Our Verdict: USE WITH CAUTION

Bromelain

CAS9001-00-7

Some regulatory concerns have been raised

This additive has been flagged by at least one major regulatory agency or peer-reviewed study. Review the evidence below before forming conclusions.

Adverse Events

39

FDA CFSAN

FDA Recalls

2

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Bromelain — food additive

Bromelain is a proteolytic enzyme extracted from pineapple stems and fruit. In food manufacturing, it functions as a flavor enhancer, texturizer, and processing aid, primarily used in meat tenderization and beverage production.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

39

FDA CFSAN

FDA Recalls

2

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Bromelain?

Bromelain (CAS Number: 9001-00-7) is a naturally occurring protease enzyme complex derived from pineapple plants (Ananas comosus). The enzyme breaks down protein bonds, which is why it has been used traditionally in food preparation and modern food manufacturing. Bromelain exists naturally in pineapple juice and stem tissue, where it serves as part of the plant's natural metabolism.

Common Uses

In the food industry, bromelain is employed primarily as:

- **Meat Tenderizer**: The enzyme's protein-degrading properties break down muscle fibers, making meat more tender and easier to cook

- **Flavor Enhancer**: By breaking down proteins into smaller peptides and amino acids, bromelain can intensify savory and umami flavors

- **Processing Aid**: Used in beverage production, particularly in juice clarification and processing

- **Texturizer**: Helps modify the texture of various food products by altering protein structure

Common food applications include processed meat products, marinades, canned fruits, and certain beverages.

Safety Assessment

Bromelain has not received GRAS (Generally Recognized as Safe) status from the U.S. FDA, though it is permitted in certain food applications under specific regulations. The FDA database contains 39 adverse event reports associated with bromelain and 2 product recalls. These adverse events are relatively low in number compared to the widespread use of bromelain in food manufacturing, though they warrant consideration.

Adverse events reported have primarily involved allergic reactions in sensitive individuals, particularly those with pineapple allergies or latex cross-reactivity (due to similar allergen proteins). Occupational exposure to bromelain powder has been associated with respiratory irritation and skin sensitization in workers.

For consumers, bromelain is generally recognized as safe when used in normal food quantities. However, individuals with pineapple allergies should be aware of bromelain-containing products. High-dose bromelain supplements (distinct from food-use concentrations) have been associated with gastrointestinal effects and allergic reactions in some individuals, though this is outside the scope of food additive use.

Regulatory Status

Bromelain's regulatory status varies internationally:

- **United States**: Not GRAS-listed; permitted in certain foods under FDA regulations as a processing aid and enzyme

- **European Union**: Approved as a food enzyme under EC Regulation 1332/2008, with specific conditions for use

- **Other Regions**: Approved in many countries including Canada, Australia, and Japan for food manufacturing purposes

The lack of GRAS status in the U.S. does not indicate unsafe use; rather, it reflects that formal GRAS determination has not been completed. The enzyme remains legally permitted in food manufacturing under established food additive regulations.

Key Studies

Scientific literature on bromelain in food applications focuses on its efficacy in meat tenderization and protein modification rather than safety concerns. Research confirms its protein-degrading capabilities and effectiveness as a processing aid. Allergenicity studies have identified bromelain as a cross-reactive allergen primarily concerning individuals with existing pineapple allergies or latex sensitivity.

Occupational safety studies have documented respiratory sensitization in workers with repeated exposure to bromelain powder, leading to workplace handling guidelines in some food manufacturing facilities.

Frequently Asked Questions

What is Bromelain?

Bromelain is a proteolytic enzyme extracted from pineapple stems and fruit. In food manufacturing, it functions as a flavor enhancer, texturizer, and processing aid, primarily used in meat tenderization and beverage production.

Is Bromelain safe?

Bromelain is currently rated "caution" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 39 FDA adverse event reports associated with this additive.

Is Bromelain banned in any country?

Bromelain is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.