ZMUni Compliance Centre has successfully helped a novel food product pass safety evaluation with Brazil’s National Health Surveillance Agency (ANVISA), marking a strong start for 2025 under Brazil’s updated regulatory framework.
In Brazil, when a substance is classified as a novel food, applicants must submit a scientific and technical dossier to ANVISA for safety evaluation. The agency then determines whether the product can be authorized for market release.
Brazil’s regulatory landscape for novel foods has been continuously evolving. In late 2023, ANVISA officially introduced RDC 839/2023 Comprovação de segurança e autorização de uso de novos alimentos e novos Ingredientes, which took effect in March 2024. This resolution aims to streamline safety evaluation procedures and establish clearer approval standards. Key updates include:
More detailed definition of new foods/ingredients as those that do not have a history of safe consumption in Brazil and inclusion of a list of different sources and situations in which they can be classified;
Broader legal concepts are introduced, including historical consumption, food uses, selective extraction or concentration, significant process changes, and nanomaterials;
Creation of an administrative procedure that allows companies to consult the classification of a certain food/ingredient regarded as "new" and published in ANVISA website;
Safety evaluation criteria are specified based on the nature and complexity of novel foods and ingredients;
Regulatory processes are optimized by easing requirements for foods with enhanced safety profiles or reduced uncertainty;
The procedure for compiling and updating regulatory lists of novel foods and ingredients is clearly outlined.
Disclosure requirements for ANVISA's decisions on novel foods and ingredients are defined for non-confidential information.
General lists, specifications, restrictions, and usage conditions for novel foods and ingredients are established in comprehensive guidelines.
Prior to RDC 839/2023, Brazil's regulations were governed by two 1999 resolutions, RES 16/1999 and RES 17/1999, which have now been replaced. This new regulation is more scientific and aligned with international standards, which will have a significant impact on the industry.
Since the introduction of the new regulation, the approval process has become more rigorous. In 2024, ANVISA approved a single novel food: a probiotic product combining Bifidobacterium longum BB536, Bifidobacterium longum M-63, and Bifidobacterium breve M-16V.
Despite these challenges, ZMUni Compliance Centre successfully guided our client through the new regulations, ensuring full compliance in preparing all necessary documentation. This ensured smooth progress through the approval process, even with the uncertainties introduced by the regulatory changes. Typically, the approval process takes six months to a year, making this achievement especially noteworthy.
Brazil, as Latin America's largest economy and a key member of the G20 and BRICS, offers vast market potential, particularly in the food sector. With a stable political environment, strong legal system, and a growing middle class, Brazil is becoming an increasingly attractive destination for foreign investment. Consumer demand is shifting toward healthy and convenient foods, presenting significant opportunities. Additionally, the country's abundant agricultural resources and large population further fuel the growth of its food market.
To seize these opportunities, businesses must navigate Brazil's evolving regulatory framework. With updates like the implementation of RDC 839/2023, it is crucial for companies to stay on top of regulatory timeliness and compliance to ensure smooth market entry. ZMUni Compliance Centre is committed to helping businesses navigate these regulatory processes, ensuring compliance with the latest regulations and unlocking new growth opportunities in Brazil.
ZMUni Compliance Centre is a global compliance solutions provider, offering comprehensive and high-quality compliance solutions to help cosmetics, food, and ingredient companies navigate regulatory requirements and enter international markets quickly and safely.
Our Food Division offers comprehensive, one-stop services, including ingredient entry (new food ingredients, food additives, and feed ingredients), product entry (compliance reviews for food products, health food registrations, and special medical food registrations), and import/export clearance.
With over 10 years of experience, our team has successfully guided numerous businesses through market entry, specializing in novel foods, synthetic biology-based foods, U.S. GRAS certification, EU Novel Food applications, and health food registrations.
Let ZMUni Compliance Centre guide your business to success in global markets. For any inquires, contact at info@zmuni.com.
