Controlled Products Regulations

SOR/88-66

HAZARDOUS PRODUCTS ACT

Controlled Products Regulations

REGULATIONS RESPECTING CONTROLLED PRODUCTS

SHORT TITLE

1. These Regulations may be cited as the Controlled Products Regulations.

INTERPRETATION

2. (1) In these Regulations,

"Act" means the Hazardous Products Act; (Loi)

"CAS registry number" means the identification number assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society; (numéro d'enregistrement CAS)

"complex mixture" means a mixture that is a combination of many chemicals, has a commonly known generic name and is

(a) naturally occurring,

(b) a fraction of a naturally-occurring mixture that results from a separation process, or

(c) a modification of a naturally-occurring mixture or a modification of a fraction of a naturally-occurring mixture that results from a chemical modification process; (mélange complexe)

"hazard information" means information on the proper and safe storage, handling and use of a controlled product and includes information relating to its toxicological properties; (renseignements sur les dangers)

"LC₅₀" means the concentration of a substance in air that, when administered by means of inhalation over a specified length of time in an animal assay, is expected to cause the death of 50 per cent of a defined animal population; (CL₅₀)

"LD₅₀" means the single dose of a substance that, when administered by a defined route in an animal assay, is expected to cause the death of 50 per cent of a defined animal population; (DL₅₀)

"laboratory sample" means, in respect of a controlled product, a sample of the controlled product that is intended solely to be tested in a laboratory but does not include a controlled product that is to be used

(a) by the laboratory for testing other products, materials or substances, or

(b) for educational or demonstration purposes; (échantillon pour laboratoire)

"mixture" means a combination of two or more products, materials or substances that do not undergo a chemical change as a result of interaction between them; (mélange)

"nurse" means a registered nurse registered or licensed under the laws of a province; (infirmier ou infirmière)

"product identification number" means the number and letters, if any, specified in Column II of an item of List II in Schedule II to the Transportation of Dangerous Goods Regulations that correspond to the product specified in Column I of an item of that List; (numéro d'identification du produit)

"product identifier" means, in respect of a controlled product, the brand name, code name or code number specified by a supplier or the chemical name, common name, generic name or trade name; (identificateur du produit)

"research and development" means systematic investigation or search carried out in a field of science or technology by means of experiment or analysis, other than investigation or search in respect of market research, sales promotion, quality control or routine testing of controlled products, and includes

(a) applied research, namely, work undertaken for the advancement of scientific knowledge with a specific practical application in view, and

(b) development, namely, use of the results of applied research for the purpose of creating new, or improving existing, processes or controlled products; (recherche et développement)

"risk phrase" means, in respect of a controlled product or a class, division or subdivision of controlled products, a statement identifying a hazard that may arise from the nature of the controlled product or the class, division or subdivision of controlled products; (mention de risque)

"supplier identifier" means, in respect of a controlled product, the name of the supplier of the controlled product. (identificateur du fournisseur)

(2) For the purposes of Part II of the Act,

"bulk shipment" means a shipment of a controlled product that is contained, without intermediate containment or intermediate packaging, in

(a) a vessel with a water capacity of more than 454 litres,

(b) a freight container, a road vehicle, a railway vehicle, a portable tank, a freight container carried on a road vehicle, railway vehicle, ship or aircraft, or a portable tank carried on a road vehicle, railway vehicle, ship or aircraft,

(c) the hold of a ship, or

(d) a pipeline; (expédition en vrac)

"hazardous waste" means a controlled product that is intended for disposal or is sold for recycling or recovery; (résidu dangereux)

"work place" means a place where a person works for remuneration. (lieu de travail) SOR/97-543, s. 13(E).

CONCENTRATION EXPRESSED AS A PERCENTAGE

3. Where in these Regulations, other than in sections 11 and 36, the concentration of an ingredient is expressed as a percentage, the percentage shall be taken as an expression of the ratio of the weight of the ingredient to the weight of the controlled product.

PART I
MATERIAL SAFETY DATA SHEET

Exemptions

Concentration Cut-off

4. The sale or importation of a controlled product, other than a complex mixture or a component of a controlled product that is a complex mixture, is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and the concentration of

(a) an ingredient that is found in the controlled product in a concentration of less than 0.1 per cent and is a teratogen or an embryotoxin referred to in section 53, a carcinogen referred to in section 54, a reproductive toxin referred to in section 55, a respiratory tract sensitizer referred to in section 56 or a mutagen referred to in section 57; or

(b) an ingredient that is an ingredient other than an ingredient referred to in paragraph (a) and that is found in the controlled product in a concentration of less than one per cent, unless the ingredient is included in the Ingredient Disclosure List and the concentration specified for the ingredient in the List is 0.1 per cent.

Complex Mixtures

5. (1) The sale or importation of a controlled product that is a complex mixture is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the complex mixture if the generic name of the complex mixture is disclosed on the material safety data sheet.

(2) The sale or importation of a controlled product that contains a component that is a complex mixture is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the component if

(a) the component is found in the controlled product in a concentration of less than 0.1 per cent and is a teratogen or an embryotoxin referred to in section 53, a carcinogen referred to in section 54, a reproductive toxin referred to in section 55, a respiratory tract sensitizer referred to in section 56 or a mutagen referred to in section 57;

(b) the component is a component other than a component referred to in paragraph (a) and is found in the controlled product in a concentration of less than one per cent, unless the component is included in the Ingredient Disclosure List and the concentration specified for that component in the List is 0.1 per cent; or

(c) the commonly known generic name and concentration of the component in the controlled product is disclosed on the material safety data sheet.

Flavours and Fragrances

5.1 (1) For the purposes of this section,

"flavour" means a product, material or substance that is used solely to impart a taste to another product, material or substance; (saveur)

"fragrance" means a product, material or substance that is used solely to impart a smell to another product, material or substance. (parfum)

(2) The sale or importation of a controlled product that is a flavour or fragrance is exempt, for as long as paragraph 12(b) of the Act is in force, from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the controlled product if

(a) the generic chemical identities of the ingredients of the controlled product and the concentrations thereof are disclosed on the material safety data sheet;

(b) the supplier of the controlled product maintains a record of the chemical identities and concentrations of the ingredients of the controlled product at a place in Canada where an inspector may enter at any reasonable time for the purposes of the administration and enforcement of Parts II and III of the Act; and

(c) for the purposes of section 30, the supplier of the controlled product discloses on the material safety data sheet an emergency telephone number by means of which access to the information set out in the record referred to in paragraph (b) may be obtained at any time.

(3) The sale or importation of a controlled product that contains a component that is a flavour or fragrance is exempt, for as long as paragraph 12(b) of the Act is in force, from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity and concentration of the ingredients of the component if

(a) the generic chemical identities of the ingredients of the component and the concentrations thereof are disclosed on the material safety data sheet;

(b) the supplier of the controlled product or of the component maintains a record of the chemical identities and concentrations of the ingredients of the component at a place in Canada where an inspector may enter at any reasonable time for the purposes of the administration and enforcement of Parts II and III of the Act; and

(c) the supplier of the controlled product or of the component discloses on the material safety data sheet, in parentheses after the information referred to in paragraph (a), the following information, namely,

(i) the product identifier of the component,

(ii) for the purposes of section 30, an emergency telephone number by means of which access to the information set out in the record referred to in paragraph (b) may be obtained at any time, and

(iii) a statement to the effect that in a medical emergency, a physician or nurse may obtain the chemical identity and concentration of any ingredient of the component set out in the record maintained pursuant to paragraph (b) by calling the emergency telephone number disclosed under subparagraph (ii) and specifying the product identifier of the component.

(4) Where an inspector obtains information from a record referred to in paragraph (2)(b) or (3)(b), the inspector shall keep the information confidential except for the purposes of the administration and enforcement of Parts II and III of the Act. SOR/89-150, s. 1.

Controlled Products with Same Product Identifier

6. The sale or importation of a controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet for the controlled product if

(a) the controlled product is part of a shipment of controlled products that have the same product identifier and a material safety data sheet is transmitted with the shipment or is obtained or prepared for one of the controlled products; or

(b) the supplier has transmitted to the person to whom the controlled product is sold or the supplier who imports the controlled product has in his possession a material safety data sheet for a controlled product that has the same product identifier and the material safety data sheet

(i) discloses information that is current at the time of the sale or importation, and

(ii) was prepared and dated not more than three years before the date of the sale or importation.

Generic Material Safety Data Sheet

7. (1) The sale or importation of a controlled product whose chemical composition is similar to the chemical composition of other controlled products in its group is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet for the controlled product if a generic material safety data sheet for the group of controlled products is transmitted, obtained or prepared.

(2) The generic material safety data sheet referred to in subsection (1) shall disclose

(a) where the range of concentration of an ingredient of the controlled product is different from the range of concentration of the ingredient in the other controlled products in the group, beside the name of the controlled product and the ingredient, the range of concentration of the ingredient in the controlled product, in accordance with section 11; and

(b) where the hazard information in respect of the controlled product is different from the hazard information in respect of the other controlled products in the group, beside the name of the controlled product, the hazard information for the controlled product.

