This guide will provide you with an overview of the process and what to expect, as well as some of the benefits and drawbacks of pursuing GRAS certification.
What is GRAS Certification?
GRAS (Generally Recognized as Safe) certification is a designation from the U.S. Food and Drug Administration that a product or material meets safety standards. This certification may be necessary if you plan to produce, distribute, or market your products in the United States. In order to obtain GRAS status, a product must demonstrate that it is safe for its intended use before it can be sold legally in the country.
What are the benefits of GRAS Certification?
GRAS certification provides a number of benefits for companies that obtain the designation. Consumers will have increased confidence in products that are backed by evidence-based research, and it’s also a necessary legal requirement for certain companies to operate in the United States. GRAS certification can also provide improvements to production and distribution processes, as well as safeguard against potential lawsuits due to food safety concerns.
What are the challenges of implementing GRAS Certification?
Implementing GRAS certification can be a time-consuming and expensive process, with some companies taking upwards of five years to obtain the designation. There are assessment fees, research costs for data gathering, administrative fees, and other expenses that can add up quickly. Additionally, if a company’s product undergoes any changes, the GRAS certification process typically has to be re-commenced at an additional cost. For some companies, this may present barriers to certification and hinder growth in certain markets.
What Are Key Requirements for GRAS Compliance?
In order to be granted GRAS status, an organization must prove that its products and production methods meet specific criteria set by regulating bodies. Companies must create a detailed application and substantiate their claims with research data. The application should include independently confirmed evidence of the product’s safety, including information on the ingredients and additives being used in the manufacturing process. The process can take anywhere from six months to several years depending on how much research is required before certification is granted.
How to make successful GRAS Applications?
It can seem like a tall task to obtain GRAS certification, and no two applications will be the same. However, by following some key tips, manufacturers can make successful applications much easier and help ensure that their product meets all current regulations and requirements. Start with planning and research, which should involve investigation into any current or pending regulation changes, including ingredient composition, facility specifications, and labeling requirements. Next, work on building out the paperwork for submitting an application with substantiated scientific data collected from industry experts. Lastly, seek support from specialized advisors who understand the process to guide you through any potential roadblocks in order to gain approval of your application.
What are the GRAS Certification Requirements?
Understanding the GRAS certification requirements is an important first step in achieving approval and getting your product to market quickly. Make sure you’re familiar with the necessary documents, such as petitions and equipment tests, that are needed for certification. Additionally, familiarize yourself with any relevant data submissions and other components required by the FDA or other regulating bodies in your jurisdiction. Familiarity with these regulations can streamline contract negotiations and speed up the process of gaining approval.
Research Certified GRAS Ingredients and Safety Data:
Researching certified ingredients and obtaining safety data is an important part of the approval process. Make sure you’re familiar with FDA requirements, including any guidance documents related to GRAS status. Additionally, review your company and product-specific safety assessments to ensure that all safety components are addressed before submitting an application for GRAS certification. This research can help you identify risks, assess potential liabilities, and understand the process required for successful approval.
Analyze Your Product’s Overall Safety Profile With an Expert Evaluator:
Make sure your safety profile is complete by bringing in a qualified expert evaluator. This independent, third party will assess the product’s ingredients and provide objective feedback on any potential risks. Additionally, they can help you understand any additional processes or formalities required by the FDA for GRAS approval. This step is critical for smoothly transitioning from submission to approval and ultimately receiving your certification.
Assemble Your Official GRAS Application Package:
Once you have identified any areas of potential risk and your safety profile is complete, the next step is to compile all the materials into an official application package. This will contain every element that the FDA requires for GRAS certification, including documentation of relevant data and research, a review of potential adverse effects, product labeling details, and other pertinent information. Be sure to double-check that you have included everything needed to ensure a successful submission.
How to submit your GRAS certification application to the FDA for Final Approval?
Now that you have your application package ready to go, it’s time to submit it to the FDA for review. The agency will thoroughly assess all of the data and evidence provided in your submission and make a determination about GRAS classification for your product. Once approved, you can use the official letter from the FDA as tangible proof that your product is safe for human consumption.
Conclusion:
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!
