Reference Manual for the Consumer Chemicals and Containers Regulations, 2001 of the Hazardous Products Act

Notice to the reader

Sections 1, 2, 3, 14, 15, 17, 19, 24, 34, 35, 39, 45, 46, 53, 60 and schedules 1 and 3 of the Consumer Chemicals and Containers Regulations, 2001 Reference Manual do not contain the 2009 or 2011 amendments to the Regulations and, as such, do not accurately reflect current requirements. For further information on these and other sections, please refer to the Regulations or contact your local Product Safety Office.

2007
ISBN: 978-0-662-45722-0
Cat. No.: H128-1/07-487E
HC Pub.: 4065E

Table of Contents

[Note: also see Index at end of manual]

Introduction

Using the Health Canada Reference Manual for the Consumer Chemicals and Containers Regulations, 2001 Requirements of the Hazardous Products Act

This manual is issued primarily to provide assistance to those who are concerned with the administration and enforcement of the federal requirements of Canada's Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) established under the Hazardous Products Act. The manual is intended to ensure a common understanding and approach in the administration of the Act and Regulations across Canada. It does not provide any legal advice regarding the CCCR, 2001. Appropriate legal advice is required by all the parties in the administration and enforcement of the CCCR, 2001.

The utility of the reference manual will be enhanced by referring to the index.

The Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) establish classification criteria, labelling and packaging requirements for chemical products used by consumers. The classification criteria are based on a scientific assessment of the hazards that a product may pose during foreseeable use. Labelling and packaging requirements are determined from the product classification. The labelling takes the form of hazard symbols, warning statements, safety instructions and first aid statements. In some cases, child-resistant packaging is also required. This approach gives Canadian consumers better health and safety information about the chemical products available to them.

Excluded Products:

The following types of products are not subject to these requirements, since they are governed by other Canadian legislation: chemical products used exclusively in the workplace, cosmetics, drugs, explosives, foods, medical devices, nuclear substances, pest control products and tobacco products.

Prohibitions:

Very hazardous products are prohibited from importation and sale. The prohibition generally applies to products classified as very toxic, very corrosive or very flammable. However, there are a few exceptions, for example, very flammable fuels such as gasoline.

The granting of an exception from prohibition involves a regulatory amendment to the CCCR, 2001 in accordance with the Canadian Federal Regulatory Process. A submission to Health Canada to request an exception from prohibition must clearly show the following:

  • no other less hazardous alternative exists and is readily available or technically feasible;
  • the benefits of the product outweigh the high degree of hazard to the user; and
  • any other information which supports the request to allow a very hazardous product into the hands of the general public.

Health Canada will exercise its discretionary authority regarding the request and may make its permission subject to restrictions on the packaging, labelling or conditions of sale. Once the Regulations have been amended, the exception would apply to all products meeting the amendment conditions.

Additional Information:

The established criteria, labelling and packaging requirements are intended to provide a guide to manufacturers and importers as to the minimum information that the Canadian government believes is required for consumer safety. No set of rules can cover every situation. Manufacturers and importers are responsible in product liability law for properly assessing the risks of each product and formulation that they sell. Any chemical product used by consumers should be appropriately labelled, whether or not the Regulations call for the specific wording. These Regulations contain minimum requirements. Manufacturers and importers can add, and are encouraged to add, further information that they consider necessary to fully inform their customers of the hazards of using their products.

Transition Between Regulations:

The CCCR, 2001 came into effect on October 1, 2001, with a transition period for existing consumer chemical products and containers that comply with the previous Consumer Chemicals and Containers Regulations (CCCR). There is a two-year transition period for upper-level suppliers of consumer chemical products and containers, with an additional one- or two-year transition period at retail, depending on the hazard posed by the product.

The transition period applies to consumer chemical products and containers that were being produced, sold or imported prior to October 1, 2001. A product must have reached the stage of production at which the plating-up of its label was completed and the plated-up label complied with the CCCR. Manufacturers, distributors and importers have until September 30, 2003 to meet the requirements of the CCCR, 2001. During the two-year transition period, products that comply with either the CCCR or the CCCR, 2001 are legal. After October 1, 2003, all consumer chemical products and containers must be in full compliance with the CCCR, 2001 when they are imported or sold above the retail level of trade.

Retailers have an additional transition period, to allow for old stock to be depleted. Products that were entitled to the manufacturer's transition period may continue to be sold at retail until September 30, 2005 if they are classified solely in the categories "harmful", "irritant", "combustible" or "pressurized container". Products classified under any other category must be sold by September 30, 2004.

The transition period does not apply in the following circumstances:

  • the product was not produced, sold or imported into Canada prior to October 1, 2001;
  • the product was produced before October 1, 2001, but it did not comply with the CCCR; or
  • the product was produced before October 1, 2001 in compliance with the CCCR, but there has been a subsequent change to the product's formulation, labelling or packaging.

Consensus Process:

The review of the CCCR was conducted over a number of years, with the active collaboration of interested stakeholders, including the medical profession and public health organizations, the chemical industry, senior- and consumer-groups, academia, technical experts and various federal government departments. All interested stakeholders were represented on a Steering Committee and on one or more of four technical working groups that developed recommendations for improving the legislation. The recommendations were accompanied by the rationale that scientifically supported the proposals. This approach meant that all groups participated in shaping the results, and that Health Canada foresees co-operation in implementing the resulting Regulations.

Section 1 - Interpretation

Definitions

1.(1) The definitions in this subsection apply in these Regulations.

"acid reserve"
« réserve acide »
"acid reserve" means the quantity of an alkali, expressed in grams of sodium hydroxide, that is required to bring 100 mL of a liquid acidic product, or 100 g of an acidic product in the form of a solid, paste or gel, to a pH of 4.00 ± 0.05.
"Act" « Loi »
"Act" means the Hazardous Products Act.
"aspiration"
« aspiration »
"aspiration" means the entry of a liquid or solid chemical product directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea or lower respiratory system.
"chemical product"
« produit chimique »
"chemical product" means a product used by a consumer that has the properties of one or more of the following:
  • (a) a toxic product;
  • (b) a corrosive product;
  • (c) a flammable product; or
  • (d) a quick skin-bonding adhesive.
"complex mixture"
« mélange complexe »
"complex mixture" means a combination of chemicals that has a generic name that is not a trade name and is
  • (a) a substance of natural origin;
  • (b) a fraction obtained by a physical separation process from a substance of a natural origin; or
  • (c) a chemical modification of a substance of natural origin or of a fraction obtained by a physical separation process from a substance of natural origin.
"container"
« contenant »
"container" means
  • (a) a Category 5 pressurized container that is or is likely to be used by a consumer, including an empty container, as described in Part 5;
  • (b) an empty container that is destined for use by a consumer to store or dispense a chemical product; or
  • (c) any other container that is or is likely to be used by a consumer to store or dispense a chemical product.
"corrosive product"
« produit corrosif »
"corrosive product" means a chemical product that
  • (a) is capable of inducing necrosis or ulceration of epithelial tissue;
  • (b) is capable of causing an erythema or edema of the skin, corneal or iris damage or conjunctival swelling or redness; or
  • (c) is identified in Part 2 as a Category 2 corrosive product.
"display surface"
« aire d'affichage »
"display surface" means the portion of the surface area of a container on which the information required by these Regulations can be displayed. It does not include the surface area of the bottom, of any seam or of any concave or convex surface near the top or the bottom of a container.
"dust"
« poussière »
"dust" means solid airborne particles that are mechanically generated.
"first aid statement"
« énoncé de premiers soins »
"first aid statement" means
  • (a) a list of the hazardous ingredients in the chemical product; and
  • (b) a statement of the first aid treatment to be administered to anyone who has come into contact with a chemical product, such as through ingestion, absorption or inhalation, or information that may be helpful to someone who is assisting that individual.
"flame projection"
« projection de la flamme »
"flame projection" means the flame resulting from the ignition of a chemical product discharged from a spray container when tested in accordance with the procedure set out in Schedule 1.
"flammable product"
« produit inflammable »
"flammable product" means a chemical product that is capable of
  • (a) spontaneous combustion;
  • (b) becoming flammable when in contact with air; or
  • (c) having a flash point below 60°C or a flame projection greater than 15 cm or exhibiting a flashback.
"flashback"
« retour de flamme »
"flashback" means the part of a flame projection that extends from the point of ignition back to the spray container when a chemical product is tested in accordance with the procedure set out in Schedule 1.
"flash point"
« point d'éclair »
"flash point" means the minimum temperature at which a substance gives off a vapour in sufficient concentration to ignite under test conditions.
"fume"
« fumée »
"fume" means solid particles in the air that are generated by condensation from the vapour of a solid material.
"fumes"
« émanations »
"fumes", in the context of the information that must be displayed on a container, means a vapour or a fume or both that may be given off by a chemical product under normal conditions of use or storage.
"good scientific practices"
« bonnes pratiques scientifiques »
"good scientific practices" means
  • (a) for the development of test data, conditions and procedures similar to those set out in the OECD Test Guidelines;
  • (b) for laboratory practices, practices similar to those set out in the OECD Principles of Good Laboratory Practice; and
  • (c) for human experience data, a peer-reviewed study of clinical cases.
"hazard category"
« catégorie de danger »
"hazard category" means a category into which a chemical product or container is classified, in particular:
  • (a) Category 1, toxic products set out in Part 1;
  • (b) Category 2, corrosive products set out in Part 2;
  • (c) Category 3, flammable products set out in Part 3;
  • (d) Category 4, quick skin-bonding adhesives set out in Part 4; and
  • (e) Category 5, pressurized containers set out in Part 5.
"hazard symbol"
« pictogramme de danger »
"hazard symbol" means a pictograph and its frame as set out in Schedule 2.
"hazardous ingredient"
« ingrédient dangereux »
"hazardous ingredient" means
  • (a) a pure chemical product;
  • (b) an ingredient present in a chemical product in a concentration of 1% or more that is taken into consideration when classifying the product and that
    • (i) is a chemical product,
    • (ii) the supplier believes on reasonable grounds may be harmful to humans,
    • (iii) has toxicological properties that are not known to the supplier, or
    • (iv) derives from a reaction between precursor constituents and the hazards associated with the chemical product are not known to the supplier; or
  • (c) a complex mixture present in a chemical product in a concentration of 1% or more that is taken into consideration when classifying the product and that
    • (i) is a chemical product,
    • (ii) the supplier believes on reasonable grounds may be harmful to humans, or
    • (iii) has toxicological properties that are not known to the supplier.
"human experience data"
« données de l'expérience humaine »
"human experience data" means data, collected in accordance with good scientific practices, that demonstrates that injury to or poisoning of a human has or has not resulted from
  • (a) exposure to a chemical product; or
  • (b) the reasonably foreseeable use of a chemical product or container by a consumer, including, in particular, the consumption of the product by a child.
"LC50"
« CL50 »
"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 at least 50% of a defined population of animals.
"LD50"
« DL50 »
"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 at least 50% of a defined population of animals.
"main display panel"
« aire d'affichage principale »
"main display panel" means the part of the display surface that is displayed or visible under normal conditions of sale to the consumer. It includes
  • (a) in the case of a rectangular container, the largest side of the display surface;
  • (b) in the case of a cylindrical container, the larger of
    • (i) the area of the top, or
    • (ii) 40% of the area obtained by multiplying the circumference of the container by the height of the display surface;
  • (c) in the case of a bag, the largest side of the bag; and
  • (d) in the case of any other container, the largest surface of the container that is not less than 40% of the display surface.
"manufacturer"
« fabricant »
"manufacturer" includes a packager and a labeller.
"mist"
« brouillard »
"mist" means droplets of liquid suspended in air that are produced by the condensation of a vapourized liquid or by the dispersion of a liquid by a spray container.
"mixture"
« mélange »
"mixture" means a combination of two or more products, materials or substances that do not undergo a chemical change as a result of their interaction.
"National Standard"
« norme nationale »
"National Standard" means a standard recognized by the National Standards System of the Standards Council of Canada.
"normal atmospheric pressure"
« pression atmosphérique normale »
"normal atmospheric pressure" means an absolute pressure of 101.324 kPa at 20°C.
"official languages"
« langues officielles »
"official languages" means the English and French languages.
"person responsible"
« responsable »
"person responsible", in respect of a chemical product or container, means, if the product or container is
  • (a) manufactured in Canada, the manufacturer; or
  • (b) imported into Canada, the importer.
"quick skin-bonding adhesive"
« adhésif qui colle rapidement la peau »
"quick skin-bonding adhesive" means a Category 4 adhesive set out in Part 4 that has properties similar to an alkyl cyanoacrylate adhesive and that is capable of bonding skin with skin instantly or nearly instantly.
"single-use container"
« contenant à usage unique »
"single-use container" means a non-reclosable container whose contents are to be used in their entirety immediately after the container is opened.
"spray container"
« contenant pulvérisateur »
"spray container" means a container that permits the dispersal of its contents in the form of a mist and includes a pressurized container and a pump-spray container.
"sub-category"
« sous-catégorie »
"sub-category" means one of the following classifications within a hazard category in which a chemical product may be classified, in particular:
  • (a) in the case of a Category 1 toxic product, "very toxic", "toxic" and "harmful";
  • (b) in the case of a Category 2 corrosive product, "very corrosive", "corrosive" and "irritant"; and
  • (c) in the case of a Category 3 flammable product, "spontaneously combustible", "very flammable", "flammable"and "combustible".
"toxic product"
« produit toxique »
"toxic product" means a chemical product that
  • (a) is capable of causing a lethal effect on a human;
  • (b) is capable of causing a serious and irreversible but non-lethal effect on a human, such as a depressed level of consciousness, muscular weakness or paralysis, acute renal or hepatic failure, arrhythmia, hypotension, dyspnea, respiratory depression, pulmonary edema or optic neuritis; or
  • (c) is identified in Part 1 as a Category 1 toxic product.
"vapour"
« vapeur »
"vapour" means the gaseous form of a substance that is found in a solid or liquid state at normal atmospheric pressure.

Table of standards and tests

(2) A standard or test set out in column 2 of the table to this subsection is referenced in these Regulations, in the provision set out in column 3, by means of the short form set out in column 1.

Table to subsection 1(2)
Standards and tests referenced in these regulations
Item*
Column 1

Short form
Column 2

Standard or test
Column 3

Provision in Regulations
1.(1) ASTM D 56 ASTM Standard D 56-00, entitled Standard Test Method for Flash Point by Tag Closed Tester, approved August 10, 2000, published October 2000 50(a), 51
2.(2) ASTM D 93 ASTM Standard D 93-00, entitled Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester, approved August 10, 2000, published October 2000 50(b)
3.(3) ASTM D 323 ASTM Standard D 323-99a, entitled Standard Test Method for Vapor Pressure of Petroleum Products (Reid Method), approved April 10, 1999 58(1)(a)
4.(4) ASTM D 1293 ASTM Standard D 1293-99, entitled Standard Test Methods for pH of Water, approved December 10, 1999 44(1)
5.(5) ASTM D 3828 ASTM Standard D 3828-98, entitled Standard Test Methods for Flash Point by Small Scale Closed Tester, approved November 10, 1998 50(a)
6.(6) 16 CFR 1700.20 U.S. Code of Federal Regulations, Title 16: Commercial Practices Safety Commission, revised January 1, 2000, section 1700.20 "Testing Procedure for Special Packaging" 9(b)
7.(7) CSA B306 CSA Standard B306-M1977, entitled Portable Fuel Tanks for Marine Use, as amended to April 1988 2(2)(b)
8.(8) CSA B339 CAN/CSA Standard B339-96, entitled Cylinders, Spheres and Tubes for the Transportation of Dangerous Goods, as amended December 1999 58(2)
9.(9) CSA B376 CSA Standard B376-M1980, entitled Portable Containers for Gasoline and Other Petroleum Fuels, published July 1980 (reaffirmed 1992) 2(2)(b)
10.(10) CSA-Z76.1 CAN/CSA-Z76.1-99, entitled Recloseable Child-Resistant Packages, published January 1999 9(b)
11.(12) Draize Test Draize Test, described in Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes, Volume 82, The Journal of Pharmacology and Experimental Therapeutics, 1944, pages 377 to 390 43(2)(a)
12.(13) ISO 8317 ISO 8317, entitled Child-resistant packaging - Requirements and testing procedures for reclosable packages, First edition, dated January 7, 1989 9(b)
13.(15) OECD No. 404 OECD Guideline for Testing of Chemicals No. 404, Acute Dermal Irritation/Corrosion, dated July 17, 1992 43(2)(b)
14.(16) OECD No. 405 OECD Guideline for Testing of Chemicals No. 405, Acute Eye Irritation/Corrosion, dated February 24, 1987 43(2)(c)
15.(17) OECD Principles of Good Laboratory Practice Number 1 of the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/MC/CHEM(98)17, dated January 21, 1998 1(1) "good scientific practices", 44(2)(a)
16.(14) OECD Test Guidelines Annex 1, entitled OECD Test Guidelines, of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, C(81)30(Final), adopted by the Council of the OECD on May 12, 1981 1(1) "good scientific practices", 6(1)(b) and (c), 35(1)-(a) and (b)
17.(11) Test L.2 "Test L.2: Sustained combustibility test" set out in section 32.5.2 of the Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Second edition, 1995, United Nations (UN)** 48(2)(b)
18.(18) ULC-S503 CAN/ULC-S503-M90, Standard for Carbon Dioxide Hand and Wheeled Fire Extinguishers, as amended April, 1999 2(2)(d)
19.(19) ULC-S504 CAN/ULC-S504-M86, Dry Chemical and Dry Powder Hand and Wheeled Fire Extinguishers, as amended April, 1999 2(2)(d)
20.(20) ULC-S507 CAN/ULC-S507-92, Standard For 9 L Stored Pressure Water Type Fire Extinguishers, as amended April, 1999 2(2)(d)
21.(21) ULC-S512 CAN/ULC-S512-M87, Standard for Halogenated Agent Hand and Wheeled Fire Extinguishers, as amended April, 1999 2(2)(d)

Legend:

ASTM
American Society for Testing and Materials (ASTM)
CSA
Canadian Standards Association International (CSA)
ISO
International Organization for Standardization (ISO)
OECD
Organization for Economic Cooperation and Development (OCDE)
ULC
Underwriters' Laboratories of Canada (ULC)

Table Notes

Note *

The numbers in parentheses that follow the item numbers indicate the item number of the standard in the French language table.

Return to table note * referrer

Note **

Test L.2 in the Third revised edition, published in 1999 and available in English only, is identical to Test L.2 in the second edition.

Return to table note ** referrer

Interpretation of "should"

(3) Where the word "should" is used in a standard or test referenced in these Regulations it is to be read as imperative, unless the context requires otherwise.

Units of measure

(4) The symbol set out in column 1 of the table to this subsection represents the unit of measure set out in column 2.

Table to Subsection 1(4)

Units of Measure
Item Column 1

Symbol
Column 2

Unit of measure
1. °C degree Celsius
2. cm centimetre
3. cm2 square centimetre
4. g gram
5. g/m2 grams per square metre
6. kg kilogram
7. kPa kilopascal
8. L litre
9. mg/kg milligrams per kilogram
10. mg/L milligrams per litre
11. mg/m3 milligrams per cubic metre
12. mm millimetre
13. mm2/s square millimetres per second
14. N newton

Concentration

(5) In these Regulations, unless otherwise specified, when a concentration of a substance is expressed as a percentage, the percentage represents the ratio of the weight of the substance to the weight of the chemical product.

Discussion Of CCCR, 2001 Section 1

Definitions:

The definitions in the Hazardous Products Act (HPA) have the same meaning in all of the regulations made under that Act, including the CCCR, 2001. Any word that is not specifically defined in the HPA or CCCR, 2001 should be given its ordinary meaning, after considering the context in which it appears and the purpose of the Regulations.

Acid Reserve / Alkali Reserve:

The principle of acid reserve and alkali reserve incorporates a parameter complementary to pH for quantifying the corrosivity which arises from the acidity or alkalinity of a product. This approach provides a more accurate method of product classification.

Chemical Product:

The words "used by a consumer" distinguishes the product from chemical products used by workers in an industrial setting or other workplace. Workplace chemicals are governed by the requirements of Canada's Workplace Hazardous Materials Information System (WHMIS) established under the HPA and associated Controlled Products Regulations. A consumer is considered to be anyone from the general public who has access to a product that is advertised, imported or sold in Canada.

Complex Mixture:

A complex mixture can be comprised of a multitude of ingredients whose concentrations may vary from batch to batch. Examples of complex mixtures are petroleum distillates, d-limonene, pine oil and air. A synthetic mixture of hydrocarbons which approximates the composition of a petroleum distillate does not fit the definition of a complex mixture because it is not naturally occurring.

Container:

All types of containers are covered under the requirements, including empty containers which are intended to dispense a consumer chemical product sold in bulk. However, there must be some evidence linking the empty container to the consumer chemical product. Such evidence would include a container that:

  • has a similar shape or colour to the bulk packaging for it to be associated with the chemical product in the mind of the buyer;
  • is labelled with the brand name;
  • is sold attached to the product or beside it; or
  • is given or sold for the purpose of diluting the product.
Pressurized Containers

The classification criteria in Part 5 describe products that are hazardous because of the internal pressure within the container. If punctured or heated, a pressurized container can rupture, resulting in flying debris or release of hazardous contents.

Spray Containers

A spray container permits the dispersal of its contents in the form of a mist and includes a pressurized container and a pump-spray container. Not all pressurized containers are spray containers, only those that permit release in the form of a mist. Mist is defined as "droplets of liquid suspended in air that are produced by the condensation of vapourized liquid or by the dispersion of a liquid by a spray container". Hence, a pressurized container that emits a product in the form of a foam, a mousse or a string would not be considered to be a spray container.

Corrosive Product:

This category includes the sub-categories "very corrosive", "corrosive" and "irritant". The classification criteria in Part 2 determine the sub-category into which a product falls. The criteria describe products that are hazardous because they can cause a chemical burn. The distinction between sub-categories is the degree of injury and whether permanent damage results.

Display Surface:

The display surface is used to determine the size of the main display panel. The listed exclusions reflect that these areas of the display surface are not customarily used for printing. However, if information appears in these areas, the calculation to determine the main display panel area must reflect this usage.

The Concise Oxford Dictionary defines surface as "the outside of a material body". The labelling requirements would not be satisfied by placing the required statements on the back of a label located on the front of a transparent container. In that case, the information would not be displayed on the outside of the container (that is, the surface) because a person would have to look through the container and its contents to see the information.

First Aid Statement:

Only those hazardous ingredients which directly contribute to the classification of the product must be listed immediately after the words "FIRST AID STATEMENT". The use of the words "may contain" and other phrases which leave some ambiguity as to the composition and, consequently, the health hazard of the product, is discouraged.

Flammable Product:

This category includes the sub-categories "very flammable", "flammable", "combustible" and "spontaneously combustible". The classification criteria in Part 3 determine the sub-category into which a product falls. The criteria describe products that are hazardous because they can catch fire. The distinction between sub-categories is the ease of ignition or length of flame projection.

"Fume" Versus "Fumes":

The definition for "fume" is the technical definition to correctly classify a product. However, the term "fumes" is used on a product label to reflect the hazards arising from vapours, gases, fumes or mists. In focus group testing among Canadian consumers, the term "fumes" was preferred, because it best conveyed in the popular, although not technical, usage, the sense of airborne material which may not be visible. No one word is technically correct for gases, fumes, mists and vapours. Since "fumes" communicates the hazard best, its use on a label leads to appropriate behaviour during the use and storage of a consumer chemical product.

Good Scientific Practices:

The standards for OECD Test Guidelines and OECD Principles of Good Laboratory Practice are given in the table to subsection 1(2). The definition of "good scientific practices" allows the use of other test data and laboratory practices that are not OECD, so long as they are similar to the OECD guidelines. If another standard is used, the user should be prepared to demonstrate that it is similar to the OECD guidelines. This is an expert's decision and an exercise in scientific judgement. Other National Standards of Canada or international standards recognized by the Standards Council of Canada and generally accepted procedures can also be used.

The term "peer-reviewed" does not mean that a study must be published in a journal or other similar scientific publication; it is more flexible. A peer-reviewed study can be external or internal to an organization, but it must be reviewed by competent and appropriate people. Health Canada's evaluators should be able to come to the same conclusions after reviewing all of the same information as the peer-review team. If there are any discrepancies, then the data are questionable and would not be acceptable for classification purposes.

Hazard Symbol:

The hazard symbols for the CCCR, 2001 are official marks of Health Canada. They were registered under the Trade Marks Act on June 10, 1970. (Trade Marks Journal, Vol. 17, No. 815). Since the correct symbols and warnings are required to prevent unnecessary and inappropriate medical treatment being given to a victim, the authority under the Trade Marks Act may be used as a means of control when the symbols are being used inappropriately. The misleading use of the symbols could also be considered to be a violation of Section 7 of the Consumer Packaging and Labelling Act or the Competition Act, both of which are administered by Industry Canada.

Hazardous Ingredient:

The term "pure chemical product" is considered to be 99.999% plus impurities.

Human Experience Data:

Reliable human data shall be taken into account in determining the appropriate classification of a product. Reliable epidemiological data and experience on the effects of chemicals on humans would include occupational data, data from accident data bases and clinical cases with a product. Testing on humans solely for hazard identification purposes is generally not acceptable.

When such data give valid results different from results with animal data, the human experience takes precedence. Human data may be used to show that the product meets or does not meet a classification criterion. Professional judgement must be used in making an assessment of what is sufficient data in each case and taking into account animal test results.

The term "reasonably foreseeable use" means that a supplier must consider the various ways in which a product might be used by the general public, regardless of the original intent. Although consumer chemical products are not intended to be consumed, the swallowing of a product by a child is considered to be reasonably foreseeable use. Another example is the common consumer practice of mixing bleach with another product, such as a toilet bowl cleaner (an acid), thereby creating toxic fumes. However, intentional abuse, such as chemical substance abuse, suicide or other criminal use, are not included within the scope of the CCCR, 2001; such uses may be subject to civil liability laws and the Criminal Code.

Main Display Panel:

The main display panel is that portion of the container which bears the identifiers of the product, that is, the brand name and purpose of the product, and is commonly referred to as the "main label" of the product. Products may have two main display panels, where one panel is labelled in English while the other displays the equivalent information in French. Where separate main display panels are used for each official language, the English warnings should appear on the English panel and the French warnings should appear on the French panel. This is acceptable provided each panel complies with the minimum size requirements for the prescribed information. Placing English and French versions of the precautionary information on both panels is also permitted.

Cylindrical Containers

With respect to tall, narrow containers, it may not be possible to see all of the display panel without rotating the container. For all practical purposes, sufficient information is visible under normal conditions of advertisement or sale to the consumer, even where slight turning of the container is necessary to read the complete sentences.

For lithographed cylindrical containers, a process where the information is printed directly onto the container surface, the area of the seam of the container should not be included, since this area is unavailable for labelling.

If the area of the top of a cylindrical container is larger than the side display panel, the top is considered to be the main display panel. The area of the top of the cylinder is calculated as π × r2, where: π = 3.1416 and r = the radius of the top of the container. The side display panel is 40% of the area obtained by multiplying the circumference of the container by the height of the display surface. Where the top is the main display panel, normal display on retail shelves allows for the product to be stacked one on top of the other so that only the short side is visible from the aisle.

Blister Cards

Display cards are cards on which the container of the product is mounted but not enclosed, for example, it is attached by wire, plastic loop or adhesive. Blister cards enclose the container in direct contact with the product, usually in a transparent plastic coating.

For blister cards and other similar display cards, since the area under the product itself is unavailable for labelling when visible during advertisement and sale, the area taken up by the product should be subtracted from the total area of the blister card.

Indented Containers

The definition of display surface is used to evaluate containers with an obvious recessed or indented section, where the top and bottom are generally rounded or curved and not available for labelling. In this case, only include the smooth, recessed or indented surfaces as the "obvious" main display panel. Do not apply this exemption where the container has been labelled outside the recessed or indented area because this outer area is undoubtedly available for labelling. Where the recessed or indented area is so small in relation to the size of the container that it is no longer an obvious main display panel, calculate the area according to paragraph (d).

National Standard:

The Standards Council of Canada is a federal Crown corporation with the mandate to promote efficient and effective standardization. The organization reports to Parliament through the Minister of Industry. The Standards Council has the mandate to coordinate and oversee the efforts of the National Standards System, which includes organizations and individuals involved in voluntary standards development, promotion and implementation in Canada.

Accredited standards-development organizations may submit standards to the Standards Council for approval as National Standards of Canada. This designation indicates that the given document meets criteria that are important to many standards users. For example, a National Standard of Canada must be developed by consensus of a balanced committee representing producers, consumers and other relevant interests. It must undergo a public review process, be available in both official languages and must not be framed in such a way that it will act as a restraint to trade. Further, the standard should be consistent with or incorporate appropriate international standards as well as pertinent national standards.

Official Languages:

In 1969, following recommendations from the Bilingualism and Biculturalism report, Parliament adopted the first Official Languages Act (OLA), which recognized English and French as the official languages of all Canadian federal institutions. The basic tenets of the current official languages policy are set out in the Canadian Charter of Rights and Freedoms (1982) and the Official Languages Act (1988).

Quick Skin-bonding Adhesive:

The labelling and packaging requirements for quick-skin bonding adhesives are given in Part 4. Alkyl cyanoacrylates are monomers with relatively low viscosities. Alkyl cyanoacrylate is a general term, indicating that there is one carbon atom double-bonded to an oxygen atom and two carbon atoms bonded to another oxygen atom somewhere in the molecule (see illustration).

The terms "instantly or nearly instantly" do not specify a set time period because the key words in the definition are "bonding skin with skin". If the product can bond skin with skin, then the hazard exists and the time it takes for the bonding to occur is less relevant. However, the faster the adhesive bonds, the less time a person has to react to prevent skin-to-skin bonding from occurring by washing-off the adhesive.

Methyl cyanoacrylate ester:

Illustration of formula for Methyl cyanoacrylate ester

Allyl cyanoacrylate ester:

Illustration of formula for Allyl cyanoacrylate ester

Ethyl cyanoacrylate ester:

Illustration of formula for Ethyl cyanoacrylate ester

Ethoxymethyl cyanoacrylate ester:

Illustration of formula for Ethoxymethyl cyanoacrylate ester

Sub-category:

Some degree of differentiation between levels of hazard is of use to emergency medical personnel and poison control centres. Therefore, the sub-categories represent the levels associated with the broad categories of products normally seen as consumer chemical products.

Toxic Product:

This category includes the sub-categories "very toxic", "toxic" and "harmful". The classification criteria in Part 1 determine the sub-category into which a product falls. The criteria describe products that are hazardous because of the immediacy of the harmful effect following exposure and because they can cause death. The distinction between sub-categories is the quantity of the product that is required to produce a harmful or fatal effect. The classification criteria do not include effects that occur over longer-term or repeated exposures, such as cancer, reproductive effects or skin sensitization.

Links to Standards and Tests:

Section 2 - General Provisions - Authorized advertising, sale and importation

Authorized advertising, sale and importation

2. (1) Subject to subsection (2) and section 3, the advertising, sale and importation of a chemical product or a container is permitted only if the product or container meets all the applicable requirements of these Regulations.

Exceptions

(2) These Regulations do not apply to

  • (a) a chemical product if a user cannot be exposed to the product or to any of its hazardous ingredients during reasonably foreseeable use;
  • (b) a portable petroleum container that conforms with CSA B306 or CSA B376;
  • (c) a lighter; or
  • (d) a portable fire extinguisher that conforms with ULC-S503, ULC-S504, ULC-S507 or ULC-S512.

Discussion of CCCR, 2001 Section 2

Definitions:

The following terms are defined in section 1 of the CCCR, 2001: chemical product, container, hazardous ingredient,
CSA B306, CSA B376, ULC-S503, ULC-S504,
ULC-S507, ULC-S512.

The following terms are defined in the Hazardous Products Act (HPA): advertise, sell, import (see the HPA reference manual).

General Provisions:

If a consumer can buy a chemical product through the retail distribution network, then that product must meet the requirements of the CCCR, 2001 regardless of whether it is also distributed to the more specialized commercial or industrial markets.

Exceptions - No Exposure:

The CCCR, 2001 do not apply if a user cannot be exposed to the product or any of its hazardous ingredients during reasonably foreseeable use. For example, if the container is a fuel tank that is permanently attached to the engine or appliance that uses the fuel, then no precautionary labelling is required. This provision is similar to the WHMIS exclusion for manufactured articles.

The term "reasonably foreseeable use" means that a supplier must consider the various ways in which a product might be used by the general public, regardless of the original intent. Although consumer chemical products are not intended to be consumed, the swallowing of a product by a child is considered to be reasonably foreseeable use. Another example is the common consumer practice of mixing bleach with another product, such as a toilet bowl cleaner (an acid), thereby creating toxic fumes. However, intentional abuse, such as chemical substance abuse, suicide or other criminal use, are not included within the scope of the CCCR, 2001; such uses may be subject to civil liability laws and the Criminal Code.

Exceptions - Paragraph 2(2)(b) to (d):

The items listed in paragraphs 2(2)(b) to (d) were included because portable petroleum containers, lighters and fire extinguishers must meet high safety and performance standards in Canada. Lighters are required to conform to the Hazardous Products (Lighters) Regulations under the HPA. Portable petroleum containers and fire extinguishers must meet the stated standards.

Lead/Acid Batteries

Lead/Acid batteries, including starter, lighter and ignition batteries that meet the safety-related specifications of the international standard IEC 60095-1 "Lead-acid starter batteries - Part 1: General requirements and methods of test", sixth edition, 2000-12, are administratively exempt from the CCCR, 2001. This International Electrotechnical Commission (IEC) standard is considered to meet the objectives of the CCCR, 2001 with respect to protecting consumers from the hazards these products may pose during reasonably foreseeable use.

Exceptions - Hazardous Products Act:

The following types of products are not subject to the HPA or its associated Regulations, since they are governed by other Canadian legislation: cosmetics, drugs, explosives, food, medical devices, nuclear substances, pest control products and tobacco products (see section 3 of the HPA Reference Manual).

Cosmetics

Section 2 of the Food and Drugs Act (FDA) defines a cosmetic by the following:

"includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes."

For example, adhesives sold in artificial fingernail kits are considered to be cosmetics and therefore are excluded from the jurisdiction of the HPA and CCCR, 2001. Another example is hairspray packaged in a aerosol container: such products must meet the safety and labelling requirements in the Cosmetics Regulations under the FDA, not the CCCR, 2001.

Drugs

Section 2 of the FDA defines a drug by the following:

"includes any substance or mixture of substances manufactured, sold or represented for use in

  • (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
  • (b) restoring, correcting or modifying organic functions in human beings or animals, or
  • (c) disinfection in premises in which food is manufactured, prepared or kept."

For example, drugs administered in aerosol form are not subject to the pressurized container requirements of the CCCR, 2001; such products must meet the FDA requirements.

Explosives

Section 2 of the Explosives Act defines an explosive as:

"any thing that is made, manufactured or used to produce an explosion or a detonation or pyrotechnic effect, and includes any thing prescribed to be an explosive by the regulations, but does not include gases, organic peroxides or any thing prescribed not to be an explosive by the regulations."

For example, any preparation that consists either wholly or partly of nitroglycerine, or of some other liquid nitro-compound, is considered to be an explosive and is therefore excluded from the jurisdiction of the HPA and CCCR, 2001.

Food

Section 2 of the FDA defines a food by the following:

"includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever."

For example, a food such as whipped cream that is packaged in an aerosol container must be packaged according to the FDA and not the CCCR, 2001.

Medical Devices

Under Section 2 of the FDA, a device means:

"any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

  • (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
  • (b) restoring, correcting or modifying a body function or the body structure of human beings or animals,
  • (c) the diagnosis of pregnancy in human beings or animals, or
  • (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring,

and includes a contraceptive device but does not include a drug."

The Health Canada Therapeutic Products Program has advised that eyeglass cleaners are considered to be devices under the FDA. Products represented for use to keep eyeglasses clean perform a function essential in enabling the lenses of the eyeglasses to correct vision. These products are therefore considered to be an accessory to a device and are included in the definition of a device.

Denture cleaners (cleansers) are considered to be devices only when they are labelled with medical claims, for example, to treat, mitigate or prevent a disease, disorder, or abnormal physical state. In the absence of any medical claims, denture cleaners are not considered to be devices and therefore fall within the purview of the CCCR, 2001.

Nuclear Substances

The Nuclear Safety and Control Act, administered by the Canadian Nuclear Safety Commission, defines nuclear substance as:

  • "(a) deuterium, thorium, uranium or an element with an atomic number greater than 92;
  • (b) a derivative or compound of deuterium, thorium, uranium or of an element with an atomic number greater than 92;
  • (c) a radioactive nuclide;
  • (d) a substance that is prescribed as being capable of releasing nuclear energy or as being required for the production or use of nuclear energy;
  • (e) a radioactive by-product of the development, production or use of nuclear energy; and
  • (f) a radioactive substance or radioactive thing that was used for the development or production, or in connection with the use, of nuclear energy."
Pest-Control Products

Section 2 of the Pest Control Products Act (PCPA) defines a control product as:

"any product, device, organism, substance or thing that is manufactured, represented, sold or used as a means for directly or indirectly controlling, preventing, destroying, mitigating, attracting or repelling any pest, and includes

  • (a) any compound or substance that enhances or modifies or is intended to enhance or modify the physical or chemical characteristics of a control product to which it is added, and
  • (b) any active ingredient used for the manufacture of a control product."

In the same section, a pest is defined as:

"any injurious, noxious or troublesome insect, fungus, bacterial organism, virus, weed, rodent or other plant or animal pest, and includes any injurious, noxious or troublesome organic function of a plant or animal."

A swimming pool chemical that contains chlorine is exempt from the CCCR, 2001 because it is a disinfectant which falls under the PCPA, administered by the Pest Management Regulatory Agency. This agency has also advised that self-defense sprays designed for the strict use against animals are considered to be pest-control products under the PCPA.

Tobacco Products

Section 2 of the Tobacco Act defines tobacco product as:

"a product composed in whole or in part of tobacco, including tobacco leaves and any extract of tobacco leaves. It includes cigarette papers, tubes and filters but does not include any food, drug or device that contains nicotine to which the Food and Drugs Act applies."

Prohibitions - Hazardous Products Act:

Some chemical products are not prohibited under the CCCR, 2001, but rather, are prohibited directly under the HPA. All products listed in Part I of Schedule I to the HPA are prohibited, for example, aerosol containers pressurized with vinyl chloride or microscopy oils containing polychlorinated biphenyls (PCB's) (see Part I of Schedule I of the HPA Reference Manual).

Restrictions in Other Canadian Legislation:

Various chemicals are restricted under other Canadian legislation. The following are examples:

The Canadian Environmental Protection Act, 1999 (CEPA-1999)

CEPA-1999, an Act respecting pollution prevention and the protection of the environment and human health in order to contribute to sustainable development, is administered by Environment Canada. Under this Act, the use of chlorofluorocarbon (CFC) propellants in pressurized containers is prohibited by the Ozone Depleting Substances Regulations. In addition, some chemicals that have been declared toxic under paragraph 64(c) of CEPA-1999 are prohibited under the Prohibition of Certain Toxic Substances Regulations, for example, certain polychlorinated terphenyls and polybrominated biphenyls.

New ⇒ The Canadian Environmental Protection Act (CEPA) may also place restrictions on substances used in some of these products. This information can be found at the Chemical Substances Portal: www.chemicalsubstances.gc.ca.

The Criminal Code

The criminal use of chemical products is restricted under the Criminal Code. For example, a prohibited weapon includes:

"any device designed to be used for the purpose of injuring, immobilizing or otherwise incapacitating any person by the discharge therefrom of

  • (a) tear gas, Mace or other gas, or
  • (b) any liquid, spray, powder or other substance that is capable of injuring, immobilizing or otherwise incapacitating any person."

In addition, stink bombs are prohibited under section 178 of the Criminal Code, including:

  • "(a) an offensive volatile substance that is likely to alarm, inconvenience, discommode or cause discomfort to any person or to cause damage to property, or
  • (b) a stink or stench bomb or device from which any substance mentioned in paragraph (a) is or is capable of being liberated"
The Transportation of Dangerous Goods Act, 1992

The transportation of dangerous goods by air, marine, rail and road is regulated under the Transportation of Dangerous Goods Act, 1992, administered by Transport Canada. The Transportation of Dangerous Goods Regulations, adopted by all provinces and territories, establishes the safety requirements for the transportation of dangerous goods. A system of diamond-shaped placards and labels is used to identify dangerous goods. Different colours and symbols, such as a flame for flammables or a skull and crossbones for poisons, depict the dangers peculiar to each regulated product.

New ⇒ The vast majority of consumer products are exempt from the TDG Regulations and their requirements since they are packaged in individual containers that weigh less than 30 kg. This explains why consumer chemicals are exempt (in addition to HPA exemptions) from the requirements of the TDG Regulations. This clarification was needed because a manufacturer was claiming that although he was required by CCCR 2001, he did not use child-resistant closures because TDG regulations require that he uses TDG-approved closures which do not exist with child-resistant features. For more information, refer to section 1.17 of the TDG Regulations.

Workplace Chemical Products:

Workplace chemicals are governed by the requirements of WHMIS, established under the HPA and associated Controlled Products Regulations (CPR). Chemical products used by consumers and regulated under the CCCR, 2001 are exempt from WHMIS labelling requirements under paragraph 12(f) of the HPA. But the reverse is not true. All chemical products available to the general public must meet the CCCR, 2001 requirements. Statements such as "For Industrial Use Only" on the label do not remove consumer products from the requirements of the CCCR, 2001.

Example

Question: What are the supplier obligations in respect of the sale of a chemical product included in Part II of Schedule I to the HPA if they are selling 100 mL containers of this product to consumers but 1 litre containers of the very same product to commercial customers?

Answer: For the purposes of the HPA, the fact that the 1 litre container is not available to consumers through retail outlets renders these different products. In such a case, the supplier would have to respect the CCCR, 2001 for the 100 mL containers and the WHMIS CPR for the 1 litre containers. If, however, both the 100 mL and 1 litre containers were available to consumers, then the CCCR, 2001 must be applied to both containers, even if 99% of the 1 litre product was being sold directly to commercial customers and only 1% to consumers.

In a store that sells to both consumers and industry, it is recommended that the store screen clients beforehand so that consumers do not get access to workplace products. This screening can be done by not allowing the product to be displayed on the floor, keeping the product behind the counter or by requiring the person requesting the product to show some industry identification before buying. If no screening can be done, then the CCCR, 2001 apply.

Section 3 - General Provisions - Importation to bring into compliance or to export

Exceptions - importation to bring into compliance or to export

3. (1) A person may import a chemical product or container that does not comply with a requirement of these Regulations for the purpose of

  • (a) bringing the product or container into compliance with the requirement;
  • (b) reselling the product or container to a manufacturer in Canada who will bring it into compliance with the requirement; or
  • (c) exporting the product or container to another country.

Credible evidence

(2) A person who imports a chemical product or a container for a purpose described in subsection (1) must, on the request of an inspector, provide credible evidence to the inspector that it is being brought into compliance with these Regulations or is being exported, as the case may be.

Subsection 29(2) of the Act applies

(3) For greater certainty, subsection 29(2) of the Act applies to the exceptions set out in subsection (1).

Discussion of CCCR, 2001 Section 3

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
Act, chemical product, container, manufacturer.

The following terms are defined in the Hazardous Products Act (HPA): import, inspector, sale (see HPA Reference Manual).

General Provisions:

Section 3 allows for the importation of chemical products or containers that do not meet the CCCR, 2001 requirements so long as the imported product is brought into compliance prior to its sale to consumers. An importer may bring a product or container into compliance, or may sell the product or container to another person who will bring it into compliance. Also, an importer may temporarily (that is, for a reasonable transition period) bring non-complying chemical products or containers into Canada to re-export them to another country.

Bringing a product or container into compliance with the CCCR, 2001 may involve re-formulation, re-packaging into a child-resistant container, or the application of over-labels with the appropriate labelling. Both product and container are included to allow an importer to bring in empty containers from other countries to be filled and packaged in Canada.

Credible Evidence:

The onus is on the importer to provide enough evidence to support the importation of non-complying product. Examples of credible evidence include answers to these questions:

  • which printing company has been hired for producing the new compliant labels?
  • where is a draft label or mock-up of the label?
  • what packager is being used?
  • where is the production line or warehouse where changes will be made to this product?
  • where is the workplan or schedule for completion of the necessary work?

Burden of Proof:

Subsection 3(3) reiterates the provision of the HPA that the importer has the burden of proving that he or she may import a chemical product or container that does not comply with the CCCR, 2001, as long as the conditions of section 3 are met.

Subsection 29(2) of the HPA states that the accused has the onus of proving that an exception or exemption operates in the accused's favour. This means that once the Crown prosecutor has proved that the accused imported a consumer chemical product that could only be imported as authorized by a regulation, the accused has the onus of proving the defence that an exception or exemption in the regulation applies to the accused and, hence, that the importation of the product in question was legal. The Crown is not required to prove a negative; that is, that the exceptions or exemptions do not operate in favour of the accused (see subsection 29(2) of the HPA Reference Manual).

Sections 4 and 5 - Requirements - Hazard Category, Container and Information

Determination by person responsible

4. (1) The person responsible, using one or more of the applicable properties, data sources or test procedures set out in section 6 or Parts 1 to 5, must determine

  • (a) the hazard categories of the chemical product or container and, if applicable, its appropriate sub-categories;
  • (b) the type of container that is required; and
  • (c) the information that is required to be displayed on the container.

Multiple hazard categories

(2) If a chemical product and its container fall into more than one hazard category, its container must display the information that is required for every applicable hazard category.

Multiple sub-categories

(3) Subject to subsection (4), if a chemical product falls into more than one sub-category within a hazard category, the person responsible must classify the product in the sub-category that represents the greatest hazard within each applicable hazard category.

Multiple sub-categories - flammable products

(4) If a chemical product falls into both the sub-category "spontaneously combustible" and another sub-category in the hazard category "Category 3, flammable product", it must be classified in both sub-categories.

Multiple routes of exposure

(5) The container of a chemical product to which an individual may be exposed by more than one route of exposure must display the required information for each route of exposure.

Record keeping and provision

5. The person responsible must

  • (a) keep or cause to be kept, for a period of at least three years after the date of manufacture or importation of a chemical product or container, all records relating to the determinations required under sub-section 4(1); and
  • (b) within 15 days after receipt of a request from an inspector, provide the records referred to in paragraph (a) to the inspector.

Discussion of CCCR, 2001 Sections 4 and 5

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, flammable product,
hazard category, person responsible, sub-category.

The following terms are defined in the Hazardous Products Act (HPA): inspector.

Requirements:

A manufacturer or importer of a consumer product has the legal responsibility to determine whether that product falls within any of the hazard categories specified by Parts 1 to 5 of the CCCR, 2001. The onus is on the "person responsible", that is, the manufacturer or importer of the product, not the retailer.

The classification results indicate whether any prohibition applies, if there are specific packaging requirements, such as child-resistant containers, and what warnings must appear on the container.

A product may fall within more than one hazard category, based on its inherent hazards. For example, a toxic product packaged in an aerosol container would fall under both the toxic and pressurized container categories (s. 4(2)). If a product is classified in more than one sub-category within a hazard category, the most hazardous sub-category is used (s. 4(3)). For flammable products, the most hazardous sub-category is used as well as labelling for spontaneous combustion, if applicable (s. 4(4)).

All possible routes through which a user could be exposed - oral, dermal and inhalation - must be considered. A product may only be accessible though one route of exposure or it may be accessible through all three routes. Subsection 4(5) ensures that the container displays the appropriate warnings for each applicable route of exposure. For example, if a product falls within the "toxic" sub-category via the oral route as well as the "harmful" sub-category via inhalation, then the product as a whole is classified as "toxic" (that is, the more severe sub-category), but both the warnings for the oral exposure (toxic) and the inhalation exposure (harmful) are required.

Section 5 requires that the person responsible must produce the record of the steps taken to classify their product. Paragraph 5(1)(b) sets out the time limit of 15 days to provide the requested information. These are calendar days, not working days.

Section 6 - Requirements - Data Sources

Precedence of data sources

6. (1) The person responsible must determine the hazards arising from the reasonably foreseeable use of the chemical product or container from one or more of the following data sources in the following order of precedence:

  • (a) human experience data pertaining to the product or container;
  • (b) data, set out in peer-reviewed, scientific literature, from tests conducted using the product in accordance with the OECD Test Guidelines;
  • (c) if tests using the product have not been conducted in accordance with the OECD Test Guidelines,
    • (i) the peer-reviewed results of tests conducted with the product in accordance with
      • (A) these Regulations,
      • (B) a National standard or an international standard recognized by the Standards Council of Canada, or
      • (C) a generally accepted procedure that accorded with good scientific practices at the time the tests were conducted,
    • (ii) the peer-reviewed results of tests conducted with a chemical product that has properties similar to those of the product under examination, in accordance with
      • (A) OECD Test Guidelines,
      • (B) a National standard or an international standard recognized by the Standards Council of Canada, or
      • (C) a generally accepted procedure that accorded with good scientific practices at the time the tests were conducted, or
    • (iii) other current, peer-reviewed information about the product;
  • (d) if the hazards associated with the product cannot be estimated from information referred to in paragraphs (a) to c), data with respect to the hazards associated with
    • (i) the hazardous ingredients, or
    • (ii) a chemical product that has properties similar to those of the product under examination; or
  • (e) the results of tests conducted by the person responsible in accordance with a test methodology that conforms with good scientific practices.

Differing data sources

(2) In the case of differing data sources,

  • (a) an original literature source must be used in preference to literature that refers to the original study; and
  • b) a source that reports test results that conform with good scientific practices and that disclose the greatest hazard must be used.

Discussion of CCCR, 2001 Section 6

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, good scientific practices,
human experience data, National standard, OECD Test
Guidelines, person responsible.

Requirements:

Section 6 provides the order of precedence of the data required to classify a product within the CCCR, 2001. Reliable human experience with the product takes precedence over data from animal experimentation. Data from OECD tests take precedence over results from other relevant test methods. In addition, the assessment of the whole product takes precedence over the classification based on the hazardous ingredients.

The use of scientific judgement must be based on an evaluation from a reasonably competent individual, knowledgeable in the appropriate science necessary to evaluate the product.

Precedence of Human Experience Data:

Human experience with a product is the best indicator of its potential hazard, in view of the variability in response to materials between individuals and between species. However, reliable human experience data is not available for most products and substances, making it necessary to accept animal test data. When human experience data give valid results different from results with animal data, the human experience data take precedence. Human experience data may be used to show that the product meets or does not meet a classification criterion.

Reliable human experience data includes epidemiological data and experience on the effects of chemicals on humans, such as occupational data, information from accident databases and clinical cases with a product. Market history data collected from company toll-free lines, or complaint databases from manufacturers may be useful, however these types of data may be less reliable than actual clinical cases collected from poison control centres or emergency wards in hospitals and clinics. Deliberate testing on humans solely for hazard identification purposes is discouraged for ethical reasons.

In order to make use of market history data, the person responsible must establish a mechanism to obtain complaints or feedback directly from the users of the product. However, once a product's formula is changed, there must be market history data on the new formulation in order to classify the modified product using human experience data.

Professional judgement must be used in making an assessment of what is sufficient data in each case and taking into account animal test results. For example, a single human experience result from exposure to a product may not be sufficient to warrant using that data instead of animal data, because there may be other contributory factors for the result in that particular case.

OECD Testing:

The Organization for Economic Cooperation and Development (OECD) has published guidelines for acute oral, dermal and inhalation toxicity tests using animals. Paragraph 6(1)(b) does not mean that a manufacturer or importer must conduct animal tests. Rather, if the data are already available, then these values can be used for classification purposes.

The CCCR, 2001 were designed to make the best use of existing toxicological data in order to assess a product's potential hazard. Acute toxicity data in the form of LD50 and LC50 values have been produced for tens of thousands of chemicals and are widely available in handbooks, databanks, and manufacturers' material data safety sheets (MSDS's). This published data has been peer-reviewed, which is a requirement prior to acceptance in most scientific journals and publications.

Other Acceptable Tests:

Paragraph 6(1)(c) allows for other available scientific evidence to be assessed during the classification process, as long as a qualified person is conducting this assessment. Precedence is given to the results of tests conducted with the product in accordance with Parts 1 to 5 of the CCCR, 2001. If tests results are not available on the product, the hazards may be extrapolated from test results on a similar product with a known hazard profile.

Ingredient Assessment:

Where it is not possible to classify the entire product, then paragraph 6(1)(d) allows the product to be assessed from the hazardous ingredients present or from information about a similar product (See also subsection 36(4) - additivity formula).

Adequate, reliable data may not be available for all ingredients of a product, for various reasons: a chemical may have been considered non-toxic and not worth testing (e.g. many polymers); it may be essentially identical to others in a family (e.g. petroleum distillates or lead salts); or the only available data may be semi-quantitative or derived from non-standard tests or sources. In all of these cases, professional judgement is needed to estimate the toxicity of the material and apply the criteria.

If no toxicological information is available for a hazardous substance, a Quantitative Structure Activity Relationship (QSAR) system may be used to obtain information about the potential toxicity of the substance. QSAR is a statistical algorithm that quantitatively defines the relationship between the chemical structure of a substance and its effect on an organism. Hence QSAR studies may be helpful in predicting the toxicity of substances that have not been tested. However, data generated from the use of QSAR is not considered to be information about which the person responsible ought reasonably to be aware.

Product Testing:

A manufacturer or importer of a chemical product or container must evaluate their product against all of the criteria established in Parts 1 to 5 of the CCCR, 2001. Under paragraph 6(1)(e), a manufacturer or importer may test their product according to the test method specified in a hazard category and use the results to determine if the product meets that criterion. The following approach to the consideration of test results is recommended:

  1. Use the results of tests carried out on the product in accordance with the test methods specified in Parts 1 to 5. Professional judgement may be required when there are varying test results for a product that has been subjected to the same specified test method.
  2. In the absence of test results referred to in (1), use test results on the product from relevant but non-specified test methods. Professional judgement must be used with these results to classify the product.
  3. In the absence of test results referred to in (1) or (2), where appropriate, extrapolate test results on a product with similar properties to classify the product. Professional judgement must be used to carry out such an extrapolation.

Professional judgement is allowed to ascertain whether the product meets the criteria without actually testing the product, on the following condition: the decision must be based upon peer-reviewed test results available on the product or, where relevant, test results available on a product with similar properties. For example, a manufacturer would not be expected to test for the flash point of a product that has no flammable ingredients or to test whether an aqueous solution is a pressurized container.

Differing Data Sources:

Discrepancies in reported values for the test data for some substances, especially toxicity data, may arise. The variance is in some cases due to errors rather than differences in actual test results. For example, the originally published value for the LC50 of mineral spirits, a common solvent and thinner, was "much greater than 1400 ppm". This value was later reproduced in many references as being equal to 1400 ppm, resulting in a different classification of a product containing this substance. Subsection 6(2) ensures that disputes over the classification of a product may be settled by reference to a single source subject of professional review.

Information Sources:

Professional judgement must be exercised when determining the source and extent of information to be reviewed and used for product classification. For example, often only article abstracts are obtained through literature searches; i.e., literature searches may not provide all of the information needed to classify a product. Manufacturers and importers should be aware of relevant information published technical literature, such as the latest edition of the sources listed below. Other sources of information include: company information on toxicity tests or illness experience; supplier MSDS's for ingredients used in products; and information made available by governmental and regulatory agencies, trade associations and labour organizations.

GENERAL REFERENCES: (Note: the latest editions should be used)

Chemical Hazards of the Workplace Proctor
NH, Hughes JP, eds. J.B. Lippincott Co. New York.

Clinical Toxicology of Commercial Products
Gleason MN, Gosselin RP, Hodge HC, Williams and
Wilkins. Baltimore.

Compendium of Safety Data Sheets for Research and Industrial Chemicals
Keith LH, Walters DB, eds., VCH Publishers, Inc.,
Deerfield Beach, Florida.

Dangerous Goods Guide to Initial Emergency Response - CANUTEC
Canadian Government Publishing Centre, Supply and
Services Canada, Ottawa.

Dangerous Properties of Industrial Materials
Sax NI, Lewis RJ Sr, eds. Van Nostrand Reinhold.
New York.

Documentation of the Threshold Limit Values and Biological Exposure Indices
American Conference of Governmental Industrial
Hygienists, Cincinnati, OH 45240.

Ethel Browning's Toxicity and Metabolism of Industrial Solvents
Snyder R, ed. Elsevier. Amsterdam.

Handbook of Reactive Chemical Hazards
Bretherick L, Butterworths. London.

Laboratory Hazard Data Sheets
The Royal Society of Chemistry, Milton Rd.,
Cambridge. UK

Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals, The
Merck and Company, Inc., Rahway NJ.

National Institute for Occupational Safety and Health (NIOSH)
Robert A. Taft Laboratories, 4676 Columbia Parkway,
Cincinnati. OH 45226.
Criteria Documents:
Occupational Health Guidelines for Chemical
Hazards (NIOSH/OSHA)
Pocket Guide to Chemical Hazards
Registry of Toxic Effects of Chemical
Substances (RTECS)

Patty's Industrial Hygiene and Toxicology
Clayton GD, Clayton FE, eds. Wiley-Interscience
Publication; John Wiley and Sons, Inc., New York.

Sigma-Aldrich Library of Chemical Safety Data, The
Lenga RE, ed. Sigma-Aldrich Corporation;
Library of Congress Catalogue No. 87-63501;
ISBN 0-941633-16-0.

Toxicological Index (Répertoire Toxicologique)
P.O. Box 1056, Postal Station Desjardins,
Montreal, Quebec, H5B 1C2;
tel: 514-873-6374 - (MSDSs and
Toxicological Information); fax: (514)864-2912.

Toxicology of the Eye
Grant, W.M., Charles, C., Thomas Publishers,
Springfield, Illinois.

Workplace Environmental Exposure Level Guides
American Industrial Hygiene Association;
Fairfax, VA 22031.

BIBLIOGRAPHIC DATA BASES:

Canadian Centre for Occupational Health and Safety, Hamilton, Ontario, tel: 1-800-263-8276:

  • CCINFOdisc:
    • MSDSs:
      • MSDS
      • CHEMINFO
    • CHEM Source:
      • Transport of Dangerous Goods (TDG)/Hazardous Materials (49 CFR)
      • CESARS (Chemical Evaluation Search and Retrieval System)
      • New Jersey Hazardous Substances Fact Sheets
    • OSH InterData: • CISILO
    • NIOSHTIC
    • RTECS

Micromedex Inc., Denver, Colorado:

  • TOMES PLUS:
    • CHRIS (Chemical Hazard Response Information System)
    • DOT Emergency Response Guide
    • HSDB (Hazardous Substances Data Base)
    • IRIS (Integrated Risk Information System)
    • New Jersey Hazardous Substances Fact Sheets
    • NIOSH Pocket Guide
    • OHM/TADS (Oil & Hazardous Materials/ Technical Assistance Data Systems)
    • RTECS
    • Other


National Library of Medicine, MEDLARS Management Section, Bethesda, MD 20209:

  • TOXLINE
  • TOXLIT
  • CANCERLIT
  • MEDLINE
  • TOXNET which includes HSDB and CCRIS (Chemical Carcinogenesis Research Information System)

Occupational Health Services, Secaucus NJ 07094:

  • MSDS
  • HAZARDLINE

Scientific, Technical & Numerical (STN) International; Licensed by the Chemical Abstract Services, Columbus, Ohio; 614-447-3731:

  • HSDB
  • MSDS-OHS
  • RTECS
  • CCINFO

MISCELLANEOUS REFERENCES1:

Agency for Toxic Substances and Disease Registry (ATSDR); U.S. Department of Health and Human Services; U.S. Public Health Service; Division of Toxicology; Atlanta GA 30333; (404)452-4113.

European Chemical Industry, Ecology and Toxicology Centre (ECETOC); Joint Assessment of Commodity Chemicals; Brussels, Belgium.

Hazard Evaluation System and Information Service Fact Sheets; State of California; Department of Health Services and Department of Industrial Relations; Berkeley, CA.

IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man; International Agency for Research on Cancer; World Health Organization; Geneva.

International Chemical Safety Cards. International Programme on Chemical Safety; (UNEP/ILO/WHO); Commission of the European Communities; Luxembourg; 1991; ISBN 92-826-2012-3.

National Research Council Canada; Associate Committee on Scientific Criteria for Environmental Quality; Publications, NRCC/CNRC, Ottawa.

National Safety Council Data Sheets; Technical Publications of the Chemical Section, Industrial Division; Chicago, Illinois.

National Toxicological Program (NTP) Annual Report on Carcinogens and Summary of the Annual Report on Carcinogens. National Technical Information Service (NTIS), Springfield, VA 22161; (703)487-4650.

Occupational Safety and Health Data Sheets; Canada Safety Council; Ottawa.

1 A comprehensive compendium of toxicological source material, bibliography and computerized information sources can be found in: Information Resources in Toxicology by Philip Wexler; Elsevier; New York.

Sections 7 and 8 - Requirements - Containers

Leakage test

7. A container of a liquid chemical product must pass the leakage test described in Schedule 3 or an equivalent test.

Single-use containers

8. A single-use container must display, in the manner set out in sections 17 to 20, subsections 24(1) and (3) and sections 25 and 26, the following primary hazard statement:

"USE ENTIRE CONTENTS ON OPENING."

"UTILISER LA TOTALITÉ DU CONTENU APRÈS OUVERTURE."

Discussion of CCCR, 2001 Sections 7 and 8

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, single-use container.

Leakage:

A container of a liquid chemical product should not leak when sold or when used for the number of openings and closings normally required for the container's size and contents. Although some products require containers that are designed to release vapours in order to avoid the build-up of internal pressures within the container, the liquid product must not be able to leak-out.

The leakage test is done on the product as it would be filled at the time of sale to the user. The use of a placebo is not a satisfactory substitute for the actual chemical product.

Empty Containers:

The leakage requirement also applies to empty containers that are destined to store and dispense a chemical product. The empty container must be filled with the product and tested in the same manner as a container that is full at the time of sale.

Single-use Containers:

Single-use containers are intended to be opened only once and not be re-closeable. The entire contents would be used in a single application. As a result, single-use containers are exempt from being tested for leakage after opening. The prescribed primary hazard statement is to highlight to consumers to not store the product in the container once opened, to avoid potential unintentional exposure.

Section 9 - Requirements - Child-resistant Containers - Design

Applicable standard

9. A child-resistant container must

  • (a) be constructed so that it can be opened only by operating, puncturing or removing one of its functional and necessary parts using a tool that is not supplied with the container; or
  • (b) meet the child test protocol requirements of one of CSA-Z76.1, ISO 8317 or 16 CFR 1700.20 or a standard that is at least equivalent.

Discussion of CCCR, 2001 Section 9

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, CSA-Z76.1, ISO 8317, 16 CFR 1700.20.

Requirements:

In Canada, requirements for child-resistant packaging for chemical products began in 1973, when the Hazardous Products (Hazardous Substances) Regulations (re-named the Consumer Chemicals and Containers Regulations in 1988) made under the HPA were amended to introduce such packaging for certain corrosive drain cleaners and liquid wood furniture polishes and cleaners. Over the years, the legislation was amended to expand the use of child-resistant packaging to cyanoacrylate adhesives, turpentine, pine oil, methyl alcohol, petroleum distillates and certain other products containing sodium peroxide.

The CCCR, 2001 prescribe the use of child-resistant packaging in Parts 1 to 5. In general, child-resistant packaging is required for the following sub-categories: "toxic", "very corrosive", "corrosive" and "quick skin-bonding adhesives".

Use of a Tool:

New ⇒ Within the context of a child-resistant requirement, paragraph 9(a) recognizes that containers which require a tool to open, such as typical paint cans (cylindrical and metallic) or soup-type cans, are considered to be child-resistant by design. However, the tool must not be supplied with the container, such as in a kit for certain tube-type products, where a pin or cap with a puncture point is included at the time of sale.

Some containers, although not intentionally designed to be child-resistant, will possess child-resistant properties inherent in their design. For example, the metallic containers for "Sterno Cooking Fuel" and "Record Chemical Jellied Cooking Fuel" have been examined in the past by Health Canada, Consumer Product Safety Bureau, and are considered to be child-resistant. Other examples include pouches made from materials that are tear-resistant such as "TYVEK ®". In order to gain access to the contents of these pouches, when they are properly sealed on each side, a child would need to use a pointed or sharp object of some sort or a pair of scissors (ie. a tool).

A violation occurs if, at any time, a child (under five years of age) is likely to gain access to the contents of the container without using a tool. In order to determine if a container meets the requirement of paragraph 9(a) the inspector must exercise a level of common sense. If the container is likely to be opened using a level of force that can reasonably be expected from a five-year old child, then it would not be considered child-resistant. In child resistant test protocols such as the CFR 1700.20 children are suggested to use their teeth. Thus, using one's teeth does not constitute using a tool. Teeth use by a 5 years old child should therefore be considered in the evaluation of a child-resistant container. The onus is on the person responsible to make sure their container cannot be opened without a tool by children. Obviously, if even an average adult cannot open the container without using a tool, it will be considered as child-resistant but this is well beyond what is required since it is a child-resistant requirement.

Child-test Protocols:

In Paragraph 9(b), a container's design is considered to be child-resistant where there exist results that show that the package meets one of the referenced test protocols using children. In general, these standards require that packages be difficult for children under five years of age to open and obtain a toxic amount within a reasonable time. It would be impossible to manufacture a package or a closure that would prevent every single child from getting into the contents under all possible circumstances. Most child-test protocols require that at least 80% of those children being tested be prevented from opening the container during a 10-minute test. This requirement means that some children may still be able to open a container, if given enough time to do so.

At present, there are no universal mechanical tests to assess whether a package is child-resistant. Children investigate several different ways of opening a container. For example, if their fingers won't work, their teeth might. Using a child-test protocol allows manufactures to design packages that meet the safety requirement without limiting technical innovation. However, once a container design has passed a child-test protocol, mechanical testing can be used to verify continued product compliance to the specifications established as effective.

Three standards are indicated in order to harmonize the requirements to the most commonly used and accepted international child-resistant container standards. Compliance with any of these standards or an equivalent test is acceptable. This allows for international harmonization. A child-resistant container that met Schedule 1 of the previous CCCR may not require re-testing to the CCCR, 2001 standards if it can be proven that the old test is equivalent to the currently listed standards. Manufacturers should use the two-year transition period to confirm that their products meet the referenced standards or an equivalent standard. No "grand-fathering" provision has been included.

Certification of child-resistant containers by the Canadian Standards Association (CSA), or any other certification body, is not required under the CCCR, 2001. A container design is acceptable so long as it meets the child-test protocol requirements.

New ⇒ There is no exact date for the expiration of a CRC certification. Generally, companies have the tests done every 10 years or so but is not required by law. However, if a company changes their CRC container in any way then it must be re-certified since the container is not exactly the same as the one originally tested according to one of the above three standards (ISO, CSA, and CFR).

Seniors and Child-resistant Packaging:

Many adults, especially seniors, have difficulty opening child-resistant packaging. Children are at risk of being poisoned if adults do not use the packaging properly, for example, by not properly re-securing the closure after use. However, there are no exceptions for allowing non-child-resistant packaging on chemical products for seniors or for people living without small children. Unlike medication, where an inability to gain immediate access may have serious life-threatening consequences, the inability to gain quick access to chemical products is of lesser concern. Moreover, chemical products do not generally have to be opened daily or many times a day. Representatives of various senior's groups have indicated to Health Canada that a senior would tolerate the frustration of removing a child-resistant closure on a chemical product if it were labelled: "DANGER: Harmful or Fatal If Swallowed".

In view of the above considerations, no recommendation was made for the addition of a senior test group to the CCCR, 2001. The CSA-Z76.1, ISO 8317 and 16 CFR 1700.20 all require testing with seniors as well as a child-test protocol for medications, and some countries also prescribe the use of this type of protocol for certain chemical products. However, the wording in Paragraph 9(b) makes it clear that only the child test is required for compliance in Canada.

Section 10 - Requirements - Child-resistant Containers - Performance

Maintain characteristics

10. (1) A child-resistant container must, when in contact with a chemical product, maintain its child-resistant characteristics throughout the useful life of the product.

Evaluation

(2) The person responsible, using good scientific practices, must evaluate

  • (a) the compatibility of the chemical product with its child-resistant container, to determine that the chemical or physical properties of the product will not compromise or interfere with the proper functioning of the container; and
  • (b) the physical wear and stress factors and the force required for opening and closing the container, to determine that the proper functioning of the container will be maintained for the number of openings and closings reasonably foreseeable for the size and contents of the container.

Discussion of CCCR, 2001 Section 10

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, good scientific practices,
person responsible.

Requirements:

Section 10 requires that a child-resistant container restrict access to the contents by young children for as long as the container holds the chemical product. The term "throughout the useful life of a product" means that the child-resistant container of a chemical product should continue to function as it was designed during shipping, during storage on the retail shelf prior to sale as well as after it is sold, for the number of openings and closings normally required for the container's size and contents. There is no time limit specified.

A Canadian retail survey in 1992 of more than 4500 containers, representing 140 different types of products fitted with 17 different types of child-resistant closures, revealed that 10% of child-resistant containers available for sale were not functioning properly. Commonly cited problems included: caps that were not screwed on all the way, two-piece caps that would jam due to improper stacking during storage and poor quality control, where the container was out of specification with the measurements supplied by the manufacturer.

In 1981, a specific case involved the Rieke Ring-Guard closure (lift outer ring and turn off) when used to package petroleum distillate-based products. Large numbers of these containers were found to be non-functional at retail. Accelerated exposure tests by the Product Safety Laboratory of the Government of Canada showed that the solvent caused the cap's inner ring to swell and engage the outer ring, allowing the cap to simply be unscrewed. Thousands of products were recalled and fitted with new caps. This closure is occasionally used on containers of petroleum distillates, but the manufacturer requires the use of a liner.

Evaluation:

This requirement does not entail the re-testing of filled containers according to a child-test protocol, due to the potential for exposure to harmful chemicals. Simple mechanical tests are available to verify the continued functioning of filled child-resistant containers, once the design prototype is deemed to be child-resistant according to a child-test protocol.

The standards listed in paragraph 9(b) prescribe mechanical "life tests" to assess whether the container is capable of maintaining its security for the number of uses corresponding to the normal depletion of the product. The limitation of these standards is that they are performed on empty container prototypes or with a placebo. This may be acceptable for assessing child-resistant containers that are intended to dispense pills, but may not adequately assess the effect of incompatibility of a chemical product with the container. Nevertheless, these tests may be useful in evaluating the container when they are performed on filled containers.

Other mechanical tests come from the American Society for Testing and Materials (ASTM) and the British Standards Institute (BSI). ASTM standard test methods for continuous thread and snap caps (listed in the ASTM Standard Classification of Child-Resistant Packages - D3475-88), are all interrelated and demonstrate the effectiveness of the assembly of a child-resistant closure system by determining certain performance elements such as down-force, reverse ratchet, removal torque and shelling forces.

However, standard mechanical tests may not exist for all container designs, due to the vast number of child-resistant containers available, and since different systems have different performance characteristics. Manufacturers, should set limits based on individual products and research. Fillers must be especially vigilant in evaluating a product where the container components and the chemical product come from different sources.

For enforcement purposes, a container is considered to fail this requirement where it can be opened without using the instructed actions, such as a seized cap that can be unscrewed without first pushing down. No failures are tolerated under the CCCR, 2001.

Caulking Guns:

Caulking tubes are considered to be child-resistant containers, since a tool is required to puncture or remove one of its functional and necessary parts -- the tip of the tube where the product is dispensed (s. 9(a)).

With regard to maintaining its child-resistant characteristics throughout the useful life of the product, it is also necessary to put the tube into a caulking gun in order to dispense the contents. The caulking gun becomes the next tool required to operate the container and it is not supplied with the container as long as the tube is not stored in the gun. In many cases the tube will be removed from the caulking gun because it is more easily stored in this manner. Without the caulking gun, the way to access the contents would be to crush the tube (very difficult) or cut into the tube, which is not foreseeable use.

However, if the user leaves the tube in the caulking gun, the contents are readily available by operating the caulking gun. It may be difficult to accept that a five-year-old child could manipulate a caulking gun to access the contents in the usual manner, since the crank is sized for an adult's hands and it requires quite a force to operate. But they might find alternate means, such as pushing the crank onto a hard surface, especially if rewarded with an interesting "worm" coming out of the tip.

In order to meet subsection 10(1) and maintain child-resistant characteristics, appropriate "closing" instructions should be present. For example, the following instructions could be used:

"THIS CONTAINER IS NOT CHILD-RESISTANT ONCE OPENED. STORE TUBE AND CAULKING GUN SEPARATELY"

"UNE FOIS OUVERT, LE CONTENANT N'EST PLUS UN CONTENANT PROTÈGE-ENFANTS. REMISEZ LE TUBE ET LE PISTOLET CALFEUTREUR SÉPARÉMENT."

Section 11 - Requirements - Child-resistant Containers - Label Directions

Directions to open and close

11. (1) Subject to subsection (2), a child-resistant container that meets the requirements of paragraph 9(b) must display directions explaining how to open and, if applicable, to close the container

  • (a) on the closure, using either or both of
  • (b) on the container, located after the positive instructions for the chemical product and set out in a manner that complies with requirements for a positive instruction in sections 17 to 19, subsection 24(1) and sections 25, 29 and 30.

Exception

(2) The directions for opening and, if applicable, closing a child-resistant container may be set out on the closure in only one official language if they are repeated on the container in the other official language in the manner set out in paragraph (1)(b).

Discussion of CCCR, 2001 section 11

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, official language.

Requirements:

Section 11 requires that child-resistant containers provide directions to operate the container. This section applies only to containers that are child-resistant by virtue of meeting a child-test protocol, and not to child-resistant containers that require a tool to open, such as a can opener.

Several complaints of accidents were reported to the Product Safety Program in the past, where people had received bad burns because they did not know how to adequately operate the child-resistant container on a corrosive product. In addition, some child-resistant containers rely on tightly re-closing the cap, or closing until a sound, such as a click is heard, to ensure their proper functioning.

In order to be effective, the directions must be clearly visible to the user. Subsection 11(1) specifies the clarity requirements for the presentation of this information, in sections 17 (legibility and durability), 18 (colour contrast), 19 (print-type), 24(1) (size of print), 25 (placement in relation to other labelling), 29 (location of instructions) and 30 (the border). Directions in the form of diagrams or symbols that are self-explanatory are satisfactory. However, if words are used, the directions must be in both official languages (that is, in English and French).

The directions may appear on the cap or on the label. If the cap is used, the size of print is not specified, but the information must be clear, legible, durable, meet the contrast requirement and, if words are used, be in the appropriate sans serif print-type. Often the directions on the cap are embossed, and do not meet the contrast requirement. In such cases, the directions must be repeated on the label in order to be clearly visible. If the directions appear on the cap in only one official language, English for example, then subsection 11(2) allows for the equivalent information to be repeated in French on the label.

Adhesive over-labels containing the directions are acceptable for compliance purposes so long as they meet the presentation requirements of paragraph 11(1)(b). These over-labels are generally not as effective from a user point of view, and should not be a permanent solution.

Section 12 - Requirements - Child-resistant Containers - Record Keeping

Record keeping

12. (1) The person responsible must keep or cause to be kept, for a period of at least three years after the date of manufacture or importation, the following information:

  • (a) for a container that comes into direct contact with the chemical product, the specifications critical to the child-resistant characteristics of the container, which specifications must include
    • (i) the physical measurements within which the container retains its child-resistant characteristics,
    • (ii) if applicable, the torque that must be applied to open or close the container, and
    • (iii) the compatibility of the container and its closure system with the chemical product that is to be put into it; and
  • (b) the test results that demonstrate that the container and its closure system comply with the requirements of a standard set out in paragraph 9(b).

Provision of information to inspector

(2) Within 15 days after receipt of a request from an inspector, the person responsible for a chemical product that is required by these Regulations to be packaged in a child-resistant container must provide the information referred to in subsection (1) to the inspector.

Discussion of CCCR, 2001 section 12

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, person responsible.

The following terms are defined in the HPA: inspector, import.

Requirements:

To verify that the container and closure system will perform as originally designed, section 12 requires that the specifications critical to the child-resistant characteristics of the container be available for inspection. The examples given in paragraphs 12(1)(a)(i) to (iii) are not exclusive. Any information which contributes to understanding the proper functioning design of the child-resistant container should be kept and ready for inspection upon request by a Product Safety inspector.

These records may be retained by the Canadian manufacturer or the importer located in Canada, or they may be retained by the supplier(s) of the container's components and provided when requested by the inspector. Retailers are not required to keep these records.

The three-year time limit for record keeping permits sufficient time for legal actions to commence before records are destroyed. Subsection 12(2) specifies a time limit of 15 days to provide the requested information. These are calendar days, not working days.

Sections 13 and 14 - Requirements - Child-resistant Containers - Exceptions

Child-resistant, single-use containers

13. A child-resistant, single-use container must display, in the manner set out in sections 17 to 20, subsections 24(1) and (3) and sections 25 and 26, the following primary hazard statement:

"USE ENTIRE CONTENTS ON OPENING. THIS CONTAINER IS NOT CHILD-RESISTANT ONCE OPENED."

"UTILISER LA TOTALITÉ DU CONTENU APRÈS OUVERTURE. UNE FOIS OUVERT, LE CONTENANT N'EST PLUS UN CONTENANT PROTÈGE-ENFANTS."

Exception - large container

14. The requirements for child-resistant containers set out in sections 9 to 13 do not apply to a container with a capacity greater than 5 L, other than the container for a chemical product that is classified in one of the following:

  • (a) the hazard category "Category 4, quick skin-bonding adhesives";
  • (b) the sub-category "very toxic"; or
  • (c) the sub-category "very corrosive"

Discussion of CCCR, 2001 sections 13 and 14

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, hazard category, quick
skin-bonding adhesive, single-use container,
sub-category.

Single-use Containers:

By definition, a single-use container may only be opened once and the contents must be used completely. Thus the container need not maintain child-resistant characteristics once opened. The prescribed primary hazard statements highlight to consumers to not store the product in the container once opened, to avoid potential unintentional exposure. section 13 requires an additional statement to that required by section 8, concerning the child-resistant nature of the package. (See section 8 for further information.)

As with other primary hazard statements, this statement must meet all applicable size and location requirements set out in the sections 17 (legibility and durability), 18 (colour contrast), 19 (print-type), 20 (upper-case letters), 24(1) and (3) (size of print), 25 (placement in relation to other labelling), and 26 (location on the main display panel).

New ⇒ Clarification of Single-Use Quantity

Containers that use the exemption under section 13 must contain a quantity of substance that is reasonably foreseeable to be used in a single use. The definition of a single use container (subsection 1.(1)) indicates that the contents should be used entirely immediately after opening. Therefore as an example, a 10 or 20 ml container of quick skin bonding adhesive would not be allowed to use the section 13 exemption because this quantity obviously corresponds to multiple uses. In order to benefit from this exemption some traders claimed unsuccessfully that the 10 ml or 20 ml was a volume that correspondws to the amount required to do a complete model car or train assembly in one sitting. In this case it is very clear that the content (adhesive) is not used entirely immediately after opening as required but rather over hours. The maximum amount tolerated to allow the use of this exception will actually vary significantly based on the intended use going from a few drops for a quick skin bonding adhesive to few hundred millilitres for a fuel additive.

Large Containers:

section 14 provides an exception for the child-resistant container requirements for certain products packaged in containers greater than 5L in size. These containers must continue to meet the labelling requirements. However, the very hazardous products listed in paragraphs 14(a) to (c) require a child-resistant container regardless of their size.

Children under the age of five are not capable of easily handling and opening large containers due to their small hand size and less developed motor skills. There remains a risk where a large container of a product that has only a small amount remaining in it could be tipped over by a child who opened it, thus exposing the child to a potential hazard. However, chemical products that are packaged in containers greater than 5 L in size tend to be for workplace use; consumer products rarely come in such a large size. If they are, manufacturers usually supply smaller dispensing containers with the larger container for consumer use. Since these dispensing containers are intended to be used with the large-sized product, they must meet the labelling and child-resistant container requirements even if they are sold empty to be filled by the consumer in Canada.

Sections 15 and 16 - Requirements - Required Information - Containers and Packaging

Containers and packaging

15. (1) Subject to section 16, the information required by these Regulations must be displayed in the manner set out in these Regulations

  • (a) on each container that is displayed to the consumer, other than in an advertisement; and
  • (b) on any packaging of a container that is displayed to the consumer, including a display card to which a container may be fixed.

Additional information

(2) Information in addition to that required by these Regulations may be displayed on a container if it does not disclaim or contradict the required information.

Exemption - packaging

16. (1) Packaging is exempt from the requirements of paragraph 15(1)(b) if the packaging

  • (a) is transparent and
    • (i) the required information displayed on the container is legible through the packaging, and
    • (ii) the transparent packaging does not obscure any of the required information on the container; or
  • (b) is not transparent and
    • (i) encloses
      • (A) a container and a product that is not subject to these Regulations, or
      • (B) two or more containers that have different information requirements, and
    • (ii) displays the following signal word and primary hazard statement, or a statement to the same effect, in the manner set out in sections 17 to 20 and 23, subsections 24(1) and (3) and sections 25, 26 and 28:

"CAUTION. CONTAINS PRODUCTS THAT MAY BE HARMFUL. READ WARNINGS ON EACH CONTAINER."

"ATTENTION. CONTIENT DES PRODUITS QUI PEUVENT ÊTRE NOCIFS. LIRE LES MISES EN GARDE SUR CHAQUE CONTENANT."

Exemption - packaging not customarily displayed

(2) Packaging that is not customarily displayed to the consumer, such as a shipping carton, is exempt from the requirements of paragraph 15(1)(b).

Discussion of CCCR, 2001 Sections 15 and 16

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container.

Requirements:

Section 15 ensures that the information required by these Regulations appears on every container displayed to a consumer during purchase, use and storage. This includes immediate containers, outer packaging, such as display cards and empty containers which the user may purchase to dispense and use a regulated product.

