Sanitizing products
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.
Applicable regulations
These are the main regulations applicable relating to the market authorization (pre-market approvals and notification) of sanitizing products exported to Brazil:
- Resolution RDC 42/2009: Electronic procedure for notification of Products of Risk I.
- Resolution RDC 109/2016: Bleaches.
- Resolution RDC 110/2016: Hypochlorite based products.
- Resolution RDC 252/2003: Prohibition of benzene and limits to the compound as a contaminant.
- Resolution RDC 35/2008: Preservatives.
- Resolution RDC 30/2011: Preservatives.
- Resolution RDC 34/2010: Technical requirements for disinfectant products.
- Resolution RDC 339/2005: Insecticidal baits in gel form.
- Resolution RDC 340/2005: Molluscicides.
- Resolution RDC 40/2008: Cleaning products.
- Resolution RDC 55/2012: Enzymatic detergents of restricted use in healthcare establishments for cleaning medical devices.
- Resolution RDC 208/2003: Odor neutralizers.
- Resolution RDC 82/2016: Bacteria-based sanitizing products.
- Resolution RDC 14/2007: Antimicrobial products.
- Resolution RDC 35/2010: Antimicrobial products used in critical and semi-critical articles.
- Resolution RDC 32/2013: Procedures and technical requirements for the market authorization of sanitizing products that are corrosive to the skin or that cause serious eye damage.
- Resolution RDC 345/2005: Specific requirements for products containing inhalants.