Regulations Amending Certain Department of Health Regulations (Miscellaneous Program): SOR/2026-113

Canada Gazette, Part II, Volume 160, Number 12

Registration
SOR/2026-113 June 4, 2026

FOOD AND DRUGS ACT
PEST CONTROL PRODUCTS ACT
ASSISTED HUMAN REPRODUCTION ACT
HUMAN PATHOGENS AND TOXINS ACT
CANADA CONSUMER PRODUCT SAFETY ACT
CANNABIS ACT

P.C. 2026-553 June 4, 2026

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) under

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

Food and Drugs Act

Food and Drug Regulations

1 Subsection B.01.454(4) of the French version of the Food and Drug Regulations footnote 1 is replaced by the following:

(4) Pour l’application du prĂ©sent article, afin d’établir si une version du tableau de la valeur nutritive ne peut ĂŞtre prĂ©sentĂ©e conformĂ©ment au prĂ©sent règlement sur 15 % ou moins de la surface exposĂ©e disponible du produit prĂ©emballĂ©, il n’est tenu compte que des renseignements qui doivent figurer dans le tableau aux termes du prĂ©sent règlement.

2 Subsection B.01.461(4) of the French version of the Regulations is replaced by the following:

(4) Pour l’application du prĂ©sent article, afin d’établir si une version du tableau de la valeur nutritive ne peut ĂŞtre prĂ©sentĂ©e conformĂ©ment au prĂ©sent règlement sur 15 % ou moins de la surface exposĂ©e disponible du produit prĂ©emballĂ©, il n’est tenu compte que des renseignements qui doivent figurer dans le tableau aux termes du prĂ©sent règlement.

3 Subsection B.29.009(4) of the French version of the Regulations is replaced by the following:

(4) Pour l’application du prĂ©sent article, afin d’établir si une version du tableau des renseignements sur les aliments supplĂ©mentĂ©s ne peut ĂŞtre prĂ©sentĂ©e conformĂ©ment au prĂ©sent règlement sur 15 % ou moins de la surface exposĂ©e disponible de l’aliment supplĂ©mentĂ©, il n’est tenu compte que des renseignements qui doivent figurer dans le tableau aux termes du prĂ©sent règlement.

4 Subsection B.29.029(3) of the French version of the Regulations is replaced by the following:

(3) Le prĂ©sent article ne s’applique pas Ă  la marque ou au nom du produit de l’aliment supplĂ©mentĂ©.

5 Section C.01.010 of the French version of the Regulations is replaced by the following:

C.01.010 S’il y a lieu de fournir le mode d’emploi appropriĂ© pour l’utilisation sĂ©curitaire d’une drogue Ă  usage parentĂ©ral ou d’une drogue sur ordonnance qui sert au traitement ou Ă  la prophylaxie d’une maladie, d’un dĂ©sordre ou d’un Ă©tat physique anormal Ă©numĂ©rĂ©s Ă  l’annexe A.1 de la Loi, les Ă©tiquettes de la drogue, notamment toute notice d’accompagnement et toute documentation supplĂ©mentaire sur l’emploi de la drogue qui est fournie sur demande, peuvent faire mention de cette maladie, de ce dĂ©sordre ou de cet Ă©tat, et la drogue est exemptĂ©e Ă  cet Ă©gard de l’application des paragraphes 3(1) et (2) de la Loi.

6 (1) Paragraph C.01.021(c) of the French version of the Regulations is replaced by the following:

(2) Subparagraph C.01.021(c)(ii) of the English version of the Regulations is replaced by the following:

7 Subparagraph C.01.062(5)(e)(i) of the English version of the Regulations is replaced by the following:

8 The heading before section C.01.131 and sections C.01.131 to C.01.133 of the Regulations are repealed.

9 Section C.01.134 of the English version of the Regulations is replaced by the following:

C.01.134 No person shall sell coated tablets containing potassium salts, with or without thiazide diuretics, unless the inner label or the package insert carries the following statement:

“WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when suitable dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occurs.”

