Overview
Brazil's health regulatory agency, Anvisa, has taken a significant step towards ensuring consumer safety with the publication of Normative Instruction No. 243 on August 9th, 2023. This regulation focuses on the declaration of a new formula on the labeling of sanitizing products, particularly when there's a change in the product's formula.
Key Points
-
Imported Product Labeling: For imported sanitizing products, the required declaration can be presented on the product's nationalization label. This label need not be positioned on the main panel, streamlining the labeling process for imported goods.
-
Duration of Declaration: The "NEW FORMULA" declaration is mandatory on product labels for a minimum of 90 days. This period commences from either the production of the initial batch or the nationalization of the product.
-
Declaration Removal: Post the specified 90-day duration, the "NEW FORMULA" declaration can be removed from the labeling or nationalization label without necessitating a formal change in the labeling through the regularization process.
-
Sanctions for Non-Compliance: Any failure to adhere to the regulations outlined in this Normative Instruction will be treated as a sanitary violation. Consequently, offenders will be subject to the procedures and penalties stipulated in the applicable law.
The provisions of Normative Instruction No. 243 will be enforced starting from August 18th, 2023.
Anvisa's introduction of Normative Instruction No. 243 underscores its commitment to enhancing consumer protection and safety. By streamlining the process of declaring new formulas on sanitizing product labels, this regulation aims to facilitate transparent information dissemination and ensure that consumers are well-informed about any modifications in the products they use.