# Papain (carica Papaya L.)

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**Safety rating:** SAFE
**CAS number:** 9001-73-4
**Category:** texturizer
**FDA GRAS:** yes
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Papain is a proteolytic enzyme derived from papaya fruit (Carica papaya L.) that breaks down proteins in food. It is widely used in the food industry as a texturizer, processing aid, and formulation agent, particularly in meat tenderization and other food applications.

## Regulatory status

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

## Detailed analysis

## What is Papain?

Papain (CAS Number 9001-73-4) is a naturally occurring enzyme extracted from the papaya plant (Carica papaya L.). It belongs to a class of enzymes called proteases, which specifically break down protein bonds through hydrolysis. The enzyme is obtained from the latex of unripe papaya fruit and is subsequently purified for food industry applications. Papain has been used in food processing for decades and remains one of the most commercially important food enzymes globally.

## Common Uses

Papain serves multiple functions in food manufacturing. Its primary application is as a meat tenderizer, where it breaks down collagen and elastin proteins, resulting in more tender meat products. The enzyme is used in both fresh meat marinades and in processed meat formulations. Beyond meat processing, papain functions as a formulation aid in various food products, helping to improve texture and consistency. It is also employed as a processing aid in the production of other food items and serves as a surface-finishing agent in certain applications. The enzyme's proteolytic activity makes it useful in the beverage industry for clarifying protein-based drinks and improving overall product quality.

## Safety Assessment

Papain has an extensive safety history in food applications. The FDA has designated papain as Generally Recognized as Safe (GRAS), indicating that it is considered safe for use in food when used according to established standards. As of current records, there are no adverse events reported to the FDA associated with papain consumption through food, and no recalls have been issued related to this additive. The enzyme is derived from a commonly consumed fruit and functions through the same mechanisms present naturally in the digestive system.

Occupational safety considerations exist for workers in facilities where papain powder is handled, as inhalation of enzyme dust can cause respiratory sensitization in some individuals. However, this represents an occupational exposure concern rather than a consumer safety issue. When consumed as a food additive in processed foods, papain is present in controlled, standardized amounts and is typically denatured during cooking or food processing, which eliminates enzymatic activity.

## Regulatory Status

Papain is approved for use as a food additive in the United States under FDA regulations. It is listed among permitted enzyme preparations in 21 CFR 184.1065. The European Food Safety Authority (EFSA) has also evaluated papain and permits its use in food applications within EU member states. The enzyme is recognized in food safety regulations across most major food-producing nations, including Canada, Australia, and Japan.

The additive is subject to current Good Manufacturing Practice (cGMP) standards. Manufacturers must ensure that papain preparations used in food are of appropriate purity and derived from approved sources. The enzyme is typically used in very small quantities—often measured in parts per million—to achieve the desired processing effect.

## Key Studies

Scientific literature supporting papain's safety includes decades of use data in traditional cuisine, particularly in Central and South American countries where papaya is native. Toxicological studies have not identified significant safety concerns for dietary exposure to papain at levels used in food processing. The enzyme's mechanism of action—protein hydrolysis—is well-understood and matches natural digestive processes.

Research on papain's efficacy in meat tenderization has consistently demonstrated its effectiveness compared to mechanical tenderization methods. Studies examining the enzyme's behavior in food matrices show that papain is typically inactivated during thermal processing or at pH extremes, limiting its activity in the final food product. This self-limiting characteristic further supports its safety profile in food applications.

## 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. "Papain (carica Papaya L.) — Safety, regulation, and evidence." https://additivefacts.com/additives/papain-carica-papaya-l. Accessed 2026-05-14.