Regulations Amending Certain Department of Health Regulations (Miscellaneous Program): SOR/2021-46

Canada Gazette, Part II, Volume 155, Number 7

Registration

SOR/2021-46 March 18, 2021

FOOD AND DRUGS ACT

RADIATION EMITTING DEVICES ACT

CONTROLLED DRUGS AND SUBSTANCES ACT

PEST CONTROL PRODUCTS ACT

P.C. 2021-159 March 17, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Department of Health Regulations (Miscellaneous Program), pursuant to

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

Food and Drugs Act

Food and Drug Regulations

1 The portion of section A.01.050 of the Food and Drug Regulations footnote 1 before paragraph (a) is replaced by the following:

A.01.050 When taking a sample of an article under paragraph 23(2)(i) of the Act, an inspector shall inform the owner of the article or the person from whom the sample is being obtained of the inspector's intention to submit the sample or a part of it to an analyst for analysis or examination, and

2 (1) Subparagraph B.01.008.2(1)(a)(i) of the French version of the Regulations is replaced by the following:

(2) Subparagraph B.01.008.2(1)(a)(ii) of the English version of the Regulations is replaced by the following:

(3) Subsection B.01.008.2(8) of the Regulations is replaced by the following:

(8) If the English and French versions of a list of ingredients appear on the label, they shall be displayed on a continuous surface of the available display surface, but need not be on the same continuous surface of the available display surface.

3 Item 24 of the table to paragraph B.01.010(3)(a) of the English version of the Regulations is replaced by the following:
Item

Column I

Ingredient or Component

Column II

Common Name
24 mollusc the name of the mollusc

4 Paragraph (i) of the definition food allergen in subsection B.01.010.1(1) of the English version of the Regulations is replaced by the following:

5 The portion of subsection C.01.004.02(3) of the Regulations before paragraph (a) is replaced by the following:

(3) If pharmaceutical ink, a fragrance or a flavour has been added to the drug, the following expressions may be included in the list of non-medicinal ingredients to indicate that those ingredients have been added to the drug, instead of listing them individually:

6 Section C.01.609 of the French version of the Regulations is replaced by the following:

C.01.609 Malgré l'alinéa C.01.401a), l'activité d'un antibiotique en quantités dépassant 50 parties par million contenu dans un aliment médicamenté du bétail, enregistré en vertu de la Loi relative aux aliments du bétail, peut être déclarée en grammes par tonne métrique.

7 Paragraph C.01A.016(3)(a) of the Regulations is replaced by the following:

8 Subsection C.02.025(1) of the Regulations is replaced by the following:

C.02.025 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year after the expiration date of the drug unless their establishment licence specifies otherwise.

9 Paragraph C.03.312(b) of the French version of the Regulations is replaced by the following:

10 The Regulations are amended by replacing “Schedule A” with “Schedule A.1” in the following provisions:

11 The English version of the Regulations is amended by replacing “injury” with “risk” in the following provisions:

Medical Devices Regulations

12 Subsection 50(1) of the English version of the Medical Devices Regulations footnote 2 is replaced by the following:

50 (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent risk to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.

Natural Health Products Regulations

13 Paragraph 34(e) of the French version of the Natural Health Products Regulations footnote 3 is replaced by the following:

14 Section 69 of the English version of the Regulations is replaced by the following:

69 The sponsor shall notify the Minister of the date of the sale or importation of a natural health product for the purposes of a clinical trial at a clinical trial site at least 15 days before the date of that sale or importation.

15 Subsection 76(2) of the English version of the Regulations is replaced by the following:

(2) The sponsor shall maintain complete and accurate records to demonstrate that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

16 Sections 103.2 and 103.3 of the Regulations are amended by replacing “Schedule A” with “Schedule A.1”.

17 The French version of the Regulations is amended by replacing “entreposé” with “emmagasiné”, with any necessary modifications, in the following provisions:

18 The French version of the Regulations is amended by replacing “entreposage” with “emmagasinage” in the following provisions:

19 The English version of the Regulations is amended by replacing “demonstrating” with “establishing” in the following provisions:

Radiation Emitting Devices Act

Radiation Emitting Devices Regulations

20 The definition dispositif in section 2 of the French version of the Radiation Emitting Devices Regulations footnote 4 is replaced by the following:

dispositif
désigne un dispositif émettant des radiations d'une catégorie prescrite par le présent règlement; (device)

21 Section 3 of the Regulations and the heading before it are replaced by the following:

Prescription of Classes of Radiation Emitting Devices and Standards

3 (1) The classes of radiation emitting devices described in Schedule I are prescribed as classes of radiation emitting devices for the purposes of the Act.

(2) The standards set out in Schedule II for prescribed classes of radiation emitting devices are prescribed as standards regulating the design, construction or functioning of those prescribed classes of radiation emitting devices and their components.

Controlled Drugs and Substances Act

Precursor Control Regulations

22 Paragraph 10.1(b) of the Precursor Control Regulations footnote 5 is replaced by the following:

23 Paragraph 57.1(b) of the Regulations is replaced by the following:

Pest Control Products Act

Pest Control Products Regulations

24 The definition common chemical name in subsection 1(1) of the Pest Control Products Regulations footnote 6 is amended by replacing “ISO 1750-1981 (E/F)” with “ISO 1750:1981 (E/F)”.

25 Subsection 24(1) of the Regulations is amended by replacing “Schedule A” with “Schedule A.1”.

26 (1) The portion of subsection 26(3) of the English version of the Regulations before paragraph (a) is replaced by the following:

(3) Unless otherwise specified by the Minister under subsection 8(2) of the Act, if a pest control product is contained in more than one package, the outermost package that is visible under normal conditions of storage, transportation or handling must bear a label that shows all of the following information:

(2) Paragraph 26(3)(b) of the French version of the Regulations is replaced by the following:

(3) The portion of subsection 26(4) of the French version of the Regulations before paragraph (a) is replaced by the following:

(4) Le paragraphe (3) ne s'applique pas si l'emballage extérieur est transparent ou s'il permet de lire l'étiquette sur l'emballage intérieur et que celle-ci satisfait aux exigences :

27 Paragraph 64(b) of the Regulations is replaced by the following:

Coming into Force

28 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Between 2016 and 2019, the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) identified a number of administrative and technical issues with the Natural Health Products Regulations, the Regulations Amending Certain Department of Health Regulations (2017–2018 MAR), the Pest Control Products Regulations, and the Food and Drug Regulations. Health Canada committed to address certain issues raised by the SJCSR through these miscellaneous amendments regulations.

Health Canada officials also identified a number of minor issues in regulations it administers through departmental review processes completed as part of Health Canada's good regulatory stewardship practises. Health Canada is proactively addressing these non-substantive issues through these miscellaneous amendments regulations. Amendments to the Natural Health Products Regulations, the Food and Drug Regulations, the Radiation Emitting Devices Regulations, the Pest Control Products Regulations, the Precursor Control Regulations and the Medical Devices Regulations are being made to address the identified issues.

Objectives

The amendments have the following objectives:

  1. To correct discrepancies between the French and English text of the regulations to improve clarity and reduce the risk of inconsistent interpretation;
  2. To harmonize terms with those used in the enabling statute and/or related regulations to improve alignment and clarity;
  3. To correct cross-reference errors to section numbering to reduce confusion and enable regulated parties to easily find the corresponding requirements;
  4. To correct typographical or grammatical errors to improve readability of the regulations;
  5. To improve clarity for various provisions to facilitate consistent interpretation; and
  6. To correct discrepancies between the use of certain terms to increase consistency in interpretation.

Description and rationale

1. Correcting discrepancies between French and English

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

a) The following amendments address commitments made by Health Canada to resolve certain issues identified by the SJCSR:

Food and Drug Regulations:

The French version of section C.01.609 of the Food and Drug Regulations respecting veterinary drugs and the declaration of the potency of an antibiotic in medicated feed is amended to replace “tonne” with “tonne métrique” to harmonize with the English version and the correct unit of measurement (i.e. a metric tonne versus an imperial tonne).

Natural Health Products Regulations (NHPR):

The English term “establish” in subsection 76(2) of the Natural Health Products Regulations is replaced by the term “demonstrate.” This change aligns the English text with the French text of subsection 76(2) that uses the term “montrant.” It also improves consistency with the English and French versions of subsection 17(1) of the NHPR that use the terms “demonstrate” and “montrant.”

