European vs. American Cosmetic Regulations

Consumers are often told that European regulations are stricter and offer better protection than those in the U.S. One of the most frequently cited claims is that the European Union (EU) has banned over 1,400 ingredients from cosmetics, while the U.S. has banned fewer than 20. This comparison has fueled the perception that European cosmetics are safer or of higher quality. But is this really the case? To fully understand the reality behind these numbers and between European and American cosmetic regulations and dispel some common myths.

The Myth of Ingredient Bans: What Do the Numbers Really Mean?

The widely repeated statistic—that the EU has banned over 1,400 ingredients while the U.S. has banned less than 20—is technically true, but highly misleading. The EU’s Annex II list, which contains the substances banned from use in cosmetics, includes many chemicals that were never intended for use in personal care products in the first place. For example, this list includes substances like jet fuel, carbon monoxide, and various pesticides, and even anti-depressants (see below) none of which would ever be considered for cosmetic formulations, whether in the U.S. or Europe. I mean anti-depressants in your moisturizer might be a million dollar idea. But that would be considered a drug in the US.

So while the number may seem impressive, the reality is that both regions have similar safety protocols for ingredients actually used in cosmetics.

In contrast, the U.S. Food and Drug Administration (FDA) has a different approach. The FDA doesn’t have a single "banned ingredients" list that matches the EU's Annex II. Instead, the FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the marketing of adulterated or misbranded products. The FDA also has the power to act if a cosmetic is proven unsafe. The smaller list of banned ingredients in the U.S. may reflect a different regulatory philosophy rather than a lack of safety oversight.

EU vs. U.S.

One of the key differences between European and American cosmetic regulations is how new ingredients are reviewed and approved. In the EU, cosmetics are regulated under the Cosmetics Regulation (EC) No 1223/2009, which requires certain cosmetic ingredients to undergo pre-market approval before being used in products. This means that the EU has established committees, such as the Scientific Committee on Consumer Safety (SCCS), that review scientific evidence on the safety of cosmetic ingredients and decide whether they can be safely used.

In the U.S., the FDA does not require pre-market approval for cosmetic ingredients, except for color additives. Instead, the it is on the cosmetic manufacturers to ensure the safety of their products before they are marketed. This "post-market" regulatory system allows products to be sold without government approval, but if an issue arises, the FDA can take action to remove unsafe products from the market. This difference in approach may explain why some believe EU regulations are more protective, although both systems ultimately aim to ensure consumer safety.

Labeling and Ingredient Disclosure

The EU has rules regarding ingredient labeling, requiring detailed information on product packaging. In the EU, cosmetic companies must list every ingredient, including fragrance allergens, using their INCI (International Nomenclature of Cosmetic Ingredients) names. Additionally, allergens present in fragrances must be disclosed if they exceed certain concentrations (0.01% in leave-on products and 0.001% in rinse-off products). This gives consumers more transparency and the ability to avoid specific allergens or ingredients they may want to avoid.

In the U.S., the FDA also requires cosmetics to list ingredients in descending order of concentration, and allergens must be present. (As of writing this, the US will be adding a list of additional allergen to add to labeling lists) For example, fragrance ingredients can be grouped under the terms “fragrance” without disclosing the specific ingredients used but the allergens must be listed. This is the same as in the EU except the EU has a list of more allergen to be disclosed on a package at the moment. Critics argue that this lack of transparency can prevent consumers from making fully informed choices, especially when it comes to potential allergens.

Safety Testing and Animal Testing

Another area of significant divergence between the U.S. and EU is the issue of animal testing. Since 2013, the EU has enforced a ban on animal testing for cosmetic products and ingredients, along with a ban on marketing any cosmetics that have been tested on animals outside of Europe. This means that even if a product was developed in a non-EU country where animal testing is allowed, it cannot be sold within the EU if animal testing was involved.

In contrast, the U.S. has no such outright ban. The FDA encourages manufacturers to use alternative testing methods but does not prohibit animal testing outright. This has led to a divide between companies that choose to follow cruelty-free practices and those that still rely on animal testing for safety validation. However, there is growing pressure within the U.S. to move away from animal testing, with states like California enacting their own cruelty-free laws.

Cultural Differences in Regulation

The differences between European and American cosmetic regulations can also be attributed to cultural views on risk and safety. In Europe, the regulatory approach tends to be more precautionary—meaning that if there's any doubt about the safety of an ingredient, it’s more likely to be restricted or banned. In contrast, the U.S. takes a more risk-based approach, allowing for more flexibility and relying on evidence that proves harm before taking action.

This difference in mindset is reflected in the types of ingredients approved for use. For example, some chemical UV filters that are commonly used in European sunscreens, such as Tinosorb M, are not yet approved for use in the U.S. because the FDA requires more data to confirm their safety and effectiveness.

One significant difference between U.S. and other global cosmetic regulations is how sunscreens are classified. In the U.S., sunscreen is regulated as an over-the-counter (OTC) drug by the FDA because it claims to block UV rays and reduce the risk of skin cancer, which requires it to go through multiple rounds of testing and approval. This rigorous process ensures safety and efficacy but also slows down the introduction of new UV-blocking ingredients. In contrast, many other countries, including those in the European Union, classify sunscreens as cosmetics. As cosmetics don’t need to go through the same extensive drug-level testing, new sunscreen formulations and ingredients often reach the market much faster outside the U.S., leading to greater innovation and availability abroad. 

 Meanwhile, other ingredients, like hydroquinone (a skin-lightening agent), are restricted in the EU due to concerns over long-term safety, but can still be used in the U.S. in lower concentrations.

Which System is Safer?

Ultimately, both the European and American regulatory systems have their strengths and weaknesses. The perception that European cosmetics are inherently safer because of the number of banned ingredients is misleading—most of those substances wouldn’t be found in cosmetics to begin with. Instead, the key differences lie in how each region approaches product approval, safety testing, and consumer transparency.

For consumers, the best way to ensure safety isn’t to rely solely on one regulatory system over another but to stay informed, understand the ingredients in the products they use, and choose brands that align with their values and preferences. Whether you're buying a product from Europe or the U.S., knowing what goes into your cosmetics is the first step to making safer, more informed choices.