Food allergen labeling will be at the forefront of a meeting of international experts seeking to standardize allergy advisories about cross-contact. The current “may contain” or “made in a facility” allergen statements on packaged foods often exasperate shoppers. They are neither defined nor regulated, so it’s impossible to know what they mean.
The lack of consistency and unreliability of precautionary allergen labeling (known as ‘PAL’ for short) has become a global issue.
“Evidence indicates consumers view PAL as unhelpful and confusing, and that it ultimately restricts rather than enables safe food choices,” states a June 2021 document from the Codex Committee on Food Labeling (CCFL).
The 47th session of the CCFL is convening in Gatineau, Canada from May 15 to 19, 2023. [See our post-meeting article as well here.] The delegates will discuss a global, standardized format for PAL labels. This involves establishing allergen threshold levels, to guide food manufacturers on when there is and isn’t an allergic reaction risk.
The delegates from up to 188 countries and the European Union also will review a recommended global list of priority allergens.
The Codex labeling committee meeting follows years of scientific data analysis and several meetings focused on revising a document called the General Standard for the Labelling of Prepackaged Foods (GSLPF).
An FDA spokesperson told Allergic Living that the current Codex work on allergen labeling is important so “international standards aimed at protecting public health and facilitating trade be updated to consider the most recent science and risk assessment.” The spokesperson said in a statement: “The last formal international review of food allergens was over 20 years ago.”
Updating Labels: Who Speaks for Patients?
The years of Codex discussions have involved food safety scientists and experts, and United Nations and government agency representatives. But notably absent in the talks and reports on allergen labeling are patient representatives, such as allergy nonprofit organizations.
Eleanor Garrow-Holding, president and CEO of the nonprofit organization Food Allergy & Anaphylaxis Connection Team (FAACT), agrees that efforts to create global standards are important. But she stresses the need for voices from the food allergy community to be represented in labeling discussions. She says this is especially the case since patient interpretation can differ from the medical community and among various countries.
“We need to participate in conversations regarding the analysis of why a global standard is essential for international trade, and how patient safety can remain at the forefront of all guidelines,” she says.
The Codex labeling committee works on behalf of the Codex Alimentarius Commission, a food standards program established 60 years ago by the Food and Agriculture Organization (FAO) and World Health Organization (WHO). The commission formulates the voluntary international standards, guides and codes of practice that make up the Codex Alimentarius. It’s also known as the “Food Code.”
In its 2019 call for participants to provide scientific advice, the Codex commission noted: “There have been many scientific developments in the understanding of food allergens and their management since the original drafting of the GSLPF”. A list of priority allergens was first included in that general standard in 1999.
Precautionary Allergen Label Issues
Current precautionary allergen advisory labels that warn shoppers of potential allergen cross-contact are notoriously inconsistent in their meaning and use. The Codex labeling committee has stated that arbitrary use of PAL reduces its effectiveness. This leads to what’s widely seen by grocery shoppers – the overuse of “may contain” labeling.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires the top 9 major allergens to be clearly labeled on packaged foods. This applies to the “intended” ingredients of a product. But U.S. allergen advisory statements for possible cross-contact are voluntary. There is no standardized manufacturers’ wording or protocols for those PAL advisories.
“When completed, the updated labeling standard for disclosing food allergens and guidelines on precautionary allergen labeling will provide a risk management framework to help harmonize allergen risk globally,” the FDA spokesperson told Allergic Living.
New Allergen Labeling Proposal
The Codex labeling committee recommends including the “Guidelines on the Use of Precautionary Allergen Labelling” as an annex to the GSLPF (the general standard). According to a March 2023 committee document, the draft proposal includes guidance, such as:
- PAL should only be used based on risk assessment.
- Threshold levels should determine the use of PAL. The label should only be used if exposure to an allergen is above an established reference dose.
- The advisory statement should be placed in the same area of the product label as the ingredient list. Font type, style or color should be used to make it stand out from surrounding text.
“Consistent and harmonized approaches to the use of PAL can help consumers make safer food choices,” according to a committee document.
