Brazil ANVISA Issues New Cosmetics Regulations: Updated Prohibited and Restricted Ingredient Lists

On June 11, 2026, the Brazilian Health Regulatory Agency (ANVISA) approved two technical resolutions—RDC No. 1,029/2026 and RDC No. 1,030/2026—significantly updating ingredient compliance for personal hygiene products, cosmetics, and perfumes. Officially published in the Diário Oficial da União (DOU) on June 15, 2026, these regulations internalize Southern Common Market (MERCOSUR) resolutions to align regional safety standards.

Below is an overview of the regulatory changes, specific chemical impacts, transition timelines, and actionable steps for brand owners, exporters, and ingredient manufacturers.

Key Regulatory Highlights

1. RDC No. 1,030/2026 — Updated Prohibited Substances List

Amending the annex of RDC No. 529/2021, this resolution incorporates MERCOSUR GMC Resolution No. 07/25 to expand and refine the list of banned substances.

  • Newly Banned Substances:
    • Boron Compounds: Strict prohibitions on Boric Acid, Borates, Tetraborates, and Octaborates (including disodium octaborate, zinc borate, and borax), Sodium Perborate, Diboron Trioxide, and dibutyltin hydrogen borate.
    • Other Banned Ingredients: Chlorine dioxide, Polyurethane-18, Polyurethane-19, Ketoconazole, Dichloromethane, Lilial (Butylphenyl Methylpropional), and Lyral (Hydroxyisohexyl 3-cyclohexene carboxaldehyde).
  • Reclassifications and Exclusions:Certain ingredients previously categorized under strict absolute bans were removed from the prohibited list (RDC 529/2021) and reclassified under the restricted framework (RDC 1,029/2026):
    1. Benzoyl Peroxide
    2. Methyleugenol (subject to specific concentration limits)
    3. Hydroquinone (1,4-dihydroxybenzene)
    4. Azelaic Acid

2. RDC No. 1,029/2026 — Updated Restricted Substances List

This resolution revokes and replaces RDC No. 530/2021, internalizing MERCOSUR GMC Resolution No. 06/25. It establishes mandatory conditions, maximum allowed concentrations, and required label warnings.

  • Aerosol & Spray System Clarification: Specific restrictions targeting spray formulations apply universally to formats generating airborne particles (e.g., aerosols, pump sprays). Formats that generate non-airborne foams or creams (e.g., mousses, shaving creams) are exempt from airborne-particle restriction parameters.

Implementation Timelines & Transition Deadlines

ANVISA has granted tiered transitional windows for existing, legally registered/notified products on the Brazilian market:

RegulationScope / Ingredient CategoryTransition WindowCompliance Deadline
RDC 1,030/2026General Prohibited Additions & Modifications12 MonthsJune 15, 2027
RDC 1,030/2026Fragrance Allergens (Lilial & Lyral)18 MonthsDecember 15, 2027
RDC 1,029/2026Updated Restricted Substances Annex24 MonthsJune 15, 2028

Recommended Action Plan for Industry Stakeholders

Update Regulatory Filings: Submit notification or registration amendments to ANVISA well in advance of the applicable 12-, 18-, or 24-month transition deadlines to avoid commercial disruption. Non-compliance constitutes a sanitary violation under Brazilian Federal Law No. 6.437/1977.

Conduct Formulation Audits: Audit active formulations marketed or planned for distribution in Brazil against RDC 1,030/2026, focusing on boron derivative preservatives, Ketoconazole, and fragrance compounds.

Review Reclassified Compounds: For products utilizing Azelaic Acid, Benzoyl Peroxide, Hydroquinone, or Methyleugenol, evaluate whether current dosage levels and intended applications comply with the conditions set under RDC 1,029/2026.

Align Packaging and Delivery Systems: Verify spray and aerosol product delivery mechanisms to confirm compliance with airborne particle restrictions.

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