Sanitizing products

Publicado em 29/10/2020 16h37

What are Sanitizing products?

According to the definition given by Law 6.360/1976, sanitizing products are cleaning products, antimicrobial products for objects e environments, and domestic pesticides, which are substances or preparations intended for household sanitation, disinfection or disinfestation in collective and/or public environments, in places of common use and in the treatment. They include:

  • Insecticides: intended for combating, preventing and controlling insects in households, private places and places of public use and their surroundings;
  • Rodenticides: intended for the control of rats, mice and other rodents, in domiciles, vessels, enclosures and places of public use, containing active substances, isolated or in combination, which do not present a risk to human or animal life or health when used in accordance with their recommendations;
  • Disinfectants: intended to destroy, indiscriminately or selectively, microorganisms, when applied to inanimate objects or environments;
  • Detergents: intended to dissolve fats and for the hygiene of containers and household applications.

Market authorizations

The general regulation applicable to market authorization for Sanitizing products is Resolution RDC 59/2010.

Products described in this Resolution as Risk 2 are subject to pre-market approval by Anvisa. Products in the Risk 1 category are exempt from pre-market approval and are subject to a notification procedure, aiming at informing Anvisa about the intention to market a product exempted from pre-market approval.

Pre-market approvals are valid for five years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods.

Notifications are valid for five years from the date when the online protocol is finalized, and may be renewed for equal and successive periods.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.

Applicable regulations

These are the main regulations applicable relating to the market authorization (pre-market approvals and notification) of sanitizing products exported to Brazil: