Biocides Regulations: SOR/2024-110

Canada Gazette, Part II, Volume 158, Number 13

Registration
SOR/2024-110 May 31, 2024

FOOD AND DRUGS ACT
PEST CONTROL PRODUCTS ACT

P.C. 2024-621 May 31, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Biocides Regulations under

Biocides Regulations

Interpretation

Definitions

1 (1) The following definitions apply in these Regulations.

Act
means the Food and Drugs Act. (Loi)
active ingredient
means a component of a biocide that is directly responsible for any of the biocide’s intended effects. (ingrédient actif)
biocide
means a drug that is manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface, but it does not include
  • (a) such a drug that is manufactured, sold or represented for use exclusively on the surface of food;
  • (b) such a drug that is manufactured, sold or represented for use on the surface of a contact lens that is a medical device, as defined in section 1 of the Medical Devices Regulations; or
  • (c) such a drug that
    • (i) is manufactured, sold or represented for use on the surface of
      • (A) an invasive device, as defined in section 1 of the Medical Devices Regulations, or
      • (B) a medical device, as defined in section 1 of the Medical Devices Regulations, that is not an invasive device, as defined in that section, but is intended to channel or store gases, liquids, tissues or body fluids, for the purpose of being introduced into the body by infusion or other means of administration, and
    • (ii) is capable of destroying or irreversibly inactivating either
      • (A) all types of pathogenic micro-organisms, but not necessarily large numbers of pathogenic bacterial spores, or
      • (B) all types of micro-organisms. (biocide)
CAS registry number
means the identification number that is assigned to a chemical substance by the Chemical Abstracts Service division of the American Chemical Society. (numéro d’enregistrement CAS)
conditions of use,
in respect of a biocide, means
  • (a) its intended uses or purposes;
  • (b) the settings in which it is intended to be used;
  • (c) its risk information;
  • (d) its directions for use; and
  • (e) its directions for storage. (conditions d’utilisation)
contact information
includes civic address, except in paragraphs 32(1)(e), 49(2)(d) and 50(1)(a). (coordonnées)
expiry date,
in respect of a biocide, means the year and month in which its shelf life ends. (date limite d’utilisation)
foreign regulatory authority
means a government agency or other entity outside Canada that controls the manufacture, sale or use of biocides within its jurisdiction and that may take enforcement action to ensure that biocides marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)
formulant
means any component of a biocide other than an active ingredient or contaminant. (formulant)
import
means import for the purpose of sale. (importer)
List of Foreign Regulatory Authorities
means the document entitled List of Foreign Regulatory Authorities for Biocides that is published by the Government of Canada on its website, as amended from time to time. (Liste des autorités réglementaires étrangères)
lot number
means any combination of letters, figures or both by which a biocide can be traced in manufacture and identified in distribution. (numéro de lot)
major change
means a change, other than a change referred to in section 14, that relates to the information or material provided to the Minister in connection with a biocide and that may reasonably be expected to have a major impact on the quality of the biocide, the benefits or risks associated with the biocide or the uncertainties related to the benefits and risks, including
  • (a) a change to a method of application, unless the changed method is similar to an approved method of application for the biocide;
  • (b) the addition of a method of application, unless the new method is similar to an approved method of application for the biocide;
  • (c) the addition of a formulant, unless the formulant is replacing a similar formulant in a similar quantity in a given quantity of the biocide;
  • (d) the removal of a formulant, unless the formulant is being replaced by a similar formulant in a similar quantity in a given quantity of the biocide;
  • (e) a change to the quantity of a formulant that a given quantity of the biocide contains; and
  • (f) a change to the conditions of use of the biocide, other than
    • (i) the removal of an intended use or purpose,
    • (ii) the removal of a setting in which the biocide is intended to be used,
    • (iii) the addition of risk information,
    • (iv) a change to or the addition or removal of a direction for use, if the change, addition or removal does not require an update to the information on the biocide’s safety or effectiveness that was provided to the Minister, or
    • (v) the removal of a direction for use that is due to the removal of a method of application or a change to the biocide’s intended use or purpose. (changement majeur)
master formula,
in respect of a biocide, means a document that sets out
  • (a) the ingredients that are used in the manufacture of the biocide and the quantities of those ingredients that are required to manufacture a given quantity of the biocide;
  • (b) the specifications for the biocide;
  • (c) a detailed description of the procedures required to manufacture, package, label and store the biocide, including safety precautions and in-process controls;
  • (d) a detailed description of the methods used to test and examine the packaging material; and
  • (e) a statement of tolerances for the properties and qualities of the packaging material. (formule type)
minor change
means a change that relates to the information or material provided to the Minister in connection with a biocide and that may reasonably be expected to have a minor impact on the quality of the biocide, the benefits or risks associated with the biocide or the uncertainties related to the benefits and risks, including
  • (a) a change to the name or contact information of the holder of the market authorization for the biocide;
  • (b) a change to the biocide’s brand names;
  • (c) the removal of a method of application;
  • (d) the replacement of a formulant with a similar formulant in a similar quantity in a given quantity of the biocide;
  • (e) a change referred to in any of subparagraphs (f)(i) to (v) of the definition major change;
  • (f) the addition, replacement or removal of an importer of the biocide or a person that manufactures the biocide or a change to the name or contact information of such an importer or person; and
  • (g) a change in the location where the biocide is manufactured. (changement mineur)
pest control product
has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)
shelf life
means the period, beginning on the day on which a biocide is packaged for sale to consumers, during which the biocide will, when stored appropriately, retain without any appreciable deterioration its stability and any other qualities claimed for it by the holder of the market authorization for it. (durée de conservation)
specifications,
in respect of a biocide, means
  • (a) a statement of its properties and qualities, and of the properties and qualities of its active ingredients and formulants, including the identity, potency and purity of the biocide and those ingredients and formulants;
  • (b) the net quantity of the biocide in the package, the type of its package and a statement of the properties and qualities of the packaging material;
  • (c) a detailed description of the methods used to test and examine the biocide and its active ingredients and formulants; and
  • (d) a statement of tolerances for the properties and qualities of the biocide and for the properties and qualities of its active ingredients and formulants. (spécifications)

Definition of serious adverse drug reaction

(2) For the purposes of section 21.8 of the Act as it relates to biocides, serious adverse drug reaction means a response to a biocide that, in respect of human health,

Non-application

Food and Drug Regulations

2 Except as otherwise provided in these Regulations, the Food and Drug Regulations do not apply to a biocide.

Import

Prohibition — import of non-compliant biocides

3 (1) Subject to subsection (2), it is prohibited to import a biocide if its sale in Canada would contravene the Act or these Regulations.

Exception

(2) The prohibition does not apply if

Prohibition — importer information not published

4 (1) Subject to subsection (2), it is prohibited to import a biocide unless the name and civic address of the importer of the biocide are published under subsection 12(2).

Exception — testing

(2) Subsection (1) does not prohibit the import of a biocide for the purpose of testing to support an application for a market authorization for that biocide submitted under section 10 or 26.

Export

Export certificates

5 (1) For the purposes of paragraph 37(1)(c) of the Act, an export certificate in respect of a biocide must be in the form set out in Appendix III to the Food and Drug Regulations.

Obligation to retain copy

(2) The exporter must retain a copy of the export certificate for at least five years after the day on which the biocide is exported.

Transhipment

Transhipment in bond

6 For the purposes of paragraph 38(c) of the Act, all biocides must be in bond.

Exemptions — Section 3 of the Act

Advertising as preventative only

7 A biocide is exempt from the application of subsection 3(1) of the Act if the biocide is not advertised to the general public as a treatment or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act.

Sale as preventative only

8 A biocide is exempt from the application of subsection 3(2) of the Act with respect to its sale by a person if

Market Authorizations

Prohibition

Import, sale or advertising

9 (1) Subject to subsection (2), it is prohibited to import, sell or advertise a biocide unless the biocide is the subject of a market authorization issued under section 11.

Exception — testing

(2) Subsection (1) does not prohibit the import or sale of a biocide for the purpose of testing to support an application for a market authorization for that biocide submitted under section 10 or 26.

Issuance

Application requirements

10 (1) An application for a market authorization for a biocide must be submitted to the Minister and contain

Application based on comparison

(2) The information referred to in paragraphs (1)(h), (i) and (l) — other than information relating to the net quantity of the biocide in the package, the type of its package and a statement of the properties and qualities of the packaging material — may be omitted from the application if

Exception — foreign biocide

(3) Subparagraph (2)(f)(i) does not apply if

Additional information and material

(4) The Minister may request the applicant to provide any additional information or any material, including samples, that is necessary to enable the Minister to determine whether the market authorization must be issued.

Issuance

11 The Minister must issue a market authorization for a biocide to an applicant if

Content of market authorization

12 (1) A market authorization for a biocide must set out

Public notice

(2) The Minister must, after issuing a market authorization, publish on the Government of Canada website the applicable information referred to in subsection (1), except for the following information:

Information not confidential business information

(3) Subject to subsection (4), any information referred to in subsection (1) that is confidential business information ceases to be confidential business information when the Minister issues the market authorization.

Exception

(4) Subsection (3) does not apply to information referred to in paragraphs (2)(a) to (f).

Terms and Conditions

Terms and conditions

13 (1) The Minister may, at any time, impose terms and conditions on a market authorization, or amend them, after considering

Obligation to amend

(2) If, after issuing a market authorization, the Minister imposes terms and conditions on the authorization or amends the terms and conditions imposed on the authorization, the Minister must

Changes

Deemed creation of new biocide

14 If the holder of the market authorization for a biocide makes any of the following changes in respect of the biocide, the holder is deemed to have created a new biocide that is not authorized to be imported, sold or advertised under the authorization:

Major change

15 (1) It is prohibited for the holder of the market authorization for a biocide to sell any version of the biocide that is affected by a major change unless the Minister has provided the holder with a notice of acceptance in respect of the major change under subsection 16(1).

Content of application

(2) An application for a notice of acceptance must be submitted to the Minister and contain

Conditions — application based on comparison

(3) The information referred to in paragraph 10(1)(h), (i) and (l) — other than information relating to the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — may be omitted from the application if

Deemed comparison — Pest Control Products Act

(4) For the purposes of subparagraph (3)(a)(i), if a biocide that was exempted from the application of these Regulations under subsection 66(1) was registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product and that other biocide is the subject of a market authorization, the following rules apply:

Deemed comparison — Food and Drug Regulations

(5) For the purposes of subparagraph (3)(a)(i), if a biocide that was exempted from the application of these Regulations under subsection 68(1) had been assigned a drug identification number under the Food and Drug Regulations on the basis of a comparison to another biocide and that other biocide is the subject of a market authorization, the following rules apply:

Conditions — foreign regulatory authority

(6) The information referred to in paragraphs 10(1)(h), (i) and (l) — other than information relating to the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — may be omitted from the application if

Additional information and material

(7) The Minister may request the holder of the market authorization to provide any additional information or any material, including samples, that is necessary to enable the Minister to determine whether the notice of acceptance must be provided in respect of the major change.

Non-application of subsection (3)

(8) Subsection (3) does not apply to a biocide that was exempted from the application of these Regulations under subsection 66(1) or 68(1) if the biocide’s market authorization was issued on the basis of an application submitted under section 26.

Definitions of applicant and holder

(9) The following definitions apply in subsection (3).

applicant
means the holder of a market authorization for a biocide that submits an application for a notice of acceptance in respect of a major change under subsection (2). (demandeur)
holder
  • (a) in respect of a registration under the Pest Control Products Act, has the meaning assigned by the definition registrant in subsection 2(1) of that Act; and
  • (b) in respect of a drug identification number assigned under the Food and Drug Regulations, means the person to whom the document setting out the drug identification number was issued under subsection C.01.014.2(1) of those Regulations. (titulaire)

Definition of authorization

(10) In paragraphs (3)(d) and (e), authorization means any of the following:

Notice of acceptance

16 (1) The Minister must provide the holder of the market authorization for a biocide with a notice of acceptance in respect of a major change if

Obligation to amend

(2) If the Minister provides the holder with a notice of acceptance in respect of a major change that relates to any information that is required to be set out in the market authorization, the Minister must

Exception

(3) Paragraph (2)(b) does not apply in respect of information referred to in subparagraph 12(1)(o)(ii).

Information not confidential business information

(4) Subject to subsection (5), any information that is required to be set out in the market authorization and is confidential business information ceases to be confidential business information when the Minister provides the notice of acceptance to the holder.

Exception

(5) Subsection (4) does not apply to information referred to in subparagraph 12(1)(o)(ii) or paragraphs 12(2)(a) to (f).

Minor change

17 (1) Subject to subsection (2), the holder of the market authorization for a biocide must provide the Minister with a written description of any minor change in respect of the biocide at least 30 days before the day on which the minor change is made or, if the minor change is not within the holder’s control, as soon as feasible after the holder becomes aware of the minor change.

Names and contact information

(2) In the case of a minor change referred to in paragraph (a) or (f) of the definition minor change, the holder must inform the Minister in writing as soon as feasible.

Identification number

(3) When providing information to the Minister under subsection (1) or (2), the holder must also provide the biocide’s identification number.

Obligation to amend

(4) If the minor change relates to any information that is required to be set out in the market authorization, the Minister must

Information not confidential business information

(5) Subject to subsection (6), any information that is required to be set out in the market authorization and is confidential business information ceases to be confidential business information when the holder provides the description of the minor change to the Minister under subsection (1).

Exception

(6) Subsection (5) does not apply to information referred to in paragraphs 12(2)(a) to (f).

Direction to Stop Sale

Prohibition

18 It is prohibited for a person to sell a lot or batch of a biocide if they have been directed to stop the sale of the lot or batch under subsection 19(1) and the direction has not been lifted.

Direction to stop sale

19 (1) The Minister may direct a person to stop the sale of a lot or batch of a biocide if the Minister has reasonable grounds to believe that

Obligation to lift direction

(2) The Minister must lift a direction if the Minister is provided with information that demonstrates, or the Minister determines, that

Suspension

Prohibition — sale or advertising

20 (1) Subject to subsection (2), it is prohibited for a person to sell or advertise a biocide if the market authorization for the biocide is suspended under section 21 and the person has been notified of the suspension.

Partial suspension

(2) In the case where the market authorization is suspended in part, a person does not contravene subsection (1) if they sell or advertise a version of the biocide other than the version described in

Power to suspend

21 (1) The Minister may, by written notice provided to the holder of the market authorization for a biocide, suspend the authorization in whole or in part if

Precondition

(2) Before suspending a market authorization in whole, the Minister must consider if a partial suspension would be sufficient to address the situation giving rise to the proposed suspension.

Content of notice

(3) The notice referred to in subsection (1) must set out

Serious and imminent risk

(4) The Minister may make the suspension effective immediately if the Minister has reasonable grounds to believe that the suspension is necessary to prevent a serious and imminent risk of injury to human health.

Notice to third parties

22 (1) If the market authorization for a biocide is suspended,

Definition of business day

(2) In subsection (1), business day means a day other than

Reinstatement of market authorization

23 (1) The Minister must reinstate a suspended market authorization if the situation that gave rise to the suspension has been corrected or if the reasons for the suspension were unfounded.

Notice of reinstatement

(2) If a market authorization is reinstated, the Minister must publish on the Government of Canada website a notice to that effect.

Revocation

Automatic revocation

24 (1) A market authorization, or a part of a market authorization, that is suspended for a reason set out in paragraph 21(1)(a) or (c) is revoked if

Power to revoke — suspension

(2) The Minister may revoke a market authorization, or a part of a market authorization, that is suspended for the reason set out in paragraph 21(1)(b) if the Minister has reasonable grounds to believe that the holder has failed, within the six-month period that begins on the effective date of the suspension, to establish that the benefits associated with the biocide outweigh the risks associated with it — or, in the case of a partial suspension, the risks that led to the suspension — taking into account any uncertainties relating to the benefits and risks.

Clarification

(3) For greater certainty, the Minister is not authorized under subsection (2) to revoke a larger part of the market authorization than the part that is suspended.

Obligation to revoke — permanent discontinuance of sale

(4) The Minister must revoke a market authorization if the holder of the market authorization informs the Minister under section 47 that they have permanently discontinued the sale of the biocide in Canada.

Public notice

25 If a market authorization for a biocide is revoked under section 24, the Minister must

Use of Foreign Decisions

Application

26 (1) Subject to subsection (2), a person may submit to the Minister an application for a market authorization for a biocide that is based on a comparison to a foreign biocide that is authorized for sale

Exceptions

(2) An application cannot be submitted under subsection (1) if the foreign regulatory authority has authorized the sale of the foreign biocide on the basis of a type of application that is set out in the List of Foreign Regulatory Authorities in connection with the regulatory authority.

Content of application

(3) The application must contain

Exception — packaging

(4) The attestation referred to in paragraph (3)(c) does not need to confirm that the applicant possesses or has immediate access to any information relating to packaging that was submitted to the foreign regulatory authority.

Additional information and material

(5) The Minister may request the applicant to provide any additional information or any material, including samples, that is necessary to enable the Minister to determine whether the market authorization must be issued.

Follow-up obligations

27 (1) The holder of a market authorization for a biocide that is issued on the basis of an application submitted under section 26 must

Clarification

(2) For greater certainty, subsection (1) applies even if a version of the biocide is affected by a major change or minor change that has not affected any version of the foreign biocide.

Exception

(3) The holder is not required to possess or have immediate access to information relating to packaging that was submitted to the foreign regulatory authority.

Additional information to be provided

(4) When providing information to the Minister under paragraph (1)(d) or (e), the holder must also provide the biocide’s identification number and a description of the foreign biocide.

Labelling and Packaging

Definitions

28 The following definitions apply in this section and in sections 29 to 37.

designated container
means a disposable metal container that is designed to release pressurized contents by the use of a manually operated valve that forms an integral part of the container. (contenant désigné)
household biocide
means a biocide that is intended to be distributed only to the general public for personal use. (biocide domestique)
immediate container
means the package that is in direct contact with a biocide. (contenant immédiat)
inner label
means a label that is on or attached to the immediate container of a biocide. (étiquette intérieure)
outer label
means a label that is on or attached to the outside of a package, other than the immediate container, of a biocide. (étiquette extérieure)
Pressurized Containers Labelling Document
means the document entitled Labelling Requirements for Pressurized Containers Containing Biocides, dated December 18, 2021 and published by the Government of Canada on its website. (Document sur l’étiquetage des contenants sous pression)
principal display panel
means the part of the label that
  • (a) is on or attached to all or part of the surface of the package that is displayed or visible under normal conditions of sale or use; or
  • (b) if the package does not have a surface described in paragraph (a), is on or attached to any part of the package except the bottom. (espace principal)

Requirement for label

29 A biocide must have an inner label and, if the immediate container of the biocide is packaged in another package, an outer label.

Bilingual labelling

30 The information that is required to be shown on a label of a biocide must be clearly and prominently displayed in both English and French.

Principal display panel

31 (1) The following information must be shown on the principal display panel of the inner label of a biocide and, if there is an outer label, on the principal display panel of the outer label:

Limit

(2) If the biocide has more than one brand name, only one of those names may be shown on the label that is displayed or visible under normal conditions of sale.

Additional information

32 (1) The following information must be shown on the inner label of a biocide — and, if there is an outer label, on the outer label — but is not required to be shown on the principal display panel:

Contact information — accessibility

(2) For the purposes of paragraph (1)(e), the contact information must provide a means for persons in Canada to contact the holder of the market authorization without cost.

Small packages

33 In the case where the immediate container of a biocide is not large enough to accommodate an inner label that complies with sections 31 and 32, those sections do not apply in respect of the inner label if

Pressurized containers — explosion hazard

34 (1) Subject to subsections 36(1) and (3), the following information must be shown, in accordance with sections 1 to 4 of the Pressurized Containers Labelling Document, on the principal display panel of the inner label of a biocide that is packaged in a designated container and, if there is an outer label, on the principal display panel of the outer label:

Additional statements

(2) Subject to subsection 36(2), the following statements must be shown, in accordance with section 5 of the Pressurized Containers Labelling Document, on one panel of the inner label of a biocide that is packaged in a designated container and, if there is an outer label, on one panel of the outer label:

Pressurized containers — flammability

35 (1) Subject to subsections 36(1) and (3), where a biocide that is packaged in a designated container has a flame projection or flashback, the following information must be shown, in accordance with sections 1 to 4 of the Pressurized Containers Labelling Document, on the principal display panel of the inner label and, if there is an outer label, on the principal display panel of the outer label:

Additional statements

(2) Subject to subsection 36(2), the following statements must be shown, in accordance with section 5 of the Pressurized Containers Labelling Document, on one panel of the inner label of a biocide described in subsection (1) and, if there is an outer label, on one panel of the outer label:

Definitions of flame projection and flashback

(3) The following definitions apply in this section.

flame projection
means the flame resulting from the ignition of a biocide discharged from a designated container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981 and published by the Government of Canada on its website. (projection de la flamme)
flashback
means the part of a flame projection that extends from the point of ignition back to the designated container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981 and published by the Government of Canada on its website. (retour de flamme)

Exceptions — small quantities

36 (1) The primary hazard statements set out in paragraph 34(1)(c) and subparagraphs 35(1)(a)(iii), (b)(iii) and (c)(iii) may be omitted from the inner label of a biocide if the net quantity shown on the inner label does not exceed 60 mL or 60 g.

Inner label— 120 mL or g

(2) The statements set out in subsections 34(2) and 35(2) may be omitted from the inner label of a biocide if the net quantity shown on the inner label does not exceed 120 mL or 120 g.

Outer label — 120 mL or g

(3) The information referred to in subsections 34(1) and 35(1) may be omitted from the outer label of a biocide if the net quantity shown on the inner label does not exceed 120 mL or 120 g.

