On August 5, 2026, the Collegiate Board of the Brazilian Health Regulatory Agency (ANVISA) approved the evaluation results of the “Detailed Analysis” stage of the pilot projects under the experimental regulation (i.e., the Regulatory Sandbox) for “personalized personal hygiene products, cosmetics and fragrances.” The four projects shortlisted in the preliminary stage were all assessed as eligible at this stage and will proceed to the next stage — the development of their respective “Experimental Regulatory Flexibility Protocols.” This is also the first time ANVISA has applied the regulatory sandbox model in the cosmetics sector. CIRS Group has summarized the main points below for your reference.
“Regulatory Sandbox” and “Personalized Cosmetics”
The regulatory sandbox allows companies to test, under ANVISA’s supervision, new business models and new technologies that do not yet fully comply with current health regulations. During the trial period, ANVISA may temporarily relax certain regulatory requirements under specific conditions, limits and safeguards, in order to generate evidence that can support future regulatory decisions — without compromising consumer safety.
“Personalized cosmetics” refers to the adjustment, at the point of sale, of the formulation, characteristics or presentation of personal hygiene products, cosmetics or fragrances to meet consumers’ individual needs or preferences (e.g., skin-tone shades, fragrance preferences, etc.), and must be achieved through technologies and procedures that ensure the product’s quality, safety, efficacy and traceability.
Selected Projects and Companies
The four projects that passed the Detailed Analysis stage come from two Brazilian cosmetics companies. They mainly involve the personalization of fragrances and face base makeup (foundation) directly at the point of sale (counters/stores), implemented through automated equipment or manual processes assisted by digital tools.
Evaluation Process and Criteria
This Detailed Analysis was carried out collectively by the Regulatory Sandbox Working Group, with the participation of ANVISA’s internal technical departments responsible for registration, inspection, company operating authorizations and post-market product monitoring, and supported by the Regulatory Impact Analysis (AIR) advisory department. The main evaluation criteria included:
- Technical capability and the technologies employed
- Quality and maturity of the project
- Regulatory compliance
- Technical-sanitary safeguards and risk management
- Monitoring potential (monitorability)
- Sustainability and social responsibility
Next Stage: Developing the “Experimental Regulatory Flexibility Protocols”
Upon completion of this stage, the companies concerned will be convened to present their projects to the Working Group and to provide the clarifications and supplementary materials needed to develop the “Experimental Regulatory Flexibility Protocols.” For each project, the protocol will specify individually: the operating conditions, the regulatory rules to be temporarily relaxed, the scope of activities, the duration, the monitoring requirements, and the risk-mitigation measures.
Once the protocols have been drafted, the proposals will undergo legal analysis and be agreed with the companies before being submitted to the ANVISA Collegiate Board for approval. Once approved, temporary authorizations will be granted to the selected companies on this basis, enabling them to actually implement their proposed business models under ANVISA’s supervision.
Expected Timeline for Implementation
ANVISA expects that the first batch of cosmetic personalization projects carried out at the point of sale will be implemented within 2026.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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