Biocides Regulations · GlobalLawDB

Contents

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Biocides Regulations under(a) section 30 of the Food and Drugs Act; and^note^note(b) subsection 67(1) of the Pest Control Products Act.^note^note

Interpretation

1Definitions#

(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)

(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

2Food and Drug Regulations#

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

Import

3Prohibition — import of non-compliant biocides#

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

(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.

4Prohibition — importer information not published#

(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).

(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

5Export certificates#

(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.

(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

6Transhipment in bond#

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

Exemptions — Section 3 of the Act

7Advertising as preventative only#

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.

8Sale as preventative only#

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

9Import, sale or advertising#

(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.

(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

10Application requirements#

(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.

(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.

(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.

(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.

11Issuance#

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

(a)the application meets the applicable requirements set out in section 10 or 26, as the case may be;

(b)the applicant has provided the Minister with any additional information and material that is requested under subsection 10(4) or 26(5);

(c)the Minister has sufficient evidence to support the conclusion that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks; and

(d)the Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the Act and these Regulations.

12Content of market authorization#

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

(a)the identification number assigned by the Minister to the biocide;

(b)the name and civic address of the holder of the authorization and the names and civic addresses of any importers of the biocide;

(c)the biocide’s brand names;

(d)the physical form of the biocide and the methods of application;

(e)a list of the biocide’s active ingredients and formulants, including 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)the terms and conditions of the authorization, if any;

(i)the date on which the authorization is issued;

(j)the dates, if any, on which the authorization is amended;

(k)in the case where the authorization was issued on the basis of an application that met the applicable conditions set out in subsection 10(2),

(i)a statement that the application was based on a comparison, and

(ii)the other biocide’s identification number;

(l)in the case where the authorization was issued on the basis of an application submitted under section 26,

(i)a statement that the sale of the biocide has been authorized on the basis of a foreign decision,

(ii)the name of the relevant foreign regulatory authority, and

(iii)a description of the foreign biocide;

(m)in the case where the authorization was issued on the basis of an application submitted under section 10 and the biocide had been registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product,

(i)a statement that the application for registration was based on a comparison, and

(ii)the registration number assigned to the other biocide under that Act;

(n)in the case where the authorization was issued on the basis of an application submitted under section 10 and a drug identification number had been assigned to the biocide under the Food and Drug Regulations on the basis of a comparison to another biocide,

(i)a statement that the application for a drug identification number was based on a comparison, and

(ii)the drug identification number assigned to the other biocide under those Regulations; and

(o)in the case where an application for a notice of acceptance in respect of a major change that affected the biocide met the applicable conditions set out in subsection 15(3),

(i)a statement that the application was based on a comparison, and

(ii)the applicable information referred to in subparagraph 15(3)(c)(i), (ii) or (iii) in respect of the other biocide.

(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:

(a)the quantity of the formulants that a given quantity of the biocide contains;

(b)the CAS registry numbers of the biocide’s active ingredients and formulants, if they have one;

(c)in the case where the authorization was issued on the basis of an application that met the applicable conditions set out in subsection 10(2), the information referred to in subparagraph (1)(k)(ii);

(d)in the case where the authorization was issued on the basis of an application submitted under section 26, the information referred to in subparagraph (1)(l)(iii);

(e)if the biocide had been registered under the Pest Control Products Act on the basis of a comparison to another biocide that is a pest control product, the information referred to in subparagraph (1)(m)(ii); and

(f)if a drug identification number had been assigned to the biocide under the Food and Drug Regulations on the basis of a comparison to another biocide, the information referred to in subparagraph (1)(n)(ii).

(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.

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

Terms and Conditions

13Terms and conditions#

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

(a)whether there are significant uncertainties relating to the benefits or risks associated with the biocide to which the authorization relates;

(b)whether the requirements under the Act are sufficient to

(i)optimize the benefits and minimize the risks associated with the biocide,

(ii)manage the uncertainties relating to the benefits and risks, and

(iii)collect information to be able to continuously assess the benefits and risks, identify any changes to them and manage the uncertainties; and

(c)whether the terms and conditions that the Minister intends to impose may contribute to meeting the objectives set out in subparagraphs (b)(i) to (iii).

(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

(a)amend the authorization to reflect the terms and conditions that have been imposed or the amendment of the terms and conditions, as the case may be; and

(b)amend the information published under subsection 12(2) accordingly.

Changes

14Deemed creation of new biocide#

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:

(a)the substitution, addition or removal of an active ingredient;

(b)a change to the quantity of an active ingredient that a given quantity of the biocide contains; or

(c)a change to the physical form of the biocide.

15Major change#

(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).

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

(a)the biocide’s identification number;

(b)a description of the major change; and

(c)subject to subsections (3) and (6), the information referred to in subsection 10(1) to which the major change relates.

(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

(a)the application is submitted on the basis of a comparison between the version of the biocide that is affected by the major change and one of the following biocides (referred to in paragraphs (b) to (i) as “the other biocide”):

(i)in the case where the biocide’s market authorization was issued on the basis of an application that met the applicable conditions set out in subsection 10(2), a version of the other biocide referred to in paragraph 10(2)(a) that is also affected by the major change,

(ii)in the case where the biocide had been registered under the Pest Control Products Act on the basis of a comparison to the other biocide referred to in subparagraph 10(1)(o)(ii), a version of that other biocide that is also affected by the major change, or

(iii)in the case where a drug identification number had been assigned to the biocide under the Food and Drug Regulations on the basis of a comparison to the other biocide referred to in subparagraph 10(1)(p)(ii), a version of that other biocide that is also affected by the major change;

(b)one of the following conditions is met in respect of the other biocide:

(i)in the case referred to in subparagraph (a)(i), it is the subject of a market authorization,

(ii)in the case referred to in subparagraph (a)(ii), it is registered under the Pest Control Products Act, or

(iii)in the case referred to in subparagraph (a)(iii), a drug identification number has been assigned to it under the Food and Drug Regulations and has not been cancelled;

(c)the application contains the following information in respect of the other biocide:

(i)in the case referred to in subparagraph (a)(i), its identification number,

(ii)in the case referred to in subparagraph (a)(ii), the registration number assigned to it under the Pest Control Products Act, or

(iii)in the case referred to in subparagraph (a)(iii), the drug identification number assigned to it under the Food and Drug Regulations;

(d)the application contains information that demonstrates that

(i)for a given quantity of biocide, the version of the biocide that is affected by the major change contains the same active ingredients in the same quantities as the other biocide,

(ii)the formulants that the version of the biocide that is affected by the major change contains are among the formulants that the other biocide may contain under the applicable authorization referred to in subparagraph (b)(i), (ii) or (iii),

(iii)for a given quantity of biocide, the quantity of each formulant that the version of the biocide that is affected by the major change contains is the same as the quantity of that formulant that the other biocide may contain under the applicable authorization referred to in subparagraph (b)(i), (ii) or (iii),

(iv)subject to subparagraph (v), the conditions of use of the version of the biocide that is affected by the major change fall within the conditions of use of the other biocide, and

(v)the version of the biocide that is affected by the major change has the same risk information and directions for storage as the other biocide;

(e)the application contains, if the applicant is not the holder of the applicable authorization referred to in subparagraph (b)(i), (ii) or (iii) for the other biocide, an attestation, by an individual who has authority to bind the holder, that

(i)confirms that either

(A)the major change resulted in an amendment to the master formula for the other biocide and the holder provided the applicant with the updated master formula for the other biocide, or

(B)the major change did not result in an amendment to the master formula for the other biocide, and

(ii)mentions, in respect of the other biocide, its brand names and the applicable information referred to in subparagraph (c)(i), (ii) or (iii);

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

(i)if the major change resulted in an amendment to the master formula for the other biocide, the version of the biocide that is affected by the major change will be manufactured in accordance with the updated master formula for the other biocide, and

(ii)the specifications for the version of the biocide that is affected by the major change — 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;

(g)in the case referred to in subparagraph (a)(i),

(i)the Minister has provided to the holder of the market authorization for the other biocide a notice of acceptance in respect of the major change, and

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

(h)in the cases referred to in subparagraph (a)(ii) and subsection (4), 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

(i)in the cases referred to in subparagraph (a)(iii) and subsection (5), 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.

(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:

(a)the biocide’s market authorization is deemed to have been issued on the basis of an application that met the applicable conditions set out in subsection 10(2); and

(b)that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).

(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:

(a)the biocide’s market authorization is deemed to have been issued on the basis of an application that met the applicable conditions set out in subsection 10(2); and

(b)that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).

