RDC Resolution n. 421/2020 of the Brazilian Health Regulatory Agency (ANVISA) issued labeling requirements for new formulas of products subject to sanitary surveillance, in accordance with a judicial sentence. The resolution covers a large set of products, such as food, hygiene products, medical devices and pesticides, each provided with a normative instruction. Companies must comply by September 1st, 2021.

Following a judicial sentence (process n. 0001185-30.2008.4.05.8500), the Brazilian Health Regulatory Agency (ANVISA) issued RDC n. 421/2020, establishing that new formulas of products subject to sanitary surveillance must present a clear label indicating that the product’s composition has changed. ANVISA also issued seven normative instructions (according to the sector) implementing the resolution’s provisions with a one-year gap, coming into force on September 1^st, 2021. The Normative Instructions (NI) are:

NI n. 67/2020 – Food and beverages, including ingredients and additives;
NI n. 68/2020 – Medical devices (for lay users);
NI n. 69/2020 – Hygiene products, including disposable products, cosmetics and perfumes;
NI n. 70/2020 – Sanitizing products;
NI n. 71/2020 – Low-risk drugs, traditional phytotherapy and cannabis products;
NI n. 72/2020 – Smoking products made with tobacco;
NI n. 73/2020 – Pesticides (crop protection products).