Not included are package liners, shipping containers or any outer wrapping or box that is used only during transportation of the product (subsection 16(2)). Legislation governing the labelling of shipping containers and transportation vehicles containing various types of dangerous goods falls under the jurisdiction of the Transportation of Dangerous Goods Act, 1992, administered by Transport Canada.

Display Cards and Blister Cards:

Display cards are cards on which the container of the product is mounted but not enclosed, for example, it is attached by wire, plastic loop or adhesive. Blister cards enclose the container in direct contact with the product, usually in a transparent plastic coating.

Display cards and blister cards are considered to be packaging under paragraph 15(1)(b) and must be labelled accordingly. However, if the required information displayed on the product is visible to the consumer through this packaging, the display card or blister card need not be labelled (paragraph 16(1)(a)).

There are two conditions in 16(1)(a): the information on the container must be legible through the packaging; and the packaging must not obscure any of the required labelling on the container. If the entire container is visible, for example: a transparent pouch that holds the chemical product is suspended from a paper card, then no CCCR, 2001 labelling is needed on the card.

If only the main display panel of the container is visible, for example: the chemical product is positioned on the front of a card, then this information need not be repeated on the front of the card. The person responsible should ensure that the main display panel on the container remains visible during retail stocking. However, the specific hazard statements, negative and positive instructions and the first aid statements that are obscured must be presented on the card -- this information may appear on the back of the card.

Note that if the display card holds a small-sized container, (i.e., the main display panel of the container is less than 35 cm2), then no CCCR, 2001 labelling is needed on the card as long as the container's main display panel is visible. This is due to the limited labelling requirements for small-sized containers (see section 25 of the CCCR, 2001). However, the person responsible is encouraged to provide the specific hazard statements, negative and positive instructions and first aid statement on the back of the card.

The size of the print on display cards and blister cards is based on the main display panel area of the card, not the attached product. However, since the area under the product is unavailable for labelling, this area should be subtracted from the total area of the card when determining the size of the main display panel. The requirements for the placement of the information should be met wherever possible (see sections 25 to 32). For example, sideways printing or display in a corner of the card is not acceptable.

Kits:

A kit is a package containing more than one product. If the packaging is a multipack of one regulated product, that is, it contains more than one container of the same chemical product, and the outer packaging is not transparent, then the outer packaging must disclose all of the required information.

However, if the kit contains another product with the regulated product, then only the warnings of subparagraph 16(1)(b)(ii) need to be displayed on the outer packaging.

The size of print on the packaging is determined from the main display panel area of the outer packaging, not the enclosed regulated product.

Advertising:

According to paragraph 15(1)(a) a product may be displayed in an advertisement without the required information on the container or package. The purpose of the Regulations is to ensure that a consumer has the information at the time of purchase and use. The advertisement of products on television or in print does not allow enough time to view the safety information and therefore may have little impact on a consumer's behaviour when the product is used. However, the container of that product that is offered for sale must fully comply.

Additional Information:

Subsection 15(2) allows for the display of additional information on the container, so long as it does not disclaim or contradict the required information. These Regulations contain minimum requirements. Manufacturers and importers can add, and are encouraged to add, information considered necessary to fully inform the public of the health hazards of using their products. In composing these statements, use short, simple sentences. Complex conditional sentences, particularly those containing negations, should be avoided. In addition, a person will remember the important product related information better, if fewer dimensions or items are listed.

However, manufacturers and importers are to be discouraged from deliberately over-stating the hazards posed by a product. If unwarranted warnings are added to products, it may lead to potentially lengthy and unnecessary or inappropriate treatment upon exposure to the product. Furthermore, such a practice minimizes the perception of risk for those products which actually need the warnings, leading to potential injuries from a lack of concern or precaution by the user.

Use of Pictures

A product that bears a picture of food, such that it creates a false impression the product is a food, is considered to disclaim the information that may be required by these Regulations. For example, a fruit-scented cleaner with a picture depicting fresh fruit in a bowl may create the impression that the product is a fruit juice, especially to someone who cannot read. Products should be examined on a case-by-case basis to ascertain whether this false impression has been created.

Sections 17 to 21 - Requirements - Presentation of Information - Technical Specifications

Languages, legibility and durability

17. The information required by these Regulations to be displayed on a container must be

  • (a) displayed in both official languages; and
  • (b) set out in a manner that is clear and legible and sufficiently durable to remain legible throughout the useful life of the chemical product or, in the case of a refillable container, the useful life of the container, under normal conditions of transportation, storage, sale and use.

Colour contrast

18. The colour contrast between the information and the background must be equivalent to at least a 70% screen of black on white.

Print - general rules

19. (1) If the information is set out in words, they must be printed in a standard sans serif type that

  • (a) is not compressed, expanded or decorative; and
  • (b) as illustrated in Schedule 4, has a large body size or "x-Height" relative to the ascender or descender of the type.

Measurement of height of type

(2) The height of the type referred to in Subsection (1) is determined by measuring an upper-case letter or a lower-case letter that has an ascender or descender, such as "b" or "p".

Print - upper-case letters

20. The following information must be printed

  • (a) in upper-case letters
    • (i) the signal word,
    • (ii) the primary hazard statement, and
    • (iii) the specific hazard statement; and
  • (b) in bold-faced, upper-case letters, the titles "FIRST AID TREATMENT" and "PREMIERS SOINS".

Hazard symbol - reproduction

21. The hazard symbol must be an exact reproduction of the applicable symbol depicted in Schedule 2, except with respect to size and colour.

Discussion of CCCR, 2001 Sections 17 to 21

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, hazard symbol,
official languages.

Requirements:

The technical specifications ensure that the warning information is presented in a clear and consistent manner for all consumer chemical products, so that consumers are able to find the information they need to safely use the product.

Official Languages:

The warnings required by these Regulations must be displayed in both official languages, that is, in English and French. section 26 of the Official Languages Act (1988) (OLA) states:

"Every federal institution that regulates persons or organizations with respect to any of their activities that relate to the health, safety or security of members of the public has the duty to ensure, through its regulation of those persons or organizations, wherever it is reasonable to do so in the circumstances, that members of the public can communicate with and obtain available services from those persons or organizations in relation to those activities in both official languages."

In addition, as a signatory to the World Trade Organization (WTO) Agreement (formerly GATT Agreement) and the North American Free Trade Agreement (NAFTA), Canada has both rights and obligations under the Agreements to Technical Barriers to Trade (TBT Agreements) which are sub-agreements found in both documents. Both the WTO and NAFTA TBT Agreements clearly state that:

"members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be made more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create."

For the purposes of the TBT Agreements, "Legitimate Objectives" are defined as:

"inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information, related processing technology or intended end uses of products."

Thus the requirement for bilingual safety labelling on consumer chemical products is considered to be a legitimate objective.

Legibility:

The hazard warnings must be clear and legible as specified in paragraph 17(b), including the contrast requirement of section 18. The following examples are not considered to be clear and legible:

  • a clear plastic over-label bearing the required information is applied over other graphic matter;
  • the precautionary information is printed in a shade or colour that does not contrast with the background;
  • the information is embossed and in the same colour as the background packaging material;
  • in the case of a transparent container, the required statements are placed on the back of a label located on the front of the container (that is, a person would have to look through the contents of the container to see the information).

Colour:

To allow for flexibility in product design, there is no specification for the colour of the warning information. The extreme variability of background and other colour elements on consumer product labels rules out requirements for specific colours. Readability is ensured with the requirements for print type, format and contrast, rather than colour.

However, label designers should take into consideration that the combination of certain colours is difficult to distinguish for people who are colour-blind. About 8 percent of men and 0.5 percent of women have some form of colour blindness. Although there are several different kinds and degrees of colour vision deficiencies, most colour-blind people (99 percent of them) have trouble distinguishing between red and green.

Durability:

Hazard warnings must remain legible throughout the lifetime of the product, and not fade, run, rub off or peel off under normal use. Print that can be dissolved by the contents, or paper and plastic label sleeves that are easily removable, do not comply. To further ensure durability, paragraph 17(b) specifies that the warning information must be displayed on the container, not the label. The common definition for label includes any mark, sign, device, stamp, seal, sticker, ticket, tag or wrapper. Placing important safety information on a hang-tag or removable wrapper would not be sufficiently durable to provide a user with the necessary information needed at the time of use of the product, especially if the product is intended to be used more than once.

New ⇒ Hang Tags, Accordion Labels and Peel-off Labels

Placing any of the CCCR 2001 mandatory safety information on a hang-tag, accordion label, peel-off label or removable wrapper would not be considered acceptable because it wouldn't meet the durability requirement of the regulations. Using these types of labels is a direct violation of s.15 and s.17 as the information may not always be available either for the life of the product or while it's on the store shelf. Furthermore, in the event where a peel-off label is used, it must never hide any of the information required by the regulations which should be visible at all times including the moment of sale.

Print Type:

Lettering which is ornate, decorative or serif is less legible and is also more prone to degradation during reproduction. This is reflected in ANSI Standards Z35.1-1972, Specifications for Accident Prevention Signs, and Z535.4-1991, Product Safety Signs and Labels, which require sans serif letters.

The term "sans serif" refers to letters which have no short cross-line stemming from the upper and lower ends of the strokes of a letter. Sans serif type is generally even in overall weight with very little contrast between thick and thin strokes. Helvetica, Gothic, Futura, Arial and Univers are examples of sans serif typefaces. Examples of standard sans serif, compressed, expanded and decorative typeface are shown below.

Standard sans serif:

Image of Standard sans serif typeface

Compressed:

Image of Compressed typeface

Expanded:

Image of Expanded typeface

Decorative:

Image of Decorative typeface

In paragraph 19(1)(b), the term "large x-height" is used in graphic design or printing to specify that the body of the letter predominates (see graphic below).

Image specifying the predominance of the body of the letter

Size of type:

Subsection 19(2) ensures a consistent manner of measuring the type-height. When the warning statements are printed in upper-case, the type size is determined by measuring the height of the characters. Measuring a lower case letter that has an ascender or descender is equivalent to measuring an upper-case letter. This approach is more lenient than that taken by Industry Canada for the enforcement of the Consumer Packaging and Labelling Act, where the lower case "o" is used to measure the type height.

Upper-case and Bold-faced print:

"Upper-case" letters means in capital letters:
THIS SENTENCE IS IN UPPER-CASE LETTERS.

"Bold-faced" letters refer to type that is heavier than the normal text type used:
This sentence is in bold-faced letters.

The requirement that the signal word, primary hazard statement and specific hazard definition appear in upper-case letters ensures maximum visibility and prominence. The requirement that the words "FIRST AID TREATMENT" and "PREMIERS SOINS" appear in upper-case and bold-faced letters ensures that they are distinct from the surrounding labelling and can be readily found in an emergency.

Symbol Reproduction:

The four hazard symbols of the CCCR, 2001 depict "poison", "corrosive", "flammable" and "pressurized container". They were registered under the Trade Marks Act on June 10, 1970. (Trade Marks Journal, Vol. 17, No. 815).

Since the correct symbols and warnings are required to prevent unnecessary and inappropriate medical treatment being given to a victim, the authority under the Trade Marks Act may be used as a means of control when the symbols are being used inappropriately. For example, the use of these symbols for the purpose of indicating environmental hazards or disposal of household hazardous waste is inappropriate. The misleading use of the symbols could also be considered to be a violation of section 7 of the Consumer Packaging and Labelling Act or the Competition Act, both of which are administered by Industry Canada.

Sections 22 to 24 - Requirements - Presentation of Information - Technical Specifications - Size of Type

Hazard symbol - minimum diameter

22. The hazard symbol must, when the main display panel has the area set out in column 1 of the table to this section, have a diameter at least as large as that set out in column 2.

Table to Section 22

Minimum Diameter of the Hazard Symbol
Item Column 1

Area of the main display panel
Column 2

Minimum diameter of
the hazard symbol
1. less than 9.5 cm2 6 mm
2. 9.5 cm2 or more but less than 655 cm2 the diameter of an imaginary circle that has an area equal to 3% of the main display panel*
3. 655 cm2 or more 50 mm

* Alternatively, this diameter may be calculated by multiplying the square root of the area in cm2 of the main display panel by 1.95.

Signal word - height

23. The height of the signal word must be at least one quarter of the minimum diameter of a hazard symbol determined in accordance with section 22.

Other information - height and body size

24. (1) Subject to subsection (3), when the main display panel has an area set out in column 1 of the table to this sub-section, the following information must be in type that is at least the height set out in column 2 and at least the body size set out in column 3:

  • (a) the primary hazard statement;
  • (b) the specific hazard statement;
  • (c) the positive and negative instructions; and
  • (d) the titles "FIRST AID TREATMENT" and "PREMIERS SOINS".
Table to Subsection 24(1)

Minimum Height and Body Size of Type
Item

Column 1

Area of the main display panel
Column 2

Minimum height of type
Column 3

Minimum body size of type
1. less than 100 cm2 2 mm 6 point
2. 100 cm2 or more but less than 330 cm2 3 mm 8 point
3. 330 cm2 or more 4 mm 12 point

First aid statement - height and body size

(2) Subject to subsection (3), the first aid statement, except for the titles "FIRST AID TREATMENT" and "PREMIERS SOINS", must be in type that has a minimum height of 2 mm and a minimum body size of 6 points.

Exception - quick skin-bonding adhesive

(3) In the case of a quick skin-bonding adhesive referred to in Part 4, when the main display panel of the container has an area set out in column 1 of the table to this subsection, the primary hazard statement, the titles "FIRST AID TREATMENT" and "PREMIERS SOINS" and the first aid statement must be in type that is at least the height set out in column 2 and at least the body size set out in column 3.

Table to Subsection 24(3)

Minimum Height and Body Size of Type - Quick Skin-bonding Adhesive
Item

Column 1

Area of the main display panel
Column 2

Minimum height of type
Column 3

Minimum body size of type
1. less than 10 cm2 1.5 mm 4.5 point
2. 10 cm2 or more but less than 35 cm2 2 mm 6 point

Discussion of CCCR, 2001 Sections 22 to 24

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, hazard symbol, first aid statement, main
display panel, quick skin-bonding adhesive.

Requirements:

The required symbol and print sizes ensure that the information is legible under regular circumstances. Visual angles of 5 to 37 minutes are the recommended minimum for printed information and symbols. The symbol size of 6 mm (or approximately ¼ inch) in height accords with the upper value in this range for a 61 cm (2-foot) viewing distance. The use of the upper value of the range is deemed reasonable, since the symbols are intended to serve, in part, as a flag and to be obvious at a greater distance than the detailed printed material.

Hazard Symbol Size:

The diameter of the hazard symbol increases with the size of the container, and must be at least as large as that of a circle covering 3% of the area of the main display panel. The minimum permitted height is 6 mm even though a smaller symbol size may be dictated by the area of the main display panel. For containers with a main display panel of 655 cm2 or more, the symbol need not be larger than 50 mm. In all cases, a larger symbol is permitted.

The calculation at the bottom of the table to section 22 shows how to determine the minimum diameter of the hazard symbol based on the area of the main display panel (1.95 × √area (cm2)). As an example, a product with a main display panel of 225 cm2 needs a symbol that is 29 mm high (that is, 1.95 × √225). The formula provides the diameter of the hazard symbol in "mm", since it incorporates the conversion from "cm" to "mm".

New ⇒ Size of Explosive Triangular Hazard Symbol

The hazard symbol for 'Explosive' is enclosed in an isosceles triangle and as such, there is a different procedure for determining its diameter to comply with the requirements of section 22. The diameter of this hazard symbol can be determined by first taking a point halfway along the top side of the triangle. A line is then drawn to the apex of the opposite corner of the triangle and the length of this line is noted. Finally, multiply the length of this line by a ratio of 1:1.1369 to determine the diameter of the triangle.

An example calculation is shown below:

Geometric expression

Imagine the triangle in the center is the outline of the 'Explosive' hazard symbol. A point 'X' is taken half-way along the top side of the triangle. A line is drawn (XY) to the apex of the opposite corner 'Y'. The length of XY is multiplied by the ratio 1:1.1369 and the resultant of this multiplication is the diameter of that hazard symbol.

Type Size:

The "point" is a printing unit of measurement and is used to designate type sizes. There are 72 points to an inch. In metric units, a "point" measures approximately 0.350 mm. The CCCR, 2001 use both "point" and "mm". For example, if a graphic designer is given instructions to use 8 point sans serif type, that designer has the flexibility to choose any sans serif font at 8 point, so long as it measures 3 mm in height on the label. Note that the type size is determined by measuring the height of an upper-case letter (see subsection 19(2)).

Minimum Size Requirements - All Products Except Quick Skin-Bonding Adhesives

Area of Main Display Panel
(cm2)
Hazard Symbol
(mm)
Signal Word
(mm)
Hazard Statements, Instructions and Title
"FIRST AID TREATMENT"
First Aid Statement After Title
≤ 11.1 6 1.5 not required * not required *
11.2 - 14.8 7 1.8 not required not required
14.9 - 19.0 8 2 not required not required
19.1 - 23.7 9 2.3 not required not required
23.8 - 29.0 10 2.5 not required not required
29.1 - 34.9 11 2.8 not required not required
35 11.5 2.9 2 mm 6 point 2 mm 6 point
35.1 - 41.1 12 3 2 mm 6 point 2 mm 6 point
41.2 - 47.9 13 3.3 2 mm 6 point 2 mm 6 point
48.0 - 55.3 14 3.5 2 mm 6 point 2 mm 6 point
55.4 - 63.2 15 3.8 2 mm 6 point 2 mm 6 point
63.3 - 71.6 16 4 2 mm 6 point 2 mm 6 point
71.7 - 80.5 17 4.3 2 mm 6 point 2 mm 6 point
80.6 - 90.0 18 4.5 2 mm 6 point 2 mm 6 point
90.1 - < 100 19 4.8 2 mm 6 point 2 mm 6 point
100 19.5 4.9 3 mm 8 point 2 mm 6 point
101 - 110 20 5 3 mm 8 point 2 mm 6 point
111 - 122 21 5.3 3 mm 8 point 2 mm 6 point
123 - 133 22 5.5 3 mm 8 point 2 mm 6 point
134 - 145 23 5.8 3 mm 8 point 2 mm 6 point
146 - 158 24 6 3 mm 8 point 2 mm 6 point
159 - 171 25 6.3 3 mm 8 point 2 mm 6 point
172 - 185 26 6.5 3 mm 8 point 2 mm 6 point
186 - 199 27 6.8 3 mm 8 point 2 mm 6 point
200 - 214 28 7 3 mm 8 point 2 mm 6 point
215 - 229 29 7.3 3 mm 8 point 2 mm 6 point
230 - 245 30 7.5 3 mm 8 point 2 mm 6 point
246 - 255 31 7.8 3 mm 8 point 2 mm 6 point
256 - 261 31 7.8 3 mm 8 point 2 mm 6 point
262 - 278 32 8 3 mm 8 point 2 mm 6 point
279 - 295 33 8.3 3 mm 8 point 2 mm 6 point
296 - 313 34 8.5 3 mm 8 point 2 mm 6 point
314 - < 330 35 8.8 3 mm 8 point 2 mm 6 point
330 35.4 8.9 4 mm 12 point 2 mm 6 point
331 - 350 36 9 4 mm 12 point 2 mm 6 point
351 - 370 37 9.3 4 mm 12 point 2 mm 6 point
371 - 390 38 9.5 4 mm 12 point 2 mm 6 point
391 - 410 39 9.8 4 mm 12 point 2 mm 6 point
411 - 431 40 10 4 mm 12 point 2 mm 6 point
432 - 453 41 10.3 4 mm 12 point 2 mm 6 point
454 - 475 42 10.5 4 mm 12 point 2 mm 6 point
476 - 498 43 10.8 4 mm 12 point 2 mm 6 point
499 - 521 44 11 4 mm 12 point 2 mm 6 point
522 - 544 45 11.3 4 mm 12 point 2 mm 6 point
545 - 569 46 11.5 4 mm 12 point 2 mm 6 point
570 - 593 47 11.8 4 mm 12 point 2 mm 6 point
594 - 619 48 12 4 mm 12 point 2 mm 6 point
620 - 644 49 12.3 4 mm 12 point 2 mm 6 point
645 - 655 50 12.5 4 mm 12 point 2 mm 6 point
≥ 655 50 12.5 4 mm 12 point 2 mm 6 point

* see subsection 25(2) for the small container exemption.

Quick Skin-bonding Adhesives:

Quick skin-bonding adhesives often come in very small packages where it may be difficult to find sufficient space to print the required information in 6 point and 2 mm type. Thus for these adhesives, there is an exemption to be able to use 4.5 point and 1.5 mm type where the main display panel area is less than 10 cm2. Other consumer chemical products of such a small size need only display the symbol and signal word, hence the smaller print type is not applicable (see subsection 25(2) and section 56).

Section 25 - Requirements - Location and Order - General Rule

Location and order

25. (1) The information required by these Regulations must be displayed on the container at the following locations and in the following order:

  • (a) on the main display panel,
    • (i) a hazard symbol,
    • (ii) the signal word "EXTREME DANGER", "DANGER" or "CAUTION", as the case may be, and
    • (iii) the primary hazard statement; and
  • (b) on any part of the display surface,
    • (i) the specific hazard statement,
    • (ii) negative instructions,
    • (iii) positive instructions, and
    • (iv) the first aid statement.

Exemption - small container

(2) Despite subsection (1) and subject to Part 4, if the main display panel of a container has an area of

  • (a) less than 35 cm2, only the hazard symbol and the signal word need be displayed; or
  • (b) 35 cm2 or more but less than 70 cm2 and more than one hazard symbol is required, the required negative and positive instructions, other than the positive instructions referred to in subsection 11(2), may be omitted.

Discussion of CCCR, 2001 Section 25

Definitions:

The following terms are defined in section 1 of the CCCR, 2001
container, display surface, first aid statement,
hazard symbol, main display panel.

Requirements:

The presentation of the labelling information is designed to capture the attention of the user of the consumer chemical product and for the subsequent ease of processing the information in the warnings. The prominent placement of the hazard symbol, signal word and primary hazard statement on the main display panel alerts consumers and significantly increases the incidence of reading the more detailed precautionary labelling. In addition, the hazard symbol provides an indication of danger to those with limited ability to read English or French, including young children. The signal word reinforces the message given by the hazard symbol while indicating the degree of hazard. The primary hazard statement provides a brief description of the main hazard associated with exposure to the product.

Since the space available on the front of the container limits the amount of labelling that can be placed there, the specific hazard statements, positive and negative instructions, and the first aid statement are allowed to be placed on any part of the display surface. This information is permitted on the front of the container, if desired.

The specific hazard statement provides a more detailed description of the hazard and introduces the negative and positive instructions. The division of the instructions into negative and positive ensures that the actions to be avoided are clearly and distinctly presented first. It is vital that the reader be informed of those actions which must not be carried out if harm is to be avoided. The next step is to provide the reader with information on the positive steps to take to avoid harm. The first aid statement is titled in boldface upper-case letters, to be easier to find in case of an emergency. It lists the hazardous ingredients which is important when seeking medical help. Finally, it gives directions for giving immediate first aid to the victim.

Use of Pictographs:

Although the hazard symbol provides an essential attention-grabber, the use of pictographs is not acceptable as a substitute for the required labelling. The hazards to be avoided and the behaviour to be carried out in order to minimize the risks posed by consumer chemical products are, in most cases, too complex to portray in a reasonable number of simple pictographs. Nevertheless, pictographs may be used to supplement the required labelling and are useful as instructions for operating a child-resistant container.

Small Containers:

Subsection 25(2) allows containers with a very small main display panel to be exempt from some requirements. Tags or inserts could be used, but they are often of limited effectiveness as they tend to be discarded by product users and hence are not available for the useful life of the product. However, when a small container of the consumer chemical product is packaged in a larger outer package, the main display panel of the outer package must display all of the required information.

The small container exemptions do not apply to quick skin-bonding adhesives (see Part 4 of the CCCR, 2001). In addition, the instructions for opening and closing a child-resistant container in subsection 11(2) are mandatory for containers with a main display panel larger than 35 cm2.

Sections 26 to 28 - Requirements - Location on Main Display Panel

Location of hazard symbol, signal word and primary hazard statement

26. (1) The information referred to in paragraph 25(1)(a) must be located as follows:

  • (a) below the common name or brand name of the chemical product;
  • (b) centred parallel to and near the base of the main display panel; and
  • (c) subject to subsection (3), immediately below one another.

Base of collapsible tube

(2) For the purpose of paragraph (1)(b), the base of the main display panel of a collapsible tube is the end from which the chemical product is discharged.

Exception - short, wide containers

(3) If the main display panel has a height that is less than 10 cm and a width that is at least twice the height, the signal word may be located immediately beside the hazard symbol instead of below it.

Multiple hazard symbols

27. If more than one hazard symbol is required, the symbols must be grouped immediately beside each other in a row parallel to the base of the container.

Precedence among signal words

28. If these Regulations require that more than one signal word be displayed on a container, only the signal word that discloses the greatest hazard must be displayed on the container.

Discussion of CCCR, 2001 Sections 26 to 28

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:

chemical product, container, hazard symbol, main display panel.

Requirements:

The layout on the main display panel is a vertical format (versus a horizontal format) where each element is located immediately below the other. Canadian consumers have indicated that the vertical format is preferred because:

  • it catches the attention better because it is central on the label;
  • the warning information is easier to see and stands out better;
  • it would be more likely to make people read the safety information; and
  • it would be more likely to make people handle the product more carefully.

Section 26 provides the consumer with a consistent, therefore familiar, location for the safety information: always below the common name of the product. The term "common name" or "brand name" has the same meaning as in the Consumer Packaging and Labelling Act (CPLA) and CPL Regulations. Section 10 of the CPLA and section 30 of the CPL Regulations mention "product identity declaration" which "is a statement of the product's common or generic name, or it may be defined in terms of its function."

New ⇒ If no hazard symbol is required, then the signal word must be located below the common name or brand name of the product and be centred parallel to and near the base of the main display panel. Please note that even if a hazard symbol is required, all of this information should appear below (but not directly) the common name and still be centred parallel to and near the base of the MDP (Main Display Panel). Do not confuse this with placing the information immediately below the common name as this is not always at the centre of the MDP.

Collapsible Tubes:

The optimum positioning of warning labelling on tubes depends upon the shape and length of the tube and how the tube is displayed for sale. However, since tubes are often intended to be rolled-up, the labelling near the compressed end would be hidden as the contents are used-up. Thus the information on the tube must be placed as close as possible to the opening.

Multiple Hazard Symbols:

Where there is more than one hazard symbol, they should be placed in a row parallel to the base of the container and centred on the main display panel. The stacking of symbols in the vertical plane is not acceptable. There is no set order for the hazard symbols to appear. It is recommended that they be placed from left to right in order of decreasing severity of the hazard.

Sections 29 to 32 - Requirements - Location of Other Hazard Information

Location of specific hazard statement, instructions and first aid statement

29. The information referred to in paragraph 25(1)(b) must be

  • (a) left justified; and
  • (b) enclosed within a border that demarcates the information from other information displayed on the display surface.

Border

30. The border referred to in paragraph 29(b)

  • (a) may include a series of dots or hatched lines, a difference in colour or shading of the background or some other graphic device;
  • (b) must be different from the label border described in Schedule III to the Controlled Products Regulations and from any other border on the label; and
  • (c) must comply with paragraph 17(b) and section 18.

