How many food additives are legal in the USA?

January 3, 2026 •

4 min read

According to a 2013 report by the Pew Charitable Trusts, more than 10,000 chemical additives have found their way into the U.S. food supply. These substances, both direct and indirect, make up the complex world of legal food additives in the USA, a system governed by multiple regulatory pathways rather than a single, definitive list.

Quick Summary

The exact count of permitted food additives in the U.S. is not public, due in part to regulatory loopholes. Several categories, including direct additives, color additives, and GRAS substances, contribute to a total estimated at over 10,000. Safety oversight varies by category, with some additives requiring premarket FDA approval while many others do not.

Key Points

No Single Count: There is no definitive, published number of all legal food additives in the USA due to multiple regulatory categories and pathways.
Thousands of Additives: Estimates range significantly, but many experts agree the total number of additives and related chemicals exceeds 10,000.
The GRAS Loophole: A large number of substances are allowed under the 'Generally Recognized as Safe' (GRAS) rule, which permits manufacturers to self-affirm safety without mandatory FDA review.
Varied Oversight: The level of FDA scrutiny depends on the additive's category, with direct food additives requiring more rigorous review than many GRAS substances.
US vs. EU: The US regulatory system is less restrictive than the European Union's, which has a much shorter, public list of permitted additives with premarket approval.
Consumer Awareness: Due to the complexity and lack of a complete public list, consumers must rely on label information and external resources to learn about specific food additives.

The Uncountable Number of US Food Additives

While consumers might imagine a simple, fixed registry, there is no single, publicly accessible list or a definitive number for all legal food additives in the USA. The total figure is in the thousands, with different reports citing numbers ranging from 3,000 to over 10,000, depending on what is included. This ambiguity stems from the complex and multi-tiered regulatory system administered by the Food and Drug Administration (FDA), which does not mandate premarket approval for all substances.

The regulatory framework includes substances approved by the FDA, those considered 'Generally Recognized as Safe' (GRAS), and substances approved before 1958 ('prior-sanctioned'). The existence of the GRAS loophole is particularly significant, allowing manufacturers to determine a substance's safety without direct FDA review. This self-assessment process makes it difficult for both the public and regulators to maintain a precise count of all substances in the food supply.

Categories of Food Additives

The FDA's regulatory system places additives into several key categories, each with its own approval process and level of oversight.

Direct Food Additives: These are added to a food for a specific purpose, such as preserving freshness or adding color. They are listed in the Code of Federal Regulations (CFR).
Color Additives: Used to impart or enhance color, these are either 'certified' (synthetic) or 'exempt from certification' (often natural). Both categories have specific regulations.
Generally Recognized As Safe (GRAS) Substances: Substances that are considered safe by qualified experts based on extensive history of use or scientific evidence. Companies can self-affirm GRAS status without notifying the FDA, though many do.
Prior-Sanctioned Substances: These are substances whose use was approved by either the FDA or the USDA prior to the 1958 Food Additives Amendment.
Indirect Additives: These are substances that may become part of the food in trace amounts due to packaging, storage, or handling, such as chemicals from plastic containers.

The GRAS Loophole and Its Implications

The GRAS provision was intended to exempt common, safe ingredients like salt and vinegar from the formal food additive approval process. However, it has evolved into a significant loophole where companies introduce new, unvetted chemicals into the food supply. Critics argue this system allows manufacturers to bypass rigorous safety evaluations, leading to concerns about consumer safety and the lack of transparency. In contrast to the US system, the European Union has a more stringent, centralized process that results in a much shorter list of approved additives.

Comparing US and EU Additive Regulation


Feature	United States (FDA)	European Union (EFSA)
Regulation	Complex system involving direct approval, GRAS, and prior-sanctioned substances.	Centralized, single list of approved additives, assigned an E-number.
Approval Process	Varies significantly. Direct additives require premarket FDA review. GRAS substances can be self-affirmed by manufacturers.	Premarket review and approval are mandatory for all additives, which are subject to re-evaluation.
Public List	No single, exhaustive list. FDA provides lists of various additive types (EAFUS, CFR).	Comprehensive public database of E-numbers and their permitted uses.
Estimated Number of Additives	Widely cited estimates suggest over 10,000 substances.	Much lower, with only a few hundred explicitly permitted.
Industry Oversight	Significant reliance on industry-led safety assessments (especially for GRAS).	Greater direct government oversight and periodic re-evaluation by the European Food Safety Authority (EFSA).

The Consumer's Role in a Complex System

Given the intricacies of food additive regulation, consumers must rely on labels and remain informed. The FDA requires direct additives to be listed on food labels by their common name or a functional descriptor, such as 'preservative' or 'color added'. However, the specific identity of a GRAS substance that was self-affirmed does not need to be disclosed beyond its functional role. This places a greater burden on consumers to research specific ingredients they may be concerned about. Independent organizations and databases can provide additional ratings and information on specific chemicals.

For those interested in the details of the US system, the FDA maintains a list of substances, often referred to as the EAFUS (Everything Added to Food in the United States) inventory, which has been replaced by the 'Substances Added to Food' list. This inventory is a good starting point for researching additives that fall under official FDA scrutiny. For example, one can search for a substance like 'acesulfame potassium', a non-nutritive sweetener that has gone through official channels and is listed in the CFR.

Conclusion

While a definitive count of legal food additives in the USA does not exist, estimates suggest the number is in the thousands, significantly higher than in many other countries. This is largely due to the unique US regulatory system, which includes the GRAS provision allowing for self-affirmation of safety by manufacturers. Consumers can find some information on labels and through official FDA lists, but the lack of a single, transparent database means a complete picture is difficult to ascertain. Staying informed and understanding the different regulatory pathways is key to navigating the complex world of American food additives. The Center for Science in the Public Interest offers safety ratings on specific additives to help consumers make informed decisions.

Frequently Asked Questions

There is no exact number because of the FDA's multi-tiered regulatory system, which includes several categories of ingredients. The GRAS loophole, in particular, allows companies to add substances to food without mandatory premarket FDA approval, making a precise count difficult to track.

GRAS stands for 'Generally Recognized as Safe.' Under this program, a substance is considered safe by qualified experts and can be added to food without FDA approval. This is based on a history of safe use before 1958 or scientific evidence.

No, not all food additives are reviewed by the FDA. While direct food additives and color additives require premarket approval, GRAS substances can be self-affirmed by manufacturers without direct FDA review.

The US system is generally less restrictive than the EU's. The EU maintains a much shorter, centralized list of approved additives, and all new additives require premarket authorization. The US system, in contrast, includes a GRAS loophole that allows for self-regulation by companies.

Common types of additives include preservatives (like citric acid or sodium benzoate), sweeteners (like sucralose or high-fructose corn syrup), color additives, emulsifiers, and flavor enhancers (like MSG).

The FDA requires most direct food additives to be listed on a product's ingredient label by their common name or a functional descriptor. However, substances designated as GRAS may sometimes be included more generally, and indirect additives are not listed.

This is an inventory maintained by the FDA that includes substances regulated as food additives, color additives, GRAS substances, and prior-sanctioned substances. It is a useful resource but does not provide a single, definitive list of all legally permitted additives.