may contain” labels on packaged foods across the globe. They are also closing in on a uniform list of top allergens, with some changes likely to raise debate in the food allergy community.
In this article, Allergic Living looks at the latest developments on both allergy labeling topics. Let’s start with proposed changes for precautionary allergen labels (or PAL). Food allergy families will know these as the “may contain” or “made in a facility” allergen statements on packaged foods.
PAL warnings have long been unreliable and inconsistent. The labels are supposed to alert consumers that certain allergens may be present due to manufacturing cross-contact. Yet, with no standards for when a precautionary warning should be used, some food makers and retailers now simply apply the labels broadly.
“Consumers are confused and fatigued by the proliferation of these labels,” says Atlanta allergist Dr. Brian Vickery. He points out that as the wording of these warnings varies, their intent is also not clear.
“Avoiding all products with PAL can place an unnecessary burden on these consumers,” notes Dr. Ruchi Gupta, founding director of the Center for Food Allergy and Asthma Research (CFAAR) in Chicago.
The Codex Committee on Food Labeling has been working to find a more transparent and reliable basis for applying precautionary labels. In May 2023, the labeling committee of experts convened in Canada over changing the top allergens list and weighed proposals that would give PAL meaning. The committee represents 188 countries and the European Union.
Allergic Living looks at the issues involved in developing a consistent and safe PAL approach. We turn to several food allergy community leaders for their insights on the Codex committee’s proposals. They also share any concerns about the draft revised standards, which will likely lead to some significant changes.
Food Code Changes: What Safety Experts Propose
The Codex labeling committee works on behalf of the Codex Alimentarius Commission. The commission formulates voluntary global food standards and guidelines that make up the Codex Alimentarius, or “Food Code.” Codex member countries are not required to adopt the commission’s standards, but those standards are influential. U.S. Food and Drug Administration experts are involved in the talks and following the developments closely.
The Codex commission was established by the Food and Agriculture Organization (FAO) and World Health Organization (WHO). The labeling committee’s draft allergen proposals would update Codex’s General Standard for the Labelling of Prepackaged Foods.
At the May 2023 meeting, the Codex labeling committee considered a challenging topic: establishing threshold levels for the top food allergens. A threshold is the amount of an allergenic protein a person can consume before triggering a reaction. As we know from oral challenges and oral immunotherapy, these levels can vary with the individual.
The committee has recommended a threshold level for each top allergen, below which the vast majority of allergic consumers would not react. These would serve as benchmarks – guiding food companies and regulators as to when a PAL warning is warranted.
As next steps, the labeling committee is getting guidance from a separate committee of method analysis experts. It is also weighing a recently published FAO and WHO report on risk assessment and precautionary labels. That report calls for “a single clear unambiguous advisory statement,” as a means to “protect consumers from unintended allergen presence.”
An FDA spokesperson said that report “is needed to appropriately consider the recommendations and to progress the [committee’s] work.”
Standardized ‘May Contains’: What are the Benefits?
Among food allergy leaders, there is considerable support for the concept of standardizing precautionary labels. However, some experts do have concerns on specifics.
Global standardization for PAL “would be incredibly helpful,” says Dr. Scott Sicherer, director of the Jaffe Food Allergy Institute at Mount Sinai in New York City. He notes that research shows consumers often assume reaction risk varies based on advisory wording.
One key study, which focused on purchasing habits, showed that about 40 percent of respondents bought food with the warning labels. They were more likely to trust PAL that says, “manufactured in a facility…” than “may contain”. Those statements don’t necessarily mean anything different regarding the level of cross-contact or the allergy risk posed. Yet, 37 percent incorrectly thought the advisory labels were based on the amount of allergen present, according to the study.
“It would be great to have agreed upon, standard, informative words,” Sicherer says.
Dr. Ruchi Gupta agrees, and points to the purchasing habits study and other research that examines the understanding of precautionary labels among people managing food allergies. In one study that she led, only 24 percent of those surveyed gave correct answers for all of the questions about precautionary labeling.
