HS Code: Food; ICS Code(s): 13, 65

Draft resolution (Consulta Publica) number 459, 28 December 2017

This Resolution establishes the requirements for proving the safety and health benefits of probiotics. This Resolution covers probiotics for use in foods, including food supplements.It does not apply to evidence of the safety and health benefits of probiotics added in infant formulas. Demonstration of the health benefits of probiotics should be performed by proving allegation of general functional property or specific functional property. In the case of a mixture of probiotics, the demonstration of health benefits should be performed by substantiating evidence of specific functional property. The requirement to prove the claim of functional property does not apply if all lineages of the mixture claim general functional property or if all lineages have the same claim of specific functional property. Requests for registration not yet decided by Anvisa upon the entry into force of this Resolution may be added within 6 (six) months in order to meet the new requirements established by it.