Packaging standards

37 The immediate container of a biocide must be constructed to

Information Requirements

Notable and Serious Incidents

Definitions

38 The following definitions apply in this section and sections 39 and 40.

notable incident
means
  • (a) a response to a biocide that adversely affects human health; or
  • (b) a failure in the effectiveness of a biocide that, in respect of human health,
    • (i) could have resulted in in-patient hospitalization, prolongation of existing hospitalization, congenital malformation or chronic or significant disability or incapacity, or
    • (ii) could have been life-threatening or resulted in death. (événement notable)
serious incident
means a response to or a failure in the effectiveness of a biocide that, in respect of human health,
  • (a) results in in-patient hospitalization, prolongation of existing hospitalization, congenital malformation or chronic or significant disability or incapacity; or
  • (b) is life-threatening or results in death. (événement grave)
serious unexpected incident
means a serious incident that is not identified in nature, severity or frequency in the risk information that is set out on the label of the biocide. (événement grave et imprévu)

Serious incident reporting

39 The holder of the market authorization for a biocide must provide the Minister with the information in their control about the following serious incidents within 15 days after becoming aware of the incident:

Information relating to incidents

40 (1) The holder of the market authorization for a biocide must compile and review, in a manner that ensures the effective and timely detection of significant safety issues associated with the biocide, information that they become aware of relating to notable incidents and serious incidents involving the biocide that occur in or outside Canada, including information about measures that have been taken outside Canada to address such issues.

Significant safety issue

(2) If, in reviewing the information, the holder concludes that there is a significant safety issue related to the benefits or risks associated with the biocide, they must notify the Minister in writing without delay.

Retention period

(3) Subject to subsection (4), the holder must retain the compiled information for at least 10 years after becoming aware of it, even if they cease to hold the market authorization.

New holder

(4) If, during the 10-year period, another person becomes the holder of the market authorization, the former holder must transfer the compiled information to the new holder and the new holder must retain it for the remainder of the period.

Request for information

(5) If the Minister becomes aware of new information relating to the benefits or risks associated with the biocide, the Minister may request in writing that the holder provide the Minister with any of the compiled information that is relevant to those benefits or risks.

Time limit

(6) The Minister must specify a period within which the information is to be provided that is reasonable in the circumstances.

Obligation to provide information

(7) The holder must provide the Minister with the requested information within the specified period.

Assessments, Tests and Studies

Issue-related report

41 (1) If the Minister becomes aware of an issue that could have significant implications for the benefits or risks associated with a biocide, the Minister may, for the purpose of assessing those implications, request in writing that the holder of the market authorization for the biocide provide the Minister with a report that contains

Time limit

(2) The Minister must specify a period within which the report is to be provided that is reasonable in the circumstances.

Obligation to provide report

(3) The holder must provide the report within the specified period.

Assessment order — condition

42 Before making an order under section 21.31 of the Act in respect of a biocide, the Minister must have reasonable grounds to believe that the benefits or risks associated with the biocide are significantly different than they were when the market authorization for the biocide was issued.

Order requiring tests and studies — conditions

43 Before making an order under section 21.32 of the Act in respect of a biocide, the Minister must

Hospital Reporting

Serious adverse drug reactions — biocides

44 (1) For the purposes of section 21.8 of the Act as it relates to biocides, hospitals are prescribed health care institutions that must provide the following information about a serious adverse drug reaction, in writing, within 30 days after the day on which the reaction is first documented within the hospital:

Exemption

(2) A hospital is exempt from the application of section 21.8 of the Act in respect of the reporting of information referred to in subsection (1) if the hospital does not have in its control all of the information referred to in paragraphs (1)(b) and (c).

Definition of hospital

(3) In this section, hospital means a facility

Clarifications

(4) For greater certainty,

Sales-related Information

Information — first sale

45 The holder of the market authorization for a biocide must provide the Minister with the following information in writing within 30 days after the day on which the biocide, as packaged and labelled for sale to consumers, is first sold in Canada under the authorization:

Annual notification

46 The holder of the market authorization for a biocide must, before October 1 of each year and in the manner specified by the Minister, inform the Minister of whether or not they are selling the biocide in Canada or have sold it in Canada in the 12 months preceding that date.

Permanent discontinuance of sale

47 (1) The holder of the market authorization for a biocide — or, if the market authorization has been revoked, the former holder — must provide the Minister with the following information in writing within 30 days after the day on which they permanently discontinue the sale of the biocide in Canada:

No sale — market authorization

(2) For the purposes of subsection (1), the holder of the market authorization for a biocide that has not sold the biocide in Canada under the authorization and that decides that they will not sell the biocide under the authorization is deemed to have permanently discontinued the sale of the biocide in Canada on the day on which they made that decision.

Exception

(3) Paragraphs (1)(b) and (c) do not apply to a holder referred to in subsection (2).

Additional information

(4) Subject to subsection (5), if a holder referred to in subsection (2) sold the biocide under a registration under the Pest Control Products Act or under a drug identification number assigned under the Food and Drug Regulations, the holder must, when providing information to the Minister under subsection (1), also provide the latest expiry date of the biocide that they sold under the registration or the drug identification number, as the case may be, and the lot number, if applicable.

Application of requirement

(5) The holder or former holder must provide the information referred to in paragraph (1)(c) or subsection (4) if the holder permanently discontinues the sale of the biocide or makes the decision referred to in subsection (2), as the case may be, before the last day of the month of the latest expiry date of the biocide that they sold under the market authorization or under the registration or drug identification number referred to in subsection (4).

Recalls

Recall system

48 (1) Any person that has sold a biocide must maintain a system of control, including records, that permits the complete and rapid recall of the biocide from the persons to whom they have sold it, other than consumers that purchased the biocide at the retail level.

Retention period

(2) The person must retain each record

Voluntary recall

49 (1) If any of the following persons decides to recall a biocide that is the subject of a market authorization without being ordered to do so by the Minister, the person must, within 24 hours after making the decision, provide the Minister with the information set out in subsection (2), in writing:

Information to be provided

(2) The information to be provided is as follows:

Communications

(3) The person must

Information requirements — 72 hours

(4) The person must, within 72 hours after making the decision to recall the biocide, provide the Minister with the following information in writing:

Information requirements — after recall

(5) The person must, within 30 days after completing the recall, provide the Minister with the following information in writing:

Recall ordered by Minister

50 (1) A person that is ordered by the Minister to recall a biocide under section 21.3 of the Act must provide the Minister with the following information in the time and manner specified by the Minister:

Change to information — representative

(2) The person must notify the Minister without delay of any change to the information referred to in paragraph (1)(a).

Communications

(3) The person must

Notification of start and completion

(4) The person must notify the Minister in writing, within 24 hours, of the start and completion of the recall.

Information requirements — after recall

(5) The person must, within 30 days after completing the recall, provide the Minister with the following information in writing:

Quality Control

Prohibition — failure to follow master formula

51 (1) It is prohibited for the holder of the market authorization for a biocide or the importer of a biocide to sell the biocide unless the biocide has been manufactured, packaged, labelled and stored in accordance with the master formula for the biocide.

Prohibition — manufacturer, packager or labeller

(2) It is prohibited for a person that manufactures, packages or labels a biocide that is the subject of a market authorization to sell the biocide if they have failed to manufacture, package or label it, as the case may be, in accordance with the master formula for the biocide or have failed to store it in accordance with the master formula.

Records — quality control

52 (1) The holder of the market authorization for a biocide and the importer of a biocide must maintain records that demonstrate that each lot or batch of the biocide that they sell has been manufactured, packaged, labelled and stored in accordance with the master formula for the biocide.

Records — manufacturer, packager or labeller

(2) Any person that manufactures, packages or labels a biocide that is the subject of a market authorization must, for each lot or batch of the biocide that they sell, maintain records demonstrating that they have manufactured, packaged or labelled, as the case may be, the lot or batch in accordance with the master formula for the biocide and have stored it in accordance with the master formula.

Retention period

(3) The holder, importer or person must — even if they cease to hold the market authorization or no longer import or sell the biocide, as the case may be — retain each record for at least one year after the last day of the month in which the shelf life of the biocide ends or, if that day cannot be determined, for at least six years after the day on which they sold the biocide.

Requirement to provide information

(4) Anyone that is required to retain a record under subsection (3) must provide the information in the record to the Minister, on request, within five days after the request is made or, if the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health, within any shorter period specified by the Minister.

Prohibition — sterile biocides

53 It is prohibited to manufacture or package a biocide that is intended to be sterile unless the manufacturing or packaging is carried out

Investigation of complaints

54 (1) If any of the following persons receives a complaint in respect of the quality of a biocide that is the subject of a market authorization, the person must investigate it and, if necessary, take corrective action:

Records

(2) The person must maintain a record of each complaint and investigation and any corrective action taken.

Retention period

(3) The person must — even if they cease to hold the market authorization or no longer import or sell the biocide, as the case may be — retain each record for at least one year after the latest of

Requirement to provide information

(4) Anyone that is required to retain a record under subsection (3) must provide the information in the record to the Minister, on request, within five days after the request is made or, if the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health, within any shorter period specified by the Minister.

[55 to 65 reserved]

Transitional Provisions

Temporary exemptions — Pest Control Products Act

66 (1) A biocide that is a pest control product is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if the biocide is registered under the Pest Control Products Act and the registration is made either

End of exemption

(2) The exemption referred to in subsection (1) ceases to apply on the earliest of

Temporary exemption — pending decision

(3) A biocide that is a pest control product is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

End of exemption

(4) The exemption referred to in subsection (3) ceases to apply on the earliest of

Exception — pest control products

67 (1) The information referred to in paragraphs 10(1)(h), (i) and (l) — other than information relating to the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — may be omitted from an application for a market authorization for a biocide that is exempt from the application of these Regulations under subsection 66(1) if

Definition of conditions of registration

(2) In subsection (1), conditions of registration has the same meaning as in subsection 2(1) of the Pest Control Products Act.

Temporary exemptions — Food and Drug Regulations

68 (1) A biocide is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if the biocide is a drug

End of exemption

(2) The exemption referred to in subsection (1) ceases to apply on the earliest of

Temporary exemption — pending decision

(3) A biocide is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

End of exemption

(4) The exemption referred to in subsection (3) ceases to apply on the earliest of

Exception — drug identification number

69 The information referred to in paragraphs 10(1)(h), (i), (l) and (n) — other than information relating to the net quantity of the biocide in the package, the type of package and the properties and qualities of the packaging material — may be omitted from an application for a market authorization for a biocide that is exempt from the application of these Regulations under subsection 68(1) if

Temporary exemption — certain sanitizers

70 (1) A surface sanitizer for use in food premises is exempt from the application of these Regulations — other than sections 10, 11 and 26 — if, immediately before the first anniversary of the day on which these Regulations are registered,

End of exemption

(2) The exemption ceases to apply on the earliest of

Definition of surface sanitizer for use in food premises

(3) In this section, surface sanitizer for use in food premises means a biocide that is manufactured, sold or represented for use exclusively in premises in which food is manufactured, prepared or kept for sale.

Market authorization — required information

71 The information referred to in subpara-graph 15(3)(c)(ii) or (iii), as those subparagraphs read immediately before the fifth anniversary of the day on which these Regulations were registered, must be set out in a market authorization if that information was required to be set out in the authorization under subparagraph 12(1)(o)(ii), as that subparagraph read immediately before that anniversary.

Amendments to These Regulations

72 Subsection 10(1) of these Regulations is amended by adding “and” at the end of paragraph (m) and by repealing paragraphs (o) and (p).

73 Subparagraph 12(1)(o)(ii) of these Regulations is replaced by the following:

74 (1) Paragraphs 15(3)(a) to (i) of these Regulations are replaced by the following:

(2) Subsections 15(4) and (5) of these Regulations are replaced by the following:

Deemed comparison — Pest Control Products Act

(4) If a biocide that was exempted from the application of these Regulations under subsection 66(1) was registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product and that other biocide is the subject of a market authorization, the following rules apply:

Deemed comparison — Food and Drug Regulations

(5) If a biocide that was exempted from the application of these Regulations under subsection 68(1) had been assigned a drug identification number under the Food and Drug Regulations on the basis of a comparison to another biocide and that other biocide is the subject of a market authorization, the following rules apply:

(3) Subsection 15(9) of these Regulations is replaced by the following:

Definition of applicant

(9) In subsection (3), applicant means the holder of a market authorization for a biocide that submits an application for a notice of acceptance in respect of a major change under subsection (2).

(4) Subsection 15(10) of these Regulations is repealed.

75 Paragraph 26(3)(a) of the Regulations is replaced by the following:

Consequential Amendments

Food and Drugs Act

Food and Drug Regulations

76 The Food and Drug Regulations footnote 1 are amended by adding the following after section A.01.068:

Non-application

A.01.069 These Regulations do not apply to a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.

77 Subsection C.01.004.02(6) of the Regulations is amended by adding “and” at the end of paragraph (a), by striking out “and” at the end of paragraph (b) and by repealing paragraph (c).

78 Paragraphs C.01.014.1(2)(c) and (d) of the Regulations are replaced by the following:

79 Subsection C.01.040.2(5) of the Regulations is repealed.

80 The definition antimicrobial agent in subsection C.01A.001(1) of the Regulations is repealed.

81 Subsection C.01A.002(1) of the Regulations is amended by adding “and” at the end of paragraph (c), by striking out “and” at the end of paragraph (d) and by repealing paragraph (e).

82 Section C.02.002.1 of the Regulations is repealed.

Medical Devices Regulations

83 The Medical Devices Regulations footnote 2 are amended by adding the following after section 2:

2.1 For greater certainty, these Regulations apply to a medical device that is a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.

Natural Health Products Regulations
84 Schedule 2 to the Natural Health Products Regulations footnote 3 is amended by adding the following after item 8:
Item Substances
9 A drug that is manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface

Pest Control Products Act

Pest Control Products Regulations

85 (1) Paragraphs 3(1)(d) and (e) of the Pest Control Products Regulations footnote 4 are replaced by the following:

(2) Paragraph 3(1)(d) of the Regulations is replaced by the following:

(3) Subsection 3(2) of the Regulations is replaced by the following:

Exemption for named uses only

(2) A pest control product that is exempt under paragraph (1)(c) or (d) is exempt only in respect of any use described in that paragraph.

Coming into Force

First anniversary of registration

86 (1) Subject to subsection (2), these Regulations come into force on the first anniversary of the day on which they are registered.

Fifth anniversary of registration

(2) Sections 71 to 75 and 77 to 82 and subsection 85(2) come into force on the fifth anniversary of the day on which these Regulations are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Products that sanitize or disinfect hard or soft non-living and non-liquid surfaces to prevent disease in humans or animals are collectively referred to as biocides. Biocides are regulated under separate frameworks in Canada with surface sanitizers, disinfectants, and surface sanitizers for use in food premises having different associated requirements, despite having similar benefits, risks, uses, and ingredients. Having different requirements for these similar biocides has not provided a consistent approach to their regulation, resulting in product classification challenges, differences in the requirements for the biocide supply chain, and potential hurdles for greater international alignment. These challenges were highlighted during the COVID-19 pandemic. The majority of the biocide industry has advocated for the implementation of a single regulatory framework for biocides that will address these challenges.

The demand for health products, including biocides, increased greatly as a result of the COVID-19 pandemic. Biocides were essential in a coordinated approach to help prevent the spread of COVID-19. To maintain a safe and effective supply of biocides for Canadians, and to alleviate certain pressures on the health care system and industry, interim orders and operational efficiencies were introduced to mitigate shortages of certain biocides in Canada during the COVID-19 pandemic. However, these were temporary measures which do not provide long-term agility to maintain or improve access to biocides in the future.

There is a need for modern regulations for biocides that will provide tailored application and regulatory requirements specific to these products. This will help to maintain a safe and effective supply of biocides for Canadians, and to facilitate future efforts in international alignment.

Description: These new regulations under the Food and Drugs Act (FDA) specific to biocides will encompass:

  • the transfer of surface sanitizers regulated under the Pest Control Products Act (PCPA) that meet the definition of a drug, disinfectants that are currently regulated under the Food and Drug Regulations (FDR), and all surface sanitizers for use in food premises that fall under the purview of the FDA, to the Biocides Regulations (also referred to as the Regulations);
  • the creation of a new, modern authorization and regulatory framework with safety, efficacy and quality requirements specific to biocides;
  • requirements and authorities that support the continuous post-market oversight of a biocide’s benefits and risks; and
  • the creation of a pathway for authorization based on decisions from foreign regulators, starting with the United States Environmental Protection Agency.

Rationale: The development of new regulations for the authorization and regulation of biocides, including a use of foreign decisions pathway, will benefit Canadians. Modern and harmonized regulations for surface sanitizers, disinfectants and surface sanitizers for use in food premises will contribute to maintaining Canadians’ access to safe, effective, and high-quality products by encouraging industry to bring new biocides to the Canadian market.

Regulating surface sanitizers as biocides under the FDA, instead of as pest control products under the PCPA, will subject manufacturers to regulatory requirements that are specific to the nature of these products and will harmonize regulatory requirements for most biocides, thereby reducing costs to industry and allowing for more timely authorization of these products without compromising the health and safety of Canadians.

The use of foreign decisions pathway will enable Health Canada to leverage authorizations from foreign jurisdictions to bring biocides to the Canadian market sooner, while reducing duplication for companies operating internationally and the associated burden in the review of applications. This will encourage companies to bring their products to Canada without compromising safety.

The total direct costs of the Biocides Regulations include one-time costs to both industry and the Government of Canada for transitioning existing products to the new framework, and ongoing costs to both industry and the Government of Canada to conduct activities related to the oversight and post-market surveillance of biocides under the new framework, which is estimated to be $397.27 million present value (PV), or $43.62 million annualized over 15 years. The total direct benefits of the Biocides Regulations are estimated to be $86.94 million PV, or $9.55 million annualized over a 15-year period. This estimate is based on cost savings for some industry stakeholders and the Government of Canada from reduced burden. The result is a net cost of $310.33 million PV, or $34.07 million annualized over the next 15 years.

Issues

Developing tailored requirements through the creation of a single framework for biocides

Certain hard and soft surface sanitizers are currently regulated under the PCPA and its associated regulations. These biocides have different requirements from disinfectants that are regulated under the FDA and the FDR. In addition, surface sanitizers for use in food premises fall under the purview of the FDA. Many industry stakeholders have consistently identified opportunities for reduced administrative burden, increased international alignment, and the need for consistent application requirements for these similar products as priorities for regulatory modernization efforts. These concerns can be addressed through the implementation of a single regulatory framework that has requirements specific to biocides.

Regulating biocides under the PCPA as pest control products was considered in 2001, but it was determined that disinfectants (and consequently biocides) were more appropriately regulated as drugs under the FDA. They meet the definition of a drug, as their primary purpose is to prevent diseases in humans and animals. In addition, there are important differences between biocides and other pest control products, such as use patterns, and their methods and rates of applications.

The application and regulatory requirements set out in the FDR were developed to regulate pharmaceuticals and have not provided a consistent approach to the regulation of products that sanitize and/or disinfect hard or soft non-living and non-liquid surfaces (referred to as surface sanitizers and disinfectants in this document) to prevent disease in humans or animals. These products are collectively referred to as biocides. Biocides are distinct from pharmaceuticals in that they are intended to be applied to non-living surfaces only and are not authorized for the diagnosis or treatment of disease. This distinction also has an impact on Health Canada’s ability to identify, assess, and manage new risks associated with the use of these products.

Due to the differences between biocides and both pest control products and pharmaceutical drugs, the application requirements and post-market safety measures that some of these products are subject to currently could be tailored to better suit the benefits, risks, and related uncertainties associated with biocides.

Surface sanitizers for use in food premises

Surface sanitizers for use in food premises are currently not required to undergo a mandatory premarket review nor have a licence or market authorization to be sold on the Canadian market. Health Canada’s Bureau of Chemical Safety evaluates products voluntarily submitted by manufacturers for their acceptability from a food chemical safety perspective. For products considered acceptable, a letter of no objection is issued. This letter does not constitute an approval under the FDR. If an individual is harmed in relation to a surface sanitizer for use in food premises, there are very limited tools available to Health Canada under the FDA to effectively protect the health and safety of Canadians. There is no system to effectively identify and track these biocides, and they are not subject to any post-market obligations.

The current voluntary approach to reviewing surface sanitizers for use in food premises has led to confusion by industry stakeholders in identifying what biocides are considered acceptable for use in food premises to address microbial contamination.

Without pre-market and post-market oversight by Health Canada, there is no assurance that these surface sanitizers for use in food premises are effective, which means they may not eliminate food-borne microbes on the surfaces they are applied to.footnote 5 The impacts on public health of food-borne illness are known and important. The Public Health Agency of Canada estimates about four million Canadians are affected by food-borne illness each year, which can lead to hospitalization, and in severe cases, death.footnote 6 While the causes of food-borne illness vary, proper sanitization of food-contact surfaces can reduce instances of these illnesses. Also, as surface sanitizers for use in food premises do not have clear labelling requirements, users of these products may be unaware of the risks to their health and any safety measures that need to be taken, for example, wearing appropriate personal protective equipment, to mitigate those risks.footnote 7,footnote 8

Maintaining Canada’s supply of biocides

One of Health Canada’s roles is to regulate and authorize health products that improve and maintain the health and well-being of Canadians. The COVID-19 pandemic created an unprecedented demand on Canada’s health care system. As a result of the pandemic, the need for health products including biocides greatly increased.footnote 9 In addition, Health Canada experienced challenges in responding to the volume of questions asked by biocide manufacturers during the pandemic regarding appropriate application pathways, application requirements and obligations. To alleviate certain pressures on industry and the health care system, interim orders and operational efficiencies were introduced to help increase the supply in Canada and mitigate shortages of certain products that sanitize or disinfect surfaces. However, these were only temporary measures that were put in place to manage the response to the COVID-19 pandemic. Regulations specific to biocides that include the ability to use an authorization or registration from a foreign jurisdiction as a basis to obtain a Canadian authorization would remove barriers to both Health Canada and industry, providing Canadians with more timely access to biocides.

The biocide industry includes not only established large companies but also small and medium-sized companies that bring innovative products to global markets. The industry also includes smaller regional companies that may only have products for sale domestically. Many Canadian biocide suppliers are large multi-national companies that have parent companies in other countries, predominantly in the United States (U.S.), and there are many that are small- or medium-sized companies that enter into licensing agreements with these companies to bring their formulations to Canada. In this context, Health Canada understands that international collaboration can be beneficial to promote the timely approval and import of a variety of safe and effective biocides. For the past several years, Health Canada has used information and data from applications submitted in other jurisdictions, when applicable, to better inform the review of biocides for market authorization in Canada. Health Canada is expanding and formalizing this practice to help ensure a safe, effective, and high-quality supply of biocides in Canada.