10 Section C.01.600 of the French version of the Regulations is replaced by the following:

C.01.600 Il est interdit de vendre pour usage vĂ©tĂ©rinaire une drogue Ă©numĂ©rĂ©e au tableau des doses limites des drogues pour adultes, sauf une drogue prĂ©sentĂ©e sous une forme qui ne convient pas Ă  l’usage humain, si les Ă©tiquettes intĂ©rieure et extĂ©rieure de cette drogue ne portent pas toutes deux la mention « Pour usage vĂ©tĂ©rinaire seulement Â» ou « Usage vĂ©tĂ©rinaire seulement Â».

11 Subsections C.02.020(3) and (4) of the Regulations are replaced by the following:

(3) Every fabricator shall maintain the following on their premises:

(4) Every person who packages a drug shall maintain the following on their premises:

12 Paragraph C.05.003(b) of the Regulations is replaced by the following:

13 The portion of section D.01.006 of the French version of the Regulations before paragraph (a) is replaced by the following:

D.01.006 Est interdite sur l’étiquette ou dans l’annonce d’un aliment toute allĂ©gation concernant l’action ou les effets d’une vitamine que contient l’aliment, sauf celle indiquant que la vitamine :

14 The portion of section D.02.004 of the French version of the Regulations before paragraph (a) is replaced by the following:

D.02.004 Est interdite sur l’étiquette ou dans l’annonce d’un aliment toute allĂ©gation concernant l’action ou les effets d’un minĂ©ral nutritif que contient l’aliment, sauf celle indiquant que le minĂ©ral nutritif :

15 The French version of the Regulations is amended by replacing “l’un ou l’autre” with “l’un”, with any necessary modifications, in the following provisions:

16 The French version of the Regulations is amended by replacing “indications” with “indication”, with any necessary modifications, in the following provisions:

Biocides Regulations

17 Paragraph 69(b) of the French version of the Biocides Regulations footnote 2 is replaced by the following:

Assisted Human Reproduction Act

Safety of Sperm and Ova Regulations

18 Paragraph 29(1)(a) of the French version of the Safety of Sperm and Ova Regulations footnote 3 is replaced by the following:

19 Paragraph 66(1)(a) of the French version of the Regulations is replaced by the following:

20 Paragraph 74(1)(a) of the French version of the Regulations is replaced by the following:

Human Pathogens and Toxins Act

Human Pathogens and Toxins Regulations

21 Paragraph 20(a) of the English version of the Human Pathogens and Toxins Regulations footnote 4 is replaced by the following:

Canada Consumer Product Safety Act

Consumer Chemicals and Containers Regulations, 2001

22 (1) The portion of item 4 of the table to subsection 1(2) of the Consumer Chemicals and Containers Regulations, 2001 footnote 5 in column 2 is replaced by the following:
Item*

Column 2

Standard or Test

4(4) ASTM Standard D1293-99(2005), entitled Standard Test Methods for pH of Water, approved December 10, 1999
(2) The portion of item 19 of the table to subsection 1(2) of the Regulations in column 2 is replaced by the following:
Item*

Column 2

Standard or Test

19(19) CAN/ULC Standard S504–12–R2018, Third Edition, entitled Dry Chemical Fire Extinguishers, published April 13, 2012

Glazed Ceramics and Glassware Regulations

23 The French version of the Glazed Ceramics and Glassware Regulations footnote 6 is amended by replacing “limite de lixiviabilitĂ©” with “limite de la migration chimique” in the following provisions:

Mattresses Regulations

24 Section 2 of the Mattresses Regulations footnote 7 is replaced by the following:

Combustion resistance

2 When a mattress is tested in accordance with the Canadian General Standards Board standard CAN/CGSB-4.2 No. 27.7-2023, entitled Textile test methods — Combustion resistance of mattresses — Cigarette test, published in January 2023, melting or charring of the surface that extends more than 50 mm in any horizontal direction from the nearest point of the original location of the test cigarette, or continuing combustion in the mattress assembly 10 minutes after the cigarette has extinguished, must not be exhibited in more than one test specimen.

