Notice of Health Canada’s proposal to modify the List of contaminants and other adulterating substances in foods as part of the modernization of Part B of the Food and Drug Regulations
Notice of Proposal – List of contaminants and other adulterating substances in foods
Reference Number: NOP/ADP C-2023-1
November 4, 2023
Contents
- Summary
- Proposed Revisions to the List of contaminants and other adulterating substances in foods
- Rationale
- Implementation and Enforcement
- Contact Information
- Appendix – List of contaminants and other adulterating substances in foods
Summary
Health Canada's Food Directorate is proposing changes to the List of contaminants and other adulterating substances in foods as part of the Department's modernization of Part B of the Food and Drug Regulations (Regulations). The amendments to modernize Part B are proposed as the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Standards, Microbiological Criteria and Methods of Analysis or FoodFootnote 1.
Prior to May 2016, maximum levels pertaining to certain contaminants in foods were prescribed in Table I of Division 15 of the Regulations. Sections B.01.046 and B.01.047 were setting out prohibitions and exemptions to the prohibitions with respect to adulterants in foods.
In May 2016, amendments to the Food and Drug Regulations were made that modernized and rendered more efficient the setting of regulatory limits and prohibitions for contaminants and other adulterating substances in food. These amendments consolidated the prohibitions and maximum levels (MLs) previously set out in sections B.01.046 and B.01.047 and Table I of Division 15 of the Regulations into the List of contaminants and other adulterating substances in foods. Incorporating by reference this list allows the Department to administratively modify the list based on current science and to respond in a timely manner to emerging issues that can have an impact on the health and safety of consumers.
These regulations are proposing significant amendments to Part B of the Regulations and include introducing modernized frameworks for setting, and updating the regulations for food compositional standards, microbiological criteria and official methods of analysis, as well as continuing the modernization of the food additives framework. As a result, the food compositional standards would be repealed from the Regulations and incorporated by reference into the Regulations through a new document entitled the Food Compositional Standards Document. The proposed regulations would also amend, among other provisions, provisions in Divisions 7, 9, 15 and 25 in Part B of the Regulations.
As a consequence to the modernization work, Health Canada intends to modify the List of contaminants and other adulterating substances in foods to reflect the proposed amendments to the forementioned provisions.
This Notice also contains the new list entries added as a consequence to the amendments of provisions from Division 7, 9 and 25. Comments and questions on the current proposal can be sent to the Food Directorate using the contact information provided at the end of this Notice until February 2, 2024.
In general, Health Canada's intent is to continue the consolidation of the rules pertaining to contaminants in foods into the list. This Notice, however, does not change existing rules as described in the list in the appendix.
Proposed Revisions to the List of contaminants and other adulterating substances in foods
A minor update to the title of the French List of contaminants and other adulterating substances in foods is proposed. The title would be updated to "Liste des contaminants et autres substances adultérantes dans les aliments".
The proposed revisions to the List of contaminants and other adulterating substances in foods reflect the addition of a new, non-regulatory column added to Part 1 and Part 2 of the list. This new column titled "Notes" would be used to provide administrative information about the contaminants or the adulterating substances entries such as the hyperlink to the Notice of Modification (NOM) associated with an entry, when applicable. Since this is a non-regulatory column it would not contain regulatory information related to the contaminants or the adulterating substances. The addition of the new non-regulatory column was initially proposed for the List of permitted food additives, and was consulted on as part of Health Canada's Proposal to Modernize the Structure and Titles of the Lists of Permitted Food Additives (NOP-0038). Given that comments received on NOP-0038 were supportive of the proposed changes, the Food Directorate is also proposing the addition of the new, non-regulatory column for the List of contaminants and other adulterating substances in foods.
Provisions in Divisions 7 and 9 that prohibit the sale of a dressing or certain fats and oils that contain more than 5% of the contaminant C22 Monoenoic Fatty Acid, and one provision in Division 25 that prohibits the sale or advertisement for sale of an infant formula that contains more than 1 kilocalorie from C22 Monoenoic Fatty Acid, would be repealed from the Regulations and the maximum levels would be moved to the List of contaminants and other adulterating substances in foods which is incorporated by reference under Division 15 of the FDR on an ambulatory basis.
Rationale
The proposed revisions to the List of contaminants and other adulterating substances in foods are consequential in nature, reflecting proposed amendments being pursued as part of the proposed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria, and Methods of Analysis for Food.
Implementation and Enforcement
The proposed changes will be effective on the day in which they are published in the List of contaminants and other adulterating substances in foods. This will be announced via a Notice of Modification which will be published on the Government of 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 to foods.
