G/SPS/N/CAN/1249  
 
12 June 2019  
(19-4016) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English/French  
 
  
NOTIFICATION  
1. Notifying Member:  CANADA  
If applicable, name of local government involved:   
2. Agency responsible:  Health Canada  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Lead in concentrated infant formula and infant formula when ready -
to-serve (ICS Code: 67.230)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Health Canada's Proposal to Lower the Maximum Levels 
of Lead in Concentrated Infant Formula and Infant Formula When Ready -to-Serve in the 
List of Contaminants and Other Adulterating Substances in Foods - Reference Number: 
NOP/AVP C -2019-1. Language(s):  English and French . Number of pages:  5 
6. Description of content:  Health Canada has conducted a scientific assessment which 
supports lowering the maximum level (ML) for lead in all types of infant formula that 
would apply to the food on an 'as consumed ' basis. Health Canada is proposing to 
consolidate the two existing M Ls for lead in concentrated infant formula and infant formula 
when ready -to-serve into a single, lower ML of 0.01 ppm.  
The purpose of this communication is to publically announce the Department's intention 
in this regard and to provide the appropriate cont act information for any inquiries or for 
those wishing to submit any new scientific information relevant to Health Canada's 
scientific assessment.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans fro m animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : The proposed lower ML (0.01 ppm) for lead in infant 
formula on an 'as consumed' basis aligns with the MLs established by both the 
European Union (EU; EC No. 2015/1005) and the Codex Alimentarius Commission 
(Codex; CODEX STAN 193 -1995) of 0.0 1 ppm lead in infant formula, formula for 
special medical purposes intended for infants and follow -up formula.  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protect ion Convention (e.g.  ISPM number) :  G/SPS/N/CAN/1249  
 
- 2 - 
 
  [ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Health  Canada's Food and Nutrition – 'Public Involvement and Partnerships' Website, 
posted 5 June 2019 (available in English and French):  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats.html  (French)   
10. Propo sed date of adoption (dd/mm/yy) : The proposed ML will be legally enabled 
once it is published in Health Canada's  List of Contaminants and Other Adulterating 
Substances in Foods ( https://www.canada.ca/en/health -canada/services/food -
nutrition/food -safety/chemical -contaminants/contaminants -adulterating -substances -
foods.html ). 
Proposed date of publicati on (dd/mm/yy) :  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : The ML noted in this document comes into force the day on which 
the modification is made to the  List of Contaminants and Other Adulterating Substances 
in Foods ( https://www.canada.ca/en/health -canada/services/food -nutrition/food -
safety/chemical -contaminants/contaminants -adulterating -substances -foods.html ). 
[ ] Trade facilitating measure   
12. Final  date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 August 2019  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number an d e-mail address 
(if available) of other body:   
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
"Health Canada's Proposal to Lower the Maximum Levels of Lead in Concentrated Infant 
Formula and Infant Formula When Ready -to-Serve in the List of Contaminants and Other 
Adulterating Substances in Foods - Reference Number: NOP/AVP C -2019-1" is available 
through the following weblinks:  
https://cana da-preview.adobecqms.net/en/health -canada/services/food -
nutrition/public -involvement -partnerships/proposal -lower -maximum -levels -lead-infant -
formula -list-of-contaminants -other -adulterating -substances/document.html  (English)  
https://canada -preview.adobecqms.net/fr/sante -canada/services/aliments -
nutrition/participation -public -partenariats/proposition -abaisser -concentrations -
maximales -plomb -preparations -nourrissons -liste-contaminants -autres -substances -
adulterantes/document.html  (Fren ch) 
 
Canada's Notification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Tel: +(343) 203 4273  
Fax: +(613) 943 0346  
E-mail: enquirypoint@international.gc.ca