Background

Historical context

Surface sanitizers, disinfectants and surface sanitizers for use in food premises are currently regulated under different legislative and regulatory frameworks: certain surface sanitizers under the PCPA, and disinfectants and surface sanitizers for use in food premises under the FDA. Despite their similar ingredients and uses, these products are assessed for their safety, efficacy and quality under different frameworks, with varying requirements, fees, and timelines.footnote 10

Historically, disinfectants used in health care facilities, food premises and on medical devices were regulated under the FDA, while institutional, agricultural, domestic and industrial uses of disinfectants were regulated under the PCPA. Products that could be used in either (e.g. both hospitals and schools) had to be approved under both the FDA and the PCPA before they could be marketed.

In 2001, a regulatory amendment to the Pest Control Products Regulations (PCPR) exempted surface disinfectants that are used to prevent human and animal disease from the PCPA to consolidate the regulation of these products under the FDA.footnote 11 This amendment substantially reduced the duplicate reviews and approvals that were occurring under both the PCPA and the FDA. However, surface sanitizers continued to be regulated under the PCPA, with the exception of those used in food premises; an exemption was included that ensured that surface sanitizers for use in food premises would fall under the purview of the FDA to reduce safety concerns related to food products. At that time, Health Canada committed to re-evaluate the transition of surface sanitizer-only products that made claims related to prevention of disease from regulation under the PCPA to the FDA in the future.

On July 2, 2014, the Government of Canada repealed the requirement for the pre-registration of construction materials, packaging materials and non-food chemicals (including surface sanitizers for use in food premises) used in federally-registered food establishments.footnote 12 As a result, the Canadian Food Inspection Agency (CFIA) no longer required the review and pre-registration of surface sanitizers for use in food premises. However, operators of federally registered food establishments still remained responsible for using products that are safe and suitable for their intended use, and that meet all provincial/territorial and municipal regulatory requirements. Health Canada has continued the practice of voluntarily reviewing surface sanitizers for use in food premises to assess acceptability from a food chemical safety perspective.footnote 13 This allows surface sanitizers for use in food premises to be used in accordance with certain provincial and territorial requirements.”footnote 14

Following the transition of disinfectants including disinfectants with certain hard surface sanitizer uses to the FDA in 2001, industry innovation led to additional products that fall within the purview of the FDA (e.g., disinfectants with additional soft surface sanitizer or residual antimicrobial claims). To respond to this innovation, Health Canada updated its guidance in April 2020 to clarify how these products are regulated.

Pandemic challenges

In response to an increased demand during the COVID-19 pandemic, Health Canada mitigated shortages of biocides by implementing a number of measures and operational efficiencies, including by permitting the temporary exceptional importation of disinfectants based on their authorization in foreign jurisdictions. This was done through the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). Stakeholders reacted positively to these measures overall, and approximately 280 disinfectants were made available for exceptional importation and temporary sale in Canada.

However, Health Canada also experienced challenges responding to the significant increase in questions asked by biocide manufacturers during the COVID-19 pandemic regarding appropriate application pathways, application requirements and obligations. Due to the separate regulatory frameworks governing various biocides, many of the inquiries Health Canada received during the pandemic pertained to questions on product classification and uncertainty relating to the inconsistent regulation of surface sanitizers for use in food premises and the type of review these products have undergone. Overall, the current regulatory environment impeded the efficient review of applications and market authorization of biocides, resulting in potential delayed access of these products to Canadians during the pandemic.

The intent of these Regulations aligns with the objective of the Health and Biosciences Sector Regulatory Review Roadmap to create integrated, risk-based approaches to regulating product categories and services.

Objective

The objective of the Biocides Regulations is to introduce a modern regulatory framework under the FDA that is specific to biocides. Tailored application and regulatory requirements for biocides will provide Canadians with more timely access to safe, effective and high-quality products, while reducing burden, where applicable.

Description

The new Biocides Regulations will encompass the following:

Scope

Surface sanitizers that meet the FDA definition of a drug and disinfectants regulated under the FDR will be subject to the new Biocides Regulations. This comprises most disinfectants and sanitizers for use on hard or soft non-living and non-liquid surfaces, including those used in premises where food is manufactured, prepared and stored, for disinfecting and sanitizing surfaces that may come into contact with food.

The following products will be excluded from the Biocides Regulations:

Application and market authorization

Currently, the majority of disinfectants receive a drug identification number (DIN) under Division 1 in Part C of the FDR. Submissions for disinfectants with a new active ingredient or a new use receive a notice of compliance (NOC) under Division 8 in Part C of the FDR and a DIN. Certain surface sanitizers receive a pest control product registration under the PCPA. Since the PCPR exempts surface sanitizers for use in food premises from the PCPA Health Canada has been reviewing these surface sanitizers for acceptability, on a voluntary basis.

The Biocides Regulations will include an authorization pathway, based on existing requirements in the FDR for disinfectants, that has been tailored uniquely to biocides. The authorization framework included in the Biocides Regulations is flexible enough to consider products with varying benefits, risks, and uncertainties, removing the need for different sets of requirements. The Regulations specify the information required to be submitted by biocide applicants to be considered for a market authorization. To further support applicants in choosing the right pathway for authorization, comprehensive guidance is available for reference. An application for biocide market authorization will require the following information:

Each biocide application that is received will undergo an assessment of the benefits and risks of the product before the Minister makes a decision on whether to issue a market authorization. Market authorization is granted if the benefits of the product outweigh the risks, taking into consideration any associated uncertainties and provided that all information requirements are met. In addition, the Minister is provided with the authority to request additional information outside of what is required in the initial application, or to obtain a sample of a product to further assess whether a market authorization will be issued.

Once issued, the content of the market authorization as outlined in the Regulations will be made public, excluding the formulant quantities, Chemical Abstracts Service (CAS) numbers, identification number of the comparison product, and description of the foreign biocide, as applicable.

Applications based on comparison

The Biocides Regulations will include an application pathway for biocides that relies on the comparison to a biocide that is already authorized in Canada.footnote 17 Under this pathway, this application must include information demonstrating that:

In addition, the applicant must attest that the biocide will be manufactured in accordance with the same master formula, including product specifications, as the biocide used as a comparator. They will also need to include confirmation from the market authorization holder (MAH) of the biocide being used as a comparator, that they have provided the master formula to the applicant, unless they are also the MAH of the biocide being used as a comparator.

This pathway will reduce authorization costs and the length of time to make a regulatory decision compared to the full review pathway since applicants using this pathway will not need to provide information related to the safety, efficacy and quality of the biocide, other than packaging information. These requirements will be satisfied through the attestation that the biocide will be manufactured according to the same master formula, including product specifications, as the biocide used as a comparator. Products receiving a market authorization through an application that is based on a comparison will be required to follow the same post-market requirements that apply to all biocides under the Biocides Regulations. The Minister will also be able to request any additional information relating to the biocide, to make a determination on its benefits and risks.

Use of foreign decisions

The Biocides Regulations will introduce a use of foreign decisions (UFD) pathway that will allow biocide applicants to leverage the decision of a trusted foreign regulatory authority when applying for a market authorization for an identical product in Canada. This pathway will reduce authorization costs and the length of time to make a regulatory decision since applicants holding an active market authorization issued by a trusted foreign authority will not be subject to a full review. This will provide an incentive for companies to bring their product to the Canadian market, thus providing Canadians with access to a greater variety of products.

Health Canada will maintain a list that identifies trusted foreign regulatory authorities whose regulatory decisions will be relied upon for the issuance of a market authorization. This list will be incorporated by reference and amended from time to time. This list of trusted foreign regulatory authorities will initially be limited to the U.S. EPA. However, Health Canada will be conducting analyses with the intent to add other trusted foreign regulatory authorities to the list. Health Canada will only accept decisions from foreign regulatory authorities that have similar regulatory standards and are comparable and reflect Canada’s review processes. Such determinations will be made through a detailed analysis. Further information on the criteria and process used to establish this list of trusted authorities is included in guidance.

Products approved through the UFD pathway will be subject to more post-market requirements compared to those that apply to all other biocides. In the event that there is an issue that impacts the benefits, risks, or related uncertainties of a product approved through the UFD pathway, the Minister will be able to request the original data package that the MAH submitted to the foreign regulator. The Minister will also be able to request any additional information to make a determination on the benefits, risks, and related uncertainties of the product. In addition to the post-market requirements that apply to all other biocides, the MAH of a biocide approved through the UFD pathway will need to notify the Minister in the event that the authorization or registration of the foreign biocide is revoked or suspended, or the foreign biocide is recalled. The MAH will also need to notify the Minister if the foreign regulatory authority requires a product change to the foreign biocide.

Variations of a biocide under one market authorization

Currently, each disinfectant authorized under Division 1 of the FDR requires a separate market authorization with a unique brand name for each formulation.footnote 18 Surface sanitizers regulated under the PCPA may have minor variations in formulants within one pest control product registration; however, each registration can only be associated with one brand name.

The Biocides Regulations will allow for one application to be submitted for market authorization for a biocide with different brand names and/or minor variations in formulants.footnote 19 The data package provided in the application will need to support all variations of the biocide and demonstrate that the same benefits and risks are associated with each variation. Allowing a biocide with minor variations under one market authorization will decrease costs and burden for biocide applicants and incentivize companies to bring their products to Canada.

This application structure will align with those in place for biocides in the U.S., the European Union, and the United Kingdom, and for surface sanitizers currently regulated under the PCPA. In addition, the U.S. EPA also allows for minor variations in formulants to be registered under a single registration. Allowing for a biocide with minor variations in formulation under one market authorization will provide a consistent approach for applicants using the UFD pathway, as this aligns with the application structure in other international jurisdictions.

An application for market authorization of a biocide with variations will need to include additional information for each variation in formulation, including confirmatory information to support the equivalence in terms of the safety, efficacy and quality, if the included formulants differ (other than fragrance or colour at concentrations of 1% or less of the product formulation).

Identification number

For disinfectants regulated under the FDR currently, each product is assigned an eight-digit DIN that is unique to each drug product. The DIN is found on the product label and is searchable on the Drug Product Database, which is publicly available. Entries within the Drug Product Database outline key characteristics of drugs authorized by Health Canada. For surface sanitizers, a pest control product registration number is assigned to each product that requires registration under the PCPA. This registration number is searchable on the Pesticide Product Information Database, which allows the public to view information on products and active ingredients related to pesticides and other pest control products that are regulated by Health Canada. Surface sanitizers for use in food premises, whether they have or have not been assessed for acceptability with the requirements of the FDA by Health Canada or the CFIA, are not required to carry an identification number. Some of these products may have a DIN if they make disinfectant claims in addition to their sanitizer claims.

For biocides, Health Canada will be assigning an eight-digit identification number. To minimize impact on existing disinfectant authorization holders, the eight-digit identification number will not need to change under the Biocides Regulations. This identification number will be published as part of the biocide’s market authorization and included on the product label.

Amendments and notifications

Post-authorization changes may impact the quality, benefits, risks, and related uncertainties of the biocide. For the Minister to assess the quality, benefits, risks, and related uncertainties associated with a post-authorization change, the Biocides Regulations will introduce the following categories of changes to a biocide or its associated administrative information and the application requirements to support the change.

Major changes
Minor changes
Changes that create a new biocide

Information about non-notifiable changes are outlined in guidance. Non-notifiable changes will not require an application for a notice of acceptance with respect to a major change or a notification to the Minister with respect to a minor change. This will include changes such as modifications to the format of the lot number on the label. However, MAHs will be expected to inform Health Canada of these changes in their next post-authorization filing for their biocide. These expectations are outlined in guidance.

Packaging and labelling

Packaging

Currently, Health Canada receives limited information about the packaging of disinfectants, relating only to the package size and container type, making it difficult to confirm that the packaging will maintain the quality of the product throughout its shelf life. Active ingredients in biocides may be corrosive in nature and could affect the integrity of the product packaging over time (e.g. may make it brittle). In addition, ingredients such as isopropyl alcohol and ethanol may evaporate over time if not packaged in appropriate containers. Appropriate packaging is necessary to maintain the stability and shelf life of a biocide.

The Biocides Regulations require that packages be able to contain the biocide under normal storage, display and distribution conditions to minimize product degradation and moisture loss. Packages will need to be constructed to permit the use of the biocide and the closure of the package in a manner that is safe to the user. These requirements are similar to those specified for surface sanitizers under the PCPR. In addition, the Regulations will require applicants to specify the size and type of packaging used for the biocide and the properties and qualities of the packaging material. This information will help ensure that biocides are not packaged in containers that could cause them to be mistaken for a food or beverage, thereby reducing the potential for accidental poisonings related to biocides.

Labelling

The FDR prescribes specific information that current disinfectant authorization holders are required to include on the principal display panel and other parts of the label. These labelling requirements were used as a basis for the Biocides Regulations, but have been tailored, where possible, to better suit the nature of biocides.

The Biocides Regulations will outline what information is required to be included on the principal display panel and other parts of the label and will require information to be clearly and prominently displayed to inform the purchase and safe use of the product. Flexibilities will be provided so that MAHs of products in small packages will be able to comply with the requirements. The labelling requirements in the Biocides Regulations will align as much as possible with the labelling requirements for disinfectants in the FDR. This will help to reduce compliance burden for industry.

The Biocides Regulations will also introduce a requirement for disinfectants to include the statement, “Keep out of reach of children”, to align with the labelling requirement that exists for surface sanitizers.footnote 20 The Regulations will also require surface sanitizers to include an identification number (instead of the pest control registration number), the expiry date,footnote 21 the physical form, and an indication that the product is sterile (if applicable) on the product label.

Post-market authorities and obligations

The post-market authorities in the Biocides Regulations will enable continuous post-market oversight of a biocide’s benefits and risks. The Regulations will carry over certain authorities available under the FDR related to safety reporting as well as authorities introduced through the Protecting Canadians Against Unsafe Drugs Act (Vanessa’s Law), which provides the Minister with the ability to compel information, require tests and studies, impose a recall, impose terms and conditions, and require the conduct assessments after a market authorization has been issued. In addition, they will maintain Health Canada’s ability to identify, assess, and manage new risks and uncertainties associated with the use of biocides and to support compliance verification activities. The Minister will have the authority to direct a person to stop selling a biocide, or to suspend or revoke (in whole or in part) a biocide’s market authorization, if necessary.

Notable incidents

The adverse drug reaction reporting requirements from the FDR will be carried over for biocides with some modifications.footnote 22 The term “adverse drug reaction” will be replaced by the term “notable incident,” which will be defined as any response to a biocide that adversely affects human health. A notable incident will also include any failures of effectiveness of a biocide that could have had serious implications in respect of human health (e.g. could have caused birth defects, chronic or significant disability, or could have been life-threatening). Notable incidents will be required to be compiled by the MAH for the purposes of the safety monitoring requirements, described in more detail below.

Serious incidents

For disinfectants, the FDR currently requires that authorization holders submit a report for serious adverse drug reactions that occur in Canada and for serious unexpected adverse drug reactions that occur outside of Canada where there was a serious human health impact related to its use or exposure.footnote 23,footnote 24 Both of these reporting requirements will be carried over from the FDR for biocides with some changes. The terms “serious adverse drug reaction” and “serious unexpected adverse drug reaction” will be replaced with “serious incident” and “serious unexpected incident,” respectively.

A serious incident will be defined as a response to a biocide that has resulted in serious implications in respect of human health. A serious unexpected incident will be defined as a serious incident that is not identified in nature, severity or frequency in the risk information set out on the Canadian label of the biocide. The scope of serious incidents and serious unexpected incidents will be expanded to include failures of effectiveness that have caused serious implications to human health. The MAH will need to submit information about a serious incident or serious unexpected incident within 15 days after becoming aware of the information.

Hospital reporting

Mandatory reporting by hospitals will apply to biocides with respect to serious adverse drug reactions. These requirements will be carried over from the FDR and will require a hospital to report when exposure to the product results in serious harm to human health, i.e. in situations when a serious adverse drug reaction has occurred, with the exception of failures of effectiveness that have caused serious implications to human health. The term “serious adverse drug reaction” is used to align with the language used in the FDA specific to hospital reporting. The hospital will be required to report the incident within 30 days after becoming aware of the information.

Safety monitoring requirements

Safety monitoring requirements have been adapted from the FDR, the PCPA, the Pest Control Products Incident Reporting Regulations and the Canada Consumer Product Safety Act to better suit the unique traits of biocides. The new safety monitoring requirements will replace the existing annual summary report requirements under the FDR. The Biocides Regulations will require the MAH to monitor the safety of their marketed biocides in a manner that allows them to detect safety issues that may emerge. If a significant safety issue is detected, including a failure of effectiveness that may cause serious harm, the MAH will be required to notify Health Canada without delay. These activities, as well as information relating to notable or serious incidents, will need to be documented in a manner that is sufficient for auditing to verify compliance and support enforcement action, if necessary.

The MAH will be required to have procedures in place to compile and review both domestic and foreign information in a manner that ensures the effective and timely detection of safety issues regarding the biocide. This may include actions taken by foreign regulatory authorities, such as recalls, which relate to the biocide as well as failures in effectiveness of the biocide. These requirements will ensure that MAHs are self-monitoring their products to detect safety concerns.

Other post-market obligations

The Biocides Regulations will carry over the following reporting and notification requirements that currently exist under the FDR for disinfectants:

Recalls

System of control

Under the Biocides Regulations, the MAH and every person who sellsfootnote 25 a biocide must have a system of control in place that allows them to take effective and rapid action to recall a biocide from whom they sold it to, other than a consumer. Records that support the recall system, including written procedures and sales records, will need to be retained in a manner that enables traceability of the biocide. A recall may be necessary if the biocide presents a risk to the health of Canadians or is in violation of the FDA or the Biocides Regulations.

Reporting to Health Canada

The Biocides Regulations will introduce recall reporting requirements for the MAH, importer, or manufacturer in Canada that are based on current guidance for the health product industry (including disinfectants) set out in Health Canada’s Drug and Natural Health Products Recall Guide (GUI-0039) and Recall Policy for Health Products (POL-0016).

The MAH, importer, or manufacturer will be required to notify the Minister within 24 hours of having made the decision to voluntarily recall a biocide from the Canadian market. The notification will include information to support Health Canada’s oversight of the recall, including:

The MAH, importer, or manufacturer will be required to submit their proposed communications to the Minister before starting the recall and may be required to provide any additional communications, on request, after the recall has commenced. Allowing Health Canada an opportunity to assess whether the communications are sufficient to mitigate the identified risk is an important step within the recall process.

Additional information is to be provided to the Minister within 72 hours of having made the decision to recall, including:

The MAH or importer will be required to provide the Minister with the results of the recall within 30 days of completing a recall, as well as more details about the corrective and preventive actions that have been, or will be, taken.

Reporting requirements will also be introduced for any person who is ordered to recall a biocide through a ministerial order under Section 21.3 of the FDA. The information to be provided will be consistent with requirements for voluntary recalls, with the exception of the time and manner, which will be specified by the Minister on a case-by-case basis.

Quality Control

The Biocides Regulations will support the quality of biocides for sale in Canada through the inclusion of provisions based on the guidance for disinfectants set out in the Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049). These provisions include:

In addition, the guidance outlines the expectation that MAHs establish quality agreements with any person they rely on for activities such as manufacturing, packaging and labelling. These quality agreements will allow the MAH to outline who is responsible for certain aspects of the quality of the biocide within the supply chain. This will facilitate the investigation of complaints and help to ensure that appropriate corrective action is taken by the person responsible for the quality issue that is the source of the complaint. For example, a packager could be responsible for investigating complaints received with respect to the quality of the package.

Records

The MAH, importer and any person who manufactures, packages or labels a biocide will be required to maintain records for biocides related to each activity that they conduct. Records will allow Health Canada to investigate product quality issues and provide assurance that the MAH, importer or a manufacturer is able to recall a product. The Regulations will require the following records to be maintained:

The retention period for quality control records will be one year past the end of the shelf life of the lot or batch of the biocide to which the record relates. The retention period for records of sale will be equivalent to the last day of the month the lot or batch of the biocide expires. If the shelf life is not known (e.g. in the case of a wholesaler), records will be required to be retained for 6 years from the date the person sold the biocide. Records related to recalls will have to be maintained until the expiry of the product. Records related to post-market safety monitoring activities to support good vigilance practices will have to be retained by the MAH for 10 years.

Other provisions

Data protection

Canada has international commitments, including under the Canada–United States–Mexico Agreement and the World Trade Organization Agreement on Trade-related Aspects of Intellectual Property Rights, to provide protection for agricultural chemicals containing new chemical entities from unfair commercial use of proprietary test data. In addition, Canada also has obligations under the Canada-European Union Comprehensive Economic and Trade Agreement to provide test data protection for plant protection products (i.e. pest control products). To meet these commitments, the PCPA and PCPR set out a data protection program for new active ingredients and their associated end-use products. Data protection is intended to both encourage the registration of new innovative pest control products and promote the availability of generic pest control products by outlining conditions that an applicant needs to follow when relying on an existing registrant’s data.

Registrants of some surface sanitizers have data protection in accordance with the PCPR. Unlike pharmaceutical drugs, disinfectants are not offered data protection under the FDR. To align with current practice for disinfectants under the FDR, the Biocides Regulations will not offer data protection for biocides. For current surface sanitizer registrants, Health Canada is allowing them to maintain their registration and data protection under the PCPA for a period up to four years following the coming into force of the Biocides Regulations.

Consequential amendments

Consequential amendments will be made to the PCPR to exempt biocides from the PCPA and its associated regulations. The FDR will be amended to remove references to disinfectants and antimicrobial agents. An amendment will be made to the Medical Devices Regulations for greater certainty, to ensure that contact lens disinfectants and high-level disinfectants and sterilants intended for use on medical devices that are classified by Health Canada as invasive or indirectly invasive, fall within the scope of those regulations. In addition, the Natural Health Products Regulations will be amended to include biocides in the list of Excluded Natural Health Product Substances.

Transition and coming into force

Coming into force

The Biocides Regulations will come into force one year following the registration of the Regulations, although certain amendments relating to transition will have a delayed coming-into-force date, as further described below. The one-year delay in coming into force will provide industry with the time to prepare their applications for new products according to the new requirements. Applicants submitting for a new market authorization will be required to meet all regulatory requirements in the Biocides Regulations following the coming-into-force date.

Transition

A transition period of four years following the coming into force of the Biocides Regulations will allow existing registration and authorization holders of already-marketed surface sanitizers and disinfectants to clear current stock, update labels (if required) within their normal business cycle and update internal processes to comply with post-market requirements. This is expected to reduce environmental impacts and compliance costs associated with meeting the requirements in the Biocides Regulations.

