August 27, 2025
Anvisa published RDC 989/2025 and IN 394/2025, repealing RDC 59/2010. The changes introduce stricter rules aligned with Mercosur, impacting manufacturers, importers, and distributors.
Main Points
Regulation: versions only permitted under specific conditions; prohibition for disinfectants and products containing microorganisms.
Documentation: expanded requirements (physical-chemical data, tests, labels, packaging, and LFEs).
Compliance: new risk criteria (pH, LD50, mandatory biodegradability of surfactants).
Labeling: prohibition of claims such as “ecological” or “non-toxic”; mandatory prominent warning phrases.
Net content: Over-the-counter sales increase from 5L/kg to 10L/kg (except for swimming pools: 50L/kg).
International harmonization: alignment with MERCOSUR/GMC Resolution No. 36/2022.
Direct impact: increased regulatory burden, revision of formulas and labels, and adjustments for importers.
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