A Brief Overview of Cosmetics Regulations in the United States (and Canada and Europe)

Richard Block

Aug 11, 2021 · 3 min read

In the United States of America, the Food and Drug Administration regulates cosmetic products in order to protect public health. Cosmetics are not FDA-approved before sale, but they are subject to rules enforced by the FDA. It is the responsibility of the manufacturer and brand to make sure beauty products comply with those cosmetic regulatory guidelines.

According to U.S. law, a “cosmetic” is defined as "[an article] intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act, sec. 201(i)).

This includes products like skin care products, fragrance, makeup, nail polish, facial cleanser, hair care products, hair coloring, and deodorant. It also includes substances intended for use as components of cosmetic products; also, while it does include specialized cleansers (i.e., synthetic detergents), it does not include soap.

Some cosmetic products may also be classified as drugs under the law. This applies if a product makes a medicinal claim (to treat skin conditions, block the sun’s harmful rays, etc.). For more information, see here.

If it is not also a drug, a cosmetic product and its ingredients do not need FDA approval before marketing (with the exception of color additives, which do need approval).

The FDA’s site says: “In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided that the ingredient and the finished cosmetic are safe under labeled or customary conditions of use, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.”

The Cosmetic Creator is responsible for making sure the product is safe, accurately labeled, unadulterated (i.e., not contaminated), and in compliance with the law. The FDA can pursue enforcement action against businesses whose products are not in compliance.

For more information, visit the FDA site here.

In Canada, cosmetics must comply with the Food and Drugs Act and the Cosmetic Regulations. These generally ensure that products are sanitary and safe.

Among other things, products must be manufactured, prepared, preserved, packed, and stored under sanitary conditions. The manufacturer and importer must provide a list of the product's ingredients and notify Health Canada, the government’s health department, that they are selling the product.

For more information on Canadian requirements, start here.

In the European Union, the requirements are different yet again. From the EU website: “Cosmetic products placed on the EU market must be safe. The manufacturer is responsible for the safety of their products, and must ensure that they undergo an expert scientific safety assessment before they are sold. A special database with information on cosmetic substances and ingredients, called CosIng, enables easy access to data on these substances, including legal requirements and restrictions.

Cosmetics legislation at EU level also requires all products to be marketed in the EU to be registered in the cosmetic products notification portal (CPNP) before being placed on the market, along with a few other provisions.

For more information, including links to the relevant authorities in individual EU member states, start here.

If you would like to sell a product in a different country, we suggest that you start by visiting the official website of the destination country’s national health department or ministry, or by contacting the destination country’s consular affairs bureau in your own country.

After you’ve done your reading, if you still have questions about regulatory matters in the country where you plan to sell your cosmetic products, we suggest contacting a regulatory adviser or consultant. You can find service providers like this right here on Goldn.

Written by

Richard Block

Richard Block is an editorial jack-of-all-trades at Goldn

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