Country of origin requirements (COOL)
As a rule, country of origin requirements applyto any type of products that is intended to be marketed in Brazil. For imported goods, all required information must be provided in Portuguese and the products must undergo formal regulation by relevant authorities, likes the Brazilian FDA (Anvisa) and the Brazilian Ministry of Agriculture, Livestock and Food Supply (MAPA) The country of origin and other related requirements are provided mainly under relevant tax and consumer rights legislation (e.g. Consumer Defense Code), aimed at assuring accurate information to consumers including on the origin of goods. From a regulatory perspective, sanitary/food-related regulation also provide labeling requirements for packaged foods, which must include essential information such as origin, manufacturing date, expiration date, product composition, among others (Anvisa Resolution No. 727/2022 and MAPA Normative Instruction No. 22/2005).
Definitions of vegetarian and vegan
While there is no specific regulation for vegetarian or vegan products, since 2005 regulatory agencies such as the Brazilian FDA (Anvisa) has published regulation that are somehow connected to the matter such as Resolution No. No. 726/2022 (applicable for vegetable products, fruit products, and edible mushrooms) and Resolution No. 839/2023 (applicable for the authorization of use of novel foods and novel ingredients). Raw vegetable products are also regulated by Federal Decree 6.268/2007.
Despite the absence of a specific regulations, more broadly, the Brazilian Consumer Defense Code (Law No. 8.078/1990) establishes the right to information as a fundamental consumer right. This includes the provision of “adequate and clear information about different products and services, with correct specifications of quantity, characteristics, composition, quality, applicable taxes, and price, as well as the risks they may pose”.
In 2023, the Brazilian Ministry of Agriculture and Livestock (MAPA) initiated a Public Consultation for the regulation of plant-based products. The proposed regulation suggests that labels must include minimum information such as the expression “PLANT-BASED MEAT ANALOGUE OF,” followed by the proper name of the corresponding animal-derived product (for example, PLANT-BASED MEAT ANALOGUE OF MEAT BALL), and a statement that the product does not substitute its animal origin correspondent form a nutritional or functional perspectives. All information must be provided in Portuguese although we have translated into English just for reference of readers.
Fortification of foods
In Brazil, food fortification is the process of adding one or more essential nutrients, whether naturally occurring in the food or not, to enhance its nutritional value or address nutritional deficiencies.
Certain foods are mandated to undergo fortification: salt intended for human consumption must be fortified with iodine, and wheat and corn flours must be enriched with iron and folic acid, as outlined in Brazilian FDA (Anvisa) Resolution No. 604/2022.
Anvisa Resolution No. 714/2022 provides the criteria and applicable requirements for food fortification. These include: (i) avoiding the introduction or formation of harmful or inappropriate substances; (ii) ensuring that added essential nutrients do not reach therapeutic levels in the foods; and (iii) using ingredients as sources of essential nutrients that are both bioavailable and safe.
If food fortification is conducted at or above the levels stipulated by Anvisa regulations, the product must include expressions like “fortified with vitamins” and “fortified with minerals” in its conventional sales name. Furthermore, fortification with vitamins and minerals should comply with the list of authorized substances by Anvisa for this purpose (e.g., Vitamin A, Vitamin B, Calcium, Iron, Magnesium, etc.).
Cannabis as an ingredient in food or supplements
Cannabis cannot be used or offered as food or as an ingredient for food or supplements in Brazil. Such prohibition derives from Ordinance No. 344 of 1998, published by Brazilian FDA (Anvisa), that defines and regulates the substances are subject to special control in the national territory, which includes Cannabis sativa as well as substances derived from the plant.
On the other hand, Cannabis-related products are lawful and regulated by Anvisa for medical purposes with limitations given the cultivation and importation of the plant are still prohibited.
Anvisa has regulated through Resolution 327/2019 the commercialization, prescription and dispensation of cannabis-derived products for medicinal purposes. Furthermore, Anvisa Resolution 660/22 defines procedures for importation of cannabis-derived products for medical and personal use. At the federal legislative level, Bill No. 399/2015 is the most advanced proposal, aimed at legalizing the cultivation of cannabis for medicinal and industrial purposes.