GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Biocides Regulations — 16
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. 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. Exception (3) Paragraph (2)(b) does not apply in respect of information referred to in subparagraph 12 (1)(o)(ii). 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. Exception (5) Subsection (4) does not apply to information referred to in subparagraph 12 (1)(o)(ii) or paragraphs 12 (2)(a) to (f).
Biocides Regulations — 17
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. 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. Identification number (3) When providing information to the Minister under subsection (1) or (2), the holder must also provide the biocide’s identification number. 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. 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). Exception (6) Subsection (5) does not apply to information referred to in paragraphs 12 (2)(a) to (f).
Biocides Regulations — 18
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.
Biocides Regulations — 19
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. 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.
Biocides Regulations — 20
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. 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).
Biocides Regulations — 21
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. 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. 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. 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.
Biocides Regulations — 22
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). 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.
Biocides Regulations — 23
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. 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.
Biocides Regulations — 24
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. 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. 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. 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.
Biocides Regulations — 25
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.
Biocides Regulations — 27
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. 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. 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. 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.
Biocides Regulations — 28
Definitions 28 The following definitions apply in this section and in sections 29 to 37 . 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 means a biocide that is intended to be distributed only to the general public for personal use. ( biocide domestique ) immediate container means the package that is in direct contact with a biocide. ( contenant immédiat ) inner label means a label that is on or attached to the immediate container of a biocide. ( étiquette intérieure ) 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 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 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 )
Biocides Regulations — Biocides Regulations
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 )
Biocides Regulations — Biocides Regulations
household biocide means a biocide that is intended to be distributed only to the general public for personal use. ( biocide domestique )
Biocides Regulations — Biocides Regulations
immediate container means the package that is in direct contact with a biocide. ( contenant immédiat )
Biocides Regulations — Biocides Regulations
inner label means a label that is on or attached to the immediate container of a biocide. ( étiquette intérieure )
Biocides Regulations — Biocides Regulations
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 )
Biocides Regulations — Biocides Regulations
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 )
Biocides Regulations — (a)
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 )
Biocides Regulations — 29
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.
Biocides Regulations — 30
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.
Biocides Regulations — 31
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”. 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.
Biocides Regulations — 32
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. 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.
Biocides Regulations — 33
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).
Biocides Regulations — 34
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 .”. 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.”.
Biocides Regulations — Biocides Regulations
“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.”
Biocides Regulations — Biocides Regulations
“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.”.