Authorization holders of disinfectants and registrants of surface sanitizers who wish to continue to hold a market authorization for their product as a biocide will be required to file a transition application and receive a market authorization under the Biocides Regulations within four years following their coming into force. As these products were previously reviewed under other regulatory frameworks with similar standards, they will be exempt from providing information relating to the benefits and risks of the biocide, as well as the product specifications, provided there are no changes being proposed to the product, except for an addition or a change in brand name and shelf life. In addition, existing authorization holders of disinfectants will be exempt from providing label text as there will be fewer changes required for disinfectant labels as compared to those of surface sanitizers.

As surface sanitizer registrations under the PCPA need to be renewed every five years, registrants will be able to file an abbreviated application under the Biocides Regulations within the four-year transition period as their product registrations are set to expire. Registrants of surface sanitizers with both sanitizer and pesticide-related claims on their product will have the option of maintaining their registration under the PCPA, but will be required to submit a label amendment application to remove all biocide-related claims and information from their product. Registrants of surface sanitizers with biocide claims who wish to continue to market their product as such will require a market authorization under the Biocides Regulations.

Authorization and registration holders that fail to transition their products within the transition period will be considered out of compliance with the FDA and the Biocides Regulations and may be subject to compliance and enforcement action. In addition, the DIN of any disinfectant issued under the FDR will no longer be valid at the end of the transition period. Transition applications will no longer be accepted after the end of transition period and applicants will be required to submit a full product application for review to receive a market authorization under the Biocides Regulations.

Surface sanitizers for use in food premises that do not have a DIN will be provided with a six-year transition period following the coming into force to obtain a market authorization under the Biocides Regulations. This will provide companies that currently market these products with time to conduct the necessary testing to support the safety, efficacy, and quality of their products and implement the systems necessary to come into compliance with the post-market requirements of the Biocides Regulations.

As some applications filed under the PCPA and the FDR have long performance standards, it is possible that there would be some applications that are filed prior to the coming into force of the Regulations that would not receive an authorization or registration by the time the Regulations come into force. Health Canada will continue to review these applications to issue a decision under those respective frameworks. However, the transition period timelines and requirements will remain the same for these authorizations and registrations to transition to the Biocides Regulations. Applicants will have to take this into consideration when choosing their approach to filing an application and this will be clearly communicated throughout the transition to stakeholders.

Regulatory development

Consultation

Consultation prior to prepublication in the Canada Gazette, Part I

To inform the proposed Biocides Regulations, consultations were undertaken prior to their prepublication in the Canada Gazette, Part I (CGI). Health Canada has closely collaborated with industry stakeholders and has maintained an open dialogue on issues related to shortages during the COVID-19 pandemic, as well as challenges surrounding application processes and requirements.

Stakeholder consultations to support the development of the proposed Biocides Regulations took place in July 2019 and on April 7, 15, and 20, 2021. Key components of the proposed framework were discussed at the sessions, including scope, market authorization, packaging and labelling, and post-market authorities and requirements, and stakeholders were provided the opportunity to submit additional written feedback following these sessions. Overall, most stakeholders expressed their support for the proposed regulations during these stakeholder sessions, as the regulation of similar products under different regulatory schemes has been a long-standing irritant for most industry stakeholders. Certain stakeholders voiced support for regulating surface sanitizers under the FDA, certain application provisions and labelling requirements, the removal of the annual summary report requirement, and continued exemptions from drug establishment licence and good manufacturing practices requirements. Some stakeholders expressed the desire to have an application framework that would allow for one market authorization that included multiple brand names and formulations. Concerns were also raised during these sessions on certain post-market requirements, as well as the length of the transition period.

There was mixed feedback with respect to the introduction of a UFD pathway. Some stakeholders strongly supported the UFD pathway and advocated for it to be expanded to include more trusted regulatory authorities, in addition to the U.S. Some raised concerns, however, that the UFD pathway would be disadvantageous for companies that do not sell biocides in the U.S.

A costing survey to inform the Cost-Benefit Analysis (CBA) was introduced at a stakeholder session conducted in April 2021. The survey was formally distributed by email to stakeholders for their response by June 25, 2021.

Health Canada analyzed the feedback obtained through these different consultation and engagement activities to inform the prepublication of the Biocides Regulations in CGI.

Stakeholder feedback in response to prepublication in the Canada Gazette, Part I and subsequent consultation activities

The proposed Biocides Regulations were published in CGI for a 70-day consultation on May 7, 2022. An engagement session with key industry associations was held on May 26, 2022, to provide a more in-depth overview of the proposed Regulations and the fee proposal as well as to provide industry an opportunity to seek clarification and ask questions.

Health Canada received 25 submissions from biocide industry stakeholders. More specifically, submissions were received from seven industry associations, 15 businesses, and three individuals. The comments were published using the Online Regulatory Consultation System.

Specific areas of support included:

Specific areas of concern included:

Diverging feedback was provided on the topics of:

Following the receipt of feedback in response to the CGI prepublication, Health Canada met with stakeholders on November 29 and December 14, 2022, as well as March 27, June 26-27, and July 11, 2023, to further clarify certain aspects of the proposal and to better understand technical issues and challenges that may arise as a result of the Biocides Regulations. Stakeholders did not voice concerns on most of the revised proposals and most were generally supportive of including surface sanitizers for use in food premises within the scope of the Regulations as this would enable a consistent and predictable approach to regulating these products to protect the health and safety of Canadians. Concerns raised were specific to the UFD pathway, regulating biocides under the FDA instead of the PCPA and the unique challenges of including surface sanitizers for use in food premises within the scope of the Biocides Regulations, including the need for sufficient time to obtain a market authorization and the costs associated with this transition.

In addition, a second costing survey to refine the information included in the CBA supporting these Regulations was sent to industry stakeholders by email on December 16, 2022, with a request for their response by March 17, 2023.

Through the formal CGI consultation and the follow-up meetings and discussions, stakeholders provided varied feedback on the proposal ranging from supportive to critical. A more in-depth summary of the comments related to specific topics and Health Canada’s response is included below. A number of adjustments have been made to the Regulations and associated guidance documents to address concerns where necessary.

Scope

Regulation of biocides as pest control products: Industry associations from Quebec have continued to advocate for the regulation of biocides under the PCPA since the 2001 regulatory amendment to the PCPR that transferred the regulation of disinfectants to the FDR. They have provided the rationale that it would increase international alignment and enable the use of claims beyond human and animal pathogens.

This concept was considered by Health Canada in 2001 and at that time it was determined that disinfectants were more appropriately regulated as drugs under the FDA. This is because the primary purpose of a disinfectant is to destroy or inactivate micro-organisms, or to reduce or control their numbers to prevent diseases in humans and animals. Health Canada’s position remains the same for biocides.

Surface sanitizers for use in food premises: An industry association commented that they would prefer to keep the process of allowing market access through a letter of no objection for surface sanitizers for use in food premises, or to create a separate authorization process outside of the Biocides Regulations with a separate cost recovery framework. They mentioned that the inclusion of surface sanitizers for use in food premises within the scope of the Biocides Regulations will increase burden, as these products are currently not subject to similar regulatory requirements. Other industry stakeholders supported the inclusion of these biocides within the scope of the Regulations. They recognized the need for consistency in the regulation of surface sanitizers for use in food premises and indicated that doing so may facilitate alignment between provincial and federal requirements. Separate stakeholders indicated that consistent regulation of surface sanitizers for use in food premises may facilitate the exportation of food products manufactured in Canadian facilities by providing greater confidence that these facilities are using authorized surface sanitizers. Even though supportive of the intent, these stakeholders highlighted concerns that the proposed one-year timeline for those marketing these products to bring them into compliance with the Biocides Regulations is not feasible. Many of these products will require testing to comply with the Regulations and their manufacturers will be submitting applications to Health Canada for review. This will place a burden on the small number of testing facilities in Canada, as well as Health Canada for the review of these applications.

To achieve the intent of regulating biocides under a single framework and to ensure that there is consistency and predictability in requirements and oversight for biocides, surface sanitizers for use in food premises will remain within the scope of the Biocides Regulations as proposed. Health Canada has provided an extended transition period of six years to allow additional time for them to be brought into compliance with the Regulations and to mitigate impacts to Health Canada and impacted industry stakeholders. In addition, Health Canada plans to facilitate the authorization of surface sanitizers for use in food premises by increasing the number that would be eligible to use lower cost abbreviated application pathways, such as the “Biocide monograph pathway”.footnote 27

Addition of other disinfectants and sanitizers to the scope: Different industry stakeholders provided feedback suggesting other categories of disinfectants and sanitizers be included in the scope of the Biocides Regulations. Specifically, they advocated for the inclusion of air and water sanitizers and disinfectants, products used on agricultural surfaces and in greenhouses, and self-sanitizing surfaces.

At this time, the oversight for these categories of sanitizers and disinfectants continues to be appropriate under other acts and regulations. These products have differences in their configuration, use patterns, methods and rates of application, and exposure as compared to biocides that fall within the scope of the Biocides Regulations. Additional analysis would be required to determine if the regulatory requirements in the Biocides Regulations would be appropriate for these products.

Application Requirements

Contact information requirements at time of application for members of the supply chain: As part of the proposed Biocides Regulations, those applying for market authorization would have been required to provide at the time of application:

In addition, any time there was a change in those who manufacture, package, label, or import a biocide, or to the civic addresses of these supply chain players, that information would have had to be updated with Health Canada.

This proposal received mixed comments from stakeholders, with some communicating that it was important to know the information about who is conducting these activities and others suggesting that providing just the country of manufacture should be sufficient. They mentioned that this information changes frequently and this proposal is not consistent with Health Canada’s more modernized approach to supply chain information requirements for other products, such as pest control products.footnote 28 For drugs regulated under the FDR, supply chain information is obtained through the application for a drug establishment licence. While those conducting activities with respect to disinfectants are not required to obtain a drug establishment licence, a voluntary standard to support compliance was developed by Health Canada for disinfectants.

The Biocides Regulations do not require a drug establishment licence for persons who conduct activities with respect to biocides; however, it is reasonable to expect that those submitting an application for authorization should be in a position to identify persons involved in any manufacturing and importation activities. This information is important in supporting Health Canada’s post-market compliance and enforcement activities. Including just the country of manufacture would not be sufficient to enable post-market activities to be carried out for facilities located outside of Canada or to facilitate international collaboration should an issue be identified. Health Canada maintains that contact and address information for the manufacturer and importer will be required at the time of application; however, if not available at the time of application, the contact information of the packager and labeller will be required at the time of first sale.

The Biocides Regulations will also require that manufacturer and importer information be updated with Health Canada if it changes post-authorization. However, to reduce burden, Health Canada has removed the requirement for the packager and labeller information to be updated with Health Canada if it changes. These updates will instead need to be kept on file by the MAH and provided to Health Canada upon request.

Decontamination procedures and directions for disposal: Industry stakeholders highlighted discrepancies between the application requirements and label requirements for decontamination procedures and directions for disposal. For decontamination procedures, they outlined that this requirement should only apply to commercial biocides. In addition, they communicated that this information is already provided to users of commercial biocides through the safety data sheet, which is a Workplace Hazardous Materials Information System requirement for products that fall under the Hazardous Products Act.

Health Canada has removed decontamination procedures and directions for disposal from the application requirements in the Biocides Regulations. The inclusion of these statements on the marketed labels will continue to be recommended through guidance and it will be the MAH’s responsibility to ensure that the information provided on the label aligns with municipal, provincial, territorial and other federal regulatory requirements. This also aligns with operational policies for cleaners regulated by Health Canada.

Intended Users: The proposed Biocides Regulations required the intended user of a biocide to be indicated in the application for market authorization and on its label. The intent of this requirement was to align with certain foreign authorities (e.g. the European Chemicals Agency). In addition, it would have allowed Health Canada to review the potential levels of exposure to certain users when analyzing a biocide’s benefits, risks, and related uncertainties and communicate appropriate information to the user. However, industry stakeholders advocated for removing this requirement. They mentioned that this information can be inferred through the settings for use, which is also required to be provided in the application and on the label of a biocide.

The inclusion of the setting for use in the application and on the label will provide sufficient information to determine how and where the biocide will be used. In addition, no disinfectant or surface sanitizer is currently authorized for use by a specific intended user. Should additional information be required to address any uncertainties with a biocide, Health Canada would be able to request this information, as necessary. Therefore, the requirement to provide the intended user in the application for market authorization and on the label has been removed from the Biocides Regulations.

Summary of information provided to determine a biocide’s benefits and risks: Industry stakeholders did not support the requirement to provide a summary of the information that is included in the application regarding the biocide’s benefits and risks. They mentioned that this would increase burden on the applicant, especially for “Biocide monograph pathway” applications, and this should remain a voluntary measure as is currently done for disinfectants in Canada, and in the U.S. per U.S. EPA guidance.

Health Canada intends these summaries to be brief, high-level documents that will help achieve efficiencies during the review process and minimize the likelihood of screening deficiencies. Health Canada has maintained the requirement for a summary to be provided, which aligns with requirements in the U.S.; however, additional clarity on how to apply the Regulations in terms of content and format has been included in guidance. In addition, unless a monograph includes specific risk information, an abbreviated summary report will be accepted for biocide applications referencing a monograph. This will help to reduce burden while still enabling Health Canada to review information about the benefits and risks of the biocide.

Product specifications: Extensive comments were provided regarding the proposed product specification requirements for biocide applications. Some industry stakeholders indicated that Health Canada’s approach would result in a disproportionate level of burden for the level of risk that biocides pose. They explained that, currently, product specifications are only required for disinfectants that receive an authorization through Division 8 of the FDR and the proposed Regulations would extend these more stringent requirements to biocides applying through the “Biocide monograph pathway” and the “Biocide comparison – administrative pathway”.footnote 29 These stakeholders suggested that product specifications should be maintained by the applicant or MAH and only provided to Health Canada upon request. Other industry stakeholders stressed the importance of biocide quality and supported that product specifications be required for all biocides.

To support a safe, effective, and high-quality supply of biocides for Canadians, Health Canada has maintained the requirement for applicants to include product specifications that was outlined in the proposed Biocides Regulations. However, the guidance has been revised to provide additional clarity on how to meet these requirements and the level of detail required, depending on the benefits, risks, and related uncertainties of the biocide.

Package specifications: Industry feedback related to the application requirement to provide packaging specifications was mixed. Certain stakeholders did not find this approach to be appropriate given their perception that biocides have lower associated risks to health. In addition, they mentioned that properties and qualities of the packaging should not be required given there have been no recent quality issues related to products that would fall within the scope of the Biocides Regulations. These stakeholders preferred standards to remain in guidance. Other stakeholders communicated that removing the requirement for packaging information in the application would be a potential risk to the health and safety of Canadians.

Health Canada has retained the requirement for packaging information to be included in applications for biocide market authorization. This information will support Health Canada in determining that the packaging meets the requirements in the Biocides Regulations before issuing a market authorization. In addition, this information will help ensure that biocides are not packaged in containers that could cause them to be mistaken for a food or beverage and reduce the potential for accidental poisonings related to biocides. In 2020, approximately 21% of calls to the poison control centre were related to disinfectants, which increased significantly during the pandemic.footnote 30 Health Canada has also clarified the type of information and level of detail needed to meet this requirement in guidance.

Shelf life and stability information: Health Canada proposed to require the shelf life of the biocide as an application requirement, and in guidance, to recommend that stability data be provided to support the stated shelf life. Industry stakeholders were supportive of the requirement to provide shelf life information at the time of application; however, some outlined that they did not support the requirement of stability data to be provided as this would introduce new compliance requirements for applicants.

As the Biocides Regulations do not include drug establishment licence or good manufacturing practices requirements similar to those required for pharmaceutical drugs regulated under the FDR, it is important that there be mechanisms in place to ensure the quality of biocides in Canada. Shelf life will continue to be an application requirement for all biocides; however, the guidance will be revised to add clarity on expectations regarding when stability data should be provided. This will enable a risk-based approach focused on biocides with increased uncertainties. Health Canada will continue to rely on an attestation that MAHs have the stability data necessary to support the shelf life of the biocide and that the biocide will be subject to a continuing stability program.

Labelling and Packaging

Small package labelling: Stakeholders communicated that there should be a clear definition in the Regulations of what constitutes a small package. In addition, despite overall concerns with the costs associated with labelling changes, some stakeholders proposed that the identification number be required on the label of the small package instead of the setting for use.

The labelling requirements in the Biocides Regulations are based on the requirements outlined in the FDR for disinfectants. Given that the suggested changes to the labelling requirements would increase costs for industry, Health Canada is maintaining the small package labelling requirement for biocides. In addition, introducing a definition of what constitutes a small package would potentially remove labelling flexibilities for industry and increase compliance burden. Health Canada encourages those who want to include the identification number and “DIN” designation on the label of a small package to do so as a voluntary measure.

Expiry date: A stakeholder indicated that household biocides with a shelf life greater than one year should not be provided an exemption from displaying an expiry date on their label.footnote 31 This stakeholder maintains that every biocide should have an expiry date on the label.

Both surface sanitizers and disinfectants are currently offered the flexibility to not include an expiry date on products with a shelf life greater than one year under their current regulatory frameworks. As such, the introduction of this requirement for biocides would be an additional cost to industry. Health Canada encourages those who want to include an expiry date on the label of an exempted biocide to do so as a voluntary measure.

Designated containers and pressurized container labelling: Industry stakeholders provided some suggestions related to the packaging and labelling of pressurized containers. They outlined that in the definition of designated container, the word “metal” should be removed to allow for innovation in this space. They also stressed that there is a need to formalize a safety labelling standard in regulation that takes into consideration alignment of international and domestic requirements, including the consideration of the Global Harmonized System of Classification and Labelling of Chemicals, the Hazardous Products Regulations for commercial biocides, and the Consumer Chemicals and Containers Regulations for household biocides. In addition, they suggested that the incorporation by reference document outlining the technical pressurized container labelling requirements should be an ambulatory list. This would allow for more efficient updates if necessary and provide the ability to expand the scope of this list beyond just pressurized containers to potentially include other labelling aspects.

The pressurized container labelling requirements included in the Biocides Regulations carry over the requirements that exist for disinfectants in the FDR to avoid additional costs for industry and maintain consistency with other health products regulated under the FDA. The incorporation by reference document outlining these requirements is incorporated as a static reference to allow for the FDR requirements to be transferred to the Biocides Regulations without any additional costs to industry. Health Canada will consider amendments to harmonize the definition of designated container across health and consumer products in the future.

Application pathways

Applications based on comparison - letter of authorization: In the guidance that accompanied the prepublication of the proposed Biocides Regulations, it was indicated that a letter of authorization would be required to show explicit consent when applying for an authorization based on comparison to another biocide already authorized in Canada, consistent with the current policy for disinfectant applications based on comparison. Industry stakeholders commented that these letters of authorization should be referenced formally in the Regulations.

Consistent with the proposed Biocides Regulations, an attestation will be required for applications based on comparison, to ensure the applicant has received the master formula for the biocide being used as the comparator. This ensures that the biocide, when manufactured, will be a true copy of the biocide being used as the comparator. Changes have been made to the Regulations and guidance to reflect these considerations.

Subsequent authorizations through the Use of Foreign Decisions pathway and by comparison: It was proposed that biocides applying for an authorization based on a comparison could not use a biocide that obtained authorization through the UFD pathway as a comparison product for subsequent Canadian authorizations. Industry stakeholders commented that this would significantly decrease the potential benefits of the UFD pathway, and the volume of applications based on comparison, as it would increase the cost for industry to bring products to the Canadian market. They stated that allowing UFD-authorized biocides to be used as comparators would benefit small- and medium-sized companies. These companies would otherwise be required to develop and submit a complete data package and be subject to a full review to receive market authorization in Canada.

Health Canada has revised the policy to allow certain biocides authorized through the UFD pathway to be used as a comparator for an application for authorization based on comparison. Health Canada understands the importance for companies with internationally authorized products to be able to use the UFD pathway to continue to support their business agreements with those, in particular small businesses, that rely on their data. To mitigate any risks associated with stakeholders’ suggestion to permit all biocides authorized through the UFD pathway to be used as a comparator, Health Canada will require the MAH of the biocide authorized through the UFD pathway to be the holder of the foreign registration or authorization. Health Canada will rely on the MAH of the biocide authorized through the UFD pathway to respond to any post-authorization requests from Health Canada regarding the benefits and risks of the biocide.

Monograph applications: Stakeholders commented that applications received through the “Biocide monograph pathway” should allow for variations in formulation beyond those related to fragrance or colour that are less than or equal to 1% of the total product.

The “Biocide monograph pathway” is considered an abbreviated review pathway. As the applicant is relying on a monograph for aspects related to efficacy, a full review is not required. Introducing the ability to include multiple formulation variations beyond 1% of fragrance or colour would require additional review. An applicant obtaining a market authorization through the “Biocide monograph pathway” will be required to submit a post-authorization change application for a notice of acceptance to add additional formulations through the appropriate full review pathway.

Transition applications: Stakeholders voiced their support of transition applications that are both low in administrative burden and cost to industry. Some suggested that Health Canada allow for the consolidation of multiple formulations and brand names under one market authorization as part of the transition application and proposed that appropriate fees be included for any associated review. As proposed, the MAH would be required to submit two applications to Health Canada; one to transition the biocide and one to consolidate formulations and/or brand names.

Health Canada has revised the Regulations to allow for companies to add or modify brand names within a transition application. Companies will still be required to submit a separate application to add or modify formulations. Including additional aspects in the transition application that require review will increase the processing time for all applications and the risk that an application may be refused, resulting in the transitioning biocide no longer being authorized for sale in Canada. Alternatively, a company will be able to choose to file a new biocide application, instead of going through the transition process to consolidate multiple formulations under one market authorization.

Use of Foreign Decisions

List should include additional foreign authorities: Industry stakeholders communicated that Health Canada should expand the incorporated by reference list that identifies trusted foreign authorities whose regulatory decisions may be relied on for the UFD pathway to include the European Union, the United Kingdom, Japan, or other countries. They suggested that Health Canada should evaluate all foreign authorities for inclusion on the list by using criteria that is publicly available and applied in a consistent and unbiased manner. Stakeholders identified that this approach has been taken by the CFIA for the equivalency of international food inspection systems.