The English term “demonstrating” in paragraphs 22(1)(e), 28(f) and 32(2)(c) of the Natural Health Products Regulations is replaced with the term “establishing” to be consistent with the French text of section 50 of the NHPR.

Pest Control Products Regulations (PCPR):

The word “information” is added to the chapeau of the English version in subsection 26(3) to be consistent with the chapeaus in subsections 26(1) and (2) and with the French version.

The French version of paragraph 26(3)(b) of the Pest Control Products Regulations is amended to clarify the French text so that both language versions have the same meaning and effect with respect to labelling requirements identifying any significant risk on the outermost package of a pest control product.

The term “sur l'emballage intérieur” is added to the French version of subsection 26(4) of the PCPR to ensure consistency between the English and the French versions.

b) The following amendments address discrepancies identified by Health Canada:

Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR):

The English text of the Food and Drug Regulations, subsection C.01.001(1), paragraph C.01A.008(4)(b), and subsection C.01A.012(1) and subsection 50(1) of the Medical Devices Regulations are amended to use the concept of “risk to health” in both the English and French versions of the FDR and the MDR. Previously, the English versions referred to “injury to health” and the French versions referred to “risk to health.” The amendments improve alignment by using the concept of risk in both languages.

Food and Drug Regulations:

The word “shellfish” in columns I and II for item 24 of the table to paragraph B.01.010(3)(a) that prescribes common names and B.01.010.1(1)(i) of the English text respecting the definition of “food allergen” in the Food and Drug Regulations is replaced by “mollusc” to be consistent with the French text.

Radiation Emitting Devices Regulations (REDR):

Subsections 3(1) and 3(2) of the French text of the Radiation Emitting Devices Regulations are amended to use the term “dispositifs émettant des radiations” instead of “dispositifs.” This improves alignment with the English version of the REDR, which uses the term “radiation emitting devices.”

2. Harmonizing terms with those used in enabling statute

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

Natural Health Products Regulations (NHPR):

Paragraph 34(e) of the French version of the Natural Health Products Regulations is amended to replace the term “entreposer” with “emmagasinage” to be consistent with the language and terminology used in the regulation-making authority of paragraph 30(1)(e) of the Food and Drugs Act. This inconsistency was raised by the SJCSR and Health Canada made the commitment to correct it.

The Department found other instances in the NHPR where variations of the term “entreposé” is used. The French version of the NHPR is amended by replacing “entreposé” with “emmagasiné,” with any necessary modifications, in the following provisions:

The French version of the NHPR is amended by replacing “entreposage” with “emmagasinage,” with any necessary modifications, in the following provisions:

Radiation Emitting Devices Regulations:

The French version of the Radiation Emitting Devices Regulations is amended to replace the term “classe” with the term “catégorie” six times [once in the definition of “Dispositif,” once in the title of section 3, twice in subsection 3(1) and twice in subsection 3(2)]. The term “catégorie” is used in subsection 13(1) of the Radiation Emitting Devices Act, which sets out the Governor in Council regulation-making authorities.

3. Correcting cross-reference errors

The following amendments correct cross-reference errors to section numbering to reduce confusion and enable regulated parties to find the corresponding requirements easily.

Food and Drug Regulations:

Section A.01.050 of the Food and Drug Regulations respecting the sampling of an article, and specifically the reference to paragraph 23(1)(a) of the Act made in this section, is amended to refer to paragraph 23(2)(i) of the Food and Drugs Act. Sections of the Act were amended through the Budget Implementation Act 2019 No. 1. This amendment corrects the cross reference to the inspector power respecting the taking of samples.

Sections A.01.067 and A.01.068 respecting the advertising and sale of a drug to the general public, and C.01.010, and paragraph C.01A.002(1)(d) of the Food and Drug Regulations are amended to replace references to Schedule A with Schedule A.1. Schedule A.1 provides a list of diseases, disorders or abnormal physical states. The Schedule was renamed in the Budget Implementation Act 2019 No. 1. This amendment corrects the cross reference.

Natural Health Products Regulations:

Sections 103.2 and 103.3 of the Natural Health Products Regulations are amended to replace references to Schedule A with Schedule A.1 which refers to diseases, disorders or abnormal physical states. The Schedule was renamed in the Budget Implementation Act 2019 No. 1. This amendment corrects the cross reference.

