Decree No. 471/2026, issued by the National Health Surveillance Agency (ANVISA), formalizes the creation of the Cosmetovigilance Technical Chamber (CTEC), a consultative body linked to the General Management of Monitoring of Products Subject to Health Surveillance (GGMON). This measure is part of a context of consolidating regulatory requirements related to cosmetovigilance, in line with RDC No. 894/2024, which establishes Good Cosmetovigilance Practices for companies holding cosmetic product registration with ANVISA, setting parameters for the structuring of safety monitoring systems by these companies.
Cosmetovigilance corresponds to the post-marketing surveillance and monitoring of cosmetic products registered in the country. In accordance with article… Article 2, XIII, of RDC No. 894/2024 covers activities related to the identification, notification, evaluation, investigation, monitoring, communication, and prevention of adverse reactions resulting from use under normal or reasonably foreseeable conditions. Its scope also includes events such as product ineffectiveness, misuse, exogenous intoxication, occupational exposure, and technical complaints that result in harm to consumer health.
In this context, CTEC will act as a technical advisory body, contributing to the analysis of data related to adverse events and to the improvement of cosmetovigilance practices in the country, without exercising a decision-making function. Among its competencies are providing technical and scientific support to ANVISA’s activities in monitoring the safety of cosmetic products, identifying potential risks, proposing regulatory and preventive measures, and developing methodological frameworks applicable to the subject, promoting greater consistency in regulatory action.
The Chamber is composed of five full members, in addition to alternates, including representatives from academic and research institutions, as well as the Health and Environment Surveillance Secretariat of the Ministry of Health. The Ordinance also regulates its operational dynamics, providing for ordinary meetings every six months and the possibility of extraordinary meetings, as needed.
Finally, it is worth highlighting that the strengthening of the cosmetovigilance structure by ANVISA reinforces the need for companies to have an effective Cosmetovigilance System, capable of ensuring compliance with their responsibilities regarding the safety of marketed products and the timely adoption of appropriate measures, when necessary, in accordance with Article 3 of RDC No. 894/2024.
This material is exclusively institutional and informative in nature, limited to the presentation of general normative and administrative aspects on the subject.
Bianca Oliveira Begossi | Bianca Begossi | leonardo.sacilotto@nascimentomourao.adv.br
Partner in the Environmental, Regulatory and Biodiversity Law area.
Leonardo Mattoso Sacilotto | leonardo.sacilotto@nascimentomourao.adv.br
Partner in the Environmental, Regulatory and Biodiversity Law area.