Lighters Regulations

25 The definition CFR in section 1 of the Lighters Regulations footnote 8 is replaced by the following:

CFR
means Title 16 of the Code of Federal Regulations of the United States, revised as of January 1, 2025. (CFR)

26 Paragraph 14(2)(b) of the French version of the Regulations is replaced by the following:

Residential Detectors Regulations

27 (1) The portion of item 1 of the table to section 1 of the Residential Detectors Regulations footnote 9 in column 2 is replaced by the following:
Item

Column 2

Standard

1 CAN/ULC-529, Smoke Detectors for Fire Alarm Systems, as amended from time to time
(2) The portion of item 2 of the table to section 1 of the Regulations in column 2 is replaced by the following:
Item

Column 2

Standard

2 CAN/ULC-530, Standard for Heat Detectors for Fire Protective Signaling Systems, as amended from time to time
(3) The portion of item 3 of the table to section 1 of the Regulations in column 2 is replaced by the following:
Item

Column 2

Standard

3 CAN/ULC-531, Standard for Smoke Alarms, as amended from time to time
28 The portion of items 1 and 2 of the table to section 2 of the Regulations in column 2 is replaced by the following:
Item

Column 2

Standard

1 CAN/ULC-525, Audible Signaling Devices for Fire Alarm and Signaling Systems, Including Accessories, as amended from time to time
2 CAN/ULC-527, Standard for Control Units and Accessories for Fire Alarm Systems, as amended from time to time

Cannabis Act

Cannabis Regulations

29 Sections 360 and 362 of the Cannabis Regulations footnote 10 are repealed.

Industrial Hemp Regulations

30 Subsection 26(2) of the French version of the Industrial Hemp Regulations footnote 11 is replaced by the following:

Variété et matériel génétique autorisés

(2) Le sélectionneur de plantes qui est titulaire d’une licence autorisant la culture ou la multiplication ne peut que cultiver ou multiplier une variété indiquée par sa licence ou que du matériel génétique dont le nom ou le numéro est indiqué par sa licence.

Coming into Force

31 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Between 2016 and 2020, the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) identified a number of administrative and technical issues with the Food and Drug Regulations. Health Canada committed to address certain issues raised by the SJCSR through these miscellaneous amendments regulations.

Health Canada and Public Health Agency of Canada (PHAC) officials also identified a number of minor regulatory issues through a review process completed as part of Health Canada’s good regulatory stewardship practices. Health Canada is proactively addressing these non-substantive issues through miscellaneous amendments to eleven regulations: the Cannabis Regulations, the Food and Drug Regulations, the Biocides Regulations, the Residential Detectors Regulations, the Consumer Chemicals and Containers Regulations, 2001, the Mattresses Regulations, the Lighters Regulations, the Glazed Ceramics and Glassware Regulations, the Safety of Sperm and Ova Regulations, the Human Pathogens and Toxins Regulations and the Industrial Hemp Regulations are being made to address the identified issues.

Objective

The amendments aim to

Description and rationale

The following amendments repeal obsolete or spent regulatory provisions that have no current application.

Cannabis Regulations

Repeal sections 360 and 362 of the Cannabis Regulations as the transition period has ended and the provisions no longer apply.

Food and Drug Regulations

Repeal section C.01.131 of the Food and Drug Regulations, since there is now a premarket evaluation system for all drugs under the Regulations. Therefore, there is no need for this provision to explicitly specify the labelling warnings required in the case of Aminopyrine or Dipyrone for oral or parenteral use. Repeal sections C.01.132 and C.01.133, as they are directly linked to section C.01.131.

Make consequential amendments to paragraph C.05.003(b) of the Food and Drug Regulations to reflect the repeal of sections C.01.131, C.01.132 and C.01.133.

The following amendments correct discrepancies between the French and English versions of the Regulations to improve clarity and reduce the risk of inconsistent interpretation.

Food and Drug Regulations

Amend the French version of subsections B.01.467(1) and (3), B.29.018(1) and (4) of the Food and Drug Regulations to replace “indications” with “indication” to align with the English version.

