 
  
Notice of Modification to the List of 
Permitted Preservatives  to Revise 
Permitted Uses of Methylparaben, 
Propylparaben and their Sodium Salts  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NO M/ADM-0171 
August 10 , 2021  
 Notice of Modification to the List of Permitted Preservatives  to Revise Permitted  Uses of Methylparaben, Propylparaben and their 
Sodium Salts – Reference Number: NOM/ADM -0171| 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.  
Health Canada’s Proposal to Revise Permitted Uses of the food additives Methyl Paraben, Propyl Paraben and 
their Sodium Salts in Various Foods  [NOP/ADP -0033] was published on November 15, 2019 , and was open to 
the public for comment for 75 days.  The objective of the proposed modifications was 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.  As n o new scientific information was submitted to the Department  as a result of this 
Notice of Proposal , Health Canada has updated  the permitted conditions of use for  methylparaben , 
propylparaben, and their sodium salts as preservatives by modifying  Part 2 of the List of Permitted 
Preservatives  as shown in the table below.  
 
Modification to  Part 2 of  the List of Permitted Preservatives  
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other Conditions  
M.1 Methyl -p-
hydroxy benzoate 
(Methyl paraben)  (1) [Removed, 202 1-08-09, (See NOM/ADM -0171 )] 
(2) [Removed, 202 1-08-09, (See NOM/ADM -0171 )] 
(3) 
Antifoam ing preparations  (3) 
5,000 p.p.m. calculated as p-hydroxybenzoic 
acid. If used in  combination with  propyl -p-
hydroxybenzoate , sodium salt of methyl -p-
hydroxybenzoic acid or  sodium salt of propyl -
p-hydroxybenzoic  acid, the total amount not 
to exceed 5,000 p.p.m. calculated as p-
hydroxybenzoic acid.   
(4)  
Aqueous colour 
formulations for use in 
marinades  (4)  
Good Manufacturing Practice. The amount of 
methyl -p-hydroxybenzoate in the marinade  
not to exceed 40 p.p.m. If used in 
combination with sodium salt of methyl -p-
hydroxybenzoate , the total amount in the 
marinade not to exceed 40 p.p.m. calculated 
as methyl -p-hydroxybenzoate.  
(5) 
Aqueous colour 
formula tions for use in 
unstandardized 
carbonated flavoured 
beverages, unstandardized 
confectionery, or (5)  
Good Manufacturing Practice. The amount of 
methyl -p-hydroxybenzoate in the beverage or 
confectionery  as consumed not to exceed 10 
p.p.m. If used in combination with sodium salt 
of methyl - p-hydroxybenzoate , the total 
amount in the beverage or confectionery  as Notice of Modification to the List of Permitted Preservatives  to Revise Permitted  Uses of Methylparaben, Propylparaben and their 
Sodium Salts – Reference Number: NOM/ADM -0171| 3 
 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other Conditions  
unstandardized frozen 
concentrated beverages  consumed not to exceed 10 p.p.m. calculated 
as methyl -p-hydroxybenzoate.   
(6)  
Enzyme preparations  (6)  
5,000 p.p.m. calculated as p-hydroxybenzoic 
acid. If used in combination with  propyl -p-
hydroxybenzoate , sodium salt of methyl -p-
hydroxybenzoic acid or  sodium salt of  propyl -
p-hydroxybenzoic acid, 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, 202 1-08-09, (See NOM/ADM -0171 )] 
(2) [Removed, 202 1-08-09, (See NOM/ADM -0171 )] 
(3) 
Antifoam ing preparations  (3)  
5,000 p.p.m. calculated as p-hydroxybenzoic 
acid. If used in combination with  methyl -p-
hydroxybenzoate , sodium salt of methyl -p-
hydroxybenzoic acid or sodium salt of propyl -
p-hydroxybenzoic acid, the total amount not 
to exceed 5,000 p.p.m. calculated as p-
hydroxybenzoic acid.   
(4)  
Aqueous colour  
formulations for use in 
marinades  (4)  
Good Manufacturing Practice. The total 
amount of propyl -p-hydroxybenzoate in the 
marinade  not to exceed 40 p.p.m. If used in 
combination with sodium salt of propyl -p-
hydroxybenzoate , the total amount in the 
marinade not to exceed 40 p.p.m. calculated 
as propyl -p-hydroxybenzoate.   
(5)  
Aqueous colour 
formulations for use in 
unstandardized 
carbonated flavoured 
beverages  (5) 
Good Manufacturing Practice. The amount of 
propyl -p-hydroxybenzoate  in the beverage 
not to exceed 10 p.p.m. If used in 
combination with sodium salt of propyl -p-
hydroxybenzoate, the total amount in the 
beverage not to exceed 10 p.p.m. calculated 
as propyl -p-hydroxybenzoate.  
(6)  
Aqueous colour  
formulations for use in 
unstandardized 
confectionery  (6)  
Good Manufacturing Practice. The amount of 
propyl -p-hydroxybenzoate in the 
confectionery not to exceed 20 p.p.m. If used 
in combination with sodium salt of propyl -p-
hydroxybenzoate , the total amou nt in the Notice of Modification to the List of Permitted Preservatives  to Revise Permitted  Uses of Methylparaben, Propylparaben and their 
Sodium Salts – Reference Number: NOM/ADM -0171| 4 
 Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other Conditions  
confectionery not to exceed 20 p.p.m. 
calculated as propyl -p-hydroxybenzoate.  
(7)  
Enzyme preparations  (7)  
5,000 p.p.m. calculated as p-hydroxybenzoic 
acid. If used in combination with  methyl -p-
hydroxybenzoate , sodium salt of methyl -p-
hydroxybenzoic acid or sodium salt of propyl -
p-hydroxybenzoic acid, 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  
 