At this time, the list of trusted foreign regulatory authorities will be limited to the U.S. EPA. Health Canada will be conducting analyses with the intent of adding additional trusted foreign regulatory authorities. Health Canada will add other foreign regulatory authorities once a determination has been made that their standards for authorizing biocides for sale and other requirements meet those included in the Biocides Regulations. The foreign regulatory authorities being prioritized in this analysis include those highlighted during consultation feedback. Furthermore, Health Canada has revised the guidance to increase clarity on the process and criteria used to establish the list and will consult with Canadian stakeholders prior to making changes to the list.

Insufficient regulatory oversight for products authorized through the Use of Foreign Decisions pathway: Industry stakeholders who did not support the UFD pathway communicated that applications for a biocide market authorization through the UFD pathway should require the same detailed information relating to package specifications, product specifications and the biocide’s benefits and risks as those subject to a full review. They also raised concerns about Health Canada’s ability to conduct post-market surveillance and evaluate emerging risks for biocides authorized through the UFD pathway.

Health Canada does not need to review product specifications as part of a UFD pathway application as these applicants are attesting that their product will be manufactured according to the same master formula as the foreign biocide. As stated in the Biocides Regulations, Health Canada will continue to require applications through the UFD pathway to submit information related to the biocide’s packaging. In addition, the list of tests and studies that is required to be provided in the application will be used to ensure that the methods used to establish the benefits and risks of the foreign biocide meet Health Canada’s standards. The post-market surveillance elements included in the Biocides Regulations, such as incident reporting, safety monitoring and records retention, will be maintained for products authorized through the UFD pathway. These measures are necessary for Health Canada to remain aware of significant safety issues and allow appropriate assessment of any emerging risks. In addition, for products authorized through the UFD pathway, Health Canada must be notified without delay if the foreign biocide has been recalled, the foreign authority has required a change to the product, or its authorization has been suspended or revoked. Health Canada can also request the information on the benefits and risks, or the specifications submitted to the foreign regulatory authority from the MAH of the biocide authorized through the UFD pathway at any time.

Disproportionate disadvantage to small businesses: Two associations representing Quebec-based industries raised that the UFD pathway is more likely to benefit large companies that already sell biocides in multiple countries and will pose a competitive disadvantage for small Canadian businesses that do not sell biocides in the U.S. They stated that this is contrary to the objectives of the small business lens and also raised concerns that this has the potential to increase dependence on foreign biocides. In contrast, another industry association voiced that many small Canadian businesses rely on authorizations based on comparison to bring their biocides to market. The use of these comparison pathways creates a more expedited authorization process and removes the need for applicants to conduct their own testing, and also, the introduction of the UFD pathway could expand the number of available comparison products.

Health Canada acknowledges that the introduction of the UFD pathway will impact industry stakeholders differently; however, Health Canada anticipates that the Biocides Regulations will benefit most of the industry and Canadians. The UFD pathway is expected to encourage innovative products to be brought to the Canadian market and increase Canadians’ access to safe and effective biocides.

Health Canada will be maintaining the UFD pathway as part of the Regulations as it will be a more efficient way to review biocides, reducing fees and the length of time for qualifying companies to obtain market authorization in Canada without compromising health and safety. Health Canada would also be able to reallocate resources to focus on the review of innovative biocides. The UFD pathway could reduce burden for Canadian small businesses who possess or can access the information used to authorize a biocide in the U.S., to support their application in Canada. Small businesses that rely on other companies for developing and obtaining authorization for biocides may also use the UFD pathway to bring a greater variety of products to the market sooner through licensing agreements.

Health Canada will be conducting an analysis with the intent of expanding the list of trusted foreign regulatory authorities so that the UFD pathway will be available to a wider range of stakeholders who do business in other jurisdictions. Before changes to the list are made, Health Canada will conduct analysis and seek stakeholder feedback to better understand the potential impacts of proposed changes.

Post-authorization changes

Definitions of major and minor change: Stakeholders commented that the proposed regulatory definitions of major and minor change do not align with current requirements for disinfectants and will increase cost and compliance burden for industry. They mentioned that the included changes relating to product specifications, package information, and shelf life do not enable a risk-based approach to the oversight of biocides. In addition, stakeholders suggested that certain types of changes such as those relating to settings for use and directions for storage should be reclassified. Stakeholders commented that the FDR does not require the MAH to file changes to setting for use and directions for storage for disinfectants. In some cases, these changes only require a notification and are not cost recovered.

Health Canada has removed references to product specifications, package information, and shelf life in the post-authorization changes section of the Regulations. The definitions of major and minor change in the Regulations will be relied on for these aspects to provide the high-level criteria to classify these changes. Guidance will provide more specificity on when a notice of acceptance is needed to support a major change. This will ensure that the appropriate information and data is provided to support the change and will reduce burden for both industry and Health Canada. In addition, Health Canada has revisited and analyzed what changes would require data for review (major change pathways) versus those that would not (minor change pathway). Following this exercise, the Regulations have been revised with respect to changes relating to the method of application and directions for use. The guidance has also been revised to clarify when changes relating to risk information, settings for use and directions for storage require a post-authorization change application or notification.

Variations in formulants and confirmatory data: The proposed Biocides Regulations allowed for variations in formulants with guidance further specifying that variations of fragrance or colour of 1% or less of the total formulation would not require the submission of additional data. This is a policy currently in place for disinfectants regulated under the FDR. Stakeholders requested that Health Canada expand this approach to allow more substantial changes to biocide formulations without requiring confirmatory data.

The Biocides Regulations continue to allow for variations in formulants with guidance further specifying that these variations of fragrance or colour of 1% or less of the total formulation do not require the submission of additional data. In addition, Health Canada will work toward addressing what was heard by developing a repository of certain formulant variations that would be considered ’similar’, and as such would not require confirmatory data.

Changes to products authorized through the Use of Foreign Decisions pathway: A stakeholder noted that an MAH submitting a major change application for a product approved through the UFD pathway would not be required to provide any supporting information for the major change if the conditions in the proposed Biocides Regulations were met. They mentioned that this would create advantages for biocides authorized through the UFD pathway and could allow for information gaps that pose risks to Canadians. They reiterated that products authorized through the UFD pathway should be subject to the same requirements as products authorized through the full review pathway provided through the Regulations.

The Regulations have been revised to require that information relevant to a major change be included in an application for a notice of acceptance, even if that change has already been authorized by a foreign regulatory authority. However, this process is still expected to save industry authorization costs and reduce the length of time for Health Canada to make regulatory decisions since applicants will not have to provide all information that is needed in a full major change application. The Minister will be able to request the data that the MAH submitted to the foreign regulator related to the change and will also be able to request additional information to make a determination on the benefits and risks of the change. Health Canada has revised the Biocides Regulations and guidance to clarify the application requirements for changes to biocides authorized through the UFD pathway.

Transparency

Stakeholder feedback was mixed regarding the information proposed to be published as part of a biocide market authorization. Some stakeholders supported this measure and suggested that a database similar to the U.S. National Pesticide Information Retrieval System be developed to house this information. Other stakeholders did not support the publication of information about the chemical identities of formulants or the identity of the comparison product or foreign biocide if one was used to obtain authorization. They mentioned that this information would provide no value to users, has the potential to identify business partnerships and ongoing contractual agreements and could penalize the industry by tying several commercial products together.

Health Canada is committed to the publication of market authorization information as it is consistent with Health Canada’s approach to openness and transparency in regulatory decision making. Health Canada has removed the requirement for the Minister to publish identifying details about the comparison product or foreign biocide used to obtain an authorization. However, the Regulations will instead require that the Minister publish information in the market authorization to indicate how the authorization was granted, for example, through the UFD pathway. Health Canada will continue to require that the contents of the market authorization be made public, excluding the formulant quantities and CAS numbers.

Data protection

Some stakeholders mentioned that Health Canada should have mechanisms in place to ensure confidentiality of business information of biocides to align with requirements for pest control products regulated in Canada, and biocides regulated in the U.S. and the European Union. Others recommended that Health Canada conduct additional stakeholder engagement to ensure that current registration holders of surface sanitizers are aware of any data protection considerations under the Biocides Regulations.

Health Canada continues to distinguish biocides as being separate from pharmaceutical products and understands that trade agreement obligations for data protection are only applicable to pharmaceutical products. In addition, Health Canada has committed to engage registrants of surface sanitizers to ensure they are aware of the data protection implications and has set a transition period that will allow implicated products to exhaust their data protection. Health Canada will also rely on product-specific test data for applications for a biocide market authorization and only allow applicants to reference another biocide’s authorization if the MAH of the biocide used as a comparator has provided the applicant with the master formula for that biocide.

Quality control requirements

Industry stakeholders did not support the quality control requirements included in the proposed Biocides Regulations. They explained that as biocides are applied to surfaces and not ingested or applied topically, that they should have requirements comparable to their lower-risk nature. They mentioned that the inclusion of these regulatory requirements did not acknowledge industry’s adherence to current guidance. It also did not acknowledge that there have been no quality issues with biocides that would support this increase in oversight. Other stakeholders expressed that it was not clear in the guidance what quality aspects were required by regulation and which ones were voluntary.

Health Canada does not support the generalization that all biocides present a lower risk to health than other health products regulated under the FDA. Biocides may pose risks to health if ingested, inhaled or not used according to the label, and can be corrosive, or harmful to the skin. They also may pose concerns regarding antimicrobial resistance. In addition, the quality of a biocide is an important factor in maintaining the effectiveness of a biocide and failures in effectiveness can pose risks to health. Therefore, quality oversight is important to help mitigate these risks. The quality control requirements in the Biocides Regulations provide a more modern regulatory approach to ensure that the final marketed product complies with the master formula, without the need for prescriptive regulations governing the manufacturing process. Health Canada has also revised the guidance to clarify which quality aspects are required by the Regulations and what aspects are voluntary but are recommended as a best practice.

Recall

Information and communication requirements: Stakeholders commented that the proposed information and communication requirements for recalls were overly prescriptive. Specifically, they did not support the prescriptive nature of the timelines required for recall communications, notifications, and reporting. In addition, they mentioned that biocides should not have requirements that are as stringent as higher-risk products such as pharmaceutical drugs, natural health products or medical devices. It was suggested that the recall process for biocides should align more with cleaning and consumer products in Canada and that oversight of communications should be addressed through policy, outside of the Regulations.

Health Canada does not support the generalization that all biocides present a lower risk to health than other health products regulated under the FDA. Some biocides are used in commercial, industrial, or institutional settings where the risks associated with exposure are amplified. As such, the information outlined in the Regulations is critical in appropriately implementing and assessing the effectiveness of a recall. Communications used in connection with the recall, and in particular the initial recall notice, are important pieces of documentation. It is important that Health Canada has an opportunity to review these documents as soon as possible to determine if the proposed approach is reflective of the health and safety risk posed by the recalled biocide. In addition, timelines prescribed in the Regulations must be precise for them to be appropriately adhered to and enforced.

System of control: Stakeholders were supportive of the proposed retention obligation for recall records and acknowledged that the requirement to maintain a system of control is consistent with what is done for pharmaceutical drugs and natural health products in Canada. However, they communicated that this requirement is overly burdensome given the lower-risk profile of biocides.

Ensuring clear obligations for supply chain players who sell a biocide is imperative to ensure an effective recall. This obligation is consistent with current disinfectant guidance (GUI-0049), as well as good manufacturing practices requirements for drugs and natural health products. Health Canada does recognize that GUI-0049 is more limited in scope with respect to whom these requirements are applicable; however, the published guidance supporting the Regulations reflects the full scope of the new requirements and how each party in the supply chain can comply with them.

Post-market surveillance

Incidents and incident reporting: Industry stakeholders communicated support for unique biocide terminology for incidents and triggers for incident reporting. However, they specified that these definitions and triggers for reporting should align more with cleaning products that are regulated under the Canada Consumer Product Safety Act instead of pharmaceutical drugs. In addition, stakeholders indicated that while including the concept of failure in effectiveness in the definitions of serious and notable incidents may be appropriate for novel biocides and other biocides that are higher risk (e.g. hospital or institutional use), Health Canada must ensure that regulatory requirements do not place a disproportionate burden on biocide authorization holders in comparison to other products regulated under the FDA.

Biocides are regulated under the FDA as drugs and not under the Canada Consumer Product Safety Act as cleaning products because of the claims they make with respect to reducing or eliminating microorganisms that can result in disease. The risks of failure in effectiveness associated with biocides can include serious illness and death and the inclusion of this within the post-market surveillance requirements is important to protect the health and safety of Canadians. The inclusion of failure in effectiveness within these definitions may also be the only way for Health Canada to become aware of any potential developments of antimicrobial resistance in microorganisms targeted by biocides.

Record keeping: Industry stakeholders stated that the 25-year retention period for records related to biocide incidents was too long and should be proportional to the lower-risk profile of biocides. Unlike pharmaceutical drugs, the consequences of serious events relating to biocides are more likely to become apparent in a shorter period. They mentioned that while the proposed safety monitoring requirements had been adapted from other Canadian legislation to better suit the unique traits of biocides, safety-related records retention had not been appropriately adjusted. It was suggested that a 6-year records retention period be used instead.

The 25-year retention period was carried over from the FDR, as the majority of products moving to the Biocides Regulations will be disinfectants and this requirement would therefore not constitute additional burden for MAHs. Health Canada has revised the retention period to 10 years, as operationally it would be unlikely for requests to go back 25 years to review data on emergent safety concerns and a retention period shorter than 10 years may be too short and lead to data being unavailable for review, for example, in cases of occupational exposure over time. This will help to reduce the burden of record keeping for authorization holders while ensuring that information is still available if an issue requires analysis, or to adequately assess trends related to safety concerns. Given that the Biocides Regulations are a new set of regulations, consideration was also given to how a change in retention period for biocides may affect future regulations for other health product lines.

Advertising: It was suggested by industry that the Biocides Regulations should outline that advertisement not be permitted for biocides in reference to the diseases listed on Schedule A.1 of the FDA.

Although biocides may not serve to prevent all diseases listed in Schedule A.1, there are some diseases that can be mitigated or prevented by biocides. For example, biocides inactivate or kill microorganisms that may cause acute infectious respiratory syndromes such as tuberculosis and COVID-19, or rheumatic fever. The Regulations provide an exemption to allow claims related to “prevention”, but not related to “treatment” or “cure” of the diseases, disorders and abnormal physical states included in Schedule A.1.

Cost Benefit Analysis

Costs to industry – new requirements: Stakeholders raised concerns with how the costs to industry were accounted for in the CBA. They focused specifically on costs related to the implementation of a system of control, post-authorization changes, transition applications for disinfectants and new application requirements. For post-authorization changes, stakeholders commented that if there is a cost to government included in the CBA for reviewing an increased volume of post-authorization change applications, then industry would be subject to similar costs to prepare these applications. For transition applications, even though the requirements are significantly reduced from a full review application, it was indicated that MAHs would still be required to complete an application and verify all details of the attestation form against internal documentation. In addition, stakeholders highlighted that costing information in the CBA did not accurately reflect application requirements in the proposed Biocides Regulations that were not status quo for disinfectant authorization holders. This would include supply chain contact information, product and packaging specifications, procedures for decontamination and requiring stability data in support of shelf life, among others. Stakeholders requested that the CBA be updated to accurately reflect these additional costs to industry and that further consideration be given to refining the associated sections of the regulations and guidance.

Following prepublication of the proposed Biocides Regulations in CGI, Health Canada conducted a supplementary costing survey and targeted consultation sessions with industry stakeholders to confirm and clarify cost estimates used in the CBA. In addition, Health Canada conducted further analysis to better identify the scope and number of impacted products. Both of these activities provided data to support updates to the CBA, the Biocides Regulations, and guidance.

Safety monitoring is considered a compliance cost for industry, while record keeping is considered an administrative cost. Based on industry responses to the initial CBA survey, the potential cost to MAHs as a result of these requirements was deemed to be cost neutral due to a lack of sufficient data provided. However, for recall reporting, record keeping and quality control, the cost may vary depending on whether those within the supply chain that sell a biocide have adequate systems in place. While Health Canada is not aware of any distributors or importers that are non-compliant with the current guidance for disinfectants, these requirements are considered new to those only selling surface sanitizers and surface sanitizers for use in food premises. Based on responses to the supplementary CBA survey, additional costs were identified for businesses where this would be deemed a new requirement. If a business is non-compliant, the associated costs for the establishment and implementation of a system of control have been outlined in the updated CBA.

Based on responses to the supplemental survey, Health Canada was able to better reflect the costs to industry in the CBA associated with application requirements that differ from the status quo, as well as for transition applications. In addition to updated costs attributed to application requirements, costs to industry were identified with the preparation of post-authorization change applications, aligning with the assumed increase in costs to the Government of Canada.

Costs to government – clarification requests: An industry association stakeholder did not support the costing information included in the CBA relating to the increase in requests for guidance or clarification from industry. They indicated that since the Biocides Regulations are tailored specifically to biocides and Health Canada has developed extensive and comprehensive biocide guidance to support the understanding of the regulatory requirements, the need for Health Canada to support applicants further should be minimal, except for those using the novel biocide pathway.

Health Canada has developed extensive guidance and will conduct information sessions following the publication of the Biocides Regulations to help impacted stakeholders understand and comply with the requirements. However, it is not possible to include every scenario that industry may have questions about in the guidance. There will be companies that market biocides that have not been subject to regulatory requirements under the FDA prior to the coming into force of the Biocides Regulations, and those applying for market authorization of novel biocides, that may require more information during the application process. In addition, the scope of the Biocides Regulations goes beyond just disinfectants and includes surface sanitizers that are regulated under the PCPA and surface sanitizers for use in food premises that fall under the purview of the FDA. This increases the volume and diversity of products that will be subject to these Regulations and of companies that will access the resources offered by Health Canada.

Costs to government – surface sanitizers for use in food premises: An industry stakeholder estimated that there are between 700 - 1200 surface sanitizers for use in food premises currently marketed in Canada that are without a DIN and will require authorization under the Biocides Regulations. They mentioned that the CBA did not account for the operational cost to the government of processing such a large number of applications related to these products during the transition period.

An internal analysis using data previously collected by the CFIA indicates there are currently an estimated 588 surface sanitizers for use in food premises, without a DIN or pest control product number, that will need to transition to the Biocides Regulations to maintain market access. Health Canada has provided an extended transition period of six years for surface sanitizers for use in food premises to allow additional time for them to be brought into compliance with the Biocides Regulation. This includes updating labels, developing any internal systems, and conducting any required testing. This additional time will also help mitigate impacts to Health Canada in terms of reviewing applications and responding to clarification requests in a timely manner. To further facilitate the transition of surface sanitizers for use in food premises to the Regulations, Health Canada will aim to expand the lower cost monograph application pathway to include some of these biocides. The associated costs and benefits included in the CBA have been updated to reflect the revised policy.

Methodology – benefits relating to the Use of Foreign Decisions pathway: Some industry stakeholders indicated that the cost differences outlined between the baseline scenario and the regulatory scenario within the CBA should not include the UFD pathway. They stated that as the UFD pathway applies to products registered in foreign jurisdictions, cost reduction will only be available to industry outside of Canada which does not need further incentives to market in Canada at the expense of Canadian companies. In addition, they mentioned that the benefits included in the CBA for the UFD pathway were exaggerated due to an overestimation of the number of biocide manufacturers marketing in Canada, both foreign and domestic. In terms of the qualitative benefits, industry stakeholders did not agree with the benefits listed relating to shortages. They communicated that shortages of biocides in Canada during the pandemic were due to Canada’s reliance on active ingredients from the U.S. and that enabling more biocides to register in Canada through the UFD pathway would not have changed this situation.

Health Canada acknowledges that the UFD pathway will benefit some industry stakeholders more than others. Many small Canadian companies have experienced challenges competing with, and maintaining their market share alongside, larger corporations and may continue to do so. However, many small Canadian businesses rely on applications based on comparison to bring their biocides to market, removing the need to conduct their own testing and generate their own data. Canadian companies are not precluded from using the UFD pathway and it could expand the number of available comparison products while expediting the process for these companies to obtain an authorization under the Biocides Regulations. It was evident during the COVID-19 pandemic that Canadians’ continued access to safe and effective biocides is important. In a situation where specific biocides or their active ingredients may be in shortage, the UFD pathway is a tool to facilitate new and innovative products being brought to the Canadian market in an expedited manner, without relying on emergency measures.

Following prepublication of the proposed Biocides Regulations in CGI, Health Canada has conducted an updated distributional analysis of biocide companies operating in Canada and internationally and this analysis has informed updates to the CBA.

Standing Committee on International Trade Study

The Standing Committee on International Trade adopted a motion introduced by a Member of Parliament to study the impact of the proposed Biocides Regulations on competition, with specific focus on the inclusion of the UFD pathway. Witnesses appeared on October 31 and November 2, 2023, and included officials from Health Canada and Global Affairs Canada, industry associations representing small businesses in Quebec (Groupement provincial de l’industrie du médicament and l’Association pour le développement et l’innovation en chimie au Québec), industry associations representing a more broad range of small and large businesses across Canada (Canadian Consumer Specialty Products Association and Food, Heath and Consumer Products of Canada), a pest control product industry association (CropLife Canada), and a Canadian manufacturer and distributor of biocides and other cleaning chemicals and supplies (Flexo Products Limited).

Overall, most of the industry witnesses testifying supported the intent of the proposed Biocides Regulations to create a single framework for the regulation of biocides in Canada. However, the Committee was informed of significant concerns by industry associations representing small Quebec businesses in relation to increased competition that could result from the introduction of a UFD pathway, which reflects concerns raised previously by these same industry associations. Another industry witness noted that Canadian businesses rely on products developed and authorized in the U.S. to obtain market authorization in Canada through licensing agreements with these U.S.-based companies, as product development and testing can be cost-prohibitive to these smaller companies. They indicated that the UFD pathway could reduce sales among domestic manufacturers, but also expressed that the UFD pathway may offer a reduced cost pathway for preparing an application for Health Canada review, including for small businesses. A different industry witness indicated support of the UFD pathway, arguing that if implemented correctly, it could help to reduce application costs while giving consumers more choice and more competitive pricing.

Concerns were raised by all industry witnesses about Health Canada allocating adequate resources to implement the Regulations to avoid bottlenecks being created in the application review process. This is due to the large quantity of surface sanitizers for use in food premises that would require a market authorization under the Biocides Regulations and the transition of already authorized disinfectants and registered surface sanitizers. This overlapped with concerns around allowing U.S.-based companies marketing surface sanitizers for use in food premises to enter the market through the UFD pathway, while Canadian companies would be required to gather the data to compile a more substantive application that would be subject to a longer review time. This may result in a disadvantage for some Canadian companies in favour of U.S.-based companies who may receive their biocide market authorization earlier.

