Features of the manufacture and sale of hemp products in Ecuador

Arcsa will compile, update and publish a monthly list of businesses that prepare, pack or import / export, store, sell, distribute, distribute and market hemp products made from low-drug hemp. The hemp products that Arcsa will control are medicines, semi-finished products and cosmetics, which have special requirements. 

On the pages of the specialized electronic edition of Ukrainian cannabis growers, the attention of our dear readers and listeners has already been focused on the fact that “ Ecuador has issued rules regulating the amount of THC in hemp products ”. Given the relevance of this topic for the domestic market, which in 2021 will most likely be able to obtain a similar regulatory document, the editors asked for additional information on this issue to the specialists of the information and analytical company Hemp Consulting. The data received from our colleagues supplement and concretize the previously stated information, which can clearly be useful in the course of the preparation and adoption of a similar document in our country.

The National Agency for the Regulation, Control and Supervision of Health (La Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, Arcsa) has published rules governing and controlling products for use and consumption that contain low-narcotic hemp or derived plants. Those wishing to manufacture, import, export and sell this raw material will be required to provide a Certificate of Analysis for the concentration of delta-9-tetrahydrocannabinol (THC / THC) in the product.

Unlike other products on the Ecuadorian market, the THC concentration in processed foods or food additives must be less than 0.3%. Those who want to manufacture, import, export and sell products containing various elements of low-narcotic cannabis should receive documents on the safety of their use for buyers. Such a document may be the “Sanitary Register” - a certificate that is issued in compliance with the requirements for quality, safety, efficiency and the ability to consume and use products that meet all the requirements established in the law “On organic health”. 

Arcsa will compile, update and publish a monthly list of businesses that prepare, pack or import / export, store, sell, distribute, distribute and market hemp products made from low-drug hemp. The hemp products that Arcsa will control are medicines, semi-finished products and cosmetics, which have special requirements. 

Finished products

Arcsa treats processed foods, beverages, food / feed / dietary / dietary supplements, beauty products, medicines, homeopathic remedies, medical devices and processed natural products as finished products. Finished hemp products are any goods containing various constituents of a plant or derivatives thereof that will be sold or distributed as a product for human use or consumption. Derivatives of low-narcotic hemp - oils, resins, tinctures, raw extracts obtained from plants, in which THC contains less than 1%. Other derived plants are not considered finished products, therefore, under no circumstances may they be sold or transferred in any way to health food stores, pharmacies, commercial establishments or similar distribution / sales places for direct use or consumption by humans or animals.

Medications

With regard to medicines in general, processed natural products for medical use and homeopathic medicines that contain various constituents of low-narcotic cannabis or their derivatives with a THC percentage below 1%, Arcsa states that they must: 

- produced exclusively in pharmaceutical laboratories with a valid work permit;

- sold in official pharmaceutical establishments. 

In addition, pharmaceutical products administered orally containing hemp with less than 1% THC must have: 

- protective packaging, which predetermines the impossibility of opening it by children;

- warning sign “Keep out of reach of children”. 

Food

The regulation states that all parts of low-narcotic hemp or plant derivatives can be used as ingredients in processed foods and nutritional supplements. In this type of food, the concentration of hemp in the container or package must be indicated on the label. It is prohibited in food or food additives: 

- the use of psychoactive hemp or plant derivatives;

- THC concentrations equal to or exceeding 0.3%;

- the use of cannabinoid concentrations with an intake level that have therapeutic activity;

- the use of logos indicating the health benefits associated with the use of cannabis;

- attributing medicinal properties to a product on its label or during promotions;

- making samples of products with a THC concentration of less than 0.3% that have no commercial value;

- making hemp products for babies and children under 12 years old. 

Cosmetics

A cosmetic product is a substance or composition designed to come into contact with the surface parts of the human body to cleanse, flavor, protect, maintain, or eliminate body odors. Not considered cosmetic products, those substances or formulations that are intended to prevent, treat or diagnose diseases or are intended to be swallowed, inhaled, injected or implanted into the human body. In order to obtain permission for cosmetics containing elements of low-narcotic hemp, the following must be submitted to Arcsa:

 - the quantitative formula of the hemp derivative ingredient that is in the product;

- technical sheet and certificate of analysis, which show that the concentration of THC contained in the finished product is less than 1%. 

Export

 Those who wish to export cannabis products to countries where the plant is a controlled substance must apply to Arcsa for an export permit in order for the Agency to request permission from the country of destination. An export request for hemp products must be made through the Document Management System - Quipux, to which the following documents must be attached:

 - invoice for exported products;

- technical file of the exported product;

- certificate of import from the country of destination;

- invoice for payment of the commission for the requested service. 

The export authorization is valid for 180 days, during which the shipment must be made.

Commentary of specialists of the Association "Ukrainian technical hemp"

The adoption of documents similar to those described in this material is extremely important for our country. This is due to the fact that in our country there have been created and entered into the corresponding register of plant varieties suitable for distribution in Ukraine, varieties of technical hemp of a therapeutic orientation, the leaves and inflorescences of which have great therapeutic potential. Providing an appropriate regulatory framework for the possibility of using flowers and leaves of a hemp plant for industrial purposes will "launch" a huge market, the functioning of which will be considered during the round table " Problems and prospects of using therapeutically active elements of hemp as a basis for nutraceuticals, medicinal cosmetics, feed for animals or other products with healing properties of the plant ", which will be held during the training of the next course of students of the" Hemp University ".