The National Health Surveillance Agency (ANVISA in Portuguese) has published Resolution RDC 839/2023, which updates the rules and procedures for testing the safety and authorizing the use of novel foods and novel ingredients.
The new resolution comes into force on March 16, 2024, with the exception of Articles 7, 8 and 9, which deal with the requirements and flows for making available the public version of the opinions and the authorization for the use of novel foods and novel ingredients. The effectiveness of these articles will begin on December 26.
Changes:
- Improvement of the definition of novel foods and ingredients, reinforcing that they are those that have no history of safe consumption in Brazil and including a list of different sources of procurement and situations in which they can be classified.
- Inclusion of other conceptual bases relevant to the application of the legal concept of novel foods and novel ingredients, with emphasis on safe food consumption history, purpose of the food, selective extraction or concentration, significant modification and nanomaterial.
- Creates an administrative procedure that allows companies to consult the classification of a given food or ingredient as novel, with confirmed responses being published on the Anvisa portal.
- Details the safety assessment requirements, according to the nature and complexity of novel foods and novel ingredients.
- Incorporates optimized analysis procedures, with relaxation of regulatory requirements for novel foods and novel ingredients that meet characteristics that increase the certainty of safety of use or reduce existing uncertainties.
- Incorporates forecasting procedures for the preparation and updating of regulatory lists of novel foods and novel ingredients.
- Defines criteria for the publication of non-confidential information from Anvisa’s opinions on novel foods and novel ingredients.
- Description of a general list of novel foods and novel ingredients, their specifications, limits and conditions of use.
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