Regulatory Sandbox – Customized Personal Care Products, Cosmetics, and Perfumes

In brief

Today, October 15, 2025, ANVISA published the Public Call No. 18/2025, aiming to select participants for the Pilot Project of the Experimental Regulatory Environment (Regulatory Sandbox) focused on Customized Personal Care Products, Cosmetics, and Perfumes. The notice provides for the selection of up to five innovative projects to test business models for offering customized products directly at points of sale, under differentiated and temporary regulatory conditions, with ANVISA’s supervision to ensure safety and compliance.

In more detail

The call targets companies holding Operating Authorization (AFE) to manufacture or import personal care products, cosmetics, and perfumes; retailers that sell these products directly to end consumers; and companies with technologies aimed at personalization. Startups may also participate, provided they meet the criteria established in the notice.

Applications will be open from 10/20/2025 to 01/18/2026 and must be submitted through electronic petitioning available in the Electronic Information System (SEI). The required documentation and application procedures are available on ANVISA’s portal.

The selection process, eligibility criteria, proposal analysis, development of the flexibility protocol, granting of temporary authorization, and timeline are also detailed on ANVISA’s portal.

The regulatory sandbox is an experimental environment designed to allow companies to test innovations under temporary and supervised regulatory conditions, promoting safety and compliance while fostering new business models.