Food & Ingredient Safety – Food Additives

February 8, 2021 - Food & Ingredient Safety - Elisabeth Anderson, Joe Zagorski

Public conversations about food additives often generate more headlines than clarity. So what exactly are food additives, how is their safety determined, and who regulates them? In this post, we take an updated look at the science and oversight behind the ingredients in our food.

Top Takeaways:

Food additives are substances intentionally added to food to achieve a purpose such as preservation, stability, or texture.
Additives must meet a safety standard of reasonable certainty of no harm under their intended conditions of use.
Safety decisions are not permanent, and ingredients can be reassessed as new science emerges.
In the U.S., multiple federal agencies share responsibility for oversight of the food supply.
The U.S. regulatory system is undergoing significant changes, including expanded post-market review and proposed GRAS reforms.

What is a food additive?

Legally, a food additive is any substance whose intended use results in it becoming a component of food or affecting its characteristics. This includes substances used during processing, packaging, transport, or storage. It’s more than the ingredients listed in a recipe.

Many everyday ingredients, such as salt, vinegar, or baking powder, meet this definition.

This definition includes substances used in:

Processing
Manufacturing
Packaging
Storage or transport

Why do we use food additives?

Food additives serve important technical roles:

Protecting food safety: Preservatives and antioxidants help prevent spoilage and reduce the risk of foodborne illness.
Maintaining stability and shelf life: Additives allow foods to remain safe and consistent during shipping, storage, and preparation.
Supporting texture and function: Emulsifiers, stabilizers, and leavening agents ensure foods behave the way consumers expect.
Enabling modern food systems: Without additives, many foods would spoil faster, cost more, or be far less available. In many ways, additives are extensions of long-standing practices such as salting, fermenting, or curing — but now evaluated through modern toxicology.

How are food additives evaluated for safety?

The modern regulatory framework began with the 1958 Food Additives Amendment, which requires pre-market evaluation of new additives.

To be authorized, an additive must demonstrate safety under its intended use. Regulators conduct risk assessments that include exposure, toxicology, and expected consumption patterns to ensure it is safe for people to consume.

What happens if an additive is found to be no longer safe?

Safety determinations can change as new evidence emerges. Scientists continually develop new tools and data that can prompt reassessment of previously approved ingredients. When warranted by evidence, the FDA can restrict or revoke authorization.

Two recent examples illustrate how this process works:

Brominated Vegetable Oil (BVO)

Originally considered GRAS, BVO was removed from the GRAS list in 1970 and allowed only as a permitted additive.
New toxicology research conducted with the National Institutes of Health identified adverse effects in animals at exposure levels approximating real-world intake.
In July 2024, the FDA revoked authorization for BVO.
Manufacturers were required to reformulate products by August 2, 2025.

FD&C Red No. 3

In January 2025, the FDA revoked authorization for Red No. 3 in food and ingested drugs.
The action was required under the Delaney Clause, which prohibits approval of additives shown to cause cancer in humans or animals.
The cancer mechanism observed occurs in male rats and is not relevant to humans, but the statute applies regardless of human risk.
Manufacturers have until January 15, 2027, to reformulate.

🔗 Read more about the Delaney Clause

These actions reflect the FDA’s commitment to post-market reassessment, a process now being formalized and expanded.

Is the FDA the only agency that regulates additives in the U.S.?

No. Food safety oversight in the United States is shared across agencies:

Food and Drug Administration (FDA): Regulates most food ingredients and additives.
U.S. Department of Agriculture (USDA): Oversees additives used in meat and poultry products.
Environmental Protection Agency (EPA): Regulates pesticide residues in food and drinking water.

Together, these agencies support the safety of the U.S. food system.

What’s changing with food additive regulations?

Post-market review is expanding

In 2025, the FDA launched a new chemical review program to systematically reassess substances already in the food supply. Early review targets include:

BHA and BHT
Azodicarbonamide
Synthetic certified color additives (e.g., Blue No. 1, Red No. 40, Yellow No. 5)

A review does not mean an ingredient is unsafe; it allows evaluation of new evidence to ensure safety when used as intended.

GRAS reform is under consideration

Policy proposals would require companies to submit GRAS notifications to the FDA, replacing the current system that allows self-affirmation without agency review.

Anticipated changes include:

Mandatory GRAS submissions
A public GRAS database
A structured post-market review pathway

🔗 Read more about GRAS Ingredients

Legislative and state-level activity is increasing

Proposed federal legislation would require notification for all GRAS substances.
California and other states have enacted restrictions on certain additives and synthetic dyes.
More than 100 state-level bills addressing food ingredients were introduced during the 2025 legislative session.

Synthetic color additives are a major focus

Continue evaluating petroleum-derived dyes.
Accelerate review of naturally derived color alternatives.
Support industry transitions already underway, with several major companies pledging to phase out synthetic dyes by 2026.

🔗 Read more about Food Dyes

What does the science say about food additive safety?

The evidence and regulation are complex, and regulatory outcomes often reflect both science and statutory requirements. That means it is not only human safety evidence that must be considered.

For example, the Red No. 3 decision illustrates this complexity. Although human risk was not supported by the data, the Delaney Clause mandated regulatory action. This highlights an ongoing tension between:

Hazard-based legal standards
Exposure-based modern risk assessment

Understanding that distinction is essential to interpreting regulatory headlines.

The Good News

Food additives are not a static list of approved substances. They are part of a continually evaluated system shaped by new science, evolving policy, and public health priorities.

If you have any questions about ingredients or ideas for a blog post, please send us an email or submit your idea at go.msu.edu/cris-idea.