Pest Control Products Regulations:

Subsection 24(1) of the Pest Control Products Regulations is amended to replace references to Schedule A to the Food and Drugs Act with Schedule A.1. Subsection 24(1) prescribes that a label must not represent a pest control product as a treatment, preventive or cure for any disease, disorder or abnormal physical state listed in the Food and Drugs Act. The Schedule was renamed in the Budget Implementation Act 2019 No. 1. This amendment corrects the cross reference.

Precursor Control Regulations:

Paragraphs 10.1(b) respecting a Class A precursor that is a preparation or a mixture and 57.1(b) respecting a Class B precursor that is a preparation or mixture contain a reference to a web link that does not exist. This amendment removes the reference to the spent web link.

4. Correcting grammatical or typographical errors

The following amendments correct typographical or grammatical errors to improve readability of the affected regulations.

Natural Health Products Regulations:

In section 69 of the Natural Health Products Regulations, in the English text, the word “clinic” is replaced with “clinical” to correct the typographical error.

Pest Control Product Regulations:

The reference to the international standard ISO 1750-1981 in the definition of “common chemical name,” as set out in subsection 1(1) of the Pest Control Products Regulations, is changed from a dash to a colon to read ISO 1750:1981 (E/F). The correction is to both the English and French versions of subsection 1(1).

Radiation Emitting Devices Regulations:

In the English text of the Radiation Emitting Devices Regulations, the title of section 3 is amended to remove the term “therefor” from the title to read “Prescription of Classes of Radiation Emitting Devices and Standards.”

5. Improving clarity

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

Food and Drug Regulations:

The French version of subparagraph B.01.008.2(1)(a)(i) is revised to provide the option to either use or not use a space between “Ingrédients” and the colon (“:”), and the English version of subparagraph B.01.008.2(1)(a)(ii) is amended to do the same. This will provide the option to either use or not use the space in both the English and French versions of the Regulations. This amendment is subject to the transitional provision of subsection 76(2) of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours).

The word “label” is removed from subsection B.01.008.2(8) of the Food and Drug Regulations to clarify that the list of ingredients is required to be placed on areas of the package that are included in the definition of “available display surface” (ADS), as per subsection B.01.001(1), which is broader in scope. This amendment is subject to the transitional provision of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours).

The words “or in combinations of them” and “ou des mélanges de ceux-ci,” are removed from the English and French versions of subsection C.01.004.02(3) of the FDR. These words allow non-medicinal ingredients to be listed in combinations. This amendment would ensure that medicinal and non-medicinal ingredients would not be listed together in combinations. This addresses the issue that no provisions currently exist that would permit non-medicinal ingredients to be listed in “combinations,” as raised by the SJCSR.

Amendments made in 2013 had the unintended effect of restricting sample retention to within Canada, while allowing regulated parties to retain samples for flexible periods as indicated on their establishment licence. Section C.02.025 of the FDR is amended to remove this restriction to realign with existing operational procedures and guidance documents (including GUI-0014).

The inadvertent repeal of the French version of subparagraphs C.03.312(b)(i) to (vii) of the Food and Drug Regulations in the Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) (SOR/2018-69) is corrected by reintroducing the previous version of the subparagraphs:

The issue of the repeal was raised by the SJCSR.

Pest Control Products Regulations:

In paragraph 64(b) of the Pest Control Products Regulations, which prescribes the conditions for import for research purposes, reference to the amount of product necessary to conduct the research is amended to clarify this only applies to research conducted as per the criteria of section 55.

6. Correcting terminology discrepancies

The following amendment corrects a discrepancy between the use of certain terms to increase consistency in interpretation.

Food and Drug Regulations:

Paragraph C.01A.016(3)(a) respecting the suspension of an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) incorrectly refers to “an inspector.” This amendment changes the reference from “an inspector” to “the Minister” in paragraph (a) when referring to who has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken.

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 businesses.

Analysis under the small business lens determined that the amendments will not impact small businesses in Canada.

Contact

Catherine Hudon
Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Address locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building
7th Floor, Room 705A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 343‑540‑8524
Email: hc.dra-arm.sc@canada.ca