July 7, 2025
Law No. 15.154/2025 exempts handmade personal hygiene products, cosmetics, and perfumes from registration with the Brazilian Food and Drug Agency. While easing regulatory burdens for small producers, the law maintains labeling requirements and sanitary oversight. The definition of "artisanal production" will be established in a forthcoming regulation.
On July 1, 2025, Law No. 15.154/2025 was enacted, exempting personal hygiene products, cosmetics, and perfumes manufactured through artisanal processes from mandatory sanitary registration with the Brazilian Food and Drug Agency (ANVISA). The new law, which amends Law No. 6.360/1976, represents a significant regulatory milestone for small producers and entrepreneurs in the sector, by eliminating one of the most burdensome and costly steps in the process of marketing these products in Brazil.
Under the new law, the exemption applies exclusively to products made using artisanal methods, as defined by a regulation yet to be issued. Although registration is waived, these products remain subject to applicable sanitary requirements, including compliance with labeling rules—such as listing ingredients, expiration dates, usage instructions, and any required warnings. ANVISA remains responsible for oversight and retains the authority to inspect and intervene in cases of public health concerns or violations of applicable sanitary regulations.
For the industry, the change may significantly reduce regulatory costs, facilitate market entry for small producers, and encourage innovation in the development of artisanal product lines. However, it is important to emphasize that the exemption from registration does not exempt companies from broader regulatory responsibilities: obligations related to product safety, traceability, and quality remain fully in effect.
Companies interested in manufacturing or marketing products in this category should closely monitor the forthcoming regulation that will define the criteria for artisanal production, and proactively prepare to meet minimum safety and control requirements—even in the absence of a formal registration process.
Our team is available to assist in interpreting the new law and adapting product portfolios to the new regulatory landscape.
For more information, please contact us at info@lickslegal.com.