The report of the Committee has yet to be published; however, Health Canada is planning for the implementation of the Regulations, including by adopting or considering several approaches raised by industry witnesses during the Committee meetings to help mitigate concerns. Health Canada has extended the transition period for surface sanitizers for use in food premises to six years following the coming into force of the Regulations and is allowing those surface sanitizers for use in food premises that are already on the market to continue to be sold during the transition period. Health Canada also plans to facilitate the authorization of surface sanitizers for use in food premises by increasing the number that would be eligible to use lower cost abbreviated application pathways, such as the “Biocide monograph pathway”. In addition, Health Canada will regularly review the List of Foreign Regulatory Authorities to determine whether decisions from other foreign regulatory authorities could be accepted for the UFD pathway. Health Canada will consult stakeholders before making changes to the list.

Health Canada will be maintaining the UFD pathway as part of the Regulations because it will be a more efficient way to review biocides, thereby reducing fees and the length of time for qualifying companies to receive a market authorization in Canada, without compromising the health and safety of Canadians. The UFD pathway will be available to all companies and could reduce burden for Canadian small businesses if they possess or can access the information used to authorize a biocide in the U.S. to support their application in Canada. It is also expected to benefit Canadians by providing earlier access to, and steady supply of an increased variety of innovative biocides.

Health Canada will continue work to consider outstanding recommendations outlined by the Committee in their published report and concerns raised by stakeholders, including those raised during the Committee meetings to facilitate effective implementation of the Regulations.

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, a detailed assessment of modern treaty implications was conducted on the Regulations. The assessment did not identify any modern treaty implications or obligations.

Instrument choice

Health Canada examined a range of regulatory options before proposing separate regulations for biocides as prepublished in CGI. Each option was assessed using the objectives of reducing the burden on Health Canada and the biocide industry while maintaining timely access of biocides for Canadians.

1. Transfer the regulation of surface sanitizers to the FDR from the PCPA and introduce regulatory requirements specific to biocides and a Use of Foreign Decisions pathway through the proposed Agile Regulations for Licensing Drugs

The intent of the proposed Agile Regulations for Licensing Drugs (Agile Framework) is to implement an agile, modern licensing scheme for drugs. If used for disinfectants, the proposed Agile Framework would be implemented through a phased approach, and would introduce regulatory tools to manage risks and related uncertainties (e.g. terms and conditions, risk management plans), introduce more targeted enforcement powers (e.g. suspension and revocation), and create formal transparency requirements to disclose information about the benefits, risks and uncertainties of drugs. In addition, the proposed Agile Framework would provide more flexible requirements and additional post-market authorities for biocides than are included in the FDR. This would allow for more efficient regulation of innovative products and would better manage the risks and uncertainties that are associated with a UFD pathway.

Phase I of the Agile Framework was included in Health Canada’s Forward Regulatory Plan 2021-2023. The introduction of a UFD pathway in the Agile Framework was planned for a future phase.

This option was not pursued, as the delay of introducing more tailored requirements and a UFD pathway for biocides until the Agile Framework comes into force may unnecessarily delay the expected benefits of this proposal to Canadians, industry and Health Canada. The increase in demand for biocides by Canadians and the number of submissions received by Health Canada during the COVID-19 pandemic has highlighted the need for a licensing and regulatory framework that is specific to biocides.

In addition, a regulatory framework for biocides that includes pharmaceutical products may unnecessarily hinder international harmonization and alignment for biocides, as any proposed changes would need to be considered in the context of a multitude of significantly different products (e.g. pharmaceuticals, biologics, vaccines and radiopharmaceuticals).

2. Transfer the regulation of surface sanitizers to the FDR from the PCPA and introduce a Use of Foreign Decisions pathway for biocides in the FDR

This option would allow for the regulation of both disinfectants and surface sanitizers under the FDR and would provide a UFD pathway for biocides, in advance of the proposed Agile Framework. As the regulatory amendments to the FDR would be minimal, this option would have the earliest coming-into-force date when compared with other options.

The regulation of both surface sanitizers and disinfectants (as biocides) under the same regulations would reduce stakeholder confusion and subject all biocides to similar requirements. Separate sets of regulations for similar products have caused confusion, as companies seeking authorization may not clearly know whether the FDR or PCPA application requirements apply to their products. This confusion can delay the entry of products into the Canadian market as they may need to set up pre-submission meetings or conduct testing before filing under the appropriate framework.

However, this option was not pursued for several reasons. Existing regulatory requirements in the FDR are tailored to pharmaceutical products. Many of its required protocols and tests to demonstrate safety and efficacy in humans (such as clinical studies) are not applicable to biocides. Even within the FDR, disinfectants are currently subject to different requirements depending on if they are authorized through Part C, Division 1 or Division 8. Introducing a UFD pathway into the FDR for biocides would have been challenging as the application requirements for disinfectants within the FDR differ from those internationally, making it difficult to ensure similar authorization thresholds. In addition, the FDR also contains fewer post-market authorities, relative to what was considered for inclusion in the proposed Agile Framework at the time of this analysis. These more robust post-market authorities are needed to effectively manage the risks and uncertainties associated with regulating innovative products or introducing a UFD pathway.

3. Create a new regulatory framework with requirements specific to biocides, outside of the FDR, that includes a Use of Foreign Decisions pathway (the Biocides Regulations)

The Biocides Regulations will allow for the authorization and regulation of disinfectants and surface sanitizers under a single framework, and separately from other health products under the FDA and pest control products under the PCPA. Separate sets of regulations for similar products have caused confusion, as companies seeking authorization may not clearly know whether the FDR (Part C, Division 1 or Division 8) or PCPA application requirements apply to their products. Subjecting these similar products to the same requirements will reduce confusion and increase the predictability of the regulatory process for applicants, enhance the efficiency of Health Canada’s regulatory assessments through the consolidation of scientific resources, and will support the biocide industry in reducing complexity in the regulation of their products. These efficiencies will provide Canadians with more timely access to biocides.

In addition, the Biocides Regulations include post-market authorities that will support a flexible approach and more effectively manage the regulation of biocides with varying risks, benefits and related uncertainties that may come with the regulation of innovative products and a UFD pathway.

The separation of the Biocides Regulations from the proposed Agile Framework will allow these Regulations to come into force sooner, expediting the expected benefits to Canadians, industry, and the Government of Canada. In addition, the Biocides Regulations will address the concern that a regulatory framework for biocides within one that includes pharmaceutical products may unnecessarily hinder international harmonization and alignment.

It is for these reasons that Health Canada has proceeded with the Biocides Regulations as the preferred option.

Regulatory analysis

Benefits and costs

The full CBA report is available upon request by email at lrm.consultations-mlr@hc-sc.gc.ca

The CBA aims to quantify the benefits and costs of the Biocides Regulations. These new regulations under the FDA for biocides aim to help reduce burden on industry, where possible, and the Government by more closely aligning international and domestic requirements. Their implementation will see the transfer of disinfectants that have been regulated under the FDR, surface sanitizers that have been regulated under the PCPA and surface sanitizers for use in food premisesfootnote 32 that fall under the purview of the FDA and which may have been subject to a voluntary review by Health Canada, to the Biocides Regulations, allowing these similar products to be subject to the same regulatory requirements. Since prepublication of the proposed Biocides Regulations in CGI, Health Canada has conducted further analysis on the scope of impacted products, companies, and small businesses in particular; this has resulted in modified estimates of the cost and benefit impacts.

The CBA has been modified to reflect updated data, and as such, changes have been made to key assumptions and variables. The significant change from CGI prepublication is predominantly due to the inclusion of surface sanitizers for use in food premises that are currently on the market under a series of voluntary frameworks as set out in guidance. Stakeholder feedback advocated for additional costs for all biocides to be assessed and included in the CBA, including, but not limited to, new application costs, labelling costs, post-authorization changes, and post-market surveillance activities. Values previously presented in CGI prepublication have also been inflated to 2023 dollars.

A costing survey was shared with industry stakeholders in April 2021 prior to prepublication to gather data for this CBA. After receiving feedback from prepublication, a supplementary survey was conducted in December 2022. Costs and benefits are projected over 15 years, reported in present value (PV) using a 7% discount rate, as required by the Treasury Board Secretariat of Canada.

Baseline scenario versus regulatory scenario

In the baseline scenario, surface sanitizers (except those for use in food premises) would continue to be regulated under the PCPA and be associated with only one brand name. In the regulatory scenario, surface sanitizers that meet the FDA definition of a drug will be regulated as biocides separately from other health products under the FDA and pest control products under the PCPA. Under the Biocides Regulations, surface sanitizer applicants will be able to submit one application for a market authorization for a product with multiple brand names and/or minor variations in formulants.

In the baseline scenario, surface sanitizers for use in food premises would continue to be subject to the FDA, allowing some oversight related to acceptability for use in food premises, on a voluntary basis, through a letter of no objection. In the regulatory scenario, surface sanitizers for use in food premises meet the regulatory definition of a biocide and will be subject to the requirements of the Biocides Regulations.

In the baseline scenario, disinfectants that are used to prevent human and animal disease would continue to be regulated under the FDA. Each disinfectant authorized under Division 1 or Division 8 of the FDR would require an assigned DIN with a unique brand name for each formulation. Products with both surface disinfectant and sanitizer uses would be solely regulated under the FDA. In the regulatory scenario, disinfectants will continue to be regulated as biocides separately from other health products under the FDA. Under the Biocides Regulations, disinfectant applicants may submit one application for a market authorization for a product with multiple brand names and/or minor variations in formulants.

In the baseline scenario, for all three product types mentioned above, the UFD pathway would not exist. Under the regulatory scenario, in addition to creating regulations for similar products under the FDA, the Biocides Regulations will introduce a UFD pathway. This UFD pathway will help reduce application costs by allowing Health Canada to rely on information that a trusted foreign regulator has already reviewed and approved (e.g. information regarding the benefits, risks, and uncertainties of the product). Health Canada will only accept decisions from foreign regulatory authorities that have similar regulatory standards and are comparable and reflect Canada’s review processes. Such determinations will be made through a detailed analysis. This pathway will also provide an opportunity for reduced costs to compile and submit applications for certain industry stakeholders and a reduced length of time to receive a regulatory decision, thereby providing an incentive for businesses to bring their products to market in Canada. Overall, the UFD pathway is expected to help to maintain a safe and effective supply of biocides for Canadians.

Key assumptions:footnote 33

Costs

The total direct cost to both industry and to the Government of Canada is estimated to be $397.27 million PV, or $43.62 million annualized over 15 years.

Costs to industry

The total direct cost to industry for the Biocides Regulations includes a one-time cost to update some labels, a one-time cost for existing registrants as well as authorization holders to submit an abbreviated application, a one-time cost for existing manufacturers of surface sanitizers for use in food premises to prepare and submit a new application for review, and additional ongoing costs regarding new application requirements, post-authorization changes, and post-market surveillance.footnote 37 These are anticipated to result in a total cost of $387.74 million PV, or $42.57 million annualized over 15 years.

Label change costs

The Biocides Regulations will introduce specific labelling requirements for biocides, while aligning as much as possible with the current requirements for disinfectants under the FDR. However, they will introduce a requirement to include the statement, “Keep out of reach of children”. Based on industry responses to the CBA survey and stakeholder consultations, it is assumed that disinfectants currently display this statement as recommended in guidance and are therefore excluded from resulting label change costs. For surface sanitizers currently regulated under the PCPA, the pest control product registration number will be replaced with a “DIN” designation and an eight-digit identification number as a new requirement; this is expected to impact all surface sanitizers. For surface sanitizers for use in food premises, there are no current label requirements. All labelling requirements for these products will be new and are required to mitigate risks and ensure consistency with other biocides.

For prepublication in CGI, it was assumed that most of industry would already be in compliance with the new labelling requirements, as they are consistent with the labelling requirements in the FDR for disinfectants, resulting in a limited number of products requiring a label change (i.e. surface sanitizers only). Health Canada has since conducted further analysis on the scope of impacted products and has identified surface sanitizers for use in food premises that will be required to update their labels.

Following prepublication in CGI, an internal analysis using data previously collected by the CFIA was completed. It is estimated that there are 588 surface sanitizers for use in food premises that will require updates to their existing labels to incorporate new requirements. There are also currently 60 surface sanitizers on the market expected to update their labels to incorporate the new biocide labelling requirements. Industry stakeholders provided average cost estimates for conducting a product label change, which ranged from $8,453 to $28,822 per stock keeping unit (SKU), depending on the complexity of the change. A one-to-one ratio is assumed for products represented by a single SKU. For the purposes of the CBA, Health Canada assumes that the lower-bound cost estimate of $8,453 per SKU best represents a proxy for addressing minor label changes on surface sanitizers with a pest control product registration and a higher-bound cost estimate of $28,822 per SKU for addressing major label changes on surface sanitizers for use in food premises.

Based on the label claims included on current surface sanitizers on the market, it is assumed that registrants for 37 of the 60 surface sanitizers will make label amendments under the PCPA to maintain their current registrations under the PCPA for uses that are specific to pest control products. As a result, these surface sanitizer registrants are expected to submit an application for a label amendment under the PCPA, creating an additional cost of $1,338 per application per product to remove biocide uses from their label that would be subject to the FDA. This is in addition to the cost of the label change required under the Regulations.

Introducing these labelling requirements for surface sanitizers and surface sanitizers for use in food premises will result in a one-time cost of $11.72 million PV. Costs are assumed to be incurred in year four for registrants of surface sanitizers and year six for those currently marketing surface sanitizers for use in food premises.footnote 38

Cost of submitting applications for transitioning products

Existing biocides with a DIN or pest control product registration will need to file an abbreviated application under the Biocides Regulations and obtain a market authorization within four years following the coming into force to continue marketing their products as biocides.

An abbreviated application for surface sanitizers with a pest control product registration will include their proposed label text, an attestation form, and an application form outlining company contact information and information about the product such as its brand name, physical form, active ingredient(s) and formulant(s), conditions of use, and packaging information. An abbreviated application for disinfectants will include the same attestation and application form as the surface sanitizer abbreviated application but will not include label text.

Companies with surface sanitizers for use in food premises will not be eligible to submit an abbreviated application and will be required to complete a new product application to come into compliance with new standards for safety, efficacy, and quality, including specifications. It is assumed that companies applying for market authorization of surface sanitizers for use in food premises will be required to submit the same information for a full review as a new biocide; however, some surface sanitizers for use in food premises may go through less burdensome pathways (e.g. “Biocide comparison – labelling only pathway” or “Biocide comparison – administrative pathway”). This is a one-time cost to companies marketing existing products.

For prepublication in CGI, the cost to submit a product’s label text and an attestation was estimated to be $12,000 per product. This amount was based on previous cost estimates outlined in the Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) and used as a proxy for the potential cost of submitting an abbreviated application for surface sanitizers.footnote 39 For disinfectants, Health Canada assumed the cost of reapplication to be $100 per disinfectant. This was based on the itemized costs for a reapplication form previously provided by industry in response to consultations that took place for the interim order transition for COVID-19 drugs.

Health Canada has since consulted with industry to confirm these cost estimates through a supplementary costing survey. It is estimated to cost $2,600 for surface sanitizers with a pest control product registration to reapply and $1,800 for disinfectants to reapply. For companies marketing surface sanitizers for use in food premises, the median cost to prepare an application for a full review as a new biocide is estimated to be $325,000. However, this cost may be considered an overestimation as companies may be able to utilize other less burdensome pathways. With 60 surface sanitizers, 1950 disinfectants, and an estimated 588 surface sanitizers for use in food premises eligible to transition to the new framework, the one-time application cost for transitioning products is expected to be $130.02 million PV. Costs resulting from submitting applications for transitioning products are expected to be incurred in year four for disinfectants and surface sanitizers, and in year six for surface sanitizers for use in food premises. The reapplication cost for disinfectants is considered an administrative burden to industry and is discussed further in the “One-for-one rule” section below.

New product application costs

The Biocides Regulations will introduce new application requirements for disinfectants and surface sanitizers. This includes providing general information (supply-chain information, ingredient CAS numbers) and quality information (e.g. product specifications and packaging information) as part of the application process for most new authorizations. Changes in application requirements are only attributed to those undergoing a full review and a “Biocide monograph pathway” review. “Biocide comparison – labelling only pathway” and “Biocide comparison – administrative pathway” will not be impacted. The requirements to provide supply chain information will apply to labelling only and administrative pathways (excluding product specifications). As surface sanitizers for use in food premises can currently obtain market access without seeking prior approval, all application requirements will be considered incremental.

The majority of disinfectants currently receive a DIN under Division 1 in Part C of the FDR, unless they are submissions for a disinfectant with a new active ingredient or a new use, which receive a notice of compliance (NOC) under Division 8 in Part C of the FDR, as well as a DIN. Certain impacted surface sanitizers submit applications for a pest control product registration under the PCPA. Surface sanitizers for use in food premises can currently use a voluntary review by Health Canada to assess their acceptability for use in food premises, but are not required to obtain a licence, authorization, registration, or undergo any form of pre- or post- market review to be sold in Canada. Health Canada currently treats these products as incidental additives and will issue a letter of no objection if the surface sanitizer for use in food premises is deemed acceptable from a food chemical safety perspective.

Prior to prepublication in CGI, Health Canada received insufficient data from its initial survey to identify incremental costs for new biocide applications. Responses to a supplementary costing survey have identified an increase in application costs for most impacted biocides, with the exception of surface sanitizers previously regulated under the PCPA which will see a reduction in application requirements. Based on industry-provided data, the current median cost to prepare an application for a full review of a new disinfectant under the FDR is $259,500, approximately $575,000 to prepare an application for a full review of a new surface sanitizer under the PCPA, and $12,500 to undergo a voluntary incidental additive review for a new surface sanitizer for use in food premises. The new cost to apply for a full review under the Biocides Regulations is estimated to be $325,000. Incremental costs are also anticipated for the Biocides monograph applications, labelling only applications and administrative applications; however, insufficient data was provided to capture the potential increase in costs.

An average of 46 full review applications for disinfectants and five applications for surface sanitizers are submitted per year for approval. An estimated 50 surface sanitizers for use in food premisesfootnote 40 enter the market freely per year. However, for surface sanitizers for use in food premises, Health Canada does not currently track submissions seeking a letter of no objection for these products as they are voluntary, but is aware of three to five voluntary submissions over the last few years. Historical data collected by Health Canada on previous full review applications submitted for disinfectants illustrates that approximately 39% of biocides may be eligible for the UFD pathway as an alternative to the standard application pathways. In addition, under the Biocides Regulations, companies will be able to submit one application for a biocide with different brand names and/or minor variations in formulants. Incremental costs for new biocide applications are assumed to begin in year two following the coming into force of the Regulations. New application costs for biocides previously known as surface sanitizers for use in food premises are assumed to begin in year four, apart from those entering through the UFD pathway, as products currently in development will need to be modified accordingly. Incremental application costs are estimated to be $179.57 million PV projected over 15 years based on an 8% growth rate in new products.

Post-authorization changes

The Biocides Regulations introduce post-authorization change application pathways based on the types of changes being made to the biocide, including those for a major change and minor change. These pathways have associated requirements for each. These post-authorizations change applications or notifications relate to the quality, risks, benefits and uncertainties associated with the change, and in the case of a major change, allow the Minister to assess the acceptability of the change. An application will be required if the change is expected to have a major impact on the quality, risks, benefits, or uncertainties associated with the biocide (e.g. a change to the directions for use if it impacts the efficacy or safety information, or the addition of an intended use or purpose that requires efficacy data). A notification will be required if the change is expected to have a minor impact on the quality, risks, benefits, and uncertainties associated with the biocide (e.g. removal of a method of application). In addition, a change that creates a new biocide will require the market authorization holder to submit an application for a new market authorization.

Prior to prepublication in CGI, Health Canada had limited data on the potential cost impacts on these post-authorization changes and was not able to monetize these impacts. For publication in the Canada Gazette, Part II, Health Canada expects a 10% increase in post-authorization changes for both disinfectants and surface sanitizers, as well new post-authorization changes for surface sanitizers for use in food premises. This is based on new requirements under the Biocides Regulations, where a change made to the specifications would result in the market authorization holder needing to consequentially file a notification with Health Canada to inform of the change. It is anticipated that 96 applications for a major change will be submitted per year at a median cost of $47,000 per application and 142 notifications for a minor change will be submitted per year at a median cost of $10,448 per notification. This includes 20 new major change applications and 25 minor change notifications per year for surface sanitizers for use in food premises. Based on Health Canada’s internal database on applications received since 2014, industry currently submits an average of 69 major change applications at a median cost of $9,000 per application and 107 minor change notifications at a median cost of $3,000 per notification. Companies selling surface sanitizers for use in food premises are not required to submit these applications, given they are subject to a voluntary review.

Incremental costs are expected to begin in year two for biocides previously known as disinfectants and surface sanitizers and in year five for biocides previously known as surface sanitizers for use in food premises. Costs attributed to submitting information to conduct a post-authorization change is expected to increase by $45.05 million PV projected over 15-years, assuming a 3% net annual growth rate in market size.footnote 41

Quality and Post-market Requirements

The Biocides Regulations include post-market requirements that some companies will need to implement to become compliant, specifically, having a recall system of control, a quality control system, and the ability to maintain records for a specified period. It is assumed that companies who supply disinfectants (referring to the responsibility of manufacturing, wholesaling, distributing, importing or the sale of a given product) with a DIN are already compliant under the FDR, since these systems are outlined in guidance. However, companies that supply surface sanitizers and surface sanitizers for use in food premises were not previously subject to any explicit regulatory requirements to have a system of control in place that allows them to take effective and rapid action to recall a biocide, including the requirement to retain records supporting this system, along with written procedures and sales records. It is assumed that companies supplying surface sanitizers and surface sanitizers for use in food premises will need to put these systems in place to comply with the Biocides Regulations.

The cost of implementing a recall system of control, a quality control system, and records retention was estimated using three academic journal articles,footnote 42,footnote 43,footnote 44 as well as stakeholder survey results. As an upper bound estimate, implementing a recall system of control, a quality control system, and records retention is assumed to be similar to implementing an ISO Quality Management System. Quality management systems include a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, allowing for companies to meet regulatory requirements for quality.footnote 45

Recall system of control and Quality control system

Based on the academic journal articles and stakeholder survey results, it is estimated that to implement a complete quality management system there will be a one-time start-up cost of approximately $248,302. Depending on the level of familiarity of post-market obligations for products with a DIN, companies are anticipated to incur varying proportions of this one-time start-up cost. Companies are assumed to implement these systems at the end of their respective transition periods, which is four years for surface sanitizers and six years for surface sanitizers for use in food premises.

