Brazil’s cosmetics and personal care sector is entering a new phase of regulatory maturity. In the past two years, Anvisa has introduced a series of measures that strengthen oversight across the entire product lifecycle—from ingredient selection and formulation compliance to post-market safety monitoring.
Together, these initiatives demonstrate a clear regulatory objective: enhancing consumer protection through science-based decision-making, greater transparency, and closer alignment with international and Mercosur standards.
A New Era of Cosmetovigilance in Brazil
A major milestone was reached with the implementation of RDC No. 894/2024, which established Good Cosmetovigilance Practices and introduced the mandatory reporting of serious adverse events associated with cosmetic products through Anvisa’s Notivisa system. This shifted cosmetovigilance from a largely voluntary activity to a structured regulatory obligation for companies operating in Brazil.
Anvisa has continued to reinforce this framework in 2026 through the creation of the Technical Chamber of Cosmetovigilance (CTEC), a consultative body dedicated to strengthening post-market surveillance of cosmetics, personal hygiene products, and perfumes. The Chamber held its first ordinary meeting in June 2026, defining priorities for the 2026–2027 period, including the development of ethical guidelines for cosmetovigilance, strategies to increase adverse event reporting, and proposals for priority research agendas in the field.
These developments signal that cosmetovigilance is becoming a strategic pillar of Brazil’s cosmetics regulatory framework, supported not only by reporting requirements but also by a growing technical and scientific infrastructure dedicated to monitoring product safety after commercialization.
Stronger Controls on Cosmetic Ingredients
At the same time, Anvisa has modernized the rules governing substances used in cosmetic products.
In July 2026, the Agency published RDC No. 1,029/2026, which establishes the first part of the revised List of Restricted Substances, defining ingredients that may only be used under specific conditions and limitations. Anvisa also issued RDC No. 1,030/2026, updating the list of prohibited substances for personal hygiene products, cosmetics, and perfumes. Both measures were developed based on updated scientific evidence and promote greater harmonization with Mercosur and international regulatory standards.
In parallel, Public Consultation No. 1,399/2026 was launched to gather stakeholder contributions on the second part of the List of Restricted Substances, reinforcing Anvisa’s commitment to regulatory transparency and continuous improvement.
What This Means for the Industry
Taken together, these initiatives create a more comprehensive safety framework for the cosmetics sector.
The updated ingredient lists strengthen preventive controls by ensuring that formulations reflect the latest scientific and regulatory assessments. Meanwhile, mandatory cosmetovigilance and the creation of CTEC enhance post-market oversight, enabling better detection, evaluation, and management of safety signals once products reach consumers.
As a result, companies should:
- Review formulations and ingredient portfolios against updated restricted and prohibited substance lists.
- Strengthen internal cosmetovigilance procedures and adverse event reporting processes.
- Ensure readiness for Notivisa reporting requirements.
- Monitor ongoing public consultations and emerging regulatory developments.
- Integrate regulatory intelligence into product development and compliance strategies.
How ClarkeModet Can Support
As Brazil’s cosmetics regulatory framework becomes increasingly sophisticated, companies need a partner capable of supporting compliance across both pre-market and post-market requirements.
ClarkeModet helps organizations navigate these changes through:
- Regulatory intelligence and monitoring of Anvisa and Mercosur developments.
- Formula and ingredient compliance reviews against restricted and prohibited substance lists.
- Cosmetovigilance implementation and optimization, including adverse event management processes and Notivisa readiness.
- Regulatory gap assessments and compliance audits.
- Support during public consultations and regulatory change management.
- Strategic regulatory guidance to facilitate market access and reduce compliance risks.
By combining regulatory expertise with deep knowledge of the cosmetics industry, ClarkeModet supports companies in adapting to evolving requirements while maintaining product safety, consumer trust, and sustainable growth in one of the world’s most important beauty markets.