Biocides Regulations (SOR/2024-110)

Marginal note:Notice of acceptance

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

  • (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);

  • (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) 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.

• Marginal note:Obligation to amend

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

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

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

• Marginal note:Exception

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

• Marginal note:Information not confidential business information

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

• Marginal note:Exception

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

Marginal note:Minor change

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

• Marginal note:Names and contact information

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

• Marginal note:Identification number

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

• Marginal note:Obligation to amend

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

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

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

• Marginal note:Information not confidential business information

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

• Marginal note:Exception

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

Direction to Stop Sale

Marginal note:Prohibition

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

Marginal note:Direction to stop sale

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

  • (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.

• Marginal note:Obligation to lift direction

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

  • (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

Marginal note:Prohibition — sale or advertising

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

• Marginal note:Partial suspension

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

  • (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).

Marginal note:Power to suspend

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

  • (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.

• Marginal note:Precondition

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

• Marginal note:Content of notice

  (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.

• Marginal note:Serious and imminent risk

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

Marginal note:Notice to third parties

• 22 (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).

• Marginal note:Definition of business day

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

  • (a) a Saturday; or

  • (b) a Sunday or other holiday.

Marginal note:Reinstatement of market authorization

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

• Marginal note:Notice of reinstatement

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

Revocation

Marginal note:Automatic revocation

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

  • (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.

• Marginal note:Power to revoke — suspension

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

• Marginal note:Clarification

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

• Marginal note:Obligation to revoke — permanent discontinuance of sale

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

Marginal note:Public notice

25 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

Marginal note:Application

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

  • (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.

• Marginal note:Exceptions

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

• Marginal note:Content of application

  (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

    • (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 foreign biocide;

  • (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.

• Marginal note:Exception — packaging

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

• Marginal note:Additional information and material

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