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An acronym used by the U.S. Food and Drug Administration for Generally Recognized as Safe, which means that a substance has been determined by qualified experts to be safe under the conditions of its intended use based on publicly available information. Examples of GRAS ingredients include vanilla, cinnamon, basil, sesame, caramel, mustard, oregano, poppy seeds, ginger, dill, parsley, licorice, spearmint and plant sterols.
Establishing that an ingredient is Generally Recognized as Safe (GRAS) for use in a food or beverage is a multi-step process. It requires:
A review of this process was published in the journal Regulatory Toxicology and Pharmacology and is available for download at www.caloriecontrol.org.
The FDA provides an explanation of the GRAS process.
"GRAS" is an acronym for the phrase Generally Recognized As Safe. Any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.
The use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
General recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.
A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. As FDA discussed in a proposed rule to establish a voluntary notification program for GRAS substances, the data and information relied on to establish the safety of the use of a GRAS substance must be generally available (e.g., through publication in the scientific literature) and there must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use. Thus, the difference between use of a food additive and use of a GRAS substance relates to the widespread awareness of the data and information about the substance, i.e., who has access to the data and information and who has reviewed those data and information.
For a GRAS substance, generally available data and information about the use of the substance are known and accepted widely by qualified experts, and there is a basis to conclude that there is consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.
WAYZATA, Minn., [December 17, 2008] — Today, Cargill received official notification from the U.S. Food and Drug Administration (FDA) stating that the agency has no objection to the conclusion of an independent expert panel which reviewed research that rebaudioside A (rebiana), the identity in Truvia™ rebiana, is generally recognized as safe (GRAS) for use as a general purpose sweetener. The FDA letter affirms and supports rebiana’s safety and the data used to make that determination.
“Given the extensive research conducted to assure the safety of Truvia™ rebiana, Cargill has tremendous confidence in the product. The FDA letter further validates what the science has concluded – that Truvia™ rebiana is safe for use for all consumers,” said Marcelo Montero, president, Cargill Health & Nutrition. “The FDA brought the appropriate rigor to the process and we are extremely pleased with the news.”
Truvia™ rebiana is a well-characterized, high-purity ingredient derived from the best tasting part of the stevia leaf. Cargill has spent the past five years developing the product to its specifications and working to produce the ingredient on a commercial scale. The high-purity ingredient - Truvia™ rebiana - is consistent in quality and composition. The FDA letter and the safety studies for Truvia™ rebiana pertain to only the high-purity products that meet the established criteria and not to all stevia.
In June 2008, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) conducted a multi-year review of all the available scientific and clinical data on high purity steviol glycosides, including rebiana. In July 2008, the Committee determined that high purity, food-grade rebiana is safe for its intended use as a general-purpose sweetener, and established a permanent Acceptable Daily Intake (ADI). (http://www.fao.org/ag/agn/agns/files/jecfa69_final.pdf)
Cargill submitted a GRAS notification to the FDA on May 15, 2008. Prior to this, an independent expert panel convened in March 2008 to review the comprehensive safety dossier for rebiana that also included safety assurance of composition and quality of rebiana. The panel unanimously affirmed that rebiana is safe for its intended use as a general-purpose sweetener. Cargill published all the safety studies for scientific and public comment.
Cargill enlisted leading scientists to design and conduct a rigorous safety evaluation program for Truvia™ rebiana – the first such program to test a well-characterized, high-purity form of rebaudioside A. The comprehensive design of the studies and the peer-review process were the foundation of the research program for rebiana. These peer-reviewed, scientific studies, published in the scientific journal Food and Chemical Toxicology establish the safety of Truvia™ rebiana. Cargill is the only petitioner to the FDA that has made the safety dossier for rebiana publicly available as part of its GRAS notification.
Stevia is a shrub in the chrysanthemum family that is native to northeastern Paraguay. First discovered by natives of Paraguay, the plant has been grown, harvested and used in South America to sweeten foods and beverages for more than 200 years. The stevia leaf is a good source of natural, zero-calorie sweetness. Due to the fact that there are more than 200 varieties of the stevia plant, all stevia is not the same and stevia products currently on the market vary in their production, composition, purity level and sensory or taste characteristics. Cargill has applied its global expertise and knowledge in agriculture and agronomy to identify the varieties of stevia that will produce the best plants for each geography. Truvia™ rebiana comes from only from the best-tasting components of the stevia leaf and is a high-purity sweetener that is consistent in quality and taste.
“The search for a great tasting natural, zero calorie sweetener has been underway for more than three decades,” added Zanna McFerson, business director for Cargill Health and Nutrition. “Consumer demand for non-caloric, natural sweeteners has increased over the years. Truvia™ natural sweetener is the first great tasting natural zero calorie sweetener available in the U.S. to meet that growing consumer demand.”
About Truvia™ natural sweetener and ingredient
Truvia™ natural sweetener is a great tasting, natural, zero calorie tabletop sweetener, made with rebiana, derived from the best tasting part of the stevia leaf. Truvia™ natural sweetener is also an ingredient used to sweeten foods and beverages. For more information, visit www.truvia.com.
About Cargill
Headquartered in Minneapolis, Minn., Cargill is an international provider of food, agricultural and risk management products and services. With 160,000 employees in 67 countries, the company is committed to using its knowledge and experience to collaborate with customers to help them succeed. For more information, visit http://www.cargill.com.
The European Food Safety Authority (EFSA) today published a Scientific Opinion, which confirms that steviol glycosides, sweeteners extracted from the stevia plant, are safe for use in foods and beverages and establishes an Acceptable Daily Intake (ADI) for their safe consumption. Truvia™ tabletop sweetener, the U.S. market leader in the new category of stevia-based sweeteners is made with rebiana, which is 97% pure rebaudioside A, the best-tasting part of the stevia leaf and one of the steviol glycosides assessed by EFSA. Truvia™ rebiana, which is 200 times sweeter than sugar, opens up a whole new range of choices for food and beverage companies to create products with sweetness from a natural source without calories.
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