Employer Exemptions

8. The sale of a controlled product to an employer is exempt from the application of paragraph 13(a) of the Act in respect of the requirement to disclose information that could be the subject of a claim for exemption under subsection 11(2) of the Hazardous Materials Information Review Act if

(a) the employer has filed a claim for exemption or is exempt from disclosing that information in respect of the controlled product under

(i) the Hazardous Materials Information Review Act, or

(ii) the laws of a province; and

(b) the material safety data sheet of the controlled product transmitted in respect of that sale discloses in place of that information

(i) the information referred to in section 26 or 27, or

(ii) where the information referred to in section 26 or 27 is not available, an emergency telephone number of the employer that will enable a physician or nurse to obtain any information referred to in paragraph 13(a) of the Act that is in the possession of the employer for the purpose of making a medical diagnosis of, or rendering medical treatment to, a person in an emergency.

Secondary Supplier Exemptions

8.1 [Repealed, SOR/97-543, s. 14]

8.2 The sale of a controlled product by a supplier, in this section referred to as the secondary supplier, is exempt from the application of paragraph 13(a) of the Act in respect of the requirement to disclose on a material safety data sheet the chemical identity or concentration of an ingredient of the controlled product if

(a) the ingredient is sold either directly or indirectly by another supplier, in this section referred to as the primary supplier, who has filed a claim for exemption or is exempted from disclosing the chemical identity or concentration of the ingredient under the Hazardous Materials Information Review Act;

(b) the chemical identity or concentration of the ingredient is

(i) unknown to the secondary supplier, or

(ii) known to the secondary supplier and the secondary supplier has obtained the information in confidence, express or implied, and is obligated by contract or trust, express or implied, or otherwise by law or equity to maintain the confidentiality of the information;

(c) the material safety data sheet for the controlled product transmitted by the secondary supplier in respect of the sale discloses, in place of the chemical identity or concentration of the ingredient,

(i) the information referred to in section 26 or 27 in respect of

(A) where the secondary supplier has filed a claim for exemption or is exempted from disclosing information that could be used to identify the primary supplier, that claim or exemption, or

(B) in any other case, the primary supplier's claim or exemption with the words "other supplier" in parentheses after that information,

(ii) where the primary supplier has filed a claim for exemption or is exempted from disclosing the chemical identity of the ingredient, the generic chemical identity of the ingredient as disclosed by the primary supplier, and

(iii) where the primary supplier has filed a claim for exemption or is exempted from disclosing the concentration of the ingredient, the concentration of the primary supplier's controlled product in the secondary supplier's controlled product; and

(d) the secondary supplier transmits with the material safety data sheet for the controlled product the material safety data sheet transmitted by the primary supplier in respect of the sale to the secondary supplier. SOR/88-555, s. 1.

Laboratory Sample

9. (1) Where a supplier has not obtained or prepared a material safety data sheet in respect of a controlled product, the sale or importation of a laboratory sample of the controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet if the laboratory sample is packaged in a container that

(a) contains a quantity of less than 10 kilograms of the controlled product; and

(b) has a label applied to it in accordance with section 16.

(2) The sale or importation of a laboratory sample of a controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to disclose the chemical identity of an ingredient of the controlled product on a material safety data sheet if

(a) the laboratory sample is intended solely to be tested for research and development purposes; and

(b) the generic chemical identity of the ingredient is disclosed on the material safety data sheet. SOR/2001-254, s. 1(F).

Laboratory Supply House

10. The sale or importation of a controlled product is exempt from the application of paragraph 13(a) or 14(a) of the Act in respect of the requirement to transmit, obtain or prepare a material safety data sheet if

(a) the controlled product

(i) originates from a laboratory supply house,

(ii) is intended for use in a laboratory, and

(iii) is packaged in a container in a quantity of less than 10 kilograms; and

(b) all the information required by paragraph 13(a) or 14(a) of the Act is disclosed on the label of the container in which the controlled product is packaged.

Mixtures containing Non-radioactive Carrier Materials

10.1 The sale or importation of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials is exempt from the application of paragraph 13(a) or 14(a) of the Act if

(a) the carrier material

(i) is present in an amount that is

(A) in the case of a liquid or gaseous carrier material, not more than 1.0 ml in volume, or

(B) in the case of a solid carrier material, not more than 1.0 g in weight, and

(ii) is not

(A) a carcinogen under Subdivision A of Division 2 of Class D referred to in section 54,

(B) a toxic or reactive material under Division 1 of Class 6 and Packing Group I of the Transportation of Dangerous Goods Regulations, or

(C) an infectious material under Division 3 of Class D of these Regulations or Division 2 of Class 6 of the Transportation of Dangerous Goods Regulations and can be handled in accordance with the physical containment requirements set out in Schedule I.1 to these Regulations;

(b) the carrier material is a vehicle for radioactive nuclides or radio-labelled compounds that are injected or ingested during medical or veterinary diagnostic or therapeutic procedures that have been approved by the Department of Health for routine clinical use; or

(c) the quantity of each radioactive nuclide is greater than the quantity specified for that radioactive nuclide in Part I of Schedule I to the Transport Packaging of Radioactive Materials Regulations. SOR/2001-254, s. 2.

Range of Concentration of Ingredients

11. (1) For the purposes of this section, where the concentration of an ingredient of a controlled product or a complex mixture that is a component of a controlled product is expressed as a percentage, the percentage shall be an expression of the ratio of

(a) the weight of the ingredient or the complex mixture to the weight of the controlled product;

(b) the volume of the ingredient or the complex mixture to the volume of the controlled product; or

(c) the weight of the ingredient or the complex mixture to the volume of the controlled product.

(2) Where the concentration of an ingredient of a controlled product or a complex mixture that is a component of a controlled product is required to be disclosed on a material safety data sheet and the ingredient or complex mixture is not always present in the same concentration in the controlled product, the material safety data sheet may disclose, in lieu of the actual concentration of the ingredient or complex mixture, that the ingredient or complex mixture falls within one of the ranges of concentration set out in subsection (3), where the actual concentration of the ingredient or complex mixture falls within that range.

(3) For the purposes of subsection (2), the ranges of concentration are the following:

(a) from 0.1 to 1 per cent;

(b) from 0.5 to 1.5 per cent;

(c) from 1 to 5 per cent;

(d) from 3 to 7 per cent;

(e) from 5 to 10 per cent;

(f) from 7 to 13 per cent;

(g) from 10 to 30 per cent;

(h) from 15 to 40 per cent;

(i) from 30 to 60 per cent;

(j) from 40 to 70 per cent; and

(k) from 60 to 100 per cent.

(4) If the concentration of an ingredient in a controlled product is not always the same, a material safety data sheet may disclose, in lieu of the actual concentration of an ingredient of a controlled product or of a complex mixture that is a component of a controlled product, a range of concentration other than a range set out in subsection (3) if the disclosed range of concentration falls entirely within a range of concentration set out in subsection (3).

(5) Where the concentration of an ingredient of a controlled product or a complex mixture that is a component of a controlled product disclosed on a material safety data sheet is expressed as a percentage or in a range of concentration set out in subsection (3) or (4), the material safety data sheet shall also disclose which of the ratios set out in subsection (1) is being expressed. SOR/2001-254, s. 3.

Information to be Disclosed on a Material Safety Data Sheet

12. (1) For the purposes of subparagraph 13(a)(v) and paragraph 14(a) of the Act, a material safety data sheet shall disclose the nine categories of information set out in Column I of an item of Schedule I and each category shall be identified by a heading that is the same as or similar to the suggested heading set out for that category in Column II of that item.

(2) Subject to subsections (3) to (10), for the purposes of subparagraph 13(a)(v) and paragraph 14(a) of the Act, the material safety data sheet of a controlled product shall disclose, under an appropriate heading set out in column II of an item of Schedule I or a similar heading, the information set out in each applicable subitem of column III of that item, including the unit of measure, where applicable, if the information is available to the supplier.

(3) The material safety data sheet of a controlled product shall disclose the information set out in column III of subitems 1(1) and 2(1) and (2) of Schedule I under the appropriate heading set out in column II of items 1 and 2 of that Schedule or the similar heading referred to in subsection (1).

(4) Information disclosed under one heading of a material safety data sheet is not required to be repeated under any other heading.

(5) Where any information required to be disclosed by subsection (2) is the subject of a claim for exemption or of an exemption under the Hazardous Materials Information Review Act, the information shall be replaced by the information required to be disclosed by section 26 or 27.

(6) Where there is no information disclosed in respect of a category set out in Column I of an item of Schedule I, the material safety data sheet shall disclose, under the heading for that category in English, the words "not available" or "not applicable", as the case may be, and the material safety data sheet shall disclose, under the heading for that category in French, the words "pas disponible" or "sans objet", as the case may be.

(7) Where a controlled product is sold to a distributor for the purpose of sale or resale, the distributor is not required, on the material safety data sheet, to disclose the supplier identifier of the distributor and particulars of the distributor, if the supplier identifier and particulars of the manufacturer or importer are disclosed on the material safety data sheet in accordance with subsection (2).

