We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.
QSS works with animal food ingredient companies from initial ingredient assessment through dossier preparation and engagement with FDA's Center for Veterinary Medicine (CVM), helping determine whether GRAS is the right pathway, what it requires, and how to build a submission that holds up to scrutiny. You will know exactly what your company is working with before committing to a pathway.
Generally Recognized as Safe (GRAS) is a designation under the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows a substance to be used in food without going through the formal food additive approval process. Under the Act, animal food is treated the same as human food, meaning that GRAS applies equally to ingredients used in pet food, livestock feed, and other animal nutrition products.
For an ingredient to qualify as GRAS, its safety under the intended conditions of use must be recognized among qualified scientific experts, based on either scientific procedures or a documented history of common use in food before January 1, 1958. For most new ingredients, the scientific procedures basis applies, and the safety data must meet the same evidentiary standard that would be required for a formal food additive approval
Animal food GRAS submissions are reviewed by FDA's Center for Veterinary Medicine (CVM) under 21 CFR Part 570, and they carry an additional layer of complexity compared to human food GRAS: the safety assessment must address not only the target animal but also, where the ingredient is used in food-producing animals, the safety of residues in edible tissues that humans ultimately consume.
QSS evaluates an ingredient against the GRAS criteria under 21 CFR Part 570, determines whether the history-of-use or scientific-data basis applies, identifies what safety data already exists and what gaps remain, and advises on whether GRAS is the right pathway. Where GRAS is not the best fit, QSS can also point toward alternatives such as an Animal Food Ingredient Consultation (AFIC, a process where a company gets FDA feedback on an ingredient before formal submission) or a food additive petition (a more formal FDA approval process).
Our team reviews existing scientific data against CVM‘s requirements, identifies gaps in target animal safety (safety for the specific species the ingredient is intended for), human food safety, or exposure assessment data, and advises on what additional studies or evidence may be needed to complete the dossier.
We prepare the full seven-part GRAS notice required under 21 CFR Part 570, Subpart E. This includes signed certifications, identity and manufacturing information, exposure assessments covering both the target animal and human food safety where relevant, and the written narrative that lays out the scientific basis for the GRAS conclusion.
For companies pursuing a self-affirmed GRAS determination (a GRAS conclusion reached internally, without submitting to FDA), QSS supports assembling and convening an independent panel of qualified scientific experts, making sure the panel’s composition, process, and documentation meet the standard needed for a defensible conclusion.
QSS supports pre-submission engagement with CVM under Guidance for Industry #262 (FDA’s published guidance on this consultation process), helping companies prepare for the meeting, interpret CVM’s feedback, and fold that feedback into the dossier before formal submission.
We manage submission of the GRAS notice to CVM and supports follow-up communication throughout the review period, including responses to CVM questions and any requests for additional data.
The right animal ingredient GRAS pathway depends on how much time is available, whether the underlying safety data can be made public, and how much marketplace confidence the ingredient needs from day one. Here's how the three options compare.
No FDA submission required
| Timeline | Fastest |
|---|---|
| Confidentiality | Stays private |
| Market confidence | Lower |
| Needs | Expert panel |
Voluntary FDA review
| Timeline | 180 + 90 days |
|---|---|
| Confidentiality | Public record |
| Market confidence | Higher |
| Needs | Full 7-part dossier |
Formal FDA approval
| Timeline | Longest |
|---|---|
| Confidentiality | Data can stay private |
| Market confidence | Highest |
| Needs | Binding regulation |
Both routes end in a GRAS conclusion, but they differ in process and visibility. Self-affirmed GRAS means a company puts together a complete dossier, convenes an independent panel of experts, and reaches its own GRAS conclusion without ever submitting to FDA. A GRAS notice means voluntarily submitting that same dossier to CVM, which reviews it and responds within 180 days, typically with a “no questions” letter that becomes part of the public record. The safety data standard is identical either way. Self-affirmation is faster and stays confidential, but a CVM “no questions” letter tends to carry more weight in the marketplace, since many retailers and manufacturers expect that FDA has reviewed a new ingredient before they will use it.
The process and evidence standard are nearly identical, but animal food GRAS adds two extra considerations. First, the safety review must show the ingredient is safe for the specific species it is intended for (target animal safety). Second, if the ingredient goes into food-producing animals like cattle, poultry, or fish, the dossier also has to address human food safety, meaning any residue that could show up in meat, milk, or eggs. CVM reviews animal food GRAS notices under 21 CFR Part 570, which is separate from the human food GRAS program run by FDA’s food safety center.
A GRAS notice submitted to CVM needs seven parts under 21 CFR Part 570, Subpart E: signed certifications, identity and manufacturing information, exposure assessments for the target animal and human food where relevant, any self-limiting levels of use, documented history of common use if applicable, a narrative explaining the scientific basis for the GRAS conclusion, and a list of supporting data that separates what is publicly available from what is not. The key safety data behind the conclusion generally needs to be publicly available, since the “generally recognized” standard depends on qualified experts being able to independently review it.
Unpublished or proprietary data can be included as supporting evidence, but the core safety data still needs to be publicly available so outside experts can evaluate it independently. If most of a company’s safety data is proprietary and cannot be published, a food additive petition (a more formal FDA approval path, described below) may be a better fit than GRAS. QSS assesses the available data and advises on the right route before a company commits to a dossier.
CVM has 180 days from the filing date to respond, with the option to extend by up to 90 additional days if more time is needed. In practice, timelines depend on how complex the ingredient is and how complete the dossier is when it’s submitted. A well-prepared submission that addresses CVM’s requirements upfront is the most reliable way to keep the review moving efficiently
Yes, self-affirmed GRAS is currently a recognized pathway under FDA regulations. FDA has signaled it may explore rulemaking that would require all GRAS determinations to go through formal notification rather than self-affirmation, but this has not been finalized as of the time of publication. QSS keeps clients informed of regulatory developments that affect their pathway options and advises accordingly.
A food additive petition, a more formal FDA approval process that results in a binding regulation, tends to be the better route when an ingredient’s safety data is mostly proprietary and cannot be published, when the ingredient is novel enough that expert consensus is hard to establish, or when its safety profile is complex enough that a formal approval offers more regulatory certainty than a GRAS conclusion. QSS assesses each ingredient and advises on the pathway that best fits the company’s situation and goals.
Yes. A GRAS determination covers whatever conditions of use are specified in the dossier, which can include pet food, livestock feed, or both. The target species and intended use are defined in the submission, and the safety assessment addresses each one. If an ingredient is intended for both companion animals and food-producing animals, the dossier needs to cover the full scope of that use, including human food safety for the food-producing species.
Talk to a specialist about your SaMD compliance pathway — whether you are determining classification for the first time or preparing a submission for the U.S. market.