And how to know if your favorite cosmetics have been tested on animals.

Humans have been using animals to test pharmaceuticals and cosmetics since 1937, when a chemical reaction caused by an untested liquid antibiotic marketed toward pediatric patients caused the death of over 100 adults and children. The tragedy led to the passage of the 1938 U.S. Federal Food, Drug, and Cosmetic Act, which required drugs be labeled with improved directions for safe use and mandated pre-market approval by the FDA of all new drugs. At the time, researchers were limited to animal toxicity testing to get their ingredients approved.

While many countries don’t report their numbers even today, Cruelty Free International estimates that about half a million animals are used to test cosmetics around the world each year.

Many of these outdated experimental techniques are ultimately pointless, since they typically produce results that cannot reliably be applied to humans.

As researchers have grown to discover since the 1930s, most animals respond differently than humans when exposed to the same chemicals. In fact, new pharmaceuticals pass preclinical animal testing to enter clinical trials about 12% of the time; of that, about 60% successfully complete the first phase of supplementary trials and a whopping 89% then go on to fail in human clinical trials.

If toxicity-related failure rates are so high in pharmaceuticals after animal testing, why are we still using these methods in the cosmetics industry—or at all?

What Exactly Are Cosmetics?

The U.S. Food and Drug Administration defines cosmetics as "articles 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." Legally, cosmetics include makeup, skin care, hair products, deodorant, and toothpaste.1

Global Regulations on Animal Testing for Cosmetics

While the current Federal Food, Drug, and Cosmetic Act regulated by the FDA prohibits the sale of mislabeled and "adulterated" cosmetics, it does not require that animal tests be conducted to demonstrate that the cosmetics are safe. However, the United States has yet to ban the practice of animal testing and the sale of cosmetics tested on animals within its borders. 

Instead, the FDA puts the decision in the hands of the manufacturers, saying:

...The agency has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products. It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to marketing. Animal testing by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient.

One of the most significant contributors to the continued use of animal testing in cosmetics is China, which before 2021 required all cosmetics products to be tested on animals in order to be imported or sold in the country. However, China has started moving away from this law for a few years now, and as of May 2021, the requirement for some cosmetics imported and sold in the country had changed.

The new law waives requirements for animal testing if companies can provide satisfactory evidence of their safety according to China’s standards. “Special” cosmetics like antiperspirants, sunscreens, and baby products continue to be subject to more in-depth information requirements, and the country can still require new ingredients to undergo animal testing if authorities are not satisfied with the quality of safety reporting provided.

On the opposite end of the spectrum, the European Union banned testing cosmetics on animals and selling cosmetics tested on animals back in 2013. This measure followed the U.K.'s lead, which became the first nation to ban the practice in 1998. The EU's decision created a major shift in the cosmetics industry for companies that marketed and produced cosmetics, since those that wanted to sell in the EU couldn’t use animal testing, but if they wanted to sell to China, they were required to.

The example set by the EU helped inspire other countries, such as India, Israel, Norway, Iceland, Australia, Colombia, Guatemala, New Zealand, South Korea, Taiwan, Turkey, Switzerland, and parts of Brazil, to pass similar laws. Most recently, Mexico became the first country in North America and the 41st nation in the world to completely ban animal testing for cosmetics.

That means cosmetic companies both in the United States and abroad that choose to conduct animal tests are not legally allowed to sell their merchandise in these countries, forcing many organizations to rethink their methods for testing new products and ingredients.

In the US, California, Hawaii, Illinois, Maine, Maryland, Nevada, and Virginia have also passed laws to ban or limit cosmetic animal testing at the state level.

What Animals Are Used in Cosmetics Testing?

These days, animals used for testing range from rabbits and guinea pigs to rats and mice, but some rare cases include dogs.

These animals are used in a few different ways, the most common of which are skin and eye irritation tests—where cosmetic chemicals are rubbed onto shaved skin or dripped into the eyes of restrained animals (usually rabbits) without pain relief. This is known as the Draize rabbit eye test, and it’s intended to discover whether or not a product or ingredient will cause injury to the human eye.

There are also tests that deliver controlled doses of chemical substances to animals (usually mice) via a feeding tube that’s forced down their throats. Generally, these kinds of tests can last for weeks or months while the researchers look for signs of general illness or long-term health effects such as cancer or congenital defects. In reproductive toxicity tests, researchers may feed chemicals to pregnant animals to see whether the substances will cause abnormalities in offspring.

Though it is undoubtedly one of the more controversial tests performed on animals, some laboratories still use lethal dose (or LD50) tests, in which substances are administered to animals topically, orally, intravenously, or through inhalation to determine how much of that substance will cause death.

The test gets its nickname from its objective to find the amount of a chemical that kills half, or 50%, of a population. LD50 tests are especially condemned among the animal welfare community because their results have very little significance when it comes to humans (learning how much of a specific chemical kills a mouse, for example, has little correlation to humans). 

Substances Tested on Animals

Developing or using new ingredients in cosmetic products comes with certain liabilities—both safety and legal. Since cosmetics must not be adulterated or misbranded under the FD&C Act, the responsibility lies on the manufacturer to identify potential hazards to humans, and companies certainly don’t want to sell a product that could result in legal issues.

Cosmetic animal testing involves testing the finished product, the chemical ingredients in a product, or both. A finished product can include a lipstick or a shampoo, while a chemical ingredient might include a dye or preservative used to formulate that lipstick or shampoo. Requirements for finished product testing are rare outside of China and a few developing countries.

Some ingredient testing is required on behalf of specialty chemical companies who supply cosmetics manufacturers and the laws behind them, threatening to undermine existing animal testing bans.

The European “Registration, Evaluation and Authorization of Chemicals (REACH)” regulation, for instance, requires chemical companies to provide new information on certain cosmetic ingredients. Per the EU European Chemicals Agency, “...this means companies must test their chemicals for safety—by using alternative methods or—as a last resort—testing on animals. Animal tests are only permitted if there is no alternative way to gather the safety information.”

Federal Protections for Test Animals

The Animal Welfare Act (AWA) is a federal law that addresses the standard of care received for animals bred for commercial sale, transported commercially, exhibited to the public, or used in research. An amendment in 1971 by the Secretary of Agriculture specifically excluded rats, mice, and birds from the AWA—animals that represent a huge majority of those regularly tested upon. Labs and research facilities are not required to report these non-AWA-protected animals.

If laboratories using live vertebrate animals in research are funded by the Public Health Service, they must also adhere to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). Although the PHS Policy sets standards for any live vertebrate animal, including those not covered by the AWA, participants are allowed to appoint their own committee responsible for inspections and reviews. PHS Policy is not federal law, as it only applies to facilities that have applied for PHS funding, so the most serious penalties for infractions are either loss or suspension of the federal grant or contract.

How Do I Know if My Cosmetics Have Been Tested on Animals?

Not sure if your favorite cosmetics brand contains ingredients tested on animals? Start by looking for cruelty free certified products. Keep in mind that there are only three official third-party organizations certifying products as cruelty free: Leaping Bunny, Cruelty Free International, and Beauty Without Bunnies.

What Does Cruelty Free Mean?

According to Humane Society International, a cosmetic can be considered cruelty free when the manufacture has committed to: “Not conduct or commission animal testing of its finished products or ingredients after a certain date,” and “monitor the testing practices of its ingredients suppliers to ensure they do not conduct or commission new animal testing either.”

Cruelty free certifications recognize companies that have met a set of cruelty free standards, signed legal documents, and submitted additional documentation to ensure compliance.

These certification programs also have online databases and mobile apps to download on your phone and make it easy to scan a product’s barcode.

If you don’t have the product package or are not sure of its ingredients, contact the company directly to address specific questions or concerns about its animal testing policies.