. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/25/Add.1 
16 July 2012  
 (12-3832) 
Committee on Technical Barriers to Trade Original:   English/ 
     French 
 
 
 
NOTIFICATION  
 
Addendum 
 
 
 The following communication, dated 9 July 2012,  is being circulated at the request of the 
delegation of Canada.  
 
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 Transition process for foods marketed as Natural Hea lth Products to the food  regulatory framework 
 
 As previously notified in G/TBT/N/CAN/25 (d ated 21 December 2001), Canada regulates 
natural health products under the Natural Health Products Regulations (NHPR) under the authority of 
the Food and Drugs Act .  
  Some products with added vitami ns, minerals or amino acids that  appear to be foods, as well 
as foods making certain health claims, have previous ly been able to gain market access as Natural 
Health Products (NHPs).  Canada is undertaking a transition process of food products marketed as 
NHPs to the food regulatory framework.  As such, these products will be required to meet all food-
related requirements.  Examples of food products th at are currently marketed as NHPs include energy 
drinks, waters and juices with adde d vitamins and minerals, and yogourts  and bars with specific health 
claims.  These products represent a very small portion (2%) of the approximately 50,000 NHPs currently in the Canadian marketplace.   
 The Department of Health has determined, b ased on consumption patterns, history of use, 
representation to consumers, and in accordance with its guidance document "Classification of 
Products at the Food-Natural Health Produc t Interface: Products in Food Formats" ( http://www.hc-
sc.gc.ca/dhp-mps/prodnatur/legislation/do cs/food-nhp-aliments-psn-guide-eng.php ), that most of 
these products fit the definition of a food.  The Department, therefore, intends to classify and 
transition most of these products to the food regulator y framework.  This is consistent with the policy 
intent of the NHPR, as outlined in the regulatory impact analysis statement 
(http://www.gazette.gc.ca/archives/p2/2003/ 2003-06-18/pdf/g2-13 713.pdf, SOR/2003-196 ), as well as 
the outcomes of the Natural Health Product Regulat ory review, conducted in 2007, which re-iterated 
that foods are excluded from the scope of the NHPR.  
 
 As of 17 April 2012, Canada is no longer ac cepting NHP applications for products that are 
represented, packaged and sold as foods.   For those products already on the market as NHPs, the 
Department has put in place a transition process to minimize the disruption to market, as long as the products are safe to be consumed as foods.  Products  that are captured under the transition are those 
where a Product Licence Application has been receiv ed by the Department's Natural Health Products 
Directorate (NHPD) and have been issued either a natural product number, an exemption number or 
are considered application in progress. G/TBT/N/CAN/25/Add.1 
Page 2  
 
   
 The transition of eligible food products mark eted as NHPs to the food regulatory framework 
will be facilitated through the issuance of a Te mporary Marketing Authorization Letter (TMAL) 
(http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/food-market-author-marche-aliment-eng.php ).  
Submissions for a Temporary Marketing Authoriza tion (TMA) are only needed for new products for 
which there is a regulatory impediment to the lega l marketing of a safe food in Canada.  New products 
that comply with the Food and Drug Regulations are not subject to pre-market scrutiny and do not require TMAs.   The end goal of this transition process is to en sure that products that look like foods and are 
consumed as foods are regulated as foods. 
  This addendum serves to inform Members of how Canada is proceeding with the transition 
process.  This information has also been provi ded in G/SPS/GEN/1170. When ready, Canada will 
notify the WTO to provide Members the opportunity to comment on the proposed regulatory changes 
to the Food and Drug Regulations that would allow the sale of these products.   
  More information on the transition process a nd other relevant docum ents can be found on 
Health Canada's website: http://www.hc-sc.gc.ca/fn-an/prodnatur/tr ansit-process-food-aliment-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/prodnatur/ transit-process-food-aliment-fra.php  (French 
 
  
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