First aid statement - order of information

31. The first aid statement must set out the following information in the following order:

  • (a) the title "FIRST AID TREATMENT" and "PREMIERS SOINS";
  • (b) the words "Contains" and "Contient";
  • (c) a list of the hazardous ingredients in the chemical product, in the manner set out in section 32, in descending order of their proportions; and
  • (d) the required statements of first aid treatment.

Hazardous ingredients

32. A hazardous ingredient referred to in paragraph 31(c) must be identified

  • (a) by its chemical identity; or
  • (b) in the case of a complex mixture, by its generic name.

Discussion of CCCR, 2001 Sections 29 to 32

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, complex mixture, display surface,
first aid statement, hazardous ingredient.

Requirements:

The specific hazard statements, instructions and first aid statements may appear on the front, sides, top or back of the container, but not the bottom.

Left Justification:

The term "left justified" means "type set to line up at the left". Left justified text is easier to read. This is particularly true for very short lines, as readers may be confused by the uneven spacing and hyphenation associated with right-justified text. On the other hand, non right-justified text, by virtue of its irregular shape, provides visual cues to the reader, thereby enhancing readability.

Border:

The border enables consumers to distinguish between the safety-related information required by the CCCR, 2001 from the other information on the label. This will ensure that the first aid statement can be readily found during the stressful conditions of an emergency situation, when the reader may not have the time or may be too upset to search for the information.

The border may be a solid line, or a series of dots or dashes. Alternatively, the border may be a difference in colour or shading between the background of the CCCR, 2001 information and the rest of the information on the label. Other graphic devices may also be used, for example, the use of different coloured print for the CCCR, 2001 information may be used, as long as it is well demarcated from the other information displayed on the display surface. However, paragraph 30(b) states that this border "must be different from the label border described in Schedule III of the Controlled Products Regulations and from any other border on the label". This avoids the use of the WHMIS border for precautionary labelling intended for consumers.

Regardless of the form used, the border must meet legibility and durability requirements, including the contrast requirements (see sections 17 and 18).

It is acceptable to place both the English and French information within the a single border, or to have one border for the English information and another border for the French information.

Can information not required by the CCCR, 2001 be placed in the border?

The object of the border is to make the information required by the CCCR, 2001 stand out from the other label information. The presence of other information within the border would defeat this purpose.

Yet subsection 15(2) of the CCCR, 2001 allows for the display of additional information on the container, and manufacturers are encouraged to fully inform the public of the hazards of using their product. In view of this, it is appropriate to allow additional safety-related information within the CCCR, 2001 border.

First Aid Statement:

The first aid statement is titled in boldface upper-case letters, to be easier to find in case of an emergency. It lists the hazardous ingredients which is important when seeking medical help. Finally, it gives directions for administering immediate first aid to the victim.

It is not necessary to include a direct telephone number to the manufacturer. The Poison Control Centres have the ability to provide up-to-date treatment advice which may not always be available to manufacturers. However, manufacturers are strongly encouraged to register their full product formulas with the Poison Control Centres, to provide them with the latest information on the product's formulation and a contact in case of an emergency.

Hazardous Ingredients:

The hazardous ingredients present at 1% or more must be listed in the first aid statement. An ingredient may be identified by its chemical name using the nomenclature system developed by the International Union of Pure and Applied Chemistry (IUPAC), or the Chemical Abstracts Service (CAS) rules of nomenclature, or any name which clearly gives the precise chemical identity. For complex mixtures, such as pine oil, the generic name may be used. The use of trade names, CAS numbers or other codes alone are not acceptable.

The hazardous ingredients must be listed in descending order of proportion. That is, the first listed ingredient is present in the highest amount in the product. Listing ingredients in this way helps health professionals to recommend the proper treatment upon exposure. The use of the words "may contain" and other phrases which leave some ambiguity as to the composition and, consequently, the health hazard of the product, is discouraged.

However, since the exact composition or percentage of ingredients present is not required, there is no "trade secret" exemption from hazardous ingredient disclosure for consumer chemical products.

Sections 33 and 34 - Part 1 - Toxic Products - Classification of Toxic Products

Data sources

33. The person responsible for a toxic product must determine the appropriate sub-category for the product from one or more of the following data sources in the following order of precedence:

  • (a) human experience data pertaining to the toxic product;
  • (b) in the case of a toxic product that contains a substance of special concern, the table to subsection 34(1);
  • c) in the case of a toxic product that poses a risk of exposure through an oral, a dermal or an inhalation route, the LD50 or LC50 or both, as the case may be, of the product as determined in accordance with the applicable table to subsections 34(2) to (4) and the data sources and formulas set out in sections 35 to 37; or
  • (d) in the case of a toxic product that poses an aspiration hazard, the properties set out in subsection 34(5).

Sub-categories - substance of special concern

34. (1) A chemical product that contains a substance of special concern set out in column 1 of the table to this subsection in a concentration set out in column 2 must be classified in the sub-category set out in column 3.

Table to Subsection 34(1) - Sub-categories - Substance of Special Concern
Item

Column 1

Substance of special concern*
Column 2

Concentration
Column 3

Sub-category
1. Carbon tetrachloride any concentration Very Toxic
2. Diethylene glycol 5% or more Harmful
3. Ethyl acetate 5% or more Harmful
4. Ethylene glycol (a) 5% or more but less than 10% Harmful
(b) 10% or more Toxic
5. Hydrocyanic acid or a hydrocyanate salt any concentration Very Toxic
6. Methyl alcohol 1% or more and a total quantity of 5 mL or more Toxic
7. Nitrobenzene 5 mg/kg or more Very Toxic
8. 1,1,2,2-tetrachloroethane any concentration Very Toxic
9. 1,2-dichloroethane (a) 5% or more but less than 10% Harmful
(b) 10% or more Toxic
10. 1,1,1-trichloroethane 5% or more Harmful
*These substances are of special concern because standard animal tests may not reflect the actual hazard posed by these substances to humans.

Sub-categories - oral exposure

(2) A chemical product that poses a risk to a consumer through an oral route and has an LD50 set out in column 1 of the table to this subsection must be classified in the sub-category set out in column 2.

Table to Subsection 34(2) - Sub-categories - Oral Exposure
Item
Column 1

LD50
Column 2

Sub-category
1. not more than 50 mg/kg Very Toxic
2. more than 50 mg/kg but not more than 500 mg/kg Toxic
3. more than 500 mg/kg but not more than 2000 mg/kg Harmful

Sub-categories - dermal exposure

(3) A chemical product that poses a risk to a consumer through a dermal route and has an LD50 set out in column 1 of the table to this subsection must be classified in the sub-category set out in column 2.

Table to Subsection 34(3) - Sub-categories - Dermal Exposure
Item
Column 1

LD50
Column 2

Sub-category
1. not more than 200 mg/kg Very Toxic
2. more than 200 mg/kg but not more than 1000 mg/kg Toxic
3. more than 1000 mg/kg but not more than 2000 mg/kg Harmful

Sub-categories - inhalation exposure

(4) A chemical product that poses a risk to a consumer through inhalation, is in the state set out in column 1 of the table to this subsection and has a 4-hour LC50 set out in column 2 must be classified in the sub-category set out in column 3.

Table to Subsection 34(4) - Sub-categories - Inhalation Exposure
Item

Column 1

State of the chemical product
Column 2

4-hour LC50
Column 3

Sub-category
1. Gas (a) not more than 2500 mg/m3 Very Toxic
(b) more than 2500 mg/m3 but not more than 5000 g/m3 Harmful
2. Vapour (a) not more than 1500 mg/m3 Very Toxic
(b) more than 1500 mg/m3 but not more than 2500 mg/m3 Toxic
(c) more than 2500 mg/m3 but not more than 10 000 mg/m3 Harmful
3. Dust, mist or fume (a) not more than 0.5 mg/L Very Toxic
(b) more than 0.5 mg/L but not more than 2.5 mg/L Toxic
(c) more than 2.5 mg/L but not more than 5.0 mg/L Harmful

Sub-category - aspiration hazard

(5) A chemical product must be classified in the sub-category "toxic" if it has a viscosity of 14 mm2/s or less at 40° and 10% or more of the product is composed of hazardous ingredients that pose an aspiration hazard, including, in particular, any of the following substances:

  • (a) an n-primary alcohol with a composition of at least 3 carbon atoms but not more than 13;
  • (b) an isobutyl alcohol;
  • (c) a terpene alcohol;
  • (d) a ketone with a composition of at least 3 carbon atoms but not more than 13;
  • (e) a hydrocarbon with a composition of at least 3 carbon atoms but not more than 13; or
  • (f) a substance that has been determined to be an aspiration hazard based on its viscosity, surface tension and water solubility through the application of generally accepted standards of good scientific practices.

Discussion of CCCR, 2001 Sections 33 and 34

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
aspiration, chemical product, dust, fume,
good scientific practices, hazardous ingredient,
human experience data, LC50, LD50, mist,
person responsible, sub-category, toxic product,
vapour.

Requirements:

Sections 33 and 34 set out the steps for classifying a product into the toxic product sub-categories: very toxic, toxic and harmful. The criteria describe products that are hazardous because of the immediacy of the harmful effect following exposure and because they can cause death. The distinction between sub-categories is the quantity of the product that is required to produce a harmful or fatal effect. The classification criteria do not include effects that occur over longer-term or repeated exposures, such as cancer, reproductive effects or skin sensitization.

The order of precedence for toxic product classification is:

  1. Human experience data with the chemical product;
  2. The presence of a substance of special concern;
  3. The LD50 and LC50 of the product; and
  4. The presence of a substance that poses an aspiration hazard.

Human experience with a product is the best indicator of its potential hazard, in view of the variability in response to materials between individuals and between species. However, reliable human experience data is not available for most products and substances, especially mixtures, making it necessary to accept animal test data.

If human experience data with the product is not available, the way to classify a product is by following section 34. That is, first examine whether there is a substance of special concern (subsection 34(1)), then assess the LD50 and LC50 of the product for the oral, dermal and inhalation routes of exposure (subsections 34(2) to (4)), then assess the aspiration hazard (subsection 34(5)). Despite the classification resulting from the application of section 34, if reliable data become available demonstrating that a product is more hazardous to a person when it is used under reasonably foreseeable conditions, then such human experience takes precedence and must be used to classify that product.

Route of Exposure:

During product classification, the person responsible must consider all possible routes through which a user could be exposed: oral, dermal, inhalation and aspiration. A product may only be accessible though one route of exposure or it may be accessible through multiple routes. If a chemical product falls into more than one sub-category, the product must be classified according to the most hazardous. However, the container must display the appropriate warnings for each applicable route of exposure. For example, if a product falls within the "toxic" sub-category via the oral route as well as the "harmful" sub-category via inhalation, then the product as a whole is classified as "toxic" (that is, the more severe sub-category), but both the warnings for the oral and inhalation exposures are required (see section 4).

Limited Exposure

The CCCR, 2001 do not apply if a consumer cannot be exposed to the product or any of its hazardous ingredients during reasonably foreseeable use (see subsection 2(2)).

Pens

Pens are included in this exception, if the ink is classified in the "harmful" sub-category, and the ink cartridge has a capacity of 2 grams or less and is constructed in such a way that, under reasonably foreseeable use, the ink will only emerge from the writing tip. This exception would not apply if the ink were classified as "toxic" or "very toxic".

Spray Containers

There is no exception from classifying a toxic product by the oral or aspiration route for spray containers that dispense the chemical product only as a mist.

As little as 10 drops of a product in the toxic sub-category could cause death to a 1-year-old child (15 drops for a 3-year old), for a product at the lower end of the toxic classification (half of the time, applying the criteria for a test animal). At the lower end of the harmful sub-category, only one swallow (5 mL or 1 teaspoon) of a product by a 3-year-old child could cause death, half of the time. Furthermore, as little as 2 or 3 mL of a chemical product that poses an aspiration hazard could prove fatal, if aspirated. Hence, it is necessary to maintain precautionary labelling to minimize the risk posed by toxic chemical products packaged in spray containers.

Human Experience:

Paragraph 33(a) gives preference to classifying a product based on human experience data with the whole product as used by the consumer. Reliable human experience data includes epidemiological data and experience on the effects of chemicals on humans, such as occupational data, information from accident databases and clinical cases with a product. Market history data collected from company toll-free lines, or complaint databases from manufacturers may be useful, however these types of data may be less reliable than actual clinical cases collected from poison control centres or emergency wards in hospitals and clinics. Deliberate testing on humans solely for hazard identification purposes is discouraged for ethical reasons.

In order to make use of market history data, the person responsible must establish a mechanism to obtain complaints or feedback directly from the users of the product. However, once a product's formula is changed, there must be market history data on the new formulation in order to classify the modified product using human experience data.

Professional judgement must be used in making an assessment of what is sufficient data in each case and taking into account animal test results. For example, a single human experience result from exposure to a product may not be sufficient to warrant using that data instead of animal data, because there may be other contributory factors for the result in that particular case.

When human experience data give valid results different from results with animal data, the human experience data take precedence. Human experience data may be used to show that the product meets or does not meet a classification criterion.

Substances of Special Concern:

The list of substances of special concern was developed as an extension of the human experience criterion. Paragraph 33(b) applies to the ingredients in the product and reflects knowledge about human experience with these substances. The substances listed in subsection 34(1) are of special concern because standard animal tests may not reflect the actual hazard posed by these substances to humans. The list of substances permits specific concerns to be identified in the regulations while maintaining parallels to the criteria. This list ensures that the product is classified accurately and that the required labelling reflects the true hazard to the consumer.

The following table provides information on the toxic effect of substances included in the list of substances of special concern:

Toxic effect of substances included in the list of substances of special concern
Substance of Special Concern CCCR, 2001 Classification Toxic Effect
Carbon tetrachloride

Very Toxic

oral inhalation aspiration

Carbon tetrachloride is very toxic and poses a very high inhalation hazard. It very readily forms high vapour concentra-tions at room temperature. It is a central nervous system depressant causing symptoms such as headache, nausea, dizziness, vomiting, drunkenness and uncoordination. It can also cause kidney and liver damage following short-term exposure. Carbon tetrachloride is toxic following ingestion. Ingestion of 14-20 mL or 50-150 mL could be fatal, although 1.5 mL has caused death in a few cases. Based on its viscosity and surface tension, carbon tetrachloride can be aspirated, resulting in a life-threatening accumulation of fluid in the lungs. Severe lung damage, respiratory failure, cardiac arrest and death may result.

1,2-Dichloro-ethane

Harmful
(5 to 10%)

Toxic
(≥ 10%)

oral
inhalation

The acute effect from inhalation of 1,2-dichloroethane is central nervous system depression, producing symptoms such as nausea, vomiting, headache, light-headedness, weakness, stupor, disequilibrium, coma and respiratory arrest. Excess ingestion produces widespread organ damage, especially to the kidney, liver and adrenal gland, as well as gastrointestinal bleeding. Death is usually due to circulatory or respiratory collapse. Death has resulted from the ingestion of 15 mL by a 14 year-old boy. Fatalities in adults have been reported after ingesting of 30 to 70 g.

Diethylene glycol

Harmful
(≥ 5%)

oral

Ingestion of diethylene glycol causes central nervous system depression and damage to the liver and kidneys. This renal effect leads to anuria which may prove fatal within days. The estimated acute oral lethal dose for humans is about 1 mL/kg. However, doses reported as fatal are highly variable, ranging from 5 to 120 mL in children and 20 to 240 mL in adults.

Ethyl acetate

Harmful
(≥ 5%)

oral

Ingested ethyl acetate may cause nausea, vomiting, shortness of breath, headache, drowsiness, dizziness and other signs of central nervous system depression. These effects may be caused in part by ethanol which is released when ethyl acetate is broken down in the body. The estimated lethal dose varies between 0.5 g/kg and 50 g/kg. High vapour concentrations may also cause headache, nausea, dizziness, uncoordination and confusion. One fatal poisoning has been reported as a result of painting the interior of a truck with a lacquer containing 80% ethyl acetate. Congestion of the upper respiratory tract, spleen and kidney and hemorrhaging in the lung tissue were observed.

Ethylene glycol

Harmful
(5 to 10%)

Toxic
(≥ 10%)

oral

Ethylene glycol has a sweet, acrid taste which is alluring to children. When ingested, it is broken down in the body to produce oxalic acid, which can cause nausea, vomiting, abdom-inal pain and weakness, as well as drunkenness, dizziness, stupor, convulsions and coma (symptoms of depression of the central nervous system). Death could result from respiratory arrest or cardiovascular collapse. The mean lethal dose appears to be about 100 mL in adults. Death has been reported from drinking as little as 30 or 60 mL, although, in rare cases, people have survived ingestion of more than 2000 mL. Due to its low vapour pressure, ethylene glycol will not normally release enough vapour at room temperature to pose an inhalation hazard.

Hydrocyanic acid or a hydrocyanate salt

Very Toxic

oral
dermal
inhalation

Cyanide is a potent and rapidly acting chemical asphyxiant, critically affecting the brain and heart. It is rapidly lethal: the inhalation of hydrogen cyanide commonly causes death within minutes and the ingestion of cyanide salts within an hour. Hydrocyanic acid is readily absorbed from the skin and mucous membranes, but the alkali salts are usually toxic only when ingested. The average lethal dose of HCN taken by mouth is believed to lie between 60 and 90 mg. (about one teaspoon of a 2% solution of hydrocyanic acid).

Methyl alcohol

Toxic
(≥ 1% and
≥ 5 mL)

oral
inhalation

Ingestion of methanol causes initial mild inebriation, immediate or delayed (usually 18-24 hours) gastrointestinal symptoms (nausea, abdominal pain and cramps, vomiting), shortness of breath (due to metabolic acidosis), central nervous system effects (headache, dizziness, confusion, lethargy, slurred speech), eye effects (blurred vision, blindness due to optic nerve damage), prolonged coma, and respiratory failure and death due to lethal acidosis. Ingestion of methanol may also cause nec-rosis and hemorrhaging in the brain.
Blindness has reportedly followed ingestion of about 4 mL of absolute methanol whereas 6 to 150 mL may be fatal. Methanol and can very readily form extremely high vapour concentrations at room temperature. It is absorbed readily following inhalation exposure and may cause central nervous system depression (fatigue, decreased concentration, impaired memory). An occupational fatality is recorded in which a female worker was exposed for about 12 hours at high concentrations, calculated to be between 4000 and 13,000 ppm.

Nitrobenzene

Very Toxic
(≥ 5 mg/kg)

oral
dermal
inhalation

Nitrobenzene (oil of mirbane) is an oily yellow liquid with an odour similar to that of oil of bitter almonds. Although nitrobenzene is absorbed by inhalation and ingestion, skin absorption poses the greatest threat of serious intoxication. The general symptoms of nitrobenzene intoxication, however absorbed, are changes in the blood, especially methaemoglobin formation, with cyanosis, headache, shortness of breath, weakness and ultimately coma and death.

1,1,2,2-Tetra-chloroethane

Very Toxic

oral
dermal
inhalation

1,1,2,2-Tetrachloroethane is one of the most toxic of the chlorinated aliphatic hydrocarbons. Ingestion results in symp-toms of central nervous system depression such as dizziness, loss of consciousness and death. Jaundice and other symptoms of severe liver injury have also occurred. A small oral dose, about 5 mL, can cause death. Acute poisoning by absorption of 1,1,2,2-tetrachloroethane through the skin has been reported. Symptoms of dermal exposure are similar to those resulting from inhalation and ingestion. One fatality has been attributed to skin absorption. Inhalation of 1,1,2,2-tetrachloroethane vapour results in nausea, vomiting, weight loss, anemia and liver injury with a sometimes fatal outcome. Damage to the peripheral nervous system is also seen in severe exposures. Many poisoning cases have observed a loss of feeling and tingling in the toes and fingers, pain in the extremities, hand tremors, difficulty walking and muscle weakness in the hands and feet. Severe acute inhalation exposure can cause depression of the central nervous system, including loss of consciousness, pulmonary edema (excessive fluid in the lungs) and kidney damage.

1,1,1-Trichloro-ethane

Harmful
(≥ 5%)

oral
inhalation

Acute oral lethal doses are estimated at 500 to 5000 mg/kg. 1,1,1-Trichloroethane is well absorbed by the lung and produces central nervous system depression until coma or anesthia. Dizziness and light-headedness have been reported at 450 to 900 ppm. Disturbances in equilibrium occur at 1900 ppm with marked uncoordination at 5000 ppm. Higher exposures produce unconsciousness leading to death from respiratory failure or severe cardiac arrhythmia. 1,1,1-trichloroethane is very volatile, and its vapours are five times heavier than air. As a result, concentrations directly above a liquid surface, including solvent soaked rags and spills, may be much higher than elsewhere. Although there are no case reports of aspiration, it has been induced in rats.

Classification of Mixtures

The classification criteria in subsection 34(1) assume that the other ingredients in the product are benign. However, if a product contains ingredients in addition to the substance of special concern that would make the product more hazardous, then the product must be classified into the higher sub-category (see subsection 4(3)). This means that the product will at least be classified according to subsection 34(1) and may be classified into a higher subcategory if other hazardous ingredients are present.

When other hazardous ingredients are present, apply subsections 34(2) to (5) using animal data, compositional information and physical properties, and compare the resulting classification to that in subsection 34(1). The product is then classified according to the greatest hazard. Note, however, that the container must display the required information for each route of exposure (see subsection 4(5)).

The LD50 and LC50 of the Product:

The classification criteria based on the LD50 and LC50 of the product for the oral, dermal and inhalation routes of exposure, are given in the tables to subsections 34(2) to (4). The determination of the LD50 and LC50 values for the whole chemical product can use the data sources listed in section 35, or they can be estimated from the product's ingredients using the additivity formulas in section 36.

New ⇒ Minimum Amount Exemption

As per subsection 40.(1) product that are classified in the sub-category 'Toxic' must be packaged in a child-resistant container. However, if the quantity of toxic product is so low that it may not pose a hazard will it be exempt from this requirement? Yes, if the total amount present in the container or in the layer for separable mixtures is less than 1/20 of the LD50 for a 10 kg child. This is the limit that was used when first drafting the CCCR, 2001 and although this limit is not recognised in legislation, it still can be used when making policy decisions.

Mixtures That Separate

In the case of a mixture that separates, the product must be assigned the LD50 and LC50 of the most toxic layer. A mixture that separates is a liquid or semi-liquid that separates into two or more distinct layers if left standing undisturbed for a period of 30 days at 20°. (See subsections 35(3) and (4)).

Inhalation Toxicity - Gas and Vapour LC50

The units for the LC50 criteria for gases and vapours should be mL/m3, not mg/m3. The toxicity limits that were developed in collaboration with all stakeholders were harmonized with WHMIS and other Canadian and international systems, in order to avoid redundant toxicity evaluations. The recommended limits were expressed in the units of parts per million by volume. In the drafting of the CCCR, 2001, it was intended to express the units in clear and unambiguous terms. However, the units were inadvertently printed as mg/m3 rather than mL/m3. As a result, the values are no longer harmonized with other systems and the criteria numbers are not what was agreed. The CCCR, 2001 will be amended to change all references from mg/m3 to mL/m3 in section 11 and the table to subsection 34(4).

The difference in units is related to the molecular weight of the substance relative to the molar volume of air. This means that higher molecular weight gases and vapours, such as toluene and xylene, would be excluded from classification when they were intended to be captured, whereas those with a lower molecular weight, such as ammonia, would be inappropriately classified into a higher sub-category.

Inhalation Toxicity - Four-hour Conversion

Four-hour exposure periods are specified in subsection 34(4). Since LC50 determinations may be conducted over various periods of time, the formulas in section 37 may be used to extrapolate such data to four-hour exposure periods. These formulas assume a simple linear relationship between times of exposure and concentration in the animal chamber for dusts, mists and fumes, and a square-root function for gases and vapours. Exposure times of longer than 10-hours are not permitted. However, caution should be used to avoid data from exposure times of less than 1-hour because, at this extreme, the conversion may not be as reliable.

Inhalation Toxicity - Saturated Vapour Concentration

The saturated vapour concentration (SVC) is the maximum concentration of the vapour of a liquid or solid that can exist in air at a particular temperature. It is a function of the vapour pressure of the substance. The SVC is important as an indicator of how readily a lethal con-centration could be reached during use or in the event of a spill. For example, a substance with a high SVC relative to the LC50 of a substance may readily exceed the lethal concentration and may be capable of causing death in a short time. On the other hand, a substance with an SVC of the same order of magnitude as the LC50 would probably not reach the lethal concentration.

The vapour toxicity criteria in the CCCR, 2001 do not include the SVC. However, professional judgement may be used to downgrade the classification to a less toxic sub-category for those products whose LC50 is similar to the saturated vapour concentration. (See paragraphs 46(d) and 49(c) of the Controlled Products Regulations as a guide for professional judgement when the SVC is of the same order of magnitude as the LC50.)

Mineral Spirits

Mineral spirits are a complex mixture: a petroleum distillate, generally characterized as having a minimum flash point of 37.7° and a distillation range of approximately 149 to 205°. Mineral spirits are also known as Stoddard Solvent, white spirits or safety solvent naphtha.

Mineral spirits have a low saturation vapour concentration in relation to the acute effects of inhaling the vapour. To date, an LC50 has not been achieved in animal studies, as long as the following conditions are met: there is an absence of smaller carbon-chain components (C-8 and below), it contains less than 0.5% of benzene and toluene, and it contains a low proportion of 1,2,4-trimethylbenzene.

In view of this, the presence of mineral spirits in a consumer chemical product does not contribute to the inhalation toxicity of that product. That is, when calculating the LC50 of the product using the formula in subsection 36(1), the term for mineral spirits should be disregarded much as one would do the inhalation toxicity of water.

However, if other substances are present that do contribute to the inhalation toxicity of the product, such as 1,2,4-trimethylbenzene, then the product must be classified using the reported toxicological data for those substances.

Aspiration Hazard:

The term "aspiration" means the entry of a liquid or solid into the lungs either directly through the mouth or nose or indirectly through vomiting. Once aspirated, small amounts of certain substances can significantly injure the lung. Thus, aspiration toxicity occurs when the aspiration of a substance results in severe acute effects, such as chemical pneumonia, other pulmonary injury or death.

There are two conditions that must be met in order to classify a product as toxic by aspiration: the product must have a viscosity of 14 mm2/s or less at 40° and it must be composed of at least 10% of ingredients that pose an aspiration hazard.

Four principal families of chemicals have been shown to pose aspiration toxicity: ketones, hydrocarbons (including petroleum distillates and turpentine), primary alcohols and carbon tetrachloride. There is human evidence mainly for petroleum products, turpentine, pine oil (a natural mixture of terpene alcohols and hydrocarbons) and carbon tetrachloride. Both animal and human data show that the effective oral LD50 of these liquids, when aspirated, is below 500 mg/kg.

Low viscosity and low surface tension favour the flow and spread, respectively, of a liquid through the lower parts of the respiratory tract. But the single most important physical property is the viscosity of the product. Water solubility and surface tension seem to be modifying factors. For example, a hydrocarbon-containing product with a viscosity below 14 mm2/sec at 40° is considered to be highly toxic by aspiration. Whereas viscous materials such as paints and glues may contain high hydrocarbon concentrations but do not represent a very great aspiration hazard, since the materials are not readily atomized and, therefore, not easily aspirated.

However, viscosity alone is not a sufficient condition for a product to pose an aspiration hazard. Water has a low viscosity (1 mm2/s) and can produce low-viscosity solutions or emulsions of many organic compounds by dilution. Many common organic compounds have viscosities below 10 mm2/s, but have not demonstrated aspiration toxicity.

