Modification to the List of Contaminants and other Adulterating Substances in Foods as part of the modernization of Part B of the Food and Drug Regulations

Reference number: M-CON-RM-1
December 18, 2024

Background

In May 2016, amendments to the Food and Drug Regulations (FDR) 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 FDR into the List of Contaminants and other Adulterating Substances in Foods (List). Incorporating by reference this List allows the Department to administratively modify it 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.

On November 4, 2023, Health Canada pre-published in the Canada Gazette, Part I proposed amendments to the FDR. This was followed by the final publication of the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food in the Canada Gazette, Part II on December 18, 2024. These regulations have led to significant amendments to Part B of the FDR and included modernized frameworks for setting, and updated the FDR for food compositional standards, microbiological criteria and official methods of analysis, as well as continuing the modernization of the food additives framework. These regulations also include amendments to provisions in Divisions 7, 9 and 15 of Part B, which have resulted in consequential modifications in the List of contaminants and other adulterating substances in foods.

Issue

As a consequence to the modernization work, it was necessary for Health Canada to modify the List to reflect the amendments to the forementioned provisions.

Rationale

The Food and Nutrition Directorate has modified the English and the French versions of the List to reflect and align with amendments to certain provisions in Divisions 7, 9, and 15 of Part B of the FDR following the publication of the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food.

The Directorate took into account scientific, policy, and legal perspectives, along with feedback from the public consultations on the proposed changes, to revise and update the list.

The updated List in the appendix incorporates the proposed changes outlined in the Notice of Proposal (NOP/ADP C-2023-1), which include:

Adding a non-regulatory column titled "Notes" to provide administrative information about the contaminants or the adulterating substances entries
Restoring alphabetical order and implementing a new numbering format
Adding language that reflects the amended provisions in Divisions 7 and 9 of the FDR regarding the contaminant C₂₂ Monoenoic Fatty Acids (Item C.1 of Part 2)
Revising the text for improved clarity in several entries (items E.1, M.1 and T.1 in Part 1 and A.2, A.3, F.1, L.1, M.1 and P.1 in Part 2 of the List)

These changes are consequential in nature to the amendments to the FDR and no not result in changes to existing rules.

Consultation

In November 2023, Health Canada's Food and Nutrition Directorate (formerly named Health Canada's Food Directorate) issued the 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 (NOP/ADP C-2023-1) and initiated a 75-day period consultation. The Notice outlined proposed modifications to the List which were part of the modernization effort to have the List reflect and align with the amendments to certain provisions in Divisions 7, 9, and 15.

The following section provides a summary of the comments received from stakeholders concerning proposed modifications to the List followed by Health Canada's responses.

Summary of comments and Health Canada's responses

Four food industry associations provided feedback during the consultation period.

One offered support for the proposed modifications.

Stakeholder comment (transition period):

Three associations shared concerns regarding the proposed modifications becoming effective at the same time as the notice of modification is published, and requested a transition period.

Health Canada response:

The MLs for C₂₂ monoenoic fatty acids in certain foods are being repealed from Divisions 7, 9 and 15 of Part B of the FDR and moved to the List. This consolidates these MLs into a single list, without making changes to the existing limits. The other proposed modifications to the List are also non-technical in nature and support its modernization. Therefore, a transition period is not needed as no technical changes to the existing MLs, nor new MLs, are being proposed.

Stakeholder Comment (international alignment):

One industry group commented that Canada's regulations for chemical contaminants are outdated and misaligned with those of other jurisdictions worldwide.

Health Canada response:

Although MLs are one way to manage risks associated with chemical contaminants in food, other approaches include removal of the contaminated food from retail shelves or corrective action at the farm or manufacturing level. In Canada, many chemicals are present in foods at low levels and do not pose a safety concern, therefore MLs are not required. Foods sold in Canada are subject to continual oversight that involves:

Monitoring and surveillance of a wide range of chemical contaminants in foods sold in Canada.
Data review and risk assessments using Canadian-specific information (e.g. food consumption patterns).
Application of Section 4(1)(a) and (d), Part I, of the Food and Drugs Act, which states that no person shall sell an article of food that has in or on it any poisonous or harmful substance or is adulterated.

If a potential risk to human health is identified by Health Canada in any of the above activities, the most appropriate risk management measures would be put in place. New or updated prohibitions or MLs proposed by the Department will be the subject of separate proposals posted for public consultation on the Department's website and supported by scientific health risk assessments. In such situations, transition periods would be considered on a case-by-case basis and in consideration of industry feedback.

In light of the absence of new information from stakeholders that would necessitate a revision of the proposal, the List has been modernized as proposed (see Appendix).

Implementation and enforcement

The modifications included in the List shown in the Appendix came into force December 18, 2024, the day they were 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 and Drugs Act and its associated regulations with respect to foods.

Contact information

Health Canada's Food and Nutrition Directorate is committed to reviewing new scientific information on the chemical safety of foods. Anyone wishing to submit an inquiry or new scientific information on any contaminants or adulterating substances in foods may do so by regular mail or email. If communicating by e-mail, please use the words "List of Contaminants and other Adulterating Substances in Foods (M-CON-RM-1)" in the subject line of your e-mail.

Bureau of Chemical Safety
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2202C
Tunney's Pasture
Ottawa ON K1A 0K9
Email: bcs-bipc@hc-sc.gc.ca

Appendix – List of Contaminants and other Adulterating Substances in Foods

Part 1
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

Part 2
Item	Column 1 Substance	Column 2 Food^{Footnote 1}	Column 3 Maximum level^{Footnote 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) Fruit juice, except grape juice; Fruit nectar, except grape nectar	(a) 0.01 ppm in the food as consumed	NOM/ADM C-2022-3
		(b) Grape juice; Grape nectar	(b) 0.03 ppm in the food as consumed	NOM/ADM C-2022-3
		(c) Husked (brown) rice	(c) 0.35 ppm	NOM/ADM C-2020-1
		(d) Polished (white) rice	(d) 0.2 ppm	NOM/ADM C-2020-1
		(e) Rice-based foods intended specifically for infants and young children	(e) 0.1 ppm	NOM/ADM C-2022-2
A.3	Arsenic, total	(a) Beverages, except fruit juice, fruit nectar, grape juice and grape nectar	(a) 0.1 ppm in the food as consumed	NOM/ADM C-2022-3 NOM/ADM C-2020-2
		(b) Edible bone meal	(b) 1 ppm	n/a
		(c) Fish protein (as defined in section 18.1.5 of Volume 18 of the Food Compositional Standards Document)	(c) 3.5 ppm	n/a
		(d) Water in sealed containers	(d) 0.01 ppm	NOM/ADM-C-2017-1
C.1	C₂₂ Monoenoic fatty acids	(a) Cooking oils; Dressings; Foods that resemble margarine or shortening; Margarine; Salad oils; Simulated dairy products; Shortening	(a) 5% of the total amount of fatty acids in the food	n/a
C.1	C₂₂ Monoenoic fatty acids	(b) Infant formula	(b) 1 kilocalorie from C₂₂ monoenoic fatty acids per 100 available kilocalories in the food as consumed	n/a
C.2	Cyanide, total extractable	Apricot kernels sold for human consumption	20 ppm	NOM/ADM C-2019-1
E.1	Ethylene thiourea	Cereals; Fruits; Vegetables	0.05 ppm	n/a
F.1	Fluoride	(a) Edible bone meal	(a) 650 ppm	n/a
F.1	Fluoride	(b) Fish protein (as defined in section 18.1.5 of Volume 18 of the Food Compositional Standards Document)	(b) 150 ppm	n/a
G.1	Glycoalkaloids, total (sum of alpha-solanine and alpha-chaconine)	Potato tubers	200 ppm	NOM/ADM C-2018-2
G.2	Free gossypol	Cottonseed flour	450 ppm	n/a
L.1	Lead	(a) Beverages, except fruit juice and fruit nectar	(a) 0.2 ppm in the food as consumed	NOM/ADM C-2020-2
		(b) Condensed milk; Evaporated milk	(b) 0.15 ppm	n/a
		(c) Edible bone meal	(c) 10 ppm	n/a
		(d) Fish protein (as defined in section 18.1.5 of Volume 18 of the Food Compositional Standards Document)	(d) 0.5 ppm	n/a
		(e) Fruit juice; Fruit nectar	(e) 0.05 ppm in the food as consumed	NOM/ADM C-2020-2 NOM/ADM-C-2017-2
		(f) Infant formula	(f) 0.01 ppm in the food as consumed	NOM/ADM C-2020-2
		(g) Tomato paste; Tomato sauce	(g) 1.5 ppm	n/a
		(h) Water in sealed containers	(h) 0.01 ppm	NOM/ADM-C-2017-2
		(i) Whole tomatoes	(i) 0.5 ppm	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	NOM/ADM C-2020-2 NOM/ADM C-2018-1
T.1	2,3,7,8-Tetrachlorodibenzo-p-dioxin	Fish	20 ppt	n/a
T.2	Tin	Canned foods	250 ppm	n/a
1 Maximum levels also apply to the food when it is used as an ingredient in other foods. Return to footnote 1 referrer 2 "Parts per million" or "ppm" has the same meaning as in subsection B.01.001(1) of the Food and Drug Regulations. "Parts per billion" or "ppb" means parts per billion by weight unless otherwise stated. "Parts per trillion" or "ppt" means parts per trillion by weight unless otherwise stated. Return to footnote 2 referrer

Page details

Date modified:: 2024-12-18

Language selection

Search