“These findings highlight an urgent need to improve consistency and regulation for food allergen labeling to better support the safety of consumers,” Gupta says.
‘May Contains’: Consistency and Clarity
Nonprofit leaders also see the benefits of consistency. “Standardized global language, while not binding, could help deliver a clear message to those with food allergies considering food choices and purchases,” says Robert Earl, vice president of regulatory affairs for Food Allergy Research & Education (FARE). He says that will help the FDA “to move from unregulated use of PAL statements to regulations that will best benefit our food allergy community.”
Earl says his nonprofit regularly communicates with the FDA and the U.S. Codex office. “FARE has advocated for a strong, uniform global standard for labeling on ingredient lists and PAL statements.”
”We live in a global society where many food products are imported, and people travel, work, and study abroad,” notes Eleanor Garrow-Holding, president and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). She says “global standards would streamline awareness of risks and ingredients information while reducing confusion.”
The variety of “may contain” terms in use hampers consumers’ ability to understand whether “products carry an actual risk or to estimate the size of that risk,” says food safety consultant Dr. Steven Gendel.
But the former expert in the FDA’s Center for Food Safety and Applied Nutrition cautions that consistent labels need a strong backbone. “While standardized wording could help improve this situation, it is more important to be sure that use of any wording is based on clear principles that provide clear, accurate, and understandable information to consumers,” he says.
Allergen Thresholds: How Established
The labeling committee has put forward what are called “reference doses” for the global priority allergens. These are based on a 2022 FAO/WHO report to establish threshold levels. The doses are the estimated percentage of an allergenic protein that 95 percent of patients are known to tolerate without allergic reaction.
Vickery, founding director of the Food Allergy Center at Children’s Healthcare of Atlanta, is comfortable with the thresholds identified. He notes the experts’ comprehensive review of available data in that report.
Importantly, he says, “this process considered not just the likelihood of any reaction to an exposure below the reference dose, but also an objective reaction (e.g. hives or vomiting), as well as a severe reaction.”
While some might question why there is not a zero-risk approach, Vickery says the FAO/WHO experts did not think that was feasible or practical. They have noted that “the total absence of protein from any product can never be proven (all analytical methods have a detection limits).”
Gupta is satisfied the threshold values “lean toward conservative amounts.” She says the reference doses are calculated from research that includes food-allergic patients with lower allergen tolerance.
Allergen Thresholds: Concern vs. Status Quo
Yet, Gendel voices concerns. “The threshold levels suggested by the expert consultation were developed without access to the underlying raw data. This means the data analysis that has been described in the literature fails to meet the basic scientific expectation that work should be capable of replication.”
The former FDA analyst also says, “the expert consultation exceeded the normal role of risk assessors.” In what way? Gendel says “they presented a single value as appropriate rather than presenting the risk managers with alternatives and a discussion of the uncertainties associated with these alternatives.”
Vickery reminds, however, of the shortcomings consumers currently face. With today’s system of voluntary PAL, a packaged food with unintended allergen presence of any amount might not carry an allergen warning label.
He’d rather rely on a framework where PAL labeling is based on testing, and thresholds are backed by clinical evidence. “Even if not everyone agrees on the definitions of ‘appreciable health risk,’ it will improve the current situation where the labels are meaningless and arbitrarily applied.”
Eating A Lot of a ‘May Contain’
But what about a consumer who eats a larger amount of food containing allergic protein that falls below the reference dose? For instance, a hungry teenager who eats half a box of cookies in one sitting.
Or, what if that teen eats a normal portion, but is susceptible to co-factors like exercise, feeling ill or using an NSAID medication? Those are co-factors that can amplify an immune response, and spark a reaction.
“Experts might be able to standardize the amount of allergen in food,” notes food allergy consultant and advocate Jen Jobrack. “But how can you predict how an individual is feeling, or how much they’ve eaten?” asks the founder of Food Allergy Pros LLC.
Jobrack worries about how risk assessments can be made for a wide population, given both co-factors and portion sizes.
