Notice of Modification to the List of Permitted 
Colouring Agents  to Enable the Use of Lycopene 
Extract from T omato in Certain Non -Carbonated 
Sweetened Flavoured  Water -Based Beverages with 
Vitamins and Mineral Nutrients Added and in 
Sports Drinks  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0143  
March 12, 2020  
 Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use Lycopene Extract from Tomato in Certain Non -Carbonated 
Sweetened Flavoured Water -Based Beverages with Vitamins and Mineral Nutrients Added and in Sports Drinks  | 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the Minister of 
Health and the Food and Drug Regulations  (Regulations) .  Approved food additives and their permitted 
conditions of use are set out in the Lists of Pe rmitted Food Additives  that are incorporated by reference in 
the MAs and published on the Canada.ca website.  A petitioner can request that Health Canada approve a 
new additive or a new condition of use for an already approved food additive by filing a foo d additive 
submission with the Department's Food Directorate.  Health Canada uses this premarket approval process to 
determine whether the scientific data support the safety of food additives when used under specified 
conditions in foods sold in Canada.  
Health Canada’s Food Directorate received a food additive submission seeking approval for the use of 
lycopene extract from tomato as a food colouring agent in sports drinks and certain non -carbonated 
sweetened flavoured water -based beverages to which vitamin s have been added. The requested maximum 
level of use is 3 ppm.  Lycopene extract from tomato has been permitted as a colouring agent in a few other 
beverage categories since 2017; however, sports drinks and certain non -carbonated sweetened flavoured 
water -based beverages to which vitamins have been added did not fall within the permitted beverage 
categories.  
Lycopene extract from tomato  is already permitted for use in Canada as a colouring agent in a number of 
foods including the following beverage categori es: n on-alcoholic carbonated water -based flavoured and 
sweetened beverages; unstandardized dairy -based beverages; and n on-carbonated unsweetened flavoured 
coloured water beverages .   
The results of the Food Directorate’s evaluation of available scientific data support the safety and efficacy of 
lycopene extract from tomato  when used as requested by the petitioner.  Therefore, Health Canada has 
modified the List of Permitted Colouring Agents  to extend the use of lycopene extract from tomato  by adding 
the entry shown below to the List. 
 
Modification to the List of Permitted Colouring Agents   
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
13. Lycopene Extract 
from Tomato  (16) Non-carbonated sweetened 
flavoured water -based beverages 
with vitamin and mineral nutrients 
added, except beverages with 
vitami ns added in accordance with 
Part D of the Food and Drug 
Regulations ; Sports drinks  
 
 (16) 3 p.p.m. calculated as 
lycopene  
 
 Notice of Modification to the List of Permitted Colouring Agents  to Enable the Use Lycopene Extract from Tomato in Certain Non -Carbonated 
Sweetened Flavoured Water -Based Beverages with Vitamins and Mineral Nutrients Added and in Sports Drinks  | 3 
 Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of  lycopene extract from 
tomato for use as a food colouring agent .  The assessment concluded that information related to chemistry, 
microbiology, nutrition, toxicology, and allergenicity  supports the safety of lycopene extract from tomato for 
its requested uses.  Therefore, the Department has enabl ed the requested uses of lycopene extract from 
tomato by adding to the List of Permitted Colouring Agents  the new entry shown in the above table.  
Other Relevant Information  
The CODEX General Standard for Food Additives provides for the use of lycopene extract from tomato, with 
the functional class “colour”, in a number of food categories including “water -based fla voured drinks 
including ‘sport’, ‘energy’, or ‘electrolyte’ drinks and particulated drinks, at a maximum use level of good 
manufacturing practice. Major trading partners such as the United States, Europe, and Australia and New 
Zealand all appear to permit the use of lycopene extract from tomato in these types of beverages, with the 
exception that the European Union allows for its use in flavoured drinks, but not “dilutable drinks”.   
The Food and Drug Regulations  require that food additives such as lycopene extract from tomato that do not 
have food -grade specifications set out in Part B of the Regulations meet the most recent food -grade 
specifications set out in the Food Chemicals Codex  or the Combined Compendium of Food Additive 
Specifications .  The Food Che micals Codex  is a compendium of standards for purity and identity for food 
ingredients, including food additives, published by the United States Pharmacopeial Convention. The 
Combined Compendium of Food Additive Specifications , which contains specification s prepared by the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture 
Organization of the United Nations.  
Implementation and Enforcement  
The above modification came into force March 12, 2020 , the day it was pu blished in  the List of Permitted 
Colouring Agents .  
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its 
associated regulations with respect to foods.   
Contact Information  
Health Canada's Food Directorate is committed to reviewing any new scientific infor mation on the safety in 
use of any food additive, including lycopene extract from tomato .  Anyone wishing to submit new scientific 
information on the use of this additive or to submit any inquiries may do so in writing, by regular mail or 
electronically.  If you wish to contact the Food Directorate electro nically, please use the words " lycope ne 
extract from tomato (NOM -0143 )" in the subject line of your e -mail.  
Bureau of Chemical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca