Introduction to GRAS:
Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have to be. This comprehensive guide gives you a detailed overview of GRAS ingredients and the regulations governing their use in food products, so you can get up to speed quickly.
What Are GRAS Ingredients?
GRAS stands for “generally recognized as safe,” and it refers to food ingredients that have been deemed safe by a qualified expert panel. Under the Federal Food, Drug, and Cosmetic Act, the FDA recognizes certain ingredients as GRAS if the scientific data and information in the form of published studies demonstrate that there is a general recognition of safety among qualified experts.
What’s Required with Labeling of GRAS Ingredients?
GRAS-related labeling requirements depend on the GRAS ingredient, its intended use, and FDA regulations. Generally, product labels and advertisements must accurately reflect the nature of the GRAS ingredients used in food products. GRAS substances must be listed alphabetically, identified with their common or usual name on a product’s label, and include a description of the substance’s functional use in the food. Additionally, important safety information about potential hazards associated with certain GRAS ingredients must be included on product labels.
What are the Safety Risks With GRAS Ingredients?
It’s important to consider potential food safety risks associated with the use of GRAS substances in the manufacturing of food products. Some common risks may include contamination, spoilage, or overuse of GRAS ingredients, which can result in an adulterated product and pose health hazards. To mitigate these risks, manufacturers must adhere to current Good Manufacturing Practices (GMPs) for ensuring each ingredient is safe for human consumption.
What are the considerations before making a GRAS Determination?
Before you make a GRAS determination, there are several factors you should consider. For example, self-GRAS determinations require extensive research regarding the safety of your ingredient, including toxicological data and evidence that it is likely to be safe for its intended use. Companies must also keep records of their assessments and be able to provide manufacturers with an up-to-date list of safe food additives. In addition, after a product has been manufactured with a GRAS-determined ingredient, companies must ensure they adhere to current label regulations.
What are the reporting requirements for GRAS Substances?
Companies making GRAS determinations must comply with the reporting requirements outlined in the Generally Recognized as Safe (GRAS) regulations. Under these rules, companies are required to annually report the amount of GRAS substances used, as well as any safety studies or other relevant information used in making their assessments. Companies must also provide manufacturers with a list of current ingredients they have determined to be GRAS and must keep records of their assessments. In addition, after a product has been manufactured using an ingredient that has been generally considered safe for its intended use, companies must adhere to the correct labeling regulations established by the Food and Drug Administration (FDA).
Conclusion:
The NDI pathway is a possible pathway for a probiotic ingredient found in the food supply. The NDI pathway is only applicable to dietary supplement usage and does not extend to regulatory compliance for use in conventional food products. The NDI pathway allows for more protection of proprietary information.
The GRAS pathway is a possible pathway for a probiotic ingredient found in the food supply and one derived from non-food sources. The GRAS pathway requires pivotal safety data to be publicly available. A conclusion of GRAS may or may not be notified to FDA. Suppose a probiotic is GRAS and placed into the food supply. In that case, the probiotic may be used in a dietary supplement as a new dietary ingredient without the required NDI notification, provided the dietary supplement does not contain significantly higher levels of the NDI than is used in already established conventional foods or does not exceed the levels established as safe in a GRAS conclusion.
Determining the best pathway to regulatory compliance can seem overwhelming but considering the above factors can direct you to the most appropriate path for your specific novel probiotic. RNI is also available to help you determine the best path forward based on your ingredient needs and goals and can support the development of your GRAS and NDIN dossiers for regulatory compliance. Learn more about self-affirmed GRAS here:
How Quality Smart Solutions can help:
We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.
Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labeling projects. Our specialists are here to help with the following services: Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!
