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Anvisa changes regulations and reduces regulatory costs for the sanitizing industry

The measure makes it easier to modify labels on sanitizers intended for donation.


To facilitate donations of sanitizing products, Anvisa decided to simplify the rules for modifying the labeling of these products when they are destined for donation. To achieve this, the Agency published RDC No. 878/2024, which amends RDC No. 492/2001. This change aims to reduce regulatory costs for the sanitizing production sector. With the new rule, labeling changes to include information about product donations are exempt from a petition and prior approval from Anvisa. Resolution RDC No. 878/2024, which modifies RDC No. 492/2001, is already in force and applies to Risk 1 and Risk 2 sanitizers.


Due to the calamity caused by intense rains in Rio Grande do Sul, Anvisa received several doubts and questions about the donations of sanitizing products and how to carry them out correctly from a regulatory point of view.


Given this situation, the Agency identified the opportunity to reduce regulatory costs for the sanitizing production sector. With this objective in mind, Anvisa decided to simplify the rules for changing the labeling of sanitizers intended for donation. This measure also eliminates the administrative burden for Anvisa, as the petition exemption could only be granted through an exception given by the Collegiate Board.


Reducing regulatory costs for sanitizers intended for donation allows for increasing the use of these products as a tool against the proliferation of microorganisms that are harmful to health. Cleaning and sanitizing objects and environments is essential to prevent infections caused by floods.