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What is the Food Code for Propylene Glycol? E1520, FDA, and Safety Explained

4 min read

The U.S. Food and Drug Administration (FDA) has classified food-grade propylene glycol as "Generally Recognized as Safe" (GRAS) for use as a direct food additive under specific conditions. This synthetic substance is regulated by different food codes worldwide, impacting how it appears on product labels.

Quick Summary

Explores the food codes for propylene glycol, detailing the U.S. FDA's GRAS status and Europe's E1520 number. Clarifies its function as a food additive and examines the safety regulations and applications in the food industry.

Key Points

  • International Codes: Propylene glycol is identified as E1520 in the EU and regulated under 21 CFR § 184.1666 (GRAS) in the US, with INS number 1520 from Codex Alimentarius.

  • Primary Functions: It acts as a humectant, solvent, emulsifier, and stabilizer in various food products like flavorings, baked goods, and dressings.

  • FDA vs. EFSA: The FDA sets maximum levels per food category, while the EFSA uses an Acceptable Daily Intake (ADI) of 25 mg/kg body weight.

  • Grades of Propylene Glycol: Only food-grade (USP/EP) propylene glycol is safe for use in food, not industrial versions.

  • Not Ethylene Glycol: It is a distinct, non-toxic substance and should not be confused with the highly toxic ethylene glycol, which is used in conventional antifreeze.

  • Allergy Potential: A small number of individuals may experience allergic contact dermatitis from PG, so checking labels is advised for sensitive individuals.

  • Safety: Toxicity from food consumption is extremely rare, though high-dose medical applications require careful monitoring for at-risk individuals.

In This Article

Propylene glycol (PG), also known as propane-1,2-diol, is a synthetic organic compound used across various industries, from food and cosmetics to pharmaceuticals. In the food industry, this colorless, odorless liquid is valued for its ability to absorb water, making it an excellent humectant and solvent. However, its presence in consumer goods is subject to specific regulations, with different food codes and identifiers used depending on the geographic location. Understanding these codes is essential for consumers and manufacturers alike, as they govern how PG is produced, used, and labeled.

The Food Codes for Propylene Glycol

Regulatory bodies worldwide use specific identifiers to approve and track food additives like propylene glycol. These codes help ensure products meet safety standards before reaching the market.

United States FDA Food Code

In the U.S., the Food and Drug Administration (FDA) has designated food-grade propylene glycol as "Generally Recognized as Safe" (GRAS). This classification is detailed in the Code of Federal Regulations, specifically 21 CFR § 184.1666. The GRAS status means the ingredient does not require premarket review and approval, provided its use adheres to good manufacturing practices and does not exceed specified maximum levels for various food categories. For example, the code outlines different maximum concentrations for alcoholic beverages, confections, and frozen dairy products.

European Union Food Additive Code

The European Food Safety Authority (EFSA) authorizes the use of propylene glycol as a food additive under the E-number E1520. This code is required on product labels within the EU when PG is used. Unlike the FDA's category-specific maximums, the EFSA primarily relies on an Acceptable Daily Intake (ADI) of 25 mg of propylene glycol per kilogram of body weight per day. The EFSA ensures that typical consumer exposure does not exceed this safe intake level.

Codex Alimentarius Code

At an international level, the Codex Alimentarius Commission sets standards for global food trade. Propylene glycol has been assigned the International Numbering System (INS) number 1520. This identifier provides a standardized way of referencing the additive, which is particularly relevant for international food labeling and commerce.

Common Food Uses and Functions

Propylene glycol's versatile properties make it a valuable additive in a wide range of processed and packaged foods. It performs several crucial functions that enhance food quality and shelf-life.

Key functions of propylene glycol in food include:

  • Humectant: Absorbs and retains moisture, preventing foods like baked goods and coconut flakes from drying out.
  • Solvent and Carrier: Dissolves and uniformly disperses flavors, colors, and extracts throughout a food product.
  • Emulsifier: Binds ingredients that would normally separate, such as oil and water, and is often used in dressings and sauces.
  • Stabilizer and Thickener: Maintains the texture and consistency of foods like dressings, desserts, and beer foam.
  • Anti-caking Agent: Prevents powdered ingredients, such as in baking mixes and seasonings, from clumping together.
  • Antioxidant: Helps extend the shelf life of food products.
  • Processing Aid: Enhances the visual appearance and overall quality of food.

