October 30, 2020
The Brazilian Health Regulatory Agency (ANVISA) published on September 3rd of 2020, Resolution of the Collegiate Board 421 of September 1st, 2020 defining a new requirement for labels of certain products when their formula or composition is modified.
The products for which this regulation applies to are those subject to health surveillance that suffer changes in their formulation and are part of one of the following categories:
- pesticides and similar products;
- sanitizing products;
- personal hygiene products, including disposables;
- cosmetics and perfumes;
- low risk notified drugs;
- traditional herbal and cannabis products;
- medical devices; and
- smoking products derived from tobacco.
For each category of product, a regulation was created to establish specific requirements and details necessary to implement this Resolution.
The products must present the “NEW FORMULA” declaration or equivalent expression on their labels.
The declaration can be included in the packaging by being fixed by an adhesive, as long as the integrity of the colors and the material with which the adhesive is made is guaranteed to prevent the declaration from being partially or totally removed.
The graphic criteria for the declaration vary slightly depending on the category, but for food, cosmetics and sanitizing products, the letter character used for declaration must satisfy the following conditions:
I – appear on the main panel;
II – upper case;
III – bold;
IV – color contrasting with the color of the main panel, in order to highlight the information; and
V – minimum height corresponding to twenty-five percent of the height of the largest letter character used in the product name.
The regulation also states that for food, cosmetics, sanitizers, medical devices and tobacco products the declaration must remain in the new product label for a minimum period of 90 (ninety) days from the approval date of the modification of the product formula with ANVISA.
However, for low-risk drugs, the declaration must appear on the label for at least 1 year from the implementation of the new formulation and for pesticides, 3 (three) years. For the latter, the declaration should be made in the right column of the label, intended for the health statements, in the item “General precautions”.
For all cases, after the minimum period, the declaration can be removed without the need to generate a petition to update the regularization process.
The proposed date of entry into force for all the categories above is September 1st, 2021.
Recommended Action Items
If you work with any of the product categories above, stay alert to any changes in your formulation in order to keep your product compliant, your customers informed and your business competitive.
Resolution of the Collegiate Board 421 of September 1st, 2020 Inclusion of a declaration in the label of products subject to health surveillance when changing their composition.
Normative Instruction No. 67, of September 1, 2020, on Food Product Labels;
Normative Instruction No. 68, of September 1, 2020, on Medical Device Labels;
Normative Instruction No. 69, of September 1, 2020, on Personal Hygiene Products, Including Disposables, Cosmetics and Perfumes Labels;
Normative Instruction No. 70, of September 1, 2020, on Sanitizing Product Labels;
Normative Instruction No. 71, of September 1, 2020, on Low-risk Drugs, Traditional Herbal Products and Cannabis Products;
Normative Instruction No. 72, of September 1, 2020, on Smoking Products Derived from Tobacco Labels;
Normative Instruction No. 73, of September 1, 2020, on Pesticides Labels