RDC 843/2024: The New Regulatory Framework for Food and Packaging in Brazil

Posted on
The New Regulatory Framework for Food and Packaging in Brazi

The Collegiate Board Resolution (RDC) 843/2024, published by ANVISA, has introduced significant changes in the processes for food and packaging regulation in Brazil. Key areas affected include procedures for notification, importation and manufacturing start communication, and product registration. This article explores these changes, highlighting their impacts and benefits for the industry and consumers.  

Why Is RDC 843/2024 Important?  

RDC 843/2024 addresses the demands of a dynamic market and increasingly discerning consumers. It not only simplifies regulatory procedures but also ensures that food products marketed in Brazil comply with stricter quality and safety standards. This benefits consumers, who can trust the safety of the products they consume, and companies, which gain a clearer and more efficient path to regulatory compliance.  

Key Changes and Benefits

1. Unification and Simplification of Processes 
The resolution consolidates the procedures for registration, notification, and communication of manufacturing or importation start. This reduces bureaucracy and enhances efficiency for companies, especially those dealing with different product categories.  

2. Responsibility and Transparency 
Companies must register with ANVISA’s system and keep their information up to date. Moreover, they are responsible for ensuring their products meet sanitary and quality requirements. This measure promotes greater transparency and corporate accountability, guaranteeing safe and high-quality products in the market.  

3. Flexibility in Post-Registration Changes 
RDC 843/2024 provides flexibility for post-registration changes, allowing updates with or without prior ANVISA approval. This facilitates quick adjustments, keeping products aligned with regulatory changes and market needs.  

4. Strengthening Sanitary Surveillance 
Post-market surveillance is essential to ensure ongoing product safety and quality. Under RDC 843/2024, ANVISA can conduct inspections and evaluations at any time, ensuring continuous compliance of products available in the market.  

5. Modernization of the Regulatory Framework 
By repealing several previous norms, the new resolution consolidates and modernizes regulatory guidelines. This not only simplifies compliance but also adapts the regulation to current market and consumer needs.  

Impacts on Industry and Consumers 

For companies, RDC 843/2024 represents an opportunity to enhance internal processes, reduce regulatory timelines, and maintain alignment with best market practices. Additionally, increased regulatory clarity and predictability foster an environment conducive to innovation and the development of new products.  

For consumers, the benefits are clear: safer products, greater transparency, and assurance of superior quality. Knowing that food and packaging have undergone rigorous regulatory processes builds trust and confidence.  

Regulatory Processes for Food 

1. Simplified and Automated Notification 
Notification is a crucial procedure for food products that do not require full registration but still need to be regulated by ANVISA. With RDC 843/2024, this process has been streamlined to make the entry of new products into the market faster and more efficient.  

  • Automated Notification: Notifications are now automatic upon submission of the petition. Once the requirements are met and the necessary documents are submitted, the product can be marketed immediately. This significantly reduces the waiting time for products to reach the market.  
  • Post-Notification Review by ANVISA: ANVISA retains the right to review notifications at any time, requesting additional information or corrections as needed. This flexibility ensures that the process remains quick without compromising product safety and quality.  

2. Import and Manufacturing Start Communication 
Another key aspect of RDC 843/2024 is the communication of the start of importation or manufacturing, applicable to products that have not yet been registered or notified but are about to begin production or importation.  

  • Simple and Direct Protocol: Companies must submit a communication to the local sanitary authority using a specific form. This communication enables the immediate start of production or importation after submission.  
  • Post-Communication Inspections: While this communication does not constitute automatic sanitary approval, it allows authorities to conduct inspections at the manufacturer’s or importer’s facilities, ensuring ongoing compliance.  
  • Indefinite Validity: Once submitted, the communication remains valid indefinitely, providing greater operational stability for production and importation, as long as conditions remain unchanged.  

3. Registration: Increased Control and Rigor 
Registration is the most rigorous procedure, required for food and packaging categories that pose higher risks or are innovative.  

  • Detailed Documentation: Registration requires a specific petition accompanied by extensive documentation proving the product’s safety, quality, and efficacy. This includes details on formulation, manufacturing processes, quality control, and other technical aspects.  
  • Validity and Renewal: Registration is valid for five years and must be renewed. The renewal petition should be submitted between three and twelve months before expiration, ensuring products remain in the market without interruptions if they continue to meet regulatory standards.  
  • Post-Registration Changes: The resolution facilitates post-registration changes, provided they are duly submitted and approved by ANVISA. Depending on the type of change, implementation can be immediate or require prior analysis.  
Impacts of the Changes 

The changes introduced by RDC 843/2024 in notification, importation and manufacturing start communication, and registration create a more agile and adaptable regulatory environment. For companies, this means less bureaucracy, faster market entry, and greater flexibility to adjust existing products to regulatory or consumer demands.  

For consumers, these changes ensure that food and packaging are rigorously regulated without hindering innovation or product availability.  

Novatrade is the ideal partner for companies seeking excellence and agility in regulatory matters related to the food sector. Our highly qualified technical team provides personalized support, guiding each step of the process to ensure your products reach the market quickly and safely. Count on Novatrade to simplify and streamline the challenges of the regulated market, ensuring the success of your business.