What does GRAS mean?
GRAS is the acronym used in food manufacturing and regulatory circles for the phrase “Generally Recognized as Safe.” It’s an FDA (United States Food and Drug Administration) designation for individual chemicals or substances added to food products that experts deem safe under the conditions of its intended use. Or more generally it is a status label identifying ingredients known to be non-hazardous to health and approved for use in foods.
Need to make a submission?
Learn about using our GRAS Notification Dietary Exposure Software for your exposure assessments and submission.
How do I get GRAS certified / approval?
For an ingredient / food additive to be GRAS, the scientific data and information about the use of a substance must be widely known and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.
In Self Affirmed GRAS, a company convenes a panel of experts to evaluate the safety of a specific ingredient and then submits a GRAS Notification to the FDA outlining the case how the use of that substance is GRAS.
The FDA reviews that information provided and responds to the company whether it agrees with the basis of GRAS determination.
How does the U.S. FDA’s GRAS Program Work?
Broadly a food additive / ingredient is any substance added to food during its production, including processing / manufacturing, treatment, and also packaging, transportation and storage. In 1958 Congress and the FDA established a federal rule that all additives must be evaluated and approved via a set process before being used in food products.
- The food additive or ingredient is generally recognized by experts as safe based on their long history of use in food prior to 1958 or
- Based upon published and widely available scientific evidence, they can be labeled as GRAS, and are not subject to premarket approval.
Companies can make a submission to the FDA detailing why the ingredient falls into the above two categories and apply for GRAS status.
Need to make a submission?
Learn about the Creme Global GRAS Notification Dietary Exposure Software and avoid the most common submission pitfalls.
How to Submit a GRAS Notice to the FDA?
The GRAS notification program provides a voluntary mechanism whereby a person may inform FDA that the use of a particular substance is GRAS (Generally Recognized as Safe).
A person or company must have convened a panel of experts to assess the safety of a particular ingredient and then informed the FDA with their evidence and argument that the use of a substance is GRAS.
You can find full details of the GRAS submission process here.
And a link to all the required GRAS forms are here.
Prior to submission you may also request a meeting with FDA to discuss issues that may be relevant to the submission of the GRAS notice.
What to include in your GRAS submission:
- A summary of your claim on why the substance is GRAS.
- A succinct description of the substance/ingredient
- The applicable conditions of use
- The basis for the GRAS determination (expert scientific panel or common use in food).
- The notice should also include information about the identity and properties of the substance and a discussion of your reasons for concluding that the substance is GRAS for its intended use.
- The notifier should discuss the information supporting the GRAS determination,
- As well as any information that would appear to be inconsistent with a GRAS determination,
- And in summary explain why, in light of all the information provided, there is an overwhelming conclusion that the substance is GRAS under the specified conditions of use.
After submission the FDA will inform you that they received your submission. Usually about 30 days but it does depend on how busy they are. They try to respond in full to your submission within 180 days but realistically this can take up to a year.
They then review and evaluate your submission based on the information you provided. On occasion the FDA may consult with other government agencies with specific knowledge of the substance or food type submitted.
At the end of the process, the FDA will reply via letter with one of three type of responses.
- The first type of response is positive and states that the FDA does not question your basis for the GRAS determination. This response may specify requirements around use and labeling.
- The second type informs you that your case is not enough to achieve a GRAS status. Maybe because you do not have enough or the right information. Or the data raises other questions about the safety of the specified substance.
- And if you decide to cancel the submission, the third type of response simply confirms this.
How long does GRAS approval take?
Once submitted, the FDA will respond to a GRAS notification within 180 days but depending on how busy they are the response can take up to a year.
What substances are considered GRAS?
A GRAS substance is a substance considered safe by experts and thus does not require a pre-market review.
To date 1068 submissions have been received by the FDA and their resulting letter and GRAS status can be found here.
Need to make a submission?
Learn about our GRAS Notification Dietary Exposure Software and our expert services in carrying out exposure assessment work using our models.
What is an exposure assessment for GRAS?
Creme Global has long been at the forefront in the advancement of exposure models for a range of industries, from food to cosmetics.
As defined by the United States Environmental Protection Agency (EPA), a human health risk assessment is ‘the process to estimate the nature and probability of adverse health effects in humans who may be exposed to chemicals, now or in the future.’ But what is risk?
Risk is defined as hazard the probability of exposure, or put another way:
Risk = Hazard X p(Exposure).
A hazard is described as the inherent property of an agent having the potential to cause adverse effects in an organism exposed to the agent, whereas a risk is the probability of an adverse effect in an organism caused by exposure to an agent.
Specifically, exposure describes both the amount of, and the frequency with which, a chemical substance comes into contact with a person, group of people or the environment. From the perspective of a company placing a product on the marketplace, proper understanding of hazard and exposure has wide ranging implications. It impacts product formulation, the conditions of use, and any safety claims or warning requirements – because it fundamentally describes how and under what circumstances a product can be used safely.
By working with Creme Global, you will gain key exposure insights to identify and manage emerging risks before your GRAS submission.
GRAS Notification Dietary Exposure Software
Need GRAS submission support? With over 15 years of experience, Creme Global provides an expert service to conduct the dietary exposure assessment for you, from worst-case to refined-case scenarios. Our models incorporate NHANES data.
We provide the key data for Part 3 of your GRAS notice, estimating the dietary exposure to the use level of your notified substance that includes exposure from all intended uses and sources in the diet (covering all or some parts (a)-(c) 170.235).
The results provide you with:
- The results. Is your substance GRAS?
Brief technical report with methodology.
- Results tables, per food category or cumulative exposure.
- Key findings from our exposure experts
- The exposure data to support your GRAS notification.
Includes a free license to Creme Global’s Dietary Intake Intelligence Tool (DIIT).
Pre-assessed dietary intake data is presented in a user-friendly, interactive dashboard with easy dropdown selections of nutrient data which can be grouped together or reviewed individually and graphed by:
- Food groups (~250 groups)
- Nutrients (60+ nutrients from the FNDDS database)
- Age categories
This dietary screening tool enables you to quickly drill down into the installed database, looking at mean intakes as well as selected percentiles of intakes.
The outputs can be segmented by age group, sex, standard population statistics (such as the mean and P90), consumer-only intake, per capita intake (and associated errors).
Training 2 hour online training session with Creme Global’s Dietary Exposure Assessment Experts.
Technical Support Creme Global software is run on Cloud computing – all computer hardware, support and maintenance is included for the period of the license.
Scientific Support Creme Global experts are available by phone or email during business hours for technical and scientific questions on Creme Global software.