Biocides Regulations (SOR/2024-110)

Interpretation

Marginal note:Definitions

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

  Act

  Act means the Food and Drugs Act. (Loi)

  active ingredient

  active ingredient means a component of a biocide that is directly responsible for any of the biocide’s intended effects. (ingrédient actif)

  biocide

  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

  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

  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

  contact information includes civic address, except in paragraphs 32(1)(e), 49(2)(d) and 50(1)(a). (coordonnées)

  expiry date

  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

  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

  formulant means any component of a biocide other than an active ingredient or contaminant. (formulant)

  import

  import means import for the purpose of sale. (importer)

  List of Foreign Regulatory Authorities

  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

  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

  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

  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

  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

  pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)

  shelf life

  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

  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)

• Marginal note: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,

  • (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.

Non-application

Marginal note:Food and Drug Regulations

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

Import

Marginal note: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.

• Marginal note:Exception

  (2) The prohibition does not apply if

  • (a) the sale of the biocide in Canada would not contravene the Act or these Regulations if the biocide was relabelled or modified; and

  • (b) the importer provides an inspector with advance notice of the import.

Marginal note: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).

• Marginal note: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

Marginal note: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.

• Marginal note: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

Marginal note: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

Marginal note: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.

Marginal note: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

• (a) the biocide is not represented by label as a treatment or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act; and

• (b) the person does not advertise the biocide to the general public as a treatment or cure for any of those diseases, disorders or abnormal physical states.

Market Authorizations

Prohibition

Marginal note: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.

• Marginal note: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

Marginal note:Application requirements

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

  • (a) the applicant’s name and contact information;

  • (b) the brand names under which the biocide is proposed to be sold or advertised;

  • (c) the physical form of the biocide and the methods of application;

  • (d) a list of the biocide’s active ingredients and their CAS registry numbers, if they have one;

  • (e) a list of the formulants that the biocide contains, including formulants that only a particular version of the biocide contains, and their CAS registry numbers, if they have one;

  • (f) the quantity of each active ingredient and formulant that a given quantity of the biocide contains;

  • (g) the conditions of use of the biocide;

  • (h) information regarding the benefits and risks associated with the biocide and any uncertainties relating to those benefits and risks, including reports of any tests and studies conducted by or on behalf of the applicant to identify and assess those benefits, risks and uncertainties;

  • (i) a summary of the information referred to in paragraph (h);

  • (j) the names and contact information of

    • (i) the persons that will manufacture the biocide, excluding individuals who are employees or agents of such persons,

    • (ii) any persons that will import the biocide, and

    • (iii) if known, the persons that will package or label the biocide, excluding individuals who are employees or agents of such persons;

  • (k) the civic addresses of the locations where the biocide will be manufactured and, if known, packaged and labelled;

  • (l) the specifications for the biocide;

  • (m) the shelf life of the biocide;

  • (n) the text of every label to be used in connection with the biocide, including any supplementary information on the use of the biocide that is to be provided to users on request;

  • (o) if the biocide is a pest control product that is registered under the Pest Control Products Act,

    • (i) the registration number assigned to it under that Act, and

    • (ii) in the case where the biocide’s registration was based on a comparison with another biocide that is a pest control product, a statement to that effect and the registration number assigned to the other biocide under that Act; and

  • (p) if a drug identification number has been assigned to the biocide under the Food and Drug Regulations and has not been cancelled,

    • (i) the drug identification number assigned to it under those Regulations, and

    • (ii) in the case where the biocide’s drug identification number was assigned on the basis of a comparison with another biocide, a statement to that effect and the drug identification number assigned to the other biocide under those Regulations.

• Marginal note: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

  • (a) the application is based on a comparison between the biocide and another biocide that is the subject of a market authorization;

  • (b) the application contains the other biocide’s identification number;

  • (c) the application contains information that demonstrates that

    • (i) for a given quantity of biocide, the biocide contains the same active ingredients in the same quantities as the other biocide,

    • (ii) the formulants that the biocide contains are among the formulants that the other biocide may contain under its market authorization,

    • (iii) for a given quantity of biocide, the quantity of each formulant that the biocide contains is the same as the quantity of that formulant that the other biocide may contain under its market authorization,

    • (iv) subject to subparagraph (v), the conditions of use of the biocide fall within the conditions of use of the other biocide, and

    • (v) the biocide has the same risk information and directions for storage as the other biocide;

  • (d) the application contains, if the applicant is not the holder of the market authorization for the other biocide, an attestation, by an individual who has authority to bind the holder, that

    • (i) confirms that the holder has provided the applicant with the master formula for the other biocide, and

    • (ii) mentions the other biocide’s brand names and identification number;

  • (e) the application contains an attestation, by an individual who has authority to bind the applicant, that confirms that

    • (i) the biocide will be manufactured in accordance with the master formula for the other biocide, and

    • (ii) the specifications for the biocide — other than in respect of the net quantity of the biocide in the package, the type of its package and the properties and qualities of the packaging material — are the same as those for the other biocide;

  • (f) the following conditions are met in respect of the other biocide’s market authorization:

    • (i) subject to subsection (3), the other biocide’s authorization was not issued on the basis of a comparison to a third biocide, and

    • (ii) the other biocide’s authorization is not suspended;

  • (g) in the case where the other biocide was exempted from the application of these Regulations under subsection 66(1), the other biocide was not registered under the Pest Control Products Act on the basis of a comparison to a third biocide that is a pest control product; and

  • (h) in the case where the other biocide was exempted from the application of these Regulations under subsection 68(1), the drug identification number assigned to the other biocide under the Food and Drug Regulations was not assigned on the basis of a comparison to a third biocide.

• Marginal note:Exception — foreign biocide

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

  • (a) the application for the other biocide’s market authorization was submitted under section 26; and

  • (b) the holder of the market authorization for the other biocide is also the holder of the authorization to sell the foreign biocide.

• Marginal note: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.