# Zinc Oxide > Source URL: https://additivefacts.com/additives/zinc-oxide > Markdown URL: https://additivefacts.com/additives/zinc-oxide.md **Safety rating:** SAFE **CAS number:** 1314-13-2 **Category:** colorant **FDA GRAS:** no **Adverse events (FDA AERS):** 0 **FDA recalls:** 0 **Last updated:** 2026-04-04 ## Summary Zinc oxide is an inorganic compound used in food as a colorant and nutrient supplement. It provides white coloring to food products while also serving as a source of bioavailable zinc, an essential mineral for human health. ## Regulatory status | Country | Status | | --- | --- | | United States | approved | | European Union | not_evaluated | | United Kingdom | approved | | Canada | approved | | Australia | approved | | Japan | approved | | South Korea | approved | | Brazil | approved | | China | approved | | India | approved | ## Detailed analysis ## What is Zinc Oxide? Zinc oxide (ZnO) is an inorganic chemical compound with the CAS number 1314-13-2. It is a white powder that occurs naturally in mineral form and is synthetically produced for various industrial and food applications. In food manufacturing, zinc oxide functions as both a colorant—providing bright white coloration—and a nutrient supplement that contributes bioavailable zinc to food products. ## Common Uses Zinc oxide is used in food applications primarily in fortified grain products, cereals, and nutritional supplements where zinc enhancement is desired. The white color and nutrient functionality make it suitable for products where both aesthetic and nutritional improvements are objectives. In the United States, zinc oxide has a long history of use in food fortification programs, particularly in enriched flour and grain-based foods. Outside of food, zinc oxide is widely used in pharmaceutical preparations, cosmetics, and industrial applications. However, food-grade zinc oxide must meet specific purity standards and regulatory requirements distinct from industrial-grade material. ## Safety Assessment Zinc is an essential trace mineral required for immune function, protein synthesis, wound healing, and numerous enzymatic processes. The FDA has established Recommended Dietary Allowances (RDAs) for zinc: 11 mg/day for adult men and 8 mg/day for adult women. When used as a food additive and nutrient supplement, zinc oxide presents minimal safety concerns when consumed at appropriate levels. Excessive zinc supplementation can lead to adverse effects including nausea, copper deficiency, and neurological symptoms, but these occur at intakes substantially above normal dietary levels and the tolerable upper intake level (UL) of 40 mg/day for adults established by the National Institutes of Health. According to FDA records, there have been zero adverse events reported and zero recalls associated with zinc oxide as a food additive, indicating a substantial safety history in food applications. The compound is not listed as a Generally Recognized as Safe (GRAS) substance by the FDA, meaning it does not have blanket GRAS status; however, its use in specific food categories may be approved through food additive regulations. ## Regulatory Status In the United States, zinc oxide is regulated as a food additive and nutrient supplement under 21 CFR 182.8991, where it is permitted for use in specified food categories. The FDA permits its use in fortification of grain products and other designated foods at levels necessary to achieve the intended nutritional benefit without exceeding safe intake levels. The European Food Safety Authority (EFSA) permits zinc oxide as a food additive under E558 classification in certain applications. Regulatory approval varies by country and specific food application, with most regulatory bodies recognizing its safety when used appropriately for fortification purposes. ## Key Studies Scientific literature supports zinc's essential role in human nutrition and demonstrates the bioavailability of zinc oxide when consumed as part of fortified foods. Research published in the American Journal of Clinical Nutrition and similar peer-reviewed sources confirms that zinc fortification effectively addresses zinc deficiency in populations with inadequate dietary zinc intake. Studies on zinc oxide bioavailability show it is effectively absorbed and utilized by the body when incorporated into food matrices. Long-term safety data from populations consuming zinc-fortified foods demonstrates the safety profile of zinc oxide at permitted fortification levels. ## Brands using Zinc Oxide - Bimbo (13 products) - KSF Acquisition Corporation (8 products) - Bimbo Bakeries USA, Inc. (5 products) - Earth's Best (5 products) - Hormel Foods Corporation (4 products) - Rexall Sundown, Inc. (4 products) - Post Consumer Brands, LLC (3 products) - Associated Wholesale Grocers, Inc. (2 products) - Body Armor Nutrition, LLC (2 products) - Rosa Foods, Inc. (2 products) - Special K (2 products) - The J.M. Smucker Company (2 products) - The Quaker Oats Co./gatorade-Van Camp (2 products) - Wal-Mart Stores, Inc. (2 products) - bimbo (2 products) - Abbott Laboratories Inc (1 product) - American Gourmet Foods LLC. (1 product) - Circle K Stores Inc. Division of Alimentation Couche-Tard (1 product) - Clif Bar and Company (1 product) - Conagra Brands, Inc (1 product) - Fabrica De Galletas La Moderna (1 product) - Fareway Stores, Inc. (1 product) - Froot Loops (1 product) - General Mills, Inc. (1 product) - Gerber (1 product) - Gilster Marylee C/o Ko-Pak Inc. (1 product) - Health Management Resources Corporation (1 product) - Jif (1 product) - Ka'chava (1 product) - Kellogg's (1 product) ## Sources - FDA Substances Added to Food (CFSAN) - OpenFDA Adverse Event Reporting System (AERS) - OpenFDA Food Recalls - EFSA OpenFoodTox - EU Food Additive Portal ## Citation Additive Facts. "Zinc Oxide — Safety, regulation, and evidence." https://additivefacts.com/additives/zinc-oxide. Accessed 2026-05-20.