Comparing US and EU Propylene Glycol Regulations

Feature United States (FDA) European Union (EFSA)
Classification GRAS (Generally Recognized as Safe) Authorized food additive
Identifying Code 21 CFR § 184.1666 E1520
Max Limits Set by "Current Good Manufacturing Practice" with category-specific maximums (e.g., up to 24% in confections) Acceptable Daily Intake (ADI) of 25 mg/kg body weight/day
Prohibited Use Prohibited in cat food under 21 CFR 589.1001 Generally permitted but with restrictions on certain uses and concentrations
Labeling Not always listed if part of a flavoring, but required for direct addition Must be labeled as E1520 for food applications

Important Safety Considerations

While largely considered safe, there are some important facts to consider regarding propylene glycol, especially to avoid confusion with other substances.

Not to be Confused with Ethylene Glycol

One of the most common points of confusion is mixing up propylene glycol with its toxic chemical cousin, ethylene glycol. While both can be used in antifreeze, they are fundamentally different substances. Food-grade propylene glycol-based antifreeze is considered non-toxic, which is why it is used in plumbing for recreational vehicles and food-processing equipment. Ethylene glycol, by contrast, is highly toxic and is never used in food products.

Allergic Reactions

A very small number of individuals may experience an allergic reaction to propylene glycol. This most often presents as contact dermatitis (a skin rash) when exposed topically, but can occur systemically in sensitive individuals after ingestion. The prevalence of this allergy is very low, and for most people, it poses no risk.

Toxicity at High Doses

At normal, regulated food consumption levels, propylene glycol is quickly metabolized and eliminated from the body within about 48 hours. Toxicity is extremely rare and is almost exclusively associated with very high dosages, typically in clinical settings where large amounts are administered intravenously as a solvent for certain medications. Individuals with impaired liver or kidney function, infants, and pregnant women may process PG more slowly and should be mindful of their intake.

Conclusion: The Bottom Line on Propylene Glycol

Propylene glycol is a widely used and carefully regulated food additive with different codes and regulations depending on the region. In the U.S., its GRAS status under 21 CFR § 184.1666 governs its use, while in Europe, it is identified as E1520. Its primary roles are to enhance moisture, consistency, and flavor in a variety of processed foods. While confusion with the toxic ethylene glycol is common, food-grade PG is distinctly different and generally safe for consumption in the amounts typically found in food. For most consumers, the small quantities present in processed foods pose no health concern, though those with a specific allergy should be aware of its presence on ingredient labels. Ultimately, the various food codes for propylene glycol are in place to ensure its safe and transparent use in the global food supply.

For further details on FDA food additive regulations, you can refer to the official Code of Federal Regulations here: LII / Legal Information Institute

Frequently Asked Questions

The E number for propylene glycol used as a food additive in the European Union is E1520.

No, regulations differ internationally. For example, the US FDA regulates its use under GRAS status, while the EU uses the E1520 code and has an Acceptable Daily Intake (ADI).

GRAS, or "Generally Recognized As Safe," is the FDA classification for propylene glycol, meaning it is considered safe for its intended use in food under specified conditions.

Food-grade propylene glycol is used in some non-toxic antifreeze, but it is not the same as toxic ethylene glycol, which is used in conventional antifreeze. You should not consume any product labeled as antifreeze unless it is specifically formulated as food-grade.

Propylene glycol is found in many processed foods, including baked goods, flavorings, salad dressings, dressings, sauces, and certain beverages.

It serves multiple purposes, such as a humectant to retain moisture, a solvent for flavors and colors, an emulsifier to blend ingredients, and a stabilizer to maintain texture.

For the vast majority of the population, the small amounts found in food pose no risk. Toxicity issues are extremely rare and typically linked to very high exposure in clinical settings, not normal food consumption.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.