(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

(a)the biocide’s market authorization was issued on the basis of an application submitted under section 26;

(b)the application is submitted on the basis of a comparison between

(i)the version of the biocide that is affected by the major change; and

(ii)a version of the foreign biocide described in the market authorization that is also affected by the major change (referred to in paragraphs (c) to (f) as “the other foreign biocide”);

(c)the foreign regulatory authority named in the market authorization has authorized the major change in respect of the other foreign biocide, other than on the basis of a type of application that is set out in the List of Foreign Regulatory Authorities in connection with that regulatory authority;

(d)the name of the foreign regulatory authority appears in that List when the application is submitted;

(e)the application contains

(i)evidence of the authorization provided by the foreign regulatory authority in respect of the major change, and

(ii)an attestation, by an individual who has authority to bind the holder of the market authorization, that confirms that the holder possesses or has immediate access to the information that was submitted to the foreign regulatory authority to obtain the authorization referred to in subparagraph (i); and

(f)the application contains an attestation, by an individual who has authority to bind the holder of the market authorization, that

(i)confirms that either

(A)the major change resulted in an amendment to the master formula for the other foreign biocide and the version of the biocide that is affected by the major change will be manufactured in accordance with the updated master formula for the other foreign biocide, or

(B)the major change did not result in an amendment to the master formula for the other foreign biocide, and

(ii)confirms that the specifications for the version of the biocide that is affected by the major change — 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 foreign biocide.

(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.

(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.

(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)

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

(a)a market authorization;

(b)a registration under the Pest Control Products Act; or

(c)a drug identification number that has been assigned under subsection C.01.014.2(1) of the Food and Drug Regulations and has not been cancelled.

16Notice of acceptance#

(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

(a)the application for the notice meets the requirements set out in subsection 15(2);

(b)the holder has provided the Minister with any additional information and material requested under subsection 15(7);

(d)in the case where the major change affects the packaging or labelling of the biocide, the Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the Act and these Regulations.

(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

(a)amend the authorization to reflect the major change; and

(b)if applicable, amend the information published under subsection 12(2) accordingly.

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

(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.

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

17Minor change#

(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.

(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.

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

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

(a)amend the authorization to reflect the minor change; and

(b)if applicable, amend the information published under subsection 12(2) accordingly.

(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).

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

Direction to Stop Sale

18Prohibition#

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.

19Direction to stop sale#

(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

(a)the lot or batch is not manufactured, packaged or labelled in accordance with the master formula for the biocide or has not been stored in accordance with the master formula; or

(b)the lot or batch is manufactured, packaged or labelled in contravention of the Act or these Regulations.

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

(a)in the case of a direction made for the reason set out in paragraph (1)(a), the lot or batch is manufactured, packaged or labelled, or has been stored, as the case may be, in accordance with the master formula for the biocide; or

(b)in the case of a direction made for the reason set out in paragraph (1)(b), the lot or batch is manufactured, packaged or labelled, as the case may be, in accordance with the Act or these Regulations, as the case may be.

Suspension

20Prohibition — sale or advertising#

(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.

(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

(a)the notice referred to in subsection 21(1) or paragraph 22(1)(c); or

(b)the information provided to them under subparagraph 22(1)(a)(i) or paragraph 22(1)(b).

21Power to suspend#

(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

(a)the Minister has reasonable grounds to believe that the holder or an importer has, in respect of the biocide, contravened any provision of the Act or these Regulations or any order made under the Act;

(b)the Minister has reasonable grounds to believe that the risks associated with the biocide — or, in the case of a partial suspension, the risks associated with certain conditions of use, formulants or other aspects of the biocide — outweigh the benefits associated with the biocide, taking into account any uncertainties relating to the benefits and risks; or

(c)in the case where the market authorization was issued on the basis of an application submitted under section 26, the Minister becomes aware that the authorization to sell the foreign biocide has been revoked or suspended.

(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.

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

(a)the reasons for the suspension;

(b)a statement of whether the market authorization is suspended in whole or in part and, if it is suspended in part, a description of the version of the biocide to which the suspension relates; and

(c)the effective date of the suspension.

(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.

22Notice to third parties#

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

(a)the holder of the authorization must

(i)without delay after receiving the notice referred to in subsection 21(1), provide the information that is set out in the notice under paragraphs 21(3)(b) and (c) as well as the biocide’s identification number — and, in the case of a partial suspension, the lot numbers of the version of the biocide to which the suspension relates — to any importer of the biocide and any person, other than a user, to whom the holder has sold the biocide or the affected version, as the case may be, and

(ii)in the case where the holder is required to provide information to importers or other persons under subparagraph (i), provide to the Minister, within two business days after receiving the notice referred to in subsection 21(1) or within any longer period specified by the Minister, written confirmation that the information has been provided to those persons;

(b)any person that receives the information referred to in subparagraph (a)(i) from the holder or from any person that has sold them the biocide must provide the information without delay to any person, other than a user, to whom the recipient of the information has sold the biocide or the affected version, as the case may be; and

(c)the Minister must publish on the Government of Canada website a notice of the suspension that sets out

(i)a summary of the reasons for the suspension, and

(ii)the information referred to in paragraphs 21(3)(b) and (c).

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

(a)a Saturday; or

(b)a Sunday or other holiday.

23Reinstatement of market authorization#

(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.

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

Revocation

24Automatic revocation#

(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

(a)in the case of a suspension under paragraph 21(1)(a), the situation that gave rise to the suspension is not corrected within the six-month period that begins on the effective date of the suspension; and

(b)in the case of a suspension under paragraph 21(1)(c), the situation that gave rise to the foreign revocation or suspension is not corrected within the six-month period that begins on the effective date of the suspension of the market authorization.

(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.

(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.

(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.

25Public notice#

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

(a)publish on the Government of Canada website a notice of revocation that sets out

(i)a summary of the reasons for the revocation,

(ii)a statement of whether the authorization is revoked in whole or in part and, if it is revoked in part, a description of the version of the biocide to which the revocation relates, and

(iii)the effective date of the revocation; and

(b)if applicable, amend the information published under subsection 12(2) accordingly.

Use of Foreign Decisions

26Application#

(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

(a)by a foreign regulatory authority named in the List of Foreign Regulatory Authorities; and

(b)under a statute or other legislative instrument that is set out in that List in connection with the regulatory authority.

(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.

(3)The application must contain

(a)the information referred to in paragraphs 10(1)(a) to (g), (j), (k), (m) and (n) — and, if applicable, subparagraph(o)(i) or (p)(i) — in respect of the biocide for which the market authorization is sought;

(b)information relating to the net quantity of the biocide in the package and the type of its package as well as a statement of the properties and qualities of the packaging material;

(c)subject to subsection (4), an attestation, by an individual who has authority to bind the applicant, that

(i)confirms that the applicant possesses or has immediate access to the information referred to in paragraphs 10(1)(h) and (l) that was submitted to the foreign regulatory authority to obtain the authorization to sell the foreign biocide, and

(ii)confirms that

(A)if the summary referred to in paragraph 10(1)(i) was submitted to the foreign regulatory authority to obtain that authorization, the applicant possesses or has immediate access to that summary, or

(B)if the summary referred to in paragraph 10(1)(i) was not submitted to the foreign regulatory authority to obtain that authorization, the summary was not so submitted;

(d)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 foreign biocide may contain under the authorization to sell the foreign biocide,

(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 foreign biocide may contain under the authorization to sell the foreign biocide, and

(iv)the biocide has the same conditions of use as the foreign biocide;

(e)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 foreign biocide, and

(f)a list of the tests and studies that have been submitted to the foreign regulatory authority in connection with the authorization to sell the foreign biocide;

(g)information that demonstrates that the sale of the foreign biocide is authorized by the foreign regulatory authority;

(h)the terms and conditions that the foreign regulatory authority has imposed on the authorization to sell the foreign biocide, if any; and

(i)the text approved by the foreign regulatory authority for every label to be used in connection with the foreign biocide.

(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.

(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.

27Follow-up obligations#

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

(a)subject to subsection (3), possess or have immediate access to the information referred to in paragraphs 10(1)(h) and (l) that was submitted to the foreign regulatory authority named in the market authorization in order to obtain

(i)the authorization to sell the foreign biocide, and

(ii)any authorization in respect of a major change for a version of the foreign biocide that is affected by the major change, if

(A)a version of the biocide is also affected by the major change,

(B)the holder made an application under subsection 15(6) on the basis of a comparison between the version of the biocide that is affected by the major change and the version of the foreign biocide that is affected by the major change, and

(C)the Minister has provided the holder with a notice of acceptance in respect of the major change under subsection 16(1);

(b)possess or have immediate access to the summary referred to in paragraph 10(1)(i), if the summary was submitted to the foreign regulatory authority to obtain the authorization to sell the foreign biocide;

(c)possess or have immediate access to the summary referred to in paragraph 10(1)(i) that relates to a major change that affects a version of the foreign biocide, if

(i)the summary was submitted to the foreign regulatory authority to obtain any authorization in respect of the major change for the version of the foreign biocide that is affected by the major change, and

(ii)the conditions set out in clauses (a)(ii)(A) to (C) are met in respect of the major change;

(d)provide the Minister, on request, with any information referred to in any of paragraphs (a) to (c) within 48 hours after the request is made or any longer period specified by the Minister;

(e)inform the Minister in writing and without delay if they become aware that

(i)the foreign biocide has been recalled, or

(ii)the foreign regulatory authority has revoked or suspended the authorization to sell the foreign biocide; and

(f)provide the Minister, without delay after becoming aware that the foreign regulatory authority has required a change in respect of the foreign biocide, with a written description of the change and the reasons for it, if they are known.

(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.

(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.

(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

28Definitions#

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)

29Requirement for label#

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

30Bilingual labelling#

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.

31Principal display panel#

(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:

(a)the brand name of the biocide;

(b)at least one of the intended uses or purposes of the biocide;

(c)the settings in which the biocide is intended to be used;

(d)the biocide’s identification number, preceded by the designation “DIN” in capital letters;

(e)the net quantity of the biocide in the package;

(f)the statements “Keep out of reach of children.” and “Tenir hors de la portée des enfants.”; and

(g)if the biocide is sterile, the words “sterile” and “stérile”.

(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.

32Additional information#

(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:

(a)the conditions of use of the biocide, other than the conditions of use that are required to be shown on the principal display panel under paragraphs 31(1)(b) and (c);

(b)the quantity of each active ingredient that a given quantity of the biocide contains;

(c)the lot number of the biocide;

(d)the expiry date of the biocide, unless the biocide is a household biocide with a shelf life of more than one year and the package contains a quantity of the biocide that may reasonably be expected to be used within one year after it is sold;

(e)the name and contact information of the holder of the market authorization for the biocide; and

(f)the physical form of the biocide, unless it is obvious.

(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.

33Small packages#

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

(a)the immediate container is packaged in another package and the outer label complies with the labelling requirements of these Regulations; and

(b)the inner label shows

(i)the brand name of the biocide,

(ii)the quantity of each active ingredient that a given quantity of the biocide contains,

(iii)the net quantity of the biocide in the immediate container,

(iv)the settings in which the biocide is intended to be used, and

(v)the information referred to in paragraphs 32(1)(c) to (f).

34Pressurized containers — explosion hazard#

(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:

(a)the hazard symbol set out in column 2 of item 4 of Schedule 2 to the Consumer Chemicals and Containers Regulations, 2001;

(b)the signal words “CAUTION” and “ATTENTION”; and

(c)the primary hazard statements “CONTAINER MAY EXPLODE IF HEATED.” and “CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ.”.

(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:“Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.”“Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant, ni le jeter au feu, ni le conserver à des températures dépassant 50 °C.”.

35Pressurized containers — flammability#

(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:

(a)if the length of the flame projection is less than 15 cm and there is no flashback,

(i)the hazard symbol set out in item 1 of the annex to the Pressurized Containers Labelling Document,

(ii)the signal words “CAUTION” and “ATTENTION”, and

(iii)the primary hazard statements “FLAMMABLE” and “INFLAMMABLE”;

(b)if the length of the flame projection is 15 cm or more but less than 45 cm and there is no flashback,

(i)the hazard symbol set out in item 2 of the annex to the Pressurized Containers Labelling Document,

(ii)the signal words “WARNING” and “AVERTISSEMENT”, and

(iii)the primary hazard statements “FLAMMABLE” and “INFLAMMABLE”; and

(c)if the length of the flame projection is 45 cm or more or there is a flashback,

(i)the hazard symbol set out in column 2 of item 3 of Schedule 2 to the Consumer Chemicals and Containers Regulations, 2001,

(ii)the signal word “DANGER”, and

(iii)the primary hazard statements “EXTREMELY FLAMMABLE” and “EXTRÊMEMENT INFLAMMABLE”.

(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)

36Exceptions — small quantities#

(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.

(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.

(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.

37Packaging standards#

The immediate container of a biocide must be constructed to

(a)contain the biocide safely under normal conditions of storage, display and distribution;

(b)permit the user to withdraw the biocide in a safe manner and to close the container in a manner that will contain the biocide safely under normal storage conditions; and

(c)minimize changes to, including degradation of, its contents.

Information Requirements

Notable and Serious Incidents

38Definitions#

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)

39Serious incident reporting#

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:

(a)any serious incident involving the biocide that occurs in Canada; and

(b)any serious unexpected incident involving the biocide that occurs outside Canada.

40Information relating to incidents#

(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.

(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.

(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.

(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.

(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.

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

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

Assessments, Tests and Studies

41Issue-related report#

(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

(a)a concise, critical analysis of the issue specified in the request;

(b)the information on which the analysis is based; and

(c)any additional information specified by the Minister that is accessible to the holder.

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

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

42Assessment order — condition#

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.

43Order requiring tests and studies — conditions#

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

(a)have reasonable grounds to believe that there are significant uncertainties relating to the benefits or risks associated with the biocide; and

(b)take into account

(i)whether the activities that the holder of the market authorization will be ordered to undertake are feasible, and

(ii)whether there are less burdensome ways of obtaining the information to be provided under the order.

Hospital Reporting

44Serious adverse drug reactions — biocides#

(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:

(a)the name and civic address of the hospital and the name and contact information of a representative of the hospital;

(b)the brand name of the biocide involved in the reaction;

(c)the identification number of the biocide involved in the reaction;

(d)the age and sex of the patient who experienced the reaction;

(e)a description of the reaction;

(f)the date on which the patient was exposed to the biocide, if known;

(g)the date on which the reaction first occurred, if known;

(h)the date on which the reaction was first documented within the hospital;

(i)if applicable, the date on which the patient’s health was restored to its state prior to the reaction;

(j)any medical condition of the patient that directly relates to the reaction; and

(k)any other factor that may have contributed to the reaction.

(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).

(3)In this section, hospital means a facility

(a)that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to individuals suffering from any form of disease or illness; or

(b)that is operated by the Government of Canada and that provides health services to in-patients.

(4)For greater certainty,

(a)in this section, serious adverse drug reaction has the same meaning as in subsection 1(2); and

(b)nothing in this section affects the application of section C.01.020.1 of the Food and Drug Regulations.

Sales-related Information

45Information — first sale#

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:

(a)the biocide’s identification number;

(b)the date of the first sale;

(c)the names and contact information of the persons that are packaging or labelling the biocide, excluding individuals who are employees or agents of such persons, and the civic addresses of the locations where the biocide is packaged or labelled; and

(d)a copy of all labels that are being used in connection with the biocide.

46Annual notification#

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.

47Permanent discontinuance of sale#

(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:

(a)the biocide’s identification number;

(b)the date on which they discontinued the sale of the biocide; and

(c)subject to subsection (5), the latest expiry date of the biocide that they have sold under the authorization and the applicable lot number.

(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.

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

(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.

(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

48Recall system#

(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.

(2)The person must retain each record

(a)in the case where an expiry date is shown on the label of the biocide to which the record relates, for a period that ends no earlier than the last day of the month that is shown as the expiry date; and

(b)in any other case, for at least six years after the day on which the person sold the biocide to which the record relates.

49Voluntary recall#

(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:

(a)the holder of the market authorization;

(b)an importer of the biocide; or

(c)a person that manufactures the biocide and sells it.

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

(a)the biocide’s brand names;

(b)the biocide’s identification number;

(c)the names and contact information of the persons that manufactured the biocide, excluding individuals who are employees or agents of such persons, and, in the case of a recall by the holder, the names and contact information of any importers;

(d)the name and contact information of the individual who is responsible for the recall;

(e)the lot numbers, dates of manufacture and expiry dates of the biocide that is being recalled;

(f)the quantity of the biocide that was manufactured in Canada;

(g)the quantity of the biocide that was imported;

(h)the quantity of the biocide that the person sold to persons in Canada;

(i)the period during which the person sold the biocide in Canada;

(j)the quantity of the biocide that the person exported from Canada, as well as the quantity exported, by country;

(k)the quantity of the biocide that is in Canada and that remains in the possession or control of the person;

(l)the names of the persons in Canada, other than consumers that purchased the biocide at the retail level, to whom the biocide was sold by the person and the quantity sold to each of the named persons;

(m)the classes of persons from whom the biocide is being recalled;

(n)the expected dates for the start and completion of the recall;

(o)the reason for the recall and the date on which, and the manner in which, the situation that prompted the recall was discovered;

(p)an assessment of the risk of injury to human health posed by the biocide that is being recalled, including because of a failure of its effectiveness; and

(q)a description of any other measures that the person is taking in respect of the recall.

(3)The person must

(a)before starting the recall, provide the Minister with a copy of the communications that they intend to use in connection with starting the recall; and

(b)after starting the recall, provide the Minister, on request and within the time specified by the Minister, with a copy of any additional communications that they use, or intend to use, in connection with the recall.

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

(a)the strategy for conducting the recall, including the time and manner in which the Minister will be informed of the progress of the recall; and

(b)a description of the measures that are intended to be taken to prevent a recurrence of the situation that prompted the recall.

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

(a)the results of the recall; and

(b)a description of the measures that have been or will be taken to prevent a recurrence of the situation that prompted the recall.

50Recall ordered by Minister#

(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:

(a)the name, title and contact information of an individual from whom the Minister may obtain additional information concerning the recall;

(b)if known, the names and contact information of the persons that manufactured the biocide that is being recalled, excluding individuals who are employees or agents of such persons, and the names and contact information of any importers;

(c)the total quantity of the biocide that has been sold by the person at the retail level to consumers in Canada;

(d)if the person has sold the biocide to persons in Canada other than consumers referred to in paragraph (c),

(i)the names of each of those persons and the quantity of the biocide that has been sold to each of them, and

(ii)the period during which the biocide was sold to those persons;

(e)the quantity of the biocide that the person has exported from Canada, as well as the quantity exported, by country;

(f)the quantity of the biocide that is in Canada and that remains in the possession or control of the person;

(g)the strategy for conducting the recall;

(h)any other information that the Minister has reasonable grounds to believe is necessary to mitigate the risk of injury to human health; and

(i)if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they intend to take to prevent a recurrence.

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

(3)The person must

(a)before starting the recall, provide the Minister with a copy of the communications that they intend to use in connection with starting the recall; and

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

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

(a)the results of the recall; and

(b)if the person is in a position to prevent a recurrence of the situation that prompted the recall, a description of the measures that they have taken or will take to prevent a recurrence.

Quality Control

51Prohibition — failure to follow master formula#

(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.

(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.

52Records — quality control#

(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.

(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.

(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.

(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.

53Prohibition — sterile biocides#

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

(a)in a separate and enclosed area;

(b)under the supervision of an individual who is trained in microbiology; and

(c)using a method that is scientifically proven to ensure the sterility of the biocide.

54Investigation of complaints#

(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:

(a)the holder of the market authorization;

(b)an importer of the biocide; or

(c)a person that manufactures, packages or labels the biocide and sells it.

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

(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

(a)the last day of the month in which the shelf life of the biocide to which the complaint relates ends, if that day can be determined,

(b)if no corrective action is taken, the day on which the investigation is completed, and

(c)if corrective action is taken, the day on which the action is completed.

Transitional Provisions

66Temporary exemptions — Pest Control Products Act#

(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

(a)before the first anniversary of the day on which these Regulations are registered; or

(b)in the case of registration on the basis of an application referred to in subsection (3), on or after that anniversary.

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

(a)the day on which the registration ceases;

(b)the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

(c)the day on which an application for a market authorization for the biocide is withdrawn; and

(d)the fifth anniversary of the day on which these Regulations are registered.

(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,

(a)the biocide is the subject of an application for registration under the Pest Control Products Act; and

(b)no final decision has been made in respect of the application.

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

(a)the day on which the Minister makes a final decision in respect of the application for registration under the Pest Control Products Act;

(b)the day on which the application for registration under the Pest Control Products Act is withdrawn;

(c)the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

(d)the day on which an application for a market authorization for the biocide is withdrawn; and

(e)the fifth anniversary of the day on which these Regulations are registered.

67Exception — pest control products#

(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

(a)the application is submitted under section 10; and

(b)the information referred to in paragraphs 10(1)(c) to (g) that is set out in the application corresponds to the relevant conditions of registration under the Pest Control Products Act.

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

68Temporary exemptions — Food and Drug Regulations#

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

(a)to which a drug identification number has been assigned under the Food and Drug Regulations

(i)before the first anniversary of the day on which these Regulations are registered, or

(ii)in the case of a drug identification number that is assigned on the basis of an application referred to in subsection (3), on or after that anniversary; and

(b)whose drug identification number has not been cancelled.

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

(a)the day on which the drug identification number is cancelled under the Food and Drug Regulations;

(b)the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

(c)the day on which an application for a market authorization for the biocide is withdrawn; and

(d)the fifth anniversary of the day on which these Regulations are registered.

(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,

(a)the biocide is a drug that is the subject of an application for a drug identification number that is made under section C.01.014.1 of the Food and Drug Regulations or of a new drug submission that is filed under section C.08.002 of those Regulations; and

(b)no final decision has been made in respect of the application or submission.

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

(a)the day on which the Minister makes a final decision in respect of the application or submission under the Food and Drug Regulations;

(b)the day on which the application or submission is withdrawn;

(c)the day on which the Minister makes a final decision in respect of an application for a market authorization for the biocide;

(d)the day on which an application for a market authorization for the biocide is withdrawn; and

(e)the fifth anniversary of the day on which these Regulations are registered.

69Exception — drug identification number#

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

(a)the application is submitted under section 10; and

(b)the information referred to in paragraphs 10(1)(c) to (g) that is set out in the application corresponds to the relevant matters that are authorized in respect of the biocide under the Food and Drug Regulations.