(8) Where a controlled product is packaged for a distributor by a manufacturer, the manufacturer is not required, on the material safety data sheet, to disclose the name of the manufacturer and particulars of the manufacturer, if the supplier identifier and particulars of the distributor are disclosed on the material safety data sheet in accordance with subsection (2).

(9) Where a supplier imports a controlled product for his own use, the supplier is not required, on the material safety data sheet, to disclose the name of the manufacturer and particulars of the manufacturer.

(10) Where the LD₅₀ or LC₅₀ of a controlled product that is a mixture is determined by testing the mixture, the supplier shall disclose, on the material safety data sheet for the controlled product, that LD₅₀ or LC₅₀ in place of the LD₅₀ or LC₅₀ of the ingredients of the mixture.

(11) A material safety data sheet shall disclose, in addition to the information required to be disclosed by subsection (2), any other hazard information with respect to the controlled product of which the supplier is aware or ought reasonably to be aware. SOR/97-543, s. 15; SOR/2001-254, s. 4.

13. (1) Where information respecting the toxicological properties of a controlled product disclosed on a material safety data sheet may be interpreted in such a way as to qualify or contradict other toxicological information disclosed on the material safety data sheet, the material safety data sheet shall include sufficient information concerning the toxicological studies so as not to mislead a person as to the nature or extent of the hazard posed by the controlled product.

(2) For the purposes of determining whether information may mislead a person as to the nature or extent of a hazard, the general impression that the information conveys shall be taken into account.

PART II
LABELS

Exemptions

Inner Containers

14. (1) For the purposes of this section, "outer container" means the most outward container of a controlled product that is visible under normal conditions of storage and handling, but does not include the most outward container if it is the only container of the controlled product. (contenant extérieur)

(2) The sale or importation of a controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act in respect of the requirement to apply a label to a container that is

(a) the inner container of the controlled product, if

(i) the outer container is not labelled in accordance with paragraph (d),

(ii) the person to whom the controlled product is sold undertakes in writing to apply a label to the inner container in accordance with paragraph 13(b) or 14(b) of the Act, and

(iii) in the case of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials, the mixture is packaged in more than one container and the outer container is labelled as required by these Regulations;

(b) a package liner of the controlled product;

(c) the outer container of the controlled product, if the label on an inner container is visible and legible through the outer container under normal conditions of storage and handling; or

(d) the outer container of a controlled product, if the outer container has applied to it a label in accordance with the Transportation of Dangerous Goods Regulations. SOR/88-555, s. 2; SOR/2001-254, s. 5.

Bulk Shipments

15. (1) The sale or importation of a bulk shipment of a controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act if

(a) a label, material safety data sheet or statement in writing disclosing the information required to be disclosed by section 19 in respect of the controlled product is transmitted to the person to whom the controlled product is sold on or before the date on which the person receives the bulk shipment; or

(b) the supplier has transmitted to the person to whom the controlled product is sold or the supplier who imports the controlled product has in his possession a label, material safety data sheet or statement in writing that

(i) is for a controlled product that has the same product identifier, and

(ii) discloses the information that is required to be disclosed by section 19 in respect of the controlled product and is current at the time of the sale or importation.

(2) For the purposes of subsection (1), where the information is transmitted on a material safety data sheet or a statement in writing, hazard symbols required to be disclosed by paragraph 19(1)(d) in respect of the controlled product may be replaced by reference to the class and, in the case of a controlled product included in Class D--Poisonous and Infectious Materials, the division into which the controlled product falls.

15.1 [Repealed, SOR/97-543, s. 16]

Laboratory Samples

16. Where a supplier has not obtained or prepared a material safety data sheet in respect of a controlled product, the sale or importation of a laboratory sample of the controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act if the laboratory sample is packaged in a container that

(a) contains a quantity of less than 10 kilograms of the controlled product; and

(b) has a label applied to it that discloses, in respect of the controlled product, the following information:

(i) the product identifier,

(ii) the chemical identity or generic chemical identity of any ingredient of the controlled product referred to in any of subparagraphs 13(a)(i) to (iv) of the Act, if known by the supplier,

(iii) the supplier identifier,

(iv) the statement "Hazardous Laboratory Sample. For hazard information or in an emergency, call (number disclosed under subparagraph (v))/Échantillon pour laboratoire de produit dangereux. Pour obtenir des renseignements sur les dangers ou en cas d'urgence, composer (le numéro divulgé en vertu du sous-alinéa (v))", and

(v) an emergency telephone number of the supplier that will enable

(A) a user of the controlled product to obtain hazard information in respect of the controlled product, and

(B) a physician or nurse to obtain any information in respect of the controlled product that is referred to in paragraph 13(a) of the Act and is in the possession of the supplier for the purpose of making a medical diagnosis of, or rendering treatment to, a person in an emergency.

