G/SPS/N/CHL/536  
21 December  2016 
(16-6984) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  NOTIFICATION  
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 wit h 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 Heal th) 
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 establ ish 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 h emp 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 f rom 
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. I SPM No. ) 
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes [ ] No 
If no, describe, whenever poss ible, 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. G/SPS/N/CHL/536  
- 2 - 
  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, husk s, 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 ident ification 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 dail y 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 da y 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 whic h 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 cir culation 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 th e date of circulation of the 
notification and/or (dd/mm/yy) : 19 February 2 017 
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