By / January 22, 2020

Officials explain the 0.2% Anvisa THC limit

Among the rules approved by the National Health Surveillance Agency for the production and sale of cannabis derivatives in Brazil, the Anvisa THC limit of 0.2% was highlighted. This is because the largest supply of THC products come from the United States where the restriction is 0.3%.

That little variation makes a big difference. Above 0.2%, a type-A prescription (yellow prescription) will be required with a 60-day renewal and numbering provided by the National Health Surveillance Agency.

The application provides you with the most current and up-to-date marijuana news and covers wide-ranging topics including hemp and cannabis stocks.

The Anvisa THC limit meets European standards

“The 0.3% limit questioned is related to the psychoactive effect of the cannabis plant. Generally, products that meet the 0.3% limit in North America are considered to have a non-psychoactive effect, while in the European community it would be 0.2%, as available in the World Health Organisation (WHO) document,” Anvisa clarified.

“As the norms for herbal medicines in Brazil have been in convergence process for some time with those of the European Community, it was decided as pertinent to follow the specification of the 0.2% Anvisa THC limit, considering that in that economic block the herbal medicines are regulated,” the Brazilian regulatory agency continued.

The agency pointed out that the Anvisa THC limit applied in the Brazilian standard does not constitute a prohibitive limit for products to be made available in the domestic market containing a higher concentration of THC.

The Anvisa THC limit could restrict the effectiveness of cannabis medication

“My son takes an oil with 0.22% THC. It will fall into the “yellow” category. Our family will remain hostages of authorization from Anvisa or, in the worst case, the manufacturer will decrease the THC in the oil that is actually working,” said filmmaker Rita Carvana, mother of a 13-year-old boy with epilepsy.

cannabis oil representing the Anvisa THC limit
Patients worry that the Anvisa THC restriction will result in less-effective medicine. (Source)

For Camila Teixeira, CEO of Indeov, a representative of North American medical cannabis companies in Brazil, there is a challenge regarding access to products from these two categories.

“The restriction is not absolute because the regulation also allows products with higher THC concentration. There is a need for an adequate concentration of products in order to keep the concentration below 0.2% so that the required prescription is blue for easier access instead of yellow,” said Teixeria.

Regulations affect patients

Viviane Sedola, CEO of Dr. Cannabis, believes that the Anvisa THC limit is a challenge that must be met by the industry.

“The 0.2% restriction mainly affects patients. Of course, 0.2% is a different percentage from other countries, so it’s something peculiar, but it’s a challenge that can be overcome,” said Sedola.

For HempMeds Brazil, the determination is not restrictive and does not generate commercial impacts. According to Medical Marijuana Inc., the company already produces products that meet this determination including 0% THC.

“We already have products that meet the Anvisa THC limit. Therefore, it is only a matter of adapting other requirements to take our cannabis-derived products to pharmacies,” HempMeds stated.


(Featured image by Enecta Cannabis extracts via Unsplash)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in SECHAT, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

Comments are closed for this post.