Animal testing for cosmetics, perfumes, and personal hygiene products now prohibited

On July 31, 2025, the Federal Government enacted Law No. 15,183/2025, which prohibits the use of live vertebrate animals in tests designed to assess the safety, efficacy, or toxicity of personal hygiene products, cosmetics, perfumes, and the ingredients used in their formulation.

Law No. 15,183/2025 changes:  

• Law No. 6,360/76, which governs products subject to health surveillance, including medicines, drugs, pharmaceutical inputs and related items, as well as cosmetics and sanitizing agents; and
• Law No. 11,794/2008, which establishes procedures for the scientific use of animals.

Among the main changes introduced by the new legislation, we highlight:

• Data from animal testing conducted after the entry into force of Law No. 15,183/2025, on July 31, 2025, can only be used if obtained for the purpose of complying with non-cosmetic regulations, whether local or international. To qualify for this exception, companies involved in the manufacture or commercialization of these products must, upon request, provide the competent authorities with documentation demonstrating that the tests conducted were not intended for cosmetic purposes.
• Manufacturers are prohibited from including phrases such as “not tested on animals” or “cruelty-free”, as well as related logos or stamps, on the labeling of products whose safety was established using data from animal testing conducted after the effective date of the law – July 31, 2025. This restriction applies even when such testing was carried out to comply with non-cosmetic regulatory requirements, whether local or international.

Both the Brazilian Health Regulatory Agency (“ANVISA”) and the National Council for the Control of Animal Experimentation (“CONCEA”), within the scope of their respective jurisdictions, will be responsible for issuing regulations, within a two-year period, concerning:

• Alternative methods for assessing the toxicity, efficacy, or safety of cosmetics, perfumes, personal hygiene products, and their ingredients – including reliance initiatives aimed at promoting the acceptance of internationally recognized and validated approaches.
• Updating cosmetic labeling requirements to reflect the prohibition on claims such as “not tested on animals” or “cruelty-free” for products whose safety has been demonstrated through animal testing.
• Measures to monitor the use of data obtained from animal testing conducted after the entry into force of Law No. 15,183/2025, for the purposes of safety assessment and cosmetic products authorization.

What are the exceptions to the prohibition established under Law No. 15,183/2025?

In exceptional circumstances that raise serious concerns regarding the safety of a cosmetic ingredient, CONCEA, linked to the Ministry of Science and Technology, may authorize testing on live animals, provided that all three of the following conditions are met simultaneously:

• The ingredient is widely used in the market and cannot be replaced by another substance with established safety data;
• The testing is necessary to investigate a specific human health concern related to the ingredient; and
• No suitable alternative testing method is available to meet the required safety assessment standards.

What are the effects of the new law on cosmetic products and ingredients tested on live vertebrate animals before Law No. 15,183/2025?

Law No. 15,183/2025 does not affect products that were regularized prior to its effective date – these products remain authorized for commercialization in Brazil.

However:

• There is no legal provision prohibiting the use of data from animal testing conducted prior to July 31, 2025, for the purpose of registering cosmetic products with ANVISA after the new law comes into effect.
• As of July 31, 2025, onward, data from animal testing conducted after the entry into force of Law No. 15,183/2025 can only be used to register cosmetic products with ANVISA when such data were generated to fulfill non-cosmetic regulatory obligations – whether local or international.

Finally, it is worth noting that ANVISA accepts alternative methods to animal testing that are recognized by CONCEA, as specified in Normative Resolutions No. 18/2014 and No. 31/2016. This acceptance is established under ANVISA’s Collegiate Board Resolution (“RDC”) No. 35/2015.

Law No. 15,183/2025 entered into force on July 31, 2025.

Demarest’s Life Sciences and Healthcare, and Environmental teams are available to provide any further clarification that may be necessary.