The Resolution RDC No. 839/2023 by Anvisa has brought significant changes to the regulatory framework governing new foods and ingredients in Brazil.
Pre-Consultation Possibility
Under the new regulatory framework, companies now have the option of seeking pre-consultation with Anvisa. This pre-consultation allows them to verify whether a specific food or ingredient falls within the scope of the regulation. If a company is uncertain about the classification of a new food or ingredient, they can submit a specific petition for consultation (referred to as “Consulta sobre a classificação de um novo alimento e novo ingrediente” with the code 4144). Anvisa’s response to this consultation does not constitute a safety assessment; it merely confirms whether the item is subject to the regulation.
Simplified Assessment Scenarios
The updated resolution also introduces four scenarios where the assessment of new ingredients and foods can be conducted in a simplified manner:
- Extension of Use: Companies can now extend the use of ingredients that were previously evaluated for new categories of foods (code 4135).
- Safety Assessment Based on Consumption History: For foods and ingredients with a consumption history in Brazil spanning 10 to 25 years, a simplified safety assessment can be performed (code 4145). Similarly, if there is a safe consumption history in other countries, companies can opt for a simplified safety assessment (code 4146).
- Equivalence Assessment by Foreign Regulatory Authorities: Anvisa recognizes assessments conducted by equivalent foreign regulatory authorities. Companies can request a simplified safety assessment based on this equivalence (code 4147).
Equivalence of Specifications
While the assessment of equivalence in specifications for previously approved ingredients (code 4133) is currently available on a provisional basis, Anvisa plans to publish a specific normative instruction listing the approved specifications.
These updates aim to streamline the evaluation process for new foods and ingredients, potentially reducing assessment times. Companies seeking regulatory approval should familiarize themselves with the new codes and consult Anvisa’s checklists for detailed information on each subject.
