Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts in Various Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Health Canada’s Proposal to Revise  
Permitted  Uses of the food additives  Methyl  
Paraben,  Propyl Paraben and their Sodium 
Salts  in Various Foods  
 
Notice of Proposal – Lists of Permitted Food Additives  
Reference Number: [NOP/A DP-0033] 
November 15 , 2019 Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts 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  (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.  
 
The Food Directorate  is proposing changes to the paraben food additive entries that appear in 
Part 2 of the List of Permitted Preservatives , based on:  
 
 Health Canada identifying parabens as a priority for safety assessmen t, both  in the Food 
Directorate and as part of the third phase1 of the Government of Canada's Chemical 
Management Plan2 (CMP) ;  
 the Food Directorate's review of the paraben listings and updated toxicological opinion 
on  parabens;  
 a determination that the existing permitted conditions of use for the parabens could result 
in exposures that may exceed the acceptable daily intake for these food additives; and  
 consultation with food industry stakeholders wh o identified that the paraben s are used in 
fewer food categories and at lower levels than currently permitted.  
 
The objecti ve of the proposed modification  to the List of Permitted Preservative s is to ensure 
that approved  food additive uses of parabens are up to date and reflective of actual uses by the 
food industry  in foods sold in Canada .  Therefore, it is the intention of H ealth Canada to modify 
Part 2 of the List of Pe rmitted Preservative s to revise the food categories and maximum levels 
for methyl -p-hydroxybenzoate  (methyl paraben), propyl -p-hydroxybenzoate (propyl paraben), 
and their sodium salts  (sodium salt of methyl -p-hydroxybenzoic acid and sodium salt of propyl -
p-hydroxybenzoic acid)  in the List of Permitted Preserva tives, as shown in the table below . 
 
 
 
Proposed Modification to Part 2 of the List of Permitted Preservative s 
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and 
Other Conditions  
M.1 (1) [Removed, 20YY -MM -DD, (See NOM/ADM -01XX)]  
(2) [Removed, 20YY -MM -DD, (See NOM/ADM -01XX)]  
                                              