Amend the French version of subsections B.01.454(4), B.01.461(4) and B.29.009(4) of the Food and Drug Regulations to replace “renseignements exigĂ©s par le prĂ©sent règlement” with “renseignements qui doivent figurer dans le tableau aux termes du prĂ©sent règlement” to align with “required by these Regulations to be included in that table” in the English version.

Amend the French version of section C.01.010 of the Food and Drug Regulations to include “utilisation sĂ©curitaire” to represent the concept of “safe use” in both English and French versions. This addresses the concern raised by the SJCSR.

Amend the English version of subparagraph C.01.062(5)(e)(i) of the Food and Drug Regulations to replace “are suitable” with “allow” to align with the use of the word “permettent” in the French version. This addresses the concern raised by the SJCSR.

Amend the French version of sections D.01.006 and D.02.004 of the Food and Drug Regulations to replace “annonces” with the singular “annonce” to harmonize with other provisions of Parts B and D of the Food and Drug Regulations, all of which use the singular “annonce.

Safety of Sperm and Ova Regulations

Amend the French version of paragraphs 29(1)(a), 66(1)(a), and 74(1)(a) of the Safety of Sperm and Ova Regulations to replace “donneur” with “receveur” to align with the English version.

Lighters Regulations

Amend the French version of paragraph 14(2)(b) of the Lighters Regulations to replace “utiliser une cartouche de recharge convenant au rĂ©servoir de combustible;” with “assurer un accouplement correct entre la cartouche de recharge et le rĂ©servoir de combustible du briquet” to align with the English version. This resolves the inconsistency between the English and French versions of this provision.

Human Pathogens and Toxins Regulations

Amend the English version of paragraph 20(a) of the Human Pathogens and Toxins Regulations from new information “not being available for consideration” to new information which “could not be taken into consideration” to align with the French version. This resolves the inconsistency between the English and French versions of this provision.

Industrial Hemp Regulations

Amend the French version of subsection 26(2) of the Industrial Hemp Regulations to add the term “plant breeder” to align with the English version. This resolves the inconsistency between the English and French versions of this provision.

Biocides Regulations

Amend the French version of paragraph 69(b) of the Biocides Regulations to replace the reference to “de la Loi sur les produits antiparasitaires” with a reference to “du Règlement sur les aliments et drogues” in order to align with the English version.

The following amendments correct discrepancies between the use of certain terms to increase consistency in interpretation.

Food and Drug Regulations

Amend the French version of subsection B.29.029(3) of the Food and Drug Regulations to replace “nom de produit” with “nom du produit” to be consistent with terminology used elsewhere within Part B.

The following amendments harmonize terms with those used in the enabling statute and/or related regulations to improve alignment and clarity.

Glazed Ceramics and Glassware Regulations

Amend the French version of sections 2, 3, and 4 of the Glazed Ceramics and Glassware Regulations to replace the term “limite de lixiviabilitĂ©” with “limite de la migration chimique” to align with the English terminology used in these and other regulations under the Canada Consumer Product Safety Act.

The following amendments improve clarity for various provisions to facilitate consistent interpretation of the regulations.

Food and Drug Regulations

Amend the French version of paragraph C.01.021(c) of the Food and Drug Regulations to replace the word “convenables” with “appropriĂ©es.” This addresses the concern raised by the SJCSR.

Amend the English version of subparagraph C.01.021(c)(ii) of the Food and Drug Regulations to remove the word “suitable,” as it is unnecessary and aligns with the French version. This addresses the concern raised by the SJCSR.

Amend the French version of section C.01.600 of the Food and Drug Regulations to replace “impropre” with “qui ne convient pas” as used in paragraph C.01.604(b). This addresses the concern raised by the SJCSR.

Amend the English version of section C.01.134 of the Food and Drug Regulations to replace “adequate” with “suitable,” since it is the health care practitioner and not the Minister who is making the assessment and only the practitioner knows what is “suitable” for the patient. In the French version, the notion of “suitable” is already present via the term “convenablement.” This addresses the concern raised by the SJCSR.

