SCOGS reports and FDA's five GRAS safety conclusion types
SCOGS means Select Committee on GRAS Substances. Learn what its five historical conclusions mean and how to find FDA reports for ingredient checks.
SCOGS stands for Select Committee on GRAS Substances, an independent expert committee that evaluated food-substance safety for FDA. Its reports are historical scientific evaluations, not a complete current GRAS list or blanket approval for every use. FDA describes the reviews in its history of the GRAS list and SCOGS.
GRAS means generally recognized as safe. For ingredient checks, the useful distinction is between a committee's safety opinion and the regulatory conditions for a particular use. FDA reviewed SCOGS reports separately and, where appropriate, pursued rules affirming specified uses as GRAS. The committee's conclusion was not itself that regulatory action, as FDA's history explains.
What the five SCOGS conclusion types mean
FDA groups the opinions into five types. In these definitions, use levels refer to the historical evaluation, not today's consumption. The table paraphrases FDA's full conclusion definitions.
| Type | Meaning of the historical conclusion |
|---|---|
| 1 | Available information did not show, or give reasonable grounds to suspect, a public hazard at then-current or reasonably expected future use levels. |
| 2 | No hazard was demonstrated at then-current levels and practices. Without more data, the committee could not assess whether a significant consumption increase would pose a dietary hazard. |
| 3 | No hazard was demonstrated at then-current levels and practices, but uncertainties required additional studies. |
| 4 | Evidence was insufficient to determine that reported adverse effects would not harm public health at former use levels and practices. |
| 5 | An almost complete lack of biological studies left too little information to evaluate safety for the intended use. |
These are not approval grades. Type 1 does not establish safety at any dose, while Types 4 and 5 do not establish a ban. Keep the distinction between Types 2 and 3: increased consumption is the specific uncertainty in Type 2. Type 3 calls for studies to resolve uncertainties. Read the full FDA wording before relying on a shortened label.
How to find an FDA SCOGS report
Start with the ingredient name in the FDA SCOGS database. Its search fields include substance name, CAS number or other ID, report number, conclusion type, report year, CFR regulation and NTIS accession number.
- Match the substance's identity. Check the CAS or other-ID field carefully: it can contain a CFSAN-assigned identifier rather than a CAS number.
- Record the report number, year and conclusion type. For example, the database lists acetic acid, identifier 64-19-7, under report 82 from 1977, with conclusion Type 1.
- Save the NTIS accession number. The acetic-acid row gives PB274670. This identifies the report for retrieval, rather than confirming permission for every current use.
These example fields appear in the FDA database.
FDA says substance-name links open opinions, CFR links lead to regulations and NTIS links lead toward complete reports. If a detail link fails, retain the report and accession numbers. Follow the accession link or search the National Technical Reports Library. The database opinion is not the complete report. FDA directs readers to NTIS for reports containing the underlying safety-study details.
Does a SCOGS entry confirm current GRAS status?
No. GRAS concerns safety recognized among qualified experts under the conditions of intended use, according to FDA's GRAS overview. A historical opinion does not automatically transfer to another food category or exposure level.
For a formulation review, start by matching the evaluated use and reading applicable current CFR conditions. Check relevant GRAS notices, response letters and later FDA actions using FDA's GRAS resources. Use the full report when its assumptions affect your decision. This is a practical review approach, not an FDA-prescribed checklist.
Absence from SCOGS does not establish that a use is prohibited. FDA says the historical review omitted many substances marketed on manufacturers' independent GRAS conclusions. RegAffairs AI's SCOGS answer explains the conclusion types and report lookup.