Laboratory Supply Houses

17. The sale or importation of a controlled product is exempt from the application of paragraph 13(b) or 14(b) of the Act if

(a) the controlled product

(i) originates from a laboratory supply house,

(ii) is intended for use in a laboratory, and

(iii) is packaged in a container in a quantity of less than 10 kilograms; and

(b) the container in which the controlled product is packaged has applied to it a label that discloses the following information in respect of the controlled product:

(i) the product identifier,

(ii) where a material safety data sheet is available, a statement to that effect,

(iii) risk phrases that are appropriate to the controlled product or to the classes, divisions or subdivisions into which the controlled product falls,

(iv) precautionary measures to be followed when handling, using or being exposed to the controlled product, and

(v) where appropriate, first aid measures to be taken in case of exposure to the controlled product.

Radioactive Nuclide Mixtures

17.1 The sale or importation of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials is exempt from the application of paragraph 13(b) or 14(b) of the Act if

(a) the carrier material

(i) is present in an amount that is

(A) in the case of a liquid or gaseous carrier material, no more than 1.0 ml in volume, or

(B) in the case of a solid carrier material, no more than 1.0 g in weight, and

(ii) is not

(A) a carcinogen under Subdivision A of Division 2 of Class D referred to in section 54,

(B) a toxic or reactive material under Division 1 of Class 6 and Packing Group I of the Transportation of Dangerous Goods Regulations, or

(C) an infectious material under Division 3 of Class D of these Regulations or Division 2 of Class 6 of the Transportation of Dangerous Goods Regulations and can be handled in accordance with the physical containment requirements set out in Schedule I.1 to these Regulations;

(b) the carrier material is a vehicle for radioactive nuclides or radio-labelled compounds that are injected or ingested during medical or veterinary diagnostic or theraputic procedures that have been approved by the Department of Health for routine clinical use; or

(c) the quantity of each radioactive nuclide is greater than the quantity specified for that radioactive nuclide in Part I of Schedule I to the Transport Packaging of Radioactive Materials Regulations. SOR/2001-254, s. 6.

Labels of Bulk Shipments

18. For the purposes of subsection 11(2) of the Act, a label of a bulk shipment is included with or accompanies the bulk shipment when it is included with the shipping documents that accompany the bulk shipment.

Information to be Disclosed on Labels

19. (1) The label applied to a controlled product or the container in which a controlled product is packaged shall disclose, in respect of the controlled product, the following information:

(a) the product identifier;

(b) subject to subsections (3) and (4), the supplier identifier;

(c) a statement to the effect that a material safety data sheet is available;

(d) subject to subsection (5), hazard symbols set out in Column II of Schedule II that correspond with the classes in which the controlled product is included and the divisions into which the controlled product falls as set out in Column I of that Schedule; and

(e) where the container has a capacity of more than 100 millilitres, the following information:

(i) risk phrases that are appropriate to the controlled product or to the classes, divisions or subdivisions into which the controlled product falls,

(ii) precautionary measures to be followed when handling, using or being exposed to the controlled product, and

(iii) where appropriate, first aid measures to be taken in case of exposure to the controlled product.

(2) Paragraphs (1)(a) and (b) do not apply in respect of the sale of a controlled product to an employer who has filed a claim for exemption or is exempt under the Hazardous Materials Information Review Act or under the laws of a province from disclosing

(a) the chemical name, common name, generic name, trade name or brand name of a controlled product, if the label discloses the code name or code number specified by the supplier; or

(b) any information that could be used to identify the supplier of the controlled product, if that information is replaced by

(i) the information referred to in section 26 or 27, or

(ii) where the information referred to in section 26 or 27 is not available, the information required to be disclosed under the laws of the province.

(3) Where a controlled product is sold to a distributor for the purpose of sale or resale, the distributor is not required, in the information disclosed on the label under paragraph (1)(b), to disclose the supplier identifier of the distributor if the supplier identifier of the manufacturer or importer is disclosed on the label.

(4) Where a controlled product is packaged for a distributor by a manufacturer, the manufacturer is not required, in the information disclosed on the label under paragraph (1)(b), to disclose the supplier identifier of the manufacturer if the supplier identifier of the distributor is disclosed on the label.

