ANVISA recently published a new Collegiate Council Resolution (RCR) and a Normative Instruction (NI), completely updating the regulation on disinfectant products and repealing the old RDC 59/2010.

This modernization process began in 2019, during the 50th meeting of Mercosur's Working Subgroup No. 11 in Buenos Aires, with the aim of harmonizing Brazilian legislation with the bloc's technical regulations for the registration and notification of these products.

Although broad regulatory alignment with Mercosur was achieved, there was no consensus on issues such as analytical tolerances and expiration dates due to climatic differences between the countries.

WHOM DOES IT IMPACT?

The direct impact is on manufacturers and distributors of disinfectant products, quality control and certification laboratories, consumers, and regulatory authorities.

CONCLUSION:

Their entry into force marks a turning point in Brazil's health regulations for disinfectants. By combining international alignment with stricter national requirements, it strengthens public health protection and modernizes the sector, although it will require a considerable adaptation effort on the part of the industry.