Biocides Regulations (SOR/2024-110)

Marginal note:Pressurized containers — explosion hazard

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

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

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

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

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  Marginal note:Additional statements

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

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  “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.”

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  “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.”.

Marginal note:Pressurized containers — flammability

• The following provision is not in force.

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

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    (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”;

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    (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

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    (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”.

• The following provision is not in force.

  Marginal note:Additional statements

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

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  “Do not use in presence of open flame or spark.”

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  “Ne pas utiliser en présence d’une flamme nue ou d’étincelles.”.

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  Marginal note:Definitions of flame projection and flashback

  (3) The following definitions apply in this section.

  flame projection

  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

  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)

Marginal note:Exceptions — small quantities

• The following provision is not in force.

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

• The following provision is not in force.

  Marginal note:Inner label — 120 mL or g

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

• The following provision is not in force.

  Marginal note:Outer label — 120 mL or g

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

Marginal note:Packaging standards

37 The immediate container of a biocide must be constructed to

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

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  (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

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

Marginal note:Definitions

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

notable incident

notable incident means

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  (a) a response to a biocide that adversely affects human health; or

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  (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

serious incident means a response to or a failure in the effectiveness of a biocide that, in respect of human health,

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  (a) results in in-patient hospitalization, prolongation of existing hospitalization, congenital malformation or chronic or significant disability or incapacity; or

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  (b) is life-threatening or results in death. (événement grave)

serious unexpected incident

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)

Marginal note:Serious incident reporting

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

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

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

Marginal note:Information relating to incidents

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

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  Marginal note:Significant safety issue

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

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  Marginal note:Retention period

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

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  Marginal note:New holder

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

• The following provision is not in force.

  Marginal note:Request for information

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

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  Marginal note:Time limit

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

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  Marginal note:Obligation to provide information

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

Marginal note:Issue-related report

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

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

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

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

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  Marginal note:Time limit

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

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  Marginal note:Obligation to provide report

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

Marginal note:Assessment order — condition

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

Marginal note:Order requiring tests and studies — conditions

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

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

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  (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.

Marginal note:Serious adverse drug reactions — biocides

• The following provision is not in force.

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

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

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

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

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

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    (e) a description of the reaction;

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

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

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

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

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

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

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  Marginal note:Exemption

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

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  Marginal note:Definition of hospital

  (3) In this section, hospital means a facility

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    (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

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

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  Marginal note:Clarifications

  (4) For greater certainty,

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

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