It is assumed that the full start-up cost will apply to companies who do not supply any drugs regulated under the FDR (i.e. those solely supplying surface sanitizers or surface sanitizers for use in food premises), representing an estimated 91 companies (25 companies that supply surface sanitizers and 66 companies that solely supply surface sanitizers for use in food premises), since they do not currently have any requirements to have these systems in place. These companies are anticipated to incur a one-time implementation cost of $248,302, which results in a total of $22.59 million at the end of their respective transition periods – specifically, in year five for companies supplying surface sanitizers and in year seven for companies supplying surface sanitizers for use in food premises.

Companies that have previously supplied any product with a DIN are assumed to be familiar with these systems or may even still have these systems in place. Therefore, to account for existing systems, companies that supply surface sanitizers for use in food premises that have previously supplied a product with a DIN are assumed to incur 2/3 of the one-time implementation cost ($165,535). It is estimated that 12 companies will incur this cost based on an internal analysis using archived CFIA data and Health Canada’s Drug Product Database.footnote 46,footnote 47 Therefore, the total one-time implementation cost for these companies is estimated to be $1.98 million and is estimated to occur in year seven of the reporting period.

For companies that currently supply surface sanitizers and/or surface sanitizers for use in food premises in addition to other products with a DIN, it assumed that these companies have similar systems in place and are expected to incur 1/3 of the one-time implementation cost ($82,767) to integrate their surface sanitizers or surface sanitizers for use in food premise products into their current systems. It is estimated that there are a total of 102 companies (20 companies with surface sanitizers and 82 companies with surface sanitizers for use in food premises) that also supply other products with a DIN, as found in Health Canada’s public Drug Product Database.footnote 46 These 102 companies are expected to incur an estimated one-time implementation cost of $8.4 million at the end of their respective transition periods – specifically, in year five for companies supplying surface sanitizers and in year seven for companies supplying surface sanitizers for use in food premises. The one-time cost for industry to implement a recall system of control and quality control is estimated to be $21.28 million PV over 15 years.

Records Retention

In addition to the implementation of these systems, there will be an increase in ongoing costs for all 205 companies to conduct the necessary records retention activities based on maintaining digital storage and making records available for a potential review during a compliance verification. It is assumed to cost companies $2 annuallyfootnote 48 to maintain records digitally using existing systems. Further, it is assumed that maintaining digital storage and making records available will result in an hour of work annually for one employee. Therefore, it is estimated to cost $1,890 a year for all companies supplying surface sanitizers and $6,720 for all companies supplying surface sanitizers for use in food premises. These companies will begin to recognize these incremental costs the year following their respective transition periods – specifically, in year six for companies supplying surface sanitizers and in year eight for companies supplying surface sanitizers for use in food premises. Based on information collected within Health Canada’s Drug Product Database, the number of companies authorized to sell biocides is assumed to increase by a 1% annual growth rate. Therefore, the ongoing cost for industry to retain records is estimated to be $35,823 PV over 15 years.

Submitting recall information

New costs have also been identified relating to the submission of recall information to Health Canada for parties who were not previously subject to recall reporting requirements (including requirements to inform the Minister of recalls and other issue with foreign biocides). It is estimated to cost $1,500 for companies to report recall information to Health Canada based on results from a recent medical device recall survey regarding a similar regulatory requirement. Analysis shows that the transition of surface sanitizers to the FDA will not increase the number of recalls expected due to the limited number of products. Therefore, there is no additional cost estimated for surface sanitizers. Disinfectants are already required to submit recall information to Health Canada, and it is assumed that there will be no incremental cost for submitting this information. For the purposes of the CBA, it is assumed that the proportion of recalls related to surface sanitizers for use in food premises, and for biocides entering the market due to the introduction of the UFD pathway, will be the same as the 0.5% proportion of recalls for all marketed products with a DIN on an annual basis, which results in approximately 3 recalls.

It is estimated that approximately 40 biocides will enter the market each year due to the introduction of the UFD pathway. This is anticipated to result in an estimated one recall each year from years six to eight, two recalls each year from years nine to 11, three recalls each year in years 12 and 13, and four recalls each year thereafter for the remaining reporting period. Based on the inclusion of approximately 588 surface sanitizers for use in food premises under the Biocides Regulations, three recalls are expected annually starting in year eight. To account for an assumed 3% net annual growth, one additional recall is expected to occur every three years. The estimated ongoing cost for industry to submit recall information is estimated to be $32,490 PV over 15 years.

Overall, the total cost for industry stakeholders to come into compliance with these quality and post-market activities is estimated to be $21.34 million PV over 15 years.

Notification for permanent discontinuation of sale

The Biocides Regulations will include a requirement for companies selling biocides to notify Health Canada when discontinuing the sale of a biocide. When notifying Health Canada, the company will be required to disclose the biocide’s DIN number, the date on which they discontinued the sale of the biocide, and the latest expiry date of the biocide that they have sold under the market authorization and the applicable lot number. This is currently a requirement for companies supplying disinfectants and surface sanitizers; however, this will be a new requirement for those currently selling surface sanitizers for use in food premises.

Health Canada has estimated a 5% attrition rate based on information collected in Health Canada’s public Drug Product Database on disinfectant products, suggesting that very few biocides under the framework will choose to exit the market each year by discontinuation of sale. Applying the 5% attrition rate to surface sanitizers for use in food premises, it is estimated that approximately 29 products will exit the market each year.

Based on a similar U.S. report on the discontinuation of drugs,footnote 49 it is estimated to cost approximately $295 per notification to Health Canada of a permanent discontinuation. It is assumed that costs to notify for discontinuation will begin in year eight, after the transition period for surface sanitizers for use in food premises has ended. As the market is anticipated to grow based on a 3% net annual growth rate, this is expected to result in a cost to industry of $34,993 PV over 15 years.

Costs to Government

The total direct cost to the Government of Canada for the Biocides Regulations will include the one-time cost of implementing internal systems, a one-time cost of revising standard letters, and a one-time cost of reviewing reapplications received from products transitioning to the Biocides Regulations. The total direct costs also include an increase in volume of both pre-authorization and post-authorization activities, an increase in requests for guidance or clarification from industry and the ongoing cost of implementing a recall and record-keeping system, which includes compliance verification activities. Resources will be reallocated as needed to ensure the lifecycle management of biocides. If needed, Health Canada will make efforts to streamline processes and prioritise activities based on risk, as needed to ensure the work to implement and maintain the framework is completed. These costs are estimated to be $9.53 million PV, or $1.05 million annualized over 15 years.

Implementation costs

There are currently separate systems (forms, databases, internal and external applications) for the 1950 disinfectants under the FDA and the 60 surface sanitizers under the PCPA; there are no current tracking systems for the estimated 588 existing surface sanitizers for use in food premises.

Implementing the high-level system requirements for the Biocides Regulations that will apply to surface sanitizers, disinfectants, and surface sanitizers for use in food premises will result in the cost of the development and ongoing maintenance of a Biocides Tracking System and the creation of the biocide application forms. Health Canada will need to develop and maintain three online forms and their associated databases for biocide side effects reporting for consumers, industry and health care providers. In addition, correspondence letter templates used by Health Canada to communicate information to disinfectant applicants throughout the submission process will need to be updated accordingly.

Overall, the cost of these updates will begin to be incurred in year one, the year of the registration of the Biocides Regulations prior to coming into force and is estimated to have a cost of $4.5 million PV over 15 years.

Cost of reviewing applications for existing products transitioning

Under the Biocides Regulations, Health Canada will need to review abbreviated applications for surface sanitizers and disinfectants being submitted by current registrants and authorization holders, in addition to applications for surface sanitizers for use in food premises transitioning to the Regulations. It is assumed that Health Canada will receive and review most of the transition applications within the last year of their respective transition period.

For surface sanitizers, it is estimated to cost Health Canada approximately $876 to review each of the 60 transitioning applications, resulting in a total one-time cost of $52,569. For disinfectants, it is estimated to cost Health Canada approximately $189 to review each of the 1950 transitioning applications, resulting in a total one-time cost of $369,016. For surface sanitizers for use in food premises, it is estimated to cost Health Canada approximately $4,627 to review each of the estimated 588 transitioning applications, the equivalent to conducting a full review for this product type, resulting in a total one-time cost of $2.72 million. This is considered an overestimation as there will be other pathways available that products may be eligible to use.

The overall cost of reviewing applications for transitioning surface sanitizers, disinfectants, and surface sanitizers for use in food premises is anticipated to be a one-time cost of $2.24 million PV. This assumes that Health Canada reviews transition applications within the final year of their respective transition periods—specifically, in year five for existing disinfectants and surface sanitizers, and in year seven for existing surface sanitizers for use in food premises.

Increased cost of reviewing new applications for biocides

For prepublication in CGI, a minor increase in screening and review time was assumed for certain disinfectant applications, including a full review and a monograph review for disinfectants. However, there will be a decrease in time to conduct a full review of new surface sanitizers. Since CGI, Health Canada has estimated the volume of surface sanitizers for use in food premises that will require ongoing oversight and pre-market approval under the Biocides Regulations.

Currently, the average cost to review an application for a new disinfectant under the FDR can range from $751 to $2,875, depending on the application type. The average cost to conduct a full review for a new surface sanitizer under the PCPA is estimated to be $7,436. The average cost to conduct a voluntary review when issuing a letter of no objection for a surface sanitizer for use in food premises is estimated to be $1,988; however, for the purposes of the CBA, Health Canada assumes a cost of $0 for issuing a letter of no objection for a surface sanitizer for use in food premises. This assumption is used because Health Canada has received only a few applications for letters of no objection over the past few years for these products which were eligible for this voluntary review program.

Under the Biocides Regulations, the average cost to review a new biocide application is estimated to range from $751 to $4,627, depending on the application type.footnote 50 This higher bound cost estimate does not include the potential costs for reviewing a novel biocide application since it is highly variable. The average cost to conduct a full review for a new biocide is estimated to be $2,875; however, it is expected to cost an average of $4,627 to conduct a full review for a surface sanitizer for use in food premises since they will also require additional safety evaluation for potential exposure to food.

Based on internal data, Health Canada expects to receive an average of 199 applications per year in the first three years following the coming into force of the Regulations, and 249 applications per year thereafter for all application types, including those considered to be disinfectants, surface sanitizers, and surface sanitizers for use in food premises, and their respective application pathways (e.g. full review, monograph, administrative, etc.). However, with the introduction of the UFD pathway, Health Canada estimates that approximately 40 applications per year will be received through this new pathway based on eligibility following the coming into force of the Regulations.

Health Canada anticipates applications for new biocides to be submitted following the coming into force of the Regulations, except for surface sanitizers for use in food premises, assuming new applications for these products will be filed starting three years following the coming-into-force date. The overall net review time for biocide applications will temporarily decrease for the first three years following the coming into force, followed by an increase in costs beginning in year five, the year that new surface sanitizers for use in food premises are assumed to start entering the market (apart from those entering through the UFD pathway). This is expected to incrementally increase the cost of reviewing new biocide applications by $1.95 million PV over 15 years based on an anticipated 8% annual growth rate for the number of applications being received each year.

Ongoing government costs

Under the Biocides Regulations, Health Canada will incur additional ongoing costs related to reviewing major and minor changes, pre-submission meetings, and client service requests.

Health Canada expects an increase in the number of post-authorization applications or notifications under the Biocides Regulations major and minor changes pathways by 10%, once the regulations are in place, in addition to new submissions under these pathways for surface sanitizers for use in food premises. This increase in volume is estimated to cost Health Canada $38,944 annually. Health Canada also anticipates an increase in the volume of pre-submission meetings by 20% and client service requests of 30%, twice as much previously estimated for CGI prepublication, which did not account for the volume of surface sanitizers for use in food premises. Increased pre-submission meetings and client service requests are expected to result in an estimated incremental cost of $12,904 annually to Health Canada. These ongoing costs are anticipated to begin in year two, the year the Regulations come into force, and are estimated to result in an incremental cost to Health Canada of $389,511 PV over 15 years, based on an anticipated 3% net annual growth rate for the number of requests being received each year from authorization holders.

Compliance verification

The cost to government for compliance verifications is expected to increase with the introduction of the Biocides Regulations, assuming an increase in the number of compliance verifications to be proportionate to the increase in the number of biocides authorized under the Regulations (i.e. additional products due to the introduction of the UFD pathway and the inclusion of surface sanitizers for use in food premises). However, it is expected that there will temporarily be a higher concentration of compliance verifications in the years following the coming into force of new requirements as industry adapts to the new regulations. This assumption is based on Health Canada’s experience authorizing new products during the COVID-19 pandemic. Following this temporary increase, it is expected that compliance verifications will stabilize. Assuming compliance verification activities begin immediately following the coming into force of the Regulations (i.e. year two) and the estimated number of biocides increases based on a 3% net growth rate, the estimated total cost to Health Canada is expected to be $435,428 PV over 15 years.

Qualitative costs
Increased competition for Canadian companies

The introduction of the UFD pathway will encourage companies that have products that are already approved by foreign jurisdictions, starting with the U.S. EPA, to apply for a market authorization in Canada. This will create greater competition for market share and may have an impact on the competitiveness of biocide companies that have products solely marketed in Canada, thus providing a potential advantage to some over others. Some Canadian companies may retain market share based on brand awareness and consumer preferences for products manufactured in Canada or sold by Canadian businesses.

A business eligible to apply for a market authorization through the UFD pathway will receive a shortened review time in Canada than if they applied through the full review pathway, and as a result, pay a lower fee associated with the lesser time that is required for review. Some industry stakeholders have indicated that without a reciprocal agreement, this pathway will provide an undue advantage to some companies who already have products approved by the U.S. EPA and are looking to access the Canadian market, while companies primarily located in Canada will be simultaneously incurring costs to come into compliance with the new Biocides Regulations. It has been expressed by some industry stakeholders that the UFD pathway could have potentially negative impacts on Canadian companies, particularly small businesses; companies that do not sell outside of Canada would likely be at a disadvantage. Companies are expected to consider the order of their approvals to use the UFD pathway to access potential savings, based on their individual circumstances. For example, companies could consider the fees, timelines, costs and revenues to be associated with obtaining a product registration in the U.S. first, to benefit from the UFD pathway, as opposed to using an alternative Canadian application pathway. Health Canada acknowledges that some Canadian companies may not have the resources in place or the capacity to consider accessing the U.S. market in combination with the UFD pathway to market their product across North America; these companies may not be best positioned compared to those that can, given that there will be no reciprocity.

Many small Canadian businesses may already be experiencing challenges in Canada. These challenges were likely exacerbated during the COVID-19 pandemic, and the introduction of the UFD pathway could further amplify this situation. Further impacts to small businesses are included in the Small Business Lens section below.

Loss of registration value

As a result of the Biocides Regulations, some surface sanitizer companies may lose the value of one year or more of their renewal fee because of the timing of the regulatory transition period. There are an estimated 21 surface sanitizers whose registration will expire prior to final publication and their typical five-year renewal cycle potentially cut short depending on when these products will transition to the Biocides Regulations.

Extension of Vanessa’s Law authorities - terms and conditions

The Biocides Regulations will carry over certain authorities available under the FDR related to safety reporting as well as authorities introduced through Vanessa’s Law, including the ability for the Minister to compel information, require tests and studies, impose terms and conditions, and conduct assessments after a market authorization has been issued. These authorities currently apply to disinfectants regulated under the FDR but will now be applicable to surface sanitizers transitioning from the PCPA and to surface sanitizers for use in food premises that fall under the purview of the FDA.

In response to the supplementary CBA survey, one industry stakeholder suggested that in the rare case that terms and conditions are imposed on a biocide authorization, it could cost up to $140,000 per incident. However, given the lower-risk nature of biocides in comparison to pharmaceutical drugs, Health Canada expects this authority would be used rarely and only in extenuating circumstances after careful consideration. The objective of imposing terms and conditions is to manage the uncertainties relating to the benefits and/or risks of a biocide at the time of authorization, or to manage emerging risks or uncertainties post-authorization. This requirement will be directly related to ensuring the health and safety of Canadians.

Potential increased reliance on foreign supply of biocides

Health Canada does not have the data to determine the market percentage of manufacturers operating in Canada, and how this percentage compares to those manufacturing outside of Canada and importing their products and/or materials into Canada. As a result, the UFD pathway could shift Canada’s reliance on biocides from domestically produced products to imported products, if companies that obtain market authorization for their biocide through the UFD pathway choose not to manufacture their products in Canada. By addressing regulatory gaps and scoping in surface sanitizers for use in food premises under the Biocides Regulations, the incremental costs for companies producing these products may be detrimental to their operations. Some companies may not be able to afford the costs to comply with the new framework, requiring them to exit the market. In combination with the introduction of the UFD pathway, this could introduce overreliance on foreign biocides, which could leave Canadians vulnerable to disruptions in the global supply chain in the long run.

Potential increase in consumer prices of surface sanitizers for use in food premises

Surface sanitizers for use in food premises are currently able to use a voluntary review program to assess their acceptability from a food chemical safety perspective for use in food premises. They are not required to obtain a licence, market authorization, registration or any form of pre-market review to be sold. They are also not subject to post-market surveillance or review while on the market. However, following the coming into force of the Biocides Regulations, these products will be subject to new regulatory requirements and an annual right-to-sell fee. The market for surface sanitizers for use in food premises is considered competitive given that there are fewer barriers to enter the market. With industry stakeholders expected to incur costs to come into compliance with new regulatory requirements, and the expected increase in competition due to the inclusion of the UFD application pathway, some businesses may exit the industry. It is assumed that costs will be absorbed by businesses; however, there is a potential risk that some costs may be passed on to consumers as compliance costs are incurred.

Benefits

The total direct benefit to industry and the Government of Canada from the Biocides Regulations is estimated to be $86.94 million PV, or $9.55 million annualized over 15 years.

Benefits to industry

Direct benefits to industry for the Biocides Regulations include the removal of the annual summary report requirement, the introduction of the UFD pathway, and the removal of the requirement for surface sanitizers to renew their registration every five years. These benefits are estimated to be $85.45 million PV, or $9.38 million annualized over 15 years.

Annual summary report cost savings

Currently, for disinfectants under the FDR, authorization holders must prepare annual summary reports and notify the Minister without delay if they conclude that there has been a significant change in what is known about the benefits and risks of the disinfectant. The Minister can decide to continue to maintain the authorization as is, require modifications (e.g. by establishing measures to mitigate risks), or cancel it. Surface sanitizers registered under the PCPA are subject to annual summary reporting requirements under the Pest Control Products Incident Reporting Regulations, if they have been implicated in at least 10 incidents within one year. In addition, Health Canada conducts post-market reviews of registered pest control products to confirm continued acceptability via periodic re-evaluations and special reviews. Manufacturers of surface sanitizers for use in food premises are not currently required to provide annual summary reports.

Under the Biocides Regulations, annual summary reports will no longer be required and will be replaced with new safety monitoring requirements. The removal of annual summary reports is anticipated to produce annual savings to industry.

Based on cost estimates provided during consultations for the Self-Care Framework, removing the requirement to prepare annual summary reports is estimated to save industry between $1,632 and $5,560 per product.footnote 51 Inflating these values to 2023 CAD, it is estimated to save industry between $1,816 and $6,188 per product. These cost savings are used as a proxy in this instance since the Self-Care Framework consultation activities also measured the impact of removing the annual summary report with similar stakeholders. The total activities related to the preparation of the annual summary report have been estimated to require between 27 and 92 hours, with an average cost of $67 per hour. The average cost would therefore be $3,987 per product. With 1950 disinfectants and 60 surface sanitizers currently on the market, the total savings to industry from the removal of annual summary reports will result in a cost savings of $52.33 million PV over 15 years based on a 3% net annual growth rate.footnote 52 Cost savings will begin once authorization holders and registrants successfully transfer their products to the Regulations, which is assumed to occur in year five for disinfectants and surface sanitizers after receiving Health Canada’s approval. These are considered administrative cost savings to industry and are discussed further in the “One-for-one rule” section below.

Use of foreign decisions — application pathway cost savings

Currently, most disinfectants receive a DIN under Division 1 in Part C of the FDR. Submissions for disinfectants with a new active ingredient or a new use receive an NOC and a DIN under Division 8 in Part C of the FDR. Surface sanitizers receive a pest control product registration under the PCPA. In both cases, for new disinfectants and surface sanitizers, an application that includes evidence to demonstrate compliance with the applicable regulations must be submitted. Surface sanitizers for use in food premises are not currently required to obtain a DIN or a pest control product registration.

The Biocides Regulations introduce an additional authorization pathway for products that have been approved by a trusted foreign regulatory authority. The UFD pathway will allow applicants with access to an existing authorization from a listed foreign jurisdiction to bring their biocides to the Canadian market sooner at a reduced cost by applying through this pathway.

Industry responses to the CBA survey have indicated that obtaining a market authorization through the UFD pathway will save $63,707 on average per application.footnote 53 Based on data collected through the initial CBA survey prior to CGI, 47 applications were anticipated to come through the UFD pathway as an alternative to the full review pathway. Based on further, more in-depth analysis conducted by Health Canada, approximately 39% of full review applications submitted to Health Canada for disinfectants each year have previously received approval by the U.S. EPA. This is applied as a proxy to capture potential applications for surface sanitizers and surface sanitizers for use in food premises. 40 applications submitted annually could benefit from the UFD pathway, and this will result in an estimated cost savings of $33.13 million PV based on an 8% annual net growth rate beginning in the year the Regulations come into force.

Benefits to Government

Direct benefits to the Government of Canada for the Biocides Regulations include the annual cost savings from the introduction of the UFD pathway and eliminating the need to review the surface sanitizer renewal applications. The total direct benefits are estimated to be $1.48 million PV, or $162,709 annualized over 15 years.

Review process for the use of foreign decisions pathway

Applications for disinfectants are currently submitted through Division 1 or Division 8, in Part C of the FDR, and applications for surface sanitizers are submitted through the PCPR. Based on application requirements under the Biocides Regulations, it is estimated to cost Health Canada $2,825 on average to conduct a full review of a biocide application; however, it is expected to cost an average of $4,627 to conduct a full review for a biocide for use in food premises since they also require additional safety evaluation for potential exposure to food.