Thresholds Levels: How to Establish?
An allergen threshold is the amount of allergenic protein a person can consume before eliciting a reaction. The threshold tolerated varies among allergic individuals. Plus, co-factors such as exercising, drinking alcohol or taking certain medications can play a role in whether someone reacts.
Following a 2022 meeting of CCFL experts, FAO and WHO issued a report to establish threshold levels for priority allergens. The committee created reference doses that “reflect a range of exposure without appreciable health risk,” according to the document. The group analyzed scientific data regarding eliciting dose values to establish reference doses. (These values are the percentage of an allergen protein dose that will bring on a reaction.)
For example, the recommendations include thresholds of 2 milligrams (mg) total protein from peanut and 5 mg total protein from wheat, according to a March 2023 Codex committee meeting document.
The FDA does not currently use thresholds for the top 9 allergens. But the United States is involved in the Codex discussions considering them. Thresholds are meant as risk assessment tools affecting when a manufacturer would include an allergen label warning.
Some countries have their own reference doses to determine when an allergen advisory should be used. For example, Australia’s Allergen Bureau integrates such doses in its allergen labeling protocols, as part of the Voluntary Incidental Trace Allergen Labelling (VITAL) Program. The program provides guidance to food manufacturers on when to use a precautionary allergen statement.
While the Codex standards carry weight on a global scale, and inform countries’ regulations, they are voluntary. Codex member countries are not required to adopt the standards that the commission adopts. Each country can decide whether and how to incorporate them into their regulations. For example, any changes to allergen labeling laws in the United States would require Congressional approval.
Proposed Top Allergens List
The 47th Codex meeting will also evaluate and consider revising the Codex priority allergen list.
The expert committee recommends (as noted in the March 2023 committee document) the following list as priority allergens:
- Cereals containing gluten (such as wheat, rye, barley)
- Crustacea (shellfish)
- Specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut)
The list reflects a global evaluation based on hypersensitivity, such as IgE-mediated food allergies and celiac disease.
The prevalence of certain allergies differ in various regions of the world. So, the committee suggests a country could determine that an allergen excluded from the recommendations is necessary on its own top allergens list.
There are some notable differences with the current U.S. top 9 allergens list. For example, soy is absent from the Codex committee’s list. Tree nuts are also listed as six specific nuts in the Codex recommendation, whereas the U.S. list has a general term to cover any tree nuts.
Wheat is shown as a standalone allergen on the U.S. list. But on Codex’s proposed list, it is among other gluten-containing cereals, such as rye and barley.
“Due to the lack of data on prevalence, severity and/or potency, or regional consumption of some foods, the Expert Committee recommended buckwheat, celery, lupin, mustard, oats, soybean and specific tree nuts (Brazil nut, macadamia and pine nuts) not be listed as priority allergens, but may need be considered at regional levels,” the March 2023 document states.
Patient Voice, Giving Your View
As a member of the Codex Alimentarius Commission, the United States will be among the delegates at the May 2023 meeting in Canada. The international delegates will discuss the recommendations on precautionary labels, threshold levels and priority allergens.
“The United States hopes that the committee will discuss whether a global list of exempted foods with specifications might be helpful for reducing trade barriers and fostering international consistency,” a U.S. Codex Office spokesperson wrote in an email to Allergic Living. The spokesperson also notes that the office “generally supports the current text; however, there remain areas requiring discussion and refinement.”
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.
Food allergy advocates should also have a chance to provide input for the guidelines that will impact millions, says FAACT’s Garrow-Holding. “Any deliberations regarding guidelines that impact the food allergy community must include advocacy organizations to express the patient’s day-to-day needs, concerns, and limitations,” she said.
“These suggestions will affect safety and food allergy management, so understanding how the patient will engage with the recommended changes and how to educate the food allergy community on the recommended changes (a primary mission and function of FAACT and other patient advocacy organizations) is critical,” Garrow-Holding continued.
Members of the public can also provide input on food allergen labeling. They can send comments to, or find out more information from the United States Codex office by emailing [email protected].
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