Notice of Modification to the List of Contaminants and Other Adulterating Substances in Foods  to Add the Maximum 
Level for Patulin in Apple Juice and Unfermented Apple Cider  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Contaminants 
and Other Adulterating Substances in Foods  to 
Add the Maximum Level for Patulin in Apple 
Juice and Unfermented Apple Cider  
 
Notice of Modification  – List of Contaminants and Other 
Adulterating Substances in Foods  
 
Reference Number: NO M/ADM C -2018 -1 
January 17 , 2018  
Notice of Modification to the List of Contaminants and Other Adulterating Substances in Foods  to Add the Maximum 
Level for Patulin in Apple Juice and Unfermented Apple Cider  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    2 Summary  
 
Food contaminants and other adulterating substances are chemicals that may be present in foods 
at levels that could impact the overall safety and/or quality of foods. These substances can either 
be inadvertently present in foods or, in some cases, intentio nally added for fraudulent purposes. 
Establishing maximum levels (MLs) is a form of risk management that may be employed to 
reduce exposure to a particular chemical contaminant in food sold in Canada. Canadian MLs for 
chemical contaminants in food are set out in the List of Contaminants and Other Adulterating 
Substances in Foods , which is incorporat ed by reference into Section B.15.001 of Division 15 of 
the Food and Drug Regulations  (Regulations), and in the List of Maximum Levels for Various 
Chemical Contaminants in Foods , which has a history of being maintained on Health Canada’s 
website outside of the Regulations. All MLs for contaminants in food are established by Health 
Canada and are enforceable by the Canadian Food Inspection Agency.  
 
The List of Maximum Levels for Various Chemical Contaminants in Foods  specifies an ML of 
50 parts per billion (p.p.b.) (expressed in the list as 50 µg/kg or micrograms per kilogram) for 
patulin in apple juice, including the apple juice portion of any juice blends or drinks, and 
unfermented apple cider. If these foods are fo und to contain patulin at concentrations above 
50 p.p.b., they would be considered in violation of section 4(1) of the Food and Drugs Act . 
 
The existing ML for patulin in apple juice was established by Health Canada in 2011. The 
Department has re -confirmed that this ML continues to be health protective and relevant in the 
Canadian context.  
 
Consequently, Health Canada published a Proposal to transfer the maximum level for patulin in 
apple juice and unfermented apple cider from the List of Maximum Levels for Vari ous Chemical 
Contaminants in Foods to the regulatory List of Contaminants and Other Adulterating 
Substances in Foods – Reference Number: NOP/ADP -C-2017 -4.  The proposal was published on 
August 4, 2017 and was open for public comment for 75 days.  
 
As no co mments were received that would alter the approach described in the Notice of 
Proposal, Health Canada has transferred the ML for  apple juice, including the apple juice portion 
of any juice blends or drinks, and unfermented apple cider from the List of Maxi mum Levels for 
Various Chemical Contaminants in Foods  to Part 2 of the regulatory List of Contaminants and 
Other Adulterating Substances in Foods , as shown in the table below. The footnote included in 
the table below was also added to Part 2 of the List.  
 
Health Canada has further considered the addition of two footnotes to Part 2 of the List, as 
outlined in two prior Notices of Proposal, NOP/ADP -C-2017 -4 and NOP/ADP -C-2017 -5 and 
two previous Notices of Modifications, NOM/ADM -C-2017 -1 and NOM/ADM -C-2017 -2. 
While Health Canada proceeded with the addition of the fi rst footnote (shown at the end of the 
table below), the second footnote (regarding the application of MLs to foods on a fresh weight 
basis and regarding the application of MLs to dehydrated and concentrated foods) was not added 
to the List.  Instead of add ing this second footnote to Part 2 of the List, the wording ‘as  
Notice of Modification to the List of Contaminants and Other Adulterating Substances in Foods  to Add the Maximum 
Level for Patulin in Apple Juice and Unfermented Apple Cider  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 consumed’ will be added, as necessary, after the ML value in column 3, when relevant to the 
particular food(s) listed in column 2. In the case of the ML for patulin in apple juice and 
unfermen ted apple cider, ‘as consumed’ has been added to column 3 after the ML value.   
 
Modification to Part 2 of the List of Contaminants and Other Adulterating Substances in 
Foods  
 
Item No.  Column 1  
Substance  Column 2  
Food1 Column 3  
Maximum Level  
10 Patulin  Apple juice ; Unfermented apple cider  50 p.p.b. as 
consumed  
1Maximum levels also apply to the food when it is used as an ingredient in other foods.  
 
Corrective Modifications  
Column number identifiers (e.g., “Column 1”) have been added to the column headings of Part 1 
and Part 2 of the List of Contaminants and Other Adulterating Substances in Foods , as illustrated 
in the table above, for consistency with the language used in Di vision 15 of the Food and Drug 
Regulations to describe the List.  
 
 
Rationale  
 
As described in the Notice of Proposal ( NOP /ADP -C-2017 -4), the ML for patulin in apple juice 
and unfermented apple cider  was originally established by Health Canada to  minimise  exposure 
to patulin in young children while also being  health protective for the general Canadian 
population. Health Canad a recently re-confirmed  that the scientific basis upon which it was 
originally established continues to support the ML. Fu rthermore, contemporary occurrence data 
for patulin in apple juice and unfermented apple cider sold in Canada support that an ML of 
50 p.p.b. in both of these commodities is readily achievable when good agricultural, 
manufacturing and storage practices are  followed.  
 
 
Other Relevant Information  
 
As described in the Notice of Proposal (NOP/ADP -C-2017 -4), the Canadian ML for patulin in 
apple juice  and unfermented apple cider aligns with the ML established by the Codex 
Alimentarius Commission ( Codex; CODEX STAN 193 -1995 ), the action level of the United 
States Food and Drug Administration ( Patulin in Apple Juice, Apple Juice Concentrates and 
Apple Juice Products ), and the ML established by the European Commission for patulin in fruit  
Notice of Modification to the List of Contaminants and Other Adulterating Substances in Foods  to Add the Maximum 
Level for Patulin in Apple Juice and Unfermented Apple Cider  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 juices, fruit nectars, spirit drinks, cider and other fermented drinks derived from a pples or 
containing apple juice ( EC No. 1881/2006 ).  
 
Codes of Practice from the Codex Alimentarius Commission  and the  Canadian Food Inspection 
Agency  are available to producers seeking information on preventing patuli n contamination in 
apple juice and unfermented apple cider.  
 
 
Notification – Summary of Comments  
 
No comments were provided during the public comment period in response to the  forementioned  
Notice of Proposal . 
 
Implementation and Enforcement  
 
The above modification came into force January  17, 201 8, the day it was published in the List 
of Contaminants and Other Adulterating Substances in Foods .  
 
The Canadian Food Inspection Agency is responsible for the enforcement of the food -related 
aspects of the Food and Drugs Act  and its associated regulations.  
 
 
Contact Information  
 
Health Canada's Food Directorate is committed to reviewing any new scientifi c information on 
the chemical the safety of foods. Anyone wishing to submit new scientific information relating to 
patulin in apple juice or unfermented apple cider may do so in writing, by regular mail or 
electronically. If you wish to contact the Food Di rectorate electronically, please use the words 
“Patulin in apple juice and cider ” in the subject line of your e -mail.  
 
Bureau of Chemical Safety, Food Directorate  
251 Sir Fred erick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail: bcs-bipc@hc -sc.gc.ca