1 List of substances in the third phase of CMP (2018 -2020): December 2018 update: 
https://www.canada.ca/en/environment -climate -change/services/evaluating -existing -substances/cmp -third -phase -
update.html   
2 Additional details about the Chemicals Management Plan are available at: https://www.canada.ca/en/health -
canada/services/chemical -substances /chemicals -management -plan.html   Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts in Various Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and 
Other Conditions  
Methyl -p-
hydroxybenzoate 
(Methyl Paraben)  (3) 
Antifoam preparations   (3) 
5,000 p.p.m. calculated as p-
hydroxybenzoic acid. If any 
combination of propyl -p-
hydroxybenzoate or the 
sodium salts of methyl -p-
hydroxybenzoic  acid or 
propyl -p-hydroxybenzoic acid 
is used , the total amount not 
to exceed 5,000  p.p.m. , 
calculated as p-
hydroxybenzoic acid.   
(4) 
Aqueous colour formulations 
for use in chewing gum, 
unstandardized carbonated 
and flavoured  beverages, 
unstandardized confectionery, 
or unstandardized frozen 
concentrated beverages  (4) 
Good Manufacturing Practice. 
The total amount of methyl -p-
hydroxybenzoate in the 
finished beverage or food not 
to exceed 10 p.p.m. If used in 
combination with its  sodium 
salt, the total amount not to 
exceed 10 p.p.m., calculated 
as methyl -p-hydroxybenzoate.   
(5) 
Aqueous colour formulations 
for use in marinades  (5) 
Good Manufacturing Practice. 
The total amount of methyl -p-
hydroxybenzoate  in the 
finished food not to exceed 40 
p.p.m. If used in combination 
with its sodium salt, the total 
amount not to exceed 40 
p.p.m ., calculated as methyl -
p-hydroxybenzoate.   
(6) 
Enzyme preparations  (6) 
5,000 p.p.m. calculated as p-
hydroxybenzoic acid. If any 
combination of propyl -p-
hydroxybenzoate or the 
sodium salts of methyl -p-
hydroxybenzoic acid or 
propyl -p-hydroxybenzoic acid Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts 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  
is used , the total amount not 
to exceed 5,000 p.p.m ., 
calculated as p-
hydroxybenzoic acid.  
P.5  Propyl -p-
hydroxybenzoate  
(Propyl Paraben)  (1) [Removed, 20YY -MM -DD, (See NOM/ADM -01XX)]  
(2) [Removed, 20YY -MM -DD, (See NOM/ADM -01XX)]  
(3) 
Antifoam preparations  (3) 
5,000 p.p.m . calculated as p-
hydroxybenzoic acid. If any 
combination of methyl -p-
hydroxybenzoate  or the 
sodium salts of methyl -p-
hydroxybenzoic acid or 
propyl -p-hydroxybenzoic acid 
is used , the total amount not 
to exceed 5,000 p.p.m ., 
calculated as p-
hydroxybenzoic acid.   
(4)  
Aqueous colour  formulations 
for use in chewing gum or 
unstandardized confectionery  (4) 
Good Manufacturing Practice. 
The total amount of propyl -p-
hydroxybenzoate in the 
finished food not to exceed 20 
p.p.m. If used in combination 
with its sodium salt, the total 
amount no t to exceed 20 
p.p.m ., calculated as propyl -p-
hydroxybenzoate.  
(5) 
Aqueous colour formulations 
for use in marinades  (5) 
Good Manufacturing Practice. 
The total amount of propyl -p-
hydroxybenzoate in the 
finished food not to exceed 40 
p.p.m . If used in combination 
with its sodium salt, the total 
amount not to exceed 40 
p.p.m ., calculated as propyl -p-
hydroxybenzoate.  
(6) (6) Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts 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  
Aqueous colour formulations 
for use in unstandardized 
carbonated and flavoured 
beverages  Good Manufacturing Practice. 
The total amount of propyl -p-
hydroxybenzoate in the 
finished beverage not to 
exceed 10 p.p.m. If used in 
combination with its sodium 
salt, the total amount not to 
exceed 10 p.p.m ., calculated 
as propyl -p-hydroxybenzoate.  
(7) 
Enzyme preparations  (7) 
5,000 p.p.m . calculated as p-
hydroxybenzoic acid. If any 
combination of methyl -p-
hydroxybenzoate or the 
sodium salts of methyl -p-
hydroxybenzoic acid or 
propyl -p-hydroxybenzoic acid 
is used , the total amount not 
to exceed 5,000 p.p.m ., 
calculated as p-
hydroxybenzoic acid.  
S.4 Sodium Salt of 
Methyl -p-
hydroxybenzoic 
acid Same foods as listed for 
Methyl -p-hydroxybenzoate  Same levels and conditions 
as prescribed  for Methyl -p-
hydroxybenzoate  
S.5 Sodium Salt of 
Propyl -p-
hydroxybenzoic 
acid Same foods as listed for 
Propyl -p-hydroxybenzoate  Same levels and conditions 
as prescribed  for Propyl -p-
hydroxybenzoate  
 
This proposal is expected to have no impact on the food industry given that the food categories  
as shown in the above  table were developed based on responses  from the food industry. For 
some food categories in which parabens  may currently be legally used, there was either no 
reports received of actual use of parabens  or there was clear indication from the industry that 
parabens are not used; hence, these food categories were not further considered.  In addition, the 
food categories corresponding to  subitems (3) to (7) are considered to be currently included in 
the broad food listing of “unstandardized foods” (subitem (2)) . 
 
Although t he proposed maximum level of  use (MLU)  of 5,000 parts per million (ppm) calculated 
as p-hydroxybenzoic acid in antifoam preparations and enzyme preparations is higher than the Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts in Various Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    6 currently permitted level of use of 1,000 ppm  in foods as per the Part 2 of the List of Permitted 
Preservatives , this MLU will result in significantly lower levels of parabens in the finished food 
or food ingredient manufactured with such preparations.  The original MLU was based on the 
direct addition of parabens to those foods in order to preserve the finished food itself. In contrast, 
the propose us of parabens  in the antifoam or  enzyme preparations is to preserve these 
preparations themselves rather that the finished food prepared with them.  
 
