Eight Major Food Allergens Photo: FDA

Regulator redoubles efforts to protect consumers from food allergens

*The US FDA’s Food Allergen Labelling and Consumer Protection Act identifies milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans as the eight major allergens

Isola Moses | ConsumerConnect

Several millions of people worldwide have food allergies and may experience adverse reactions to products that contain food allergens.

According to the United States Food and Drug Administration (FDA), millions of Americans as well have food allergies, and may experience adversative reactions to products containing food allergens.

The FDA in a piece on its Web site noted that eight foods have been identified as major food allergens, and it is aware of other food allergens, such as sesame.

Most allergic reactions cause mild symptoms, but some are severe and may even be life-threatening, according to the regulatory agency.

It uses its authorities to help protect those with food allergies and is implementing initiatives to build on the agency’s important work.

“Our goals are to provide consumers with the information they need to make informed decisions, to enforce regulations that require the industry to properly label food allergens, and to significantly minimise or prevent the presence of undeclared major food allergens in food,” said the FDA.

On emphasis on prevention and protection for consumers, the Food Allergen Labelling and Consumer Protection Act has been in place for many years and greatly improved the FDA’s ability to inform consumers about the presence of major food allergens in food.

The regulator added that under this law, packaged foods must identify the source of all major allergens used to make the food. The Act identified the following eight allergens as major: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans.

The allergen’s food source must be declared on the food label in one of two ways—in parentheses following the name of the ingredient, such as flour (wheat), or immediately next to the list of ingredients in a statement that says “Contains wheat, milk, and soy.” This requirement is met if the common or usual name of an ingredient already identifies that allergen’s food source name (for example, buttermilk), it noted.

The agency further explained: “We know that the eight major food allergens are not the only food allergens or allergenic substances that can cause problems in sensitive individuals, and that is why the FDA monitors the food supply to determine if other substances pose a significant public health risk.”

The FDA stated it issued draft guidance for industry November 2020, to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a flavouring or spice, or when the common or usual name, such as tahini, does not specify sesame.

“We know that sesame allergies in the US population appear to have increased, and severe reactions have been reported,” said the agency.

This draft guidance is an initial first step, while we explore other potential actions to protect consumers who may have allergies to sesame or other food allergens beyond the major eight.

Gluten is a substance that can pose a risk to individuals with celiac disease. Gluten is found in certain grains such as wheat, barley and rye and when consumed can trigger an immune response that attacks and damages the lining of the small intestine.

It explained that “in 2013, we took the much-needed step to protect people with celiac disease by issuing a final rule defining ‘gluten-free’ for food labeling, which helps consumers be confident that food items labeled ‘gluten-free’ meet a defined standard for gluten content.

“Following this, in 2020, we took another important step forward with a related final rule to establish compliance requirements for gluten-free labelling for fermented and hydrolyzed foods, such as pickles, soy sauce and cheese, so that consumers can be confident that manufacturers who declare their products as gluten-free know how the FDA will be enforcing the defined standards for these foods as well.”

Besides these requirements regarding food labelling, as part of the Food Safety Modernization Act, the FDA has in place requirements for certain facilities to implement preventive controls in their manufacturing operations to significantly minimize or prevent the hazard of undeclared major food allergens.

This places an emphasis on preventing allergen contamination, protecting consumers, and reducing the need for food recalls.

In connection with commitment to compliance and enforcement, therefore, the regulatory agency disclosed that undeclared food allergens have been the number one leading cause of Class I food recalls for at least the last three years in the US. Approximately one-third of foods reported to the FDA through the Reportable Food Registry as serious health risks involve undeclared food allergens, it added.

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