Food Coloring, Stabilizers, and Preservatives: How Are Food Additives Regulated?

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Jan 16, 2024 10:00:00 AM

Trust20 Contributors • 11 minute read

When food additives like colorings, stabilizers, and preservatives are used correctly, they can enhance foods and prolong their shelf-life. Since food additives can either support food safety or contribute to foodborne illnesses, the U.S. Food and Drug Administration (FDA) regulates how they are used in order to protect you and your customers.

In this article, we’ll look at the different types of food additives, decode the FDA Food Code’s regulations around additives, and more. Read on to learn about:

The history of food additives and preservation

What are food additives, and how does the FDA approve them?

What is GRAS, and how does the FDA certify it?

What is food coloring, and how does the FDA keep it safe?

What’s the is a stabilizer, and why are they used?

What are preservatives, and how are they regulated?

Misunderstanding and misinformation

Let’s start with a brief history of food additives and how the FDA began regulating them.

The history of food additives and preservation

In ancient times, naturally occurring additives–think paprika, turmeric, saffron, and iron–were used to color food and cosmetics. Egyptians used artificial colors in cosmetics and hair dyes; the Chinese burned paraffin wax to ripen fruit, and Romans added alum to bread to make it whiter.

People used salt to preserve fish and meat, even before we understood how food goes bad. In the 19th century, the tin can was a revolutionary discovery for food preservation, combining an air-tight container with heat sterilization.

During the Industrial Revolution, people began using food additives significantly more often. The first synthetic dye, mauve, was discovered in 1856, and more followed. These synthetic dyes, called “coal tar colors,” were byproducts of coal processing.

Federal oversight of color additives began in the 1880s, and butter and cheese were the first foods to receive federal approval for artificial coloring.

The Pure Food and Drug Act

Early on, federal oversight wasn’t far-reaching. By the 1900s, many of the foods, drugs, and cosmetics that used artificial coloring also contained outright poisonous chemicals like lead, arsenic, and mercury. Dangerous food additives were frequently used to hide defective food.

Congress passed the Pure Food and Drug Act in 1906, prohibiting the sale of “misbranded or adulterated food and drugs.”¹ This legislation also paved the way for the creation of the FDA.

Food Inspection Decision 76

At the time, the U.S. Department of Agriculture (USDA) had authority over the Pure Food and Drug Act. In 1907, the USDA issued Food Inspection Decision 76, which approved seven straight colors for use in foods. Later, food inspection decisions led to a voluntary certification program for manufacturers.

The Federal Food, Drug, and Cosmetic Act of 1938

The enforcement of the Pure Food and Drugs Act became the FDA’s responsibility in 1927. However, as the organization took over, it became clear the original legislation did not go far enough to protect consumers.

The Federal Food, Drug, and Cosmetic Act of 1938 increased government oversight. It made the certification program mandatory, established labeling and record-keeping provisions, and created procedures for requesting certification. The FDA still relies on this essential framework today.

The Color Additive Amendment of 1960

The Color Additive Amendment of 1960 defined “color additive” and stated that only those listed as “suitable and safe” could be used. The amendment also included the “Delaney Clause,” which prohibited the listing of any additives proven to be carcinogenic. Since then, the FDA has slowly removed about half of the color additives from the approved list.²

At this time, additives were also categorized into eight groups:

Food preservatives
Coatings, films, and relative substances
Special dietary and nutritional additives
Anti-caking agents
Flavoring agents and related substances
Gums, chewing gum bases, and related substances
Other specific usage additives
Multipurpose additives.³

These milestones in the history of federal food regulation largely resulted from major events that caused public outcry and concern. Additives were created and used, and then people discovered they were harmful. Today, the FDA oversees a series of approval processes that review new products before they are released to the public–aiming to proactively protect consumers nationwide.

What are food additives, and how does the FDA approve them?

Additives are an umbrella term that covers colorings, stabilizers, and preservatives. An additive is any substance that directly or indirectly becomes part of a food or affects its characteristics.

