Compliance with ANVISA’s labeling requirements is crucial for companies that want to sell their cosmetics in Brazil. It is recommended to consult with ANVISA or a legal advisor to ensure that your products comply with all applicable regulations.
Import Requirements: Imported cosmetics must comply with Brazilian labeling requirements and be registered with ANVISA before they can be placed on the market.
Product Identity: The label must include the name of the product, its purpose, and its composition.
Net Quantity: The label must indicate the net quantity of the product in metric units (e.g., grams, milliliters).
Manufacturer Information: The label must include the name and address of the manufacturer, importer, or distributor responsible for placing the product on the market.
Country of Origin: The label must indicate the country of origin of the product.
Instructions for Use: The label must include instructions for use, including any warnings, precautions, or contraindications.
Batch Number: The label must include a batch number or another identification code that allows the product to be traced back to its production batch.
Expiration Date: The label must indicate the expiration date or the period after opening during which the product should be used.
INCI Name: The label must include the International Nomenclature of Cosmetic Ingredients (INCI) name of each ingredient, listed in descending order by weight.
Language: The label must be in Portuguese, the official language of Brazil.
Labeling for Animal Testing: The label must indicate whether or not the product or its ingredients have been tested on animals.
Label Review: The labeling of cosmetics must be reviewed and approved by ANVISA before the product can be sold in Brazil.
Font Size: The font size of the information on the label must be legible and easily readable.
Symbols and Icons: Symbols and icons can be used on the label, but they must be accompanied by clear and understandable text.
Product Category: The label must indicate the product category (e.g., shampoo, moisturizer, sunscreen).
Packaging: The packaging of the product must be in compliance with ANVISA’s regulations for hygiene, safety, and environmental sustainability.
Labeling for Special Purposes: Certain types of cosmetics, such as those intended for professional use or for use in spas or salons, may have additional labeling requirements.
Labeling for Ingredients: The list of ingredients on the label must include the INCI name of each ingredient, and if an ingredient is not an approved cosmetic ingredient in Brazil, its use must be authorized by ANVISA.
Labeling for Allergens: If the product contains any of the 13 most common allergens, such as peanuts, milk, or soy, they must be listed on the label.
Labeling for Environmental Claims: Any environmental claims made on the label, such as “biodegradable” or “eco-friendly,” must be supported by scientific evidence and comply with ANVISA regulations.
Advertising: Any advertising or promotional materials for cosmetics must comply with ANVISA regulations and not make false or misleading claims.
Claims: Any claims made on the label, such as “hypoallergenic” or “dermatologist-tested,” must be substantiated by scientific evidence and must comply with ANVISA regulations.
Labeling Claims: The labeling claims made by the cosmetic products must be truthful and supported by scientific evidence. In addition, labeling claims related to specific health conditions or diseases are not allowed in Brazil.