Biocides Regulations (SOR/2024-110)

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:

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

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

Marginal note:Information relating to incidents

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Marginal note:Obligation to provide information

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

Assessments, Tests and Studies

Marginal note:Issue-related report

• 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

  • (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.

• 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.

• 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

• (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

Marginal note:Serious adverse drug reactions — biocides

• 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:

  • (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.

• 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).

• Marginal note:Definition of hospital

  (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.

• Marginal note:Clarifications

  (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

Marginal note:Information — first sale

45 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.

Marginal note:Annual notification

46 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.

Marginal note:Permanent discontinuance of sale

• 47 (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.

• Marginal note:No sale — market authorization

  (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.

• Marginal note:Exception

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

• Marginal note:Additional information

  (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.

• Marginal note:Application of requirement

  (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

Marginal note:Recall system

• 48 (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.

• Marginal note:Retention period

  (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.

Marginal note:Voluntary recall

• 49 (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.

• Marginal note:Information to be provided

  (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.

• Marginal note:Communications

  (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.

• Marginal note:Information requirements — 72 hours

  (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.

• Marginal note:Information requirements — after 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.

Marginal note:Recall ordered by Minister

• 50 (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.

• Marginal note:Change to information — representative

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

• Marginal note:Communications

  (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.

• Marginal note:Notification of start and completion

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

• Marginal note:Information requirements — after 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.