What is Propyl Gallate? Learn Its Impact on Health & Safety

Propyl gallate is a preservative used in foods like chewing gum, meat products, vegetable oil and more. It helps prevent fat and oil from spoiling and is frequently used together with the food chemicals butylated hydroxyanisole and butylated hydroxytoluene.

Propyl gallate is associated with serious health concerns. Nonetheless, a federal regulatory loophole means the chemical is considered to be “generally recognized as safe,” or GRAS, and continues to be allowed for use in food.

Health concerns

Concerns about propyl gallate and its potential to harm health stem from multiple studies in cells. This research shows it is linked to hormone disruption, interference with the regular functioning of the hormone system that can cause a wide range of health harms. Specifically, propyl gallate can interact with the estrogen receptor, impacting the normal signaling of this important hormone. It may also interfere with normal thyroid function.

Studies from the National Toxicology Program reported that long-term exposure to propyl gallate caused some mice and rats to develop tumors, though the link to cancer needs further research.

Endocrine disruptors 

Propyl gallate is a type of endocrine disruptor – these can be found in thousands of consumer products, including food and food packaging materials.

Endocrine disruptors are natural or synthetic chemicals that can disrupt the hormone system in many ways – increasing or decreasing the production of some hormones and interfering with their signaling. This can lead to health harms that include changes to fertility, early puberty, risk of low birth weight, obesity, diabetes, immune system impacts, cardiovascular and respiratory problems, some types of cancer and neurological and behavioral problems. 

The developing fetus, infants and children are especially vulnerable, since their physiological systems are still developing. 

The GRAS loophole

Propyl gallate is categorized as GRAS, a regulatory loophole that allows food companies to add new, potentially harmful additives to their products without safety review by the Food and Drug Administration. Instead, companies are permitted to bypass federal pre-market review and decide on their own that their chemicals are safe. 

When Congress created GRAS in 1958, it was intended to apply only to ingredients widely recognized as safe, such as salt, water and yeast. Instead it’s led to a regulatory Wild West where food companies police themselves.  

In 1997, the FDA further weakened oversight of food chemicals by creating a voluntary notification system that lets manufacturers bypass federal regulators’ review. Companies can use new GRAS ingredients without informing the FDA. 

Even if a company does choose to notify the agency, it can withdraw the submission for review – effectively shutting it down – if the FDA starts asking questions about the company’s safety data.

Our broken food chemical review system

The U.S. food additive review system repeatedly fails to keep Americans safe. It needs an overhaul if it is to protect us from endocrine-disrupting chemicals like propyl gallate.

State action on food chemicals can help apply pressure to the FDA to act. For example, in 2023, the California Food Safety Act was enacted, banning four harmful additives from food: potassium bromate, propyl paraben, brominated vegetable oil and Red 3. Just one month later, the FDA proposed to revoke the authorization of brominated vegetable oil for use in food. In January, the agency then announced a ban on Red 3 in food.

While we await the passage of more state legislation or new federal action, consumers can minimize exposure to propyl gallate by using these tips:

• Check food product labels and avoid those that contain propyl gallate. Food companies must list this chemical on packaged food ingredient labels.
• Consult EWG’s Food Scores database to find products without propyl gallate and other concerning ingredients. When you’re on the go, use EWG’s Healthy Living app to find products without toxic chemicals.
• Look for packaged foods that are certified organic whenever possible. These products must meet strong standards that protect consumers from exposure to potentially harmful artificial additives.
• Reduce consumption of ultra-processed foods when possible. Many contain concerning ingredients, including other food chemicals that could harm your health.