Consequential Modification  to Part 2 of  the List of Permitted Preservatives  
 
A consequential modification will also be required to Part 2 of the List of Permitted 
Preservativ es, as shown in the table below,  to remove duplicat ion in the listing of Items M.1 and 
M.2, Methyl -ρ-hydroxy Benzoate and Methyl Paraben, respectively, and Items P.5 and P.6, 
Propyl -ρ-hydroxy Benzoate and Propyl Paraben, respectively.  Synonymous names for  the same 
compound should not appear separately as different Item numbers in the same List, and reflect an 
unnecessary redundancy.  Instead, the synony ms will appear in parentheses under the lowest 
Item number, M.1 and P.5 , as shown in the table above . 
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and 
Other Conditions  
M.2 [Removed, 20YY -MM -DD, (See NOM/ADM -01XX)]  
P.6 [Removed, 20YY -MM -DD, (See NOM/ADM -01XX)]  
 
 
Rationale  
 
The Food Directorate identified the parabens as a priority for safety assessment, committ ing 
itself to  a review of  the existing listings  and toxicological database  for the parabens , as well as  to 
an evaluat ion of  paraben exposure from their use as food preservatives in foods s old in Canada .  
 
Consultation with the food industry and information in the literature  indicate that the  use of 
parabens in food preservations has declined.  Overall, there is minimal use of parabens by the 
food industry in food s sold in Canada , and the use levels in finished foods are low.  
 
The Food Directorate  completed a re -evaluation of the potential exposure to parabens from their 
use as a preservative in foods  at their existing maximum levels of use as per Part 2 of the List of 
Permitted Preservatives .  It was estimated that , if the parabens were used at these maximum 
levels of use in all foods identified according to the listings for parabens3, exposures for certain 
                                              
3 The exposure assessment included the following unstandardized foods: baked goods, including cakes (especially 
fruit cakes), pie crusts, and pastries (non -yeast); icings, toppings and fillings (especially fruit, jellies, a nd creams); 
beverages such as soft -, fruit -, and energy - drinks; alcoholic beverages; creams and pastes; snack foods such as 
tortilla chips; fruit products such as fruit salads; sauces, syrups and sweet sauces; frozen dairy products; sugar Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts in Various Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    7 age groups could potentially exceed the established Acceptable Daily Intake  (ADI)  for  
parabens4. Exposure was further  estimated based on the levels of parabens presentl y in use, as 
identified  by the food industry5.  The Food Directorate  concluded that there is no safety  concern 
based on these  current reported  uses by industry.  Health Canada is therefore proposing to revise 
the use of methyl - and propyl - paraben, and their sodium salts  as described above.  
 
Those food industry  members utilizing the parabens have  indicated that there are no known  
preservative  substitutes for the remaining identified paraben uses .  Scientific evidence has 
demonstrated that the  parabens are particular ly effective in the more alkaline end on the neutral 
pH range ( above a pH of 6.5 ) as broad -spectrum antimicrobial agents . 
 
Although the proposed food categories are more restrictive than those currently appearing in Part 
2 of the List of Permitted Preservatives , removing those food categories where the parabens are 
no longer used will add gre ater specificity to the listings and reflect current uses.  Potential 
exposures associated with the proposed maximum levels of use were confirmed to be  well below 
the ADI  for all age groups.  
 
Based on the results of the safety  assessment, Health Canada’ s Food Directorate recommends 
that the use of methyl -p-hydroxybenzoate (methyl paraben)  and propyl -p-hydroxybenzoate  
(paraben  paraben) , and their sodium salts  (sodium salt of methyl -p-hydroxybenzoic acid and 
sodium salt of propyl -p-hydroxybenzoic acid)  be re vised as described above.  
  
 
Other Relevant Information  
 
International Comparison  
 
The food categories and maximum levels proposed by the Food Directorate  are generally in line 
with those established by regulatory bodies who have more recently assessed permitted paraben s 
maximum levels in food.  Differences that exist between international regulations and those that 
the Food Directorate  is proposing are the  following: (1) the Food Directorate 's recent assessment 
of the latest toxicological evidence; (2) the specific parabens that are allowed in foods (methyl - 
and ethyl - paraben are permitted in the E uropean Union and by the Codex  General Standard for 
Food Additives  (GSFA); (3) the food categories in which they are permitted (more extensive in 
U.S.A. and Codex GSFA); and (4) the levels of parabens in finished foods (higher concentrations 
in general are permitted in finished foods b y other authorities, with the exception of enzyme 
preparations where concentration s are lower in the E uropean Union). 
 
                                              
substitutes; can dies and sweets; and coffee extracts.  These are unstandardized foods in which parabens may have 
been used in the past.  
4 The current ADI for methyl - and propyl -paraben and their sodium salts is 0 -10 mg/kg bw.   
 
5 Responses received from food industry stak eholders  in reply to the Food Directorate's call for data  on August 31, 
2017.  Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts in Various Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    8 The Joint FAO/WHO Expert Committee on Food Additives ( JECFA ) established an ADI of 0 -10 
mg/kg bw for the parabens in 1974.  The ADI repre sented the sum of methyl -, ethyl - and propyl 
paraben, and their sodium salts, since they are commonly used in combination.  In 2006, the 
JECFA removed propyl paraben from this group ADI, based on a toxicological study6 suggesting 
that this ADI was not appropriate for propyl paraben7 and, in part, on recommendations from the 
European Food Safety Authority (EFSA) in 20048 which were based on the same study.  To date, 
neither authority has re -assessed the parabens.  
 
The d ifference in specific parabens allowed between Canada, the EU and the Codex GSFA is the 
result of the Food Directorate 's assessment of new toxicological evidence on the parabens, which 
does not support the conclusions made by JECFA  and EFSA  in their respec tive assessments .  
Therefore, the Food Directorate  includes propyl paraben in its  ADI for the parabens and 
considers that current propyl paraben uses by the food industry are acceptable from a food safety 
perspective.  Contrary to the EU and Codex GSFA, t he Food Directorate  has never received a 
request  from the food industry for approval of  its use in foods sold in Canada  and therefore 
ethyl -paraben is not currently permitted . 
 
Concentrations of the parabens measured in food in other countries also suggest that the use of 
parabens in food is limited, with actual levels in the finished foods being in the low parts per 
million (ppm ) range.  
 
 
Implementation and Enforcement  
 
The proposed changes  will be effec tive the day on which they are published in Part 2 of the List 
of Permitted Preserva tives.  This will be announced via a Notice of Modification that will be 
published on the Government of Canada ’s W ebsite .  
 
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  
 
For additional information or to submit comments related to this proposal, please contact:   
 
Bureau of Chemical Safety, Food Directorate  
                                              
6 Oishi, S. (2002), Food and Chemical Toxicology , 40(12):1807 -1813.  
7 Evaluation of certain food additives and contaminants (Sixty -seventh report of the Joint FAO/WHO Expert  
Committee on Food Additives).  WHO Technical Report Series, No. 940, 2006; and WHO Food Additives Series, 
No. 58, 2006 . 
8 EFSA (2004) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in 
Contact with Food on a Re quest from the Commission related to para hydroxybenzoates (E214 -219).  Question 
number EFSA -Q-2004 -063. Adopted on 13 July 2004.  Health Canada's Proposal to Revise Permitted Uses of the food additives  
Methyl  Paraben,  Propyl Paraben and their Sodium Salts in Various Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    9 251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0 K9 
E-mail: hc.bcs -bipc.sc@canada.ca  
 
If communicating b y e-mail, please use the words “parabens  (NOP-0033)” in the subject line of 
your e -mail.  Health Canada is able to consider information received by January 28, 2020,  75 
days from the date of this posting.