New Anvisa Regulation in Brazil: Over 500 Cosmetic Registrations Canceled; TPO and DMPT Substances Fully Banned!

Three cosmetic items displayed against a neutral background for elegant product photography.

The Brazilian National Health Surveillance Agency (Anvisa) has officially announced the cancellation of all cosmetic product registrations containing TPO (Diphenyl(2,4,6-trimethylbenzoyl) phosphine oxide) and DMPT (N,N-dimethyl-p-toluidine). More than 500 products are affected, primarily within the professional nail care sector, such as UV gel polishes and phototherapy gels.

As a result, the production, sale, and use of these products are now strictly prohibited throughout Brazil.

01 | Regulatory Background: From Prohibition to Total Removal in 90 Days

In October 2025, Anvisa issued Resolution RDC 995/2025, which added TPO and DMPT to the list of prohibited substances and established a 90-day transition period. Following the expiration of this period:

  • Products containing these ingredients may no longer be sold.
  • Existing stock on the market must be recalled and usage must cease immediately.
  • In March 2026, Anvisa executed the planned enforcement by issuing RE 1.146/2026, officially publishing the list of canceled product registrations.

02 | Why the Ban? Internationally Verified Health Risks

These two components were widely used as photoinitiators or stabilizers in gel nail polishes 그리고 LED/UV-cured nail systems. However, international scientific studies have confirmed severe health risks:

  • DMPT (N,N-dimethyl-p-toluidine): Classified as a possible carcinogen; long-term exposure may increase cancer risks.
  • TPO: Classified as a Reproductive Toxicant (Category 1B); it may impair fertility. Professional nail technicians are at particularly high risk due to chronic daily exposure.

Anvisa emphasized that these measures are essential to safeguard the health of both consumers and beauty industry professionals.

03 | Aligning with the EU: Global Safety Harmonization

This move aligns Brazil with the European Union (EU), which recently implemented a similar ban on TPO and DMPT in cosmetics. By synchronizing its standards with international benchmarks, Brazil ensures that unsafe products cannot bypass regulations by flowing into “regulatory havens.” This reflects a broader global trend where photoinitiators used in nail systems are undergoing intense scrutiny and phased elimination.

04 | Conclusion: Upgraded Oversight as a Catalyst for Industry Evolution

The large-scale cancellation of registrations by Anvisa marks a pivotal moment in Brazilian cosmetic regulation. It serves not only as a “cleanup operation” but as a critical step toward a safer, more transparent, and internationally aligned industry.

Moving forward, formula innovation will be the industry’s new focus. Companies that can take the lead in developing safe, stable, and compliant alternatives will secure a competitive advantage in this new regulatory era.

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