EU Considers Adoption of Harmonized Precautionary Allergen Labeling Rules

The European Commission has posted a forthcoming draft act to its public feedback portal on harmonized requirements for the use of voluntary Precautionary Allergen Labeling (PAL) statements. Adoption of this regulation is planned for the fourth quarter of 2027.
According to the posting, harmonized PAL requirements would give consumers with allergies clear and consistent information, prevent unnecessary food-choice restrictions, and support the market by ensuring a level playing field for food businesses.
Voluntary PAL statements on food products are intended to protect allergic consumers from accidentally eating foods containing undeclared allergens that may cause a reaction.
The Need for Harmonized PAL
At present, despite food allergies affecting more than 10 percent of global consumers, EU Member States maintain their own, differing rules on the management of unintentional allergens in food products, which experts say leads to consumer uncertainty and limited choices for allergic people, and hinders collaboration between laboratories.
Some experts also assert that the lack of harmonized PAL standards may lead to their overuse and inconsistent application, potentially eroding their risk communication effectiveness.
Global Progress Toward Harmonized PAL
Addressing the need for a harmonized approach to PAL, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) recently published a Codex framework for risk-based labeling of priority allergens, establishing threshold levels and reference doses for different allergenic foods. Studies have shown that adoption of these recommended thresholds would be widely protective of the allergic population.
Regulatory bodies like the U.S. Food and Drug Administration and the UK Food Standards Agency are considering adopting Codex-recommended thresholds for national allergen labeling guidance.
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