The viscosity is expressed in kinematic units. Kinematic viscosity is the ratio of absolute viscosity to density. No test method to determine the viscosity is specified; any test method which conforms to the requirements of good scientific practices may be used. Note that one centistoke equals one mm2/s. At 40°, 14 mm2/s is equivalent to 73.4 Saybolt Seconds (SUS).

Isopropyl Alcohol

Isopropyl alcohol is not specifically named in paragraphs 34(5)(a) to (e), the list of substances that are toxic by aspiration. However, isopropyl alcohol is included in the classification criteria in paragraph 34(5)(f) because it is considered to be toxic by aspiration at 100% concentration.

Isopropanol has a viscosity of 2.3 mm2/s and a surface tension of 21.7 dynes/cm. A paper by Gerarde and Ahlstrom ("The Aspiration Hazard and Toxicity of a Homologous Series of Alcohols," Arch Environ Health, v 13, October 1966) presented the following animal test results: 6 out of 10 rats died as a result of aspiration of 100% isopropanol; 1 out of 10 rats died from this cause at 85% and at 70% concentration. There have been no documented reports of aspiration in humans from this substance.

Thus, 100% isopropanol is considered to pose a high risk for aspiration toxicity, but 85% and 70% isopropanol have a low propensity to be toxic by aspiration. Rubbing alcohol (70% isopropyl alcohol) has been used in the home for many years without indication from poison control centres that it poses an aspiration hazard. However, between 85% and 100% concentration, the aspiration hazard is unclear. Professional judgement according to good scientific practices must be used to assess products in this range.

Turpentine and Pine Oil

Turpentine is an oleoresin, a derivative of the Pinus tree species, manufactured by the steam distillation of their resins. The chief ingredient of turpentine is ∝-pinene, but it also contains terpenes, dipentene and sylvestrene. Turpentine is captured in the aspiration hazard criteria under paragraph 34(5)(e): "a hydrocarbon with a composition of at least 3 carbon atoms but not more than 13".

Pine oil is extracted from the same pine wood as turpentine, as the less volatile fraction. It consists mainly of ∝-turpineol plus turpene hydrocarbons, borneol and terpene ethers. Pine oil is considered to pose an aspiration hazard, as turpene alcohol is included in paragraph 34(5)(c), and terpene hydrocarbons in paragraph 34(5)(e).

Mixtures That Separate

In the case of a mixture that separates, it is recommended that the aspiration toxicity of each layer be assessed according to the criteria of subsection 34(5). The toxic product should be assigned the classification of the most toxic layer.

Harmonization With the Controlled Products Regulations (WHMIS):

The CCCR, 2001 classification criteria for toxic products in subsections 34(2) to (4) are harmonized with those for workplace chemicals under the requirements of WHMIS for acute toxicity. The "very toxic" sub-category is equivalent to WHMIS D1A (class D, division 1, subdivision A), and the "toxic" sub-category is equivalent to WHMIS D1B (class D, division 1, subdivision B). However, since children and other vulnerable people may be exposed to consumer chemical products, but not likely exposed to workplace chemicals, the CCCR, 2001 have a third sub-category for "harmful", which is not included in WHMIS. Note also that the WHMIS criteria do not classify based on the aspiration hazard (subsection 34(5)) or the substances of special concern (subsection 34(1)).

However, the CCCR, 2001 do not include criteria for chronic toxic effects that would develop over time, following a single exposure to a substance, or from the prolonged or repeated exposure to a substance. Hence there is no equivalent CCCR, 2001 classification for toxic products in class D division 2 of WHMIS. (Note, see section 42 regarding the harmonization of WHMIS D2B concerning irritants.)

New ⇒ MEKP (Methyl ethyl ketone peroxide) Curing Agents:

MEKP is a highly reactive, colourless liquid organic oxidizer, with a pungent burning odour. It is strongly irritating to the nose, throat and lungs and upon exposure to skin can cause defatting leading to dermatitis. Inhalation studies in the past had shown that this chemical would be classified in the sub-category "very toxic" according to the criteria set out within subsection 34(4), thus prohibiting its use in consumer chemical products. However, a toxicological review showed that the more likely hazard was not from inhalation but rather ingestion exposure. This review of more recent exposure data concluded that MEKP would more accurately be classified in the sub-category "toxic" for ingestion (LC50 and LD50 values). The substance would also be classified in the sub-category "corrosive" for ingestion and ocular exposure (based on the percentage on MEKP in the product (greater than 5%) and its ability to cause necrosis of epithelial tissue and eyes.

It should be noted that as a result of this review, additional requirements, such as child-resistant containers, would now be required in addition to the required labelling.

Sections 35 to 37 - Part 1 - Toxic Products - Determination of Toxicity

Data sources

35. (1) The person responsible for a toxic product must determine, from one or more of the following data sources in the following order of precedence, its toxicity or, in the case of a mixture that separates, the toxicity of each layer of the mixture:

  • (a) the LD50 or LC50 or both, as the case may be, of the product or of the layer as determined by the peer-reviewed results of acute toxicity tests using the product on animals, which tests were conducted in accordance with the OECD Test Guidelines for acute toxicity testing;
  • (b) if tests on animals using the product have not been conducted in accordance with the OECD Test Guidelines for acute toxicity testing, the LD50 or LC50 or both, as the case may be, of the product or of the layer as determined by
    • (i) peer-reviewed results of acute toxicity tests of the product or the layer, which tests were conducted on animals in accordance with
      • (A) a National standard or an international standard recognized by the Standards Council of Canada, or
      • (B) a generally accepted procedure that conformed with good scientific practices at the time the tests were conducted,
    • (ii) if the product is a mixture, other than a mixture that separates, section 36,
    • (iii) peer-reviewed results of tests of a chemical product or a substance that has similar properties to those of the product or of the layer under examination, which tests were conducted on animals in accordance with
      • (A) OECD Test Guidelines for acute toxicity testing,
      • (B) a National standard or an international standard recognized by the Standards Council of Canada, or
      • (C) a generally accepted procedure that conformed with good scientific practices at the time the tests were conducted, or
    • (iv) other current, peer-reviewed information about the product or the layer; or
  • (c) the LD50 or LC50 or both, as the case may be, of the product or of the layer as determined by the results of tests conducted with the toxic product by the person responsible in accordance with a test methodology that conforms with good scientific practices.

Differing data sources

(2) In the case of differing data sources,

  • a) an original literature source must be used in preference to a literature source that refers to the original study; and
  • (b) a source that reports test results that conform with good scientific practices and that disclose the greatest hazard must be used.

Mixture that separates

(3) In the case of a mixture that separates, the toxic product must be assigned the LD50 or LC50 or both, as the case may be, of the most toxic layer.

Definition of "mixture that separates"

(4) In this section, "mixture that separates" means a chemical product in a liquid or semiliquid state that separates into two or more distinct layers if left standing undisturbed for a period of 30 days at 20°C.

Additivity formulas - LD50 or LC50 of mixtures

36. (1) The LD50 or LC50 of a mixture may be determined from the LD50 or LC50 of its ingredients that are present in a concentration of 1% or more, using one of the following additivity formulas, as the case may be:

  • (a) for a solid or a liquid

    Additivity formula for a solid or a liquid

    where
    LD50 represents the LD50 of the mixture,
    LD50a to LD50n represent the LD50 of each ingredient that is present in a concentration of 1% or more, and
    Pa to Pn represent the proportion by weight of each ingredient that is present in a concentration of 1% or more; or

  • (b) for a gas, vapour, dust, mist or fume

    Additivity formula for a gas, vapour, dust, mist or fume

    where
    LC50 represents the LC50 of the mixture,
    LC50a to LC50n represent the LC50 of each ingredient that is present in a concentration of 1% or more, and
    Pa to Pn represent the proportion by weight of each ingredient that is present in a concentration of 1% or more.

Complex mixture

(2) For the purposes of the additivity formulas set out in subsection (1), "ingredient" includes a complex mixture.

When LD50 or LC50 of ingredient is not known but can be estimated

(3) When the LD50 or LC50 of one or more ingredients present in a chemical product in a concentration of 1% or more is not known, the person responsible may, in the additivity formulas set out in subsection (1), use an estimated LD50 or LC50 determined in accordance with good scientific practices.

When LD50 or LC50 of ingredient is not known and cannot be estimated

(4) When the LD50 or LC50 of one or more ingredients present in a chemical product is not known and cannot be estimated from information referred to in Paragraph 35(1)(b) or (c), the person responsible, in the additivity formulas set out in subsection (1), must substitute for the LD50 or LC50 of the ingredient, the LD50 or LC50 of the most toxic known ingredient that is present in the product at a concentration of 1% or more.

Conversion to a 4-hour LC50

37. An LC50 obtained during a duration of exposure of other than four hours must be converted to an LC50 equivalent to a duration of exposure of four hours by using one of the following formulas, as the case may be:

Graphical formula illustrating the conversion of an LC50 value from 'x' hours (where x is between 1 and 10) to a 4 hour value for gases or vapours. The 4-hour value is equal to the LC50 of 'x' duration multiplied by the square root of x hours divided by 4.

  • (a) for a gas or vapour

    Formula for a gas or vapour

    where
    LC50 of 4 hours represents the LC50 of the mixture for a duration of exposure of four hours,
    LC50y represents the LC50 of the mixture for a duration of exposure of y hours, and
    y represents the actual duration of exposure expressed in hours and must be no greater than 10 hours; or

  • (b) for a dust, mist or fume

    Formula for a dust, mist or fume

    where
    LC50 of 4 hours represents the LC50 of the mixture for a duration of exposure of four hours, LC50y represents the LC50 of the mixture for a duration of exposure of y hours, and
    y is the actual duration of exposure expressed in hours and must be no greater than 10 hours.

Discussion of CCCR, 2001 Sections 35 to 37

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, complex mixture, dust, fume,
good scientific practices, LC50, LD50, mist, mixture,
National Standard, OECD Test Guidelines,
person responsible, toxic product, vapour.

Requirements:

Sections 35 to 37 are used in the determination of a product's LD50 and LC50 for the oral, dermal and inhalation routes of exposure (refer to Paragraph 33(c) and subsections 34(2) to (4)). This classification step is performed after examining human experience data with the chemical product and after assessing the presence of substances of special concern.

Section 35 provides the order of precedence of the data required to assess the LD50 and LC50 of the product. If the product is a mixture that separates into layers, then the determination must be done on each layer and the product is classified according to the most hazardous layer. Only acute toxicity test data using the product or layer on animals are acceptable.

Precedence is given to data from an assessment of the whole product or layer by using animal test results from OECD tests for acute toxicity (Paragraph 35(1)(a)).

Paragraph 35(1)(b) sets out the four steps available to assess the data determined using animal test results other than OECD Tests. Sub-Paragraph (i) allows a manufacturer to use toxicity data for the product or layer from animal test results from non-OECD acute toxicity tests. Subparagraph (ii) refers to section 36, the additivity formulas that may be used for mixtures that do not separate. Sub-Paragraph (iii) allows for the bridging of data from a similar product or substance using OECD tests or non-OECD tests. And, sub-Paragraph (iv) would be applicable if no animal tests had been conducted but there was still information on the toxicity.

Paragraph 35(1)(c) gives a person responsible the flexibility to conduct animal tests on their product or layer, if data do not already exist according to paragraphs 35(1)(a) and (b). However, Health Canada does not encourage conducting animal tests for the purposes of classifying a product. There is enough published data on commonly used chemicals, and the precedence for using the additivity formulas in 35(1)(b)(ii) should reduce the need to conduct animal tests unnecessarily.

The term "peer-reviewed" does not mean that a study must be published in a journal or other similar scientific publication; it is more flexible. A peer-reviewed study can be external or internal to an organization, but it must be reviewed by competent and appropriate people. Health Canada's evaluators should be able to come to the same conclusions after reviewing all of the same information as the peer-review team. If there are any discrepancies, then the data are questionable and would not be acceptable for classification purposes.

Animal Testing:

As with Section 6, section 35 does not mean that a manufacturer or importer must conduct animal tests. Rather, if toxicological data on a product's ingredients are already available, or can be estimated using good scientific practices, then this information can be used for classification purposes. The CCCR, 2001 were designed to make the best use of existing toxicological data in order to assess a product's potential hazard. Acute toxicity data in the form of LD50 and LC50 values have been produced for tens of thousands of chemicals and are widely available in handbooks, data banks, and manufacturers' material data safety sheets (MSDS's). This published data has been peer-reviewed, which is a requirement prior to acceptance in most scientific journals and publications. See section 6 for a list of reliable reference sources.

Differing Data Sources:

Discrepancies in reported values for the test data for some substances, especially toxicity data, may arise. The variance is in some cases due to errors rather than differences in actual test results. For example, the originally published value for the LC50 of mineral spirits, a common solvent and thinner, was "much greater than 1400 ppm". This value was later reproduced in many references as being equal to 1400 ppm, resulting in a different classification of a product containing this substance. Subsection 35(2) ensures that disputes over the classification of a product may be settled by reference to a single source, subject to professional review.

Mixtures That Separate:

Components of consumer chemical products may separate out over time, especially in the case of emulsions of petroleum distillates. Estimation of the toxicity of the product as a whole in such cases may significantly misrepresent the hazard when the upper layer that separates, or supernatant layer, will be accessible as a distinct mixture or solution and may be so ingested by a child.

Subsections 35(3) and (4) address this concern by specifying a test to determine if a mixture separates into layers during the likely storage conditions in the home. The test procedure assesses if a product separates after standing for 30 days at 20°C. Where the product separates into layers, the toxicity of each layer must be assessed and the product must be assigned the LD50 and LC50 of the most toxic layer. The term supernatant mixture was not used because it implies only the top layer of the separated mixture. If no separation occurs, then the toxicity classification is determined from the entire product.

Subparagraph 35(1)(b)(ii) specifies that the additivity formulas of section 36 apply only to mixtures that do not separate. However, if the precise composition of each layer has been ascertained, the additivity formulas can be used to estimate the LD50 and LC50 of each layer, based on its chemical composition (35(1)(b)(iii) or (iv)).

Untested Mixtures:

Most products are mixtures, formed as the result of the combination of specific ingredients in definite proportions. Since most formulations are not tested for toxicity, their toxicity must be estimated from the ingredients.

The additivity formulas of section 36 assume that the components act by similar mechanisms at the same sites, but toxicokinetic or toxicodynamic interactions are negligible. Substances with similar uses and properties, for example, various petroleum solvents, often have approximately additive toxicity. The available information indicates that the acute toxicity of mixtures of chemicals for consumer products is reasonably well predicted by the additivity formulas.

When the Toxicity of All Ingredients is Known

Subsections 36(1) and (2) are used when the LD50 or LC50 values are known for each ingredient. The cut-off concentration for including an ingredient is 1%. A complex mixture is treated as a single ingredient.

When the Toxicity of an Ingredient is Not Known

Where information about the LD50 or LC50 of an ingredient is limited or not available, subsection 36(3) allows an estimate of the value in accordance with good scientific practices. The additivity formula is then adapted to use the estimated value. Some examples are as follows:

  1. The LD50 or LC50 has been estimated in an alternative test, such as the Fixed Dose Method. The LD50 or LC50 is known to exceed one of the fixed doses. The calculation can be performed as an inequality.

    For example,
    component A (40%) has an LD50 = 300 mg/kg and
    component B (60%) has an LD50 > 2000 mg/kg.

1 = 0.4 + 0.6
LD 50 300 (> 2000)
= 0.00133 + (< 0.0003)
= 0.00133 to 0.00163
LD 50= 613 to 752 mg/kg

  1. The LD50 or LC50 can be estimated by a comparison to similar substances. By professional judgement, it is often possible to estimate that the LD50 or LC50 exceeds a certain value. For example, if the known LC50's of several members of a family of solvents all exceed 6000 mL/m3, then one may judge that an untested member of the family with similar properties has an LC50 exceeding 6000 mL/m3. This value can be used in the formula as in the above example.
  2. The LD50 of a substance is not known, but testing shows that serious non-lethal effects occur. By professional judgement, this dose could be substituted into the formula.
New ⇒ Determination of p-value

In order to properly use the additivity formula set out in s.36(a) and (b), the p-value for each component must be entered correctly into the equation. The p-value is a decimal representation of the percentage of a certain ingredient in the whole final product. For example, if a given ingredient X constituted 60% of the total product, then we would use the number Px = 0.60.

When the Toxicity of an Ingredient is Not Known and Cannot Be Estimated

When the toxicity of a component of a consumer chemical product is completely unknown and cannot be estimated, subsection 36(4) assumes that the LD50 or LC50 of that component is equal to the value for the most toxic component present in the mixture at a concentration of 1% or more. This is unlike WHMIS, where the whole product takes on the value of the most toxic known component present at over 1%.

Inhalation Toxicity - Four-hour Conversion:

Four-hour exposure periods are specified in subsection 34(4). Since the LC50 determinations may be conducted over various periods of time, the formulas in section 37 may be used to extrapolate such data to four-hour exposure periods. These formulas assume a simple linear relationship between times of exposure and concentration in the animal chamber for dusts, mists and fumes, and a square-root function for gases and vapours. Exposure times of longer than 10-hours are not permitted. However, caution should be used to avoid data from exposure times of less than 1-hour because at this extreme, the conversion may not be as reliable.

New ⇒ Haber's Rule - LC50 4-hour Conversion:

The reason behind the square root function being present in the formula in s.37(a) and absent in the formula in 37(b) is due to the application of Haber's Rule when the CCCR, 2001 was being initially drafted. This Rule states that the application of certain mathematical operations (such as square root functions) to a set of data can make the data closer reflect what is seen in reality. In other words, the square root function is applied to gases and vapours because this make the data fit what is seen in real life, and it is removed from the formula for dusts, mists, and fumes for the same reason.

Section 38 - Part 1 - Toxic Products - Very Toxic Products - Prohibition

Prohibition

38. The advertising, sale or importation of a chemical product that is classified under section 33 in the sub-category "very toxic" is prohibited.

Discussion of CCCR, 2001 Section 38

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, sub-category.

Requirements:

Products classified as very toxic are too hazardous to be routinely made available to consumers who lack the specialized knowledge and training to use such products. No known consumer products currently on the market would fall into this sub-category. Various ingredients of several consumer products would be captured by the very toxic sub-category if sold in pure form. However, these ingredients are usually mixed with other less toxic ingredients, rendering the product as a whole less toxic.

Exceptions

All products classified as very toxic are prohibited from advertisement, sale or importation into Canada. There are no exceptions.

However, Health Canada will accept submissions to request an exception from prohibition. The granting of such an exception involves a regulatory amendment to the CCCR, 2001 in accordance with the Canadian Federal Regulatory Process. A submission to Health Canada to request an exception from prohibition must clearly show the following:

  • no other less hazardous alternative exists and is readily available or technically feasible;
  • the benefits of the product outweigh the high degree of hazard to the user; and
  • any other information which supports the request to allow a very hazardous product into the hands of the general public.

Health Canada will exercise its discretionary authority regarding the request and may make its permission subject to restrictions on the packaging, labelling or conditions of sale. Once the Regulations have been amended, the exception would apply to all products meeting the amendment conditions.

Section 39 - Part 1 - Toxic Products - Required Information

Required information - sub-category "toxic"

39. (1) Subject to subsection (3), the container of a chemical product that is classified in the sub-category "toxic" under section 33 must display, for each type of information set out in column 1 of the table to this subsection, and for each applicable route of exposure set out in column 2, the information set out in columns 3 and 4, other than the instructions set out in italics.

Table to Subsection 39(1) - Required information - sub-category 'toxic'
Item

Column 1

Type of information
Column 2

Applicable route of exposure
Column 3

English
information
Column 4

French
information
1. Hazard symbol All
2. Signal word All DANGER DANGER
3. Primary hazard statement All POISON POISON
4. Specific hazard statement (a) Oral or aspiration CONTENTS HARMFUL CONTENU NOCIF
(b) Dermal CONTENTS HARMFUL CONTENU NOCIF
(c) Inhalation

CONTENTS HARMFUL

or, if only the vapour or fume poses a hazard:

FUMES HARMFUL

CONTENU NOCIF

or, if only the vapour or fume poses a hazard:

ÉMANATIONS NOCIVES

5. Negative instructions (a) Oral or aspiration Do not swallow. Ne pas avaler.
(b) Oral and contains 1% or more methyl alcohol and a total quantity of 5 mL or more May cause blindness if swallowed. L'ingestion peut causer la cécité.
(c) Dermal Do not get in eyes or on skin or clothing. Éviter tout contact avec les yeux, la peau et les vêtements.
(d) Inhalation Do not breathe fumes. Ne pas respirer les émanations.
6. Positive instructions (a) All Keep out of reach of children. Tenir hors de la portée des enfants.
(b) Oral or aspiration Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque.].
(c) Dermal Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., rubber gloves, safety glasses.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., des gants de caoutchouc, des lunettes de sécurité.].
(d) Inhalation

Use only in a well-ventilated area.

Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask, a respirator.].

N'utiliser que dans un endroit bien aéré.

Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque, un respirateur.].

7. First aid statement (a) All

FIRST AID TREATMENT

Contains [name of hazardous ingredients in descending order of proportion].

If swallowed, call a Poison Control Centre or doctor immediately.

PREMIERS SOINS

Contient [name of hazardous ingredients in descending order of proportion].

En cas d'ingestion, appeler immédiatement un centre antipoison ou un médecin.

(b) Oral or aspiration If person is [Insert instructions for administering first aid, e.g., for methyl alcohol: If person is alert, induce vomiting.]. Si la personne est [Insert instructions for administering first aid, e.g., for methyl alcohol: Si la personne est consciente, provoquer le vomissement.].
(c) Dermal If in eyes or on skin, rinse well with water. If on clothes, remove clothes. En cas de contact avec les yeux ou la peau, bien rincer avec de l'eau. En cas de contact avec les vêtements, enlever ceux-ci.
(d) Inhalation If breathed in, move person into fresh air. En cas d'inhalation, transporter à l'air frais la personne exposée.

Required information - sub-category "harmful"

(2) Subject to subsection (3), the container of a chemical product that is classified in the sub-category "harmful" under section 33 must display, for each type of information set out in column 1 of the table to this subsection, and for each applicable route of exposure set out in column 2, the information set out in columns 3 and 4, other than the instructions set out in italics.

Table to Subsection 39(2) - Required information - sub-category 'harmful'
Item

Column 1

Type of information
Column 2

Applicable route of exposure
Column 3

English
information
Column 4

French
information
1. Hazard symbol All
2. Signal word All CAUTION ATTENTION
3. Primary hazard statement All POISON POISON
4. Specific hazard statement (a) Oral or aspiration CONTENTS MAY BE HARMFUL LE CONTENU PEUT ÊTRE NOCIF
(b) Dermal CONTENTS MAY BE HARMFUL LE CONTENU PEUT ÊTRE NOCIF
(c) Inhalation

CONTENTS MAY BE HARMFUL

or, if only the vapour or fume poses a hazard:

FUMES MAY BE HARMFUL

LE CONTEN PEUT ÊTRE NOCIF

or, if only the vapour or fume poses a hazard:

LES ÉMANATIONS PEUVENT ÊTRE NOCIVES

5. Negative instructions (a) Oral or aspiration Do not swallow. Ne pas avaler.
(b) Dermal Do not get in eyes or on skin or clothing. Éviter tout contact avec les yeux, la peau et les vêtements.
(c) Inhalation Do not breathe fumes. Ne pas respirer les émanations.
6. Positive instructions (a) All Keep out of reach of children. Tenir hors de la portée des enfants.
(b) Oral or aspiration Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque.].
(c) Dermal Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., rubber gloves, safety glasses.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., des gants de caoutchouc, des lunettes de sécurité.].
(d) Inhalation

Use only in a well-ventilated area.

Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask, a respirator.].

N'utiliser que dans un endroit bien aéré.

Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque, un respirateur.].

7. First aid statement (a) All

FIRST AID TREATMENT

Contains [name of hazardous ingredients in descending order of proportion].

If swallowed, call a Poison Control Centre or doctor immediately.

PREMIERS SOINS

Contient [name of hazardous ingredients in descending order of proportion].

En cas d'ingestion, appeler immédiatement un centre antipoison ou un médecin.

(b) Oral or aspiration If person is [Insert instructions for administering first aid, e.g., for methyl alcohol: If person is alert, induce vomiting.]. Si la personne est [Insert instructions for administering first aid, e.g., for methyl alcohol: Si la personne est consciente, provoquer le vomissement.].
(c) Dermal If in eyes or on skin, rinse well with water. If on clothes, remove clothes. En cas de contact avec les yeux ou la peau, bien rincer avec de l'eau. En cas de contact avec les vêtements, enlever ceux-ci.
(d) Inhalation If breathed in, move person into fresh air. En cas d'inhalation, transporter à l'air frais la personne exposée.

Exception - fuels

(3) Subsections (1) and (2) do not apply to a container of a fuel, such as gasoline, ethanol or propane, if the container is directly connected to an internal combustion engine, a gas turbine or an appliance that uses the fuel.

Discussion of CCCR, 2001 Section 39

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
aspiration, chemical product, container, first aid statement,
fume, fumes, hazard symbol, hazardous ingredients,
sub-category, vapour.

Requirements:

The wording for the warnings was developed through a consensus process, with the active collaboration of interested stakeholders, including the medical profession and public health organizations, the chemical industry, consumers' and seniors' groups, academia, technical experts and various federal government departments. During the label development, all sectors involved agreed that the regulations should prescribe mandatory warnings for the various hazard categories and sub-categories. The label statements are generic in terms of the hazard in order to be applicable to all types of consumer chemical products which fall within a particular sub-category. This ensures a constancy in the messages seen by consumers as well as a consistent set of rules for all companies. In addition, the general nature of the statements eliminates the need for ongoing regulatory amendments, but still provides the flexibility to add more specific information that may be appropriate to the chemical product.

All of the appropriate statements are required for all applicable routes of exposure. Statements may be combined. However, if a person under reasonably foreseeable use of the product cannot be exposed through a specific route, then it is not considered applicable, and the warnings are not required for that route of exposure.

Presentation Requirements:

See sections 17 to 32 of the CCCR, 2001 for the presentation format of the required information.

"Fumes":

The term "fumes" is used on a product label to reflect the hazards arising from vapours, gases, fumes or mists. In focus group testing among Canadian consumers, the term "fumes" was preferred, because it best conveyed in the popular, although not technical, usage, the sense of airborne material which may not be visible. No one word is technically correct for gases, fumes, mists and vapours. Since "fumes" communicates the hazard best, its use on a label leads to appropriate behaviour during the use and storage of a consumer chemical product.

Protective Equipment:

The positive instructions include a requirement to prescribe specific safety equipment relevant to the hazard, such as rubber gloves or a mask. However, the specific protective equipment must address the nature of the hazard during reasonably foreseeable use of the product.

First Aid Statement:

Only those hazardous ingredients present at least at 1% and which directly contribute to the classification of the product must be listed immediately after the words "FIRST AID STATEMENT" and "PREMIERS SOINS". The use of the words "may contain" and other phrases which leave some ambiguity as to the composition and, consequently, the health hazard of the product, is discouraged.

Instructions for administering first aid for the oral or aspiration routes of exposure are required only when appropriate to the hazard. The person responsible should consult a Poison Control Centre for the latest medical advice to get the appropriate recommendation on inducing vomiting for their product. For example, to avoid the risk of aspiration, products that pose an aspiration hazard should bear the instruction "do not induce vomiting" and "ne pas faire vomir".

New ⇒ Methanol

The example provided in the instructions for administering first aid is no longer appropriate, in light of current treatment practices. Traditionally, vomiting was recommended in the treatment of methyl alcohol poisoning. However, current practice does not recommend inducing vomiting because methanol is absorbed so rapidly that there would be little opportunity to prevent absorption, and inducing vomiting may introduce the risk of aspirating the gastric contents. The CCCR, 2001 will be amended to correct this first aid instruction.

