Brazil- Anvisa


The new standard, RDC 421/2020, requires companies to warn about formula changes in products subject to health surveillance.

RDC 421/2020

Anvisa has established through the Resolution of the Collegiate Board – RDC 421/2020 the obligation of including a declaration about a new formula on the labeling of products subject to health surveillance, when there is a change in composition. The declaration must be clear, legible and in evidence on the label (“NEW FORMULA” or equivalent expression), in order to leave the message very visible to the consumer.

The rules apply to food, medical devices, pesticides, sanitizers and personal hygiene products, including disposables, cosmetics and perfumes. Also included are low-risk notified drugs, traditional herbal medicines and cannabis products.

The declaration may be inserted in the packaging by fixing adhesive, provided that the integrity of the colors and material manufactured is guaranteed, in order to prevent the adhesive from being partially or totally removed.

The Resolution will take effect from September 25th of this year, however, the companies will have one year to adapt, that is, the obligation will take place from September 1st, 2021. 

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at

Navigate the Global Regulatory Landscape 

Follow GRP on Social Media

Subscribe to our Blogs & Newsletter

More Resources:

Share This Post: