When you buy cosmetics in the United States, you might assume that every ingredient is regulated under one consistent national standard. Formaldehyde shows why that is not always the case.
What Is Formaldehyde?
Formaldehyde is a chemical used in manufacturing, building materials, and some personal care products. It can function as a preservative or antimicrobial ingredient.
It is also a known human carcinogen and can cause skin and respiratory irritation and allergic reactions.
Consumers may also encounter formaldehyde-releasing preservatives, such as DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea, quaternium 15, and bronopol. These ingredients are not the same as formaldehyde, but they can release formaldehyde under certain conditions.
How Europe and Asia Regulate Formaldehyde in Cosmetics
Europe Takes a Prescriptive Approach
The European Union prohibits formaldehyde itself in cosmetics because it is classified as a carcinogen and skin sensitizer.
The EU also regulates formaldehyde-releasing preservatives. Products that release formaldehyde above a specific threshold must carry a warning indicating that they release formaldehyde.
This creates an explicit regulatory framework around both formaldehyde and potential exposure from formaldehyde-releasing ingredients.
Japan Also Prohibits Formaldehyde
Japan's Ministry of Health, Labour and Welfare maintains detailed cosmetic ingredient standards, including prohibited, restricted, and permitted ingredient lists.
Similar to the EU, formaldehyde itself is prohibited in Japanese cosmetics.
Japan does not automatically prohibit every formaldehyde-releasing preservative, but these ingredients are permitted under specific restrictions and carefully monitored.
Other Asian Markets
Several Asian markets also use more structured ingredient regulations.
The ASEAN Cosmetic Directive, implemented across participating Southeast Asian countries, includes prohibited and restricted ingredient lists as well as permitted preservatives and other cosmetic ingredients.
Individual Asian markets have their own requirements, but the broader trend is toward clearly defining which cosmetic ingredients are prohibited, restricted, or permitted.
How Does the U.S. Regulate Formaldehyde Today?
The U.S. takes a different approach to cosmetic ingredient regulation than many other major markets.
Under federal law, cosmetics generally do not require FDA approval before going on the market. Companies are responsible for ensuring that their products are safe, while the FDA can take action when products violate federal requirements.
Importantly, formaldehyde is not currently specifically prohibited from cosmetics under federal U.S. regulations.
The U.S. did strengthen cosmetic oversight through the Modernization of Cosmetics Regulation Act of 2022, or MoCRA. However, MoCRA did not create a federal ban on formaldehyde.
California and Washington are Already Taking Action
Because federal regulation does not specifically prohibit formaldehyde, individual U.S. states have stepped in.
California prohibits intentionally added formaldehyde in cosmetics under the California Toxic-Free Cosmetics Act, effective January 1, 2025.
Washington also restricts intentionally added formaldehyde beginning January 1, 2025. Even more significantly, Washington has adopted restrictions on 25 formaldehyde-releasing chemicals in cosmetics that take effect January 1, 2027.
This creates an increasingly complicated situation for cosmetic companies. A product may comply with federal requirements but face additional restrictions when sold in California or Washington.
Why We Need a Federal Standard
Cosmetics are sold across state lines every day. Consumers should not have to understand federal regulations, California requirements, Washington requirements, and potentially additional state laws just to know whether an ingredient is permitted.
Moreover, cosmetic safety should not depend on your ZIP code.
California and Washington are demonstrating that stronger restrictions are possible. Europe and Japan have already established national frameworks that prohibit formaldehyde itself.
The U.S. should build on these examples and establish a clear, science-based federal standard for formaldehyde in cosmetics.
That could mean:
Prohibiting intentionally added formaldehyde nationwide
Evaluating formaldehyde-releasing preservatives separately based on actual exposure
Establishing consistent national requirements
Encouraging safer alternatives when effective options exist
Giving consumers clear and consistent information
Preservatives are important because cosmetics need protection against bacteria, yeast, and mold. The goal is not to eliminate necessary preservatives. It is to avoid unnecessary exposure to ingredients with significant health concerns when effective alternatives are available.
Our Perspective
At Rei Cosmetics, we believe ingredient transparency means asking more than whether an ingredient is technically legal.
When we choose which products to carry, we look closely at ingredient lists, review consumer feedback and product trends in Japan, and test products ourselves. We know that manufacturers are ultimately responsible for the safety and formulation of their products, but we also believe retailers have an important role to play.
We are often the bridge between brands and consumers. That means we have a responsibility to be thoughtful about the products we put on our shelves and recommend to our customers.
Our goal is simple: to help people feel confident about the products they use every day and enjoy their beauty routines without unnecessary concerns.