11 vs. 1,700: Understanding U.S. and EU Cosmetics Regulations

-By Chase Kirkland, Founder & CEO, Relterra

Building Relterra has meant becoming a student of the cosmetics industry. Among everything I've learned, one topic stands out as both fascinating and critical: the regulations that determine what ingredients can touch your skin. And the differences between the U.S. and EU are more significant than you might think.

Who's in Charge?

First, let's meet the regulatory players:

• In the U.S., the Food and Drug Administration (FDA) oversees cosmetic safety and labeling
• Additionally in the U.S., The Federal Trade Commission (FTC) monitors advertising and marketing claims to ensure consumers aren't misled by false or exaggerated promises.
• In the EU, oversight falls to the European Commission, supported by the Scientific Committee on Consumer Safety (SCCS), which evaluates ingredient safety.

The Banned Ingredients Gap

The most striking difference lies within banned ingredients. The U.S. bans just 11 ingredients at the federal level. The EU? About 1,700. The EU additionally has restrictions for ~800 ingredients as well. In the U.S., some states do impose additional restrictions — California leads with 136 banned or restricted ingredients, followed by Colorado (86), New York (26), and Washington (14). But 31 states don't regulate cosmetic ingredients at all.

Two Different Philosophies

This gap comes down to philosophy. The U.S. requires substantial evidence of actual harm before banning an ingredient. Whereas the EU restricts ingredients based on reasonable suspicion of risk—a precautionary approach. In the U.S, until there is undisputed evidence that ingredients are damaging and harmful, the regulators do not enforce any restrictions. In contrast, the EU actively restricts ingredients that are suspected of being harmful to people.

How Decisions Are Made

So how does each jurisdiction determine which ingredients to restrict? The FDA doesn't follow a robust framework for ingredient decisions. Instead, it reviews public research, adverse event reports, consumer complaints, and Cosmetic Ingredient Review Reports—then acts only when substantial evidence proves harm. On the other hand, the EU works with Scientific Committee on Consumer Safety (SCCS), an independent panel of toxicologists, dermatologists, chemists, and other scientists that regularly use industry safety dossiers, peer-reviewed studies, WHO/IARC data, NGO findings, and their own SSCS evaluations to analyze ingredients across categories such as toxicology, skin sensitization, carcinogenicity, reproductive toxicity, and environmental risk. The SCCS then presents their opinion to the European Commission which then amends the banned and restrictive list in accordance with the SCCS opinion. Applying their risk based approach, the European Commission creates new restrictions when there is any possibility of an ingredient being harmful, even if conclusive evidence is not found.

Pre-Market Testing Requirements

A second important difference between the U.S. and EU regulations is that the EU requires companies to submit product testing for each newly developed product prior to selling them in the market. Cosmetic producers must perform and submit a Cosmetic Product Safety Report to the European Commission. Meanwhile the U.S. does not require any product testing submissions. Products and manufacturing facilities simply need to be registered with the FDA so that they are aware of the products being sold in the market and who is manufacturing the products, a new requirement that was only introduced recently via the MoCRA Act of 2022 and implemented in 2023/2024. Of course, these products must abide by the ingredient restrictions but they are not scrutinized at the same level as in the EU. This further magnifies the gap in proactive testing in the U.S. which poses risks to consumers as a consequence of the loose regulations.

What This Means for You

All of that being said, the regulations, and lack thereof, governing cosmetic products in the U.S. invokes a responsibility for U.S. consumers to educate themselves on the products they are using. It is important to take an a extra few minutes to analyze products prior to purchasing by reviewing product ingredients directly or by employing an app like Yuka for guidance.

The Sunscreen Paradox

If you've happened to read this far, first of all kudos to you. Second you may be asking yourself, but why are sunscreen products more limited in the U.S. than in the EU? Well this is because in the U.S. sunscreen products are classified as over the counter drugs whereas the EU classifies sunscreen products as cosmetics. The FDA considers sunscreens to have a therapeutic process which prevents sunburn and reduce risk of skin cancer, causing sunscreen to fall into the classification of a "drug" under the FDA framework. Although cosmetic products may not be highly regulated by the FDA, drugs are and thus a limited number of sunscreen filters (filters are the core ingredient for sunscreens) have been approved by the FDA. Most of the FDA filter approvals took course over the 1970s and 1980s, with the last filter being approved in 1996. I haven't even been alive long enough to see a new filter approved in the U.S. A lot changes over 28-50 years, including new innovations and studies resulting in the development of new products that are safe for use. Some of these new innovations include UVA filters such as Tinosorb and Mexory which are more effective than many filters previously approved, and are utilized in sunscreen products across Europe. Unfortunately the rigid bureaucracy in the U.S. prevents lawmakers from efficiently using new findings to update the list of approved filters, and so for now here in the U.S we are stuck with the science and approvals from many years ago.

A Glimmer of Hope

Even so, there is hope for progress in coming years. The Sunscreen Innovation Act was passed by U.S. Congress in 2014 to speed up reviews and approvals. Yet the FDA has rejected foreign data and studies from innovations over the last 20 years and requires that a manufacturer must perform substantive testing of the products and ingredients in the U.S. So there is a better framework in place today for approval, but a U.S. manufacturer needs to pony up some high spend (millions of dollars) and time (3-5 years of testing) for U.S. consumers to reap the benefits of already science backed improved sunscreen products. I hope we see a U.S. company lead the charge on testing—or better yet, that the FDA changes its stance—before another 25 years pass.