Anvisa to vote on draft regulation on the cultivation of cannabis this Wednesday (14)
Draft discussed in a meeting with a YouTube broadcast contains points on THC limit, Sanitary control execution, import and export, destination of the cultivated plant among others
The National Health Surveillance Agency (Anvisa), scheduled for tomorrow, Wednesday (14), the update of the list of controlled substances in Brazil.
The main change is related to the establishment of criteria for the handling of Cannabis sativa L. with low THC content by duly registered legal entities, in compliance with Superior Court of Justice (STJ) decision on industrial hemp cultivation.
The Agency is discussing a draft on the topic during the 7th Public Meeting of the Collegiate Board of Directors (Dicol) of 2025. The meeting starts at 9:30 AM and will be broadcast live on Anvisa's official channel on YouTube.
According to Anvisa, the available draft exclusively deals with the cultivation of Cannabis sativa L. with low THC content for industrial purposes. "There is no way to anticipate further information before the decision," the Agency said.
The Ministry of Agriculture, also responsible for the regulation of industrial hemp, stated that the definitive regulation will be published by next Monday, May 19.
What does Anvisa's draft say about industrial hemp cultivation?
In addition to the THC limit, set at less than or equal to 0.3%, the proposal includes other definitions such as:
- Sanitary control execution: Sanitary control does not apply when the plant is used exclusively by legal entities for medicinal purposes regulated by Anvisa or for veterinary medicinal purposes regulated by MAPA.
- Cultivation restricted to authorized companies: Only legal entities registered in the National Registry of Seeds and Seedlings (Renasem), with the approved cultivar in the National Registry of Cultivars (RNC) and in compliance with Law No. 10,711/2003, Decree No. 10,586/2020, and MAPA ordinances No. 501 and 502/2022 may carry out the cultivation of the plant.
- Import and export: Import of the plant species with up to 0.3% THC is allowed, except in accompanied or unaccompanied baggage and express or postal shipment. Species with THC above 0.3% are also prohibited.
- Destination of the cultivated plant: Supply will only be allowed to companies with special authorization from Anvisa (for the manufacture of pharmaceutical inputs - RDC No. 16/2014 or substitute norm) or companies with MAPA authorization to produce veterinary inputs.
- Monitoring and environmental safety: Companies cultivating Cannabis sativa L. must periodically monitor the THC content through laboratory analyses; ensure environmental safety and containment, preventing the spread of the species and any misuse, and comply with guidelines to be defined by MAPA.