Wiping Cloths

Oral exposure to a chemical absorbed into a wiping cloth is not likely. For example, it is unlikely that a polish absorbed into a cloth would be ingested, as long as the mixture cannot be squeezed-out. In view of this, the statement "If swallowed, call a Poison Control Centre or doctor immediately" is not required for products in which a liquid is absorbed onto a solid, semi-solid or fibrous material, as long as the liquid cannot be released from the substrate material with any reasonably foreseeable conditions of use or manipulation.

It is recommended that written records be kept of the decisions and justifications taken in this regard, so that, if necessary, a Product Safety inspector may review the rationale for these actions.

Additional Information:

The required labelling is the minimum necessary, and is an indication of the minimum standard of care imposed on a person responsible. Manufacturers and importers can add, and are encouraged to add, information considered necessary to fully inform the public of the hazards of using their products (see subsection 15(2)). In composing these statements, use short, simple sentences. Complex conditional sentences, particularly those containing negations, should be avoided. In addition, a person will remember the important product related information better, if fewer dimensions or items are listed.

However, the person responsible is discouraged from deliberately over-stating the hazards posed by a product. If unwarranted warnings are added to products, it may lead to potentially lengthy and unnecessary or inappropriate treatment upon exposure to the product. Furthermore, such a practice minimizes the perception of risk for those products which actually need the warnings, leading to potential injuries from a lack of concern or precaution by the user.

Exception - Fuel Tanks:

Subsection 39(3) allows an exception from labelling on a permanently attached fuel tank, such as an automobile, lawn mower or home heating fuel tank. This is due to the limited exposure to the chemical product during reasonably foreseeable use of the engine or appliance.

Spray Containers:

There is no exception from the toxic product labelling requirements for spray containers (see section 33).

Section 40 - Part 1 - Toxic Products - Child-resistant Containers

Sub-category "toxic"

40. (1) Subject to Subsection (2) and section 14, a chemical product that is classified under section 33 in the sub-category "toxic" must be in a child-resistant container that complies with sections 9 to 13.

Exceptions - spray container and single-drop dispenser

(2) Subsection (1) does not apply to a chemical product classified under section 33 in the sub-category "toxic" that is in

  • (a) a spray container that cannot be opened and that disperses the product as a mist; or
  • (b) a container that
    • (i) dispenses only one drop of the product at a time, and
    • (ii) displays the following primary hazard statement in the manner set out in sections 17 to 20, subsections 24(1) and (3) and sections 25 and 26:

      "THIS CONTAINER IS NOT CHILD-RESISTANT. KEEP OUT OF REACH OF CHILDREN."
      "CE CONTENANT N'EST PAS UN CONTENANT PROTÈGE-ENFANTS. TENIR HORS DE LA PORTÉE DES ENFANTS."

Discussion of CCCR, 2001 section 40

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, mist, spray container,
sub-category.

Requirements:

Chemical products that are classified as toxic are required to be packaged in child-resistant containers because of the likelihood of death or severe injury should a child come into contact with the product.

See sections 9 to 13 for the design and performance requirements for child-resistant containers. In general, these requirements make it difficult for a child under five years of age to open the container and obtain a toxic amount within a reasonable time. This requirement means that some children may still be able to open a container if given sufficient time to do so.

Exceptions:

Large Containers

Containers of toxic chemical products that are greater than 5L in capacity need not be child-resistant (see section 14).

Spray Containers

For toxic products, a spray container that dispenses only as a mist need not be child-resistant (40(2)(a)). It would be difficult for a child to manipulate such a container, and the risk is lessened by the toxic product labelling on the container. There is no similar exception for corrosive products or quick skin-bonding adhesives (see sections 47 and 57).

It must not be possible to open the container any other way. If a container has a detachable sprayer, for example: a re-fillable pump-spray container, the outlet between the bottle and the sprayer must be child-resistant.

The exception does not apply if the product may also be dispensed in a stream form, since the stream provides more product that is easier to ingest or aspirate.

New ⇒Tube Attachments

Certain spray containers, such as automotive lubricants, are packaged with a tube that is intended to be inserted into the nozzle to confine the application of the product. Without the tube, the spray is a mist and the product qualifies for the exemption of paragraph 40(2)(a). However, with the tube inserted, the product is released as a stream and, if the user leaves the tube in the nozzle, the contents are readily available to a child. In order to maintain the exception of paragraph 40(2)(a), the container must be designed so that the tube can stored when the lid is closed. In addition, the label should include instructions to remove the tube from the nozzle when storing. For example, the following instructions could be used:

"THIS CONTAINER IS NOT CHILD-RESISTANT WHEN THE TUBE IS USED. REMOVE AND STORE TUBE IN THE HOLDER PROVIDED."

"AVEC LE TUBE, LE CONTENANT N'EST PLUS UN CONTENANT PROTÈGE-ENFANTS. RETIRER LE TUBE ET LE PLACER DANS LE SUPPORT FOURNI."

Single Drop Dispensers

Paragraph 40(2)(b) allows single-drop dispensers of toxic products to not be child-resistant when the main display panel bears the primary hazard statements "THIS CONTAINER IS NOT CHILD-RESISTANT. KEEP OUT OF REACH OF CHILDREN." and "CE CONTENANT N'EST PAS UN CONTENANT PROTÈGE-ENFANTS. TENIR HORS DE LA PORTÉE DES ENFANTS." Such metered outlet nozzles are commonly used for lighter fluids and penetrating oils, such as sewing-machine oil.

This exception does not exist for corrosive products or quick skin-bonding adhesives (see sections 47 and 57).

This exception applies to containers where the single-drop dispenser is the only outlet. It must not be possible to unscrew the nozzle or remove the insert that releases the contents in single drops.

The container must dispense only one drop of the chemical product at a time. To assess a container, invert it without agitation or squeezing, and examine the flow. In order for the exception to apply, the contents must be released in single drops under their own weight.

Since the main display panel must bear the primary hazard statement "KEEP OUT OF REACH OF CHILDREN" and "TENIR HORS DE LA PORTÉE DES ENFANTS", the requirement for this statement in the positive instructions within the border (usually on the back of the container) need not be repeated.

Limited Free Flow

This exception also applies to products from which the liquid cannot flow freely, including but not limited to: paint markers and battery terminal cleaners.

Limited Flow Orifices

Limited flow orifices are not included in this exception, since they may allow up to 2 mL of the contents to be dispensed at a time.

Sections 41 and 42 - Part 2 - Corrosive Products - Classification of Corrosive Products

Data sources

41. (1) The person responsible for a corrosive product must determine the appropriate sub-category for the product from one or more of the following data sources in the following order of precedence:

  • (a) subject to subsection (2), human experience data for the corrosive product;
  • (b) the table to subsection 42(1), in the case of a corrosive product that contains a substance of special concern;
  • (c) one or more of the following sources in the following order of precedence, in the case of a corrosive product that contains one or more acids or one or more bases:
    • (i) the data sources set out in paragraph 6(1)(b), (c) or (e), or
    • (ii) the pH and, if applicable, the acid reserve or the alkali reserve of the corrosive product as set out in the tables to subsections 42(2) and (3), determined using the test methods set out in section 44;
  • (d) the table to subsection 42(4), in the case of a corrosive product that contains a substance, other than an acid or a base, that is capable of inducing necrosis or ulceration of epithelial tissue at the site of application determined using the data sources set out in subsection 43(1); or
  • (e) subsection 42(5), in the case of a corrosive product that contains a substance, other than an acid or a base, that is capable, when tested when using the test methods set out in subsection 43(2), of causing any of the following at the site of application, namely,
    • (i) an erythema or edema of the skin graded at 2 or more,
    • (ii) corneal damage graded at 2 or more,
    • (iii) iris damage graded at 1 or more, or
    • (iv) conjunctival swelling or redness graded at 2.5 or more.

Classification using human experience data

(2) If the human experience data for a corrosive product demonstrates that the product is capable of causing an effect described in

Sub-categories - substance of special concern

42. (1) A chemical product that contains one or more of the substances of special concern set out in column 1 of the table to this subsection in a concentration set out in column 2 must be classified in the sub-category set out in column 3.

Table to Subsection 42(1) - Sub-categories - substance of special concern
Item

Column 1

Substance of special concern
Column 2

Concentration
Column 3

Sub-category
1. Ethyl bromoacetate any concentration Very Corrosive
2. Fluoride 0.5% or more of available fluoride ions Very Corrosive

Sub-categories - one or more acids

(2) A chemical product that contains one or more acids, is in the state set out in column 1 of the table to this subsection and has the properties set out in column 2, as determined under section 44, must be classified in the sub-category set out in column 3.

Table to Subsection 42(2) - Sub-categories - one or more acids
Item Column 1

State
Column 2

Properties
Column 3

Sub-category
1. Liquid (a) a pH of not more than 1.0 Corrosive
(b) a pH of more than 1.0 but not more than 3.0, and an acid reserve of 5.0 or more Corrosive
(c) a pH of more than 1.0 but not more than 3.0, and an acid reserve of 3.0 or more but less than 5.0 Irritant
2. Solid, paste or gel (a) a pH of not more than 1.0 Corrosive
(b) a pH of more than 1.0 but not more than 3.0, and an acid reserve of 10.0 or more Corrosive
(c) a pH of more than 1.0 but not more than 3.0, and an acid reserve of 5.0 or more but less than 10.0 Irritant

Sub-categories - one or more bases

(3) A chemical product that contains one or more bases, is in the state set out in column 1 of the table to this subsection and has the properties set out in column 2, as determined under section 44, must be classified in the sub-category set out in column 3.

Table to Subsection 42(3) - Sub-categories - one or more bases
Item Column 1

State
Column 2

Properties
Column 3

Sub-category
1. Liquid (a) a pH of 13.0 or more Corrosive
(b) a pH of less than 13.0 but not less than 11.0, and an alkali reserve of 5.0 or more Corrosive
(c) a pH of less than 13.0 but not less than 12.0, and an alkali reserve of less than 5.0 Irritant
(d) a pH of less than 12.0 but not less than 11.0, and an alkali reserve of less than 5.0 but not less than 3.0 Irritant
2. Solid, paste or gel (a) a pH of 13.0 or more Corrosive
(b) a pH of less than 13.0 but not less than 11.0, and an alkali reserve of 10.0 or more Corrosive
(c) a pH of less than 13.0 but not less than 12.0, and an alkali reserve of less than 10.0 Irritant
(d) a pH of less than 12.0 but not less than 11.0, and an alkali reserve of less than 10.0 but not less than 5.0 Irritant

Sub-categories - substances causing necrosis or ulceration

(4) A chemical product that contains substances described in paragraph 41(1)(d) that are capable of causing necrosis or ulceration, in a total concentration set out in column 1 of the table to this subsection, must be classified in the sub-category set out in column 2.

Table to Subsection 42(4) - Sub-categories - substances causing necrosis or ulceration
Item Column 1

Total concentration of the substances
Column 2

Sub-category
1. 5% or more Corrosive
2. 1% or more but less than 5% Irritant

Sub-category - substances causing other effects

(5) A chemical product that contains substances that are capable of causing an effect described in paragraph 41(1)(e) in a total concentration of 5% or more must be classified in the sub-category "irritant".

Discussion of CCCR, 2001 Sections 41 and 42

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
acid reserve, alkali reserve, chemical product,
corrosive product, human experience data,
person responsible, sub-category.

A corrosive substance is capable of causing necrosis or ulceration of epithelial tissue. Necrosis means the death of cells or tissues, and ulceration means the development of a lesion of the skin or a mucous membrane that causes necrosis of the surrounding tissue. Epithelial tissue refers to the covering of most of the internal and external surfaces of the body and its organs, and it includes the skin as well as the throat. Hence, contact with a corrosive substance results in significant and permanent tissue destruction.

An irritant substance can induce erythema, edema, or eye irritation, but the effect is reversible. Erythema is a sign of inflammation; it is a redness of the skin caused by dilatation and congestion of the capillaries. Edema means swelling due to abnormally large amounts of fluid in the tissue spaces of the body. The terms "cornea", "iris", and "conjunctive" all refer to eye tissue.

Requirements:

Sections 41 and 42 set out the steps for classifying a product into the corrosive product sub-categories: very corrosive, corrosive and irritant. The criteria describe products that are hazardous because they can cause a chemical burn. The distinction between sub-categories is the degree of injury and whether permanent damage results.

The order of precedence for corrosive product classification is:

  1. Human experience data with the chemical product;
  2. The presence of a substance of special concern;
  3. The presence of acids or bases;
  4. The presence of a corrosive substance that can induce necrosis or ulceration; and
  5. The presence of an irritant substance that can induce erythema, edema, or eye irritation.

If human experience data with the chemical product is not available, the way to determine the corrosive product classification is to follow section 42. That is, first examine whether there is a substance of special concern (subsection 42(1)), then assess the pH and acid/alkali reserve (subsections 42(2) and (3)), then assess the presence of a corrosive substance (subsection 42(4)) and finally assess the presence of an irritant substance (subsection 42(5)).

Despite the classification resulting from the application of section 42, if reliable data become available demonstrating that a product causes more harm to a person when it is used under reasonably foreseeable conditions, then such human experience takes precedence and must be used to classify that product.

Route of Exposure:

During product classification, the person responsible must consider all possible routes through which a consumer could be exposed -- oral, dermal, eye contact and inhalation. If a chemical product falls into more than one sub-category, the product must be classified according to the most hazardous. However, the container must display the appropriate warnings for each applicable route of exposure. For example, if a product falls within the "corrosive" sub-category via the oral route as well as the "irritant" sub-category via skin contact, then the product as a whole is classified as "corrosive" (that is, the more severe sub-category), but both the warnings for oral and dermal are required (see section 4).

Human Experience:

Subsection 41(2) gives the classification for a product based on human experience data. The human experience data must be for the chemical product as it is used by the consumer, not just on certain ingredients.

Human experience with a product is the best indicator of its potential hazard. A corrosive effect results from an interaction between the corrosive substance and the site of application. The complexity and variability of living tissue means that the results of any specific test does not always accord with other tests or known exposure outcomes. Some products produce corrosive effects due to the action of strong acids or bases, while others function through more complex interactions with specific tissue types.

The ingestion of a corrosive substance may cause serious effects, such as circulatory collapse, asphyxia (due to edema of the larynx and glottis), mediastinitis (inflammation of the tissues and organs separating the two lungs), peritonitis (inflammation of the serous membrane lining the abdominopelvic walls), infection and stricture (narrowing) of the esophagus and stomach. Stricture is a complication that occurs more commonly in alkali poisoning than in acid poisoning. Strong mineral acids would be swallowed less often than caustic alkalis because the acids produce intense and immediate pain when taken into the mouth, and the spasm after the first swallow tends to prevent further ingestion.

The effect of skin contact with a corrosive substance is also more intense with alkalis than with acids. This is because, in general, acids cause coagulation of the tissue proteins which tends to protect the underlying tissues. In contrast, alkalis dissolve tissue proteins and collagen, the main supportive protein of skin, tendon, bone, cartilage and connective tissue, thereby liquefying the tissue and promoting deeper penetration by the corrosive chemical.

An irritant effect involves tissue damage from minor to severe, but short of necrosis or ulceration. Irritation may cause discomfort or may lead to tissue destruction indirectly, for example, by severe coughing on exposure to a respiratory irritant, by the scratching or rubbing of irritated tissue, or by making it easier for bacteria or other infectious agents to invade.

Classification

Subsection 41(2) gives the classification criteria for a product based on human experience data. Reliable human experience data includes epidemiological data and experience on the effects of chemicals on humans, such as occupational data, information from accident databases and clinical cases with a product. Market history data collected from company toll-free lines, or complaint databases from manufacturers may be useful, however these types of data may be less reliable than actual clinical cases collected from poison control centres or emergency wards in hospitals and clinics. Deliberate testing on humans solely for hazard identification purposes is discouraged for ethical reasons.

In order to make use of market history data, the person responsible must establish a mechanism to obtain complaints or feedback directly from the users of the product. However, once a product's formula is changed, there must be market history data on the new formulation in order to classify the modified product using human experience data.

Professional judgement must be used in making an assessment of what is sufficient data in each case and taking into account animal test results. For example, a single human experience result from exposure to a product may not be sufficient to warrant using that data instead of animal data, because there may be other contributory factors for the result in that particular case.

When human experience data give valid results different from results with animal data, the human experience data take precedence. Human experience data may be used to show that the product meets or does not meet a classification criterion.

A corrosive substance causes tissue destruction, or necrosis, from skin or eye contact or from ingestion. A test material is considered to be corrosive if there is extensive damage, such as scarring, ulceration or necrosis, which constitutes irreversible tissue destruction. In addition, corrosion occurs when the exposure of the eye to the material under the specified conditions results in significant tissue destruction (necrosis) and that the injuries persist or are expected to persist for twenty-one days or more.

With regard to the irritant criteria, OECD No. 404 is used to determine whether there is an erythema or edema of the skin graded at 2 or more (see section 43). This test method grades skin reaction on a scale of 0 to 4, where 0 means no erythema and 4 means severe erythema (beet red) to scab formation (eschar) which prevents the grading of erythema. OECD No. 405 evaluates corneal damage, iris damage and conjunctival swelling or redness. Corneal damage is graded from 0 to 4 (2 or more is irritant), where 0 means no ulceration or opacity, and 4 means that the cornea is opaque and the iris is not discernible through the opacity. Iris damage is graded from 0 to 2 (1 or more is irritant), where 0 means normal and 2 means that there is no reaction to light, hemorrhage, or gross destruction. Conjunctive damage is graded from 0 to 4 (2.5 or more is irritant), where 0 means that the blood vessels are normal, and 4 means that there is swelling with lids more than half closed.

Substances of Special Concern:

Paragraph 41(1)(b) includes two items: ethyl bromoacetate and fluoride. They are both classified as very corrosive.

Ethyl Bromoacetate

Ethyl bromoacetate vapours are irritant to all mucous membranes, especially the eyes, and are unbearable for more than a minute at a concentration of 8 ppm in air. When liquid ethyl bromoacetate comes into contact with the eyes, permanent damage may result. In the past, this chemical was sold to consumers as a tear gas, intended as a joke or novelty product.

Elemental Fluoride

Hydrofluoric acid is the principle source of available fluoride ions. Other sources of fluoride ions, such as sodium fluoride, sodium and ammonium bifluoride, and fluorosylicic acid, produce hydrofluoric acid in aqueous solutions. These chemicals have been used in metal cleaners, rust removers, bathtub etchants and glass etchants.

Deep and extremely painful burns can result from contact with products containing relatively low concentrations of hydrofluoric acid. Serious skin damage is the result of the fluoride ions which have a unique ability to penetrate through body tissue, including bone. In addition, substantial damage can occur prior to the appearance of physical symptoms, which leads to delays in seeking medical treatment. Unlike other acids that are neutralized quickly, fluoride ion reactions in the body can continue for several days.

Products That Contain Acids or Bases:

The classification of a product that contains acids or bases may be determined from animal tests on the chemical product according to paragraphs 6(1) (b), (c) or (e), or from the pH and acid/alkali reserve of the product using the test methods in section 44.

The classification criteria for pH and acid/alkali reserve are given in the tables to subsections 42(2) and (3). The application of the pH and acid/alkali reserve criteria of subsections 42(2) and (3) are intended to minimize the need for animal testing, and do not require animal testing for enforcement purposes. According to OECD No. 404, materials that have predictable corrosive potential based on structure-activity relationships and/or physicochemical properties such as strong acidity or alkalinity, for example, when the material to be applied has a pH of 2 or less or 11.5 or greater, should not be tested on animals for dermal irritation/corrosion; -- alkaline or acidic reserve should also be taken into account. Hence the criteria support the concepts of OECD No. 404.

Acid Reserve and Alkali Reserve

The acid reserve and alkali reserve measures the capacity of a product to maintain its pH. It is an important factor in the evaluation of the degree of damage that can occur on exposed tissue. The concept of acid reserve and alkali reserve is that any product can be titrated to a predetermined uniform pH value to obtain its equivalence in grams of sodium hydroxide (NaOH). Thus the acid reserve and alkali reserve provides a finer appraisal of the degree of product's acidity or alkalinity than pH alone. Values at both ends of the pH scale may be sufficient for identifying corrosive materials. However, as the pH moves from the highly acidic and highly alkaline extremes, the distinction between borderline corrosive and irritant substances, and between the moderate and weak irritants, becomes less obvious. This difficulty may be the result of the logarithmic basis of the pH scale, where 1 pH unit corresponds to a factor of 10 in hydrogen ion concentration. Also, the pH alone may not always determine the total acid or alkali in a solution. The acid reserve and alkali reserve criteria thus supplement the pH criteria. This is particularly important in the low-to-moderate acid range and the moderate-to-high alkaline range.

The acid reserve and alkali reserve criteria for liquid products are more stringent than for products in the form of a solid, paste or gel. The potential for harmful effects from liquids is greater in case of ingestion, since a liquid is swallowed more readily and is more hazardous to the esophagus and stomach lining. Ingesting a solid, paste or gel tends to result in local injury to the oropharynx and upper esophagus.

Corrosive and Irritant Substances:

The classification of a product that contains substances other than acids or bases may be determined from paragraphs 41(1)(d) and (e) using the test methods in section 43. The classification criteria for these products are given subsections 42(4) and (5).

Some substances are known to have a corrosive or irritant potential unrelated to pH and acid reserve or alkali reserve. Examples of known corrosive or irritant substances that are not acids or bases are: silver salts, peroxides (organic and inorganic), halogens, isocyanates, phenols, amines, iodine and zinc chloride.

The criteria of subsections 42(4) and (5) require that the total concentration of corrosive or irritant substances be used. That is, if a product contains two corrosive substances that are not acids or bases, the total concentration of these substances is used.

Alternatives to Animal Tests

Historically, the classification of substances as corrosive to tissue has been based on the results of animal tests, primarily the Draize Test. The need to minimize or eliminate tests involving living animals has led to the development of alternative in-vitro tests which use tissue cultures or tissue substitutes. These alternative in-vitro tests also systematically correlate fundamental properties of materials with corrosive effects, eliminating the need for direct testing. The use of tissue substitutes or cultured tissue shows great promise, but has not yet sufficiently matured to serve as the basis for criteria.

Harmonization With the WHMIS Controlled Products Regulations:

In general, the CCCR, 2001 classification criteria for corrosive products are harmonized with those for workplace chemicals under the requirements of the Controlled Products Regulations (CPR) of WHMIS. The "corrosive" subcategory is generally equivalent to WHMIS Class E - Corrosive Material. For example, CCCR, 2001 subsections 42(2) and (3) expand on the OECD No. 404 requirement of CPR paragraph 65(b), with regard to acid reserve and alkali reserve. However, the WHMIS criteria for mixtures containing a corrosive substance, in CPR paragraph 65(f), is more stringent, in that it applies when the substance is present at 1% concentration, rather than at 5% (total amount of all corrosive substances) in the CCCR, 2001. Note also that the WHMIS Class E criteria include the corrosion of metal, which is not included in the CCCR, 2001.

The CCCR, 2001 classification criteria for skin or eye irritants in paragraph 41(1)(e) are harmonized with those for WHMIS in CPR section 60.

Sections 43 and 44 - Part 2 - Corrosive Products - Test Methods

Determination - necrosis and ulceration

43. (1) The capability of a substance in a corrosive product to induce necrosis or ulceration of epithelial tissue at the site of application must be determined from an applicable data source set out in paragraphs 6(1)(a) to (c) or (e).

Determination - other effects

(2) The capability of a substance in a corrosive product to cause an erythema or edema of the skin, corneal or iris damage or conjunctive swelling or redness at the site of application, to the grade specified in paragraph 41(1)(e), must be determined from the applicable data source set out in paragraphs 6(1)(a) to (c) or (e), including

  • (a) the Draize Test;
  • (b) in the case of an erythema or an edema, OECD No. 404; and
  • (c) in the case of corneal or iris damage or conjunctive swelling or redness, OECD No. 405.

Determination of the pH

44. (1) The person responsible for a corrosive product must determine the pH of the product by using good scientific practices that are in accor-dance with a procedure similar to that described in ASTM D 1293, from

  • (a) in the case of a product in the form of a liquid, the product as it is dispensed from its container; and
  • (b) in the case of a product in the form of a solid, paste or gel, or in a form otherwise unsuitable for direct measurement of the pH, a 10% aqueous solution of the product.

Determination of acid reserve or alkali reserve

(2) The person responsible for a corrosive product must determine, where applicable, the acid reserve or the alkali reserve of the product by

  • (a) titrating, in accordance with the OECD Principles of Good Laboratory Practice,
    • (i) in the case of a product in the form of a liquid, a suitable aliquot of the product as it is dispensed from its container, and
    • (ii) in the case of a product in the form of a solid, paste or gel, or in a form otherwise unsuitable for direct measurement of the pH, a suitable aliquot of a 10% aqueous solution of the product; and
  • (b) calculating
    • (i) in the case of an acidic product, the amount of an alkali, expressed in grams of sodium hydroxide, that is required to bring 100 mL of the product in the form of a liquid, or 100 g of the pro-duct in the form of a solid, paste or gel, to a pH of 4.00 ± 0.05, and
    • (ii) in the case of a basic product, the amount of an alkali, expressed in grams of sodium hydroxide, that is neutralized when 100 mL of the product in the form of a liquid, or 100 g of the product in the form of a solid, paste or gel, is brought to a pH of 10.00 ± 0.05 by the addition of hydrochloric acid.

Unstable end point

(3) If the end point of the titration referred to in subsection (2) is unstable and exhibits drifting, the pH end point reached within 30 seconds after the last addition of titrant is to be used as the effective end point for classification purposes.

Discussion of CCCR, 2001 sections 43 and 44

Definitions:

The following terms are defined in section 1 of the CCCR, 2001: acid reserve, alkali reserve, container, corrosive product, good scientific practices, person responsible, ASTM D 1293, Draize Test, OECD No. 404, OECD No. 45, OECD Principles of Good Laboratory Practice.

Requirements:

sections 43 and 44 provide the test methods and data sources for assessing and classifying corrosive products.

Corrosive Effects:

Subsection 43(1) gives the data sources for determine the capability of a substance to induce tissue destruction. A corrosive substance causes tissue destruction, or necrosis, from skin or eye contact or from ingestion. A test material is considered to be corrosive if there is extensive damage, such as scarring, ulceration or necrosis, which constitutes irreversible tissue destruction. In addition, corrosion occurs when the exposure of the eye to the material under the specified conditions results in significant tissue destruction (necrosis) and that the injuries persist or are expected to persist for twenty-one days or more.

The data sources for determining the capabiity of a substance in a chemical product to induce a corrosive effect are 6(1)(a) (human experience data pertaining to the product), 6(1)(b) (existing data from tests conducted in accordance with the OECD Test Guidelines), 6(1)(c) (existing data from tests other than OECD), and 6(1)(e) (the results of tests conducted by the person responsible).

If human experience data for the whole product demonstrates that it is capable of causing necrosis or ulceration, then the product is classified as corrosive. If data on the whole product is lacking, but the product contains 5% or more of substances (in total), other than acids or bases, that are capable of causing necrosis or ulceration, then the product is classified as corrosive (see sections 41 and 42).

