Legislation and Regulations Regarding the Use of Ionizing Radiation in Phytotherapeutics in Brazil: A Documentary Analysis

This study aimed to conduct a documentary analysis of federal legislation and regulations in Brazil regarding the irradiation of phytotherapeutic products. The research was carried out between April and June 2024 through a review of official documents, including regulations, resolutions, constitutional amendments, and decrees published between 1983 and 2018. Although the analysis revealed the existence of specific norms and resolutions related to food irradiation, no direct regulation concerning the use of ionizing radiation in phytotherapeutics was identified in Brazil. National legislation addresses the use of ionizing radiation in food, particularly for radio-sterilization, with emphasis on RDC No. 21/2001, which may be indirectly applicable to medicinal plants. Normative Instruction No. 44/2014 provides the most relevant guidelines regarding the application of ionizing radiation in pharmaceuticals. In contrast, international legislation—such as that from the FDA (USA) and FSSAI (India)—explicitly regulates the radio-sterilization of medicinal herbs and plants. The documentary analysis highlights the need for the expansion, regulation, and harmonization of Brazilian standards and protocols to ensure the safe application of ionizing radiation in phytotherapeutics.