Is Solein safe to eat? What is the GRAS process in the United States and how do we ensure the safety of our product?
Every new food or ingredient goes through official approval processes and tests determined by local authorities before it can be sold or used in a food product. This is standard procedure and ensures that Solein is 100% safe for consumers.
Solein received its first novel food regulatory approval in September 2022 in Singapore. In the United States, GRAS (Generally Recognized as Safe) status is a common way to meet regulatory requirements for ingredients added to food, to confirm their safety and protect public health under intended conditions of use. Solein® obtained an Independent Conclusion of GRAS (Generally Recognized As Safe) status also known as self- affirmed GRAS status in the United States in September 2024.
A key part of GRAS documentation is the “Intended Uses” section, which specifies how the ingredient will be used, including the types of food it will be added to, the addition level of the ingredient, and who the product is intended for (for example adults, children, or infants). Safety assessments evaluate whether these uses could lead to excessive or unsafe consumption when combined with other dietary sources.
To determine the overall estimated exposure of the ingredient to consumers and ensure that the level is safe, experts rely on the intended uses along with dietary data (for example NHANES studies in the United States or other data on use patterns). The experts assess typical consumption patterns and consider intake at high levels. This is put in the context of safety data (such as toxicological studies) to determine if the high levels are reasonably certain to be safe.
This very thorough approach ensures the ingredient remains safe even for those with above-average consumption. The GRAS process confirms that intended uses keep exposure within safe levels. Overall, the GRAS process safeguards public health by ensuring safe consumption of new food ingredients, even for consumers with a high intake.
Solar Foods is also seeking novel food approvals for Solein in the EU and the UK.
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