Resolution No. 902, dated September 6, 2024, published by ANVISA, establishes that products subject to health surveillance that undergo changes in their composition must display the statement “NEW FORMULA” on their packaging. The labeling must be clear and prominent to consumers and can be applied using stickers. The resolution aims to ensure transparency regarding changes in products and imposes penalties for non-compliance with the regulations.
The products covered include:
- Low-risk medicines.
- Traditional herbal products.
- Cannabis-based products.
- Packaged food.
- Medical devices.
- Pesticides.
- Cleaning products.
- Cosmetics and perfumes.
- Personal hygiene products, including disposables.
- Tobacco products.
Final Considerations
Resolution No. 902/2024 reinforces the importance of transparency in the composition of products subject to health surveillance, ensuring that consumers are properly informed about any changes. Implementing the “NEW FORMULA” expression in labeling is an important measure to ensure that consumers are aware of any modifications in the products they consume. The use of stickers is a viable alternative while labels are not yet updated, if conditions of integrity and legibility are respected. Non-compliance with the established requirements may result in penalties, emphasizing the need for attention to the new rules that will define implementation deadlines and specific guidelines.
馃摑 Access the RDC 902/24 :
- The translated version in English is available here: RDC – 902/2024
The text in the original language of this announcement is the official authorized version. The translations are provided for convenience only and should refer to the text in the original language, which is the only version of the text that has legal effect.
If you have any questions, contact Brisa Advisors for specialized regulatory support.
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