Brazil – Draft on safety and authorization for the use of novel foods and new ingredients

Brazilian Health Regulatory Agency (ANVISA) published Draft resolution N°1158 on safety and authorization for the use of novel foods and novel ingredients.

The text submitted for public consultation brings a series of regulatory novelties, among which the following stand out:

  • The improvement of the definition of novel foods and ingredients, reinforcing that they are those that do not have a history of safe consumption in Brazil and including a list of the different sources of procurement and situations in which they can be classified;
  • The inclusion of other conceptual bases relevant to the application of the legal concept of novel foods and novel ingredients, with emphasis on the history of safe food consumption, food purpose, therapeutic purpose, selective extraction or concentration, significant modification and nanomaterial;
  • Creation of an administrative procedure that allows companies to consult the classification of a certain food or ingredient as novel, with confirmed answers published on the Anvisa portal;
  • Detailing safety assessment requirements, according to the nature and complexity of novel foods and novel ingredients;
  • Incorporation into the regulation of optimized analysis procedures, with flexibility of regulatory requirements for novel foods and novel ingredients that combine characteristics that increase the certainty of safe use or reduce existing uncertainties;