U.S – A recent study of recall data for products governed by the U.S. Food and Drug Administration (FDA) has found that the majority of recalls involving food allergens are the result of avoidable labeling mistakes.

Preventative allergen controls, including labeling requirements, are defined in the 2015 “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” rule (21 Code of Federal Regulations (CFR) Part 117).

In addition, milk continues to be the primary major food allergy linked to significant food allergen recalls.

There were 1,471 food allergy and gluten recalls during the fiscal years 2013 and 2019 that were covered by the study which collected data from the FDA’s Recall Enterprise System (RES).

A health hazard evaluation (HHE) and recall classification (Classes I, II, and III) are required for every recall entered into RES to describe the relative level of health risk offered by the product under recall.

Product recalls fall into one of three categories: Class I, Class II, or Class III.

Class I recalls involve a product that presents a plausible risk of major adverse health outcomes or death; Class II recalls present a remote risk of serious or transient adverse health effects; and Class III recalls are not likely to present a risk of serious adverse health effects.

A total of 1,471 products were recalled, of which 1,415 were because of serious food allergies, 34 were because of mistakes in gluten-free labeling, and 23 were because of other allergens.

Generally speaking, recalls resulting from significant food allergens rose during the research period, reaching a peak incidence rate in the fiscal year 2017.

Significant food allergen recalls were broken down into three classes: Class I (51.2%), Class II (45.5%), and Class III (3.3%). Most recalls involved just one allergen (78.8 percent).

Milk was the most frequently recalled major food allergy (37.5%), followed by soy (22.5%) and tree nuts (tree nut recalls) (21.6 percent).

The most often recalled allergens in the three major food allergen categories—tree nuts, fish, and crustacean shellfish—were almond, anchovy, and shrimp.

Major food allergy recalls involved one product category in about 97 percent of cases.

Bakery products were the food category that was recalled the most (31.5%), followed by snack foods (12.1%), candy (10%), dressing (8%), and dairy (7.9 percent).

71.1 percent of the 914 significant food allergen recalls with documented root causes involved labeling-related issues.

Cross-contamination was responsible for another 23.4% of the recalls with established underlying causes.

The analysis discovered that, in comparison to 21 CFR 117, 76.8% of significant food allergen recalls with a known root cause were probably brought on by insufficient label controls.

Particularly, among the 893 recalls with labeling-related root causes, proper label content controls and adequate label management controls might have each prevented 63.5 percent and 36.5 percent of the recalls, respectively.

The results indicate that in order to safeguard public safety and avoid food allergen recalls, food manufacturers should pay particular attention to make sure that sufficient allergen label regulations are in place.

Food allergens are components of food, typically protein, which can trigger an immune-mediated allergic reaction in sensitive individuals. Some allergic reactions can result in anaphylaxis, a serious and life-threatening adverse health consequence.

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