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The Brazilian food and dietary supplements market has undergone a period of uncertainty in recent years. However, several factors indicate its potential for growth. With a population of over two hundred and fifteen (215) million, Brazil has a large consumer base with a high purchasing power as well as a growing middle class. Consumer demand is especially prominent in niche sectors such as weight management. Brazil’s rich agricultural resources and biodiversity also allow for the incorporation of local ingredients like guaraná or yerba-maté in functional nutrition products; this is a brilliant example of leveraging a country’s natural assets.
The Regulatory landscape of the Brazilian food and dietary supplements market has been revamped to provide clarity to manufacturers and streamline the approval process. The Brazilian Health Authority (HA), the Agência Nacional de Vigilância Sanitária (ANVISA), or the National Health Surveillance Agency/Brazilian Health Regulatory Agency, introduced new regulations in 2018 for harmonizing the Regulatory framework of food supplements.
As per Resolution (RDC) No. 243/2018, food supplements, referred to as “suplementos alimentares” in Brazil, are described as products intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes, or probiotics, either in isolation or in combination. The supplements can be presented in various pharmaceutical dosage forms such as capsules, tablets, liquids, powders, bars, gels, lozenges, and chewing gums.
In Brazil, the registration process for food supplements varies, depending on factors such as the presence of functional claims, health properties, novel ingredients, and specific requirements.
Food and dietary supplements without functional and/or health claims on their packaging are exempt from registration, as per RDC No. 240/2018. However, those with functional claims and/or health properties on the packaging, including supplements with enzymes or probiotics, must be registered. Additionally, food supplements with novel ingredients also require registration.
For exempted food and dietary supplements, companies need to notify ANVISA of their manufacturing activities by submitting the necessary information. A health inspection is carried out within sixty (60) days from the notification to ensure compliance with regulations.
On the other hand, registered food and dietary supplements need to go through the electronic petitioning system. The documentation, along with the required fee, must be printed and submitted to ANVISA. In fact, foreign companies cannot obtain market authorizations directly; they must have Legal Representatives (LRs) within the country who will assume responsibility for the imported and distributed products.
Notification Process
For exempted food and dietary supplements, companies need to follow the notification procedure. Obtaining product notification with ANVISA and monitoring its progress until approval are virtual processes that you need to carry out online on ANVISA’s official website.
Registration Process
The registration process for food and dietary supplements involves providing relevant information on the company, product category, brand, and packaging type and complying with safety and efficacy requirements. The registration approval is valid for five (05) years, and it can be renewed upon expiry.
Labeling Requirements
The labels must clearly identify products as “suplementos alimentares,” followed by the presentation forms and individual names of nutrients, bioactive substances, or enzymes. They should also include recommendations for use, storage instructions, and specific warnings, such as “This product is not a medicine” and “Do not exceed the recommended daily consumption.”Top of Form
Conclusion
On the one hand, the changes in Brazil’s food and dietary supplement regulations aim at ensuring consumer safety, while on the other, they also present significant challenges for manufacturers, as complying with the complex Regulatory structure set in place by ANVISA can be a daunting task.
With its team of Regulatory experts, Freyr assists manufacturers in effortlessly launching their food and dietary supplements in Brazil. Consult Freyr to receive complete end-to-end Regulatory guidance for a successful market entry!
