Brazil ANVISA's New Normative Instruction Sets Guidelines for Labeling Changes in Personal Care Products

ANVISA has taken a significant step toward ensuring transparency and consumer safety within the personal care product industry. With the introduction of a new Normative Instruction, ANVISA is set to regulate the inclusion of declarations of new formulations on the labeling of personal hygiene products, cosmetics, and perfumes when formula modifications occur. 

Outlined in Instruction No. 243, this new measure mandates manufacturers to prominently display the term "new formula" on the labels of reformulated sanitizing products falling under ANVISA's regulatory purview, for a stipulated period of at least 90 days. The prescribed phrasing should be rendered in a bold, capital-letter font with a minimum height of 1 mm, sharply contrasting with the label's background color. 

Moreover, labels must also incorporate the phrase "new formula" in instances where alterations to the product entail revisions in any of the following aspects: Stated concentration, usage instructions, precautionary or advisory measures and promised benefits of use 

Scheduled for implementation on the 18th of August, this update builds upon a resolution from April that originally established labeling and prerequisites for sanitizing products boasting antimicrobial attributes. 

In a separate development, ANVISA is actively soliciting input from the public regarding a proposition that seeks to modernize the prerequisites governing classification, labeling, and packaging of personal hygiene products, cosmetics, and perfumes. Interested parties are encouraged to submit their comments prior to the looming deadline of the 18th of August. 

The new Normative Instruction aligns with ANVISA's overarching goal of ensuring consumer safety and enhancing transparency within the personal care product sector. By requiring clear and prominent declarations for modified products, ANVISA intends to empower consumers to make informed choices while promoting responsible practices within the industry.