New Portal and Procedures for Sanitizers in Brazil

In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -RDC) 692 . The change is intended to facilitate the process and reduce paperwork.

Referred to as "risk 1" sanitizers, the low-risk sanitizers are now required to notify the agency exclusively through the online notification system. In addition, risk 1 sanitizers are exempted from registration, and their notification is exempted from revalidation. The declaration of interest for continued commercialization lasts ten years.

Accordingly, "Risk 2" sanitizers had their registry validity extended for a similar period. The validity period of registration granted before is October 16, 2019, which is accordingly extended to 10 years, counted from the granting of the registration.

Risk 1 sanitizers differ from risk 2 sanitizers in the absence of corrosive characteristics, antimicrobial activity, disinfestation action, and they are not based on viable microorganisms, while these attributes are used for risk 2 sanitizers classification. In addition, risk 1 sanitizers may not contain inorganic acids [Hydrofluoric (HF), Nitric (HNO3), Sulfuric (H2SO4)] in their formulation or release related salts during product usage.

Accordingly, ANVISA updated the list of permitted preservative substances for the formulation of sanitizing products. The Normative Instruction (Instrução Normativa – IN) 153/2022 displays 46 substances by chemical name, CAS number, and maximum permitted concentration limit.