Direct additives are added directly to food for a specific purpose (e.g., aspartame as a low-calorie sweetener). Indirect additives are not intentionally added to food, but they become a part of it during processing, packaging, or storage (e.g., an ink or coating from a food’s packaging that comes in contact with the food).

Additives in the FDA Food Code

The 2022 FDA Food Code refers to “additives” quite a lot, specifically because additives have such a wide variety of uses. Just a few of these regulations include: you cannot use additives to misrepresent products, there must be variance if you intend to use additives for preservation purposes, which additives are approved for washing fruits and vegetables, and protections against the use of unapproved additives.³

These guidelines, and the rest of the regulations surrounding additives in the FDA Food Code, are very specific because you must use the right additive in the proper amount to prevent foodborne and other illnesses.

What is the approval process for additives?

Under the Federal Food, Drug, and Cosmetic Act, additives undergo a rigorous process before they are approved by the FDA. The process is summarized below.

A manufacturer or other sponsor must fill out a food additive petition.⁴
The FDA consults with the USDA if the additive proposed is used for meat or poultry.
The FDA publishes a notice of the petition in the public Federal Registrar.
Evaluation period for the petition for safety, including answers to these questions:
- What is the food ingredient?
- How will the food ingredient be made?
- How much of the ingredient will be in food?
- What types of foods will the ingredient be used in?
- How much of the food ingredient will consumers eat?
- How does the body metabolize the food ingredient?
- What are the results of relevant scientific studies on the ingredient's safety?⁵
The FDA decides on an Acceptable Daily Intake. Many variables are considered for this decision so that the consumption of an additive is much lower than what would constitute adverse effects.
If approved, the FDA issues a regulation for that specific additive.

There is a public record of the petitions under active review and petitions filed but not active because of problems the FDA identified so that anyone can learn more about the additives undergoing the approval process.

What is GRAS, and how does the FDA certify it?

GRAS stands for “generally recognized as safe” and refers to substances considered safe under their intended use. GRAS ingredients are not considered food additives, and there is a specific provision in the Federal Food, Drug, and Cosmetic Act for them.

Common GRAS ingredients include sodium chloride (salt), acetic acid, and canola oil. While these substances do not require prior approval by the FDA, there must be publicly available data that proves that the substance is safe for its intended use.⁶

GRAS in the Food Code

GRAS substances appear in the FDA Food Code in relation to chemicals for washing, treating, and storing fruits and vegetables, additives used as drying agents, and additives used in antiseptics.

FDA approval process for GRAS

To receive GRAS certification, any manufacturer or person must notify the FDA via the GRAS Notification Program. The FDA evaluates a GRAS Notice similarly to how it evaluates additives, researching all relevant and reliable information to answer the same questions.

What is the food ingredient?
How will the food ingredient be made?
How much of the ingredient will be in food?
What types of foods will the ingredient be used in?
How much of the food ingredient will consumers eat?
How does the body metabolize the ingredient (absorption, digestion, metabolism, and excretion)?
What are the results of relevant scientific studies on the safety of the ingredient?⁵

The FDA follows up the evaluation with a letter to the manufacturer or person, letting them know if the FDA questions their definition of that particular item being defined as GRAS. If the item doesn’t meet the FDA’s safety standards, the FDA may issue a public warning, issue a public alert, or take enforcement action to stop the distribution of the substance.

Regulators also perform post-market assessments so that all listings stay up to date as new scientific research emerges with respect to safety. The FDA can revoke a GRAS item from its list at any time (e.g., when the FDA revoked the GRAS status of trans fats after new research emerged).

What is food coloring, and how does the FDA keep it safe?

Food coloring, also known as color additives, includes any dye, pigment, or other substance that can impart a color to a food, drug, cosmetic, or the human body. There are three primary classifications of color additives: straight colors, lakes, and mixtures.

