New regulations on the commercialization of Cannabis seeds

After the enactment of Law No. 27,350, which authorized the cultivation of the Cannabis sativa L.’s species for research and medical purposes, and of Law No. 27,669, which determined the regulatory framework for the development of the Medical Cannabis and Industrial Hemp Industry, the National Seed Institute (hereinafter, “INASE”) issued on June 23, 2022, the Resolution No. 260/2022 (hereinafter, the “Resolution”) – which was published in the Official Gazette on July 5, 2022 –, which established new provisions regarding the commercialization of Cannabis seeds.

Among those provisions, the Resolution defined the propagation organs of the identified class of Cannabis sativa L. as those parts of the Cannabis plant that are used for the purpose of multiplying new individuals, establishing as an obligation that they must bear a mention “to cultivate” on their label, which has been required since the entry into force of the Resolution.

In accordance with the provisions of Annex 1 of the Resolution, the authorized propagation organs are defined as follows:

1. Seedling: a plant no taller than 25 cm from the upper limit of the container, which origin is a seed.
2. Rooted cutting: a plant not less than 25 cm in height from the upper limit of the container, which origin is from a cutting or tissue from another plant.
3. Batch: is the set of plant organs, seedlings, or cuttings of the same variety, which come from the same origin, have the same age, and are grown with spatial continuity and subjected to a uniform degree of agronomic management.
4. Seed: is an organ of propagation that can give rise to a new individual.

Additionally, and for the purpose of commercialization, the Resolution sets forth that the entry and/or diffusion of the seed of the Cannabis sativa L.’s species in Argentina, can only be carried out after the registration of the variety/ies of such species before the National Register of Cultivars of INASE, except for those varieties used in research projects approved by the National Ministry of Health.

Furthermore, and in accordance with the terms of Section 16 of Law No. 20,247 on Seeds and Phytogenetic Creations, which imposes the registration of any identified variety of the Cannabis sativa L.’s species, the Resolution establishes that the importation of seeds of Cannabis sativa L. will not be approved if the seeds’ variety has not been previously registered before the National Register of Cultivars or is not in the process of registration.

Also, the Resolution sets forth that the propagation organs must be commercialized using the security label previously determined by INASE’s Resolution No. 182, or a document containing a similar system of codification and verification of authenticity. Each package of seeds must have its respective security label, while seedlings or rooted cuttings must have a security label per lot, or for every fifty units at the most.

In accordance with the Resolution, propagation organs with visible symptoms of diseases or signs of pests, as well as seedlings and/or rooted cuttings with deformations in the aerial and/or root parts, must not be commercialized.

Moreover, pursuant to the provisions of the Resolution, the seeds’ security label must have certain specifications, including, but not limited to:

1. Name and address of the identifier and No. of registration before the National Registry of Trade and Seed Control.
2. Common and botanical name of the species.
3. Name of the cultivar.
4. Net content.
5. Country of origin.
6. Year of harvest.
7. Minimum germination percentage, in case of botanical seed.
8. The legend “CURE SEED – POISON” in red letters, in case the seed or organ has been treated with a seed cure.
9. The legend “The identifier is responsible for the specifications contained in the label. As for germination, the supplier is responsible to the purchaser within 45 days from the date of shipment of the merchandise or within the term established by agreement between the parties (Art. 14 Law 20.247)”..

Lastly, any violation to the provisions of the Resolution shall make the offender responsible and subject to the penalties established in Section 28 of Law No. 20,247, which may include fines and seizure of the infringing merchandise.

This report cannot be considered as legal or any other kind of advice by Allende & Brea.