The food s and maximum levels of use  shown in the above  table are the same modifications that were  
consulted on in Health Canada’s Proposal [ NOP/ADP -0033 ], with the exception that subitems M.1( 5) and 
P.5(6) shown above do not specify “chewing gum” as had been  originally proposed . This is because 
“unstandardized confectionery”  is a broad category that,  for the purpose of the Lists of Permitted Food 
Additives,  includes chewing gum . Finally, i n order to keep  the list of foods in alphabetical order  in the English 
version of the List , the subitems M.1(4), M.1(5), P.5(4), P.5(5) and P.5(6) were renumbered.  
Consequential Modification s to Part 2 of the List of Permitted Preservatives  
As p ut forward in Health Canada’s Proposal [ NOP/ADP -0033 ], the names “Methylparaben” and 
“Propylparaben” are now shown as synonyms in parentheses in the Column 1 entries for item M.1 methyl -p-
hydroxybenzoate and item P.5 propyl -p-hydroxybenzoate , respectively, as shown in the above table . Since 
this change would have made the entries for i tem M.2 Methyl Paraben and P.6 Propyl Paraben redundant, 
they have been removed. This minor modification does not result in any change s to the  permitted uses of 
these food additives . 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum  Level of Use and Other 
Conditions  
M.2 [Removed, 202 1-08-09, (See NOM/ADM -0171 )] 
P.6 [Removed, 202 1-08-09, (See NOM/ADM -0171 )] 
 
In addition, entries shown in the first table above include the following revisions to the names of parabens:  
(1) the Greek letter “ρ”  was replaced  by an  italicized “ p” where the former had been used ; (2) the term  Notice of Modification to the List of Permitted Preservatives  to Revise Permitted  Uses of Methylparaben, Propylparaben and their 
Sodium Salts – Reference Number: NOM/ADM -0171| 5 
 “hydroxy Benzoate” was revised to "hydroxybenzoate" , and “hydroxy Benzoic Acid" revised to 
"hydroxybenzoic acid ”; and (3) the terms "Propyl Paraben" and "Methyl Paraben" were changed to 
"Propylparaben" and "Methylparaben" . 
Rationale  
As indicated in Health Canada’s Proposal [ NOP /ADP -0033 ], the Food Directorate identified parabens as a 
priority for safety assessment . As a result of Health Canada modifying Part 2 of the List of Permitted 
Preservati ves as shown in the tables above, t he permitted food additive uses of these parabens are more 
specific  and reflect current uses.  Potential exposure  to parabens as a result of the revised listings is expected 
to be well below the Acceptable Daily Intake (ADI) of 0-10 mg/kg bw that Health Canada applies to  methyl - 
and propyl -paraben and their sodium salts . 
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as methyl -p-hydroxybenzoate 
(methylparaben), propyl -p-hydroxybenzoate (propylparaben), and their sodium salts , that do not have food -
grade specifications set out in Part B of the Regulations meet the food -grade specifications set out in the  
most recent edition of the  Food Chemicals Codex  or the Combined Compe ndium of Food Additive 
Specifications .  The Food Chemicals 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 A dditive Specifications , which contains specifications prepared by JECFA, is 
published by the Food and Agriculture Organization of the United Nations.  
Notification – Summary of Comments  
No comments were received in response to Health Canada’s  Proposal to Revise Permitted Uses of the food 
additives Methyl Paraben, Propyl Paraben and their Sodium Salts in Various Foods  [NOP/ADP -0033], 
published on November 15, 2019 . 
Implementation and Enforcement  
The above modification s took effect  August 10, 202 1, the day they  were  published in  Part 2 of the  List of 
Permitted Preservatives .  
Regulat ions specific  to the use of parabens  as preservatives pre-date the List of Permitted Preservatives . 
These still appear in subparagraph B.21.005(b)(ii) and paragraph B.21.021(c) , and in Table XI of Division 16 of 
Part B of the Food and Drug Regulations . As indicated in the transition guide  published by the Food 
Directo rate in November 2012, the Lists are acknowledged as the official repository of approved additives. 
Health Canada intends to repeal the regulations for  parabens  from the Regulations under a Targeted 
Regulatory Review  that is part of the Agri -food and Aquaculture Roadmap.  
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its 
associated regulations with respect to foods.   Notice of Modification to the List of Permitted Preservatives  to Revise Permitted  Uses of Methylparaben, Propylparaben and their 
Sodium Salts – Reference Number: NOM/ADM -0171| 6 
 Contact Information  
Health Canada's Food Directorate is committed to reviewing new scientific information on the safety in use of 
any permitted food additive, including methyl -p-hydroxybenzoate (methylp araben), propyl -p-
hydroxybenzoate (propylparaben), and their sodium salts (sodium salt of methyl -p-hydroxybenzoic acid and 
sodium salt of propyl -p-hydroxybenzoic acid) .  Anyone wishing to submit new scientific information on the 
use of these permitted additives  or to submit 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 " parabens  (NOM -0171)" 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