Biocides Regulations (SOR/2024-110)

Marginal note:Follow-up obligations

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

  • (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.

• Marginal note:Clarification

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

• Marginal note:Exception

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

• Marginal note:Additional information to be provided

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

Labelling and Packaging

Marginal note:Definitions

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

designated container

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

household biocide means a biocide that is intended to be distributed only to the general public for personal use. (biocide domestique)

immediate container

immediate container means the package that is in direct contact with a biocide. (contenant immédiat)

inner label

inner label means a label that is on or attached to the immediate container of a biocide. (étiquette intérieure)

outer label

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

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

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)

Marginal note:Requirement for label

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

Marginal note:Bilingual labelling

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

Marginal note:Principal display panel

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

  • (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”.

• Marginal note:Limit

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

Marginal note:Additional information

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

  • (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.

• Marginal note:Contact information — accessibility

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

Marginal note:Small packages

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

• (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).

Marginal note:Pressurized containers — explosion hazard

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

  • (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.”.

• 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:

  “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.”.

Marginal note:Pressurized containers — flammability

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

  • (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”.

• 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:

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

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

• 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

• 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.

• 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.

• 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

• (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

Marginal note:Definitions

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

notable incident

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

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

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)