Global Rules on Cosmetics and Animal Testing | Differences Between the EU, the United States, and Japan

You may see phrases such as “not tested on animals” on products or websites. However, the treatment of animal testing for cosmetics varies greatly by country and region. Some regions prohibit it by law, while in others the wording used on labels has no legal definition. Here is an overview based on information from public agencies and industry organizations in the EU, the United States, and Japan.

EU: A two-part framework banning both testing and sales

According to the European Commission, the EU banned animal testing of finished products on September 11, 2004, and animal testing of ingredients (and combinations of ingredients) on March 11, 2009. At the same time, a “marketing ban” prohibiting the sale on the EU market of products and ingredients that had undergone animal testing was introduced in stages. It applied to most test items from March 11, 2009, and to the remaining three areas of repeated-dose toxicity, reproductive toxicity, and toxicokinetics from March 11, 2013. Under the current Cosmetics Regulation (EC) No 1223/2009, this is set out in Article 18 and applies to animal testing conducted for the purpose of meeting the requirements of that regulation.

The EU rules are a two-part framework: not only “do not test within the region,” but also “do not sell what has been tested.” On the other hand, there are regions such as the United States where the labeling terms themselves have no legal definition, so even the same expression “not tested on animals” can be backed by different systems depending on the region.

United States: The law does not require animal testing, and labeling terms are not defined

The U.S. Food and Drug Administration (FDA) explains that the FD&C Act does not specifically require the use of animals in safety testing for cosmetics, and that cosmetics are not subject to premarket approval. The FDA supports the development and use of alternative methods, and in 1997 it joined 13 other federal agencies in establishing an organization (ICCVAM) to coordinate matters such as the validation of alternative test methods. The FDA also clearly states that terms such as “cruelty-free” and “not tested on animals” have no legal definition. The MoCRA enacted in 2022 also does not require animal testing for safety substantiation.

Japan: Guidance on alternative methods continues to develop

In Japan, there is no legal marketing ban like the EU’s, and efforts mainly focus on promoting the use of non-animal test methods (alternative methods). The Japan Cosmetic Industry Association established the “Committee on Alternatives to Animal Testing” in 1991 and has supported the development and spread of alternative methods. The Ministry of Health, Labour and Welfare has issued guidance by test method on approaches for using alternative methods in the safety evaluation of quasi-drugs and cosmetics. In the association’s summary, these include phototoxicity (2012), eye irritation (2014), skin irritation (2021), and combined assessment for skin sensitization (2025). In 2022, the association also established a working group on next-generation risk assessment (NGRA) that does not use animals.

For the distinction between cosmetics and medicated cosmetics (quasi-drugs), see The Difference Between Cosmetics and Medicated Cosmetics introduced here.

References: European Commission, Official Journal of the European Union (Regulation (EC) No 1223/2009), U.S. Food and Drug Administration (FDA), Ministry of Health, Labour and Welfare, Japan Cosmetic Industry Association

—The Value Village Editorial Team