1.

Notifying Member: CHILE

If applicable, name of local government involved:

2.

Agency responsible: Ministerio de Salud (Ministry of Health)

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Hemp (Cannabis sativa) based foods.

4.

Regions or countries likely to be affected, to the extent relevant or practicable:

[X]    All trading partners

[ ]      Specific regions or countries:

5.

Title of the notified document: Nuevo Artículo 170 bis del Reglamento Sanitario de los Alimentos, Decreto Supremo N° 977/96 del Ministerio de Salud (New Article 170 bis of the Food Health Regulations, Supreme Decree No. 977/96 of the Ministry of Health) Language(s): Spanish Number of pages: 2

http://members.wto.org/crnattachments/2016/SPS/CHL/16_5239_00_s.pdf

6.

Description of content: The proposed text seeks to establish a maximum level for tetrahydrocannabinol (THC) in hemp-based foods by adding a new article to Paragraph V of Section IV ("Contaminants and residues") of the Chilean Food Health Regulations.

Article 170 bis. - The tetrahydrocannabinol (THC) content of hemp seeds for human consumption and hemp seed-based foods must not exceed 10 mg/kg of food.

7.

Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.

8.

Is there a relevant international standard? If so, identify the standard:

[ ]        Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text)

[ ]        World Organisation for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number)

[ ]        International Plant Protection Convention (e.g. ISPM No.)

[X]      None

Does this proposed regulation conform to the relevant international standard?

[ ] Yes [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard: In light of the increased availability of hemp seed-based foods on the domestic market, mainly through importation, a limit needs to be established for THC.

Although the seed is enclosed by the bracteole, which is the part of the plant with the highest density of glandular trichomes and thus the highest THC concentration, the seeds themselves do not contain THC. However, they may be contaminated with cannabis materials (e.g. flowering tops, husks, resin), resulting in detectable amounts of THC. Similarly, if THC is detected in cannabis seed oil, it most likely originated from a poor separation of the seeds from the bract (United Nations Office on Drugs and Crime, Recommended methods for the identification and analysis of cannabis and cannabis products). In addition, the European Food Safety Authority (EFSA) document, Scientific Opinion on the safety of hemp (Cannabis genus) for use as animal feed, states that the provisional maximum tolerable daily intake (PMTDI) would amount to 0.0004 mg/kg body weight, which corresponds to 0.024 mg for a 60 kg adult and 0.0048 mg for a 12 kg child. With the proposed limit of 10 mg of THC/kg of food, it would be necessary to consume 2.5 g of hemp-based food per day in order to exceed the PMTDI for adults and, 0.5 g for a child of 12 kg.

A review of different legislation showed that Canada applies a limit of 10 mg of THC/kg of food. This limit was used as a model.

9.

Other relevant documents and language(s) in which these are available: Canada's limit and EFSA background material were used for reference purposes.

10.

Proposed date of adoption (dd/mm/yy): Upon publication in the Official Journal.

Proposed date of publication (dd/mm/yy): 80 days from the date of circulation of the notification.

11.

Proposed date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy): Upon publication in the Official Journal.

[ ]      Trade facilitating measure

12.

Final date for comments: [X] Sixty days from the date of circulation of the notification and/or (dd/mm/yy): 19 February 2017

Agency or authority designated to handle comments: [X] National Notification Authority, [ ] National Enquiry Point. Address, fax number and email address (if available) of other body:

Email: sps.chile@sag.gob.cl

13.

Text(s) available from: [X] National Notification Authority, [ ] National Enquiry Point. Address, fax number and email address (if available) of other body:

Email: sps.chile@sag.gob.cl