# Menthyl Pyrrolidonecarboxylate

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**Safety rating:** UNKNOWN
**CAS number:** 52528-10-6
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Menthyl Pyrrolidonecarboxylate (CAS 52528-10-6) is a synthetic organic compound with an unclear functional role in food applications. Currently, this additive lacks FDA GRAS status and has minimal documented use in food products.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | not_evaluated |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is Menthyl Pyrrolidonecarboxylate?

Menthyl Pyrrolidonecarboxylate is a synthetic chemical compound identified by CAS number 52528-10-6. It is composed of menthol, a naturally-derived cooling agent, chemically bonded to a pyrrolidonecarboxylate moiety. The resulting compound represents a modified version of menthol with altered chemical properties compared to the parent compound.

The exact structure combines menthol's characteristic cooling sensation properties with a pyrrolidone ring system, creating a molecule distinct from both menthol and pyrrolidonecarboxylic acid alone. This hybrid structure suggests potential applications in flavoring or sensory modification, though its precise intended function in food systems remains undocumented in available scientific literature.

## Common Uses

The documented use of Menthyl Pyrrolidonecarboxylate in food applications is extremely limited. Unlike menthol, which appears widely in candies, beverages, and flavoring applications, this specific derivative has not established a significant market presence in food products. The lack of FDA GRAS (Generally Recognized as Safe) status suggests either minimal commercial adoption or insufficient safety data submission to the agency.

Any applications would theoretically relate to flavoring or sensory enhancement given the menthol component, but such uses remain theoretical rather than documented in commercial food manufacturing.

## Safety Assessment

Safety data for Menthyl Pyrrolidonecarboxylate is limited. The FDA has recorded zero adverse events associated with this additive and zero product recalls, indicating either minimal exposure in the food supply or absence of documented health complaints. However, the absence of adverse event reports does not constitute positive safety confirmation—it reflects the lack of widespread use rather than established safety.

The compound has not undergone the formal safety assessment required for GRAS status. Unlike menthol, which has extensive toxicological data supporting its use as a food flavoring, Menthyl Pyrrolidonecarboxylate lacks comparable documentation. Toxicological studies would need to address absorption, metabolism, distribution, and potential systemic effects, none of which appear in the public record.

Because this is a synthetic modification of menthol, the toxicological profile cannot be directly extrapolated from menthol's safety record. Chemical modifications can produce unexpected biological effects, requiring independent evaluation.

## Regulatory Status

Menthyl Pyrrolidonecarboxylate does not hold FDA GRAS status, meaning it cannot be legally used in food without premarket approval or authorization under another regulatory pathway. It does not appear on the FDA's approved food additives list, color additives list, or indirect additives list.

In the European Union, this compound is not listed among approved food additives, flavor compounds, or processing aids. International regulatory databases show minimal to no regulatory history for this substance in food applications.

The lack of regulatory approval worldwide suggests either no commercial development or insufficient business interest to pursue the regulatory approval process. Manufacturers wishing to use this additive would need to file a Food Additive Petition with the FDA, providing comprehensive safety and manufacturing data.

## Key Studies

No peer-reviewed safety studies specifically evaluating Menthyl Pyrrolidonecarboxylate in food applications appear in the scientific literature accessible through PubMed or other major databases. The compound may have industrial or cosmetic applications with associated research, but food safety evaluations have not been published.

Without toxicological, kinetic, or dietary exposure studies, no evidence-based safety conclusion can be drawn. The scientific community has not established acceptable daily intake levels, maximum use levels, or food categories where this additive might be appropriate.

Future regulatory approval would require submission of studies addressing acute and chronic toxicity, genotoxicity, reproductive/developmental toxicity, and other standard safety endpoints required for food additives.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Menthyl Pyrrolidonecarboxylate — Safety, regulation, and evidence." https://additivefacts.com/additives/menthyl-pyrrolidonecarboxylate. Accessed 2026-05-19.