QR Group Explains ANVISA’s New Labeling Rules: How to Adapt Your Products

Normative Instruction IN No. 242/2023, published by ANVISA, brought significant changes to the labeling of personal care products, cosmetics, perfumes, and disposables. Now, whenever there is a formula modification, the “NEW FORMULA” or “NEW COMPOSITION” statement must be included in the label.

If your company operates in this sector, understanding and adapting to these requirements is essential to avoid regulatory problems and ensure transparency for the consumer. QR Group, a specialist in ANVISA regulation, can help your brand in this compliance process quickly and safely.

Mandatory Declaration for Formula Modification

The new rule defines that any qualitative or quantitative change in the formula of a product already registered must be communicated to the consumer. To do this, the main panel of the label — the most prominent area — must contain the expression “NEW FORMULA” or “NEW COMPOSITION” in capital letters, bold and contrasting color.

For imported products, ANVISA allows this declaration to be made on the nationalization label, dispensing with its inclusion on the main panel.

Criteria for Insertion of the Declaration

The obligation to declare occurs when the modification of the formula impacts essential aspects of the labeling, such as:

• Addition or exclusion of ingredients;
• Changes in the concentration of components;
• Changes in the mode of use;
• Updates to warnings and restrictions on use;
• Modifications to the appeals or benefits attributed to the product.

Declaration Length of Stay

IN 242/2023 establishes that the declaration of a new formula must remain on the label for at least 90 days after the production of the first batch or the nationalization of the product.

Flexibility in the Label Change Process

One of the main advantages of the new regulation is the exemption from petitioning for changes in labeling that involve only the inclusion or exclusion of the mandatory declaration. This simplifies the process for manufacturers, making adaptation more agile.

How QR Group Can Help Fit Your Business

Regulatory compliance is essential to ensure that your products are in line with ANVISA standards. QR Group offers specialized advice to manufacturers and importers of hygiene products, cosmetics and perfumes, ensuring an efficient and safe regularization process.

Our team assists your company from the analysis of changes in the formula to the adequacy of labeling, ensuring that all the requirements of IN 242/2023 are met without complications.

If you need support to adapt the labeling of your products to the new requirements of ANVISA, count on QR Group’s expertise. Contact our experts and ensure compliance quickly and securely.

Source: B&V Records