Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Health Canada’s Proposal to Modify the Currently 
Permitted Uses of the Colouring Agent Amaranth in 
Various Foods  
Notice of Proposal  – Lists of Permitted Food Additives  
Reference Number: [ NOP/AV P-0023 ] 
 
 
 January  4, 201 7  
Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     2 Summary  
 
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the 
Minister of Health and the Food and Drug Regulations.  Approved food additives and their 
permitted conditions of use are set out in the Lists of Permitted Food Ad ditives  that are 
incorporated by reference in the MAs and published on Health Canada’s 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 food additive sub mission 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 ha s conducted a re -evaluation of the food additive uses of the colouring agent 
amaranth, which is currently permitted at a maximum level of use of 300 parts per million 
(p.p.m.), singly or in combination with other specified synthetic colours, in a range of foods 
including bread, jams, concentrated fruit j uice, flavoured milk, ice cream  and tomato catsup.  The 
re-evaluation was conducted in support of a broader review of fifty -two azo acid dyes1 carried out 
as part of the Government of Canada’s Chemicals Management Plan.2 
 
The results of Health Canada’s re -evaluation of available data on the concentrations of amaranth 
actually used in foods sold in Canada reveal that exposure to amaranth is withi n acceptable levels 
from a food safety perspective.  However, the existing maximum levels of use for amaranth that 
appear in the List of Permitted Colouring Agents  are gener ally higher than actual use levels and 
would allow for elevated exposures if actual use levels ever increased.  In order to ensure that 
potential exposure to the food colouring agent amaranth remains within acceptable levels, it is the 
intention of Health Canada to modify the List of Permitted Colouring Agents by creating a unique 
listing for “Amaranth” (it is currently grouped in the List with five other synthetic colours) and 
by identifying areas of use and maximum levels of use that align with actual cur rent uses, as 
shown below.  No changes to the singly or in combination maximum use levels for the other 
synthetic colours (i.e., Allura Red, Erythrosine,  Indigotine, Sunset Yellow FCF and Tartrazine) 
are being proposed.  
 
 
 
 
 
                                              
1 Of the fifty -two substances covered in the azo acid dye re -evaluation under the Chemicals Management Plan, 
only two, amaranth and tartrazine, have food additive uses.  
http://www.chemicalsubstanceschimiques.gc.ca/group/azo_benzidine/dyes -colorants -eng.php    
2 Additional details about the Chemicals Management Plan are ava ilable at: 
http://www.chemicalsubstanceschimiques.gc.ca/plan/index -eng.php    
Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Proposed Modifications 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  
3.2.1  Amaranth  (1)  
Apple (or rhubarb) and (naming the fruit) 
jam; Fig marmalade  with pectin; (naming 
the fruit) Jam with pectin; (naming the 
fruit) Jelly with pectin; Pineapple 
marmalade with pectin  (1)  
100 p.p.m. singly or in combination. 
If used in combination with one or 
more of the colouring agents listed 
in column 1 of item 3 o f this list, the 
combined maximum level of use not 
to exceed 300 p.p.m.  
(2)  
Liqueur; Unstandardized alcoholic 
beverages  (2)  
300 p.p.m . singly or in combination. 
If used in combination with one or 
more of the colouring agents listed 
in column 1 of item 3 of this list, the 
combined maximum level of use not 
to exceed 300 p.p.m.  
(3)  
Hard candies; (naming the flavour) Milk; 
(naming the f lavour) Partly skimmed 
milk; (naming the flavour) Partly 
skimmed milk with added milk solids; 
(naming the flavour) Skim milk; (naming 
the flavour) Skim milk with added milk 
solids; Unstandardized dairy beverages, 
except eggnog  (3)  
50 p.p.m. singly or in c ombination. 
If used in combination with one or 
more of the colouring agents listed 
in column 1 of item 3 of this list, the 
combined maximum level of use not 
to exceed 300 p.p.m.  
(4)  
Cream soda; Grape soda; Unstandardized 
non-carbonated fruit -flavoured beverages, 
concentrates and mixes  (4)  
90 p.p.m. singly or in combination 
as consumed. If used in combination 
with one or more of the colouring 
agents listed in column 1 of item 3 
of this list, the combined maximum 
level of use not to exceed 300 
p.p.m., as  consumed.  
(5)  
Unstandardized frozen desserts  (5)  
55 p.p.m. singly or in combination. 
If used in combination with one or 
more of the colouring agents listed 
in column 1 of item 3 of this list, the 
combined maximum level of use not 
to exceed 300 p.p.m.  
  
