Trajetória da nova regulamentação de cosmetovigilância no Brasil: uma revisão documental

Introduction: Cosmetovigilance protects public health by monitoring and preventing adverse events related to cosmetic products. Objective: To describe the trajectory of the development of the new cosmetovigilance regulation aimed at companies responsible for the regularization of cosmetic products in Brazil. Method: Documental review based on a systematic analysis of documents from the Brazilian Health Regulatory Agency (Anvisa), covering the period from April 2018 to August 2024. Aspects such as duration and stages of the regulatory process and participation of stakeholder groups were analyzed. Results: 251 documents were identified, of which 77 (30.7%) were included, representing the total regulatory activities executed by Anvisa. The process lasted six years and four months, concluding with the publication of Collegiate Board Resolution No. 894, dated August 27, 2024. The new rulemaking contains 55 articles in three chapters, with the chapter “Company Cosmetovigilance System” covering 85.4% of the articles. The three main stages were: public consultation of the proposed rulemaking (26.7% of regulatory activities), development of the regulatory instrument (25.3%), and social participation (22.7%). The public consultation and social participation involved nine and eight stakeholder groups, respectively, while the development of the regulatory instrument involved three groups, with notable engagement from the regulated sector. Conclusions: This study revealed a relatively lengthy regulatory process. Although the regulatory impact analysis and various social participation mechanisms prolonged the process, they reinforced the robustness and legitimacy of the published rulemaking. The extensive stakeholder participation and comprehensiveness of the new rulemaking suggest a significant advancement in cosmetovigilance regulation in Brazil.