On November 16, 2021, Provision No. 8504/2021 of the National Administration of Medicines, Food and Medical Technology (ANMAT) was published, which establishes that products that fall under the definition of Cosmetic Products, Personal Hygiene Products and Perfumes according to the Resolution of the (former) Ministry of Health and Social Action No. 155/98, and that contain the cannabinoid called pure Cannabidiol (CBD) of natural origin or CBD present in extracts and natural oils of certain parts of the Cannabis sativa L. plant, with no more than 0.2% w/w of THC, may be registered as Cosmetic Products, Personal Hygiene Products and Perfumes under the classification Grade 2, according to the provisions of ANMAT Provision No. 345/06.
Products covered by ANMAT Provision No. 8504/2021
The products covered are those that fall under the definition of Cosmetic Products, Personal Hygiene Products and Perfumes according to Resolution of the (former) Ministry of Health and Social Action No. 155/98, and that may contain as ingredient pure Cannabidiol (CBD) exclusively of natural origin, its isomers, acids, salts and salts of isomers, or CBD present in extracts and natural oils of certain parts of the Cannabis sativa L. plant, provided that the THC content does not exceed 0.2 % w/w. Documentation required for the registration of the products referred to in ANMAT Provision No. 8504/2021. For the registration of the products the following documentation must be submitted:
Authorization of the supplier of the raw material issued by the competent authority of the country of origin for the production and/or commercialization of ingredients derived from cannabis.
Certificate of analysis of the supplier of the aforementioned ingredients that includes the determination of THC. The THC determination must consider the potential to convert ATHC to THC.
Validated quality control methods.
Local certificate of analysis of the raw material issued by the manufacturer of the finished product that includes THC determination. The THC determination must consider the potential to convert ATHC to THC. In case of outsourcing the determination of THC in raw material, the certificate of analysis must be issued by a laboratory of official agencies or entities.
Note in the form of a sworn statement on the irrecoverability of the traces of THC in the final product.
Declaration of compliance with the “Safety Evaluation” established by ANMAT Provision No. 2196/2019.
Product Labeling
The labeling of the products shall be governed by ANMAT Provision No. 374/06 and its amendments and shall not mention the percentage of CBD ingredient that composes the formulation, nor therapeutic properties attributable to the product. Likewise, the labeling must contain the following warnings: “Do not ingest, for topical use only”, “Cosmetic product, not suitable for medicinal use”, “Exclusive use in adults”, “Not recommended for use during pregnancy or breastfeeding”, “Do not apply on wounds or where the skin is not intact”.
Imports of products and raw materials
Applications for import authorization of finished products and bulk, as well as applications for certificates of free sale and export testimonials of finished products with CBD of natural origin with no more than 0.2% w/w of THC, will be made with the intervention of the ANMAT’s Directorate of Evaluation and Management of Monitoring of Health Products. Requests for import of raw material, of the CBD component with traces of less than 0.2% w/w of THC, will be made with the intervention of the foreign trade area of the National Institute of Medicines (INAME). Advertising of products
All advertising of the products shall strictly comply with the provisions of the product registration under the terms of Resolution (ex) MS and AS) No. 155/98 and shall be governed by the provisions of Annexes I and V of ANMAT Provision No. 4980/2005. Likewise, advertising must include the legend “Cosmetic product containing CBD cannabinoid. Not suitable for medicinal use or ingestion” and shall not be directed and/or starred by minors, pregnant women and/or nursing mothers.