Contact Information
For additional information or to submit comments related to this proposal, please contact:
Bureau of Policy, Intergovernmental and International Affairs
Food Directorate
Health Products and Food Branch
Health Canada
251 Sir Frederick Banting Driveway
Tunney's Pasture
Ottawa, ON
K1A 0K9
Address locator: 2204C
Email: bpiia-bpaii@hc-sc.gc.ca
If communicating by e-mail, please use the words "List of contaminants and other adulterating substances in foods (NOP/ADP C-2023-1)" in the subject line of your e-mail. The Food Directorate is able to consider information received by February 2, 2024, 90 days from the date of this posting.
Appendix – List of contaminants and other adulterating substances in foods
Item | Column 1 Substance |
Column 2 Food |
Notes |
---|---|---|---|
C.1 | Chlorinated dibenzo-p-dioxins, except 2,3,7,8-tetrachlorodibenzo-p-dioxin | All foods | n/a |
C.2 | Cinnamyl anthranilate | All foods | n/a |
C.3 | Coumarin, an extract of tonka beans, the seed of Dipteryx odorata Willd. or Dipteryx oppositifolia Willd. | All foods | n/a |
D.1 | Dihydrosafrole | All foods | n/a |
E.1 | Ethylene thiourea | All foods, except those foods set out in column 2 of item E.1 of Part 2 of this list. | n/a |
F.1 | Fatty acids and their salts containing chick-edema factor or other toxic factors | All foods | n/a |
I.1 | Isosafrole | All foods | n/a |
M.1 | Mineral oil | All foods, except those foods set out in column 2 of item M.1 of Part 2 of this list. | n/a |
O.1 | Oil of American sassafras from Sassafras albidum (Nutt). Nees | All foods | n/a |
O.2 | Oil of Brazilian sassafras from Ocotea cymbarum H.B.K. | All foods | n/a |
O.3 | Oil of camphor sassafrassy from Cinnamomum camphorum Sieb. | All foods | n/a |
O.4 | Oil of micranthum from Cinnamomum micranthum Hayata | All foods | n/a |
O.5 | Oil, extract or root of calamus from Acorus calamus L. | All foods | n/a |
P.1 | Paraffin wax | All foods, except chewing gum with a paraffin wax base | n/a |
P.2 | Partially hydrogenated oils (PHOs), a fat or oil that is hydrogenated and has an iodine value of greater than 4 | All foods | NOM/ADM-C-2022-1 NOM/ADM-C-2017-3 |
P.3 | Petrolatum | All foods | n/a |
S.1 | Safrole | All foods | n/a |
T.1 | 2,3,7,8-Tetrachlorodibenzo-p-dioxin | All foods, except those foods set out in column 2 of item T.1 of Part 2 of this list. | n/a |
Item | Column 1 Substance |
Column 2 FoodFootnote 1 |
Column 3 Maximum levelFootnote 2 |
Notes |
---|---|---|---|---|
A.1 | Aflatoxin | Nut; Nut products |
15 ppb of the nut meat portion |
n/a |
A.2 | Arsenic, inorganic (sum of arsenite (As III) and arsenate (As V)) | (a) |
(a) |
|
(b) |
(b) |
|||
(c) |
(c) |
|||
(d) |
(d) |
|||
(e) |
(e) |
|||
A.3 | Arsenic, total | (a) |
(a) |
|
(b) |
(b) |
n/a |
||
(c) |
(c) |
n/a |
||
(d) |
(d) |
|||
C.1 | C22 Monoenoic fatty acids | (a) |
(a) |
n/a |
(b) |
(b) |
n/a |
||
E.1 | Ethylene thiourea | Cereals; Fruits; Vegetables |
0.05 ppm |
n/a |
F.1 | Fluoride | (a) |
(a) |
n/a |
(b) |
(b) |
n/a |
||
F.2 | Free gossypol | Cottonseed flour |
450 ppm |
n/a |
G.1 | Glycoalkaloids, total (sum of alpha-solanine and alpha-chaconine) | Potato tubers |
200 ppm |
|
L.1 | Lead | (a) |
(a) |
|
(b) |
(b) |
n/a |
||
(c) |
(c) |
n/a |
||
(d) |
(d) |
n/a |
||
(e) |
(e) |
|||
(f) |
(f) |
|||
(g) |
(g) |
n/a |
||
(h) |
(h) |
|||
(i) |
(i) |
n/a |
||
M.1 | Mineral oil | Foods requiring the use of mineral oil as part of good manufacturing practices |
3,000 ppm |
n/a |
P.1 | Patulin | Apple juice; Unfermented apple cider |
50 ppb in the food as consumed |
|
T.1 | 2,3,7,8-Tetrachlorodibenzo-p-dioxin | Fish |
20 ppt |
n/a |
T.2 | Tin | Canned foods |
250 ppm |
n/a |
T.3 | Total extractable cyanide | Apricot kernels sold for human consumption |
20 ppm |
|
|
Footnotes
- Footnote 1
-
Consultation on the proposed Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food, pre-published in the Canada Gazette, Part I, on November 4, 2023
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