Vickery says the thresholds levels report to the Codex committee does consider the portion size issue. “It was recognized by the panel that people will react based on the total amount consumed, not a concentration,” he says. “A range of intakes (e.g. portion sizes) must be considered in the application of PAL.”
Codex experts recommend, for example, a reference dose of 2 milligrams total protein for the peanut threshold, according to a recent labeling committee meeting document. For context, one peanut is about 300 mg of protein.
Road Ahead: Communication Challenge
“There is no question that the use of reference doses is technically appropriate,” says Gendel. However, “the use of these values makes communication with consumers and food makers much more complex.”
Integrating threshold levels food allergy management discussions will be a big change, Garrow-Holding says.
“There must be a complete shift in how doctors and advocacy groups educate, raise awareness, and train patients and their caregivers,” she says. “We need to explore how an education shift will impact the traditionally under-resourced and how knowledge equity will be spread.”
FARE’s Earl agrees. “Public education about when PAL statements are used and not used must be a coordinated effort by groups like FARE, the FDA, the medical community (allergists and other health-care professionals), and food manufacturers and retailers.”
Jobrack says it is beneficial to be evaluating allergen cross-contact as a public health issue. She thinks there’s another form of communication that’s needed, too. “I worry about the lack of regulatory enforcement of unintended allergens in products,” she says.
In her view, manufacturers should be questioned about and held accountable for why they need “may contain” labels in the first place. “Regulations and manufacturing processes are in place that many companies already use that would dramatically curtail the need for PAL,” Jobrack says.
Revising the Top Allergens List
At the May 2023 meeting, the Codex labeling committee also supported a proposal to revise a global list of priority allergens in Codex’s General Standard. The recommendation reflects a global evaluation of published scientific data on IgE-mediated food allergies and celiac disease. (See also Allergic Living’s related earlier article.)
The following list is proposed as priority allergens:
- Cereals containing gluten (such as wheat, rye, barley)
- Crustacea (shellfish)
- Specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut)
The FDA spokesperson notes that while moving forward with this main list, the committee also chose to retain a second list of allergens. (It includes soybean, other tree nuts and some current EU top allergens.) Allergens from that list “may also be declared based on national or regional needs.”
The work is not final, but the spokesperson says “substantial progress was made” at the most recent meeting. As a result, the draft allergens list now heads to a Codex Commission group for review. The results of that will go before the next session of Codex labeling committee, expected to be held by the end of 2024.
The recommended priority allergen list differs from the Top 9 allergens list in the United States. But again, the global proposal allows for regional differences. So, a country could include a top allergen on its own list that is not on the global priority list. Any changes to the top allergen list in the United States would require Congressional approval.
Gendel says the proposed list of priority allergens is a strong recommendation, as it is based on data that was not available more than 20 years ago. That’s when the initial list was developed.
“However, it is critical to realize that the list should be taken as a base not as a limit. Additional allergens can and should be added in different countries based on factors such as population exposure and community expectation,” Gendel says.
“There is more discussion needed to understand how the global list of priority allergens will work for manufacturers, food allergy consumers, and international trade if the priority list varies by region,” notes Gupta.
Food Allergy Public: Have Your Say
The process to review the proposals from food safety experts involves several steps. The Codex commission, labeling committee and working groups will continue to assess the recommended revisions to allergen labeling for the commission’s General Standard.
The FDA is monitoring the Codex progress, the agency spokesperson says. “We will take that work under advisement in considering any steps the FDA may take in this area.”
The United States is among the delegates that participates in Codex meetings. But the voices of the general public also need to be heard, Gendel says.
“I think that what is most needed now is input from the affected consumers,” he says.
Those managing food allergies in the United States can learn more about the work being done regarding the Codex standards for food allergen labeling on the U.S. Codex Office website.
It announces meetings in the Federal Register where members of the public can also submit comments.
Consumers can also provide food allergen labeling comments to the U.S. Codex Office by emailing [email protected].
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