^note

70Temporary exemption — certain sanitizers#

(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,

(a)a drug identification number has not been assigned to the surface sanitizer for use in food premises under the Food and Drug Regulations; and

(b)the surface sanitizer for use in food premises is not a pest control product that is registered under the Pest Control Products Act.

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

(a)the day on which the Minister makes a final decision in respect of an application for a market authorization for the surface sanitizer for use in food premises;

(b)the day on which an application for a market authorization for the surface sanitizer for use in food premises is withdrawn; and

(c)the seventh anniversary of the day on which these Regulations are registered.

(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.

71Market authorization — required information#

The information referred to in subparagraph 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 #

[Amendments]

73 #

[Amendments]

74 #

[Amendments]

75 #

[Amendments]

Consequential Amendments

Food and Drugs Act

Food and Drug Regulations

76 #

[Amendments]

77 #

[Amendments]

78 #

[Amendments]

79 #

[Amendments]

80 #

[Amendments]

81 #

[Amendments]

82 #

[Amendments]

Medical Devices Regulations

83 #

[Amendments]

Natural Health Products Regulations

84 #

[Amendments]

Pest Control Products Act

Pest Control Products Regulations

85 #

[Amendments]

Coming into Force

86First anniversary of registration#

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

(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.

Amendments not in force

— SOR/2024-110, s. 72Subsection 10(1) of these Regulations is amended by adding “and” at the end of paragraph (m) and by repealing paragraphs (o) and (p). — SOR/2024-110, s. 73Subparagraph 12(1)(o)(ii) of these Regulations is replaced by the following:the other biocide’s identification number. — SOR/2024-110, s. 74Paragraphs 15(3)(a) to (i) of these Regulations are replaced by the following:the market authorization for the biocide was issued on the basis of an application that met the applicable conditions set out in subsection 10(2);the application is submitted on the basis of a comparison between the version of the biocide that is affected by the major change and a version of the other biocide referred to in paragraph 10(2)(a) that is also affected by the major change (referred to in paragraphs (c) to (k) as “the other biocide”);the other biocide is the subject of a market authorization;the application contains the other biocide’s identification number;the application contains information that demonstrates thatfor a given quantity of biocide, the version of the biocide that is affected by the major change contains the same active ingredients in the same quantities as the other biocide,the formulants that the version of the biocide that is affected by the major change contains are among the formulants that the other biocide may contain under its market authorization,for a given quantity of biocide, the quantity of each formulant that the version of the biocide that is affected by the major change contains is the same as the quantity of that formulant that the other biocide may contain under its market authorization,subject to subparagraph (v), the conditions of use of the version of the biocide that is affected by the major change fall within the conditions of use of the other biocide, andthe version of the biocide that is affected by the major change has the same risk information and directions for storage as the other biocide;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, thatconfirms that eitherthe major change resulted in an amendment to the master formula for the other biocide and the holder provided the applicant with the updated master formula for the other biocide, orthe major change did not result in an amendment to the master formula for the other biocide, andmentions the other biocide’s brand names and identification number;the application contains an attestation, by an individual who has authority to bind the applicant, that confirms thatif the major change resulted in an amendment to the master formula for the other biocide, the version of the biocide that is affected by the major change will be manufactured in accordance with the updated master formula for the other biocide, andthe specifications for the version of the biocide that is affected by the major change — 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;the Minister has provided to the holder of the market authorization for the other biocide a notice of acceptance in respect of the major change;the other biocide’s market authorization is not suspended;in the case referred to in subsection (4), 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; andin the case referred to in subsection (5), 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.Subsections 15(4) and (5) of these Regulations are replaced by the following: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:for the purposes of paragraph (3)(a), the biocide’s market authorization is deemed to have been issued on the basis of an application that met the applicable conditions set out in subsection 10(2); andfor the purposes of paragraph (3)(b), that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).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:for the purposes of paragraph (3)(a), the biocide’s market authorization is deemed to have been issued on the basis of an application that met the applicable conditions set out in subsection 10(2); andfor the purposes of paragraph (3)(b), that other biocide is deemed to be the other biocide referred to in paragraph 10(2)(a).Subsection 15(9) of these Regulations is replaced by the following: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).Subsection 15(10) of these Regulations is repealed. — SOR/2024-110, s. 75Paragraph 26(3)(a) of the Regulations is replaced by the following:the information referred to in paragraphs 10(1)(a) to (g), (j), (k), (m) and (n) in respect of the biocide for which the market authorization is sought;

Federal laws of Canada reproduced under the Reproduction of Federal Law Order (SI/97-5); not the official version. Source: Justice Laws Website.