What Food Allergen Labeling Law requires
Regulatory frameworks governing food allergen labeling establish non-negotiable compliance obligations for manufacturers. The primary U.S. authority, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), as amended by the FASTER Act of 2021, mandates explicit declaration of nine major food allergens, a requirement which now includes sesame. This legislation requires plain language naming for allergens and permits disclosure using either an inline parenthetical format within the ingredient list or an adjacent “Contains” statement format. Meanwhile, European Union regulations, chiefly Regulation (EU) No 1169/2011, are more expansive, identifying a total of fourteen major allergens requiring declaration. The EU uniquely mandates typographical emphasis, such as bolding or underlining, for allergenic ingredients listed and specifies a minimum font size of 1.2mm for mandatory particulars. While FALCPA generally exempts highly refined oils derived from major allergens, such specific carve-outs are narrowly defined. Beyond finished product labeling detailed in 21 CFR Part 101.9, broader food safety mandates under 21 CFR Part 117 compel manufacturers to implement robust preventive controls. This operational requirement mandates cross-contact prevention measures throughout production and also necessitates a rigorous supplier allergen verification program to ensure the integrity of raw materials and mitigate undeclared allergen risks from the supply chain.
Pillar: Food & Hospitality · Authority: US Food and Drug Administration (FDA) · Version: 1.1.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-101
SHA-256 integrity: d0244f237da66a7bdc562bf8d4075309099310d8ccd74cb8157a8f495089ccbd
Primary Citations — 6 traced to source
- Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), Public Law 108-282, Title II
- Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021, Public Law 117-11
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