(6)  
Eggnog; Unstandardized dressings; 
Vinaigrettes; Yogurt  (6)  
15 p.p.m. singly or in combination. 
If used in combination with one or 
more of the colouring agents listed  
Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Item 
No. Column 1  
Additive  Column 2  
Permitted In or Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
in column 1 of item 3 of this list, the 
combined total not to exceed 300 
p.p.m.  
(7)  
Pancake mixes; Unstandardized bakery 
products; Waffle mixes  (7)  
40 p.p.m. singly or in combination 
as consumed. If used in combination 
with one or more of the colouring 
agents listed in column 1 of item 3 
of this list, the combined maximum 
level of use not to exceed 300 
p.p.m., as consumed.  
(8)  
Potato chips; Unstandardized desserts, 
except unstandardized frozen desserts; 
Unstandardized dessert toppings  (8)  
100 p.p.m . singly or in combination. 
If used in combination with one or 
more of the colouring agents listed 
in column 1 of item 3 of this list, the 
combined maximum level of use  
not to exceed 300 p.p.m.  
 
Consequential changes will also be required to item 3 of th e List of Permitted Colouring Agents  
to remove “Amaranth” from column 1; to regroup some of the foods shown in column 2; and to 
remove reference to section B.06.002, which sets out “in combination” rules, and replace that 
reference with text describing the  “in combination” rules in column 3, as shown below.  For 
column 2, the food categories shown below are the same as currently listed but foods that are 
currently grouped as sub -item (1) would be separated into two groups.  Sub -items (1) and (2) 
shown below  are those foods in which amaranth may also be used and for which the maximum 
level of use also reflects the possible use of amaranth.  Sub -items (3) and (4) shown below are 
those foods in which amaranth is not reported to be used and for which the maximum  level of use 
does not need to reflect the possible use of amaranth.  
 
Consequential Changes 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  
3 Allura  Red; 
Erythrosine;  
Indigotine;  
Sunset Yellow 
FCF;  
Tartrazine  (1)  
Apple (or rhubarb) and (naming the fruit) 
jam; Fig marmalade with pectin; (naming 
the fruit) Jam with pectin; (naming the 
fruit) Jelly with pectin; Liqueur; (naming 
the flavour) Milk; (namin g the flavour) 
Partly skimmed milk; (naming the flavour) 
Partly skimmed milk with added milk (1)  
300 p.p.m. singly or in combina tion 
with one or more of the colouring 
agents listed in column 1 of item 3 
of this list and amaranth , provided 
the conditions of use of amaranth 
are respected.   
Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and 
Other Conditions  
solids; Pineapple marmalade with pectin;  
(naming the flavour) Skim milk; (naming 
the flavour) Skim milk with added milk 
solids  
(2)  
Unstandardized foods  (2)  
300 p.p.m . singly or in combination 
with one or more of the colouring 
agents in column 1 of item 3 of this 
list and amaranth, provided the 
conditions of use of amaranth are 
respected.  
(3)  
A blend of prepared fish and prepared 
meat referred to in paragraph B.21. 006(n) (3)  
300 p.p.m. singly or in combination 
with one or more of the colouring 
agents in column 1 of item 3.  
(4)  
Bread; Butter; Concentrated (naming the 
fruit) juice except frozen concentrated 
orange juice; Fish roe (caviar); Ice cream 
mix; Ice milk  mix; Icing sugar; Lobster 
paste; Pickles; Relishes; Sherbet; Smoked 
fish; Tomato catsup  (4)  
300 p.p.m. singly or in combination 
with one or more of the colouring 
agents in column 1 of item 3 of this 
list. 
 
This proposal is expected to have no impact on the food industry given that  the food categories , 
as shown in the first table , were developed based on the following two sources of information: 
(1) feedback from the food industry which had identified the foods in which amaranth is currently 
used and at what levels ; and (2) the results of targeted surveys of amaranth in food that were 
conducted by the Canadian Food Inspection Agency .  For some food categories in which 
amaranth may currently be legally used,  there was  either no reports received of actual use of 
amaranth or there was clear indication from the industry that amaranth is not used.  These food 
categories have not been included among the proposed list of foods in which amaranth may be 
used.  
 
Ratio nale 
 
In 2014, Health Canada’s Food Directorate completed a re -evaluation of the potential exposure to 
amaranth from its use as a food colouring agent.  The re -evaluation was conducted in support of 
the Government of Canada’s Chemicals Management Plan Groupings Initiative, in which fifty -
two azo acid dyes, including amaranth, were assessed.  As part of the evaluation, the actual 
concentrations of amaranth presently added to food were obtained from the food industry through 
a Call for Data . The f eedback received was  used to estimate potential exposure to amaranth  
Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     6 among the population in Canada.  The conclusion that there is not expected to be a health risk is 
based on the present use patterns among the food industry.  
 
For a major ity of the foods in which amaranth was reported to be used, the actual concentrations 
of amaranth in the food were below the maximum permitted level of use.  The current regulatory 
conditions of use for amaranth, some of which are based on usage data from the 1970’s and 
which were based on the body of scientific evidence available at that time, evidently no longer 
reflect current use patterns and generally permit the use of amaranth at higher use levels and in 
more food categories than necessary.  An exposu re assessment demonstrated that if amaranth 
were used at its current maximum permitted level in all permitted foods , it would result in an 
unacceptably elevated exposure to amaranth.  Therefore, updated conditions of use for amaranth 
are being proposed to ensure that exposures remain within acceptable levels and to reflect current 
use patterns of amaranth in foods.  
 
In order to develop a proposal on revised conditions of use for amaranth, the assessment of 
potential exposure to amaranth from its food additi ve uses in foods for which there was evidence 
of its use was conducted again, this time using the actual concentrations of amaranth in foods 
sold in Canada, as reported in 2013 and 2014 by the food industry and as well as the 
concentrations measured in tar geted surveys by the Canadian Food Inspection Agency.  
 
The updated exposure assessment employed single -day (24 -hr recall) data on the consumption of 
foods3; it assumed a daily frequency of consumption of foods; it assumed that all of the foods 
included in  the assessment always contain added amaranth and that the concentration was at the 
upper range of reported levels; and it sometimes assumed that amaranth was present in all foods 
within a particular food category when it could actually only be present in a sub -set of foods 
within that category.  The exposure assessment can therefore be described as conservative.  
 
The conservatively estimated mean intakes of amaranth among the various age groups were 
either below or approximated the Acceptable Daily Intake (ADI) of 0.5  mg/kg bw/day  which was 
established by the Joint Expert Committee on Food Additives (JECFA).  The intakes were also 
similar to or lower than the estimates that were published in the Chemicals Management Plan 
Screening Assessment Report which ha d concluded that reported food additive use levels of 
amaranth do not pose an unacceptable health risk .  The ADI is the dose of a substance that an 
individual can ingest daily over a lifetime without an appreciable health risk.  The ADI for 
amaranth  incorp orates an uncertainty value of 100, meaning that the ADI is 100 times less than 
the minimum dose at which no adverse effects were seen in experimental animals.  
 
Based on the results of the exposure assessment, the Food Directorate considers that the propo sed 
new conditions of use for amaranth will ensure that total dietary exposure to amaranth will 
remain within acceptable levels.   As such, the Directorate is proposing to amend the List of 
                                              
3 Canadian Community Health Survey Cycle 2.2 (Statistics Canada 2004)   
Health Canada’s Proposal to Modify the Currently Permitted Uses of the Colouring Agent Amaranth in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     7 Permitted Colouring Agents  by adjusting the food categories and the  majority of the 
corresponding maximum levels of use to better reflect actual areas and levels of use of amaranth.  
 
As noted, this proposal is expected to have no impact on the food industry because the food 
categories as shown in the first table were developed based on feedback from the food industry, 
which identified the foods in which amaranth is currently used and a t what levels, and based on 
targeted surveys conducted by the Canadian Food Inspection Agency.  
 
Other Relevant Information  
 
Amaranth has permitted food additive uses in other jurisdictions, including Europe, Australia and 
New Zealand.  Based on studies co nducted internally by the United States Food and Drug 
Administration  (U.S. FDA), it was delisted for use in food in the United States in 1976.  Canada 
and other international regulatory agencies consider that the earlier studies upon which the U.S. 
FDA bas ed its decision had significant limitations and that the current body of scientific evidence 
supports the safety in use of amaranth as a food additive within specific conditions.  
 
Implementation and Enforcement  
 
The proposed changes will be effective the day on which they are published in the List of 
Permitted Colouring Agents . This will be announced via a Notice of Modification whi ch will be 
published on Health Canada’s Website .  
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs 
Act and its associated regulations with respect t o foods.  
 
Contact Information  
 
For additional information or to submit comments related to this proposal, please contact:   
 
Bureau of Chemical Safety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail: bcs-bipc@hc -sc.gc.ca  
 
If communicating  by e-mail, please use the word  “Amaranth ” in the  subject line of your e -mail. 
Health Canada is able to consider information received by March  18, 2017 , 75 days from the 
date of this posting.