Amend the English version of subsection C.02.020(3) of the Food and Drug Regulations to clarify what information fabricators must maintain on their premises, including written specifications for all raw materials, evidence demonstrating that the testing of those raw materials was performed according to section C.02.009, and the results of those tests. Amend the French version of subsection C.02.020(3) of the Food and Drug Regulations to clarify what information fabricators must maintain on their premises, including “des spĂ©cifications Ă©crites pour toutes les matières premières, une preuve attestant que les analyses sur ces matières premières ont Ă©tĂ© effectuĂ©es conformĂ©ment aux exigences Ă©noncĂ©es Ă  l’article C.02.009; et les rĂ©sultats de ces analyses.” This addresses the concern raised by the SJCSR by reducing the subjectivity and vagueness of the existing provision.

Amend the English version of subsection C.02.020(4) of the Food and Drug Regulations to clarify what information drug packagers must maintain on their premises, including “written specifications for all packaging materials, evidence demonstrating that the examination or testing of those packaging materials was performed in accordance with the requirements set out in section C.02.016, and the results of those tests or examinations.” These amendments address the subjectivity and vagueness of the existing provision raised by the SJCSR.

Amend the French version of subsection C.02.020(4) of the Food and Drug Regulations to clarify what information the drug packager must maintain on their premises, including “les spĂ©cifications Ă©crites pour tous les matĂ©riels d’emballage, une preuve attestant que les analyses ou l’examen de ces matĂ©riels d’emballage ont Ă©tĂ© effectuĂ©s conformĂ©ment aux exigences Ă©noncĂ©es Ă  l’article C.02.016, et les rĂ©sultats de ces analyses ou de ces examens.” These amendments address the subjectivity and vagueness of the existing provision raised by the SJCSR.

Amend the French version of the following provisions of the Food and Drug Regulations to replace the dated “l’un ou l’autre” with the modern formulation “l’un” found in other regulatory provisions:

The following amendments update references to documents incorporated by reference where the changes are non-substantive.

Lighters Regulations

Amend the English and French definitions for “CFR” in section 1 of the Lighters Regulations to replace the reference to “Title 16 of the Code of Federal Regulations of the United States, revised as of January 1, 2004” with its latest annual edition published on January 1, 2025. Updating the reference to the latest published edition does not have any impact on the requirements of the Regulations.

Mattresses Regulations

Amend the English and French versions of section 2 of the Mattresses Regulations to replace the reference to CAN/CGSB-4.2 No. 27.7-2013 with the latest version CAN/CGSB-4.2 No. 27.7-2023, published in January 2023. Updating the reference to the latest published edition does not have any impact on the requirements of the Regulations.

Consumer Chemicals and Containers Regulations, 2001

Amend the English and French versions of the table to subsection 1(2), item 4 of the Consumer Chemicals and Containers Regulations, 2001 to reflect the latest reaffirmed date for the referenced ASTM Standard D1293-99. Amend the table in subsection 1(2), item 19 of the Consumer Chemicals and Containers Regulations, 2001 in both English and French versions to correct the publication date of the CAN/ULC Standard S504-12. Updating the reference to the latest published edition does not have any impact on the requirements of the Regulations.

Residential Detectors Regulations

Amend the English and French versions of the section 1 and 2 tables of the Residential Detectors Regulations to update the titles of the five standards that are incorporated by reference on an ambulatory basis. Updating the titles of the standards harmonizes them with the titles of the current versions and provides clarity to stakeholders. Updating the reference to the latest published edition does not have any impact on the requirements of the Regulations.

One-for-one rule and small business lens

The one-for-one rule does not apply to these amendments, as there is no change in administrative costs or burden to business. Analysis under the small business lens determined that the amendments will not impact small businesses in Canada.

Contact

Stephanie Mangan
Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
200 Eglantine Driveway
Jeanne Mance Building, 7th Floor
Ottawa, Ontario
K1A 0K9
Telephone: 343‑550‑4584
Email: dra-arm@hc-sc.gc.ca