GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Biocides Regulations — 35
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 ”. 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.”. Definitions of flame projection and flashback (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 )
Biocides Regulations — Biocides Regulations
“Do not use in presence of open flame or spark.”
Biocides Regulations — Biocides Regulations
“Ne pas utiliser en présence d’une flamme nue ou d’étincelles.”.
Biocides Regulations — Biocides Regulations
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 )
Biocides Regulations — Biocides Regulations
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 )
Biocides Regulations — 36
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. 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. 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.
Biocides Regulations — 37
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.
Biocides Regulations — 38
Definitions 38 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 )
Biocides Regulations — (a)
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 )
Biocides Regulations — (a)
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 )
Biocides Regulations — Biocides Regulations
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 )
Biocides Regulations — 39
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.
Biocides Regulations — 40
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. 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. 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. 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. 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. Time limit (6) The Minister must specify a period within which the information is to be provided that is reasonable in the circumstances. Obligation to provide information (7) The holder must provide the Minister with the requested information within the specified period.
Biocides Regulations — 41
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. Time limit (2) The Minister must specify a period within which the report is to be provided that is reasonable in the circumstances. Obligation to provide report (3) The holder must provide the report within the specified period.
Biocides Regulations — 42
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.
Biocides Regulations — 43
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.
Biocides Regulations — 44
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. 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). 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. 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 .
Biocides Regulations — 45
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.
Biocides Regulations — 46
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.
Biocides Regulations — 47
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. 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. Exception (3) Paragraphs (1)(b) and (c) do not apply to a holder referred to in subsection (2). 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. 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).
Biocides Regulations — 48
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. 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.
Biocides Regulations — 50
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. 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). 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. 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. 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.
Biocides Regulations — 51
Prohibition — failure to follow master formula 51 (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. Prohibition — manufacturer, packager or labeller (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.
Biocides Regulations — 52
Records — quality control 52 (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. Records — manufacturer, packager or labeller (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. Retention period (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. Requirement to provide information (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.
Biocides Regulations — 53
Prohibition — sterile biocides 53 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.
Biocides Regulations — 54
Investigation of complaints 54 (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. Records (2) The person must maintain a record of each complaint and investigation and any corrective action taken. Retention period (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. Requirement to provide information (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.