(5) Where a controlled product falls into Divisions 1 and 2 of Class D--Poisonous and Infectious Material, paragraph (1)(d) does not apply in respect of the requirement to disclose on the label applied to the controlled product or the container in which the controlled product is packaged the hazard symbol set out in Column II of Schedule II that corresponds to Division 2 of Class D--Poisonous and Infectious Material as set out in Column I of that Schedule.

(6) Paragraphs (1)(b) and (e) do not apply to the sale or importation of a controlled product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carrier materials. SOR/2001-254, s. 7.

Label Design

20. (1) The label of a controlled product or container in which a controlled product is packaged shall be applied

(a) within a border that is

(i) in a colour that contrasts with the background against which it appears, and

(ii) designed as depicted in Schedule III; and

(b) on a part of the controlled product or container that is displayed under normal conditions of storage and use.

(2) Paragraph (1)(a) does not apply in respect of the sale or importation of a controlled product that is packaged in a container that meets the requirements of section 17. SOR/88-555, s. 4.

Legibility of Labels

21. (1) The information required to be disclosed on the label of a controlled product or container in which a controlled product is packaged shall be clearly and prominently displayed, easily legible and contrasted with other information on the controlled product or container.

(2) A label applied to a controlled product or container in which a controlled product is packaged shall be sufficiently durable and resistant under normal conditions of transport, storage and use to remain attached and legible.

Reproduction of Hazard Symbols

22. Any hazard symbol required to be displayed on a label shall

(a) except with respect to size and colour, be an exact reproduction of that hazard symbol as depicted in Schedule II; and

(b) be displayed in a colour that is not likely to create confusion with a safety mark required by Part V of the Transportation of Dangerous Goods Regulations.

PART III
GENERAL

Exemption

23. (1) The importation of a controlled product that is to be labelled or repackaged in Canada is exempt from the application of section 14 of the Act in respect of the requirements to obtain or prepare a material safety data sheet with respect to the controlled product and to have a label applied to the controlled product or container in which the controlled product is packaged on the following conditions:

(a) subject to subsection (2), the supplier provides to an inspector in each province into which the controlled product is imported, on or before the date of importation, a statement indicating

(i) that he intends to import the controlled product,

(ii) the nature of the controlled product to be imported,

(iii) the address of the premises in the province at which the controlled product is to be labelled or repackaged, and

(iv) the provinces into which the controlled product is to be imported; and

(b) the supplier, if so requested by an inspector in a province into which the controlled product is imported, provides to the inspector

(i) a sample of the controlled product on or before the date of importation,

(ii) the proposed dates and places of importation, and

(iii) the approximate quantity of the controlled product to be imported.

(2) A statement provided in accordance with paragraph (1)(a) is valid in respect of the importation of that controlled product to those premises for a period not exceeding three years from the date the supplier provides the statement to the inspector.

(3) An importer who imports a controlled product in accordance with subsection (1) shall obtain or prepare a material safety data sheet in respect of the controlled product in accordance with the Act and these Regulations before the controlled product is used or sold.

(4) An importer who imports a controlled product in accordance with subsection (1) shall apply a label to the controlled product or to the container in which the controlled product is packaged in accordance with paragraph 14(b) of the Act

(a) where the controlled product is delivered to the address of the importer for his use or for sale, before the controlled product is used or sold; and

(b) where the controlled product is imported to the address of the person to whom the importer has sold the controlled product, before the controlled product is used by that person.

(5) Paragraph (4)(b) does not apply where the person to whom the importer sold the controlled product undertakes in writing to apply a label to the controlled product or to the container in which the controlled product is sold in accordance with paragraph 13(b) of the Act.

Manner of Disclosing Information

24. (1) The information required to be disclosed on a material safety data sheet of a controlled product shall be disclosed at the time of the sale of the controlled product in English and in French on a single material safety data sheet or on two material safety data sheets.

(2) Where a supplier transmits a material safety data sheet in respect of a controlled product, the information shall be disclosed on the material safety data sheet in English or in French, or both, in accordance with the request of the person to whom the controlled product is sold or, where the person does not specify the language in which the information shall be transmitted, the information shall be transmitted in English or in French, whichever is used in the course of the sale between the supplier and the person.

(3) The information required to be disclosed on the label of a controlled product or the container in which a controlled product is packaged shall be disclosed in English and in French.

25. The information required to be disclosed on a material safety data sheet, on a label of a controlled product or on a container in which a controlled product is packaged shall not be disclaimed or contradicted by information in respect of the controlled product that is

(a) not required under the Act; and

(b) disclosed on the material safety data sheet, the label, the controlled product or the container. SOR/97-543, s. 17.