Under the Biocides Regulations, the Minister will have the ability to issue a market authorization by leveraging a decision issued by a foreign regulatory authority when reviewing applications. Conducting a review of a single application through the UFD pathway, compared to that of a new biocide, is expected to save $1,949 for biocides that are considered disinfectants or surface sanitizers, and $3,751 for a biocide for use in food premises.

Based on an internal analysis, approximately 39% of disinfectant full review applications submitted to Health Canada each year have previously received approval by the U.S. EPA. This is applied as a proxy to capture potential biocide applications that will be received through the UFD pathway. Using results from the analysis, Health Canada expects to receive approximately 40 applications, on average, that will be considered eligible for the UFD pathway on an annual basis. Therefore, reviewing applications received through the UFD pathway will save Health Canada a total of $114,000 annually starting in year two, the year the Regulations come into force. This is anticipated to result in a cost savings of $1.48 million PV over 15 years, based on an estimated 8% annual growth rate for the number of applications being received through this pathway each year.

Net impacts

Overall, when accounting for all monetized costs and benefits, a net cost of $310.33 million PV, or $34.07 million annualized, is anticipated over the next 15 years applying a 7% discount rate.

Qualitative benefits
Ability to include multiple brand names and formulations in a market authorization

The Biocides Regulations will introduce the ability for one market authorization to include multiple brand names and/or multiple variations in formulants for a biocide. This will have cost savings for industry and Health Canada, as it would allow for a more efficient application submission and review process. This is anticipated to reduce burden to both industry and Health Canada.

Five out of the seven (71%) responses to the supplementary CBA survey indicated a plan to submit an application to bring more than one product under a single application. If Health Canada were to assume that 71% of new applications coming in each year included at least two products within a single application, this could reduce the anticipated incremental cost for new applications by $16.83 million PV (reducing the total incremental cost from $179.57 million to $162.74 million PV over 15 years). Some stakeholders suggested the potential of five or more products being included under one application, suggesting a high variability in potential cost reductions. Internal data shows that currently 23% of disinfectant authorization holders supply five or more products.

Eliminating the renewal requirement for certain surface sanitizers

Health Canada currently reviews renewal applications submitted by industry every five years for approved surface sanitizers under the PCPA. However, under the Biocides Regulations, certain surface sanitizers without pest control claims will be solely regulated under the Regulations, eliminating the need to renew their registrations under the PCPA. This is expected to result in cost savings to both Health Canada and industry. It is assumed that 27 out of the 70 surface sanitizers expected to be on the market in 2028 will completely transition to the Biocides Regulations, eliminating the need to renew their registration under the PCPA.

Surface sanitizers with pest control claims will continue to be required to renew their registrations every five years under the PCPA. This is because these products will hold a dual registration under the PCPA and the Biocides Regulations following the coming into force, specifically so that these products can maintain their current authorized pest control product claims.

Increased regulatory oversight of surface sanitizers for use in food premises

The creation of a regulatory framework for surface sanitizers for use in food premises will help ensure they are safe, effective, and of high quality. Health Canada is aware of approximately 8% of surface sanitizers for use in food premises which have undergone a pre-market review by obtaining a letter of no objection to determine acceptability from a food safety perspective. The remaining surface sanitizers for use in food premises on the market are considered to have never been reviewed for food safety by Health Canada. Without the regulatory oversight provided by the Biocides Regulations, there is no assurance that a product will be effective. If it does not kill food-borne microbes on the surface that it is applied to, this may result in the contamination of food products that come into contact with the surface and potentially result in food-borne illness. Including surface sanitizers for use in food premises within the scope of the Regulations will help address inconsistencies in regulatory oversight as it extends to provinces and territories who have inconsistent standards relating to which types of biocides are considered acceptable for use in food premises to reduce microbial contamination.

Improved potential to obtain licensing agreements with foreign-based companies

The cost involved in developing a formulation can be cost prohibitive for small businesses. In some cases, companies in Canada reference products that have been developed by other companies through licensing agreements to obtain authorization to sell the product under their own brand name. The UFD pathway will allow multinational companies to obtain their Canadian authorization faster, which could then be licensed out to other Canadian companies, including small businesses, through a licensing agreement, and applications can be submitted for products based on comparison. The UFD pathway may also increase the volume and variety of products available for companies to reference; however, the extent to which this may take place is unknown.

Facilitating and maintaining timely access to a larger variety and supply of biocides will support greater consumer and commercial product choice

The COVID-19 pandemic created an unprecedented demand on Canada’s health care system and increased the need for health products, including disinfectants and surface sanitizers, at that time. The Biocides Regulations introduce a UFD application pathway that will remove barriers to both Health Canada and industry, providing Canadians with more timely access to biocides. Many Canadian biocide suppliers have parent companies in other countries, predominantly in the U.S. Through the UFD pathway, international collaboration may promote the timely approval of a variety of safe and effective biocides. For the past several years, Health Canada has leveraged data from other regulatory agencies, when applicable, to better inform the review of biocides for market authorization in Canada. By expanding this practice, it will be of benefit to Canadians by helping to ensure a safe, effective, and high-quality supply of biocides is maintained. Canadians are also expected to have access to a larger variety of biocides, including innovative biocides. With the potential increase in biocides expected to be authorized through the UFD pathway in combination with the allowance of multiple products being included under a single market authorization, it is anticipated there may be an impact on product pricing and competition in the market that would benefit Canadian consumers.

Cost-benefit statement
Monetized benefits
Impacted stakeholder Description of cost Year 1 (2024) Year 4
(2027)		 Year 6 (2029) Year 15 (2038) Total (PV) Annualized value
Industry Annual summary report cost savings $0 $0 $8.25M $10.77M $52.33M $5.75M
UFD pathway application cost savings $0 $2.97M $3.47M $6.93M $33.13M $3.63M
Government Review process for UFD $0 $132,970 $155,096 $310,037 $1.48M $162,709
All stakeholders Total benefits $0 $3.11M $11.88M $18.01M $86.94M $9.55M
Monetized costs
Impacted stakeholder Description of cost Year 1 (2024) Year 4
(2027)		 Year 6 (2029) Year 15 (2038) Total (PV) Annualized value
Industry Label change $0 $556,686 $16.95M $0 $11.72M $1.29M
Cost of submitting applications for transitioning products $0 $3.51M $191.10M $0 $130.02M $14.28M
New application costs $0 $18.31M $21.35M $42.68M $179.57M $19.72M
Post-authorization pathway changes $0 $4.09M $5.57M $7.27M $45.05M $4.95M
Quality and post-market requirements $0 $0 $3,390 $19,823 $21.34M $2.34M
Notification for permanent discontinuation of sale $0 $0 $0 $10,522 $34,993 $3,842
Government Implementation costs $1.63M $338,000 $328,921 $299,148 $4.5M $495,816
Cost of reviewing applications for transitioning products table d3 note a $0 $0 $0 $0 $2.24M $245,966
Increase cost in reviewing new applications $0 $6,463 $262,308 $500,080 $1.95M $213,775
Ongoing costs $0 $24,645 $54,916 $71,653 $389,511 $42,766
Compliance verification $0 $4,958 $14,875 $114,045 $435,428 $47,808
All stakeholders Total costs $1.63M $26.82M $235.64M $50.97M $397.27M $43.62M

Table d3 note(s)

Table d3 note a

Costs to Health Canada for reviewing the applications of transitioning products are assumed to be incurred within the final year of the transition period, to allow the Department time to review each application based on existing service standards provided. Thus, the one-time cost to review these applications is assumed to be incurred in yeaur faive for existing surface sanitizers and disinfectants and yeaur seven for surface sanitizers for use in food premises.

Return to table d3 note a referrer
Summary of monetized benefits and costs
Impacts Year 1
(2024)		 Year 4
(2027)		 Year 6 (2029) Year 15
(2038)		 Total (PV) Annualized value
Total benefits $0 $3.11M $11.88M $18.01M $86.94M $9.55M
Total costs $1.63M $26.82M $235.64M $50.97M $397.27M $43.62M
NET COST $1.63M $23.72M $223.76M $32.96M $310.33M $34.07M
Quantified (non-monetized) and qualitative impacts

Positive impacts

Negative impacts

Small business lens

According to Health Canada’s records, there are approximately 193 small businesses, including 114 small businesses that produce disinfectants and 36 small businesses producing surface sanitizers authorized for sale in Canada. It is unknown how many small businesses produce surface sanitizers for use in food premises; however, if Health Canada were to apply the same lower-bound percentage as disinfectant companies (24%) and products (23%) represented by small businesses, it could be assumed that 135 surface sanitizers for use in food premises could be represented by 43 small businesses. These companies typically have fewer resources and are mostly operating in Canada, as 178 out of 193 small businesses are assumed to be mainly located within Canada (92%). Based on a sampling of companies in Health Canada’s database, an average small business has between 3-4 products that will be regulated under the Biocides Regulations. Small businesses account for approximately 451 products, including 440 disinfectants and 48 surface sanitizers authorized for sale in Canada.

These small businesses are expected to incur the following costs over the next 15 years (in PV):

Taken over a 15-year period, with some of the costs assumed to be incurred starting in years four and six depending on products’ respective transition periods, discounted at 7%, costs to small businesses will be approximately $86.48 million in PV, or $9.50 million annually.footnote 54 For prepublication in CGI, Health Canada considered a transition period of four years to help alleviate some of the burden for large, medium and small companies. Based on industry feedback, the transition period for surface sanitizers for use in food premises will be extended to six years to provide sufficient time to transition over to the new framework and come into compliance with new regulatory requirements.

Small businesses are expected to save the following amounts over the next 15 years (PV):footnote 55

Taken over a 15-year period, with some of the benefits starting in year five, discounted at 7%, this will save small businesses approximately $22.45 million PV, or $2.47 million annually.

Overall, the net cost to small businesses will be $64.03 million PV over 15 years using a 7% discount rate. Divided by 193 small businesses, this creates a net cost of $331,771 or $36,426 annualized per small business.footnote 56

The introduction of the UFD pathway may encourage small businesses to expand by accessing foreign products to sell in Canada. Small businesses that tend to introduce products onto both the Canadian and U.S. markets may take advantage of the cost savings under the UFD pathway. Small businesses that have sought Canadian market access first may change their business practice for subsequent biocide applications and seek U.S. approval first as a result of the UFD pathway. In addition, small businesses that previously did not seek or intend to seek U.S. approval may choose to change their approach, where it is economically feasible. In addition, the Regulations may also benefit small businesses whose business models rely on licensing agreements between companies that have biocides authorized in the U.S., to bring their products to the Canadian market.

It is possible that the UFD pathway may harm rather than benefit small businesses. Many small Canadian businesses may already be experiencing challenges with competing with larger multinational corporations and maintaining their market share. As a result of the COVID-19 pandemic, these challenges have been amplified, and could continue to exist with the introduction of the UFD pathway. As UFD will allow companies with foreign authorizations to go through an expedited approval process for the same product in Canada, this is expected to increase competition and barriers for businesses that only sell in Canada. Unintended impacts of the timing of the transition periods are also not known. Small businesses that do not intend to market in the U.S. may find that the Canadian market will be more competitive as a result of the Regulations, reducing margins and thereby profits. These reduced margins could also mean that any additional costs from the Biocides Regulations may be passed on to consumers by small businesses, since the ability for these businesses to absorb additional costs in the short term is less likely. However, in a more competitive marketplace, price changes may not be possible to implement, and thus cost increases would have to be absorbed by companies, decreasing their viability. The 2020 fee update for drugs, including disinfectants, introduced small business fee reduction measures that would be maintained for biocides in the accompanying fee proposal. These small business fee reduction measures would help to protect the interests of small businesses.

Small business lens summary
Costs
Compliance Present value Annualized value
Updating labels (one-time cost) $2.93M $322,014
Applications for existing products to transition – surface sanitizers and surface sanitizers for use in food premises (one-time cost) $29.33M $3.22M
Increase in application costs (ongoing cost) $40.02M $4.39M
Increase in post-authorization changes pathways (ongoing cost) $4.51M $494,783
Post-market surveillance systems (one-time cost) $9.05M $993,921
UFD Pathway (ongoing benefit) $9.75M $1.08M
Total compliance cost $76.09M $8.35M
Administrative Present value Annualized value
Reapplication — Disinfectants (one-time cost) $604,213 $66,339
Recall Reporting (ongoing cost) $9,067 $966
Record Keeping (ongoing cost) $22,168 $2,434
Removal of annual summary reports (ongoing benefit) $12.70M $1.39M
Notifications for permanent discontinuation of sale (ongoing cost) $8,145 $894
Total administrative cost savings $12.07M $1.33M
Net impacts
Amount Present value Annualized value
Net cost on all impacted small businesses $64.03M $7.03M
Average net cost on each impacted small business table d7 note a $331,768 $36,426

Table d7 note(s)

Table d7 note a

The cost was calculated based on the assumption that there are approximately 193 small businesses.

Return to table d7 note a referrer

One-for-one rule

For the purposes of the one-for-one rule, the Regulations would be a title “in,” as the proposal creates a new regulatory title under the FDA. For the purposes of counting administrative burden, the Regulations will be an “out”. The annualized administrative cost savings are estimated to be $1.58 million in total (approximately $2,287 per business). The details on the calculations and key assumptions for the standard cost model can be found in the full CBA report as well as the CBA section above.

Application costs for transitioning surface sanitizers and surface sanitizers for use in food premises

Under the Policy on Limiting Regulatory Burden on Business, pre-market approval processes are considered a compliance cost. The transfer of surface sanitizers to the Biocides Regulations under the FDA and the requirement to submit abbreviated applications for surface sanitizers for approval will not be considered an administrative burden under the one-for-one rule. These abbreviated applications for surface sanitizers will be used to expedite approval from one regime (PCPA) to another (FDA) and will fall under the pre-market approval process. The requirement to submit a new application for surface sanitizers for use in food premises for approval will also not be considered an administrative burden under the one-for-one rule, as they will also fall under the pre-market approval process.

Extension of terms and conditions for surface sanitizers and surface sanitizers for use in food premises

Market authorization holders of biocides may be required to submit information to Health Canada arising from broadened terms and conditions. The objective of imposing terms and conditions will be to manage uncertainties relating to the benefits and/or risks of a biocide at the time of authorization or to manage emerging risks or uncertainties post-authorization. This requirement is directly related to ensuring the health and safety of Canadians. Therefore, the costs of fulfilling the terms and conditions are not considered as administrative burden as defined by the Red Tape Reduction Act as their primary purpose is not for ensuring compliance.

Administrative costs: abbreviated application to transition disinfectants

Under the Biocides Regulations, authorization holders of disinfectants must transition their biocide by filing an abbreviated transition application to Health Canada if they plan to continue the sale of these products as biocides. The abbreviated application filed to Health Canada by existing disinfectant authorization holders currently operating under the FDR will be considered a one-time administrative cost. This one-time cost is estimated to be $1,800 in 2023 CAD ($1,400 in 2012 CAD) per application.

Administrative costs: record keeping

The Biocides Regulations include post-market requirements that some companies will need to implement to become compliant, specifically, having a system in place to effectively and rapidly conduct recalls, as well as maintain the necessary records for a specific period. The one-time implementation of these systems is considered a compliance cost; however, the requirement to retain and maintain records will be considered an administrative cost. Companies that sell surface sanitizers and surface sanitizers for use in food premises were not previously required to maintain records for a specified period; these systems must be in place to comply with the Biocides Regulations. It is estimated to cost $1,890 a year in 2023 CAD ($1,451 in 2012 CAD) for all companies producing surface sanitizers and $6,720 a year in 2023 CAD ($5,158 in 2012 CAD) for all companies producing surface sanitizers for use in food premises; companies will begin to incur these incremental costs the year following the end of their respective transition periods.

Administrative costs: Notification for permanent discontinuation of sale

The Biocides Regulations will include a requirement for companies selling biocides to notify Health Canada when permanently discontinuing the sale of a biocide. This is currently a requirement for companies manufacturing disinfectants and surface sanitizers, but this will be a new requirement for those currently supplying surface sanitizers for use in food premises. The estimated cost to notify Health Canada for permanently discontinuing the sale of a biocide is $295 per discontinuation notification in 2023 CAD ($226 in 2012 CAD).

Administrative cost savings: removal of annual summary report

The reduced cost from removing the annual summary report requirement for biocide MAHs will result in a cost savings. The removal of the requirement to submit an annual summary report has been estimated by industry to save between $1,816 and $6,188 per product in 2023 CAD ($1,394 and $4,749 in 2012 CAD respectively).footnote 57 The activities related to the preparation of the annual summary report has been estimated by industry to require between 27 and 92 hours at an average cost of $68 per hour in 2023 CAD (52.64 in 2012 CAD).

Regulatory cooperation and alignment

The Biocides Regulations will allow for the authorization and regulation of biocides under a single framework and separately from other health products under the FDA and pest control products under the PCPA. This is consistent with the approach taken by the U.S., the United Kingdom and the European Union.

Following initial consultation with industry stakeholders on the proposed Biocides Regulations, Health Canada considered the market authorization and application process for biocides in the U.S., the United Kingdom, Australia and the European Union. In response, changes were made to the Regulations to allow for one application to be submitted for a biocide with minor variations in formulation and brand names.

The UFD pathway in the Biocides Regulations is based on the confidence that Health Canada has in other foreign regulators as a result of collaboration and other regulatory confidence-building activities. The intent of this pathway is to improve access to a larger variety of safe and effective biocides for Canadians. Recently, Health Canada has been making joint efforts with the U.S. EPA to streamline requirements for pest control product submissions.

It is to be noted that differences may always exist between the requirements in Canada and other international jurisdictions. These differences are necessary to align with the structure and requirements in other applicable legislation and regulations in Canada, and to align with Canada’s bilingual labelling requirements.

Strategic Environmental Assessment

As there are new labelling requirements introduced through the Biocides Regulations, it is anticipated that labels of all surface sanitizers will require changes to come into compliance with the Regulations. The Biocides Regulations come into force one year after they are registered. At this point, all new products entering the market will have to meet the new requirements. To continue sales, those who hold a registration for a surface sanitizer under the PCPA or an authorization for a disinfectant under the FDR will have a transition period of four years from the coming-into-force date to obtain an authorization under the Biocides Regulations. In addition, companies marketing surface sanitizers for use in food premises will have six years to obtain a market authorization for these biocides under the Regulations. Some companies will have to engage in some form of relabelling to comply with the new requirements, and providing an extended transition period will lessen costs on industry and avoid the risk of supply chain bottlenecks with third party designers, labellers, and packagers. In addition, this will help minimize waste by enabling MAHs to sell off existing stock instead of having to recall, repackage, discard, or relabel their products at an earlier date to comply with the Regulations.

Gender-based analysis plus

Health Canada expects that the introduction of the Biocides Regulations will have a positive impact on the health and safety of Canadians.

Incidents

Certain vulnerable populations may be more prone to incidents from misuse, overuse, or accidental poisoning related to biocides. According to data from poison control centres in the U.S., exposures among children aged five years or younger consistently represented a large percentage of total reports throughout the three-month period for each year that was studied (January to March 2018, 2019, and 2020).footnote 58,footnote 59 Similar findings were reported from Canadian poison control centres.footnote 60 The Biocides Regulations will help mitigate this by requiring the statement, ’’Keep out of reach of children’’, on the principal display panel of all biocides to help prevent any unintentional exposure by this subpopulation. In addition, the Regulations include application requirements that will help ensure biocides are not packaged in containers that could cause them to be mistaken for a food or beverage. Appropriate safety labelling statements will continue to be a regulatory requirement to mitigate risks associated with biocides.

Workplace-related exposure

The exposure to biocides may be greater in occupational settings. For example, people in health care, food preparation, livestock care, childcare and janitorial service industries are likely to have greater exposure than the general public, due to the volume and frequency use of biocides in these settings to prevent microbial growth and outbreaks.footnote 61 There may be increased adverse effects observed for some population groups, such as allergic responses,footnote 8 or chronic obstructive pulmonary disease as a result of this increased occupational exposure.footnote 7

The Biocides Regulations will require that the MAH of a biocide monitor the safety of their product in a manner that reliably allows them to detect significant safety issues or changes to the benefits and risks associated with the product that may emerge over time. The Minister will have the authority to compel label changes, recall a product, request information from an authorization holder, suspend or revoke a market authorization and direct persons to stop the sale to mitigate risks, if necessary.

Implementation, compliance and enforcement, and service standards

Implementation

Forms and webpages have been updated to reflect the publication of the Biocides Regulations. Health Canada will publish communication materials and host information sessions following the publication of the Regulations to facilitate stakeholder understanding of the new requirements. Communications will clearly outline the transition processes for surface sanitizers, disinfectants, and surface sanitizers for use in food premises, to encourage the transition of these products before the end of the transition period.

Health Canada will regularly review the List of Foreign Regulatory Authorities associated with the UFD pathway to provide opportunities to add trusted regulatory authorities or application pathways, or to remove them, if necessary. Health Canada will consult with Canadians as required on the Department’s website prior to implementing changes to the List of Foreign Regulatory Authorities.

In addition, guidance has been published to help facilitate stakeholder compliance and understanding of the Biocides Regulations.

Compliance and enforcement

As part of its regulatory responsibilities, Health Canada monitors compliance, undertakes enforcement actions, and works towards preventing non-compliance through compliance promotion activities. Health Canada will extend its current Compliance and enforcement policy for health products (POL-0001) to include biocides. Any impacted quality documents will be updated prior to the coming into force of the Biocides Regulations.

Surface sanitizers and disinfectants will not be subject to the requirements related to drug establishment licences and good manufacturing practices outlined in the FDR. Health Canada has conducted compliance and enforcement activities for these products using a combination of compliance monitoring, compliance promotion, and a risk-based approach to inspection and compliance verification that is typically triggered by international monitoring, identified quality issues, or complaints. This risk-based compliance and enforcement approach will continue to apply for biocides under the Regulations.

Performance standards

Health Canada consulted on performance standards along with the prepublication of the Biocides Regulations. Performance standards have been established according to the level of effort and workload management required to review each application type and to issue a decision. Performance standards for the review of biocide applications are published in the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order. Performance results will be published each fiscal year in the Report on Fees, which is tabled in Parliament in the following fiscal year and will be posted on Health Canada’s website.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca