California Cosmetics Allergens Labeling Requirements

Do Businesses Have to List Allergens on Cosmetic Labels?


An estimated 10% of people experience allergy-related irritation or hypersensitivity from cosmetic products. The severity of allergic reactions can range from mild dermatitis to anaphylaxis, a potentially life-threatening reaction. Of course, allergens are always a concern with any consumer product, but when it comes to cosmetics, the rules are murky at best.


The FDA heavily regulates the declaration of allergens on food and drink labels. However, these same regulations don’t apply to allergens found in cosmetics. Although the FDA has limited authority on the federal level to regulate cosmetic products, companies that sell these products should still be aware of allergens that may produce a reaction in customers. Additionally, cosmetic firms should be aware of the information that they are required to include on their labels.


While the FDA’s authority may be more limited on the federal level, California is more stringent on the state level. Businesses should be aware of California’s requirements, as the state represents the largest economy in the nation.


Let’s take a closer look at California’s and the FDA’s allergen labeling requirements for cosmetic products.

Cosmetic Product Labeling Requirements

It’s important for cosmetic companies to be aware of allergen-related labeling requirements both on the federal level and in California. Other states may have additional requirements, but we’re going to focus on California due to the size of their economy.

FDA Labeling Requirements

Food products regulated by the FDA must list any “major food allergen” on its label. However, these requirements do not extend to cosmetics and other personal care items.


According to the FDA, the allergens that cause the most reactions in cosmetic product use are:

• Metals
• Dyes
• Fragrances
• Preservatives
• Natural rubber

Under the Fair Packaging and Labeling Act, the FDA has the authority to require companies to declare ingredients on retail cosmetic products. However, the rules for ingredient declaration are lax, and some ingredients that commonly contain allergens may be exempt from having to declare their common name. Fragrances commonly contain allergens, but cosmetic firms are permitted to simply declare this ingredient as a “fragrance” without specifying its ingredients.


Additionally, the FDA’s regulations do not govern or define allergy claims such as “fragrance-free” or “hypoallergenic.” These are terms defined by companies themselves, and the FDA itself has no policies or definitions for them. In other words, they have very little meaning apart from marketing purposes. Despite this, the FDA has no specific restrictions on the use of these terms on cosmetic labels.

Reporting Requirements in California

The FDA may not have allergen labeling requirements for cosmetics, but California is more stringent. Cosmetic firms will face more stringent requirements. There are two primary requirements to be aware of in California:

• • The California Safe Cosmetics Act of 2005 established a list of ingredients that were suspected of causing reproductive harm or cancer. Any product containing any of these ingredients must be reported to the state.

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  • The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020, which went into effect in 2022, has designated a subset of ingredients known as fragrance allergens. Within this list, there are ingredients that must be reported only if used in fragrances, and if they are at a concentration of 0.001% for leave-on cosmetics and 0.01% for rinse-off cosmetics.

While California’s regulations are more stringent than the FDA’s, the state’s laws still do not cover all allergens found in cosmetic products. That said, cosmetic companies will still need to adhere to the state’s requirements if they wish to sell their products in California.

The Future of Cosmetics Labeling

The FDA may soon have more authority over cosmetic product labeling. Congress has introduced The Personal Care Products Safety Act, which would require cosmetic businesses to submit a statement to the FDA for each cosmetic product they intend to market in the U.S.


Those statements would require, among many other things:

• The product’s ingredients
• Any applicable warnings
• Information about the cosmetic manufacturing facility

Cosmetic companies would also be required to include the names of certain allergens if that ingredient is found in the product in a certain amount. The bill itself contains a list of known allergens that would need to be included in labels, but the FDA would have the ability to extend this list.


If you have doubts on California Cosmetic Allergens Labeling Requirements, Cosmereg can assist you in each step. For more information just contact us through our contact form.