Science Update: Allergen Threshold Values

20 ppm
The threshold value followed by the European Union and proposed by FDA for labeling a product as gluten-free.

10 ppm
The level required by most companies for gluten detection.

5 ppm
The sensitivity threshold set by many third-party labs and tests.

Which is correct?

“We know that technology is capable of being more sensitive,” said Tony Lupo, Neogen director of technical services. “The question is, what is the risk and reward of that?”

Do lower levels better protect the food-allergic and food-sensitive populations? Or do they place unrealistically low levels on manufacturers? If testing detects continually lowered levels, “what does that do to the industry in performing due diligence?” Lupo asked.

Of course, anytime an allergenic ingredient is added to a product, regardless of the amount, it must be declared. But when testing for unintentional cross contamination, it is currently up to the processor to determine what is acceptable. Most choose to test at 5 ppm, Lupo said. And that is a level that can be maintained through good sanitation and allergen programs. But going much below that, he added, “may mean that certain products may not be manufacturable.”

Allergen threshold values have changed through the years, said Thomas Grace, CEO of Bia Diagnostics. So much so that they can be considered moving targets. In the past, a gluten level of 200 ppm was considered to be safe. Now proposed U.S. regulation is considering a 20 ppm level for label declaration. In addition, he said, the effect of an allergen on a sensitive person can be impacted by factors such as the amount of food eaten, other foods eaten, stress the individual is undergoing, and physical or emotional well-being. “All of these can have an effect on a person’s immune system,” Grace said.

Global Challenges. Allergen labeling is further complicated by global variation of foods regulated as allergens, as well as the specified levels—or lack of specification—that requires labeling.

Europe, for example, has 14 allergens on its list, adding those such as celery, lupines, and sulfites to the Big 8 of the U.S., and, said Romer Labs UK Sales Director Richard Fielder, “the European communities have tried to harmonize regulations.” In doing so, he said, regulatory, clinical, research, and industry groups are working closely together to develop clinical threshold data, and we can expect to see some of the groups begin to publish reports this year. The reports are expected to include proposed threshold levels based on portion sizes.

In Europe, as in the U.S., “industry is being pressured to move away from may contain or ‘alibi’ labeling,” Fielder said. “That’s where thresholds should potentially help us.”

The VITAL (Voluntary Incidental Trace Allergen Labeling) system, originally developed by the Allergen Bureau of Australia and New Zealand and now referenced by numerous other countries as well, includes a “traffic light” labeling system:

• If the allergen level falls in the green zone, no precautionary statement is needed.
• Yellow indicates that a “may be present” (may contain) statement is needed.
• Red denotes that allergen labeling is required.

With VITAL currently undergoing an update, the grid levels are also expected to be revised this year based on new clinical data, Fielder said.

Allergen Issues. Until threshold levels are set, the only sure way of avoiding a recall for mislabeling is testing as low as possible to label any indication of an allergen. Some of the most common processing challenges and routes of contamination or mislabeling include:

• Suppliers – Ingredients can be contaminated in the field, in transportation, or in storage. For this reason, it is important to ensure that you audit your suppliers; obtain certificates of analysis from each; and ensure all are as close to allergen-free as possible.
   
• Inadvertent ingredient change – If all workers are not properly informed that a run is allergen free, a substitution could occur mid-run impacting allergen presence in the product. The example Grace gave was that of a shift change mid-run and an ingredient running low; if butter is added instead of margarine, the product that was to be labeled as dairy-free will now contain a milk product.
   
• Test method – Processors must ensure that the methods they—and their suppliers—use are validated for the allergen to be detected, and are compatible with the food products on which they are used. For example, Grace said that some methods can detect gluten in some grains but not all; so if a test is run that only detects wheat, then barley or rye in the product won’t be detected. “Whatever method you are using should always be validated for your matrix,” he said.

Manufacturers that produce products with allergen-free claims on the labels will generally test finished product; other manufacturers, Lupo said, are more likely to conduct incoming ingredient, in-process, and environmental tests, rather than finished product.

An additional testing challenge is the standardization of calibration methods used by test manufacturers. “If we want to have agreement when quantifying allergens, we all have to be calibrated in the same manner and know what we want to measure,” Fielder said. For example, when testing for eggs—does this mean chicken eggs? Or other types as well? In a test for tree nuts, which are included? “We have started defining these, but some areas still need interpretation,” he said.
 

Preventive Controls. Regardless of the challenges, undefined threshold levels, and international variation, food producers should focus on implementing good allergen controls in production, not only to limit recalls but to protect consumers. “At the end of the day, it is a food safety risk, and the way any responsible manufacturer should deal with risk is through a management system,” Fielder said. “Every company should see it as a risk, not just something they can label themselves out of.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.

(Editor’s Note: Tony Lupo is no relation to the author.)

Further resources

• Threshold Doses for Allergenic Foods – How Much Is Too Much?
  http://farrp.unl.edu/research/article-3
   
• Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.
  http://www.fda.gov/food/labelingnutrition/foodallergenslabeling/guidancecomplianceregulatoryinformation/ucm106108.htm
   
• Food Allergens Labeling.
  http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling
   
• Food Safety Working Group. http://www.foodsafetyworkinggroup.gov/
   
• VITAL System. http://www.allergenbureau.net/vital/
   
• Allergen Labeling. in this issue’s AIB Update insert, page 13.