Information in Respect of Exemptions

26. (1) A supplier who, pursuant to subsection 11(1) of the Hazardous Materials Information Review Act, files a claim for exemption from a requirement to disclose information in respect of a controlled product on a material safety data sheet or on a label shall, in respect of the sale or importation of the controlled product or any controlled product having the same product identifier, disclose on the material safety data sheet and, where applicable, on the label of the controlled product or container in which the controlled product is packaged the date that the claim for exemption was filed and the registry number assigned to the claim under the Hazardous Materials Information Review Act.

(2) The requirements of subsection (1) apply in respect of a supplier who receives notice of a decision that the claim for exemption is valid

(a) if there is no appeal of the decision under subsection 20(1) of the Hazardous Materials Information Review Act, for a period not exceeding 30 days after the expiry of the appeal period; and

(b) if there is an appeal of the decision under subsection 20(1) of the Hazardous Materials Information Review Act, for a period not exceeding 30 days after the expiry of all appeal periods in respect of the decision on appeal. SOR/2001-254, s. 8.

27. A supplier who receives notice of a decision made pursuant to the Hazardous Materials Information Review Act that his claim or a portion of his claim for exemption from a requirement to disclose information in respect of a controlled product on a material safety data sheet or a label is valid shall, during the period beginning not more than 30 days after the final disposition of the claim and ending on the last day of the exemption period, in respect of the sale or importation of the controlled product or any controlled product having the same product identifier, disclose on the material safety data sheet and, where applicable, on the label of the controlled product or container in which the controlled product is packaged the following information:

(a) a statement that an exemption has been granted;

(b) the date of the decision granting the exemption;

(c) the registry number assigned to the claim under the Hazardous Materials Information Review Act; and

(d) the generic chemical identity of the controlled product or ingredient as required by section 16 of the Act. SOR/88-555, s. 5; SOR/97-543, s. 18.

Identical Product Identifiers

28. The product identifier that is disclosed on the label of a controlled product or container in which a controlled product is packaged shall be identical to the product identifier that is disclosed on the material safety data sheet for the controlled product.

Revisions to Material Safety Data Sheets and Labels

29. (1) Where new information in respect of a controlled product or an ingredient of a controlled product becomes available, the supplier shall

(a) revise the material safety data sheet and the date thereof and, where applicable, the label of the controlled product; and

(b) in respect of the revised material safety data sheet and, where applicable, the revised label,

(i) in the case of the sale of the controlled product subsequent to the information becoming available, transmit the revised material safety data sheet and apply the revised label in accordance with section 13 of the Act, and

(ii) in the case of an importation of the controlled product subsequent to the information becoming available, obtain or prepare the revised material safety data sheet and apply the revised label in accordance with section 14 of the Act.

(2) Where no new information in respect of a controlled product or an ingredient of a controlled product becomes available in the three years following the date of preparation of a material safety data sheet of the controlled product, the supplier shall

(a) review the accuracy of the information disclosed on the material safety data sheet and, if necessary, revise the material safety data sheet and, where applicable, the label of the controlled product;

(b) revise the date of preparation disclosed on the material safety data sheet; and

(c) in respect of the revised material safety data sheet and, where applicable, the revised label of the controlled product,

(i) in the case of the sale of the controlled product after the revision of the material safety data sheet, transmit the revised material safety data sheet and, where applicable, apply the revised label in accordance with section 13 of the Act, and

(ii) in the case of an importation of the controlled product after the revision of the material safety data sheet, obtain or prepare the revised material safety data sheet and, where applicable, apply the revised label in accordance with section 14 of the Act.

Provision of Information

30. (1) Any supplier who sells or imports a controlled product intended for use in a work place in Canada shall provide, as soon as is practicable in the circumstances, any information in respect of the controlled product that is referred to in paragraph 13(a) of the Act and is in the possession of the supplier to any physician or nurse who requests that information for the purpose of making a medical diagnosis of, or rendering medical treatment to, a person in an emergency.

(2) Any physician or nurse to whom information is provided by a supplier pursuant to subsection (1) shall keep confidential any information specified by the supplier as being confidential except for the purpose for which it was provided.

31. Subject to the Hazardous Materials Information Review Act, a supplier who sells or imports a controlled product intended for use in a work place in Canada shall identify as soon as is practicable in the circumstances, on the request of an inspector, any person to whom a controlled product is sold or any user of a controlled product, the source of information for any toxicological data used in the preparation of any material safety data sheet that has been transmitted by the supplier to any person pursuant to paragraph 13(a) of the Act or has been obtained or prepared by the supplier pursuant to paragraph 14(a) of the Act.