Food coloring categories

Straight colors: These additives have not been mixed or chemically reacted with other substances (e.g., Blue 1, found in baked goods, canned peas, and candies).

Lakes: These additives are formed by chemically reacting straight colors with precipitants (a substance that causes precipitation) and a substrate (an underlying layer). “Blue 1 Lake” is a synthetic coloring found in lipstick. Organic lake pigments include elderberry concentrate and paprika.

Mixtures: These additives are formed by mixing one color additive with one or more color additives without a chemical reaction (e.g., food ink used to mark candies).²

The categories don’t end there. The FDA has two categories of permitted food colorings: certifiable and exempt. Certifiable color additives are human-made and come primarily from petroleum and coal sources. Exempt color additives are obtained mainly from plant, animal, or mineral sources and are ‘exempt’ from batch certifications.⁷

Current regulations do not refer to coloring often. Still, when they do, regulations primarily focus on properly labeling food coloring products–especially when coloring contributes to the base recipe of a food.

FDA approval for food coloring

Color additives must be approved by the FDA before they can be used in U.S. products. Once approved, those additives may only be used in compliance with the specifications and restrictions laid out in the approval–meaning you can’t use a color additive in food if it has only been approved for use in cosmetic products.

The FDA approves new, certifiable color additives by conducting a certification program for batches before they are marked for sale (remember that certain color additives are exempt).

Anyone can submit a petition for a new color additive by following instructions in Part 71 of the Code of Federal Regulations.⁸ After a color is approved and put to market, the FDA monitors the use of the color additive to ensure they are being used correctly and are appropriately listed on labels.

What is a stabilizer, and why are they used?

A stabilizer is a substance added to food products to help maintain or enhance the food’s original texture or physical and/or chemical characteristics. Stabilizers like pectin, lecithin, and guar gum can improve the texture of a product by thickening it or increasing its creaminess.

Technically, stabilizers do preserve food, but they primarily make foods more appetizing to consumers without increasing sugar or fat content.

You can find a common stabilizer in many kinds of peanut butter. Palm oil stabilizes peanut butter and prevents oil separation–meaning consumers do not have to stir their peanut butter before they dig in.

The FDA Food Code does not explicitly call out the term “stabilizer.” They are regulated under the umbrella term of “additives.”

What are preservatives, and how are they regulated?

A food preservative is any additive used to prevent or prolong food spoilage. Depending on the food, spoilage can refer to mold, rancidity, or bacteria. Some preservatives also improve the appearance of food.

Salt, vinegar, alcohol, citric acid, and sodium nitrite are all preservatives used for centuries. Modern preservatives have longer names and are used for different types of food (salad dressings, canned tuna, cheeses, and potato chips, just to name a few).

It may be a no-brainer, but when used properly, preservatives can help prevent the spread of foodborne illnesses.

Preservatives in the Food Code

Preservatives must undergo the same review process as other food additives to be approved by the FDA. The FDA Food Code provides specific guidance regarding preservatives. Some of these regulations are listed below.

Specific instructions about how to name preservatives on labels of food.
Guidelines regarding preservatives and wood as a food contact surface.
Directives about using preservatives to prevent the growth of the bacteria Listeria monocytogenes in deli salads.

Misunderstanding and misinformation

Despite the lengths the FDA goes to prevent foodborne illness and monitor food additives, there is still widespread concern and mistrust among consumers. Marketing campaigns and labels full of names that are difficult to pronounce only add to the confusion.

If your customers ever express concern about the additives used in your kitchen, you can encourage them to relax! You now know that food additives are highly regulated, and the FDA has reviewed and regulated the food products that make it to the public market.

Sharing your knowledge about how food additives are regulated can even help prevent misunderstanding and misinformation!

The Takeaway

Food coloring, stabilizers, and preservatives are all food additives regulated by the FDA. A rigorous evaluation process is in place to ensure that additives are safe for use in our food and, when used in the right amounts, can significantly help your food safety efforts.

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