Irritant Effects:

Subsection 43(2) gives the data sources for determine the capability of a substance to produce an irritant effect, which are 6(1)(a) (human experience data pertaining to the product), 6(1)(b) (existing data from tests conducted in accordance with the OECD Test Guidelines), 6(1)(c) (existing data from tests other than OECD), and 6(1)(e) (the results of tests conducted by the person responsible), including OECD Nos. 404, 405 and the Draize Test.

The classification criteria in paragraph 41(e) are that the substance is not an acid or a base and it is capable of causing any of the following at the site of application:

  • (i) an erythema or edema of the skin graded at 2 or more,
  • (ii) corneal damage graded at 2 or more,
  • (iii) iris damage graded at 1 or more, or
  • (iv) conjunctival swelling or redness graded at 2.5 or more.

The result should be measured at any of the times specified in the test, usually 24, 48 and 72 hours after patch removal; it is not a mean score value over the test times. This harmonizes the criteria with WHMIS (see section 60 of the Controlled Products Regulations).

If human experience data for the whole product demonstrates that it is capable of causing an irritant effect, then the product is classified as irritant. If data on the whole product is lacking, but the product contains 5% or more of substances (in total), other than acids or bases, that are capable of causing an irritant effect, then the product is classified as irritant. In addition, if the product contains 1 to 5% of substances (in total), other than acids or bases, that are capable of causing a corrosive effect (necrosis or ulceration), then the product is classified as irritant (see sections 41 and 42).

Descriptive Statements:

Where irritant results have been indicated as descriptive statements rather than a grading value, the following guide has been taken from OECD Nos. 403, 404 and from the Draize Test literature:

Irritant results as descriptive statement
OECD Nos. 404, 405 Draize Test Grade
Effect: erythema and eschar formation
(where erythema means "abnormal redness of the skin due to capillary congestion (as in inflammation)" and eschar means "a scab formed especially after a burn")
no erythema   0
very slight erythema (barely perceptible) very slight erythema (barely perceptible) 1
well defined erythema well defined erythema 2
moderate to severe erythema moderate to severe erythema 3
severe erythema (beet redness) to eschar formation prevents grading of erythema severe erythema (beet redness) to eschar formation (injuries in depth) 4
Effect: edema formation
(where edema means "an abnormal excess accumulation of serous fluid in connective tissue or in a serous cavity called also dropsy")
no edema   0
very slight edema (barely perceptible) very slight edema (barely perceptible) 1
slight edema (edges of area well defined by definite raising slight edema (edges of area well defined by definite raising 2
moderate edema (raised approx. 1 mm) moderate edema (raised approx. 1 mm) 3
severe edema (raised more than 1 mm and extending beyond area of exposure) severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Effect: corneal damage
(Opacity: degree of density (area most dense taken for reading))
no ulceration or opacity   0
scattered or diffuse area of opacity (other than slight dulling or normal lustre), details of iris clearly visible scattered or diffuse area, details of iris clearly visible 1
easily discernible translucent area, details of iris slightly obscured easily discernible translucent areas, details of iris slightly obscured 2
nacrous area, no details of iris visible, size of pupil barely discernible opalescent areas, no details of iris visible, size of pupil barely discernible 3
opaque cornea, iris not discernible through the opacity opaque, iris invisible 4
Effect: iris damage
normal   0
markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof, iris still reacting to light, sluggish reaction is positive) 1
no reaction to light, haemorrhage, gross destruction (any of these) no reaction to light, haemorrhage; gross destruction (any of these) 2
Effect: conjunctival damage
(redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
blood vessels normal   0
some blood vessels definitely hyperaemic (injected) vessels definitely injected above normal 1
diffuse, crimson colour, individual vessels not easily discernible more diffuse, deeper crimson red, individual vessels not easily discernible 2
diffuse beefy red diffuse beefy red 3
Effect: conjunctival damage
(chemosis: lids and/or nictitating membranes)
no swelling   0
any swelling above normal (includes nictitating membranes) any swelling above normal (includes nictitating membranes) 1
obvious swelling with partial eversion of lids obvious swelling with partial eversion of the lids 2
swelling with lids about half closed swelling with lids about half closed 3
swelling with lids more than half closed swelling with lids about half closed to completely closed 4

PH Test Method:

Although ASTM D1293 (Standard Test Methods for pH of Water) has been specified, subsection 44(1) allows other similar test methods to be used.

Acid Reserve and Alkali Reserve:

The acid reserve is required for products with a pH of 1 to 3; the alkali reserve for products with a pH of 11 to 13. Products with a pH at the extremes (that is, a pH of 1.0 or less or of 13.0 or more) are classified as corrosive regardless of the acid reserve or alkali reserve.

The acid reserve and alkali reserve of a product is derived directly from a titration. The results of titration of any product are expressed in terms of the equivalent amount of sodium hydroxide used or neutralized to bring the pH of a set amount of product to the end point. The set amount of product is 100 mL for liquids and 100 g for solids, pastes or gels. During the test, it is not necessary to use 100 mL or 100 g of the product, but the results must be reported in terms of these amounts.

The testing of products in the form of a solid, paste or gel is performed on a 10% w/w aqueous solution of the product. The weight of product is used rather than the volume, to avoid introducing uncertainty due to the variability of the bulk density of a solid product, for example, from compaction or settling of a powder during shipment or storage. However, the result must be expressed in terms of 100 g of the product.

The titration end point is set at a pH of 4.0 for an acid. When titrating an acid, the result is expressed as the quantity, in grams, of sodium hydroxide that is required to bring the pH up to 4.0.

For a base, the titration end point is set at a pH of 10.0. When titrating an alkali, the result is expressed as the equivalent quantity of sodium hydroxide that is neutralized to bring the pH down to 10.0. The alkali reserve is not the quantity of acid used in the titration -- it is based on the amount of sodium hydroxide that is neutralized and is expressed as grams of sodium hydroxide.

Subsection 44(3) sets out a time period of 30 seconds to record the result, so that the tester is not waiting an extensively long period for stability to occur.

Calculation

Mathematical formula used to determine the acid or alkali reserve for a given product. For liquid products, the number of grams of sodium hydroxide per 100mL of liquid product is equal to 100 multiplied by the product of the normality of hydrochloric acid or sodium hydroxide and the volume of hydrochloric acid or sodium hydrochlordie in millilitres all divided by the volume of the sample in milliliters and then multiplied by 0.04. For solids, pastes and gels the number of grams of sodium hydroxide per 100mL of solid/paste/gel product is equal to 100 multiplied by the product of the normality of hydrochloric acid or sodium hydroxide and the volume of hydrochloric acid or sodium hydrochloride in millilitres and the weight of distilled water all divided by the product of the volume of the sample in milliliters and the weight of the sample in grams, then multiplied by 0.04.

  1. Liquid products:
    (Grams of soduim hydroxide per 100 mL of liquid product)

    Formula for liquid products

    Where

    NA or B = Normality of HCl or NaOH
    VA or B = Volume of HCl or NaOH (mL)
    Vs = Volume of sample (mL)

  2. Solids, pastes or gels:
    (Grams of sodium hydroxide per 100 grams of product (solid, paste or gel))

    Formula for solids, pastes or gels

    Where:

    NA or B = Normality of HCl or NaOH
    VA or B = Volume of HCl or NaOH (mL)
    Vs = Volume of sample (mL)
    Wts = Weight of sample (g)
    Wtw = Weight of distilled water

Section 45 - Part 2 - Corrosive Products - Very Corrosive Products

Prohibition and exception

45. The advertising, sale or importation of a corrosive product that is classified in the sub-category "very corrosive" under section 41 is prohibited unless it is set out in column 1 of the table to this section and meets the conditions set out in column 2.

Table to Subsection 45 - Conditions for advertising, selling or importing very corrosive products
Item Column 1

Chemical product
Column 2

Conditions
1. A product that contains a concentration of 0.5% or more of available fluoride ions Product is in the form of a paste or a gel, is used for etching glass and its container

Discussion of CCCR, 2001 Sections 45

Definitions:

The following terms are defined in section 1 of the CCCR, 2001: chemical product, container, corrosive product, sub-category.

Requirements:

Products classified as very corrosive are too hazardous to be routinely made available to consumers who lack the specialized knowledge and training to use such products.

Ethyl Bromoacetate

In the past, ethyl bromoacetate was sold as a joke product: a tear gas, known as "Ondes Lacrymogènes". The product was packaged in a vial that, when broken, released the liquid which immediately vaporized to produce tears. The problem was resolved by the removal of the product from the market and the prohibition of ethyl bromoacetate in 1974. (See section 42 for a description of the health effects of ethyl bromoacetate.)

Glass Etchants

(See section 42 for a description of the health effects of elemental fluoride.)

Consumer chemical products that contain 0.5% or more of available fluoride ions are prohibited, except for glass etchants that meet the conditions of the table to section 45. Products used for glass etching are not included in the prohibition, since there is no effective substitute for the frosting of glass, a technique used by artists and artisans. Fluoride-containing glass etchants must be in the form of a paste or gel, must be packaged in a child-resistant container and must be labelled according to the table to subsection 46(1). This promotes a controlled application and reduces the possibility of splashing.

The child-resistant packaging requirement is harmonized with the United States' Poison Prevention Packaging Act, where child-resistant packaging is required for household products containing more than 0.5 % and more than 50 mg of elemental fluoride. However, unlike Canada, other household products are not prohibited from containing fluoride ions in the U.S.

Toothpaste contains around 0.2% fluoride, and the Canadian Dental Association recognizes these products as safe and effective when used as directed. In Canada, consumer chemical products that contain more than 0.5% of available fluoride ion are prohibited, unless they are used for etching glass.

Exceptions:

An exception from prohibition may be requested, but the granting of such an exception involves a regulatory amendment to the CCCR, 2001 in accordance with the Canadian Federal Regulatory Process. A submission to Health Canada to request an exception from prohibition must clearly show the following:

  • no other less hazardous alternative exists and is readily available or technically feasible;
  • the benefits of the product outweigh the high degree of hazard to the user; and
  • any other information which supports the request to allow a very hazardous product into the hands of the general public.

Health Canada will exercise its discretionary authority regarding the request and may make its permission subject to restrictions on the packaging, labelling or conditions of sale. Once the Regulations have been amended, the exception would apply to all products meeting the amendment conditions.

Section 46 - Part 2 - Corrosive Products - Required Information

Required information - sub-category "very corrosive"

46. (1) When a corrosive product classified in the sub-category "very corrosive" under section 41 has an information requirement under the table to section 45, the container of the product must display, for each type of information set out in column 1 of the table to this subsection and for each applicable route of exposure set out in column 2, the information set out in columns 3 and 4, other than the instructions set out in italics.

Table to Subsection 46(1) - Required information - sub-category 'very corrosive'
Item


Column 1

Type of information
Column 2

Applicable route of exposure
Column 3

English
information
Column 4

French
information
1. Hazard symbol All
2. Signal word All EXTREME DANGER DANGER EXTRÊME
3. Primary hazard statement All VERY CORROSIVE TRÈS CORROSIF
4. Specific hazard statement (a) All CAUSES SEVERE BURNS PROVOQUE DE GRAVES BRÛLURES
(b) Dermal and con-tains a concentration of 0.5% or more of available fluoride ions SYMPTOMS MAY NOT APPEAR IMMEDIATELY LES SYMPTOMES PEUVENT NE PAS SE MANIFESTER IMMÉDIATEMENT
(c) Inhalation DANGEROUS FUMES FORM WHEN MIXED WITH OTHER PRODUCTS DÉGAGE DES ÉMANA-TIONS DANGEREUSES LORSQUE MÉLANGÉ AVEC D'AUTRES PRODUITS
5. Negative instructions (a) All When appropriate and before the other negative instructions: When appropriate and before the other negative instructions:
Do not mix with [Insert description of other products that react with the chemical product, such as toilet bowl or drain cleaners, bleach or ammonia.]. Ne pas mélanger avec [Insert description of other products that react with the chemical product, such as des nettoyants pour cuvettes de toilette ou tuyaux d'évacua-tion, des agents de blanchi-ment ou de l'ammoniaque.].
(b) Oral Do not swallow. Ne pas avaler.
(c) Eyes Do not get in eyes. Éviter tout contact avec les yeux.
(d) Dermal Do not get on skin or clothing. Éviter tout contact avec la peau ou les vêtements.
(e) Inhalation Do not breathe fumes. Ne pas respirer les émanations.
6. Positive instructions (a) All Handle with extreme care. Keep out of reach of children. Manipuler avec grand soin. Tenir hors de la portée des enfants.
(b) Oral Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque.].
(c) Dermal Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., rubber gloves, safety glasses.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., des gants de caoutchouc, des lunettes de sécurité.].
(d) Inhalation Use only in a well-ventilated area. N'utiliser que dans un endroit bien aéré.
Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask, a respirator]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque, un respirateur.].
7. First aid statement (a) All FIRST AID TREATMENT PREMIERS SOINS
Contains [name of hazar-dous ingredients in descen-ding order of proportion]. Contient [name of hazar-dous ingredients in descen-ding order of proportion].
If swallowed, call a Poison Control Centre or doctor immediately. Do not induce vomiting. En cas d'ingestion, appe-ler immédiatement un centre antipoison ou un médecin. Ne pas provo-quer le vomissement.
(b) Eyes If in eyes, rinse with water for [Insert appropriate period of time.]. En cas de contact avec les yeux, rincer avec de l'eau pendant [Insert appropriate period of time.].
(c) Dermal If on skin, rinse well with water. If on clothes, remove clothes. En cas de contact avec la peau, bien rincer avec de l'eau. En cas de contact avec les vêtements, enlever ceux-ci.
(d) Inhalation If breathed in, move person to fresh air. En cas d'inhalation, transporter à l'air frais la personne exposée.

Required information - sub-category "corrosive"

(2) The container of a corrosive product that is classified in the sub-category "corrosive" under section 41 must display, for each type of information specified in column 1 of the table to this subsection and for each applicable route of exposure set out in column 2, the information set out in columns 3 and 4, other than the instructions set out in italics.

Table to Subsection 46(2) - Required information - sub-category 'corrosive'
Item


Column 1

Type of information
Column 2

Applicable route of exposure
Column 3

English
information
Column 4

French
information
1. Hazard symbol All
2. Signal word All DANGER DANGER
3. Primary hazard statement All CORROSIVE CORROSIF
4. Specific hazard statement (a) All CAUSES BURNS PROVOQUE DES BRÛLURES
(b) Inhalation DANGEROUS FUMES FORM WHEN MIXED WITH OTHER PRODUCTS DÉGAGE DES ÉMANATIONS DANGEREUSES LORSQUE MÉLANGÉ AVEC D'AUTRES PRODUITS
5. Negative instructions (a) All When appropriate and before the other negative instructions: When appropriate and before the other negative instructions:
Do not mix with [Insert description of other products that react with the chemical product, such as toilet bowl or drain cleaners, bleach or ammonia.]. Ne pas mélanger avec [Insert description of other products that react with the chemical product, such as des nettoyants pour cuvettes de toilette ou tuyaux d'évacuation, des agents de blanchiment ou de l'ammoniaque.].
(b) Oral Do not swallow. Ne pas avaler.
(c) Eyes Do not get in eyes. Éviter tout contact avec les yeux.
(d) Dermal Do not get on skin or clothing. Éviter tout contact avec la peau ou les vêtements.
(e) Inhalation Do not breathe fumes. Ne pas respirer les émanations.
6. Positive instructions (a) All Handle with care. Keep out of reach of children. Manipuler avec soin. Tenir hors de la portée des enfants.
(b) Oral Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque.].
(c) Dermal Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., rubber gloves, safety glasses.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., des gants de caoutchouc, des lunettes de sécurité.].
(d) Inhalation Use only in a well-ventilated area. N'utiliser que dans un endroit bien aéré.
Wear [Insert description of the specific safety equipment relevant to the hazard, e.g., a mask, a respirator.]. Porter [Insert description of the specific safety equipment relevant to the hazard, e.g., un masque, un respirateur.].
7. First aid statement (a) All FIRST AID TREATMENT PREMIERS SOINS
Contains [name of hazar-dous ingredients in descen-ding order of proportion]. Contient [name of hazar-dous ingredients in descen-ding order of proportion].
If swallowed, call a Poison Control Centre or doctor immediately. Do not induce vomiting. En cas d'ingestion, appeler immédiatement un centre antipoison ou un médecin. Ne pas provoquer le vomissement.
(b) Eyes If in eyes, rinse with water for [Insert appropriate period of time.]. En cas de contact avec les yeux, rincer avec de l'eau pendant [Insert appropriate period of time.].
(c) Dermal If on skin, rinse well with water. If on clothes, remove clothes. En cas de contact avec la peau, bien rincer avec de l'eau. En cas de contact avec les vêtements, enlever ceux-ci.
(d) Inhalation If breathed in, move person to fresh air. En cas d'inhalation, transporter à l'air frais la personne exposée.

Required information - sub-category "irritant"

(3) Subject to subsection (4), the container of a corrosive product that is classified in the sub-category "irritant" under section 41 must display, for each type of information specified in column 1 of the table to this subsection and for each applicable route of exposure set out in column 2, the information set out in columns 3 and 4, other than the instructions set out in italics.

Table to subsection 46(3) - >Required information - sub-category 'irritant'
Item


Column 1

Type of information
Column 2

Applicable route of exposure
Column 3

English
information
Column 4

French
information
1. Signal word Dermal CAUTION ATTENTION
2. Primary hazard statement Dermal IRRITANT IRRITANT
3. Specific hazard statement (a) Eye MAY IRRITATE EYES PEUT IRRITER LES YEUX
(b) Dermal MAY IRRITATE SKIN PEUT IRRITER LA PEAU
(c) Inhalation DANGEROUS FUMES FORM WHEN MIXED WITH OTHER PRODUCTS DÉGAGE DES ÉMANA-TIONS DANGEREUSES LORSQUE MÉLANGÉ AVEC D'AUTRES PRODUITS
4. Negative instructions (a) All When appropriate and before the other negative instructions: When appropriate and before the other negative instructions:
Do not mix with [Insert description of other products that react with the chemical product, such as toilet bowl or drain cleaners, bleach or ammonia.]. Ne pas mélanger avec [Insert description of other products that react with the chemical product, such as des nettoyants pour cuvettes de toilette ou tuyaux d'évacuation, des agents de blanchiment ou de l'ammoniaque.].
(b) Eyes Do not get in eyes. Éviter tout contact avec les yeux.
(c) Dermal Do not get on skin or clothing. Éviter tout contact avec la peau ou les vêtements.
(d) Inhalation Do not breathe fumes. Ne pas respirer les émanations.
5. Positive instructions All Keep out of reach of children. Tenir hors de la portée des enfants.
6. First aid statement (a) All FIRST AID TREATMENT PREMIERS SOINS
Contains [name of hazar-dous ingredients in order of decreasing proportion]. Contient [name of hazar-dous ingredients in order of decreasing proportion].
If swallowed, call a Poison Control Centre or doctor immediately. Do not induce vomiting. En cas d'ingestion, appeler immédiatement un centre antipoison ou un médecin. Ne pas provoquer le vomissement.
(b) Eyes If in eyes, rinse with water for [Insert appropriate period of time.]. En cas de contact avec les yeux, rincer avec de l'eau pendant [Insert appropriate period of time.].
(c) Dermal If on skin, rinse well with water. En cas de contact avec la peau, bien rincer avec de l'eau.

Exception - another primary hazard statement

(4) The primary hazard statement set out in columns 3 and 4 of item 2 of the table to subsection (3) may be omitted when other provisions in these Regulations require another primary hazard statement to be displayed on the container.

Discussion of CCCR, 2001 Section 46

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, corrosive product, first aid statement,
hazard symbol, hazardous ingredients, sub-category.

Requirements:

The wording for the warnings was developed through a consensus process, with the active collaboration of interested stakeholders, including the medical profession and public health organizations, the chemical industry, consumers' and seniors' groups, academia, technical experts and various federal government departments. During the label development, all sectors involved agreed that the regulations should prescribe mandatory warnings for the various hazard categories and sub-categories. The label statements are generic in terms of the hazard in order to be applicable to all types of consumer chemical products which fall within a particular sub-category. This ensures a constancy in the messages seen by consumers as well as a consistent set of rules for all companies. In addition, the general nature of the statements eliminates the need for ongoing regulatory amendments, but still provides the flexibility to add more specific information that may be appropriate to the chemical product.

All of the appropriate statements are required for all applicable routes of exposure. Statements may be combined. However, if a person under reasonably foreseeable use of the product cannot be exposed through a specific route, then it is not considered applicable, and the warnings are not required for that route of exposure.

Presentation Requirements:

See sections 17 to 32 of the CCCR, 2001 for the presentation format of the required information.

Irritants:

Unlike corrosive materials, the irritant hazard does not warrant the use of a symbol, due to the reversible nature of health effects upon exposure. The signal word "CAUTION" indicates the lower degree of hazard associated with exposure to the product. This signal word and primary hazard statement are not required for products that are an eye irritant only. In addition, the primary hazard statement "IRRITANT" may be omitted for products which already require a primary hazard statement from another sub-category. The intent of labelling on the main display panel is to direct a user to the safe usage and first aid labelling elsewhere on the product. This objective will have been met by the signal word and primary hazard statement for toxicity, corrosivity or flammability that already appears on the main display panel.

Mixing:

The specific hazard statement and negative instructions related to mixing is intended to warn of the hazard when a consumer chemical product is mixed with another product, such as bleach and household ammonia, or acidic toilet-bowl cleaner and bleach. These are documented foreseeable uses of consumer chemical products. The intent is to discourage a user from mixing any product not specifically identified as suitable for mixing on the directions for use.

These statements are only required when appropriate to the product. If there is no mixing issue with the product, then the specific hazard statement need not be used. This is consistent with the negative instruction, where the "do not mix with..." statement is only used when appropriate.

First Aid Statement:

Only those hazardous ingredients present at least at 1% and which directly contribute to the classification of the product must be listed immediately after the words "FIRST AID TREATMENT" and "PREMIERS SOINS". The use of the words "may contain" and other phrases which leave some ambiguity as to the composition and, consequently, the health hazard of the product, is discouraged.

Wiping Cloths

A wiping cloth that contains a consumer chemical product may not pose a significant oral hazard. For example, it is unlikely that a cleanser absorbed into a cloth would be ingested, as long as the mixture cannot be squeezed-out. The statement "If swallowed, call a Poison Control Centre or doctor immediately" is not required for products in which a liquid is absorbed onto a solid, semi-solid or fibrous material, as long as the liquid cannot be released from the substrate material with any reasonably foreseeable conditions of use or manipulation.

It is recommended that written records be kept of the decisions and justifications taken in this regard, so that, if necessary, a Product Safety inspector may review the rationale for this action.

Additional Statements:

The required labelling is the minimum necessary, and is an indication of the minimum standard of care imposed on a person responsible. Manufacturers and importers can add, and are encouraged to add, information considered necessary to fully inform the public of the hazards of using their products (see subsection 15(2)). In composing these statements, use short, simple sentences. Complex conditional sentences, particularly those containing negations, should be avoided. In addition, a person will remember the important product related information better, if fewer dimensions or items are listed.

However, the person responsible is discouraged from deliberately over-stating the hazards posed by a product. If unwarranted warnings are added to products, it may lead to potentially lengthy and unnecessary or inappropriate treatment upon exposure to the product. Furthermore, such a practice minimizes the perception of risk for those products which actually need the warnings, leading to potential injuries from a lack of concern or precaution by the user.

Cement

To assist consumers who are working with cement, containers of dry cement may add the phrase "forms calcium hydroxide when wet / fait de l'hydroxyde de calcium lorsque trempé", or a similar phrase that conveys the same meaning.

Inhalation Hazards

When a corrosive product poses an inhalation hazard, a specific hazard statement such as "IRRITATING FUMES RELEASED WHEN USED / DÉGAGE DES ÉMANATIONS LORS DE SON UTILISATION" may be added. This would not contradict the CCCR, 2001 labelling, but it would help the person responsible meet their obligations to warn of the hazards posed by their product.

Section 47 - Part 2 - Corrosive Products - Child-resistant Containers

Sub-categories "very corrosive" and "corrosive"

47. Subject to section 14, a corrosive product must be in a child-resistant container that complies with sections 9 to 13 if the product has been classified in accordance with section 41

  • a) in the sub-category "very corrosive" and is listed in the or table to section 45;
  • b) in the sub-category "corrosive".

Discussion of CCCR, 2001 ection 47

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, corrosive product, sub-category.

Requirements:

Chemical products that are classified as very corrosive or corrosive are required to be packaged in child-resistant containers because of the likelihood to death or severe injury should a child come into contact with the product.

See sections 9 to 13 for the design and performance requirements for child-resistant containers. In general, these requirements make it difficult for a child under five years of age to open the container and make contact with the corrosive product within a reasonable time. This requirement means that some children may still be able to open a container if given sufficient time to do so.

Exceptions:

Large Containers

Containers of chemical products classified in the "corrosive" subcategory need not be child-resistant if they have a capacity of greater than 5L. This exception does not apply to products classified in the "very corrosive" subcategory (see section 14).

Sections 48 and 49 - Part 3 - Flammable Products - Classification of Flammable Products

Data sources and tests

48. (1) The person responsible for a flammable product must determine the appropriate sub-category for the product in accordance with section 49 using human experience data or the results of tests conducted in accordance with the test methods set out in sections 50 to 52 and Schedule 1.

Exemption

(2) A flammable product that is classified in the sub-category "combustible" is exempt from the requirements of this Part if it

  • (a) is composed of 50% or more of water and 50% or less of water-miscible solvent; and
  • (b) does not sustain combustion when tested in accordance with Test L.2.

Sub-categories of hazard category "Category 3, flammable products"

49. (1) A flammable product described in column 1 of the table to this subsection must be classified in the sub-category set out in column 2.

Table to Subsection 49(1) - Sub-categories of hazard category 'Category 3, flammable products'
Item Column 1

Product Description
Column 2

Sub-category
1. A product that spontaneously combusts under reasonably foreseeable conditions of use Spontaneously Combustible
2. A product that heats spontaneously on contact with air to the point that it begins to burn Spontaneously Combustible
3. A liquid, other than a liquid in a spray container, that has a flash point, determined in accordance with one of the standards set out in section 50, of  
(a) less than −8.0°C; Very Flammable
(b) −18.0°C or more but not more than 37.8°C; or Flammable
(c) more than 37.8°C but not more than 60.0°C Combustible
4. A solid, paste or gel that emits a vapour that has a flash point, determined in accordance with the standard set out in section 51, of  
(a) less than −8.0°C; Very Flammable
(b) −18.0°C or more but not more than 37.8°C; or Flammable
(c) more than 37.8°C but not more than 60.0°C Combustible
5. A gas, other than a gas in a spray container, that forms a flammable mixture with air at a concentration of 13% or less by volume at normal atmospheric pressure Flammable
6. A gas, other than a gas in a spray container, that forms a flammable mixture with air over a concentration range of 12% or more by volume at normal atmospheric pressure Flammable
7. A liquid or gas in a spray container that, when tested in accordance with the procedure set out in Schedule 1,  
(a) has a flame projection of 100 cm or more; Very Flammable
(b) has a flame projection of 15 cm or more but less than 100 cm; or Flammable
(c) exhibits a flashback Very Flammable

Flammable liquid in a refillable spray container

(2) In the case of a liquid flammable product in a refillable spray container, the person responsible must

  • (a) determine both the product's flash point, in accordance with section 50, and its flame projection and flashback, in accordance with section 52; and
  • (b) classify the product in the most flammable sub-category of the applicable sub-categories as determined under items 3 and 7 of the table to subsection (1).

Discussion of CCCR, 2001 Sections 48 and 49

Definitions:

The following terms are defined in section 1 of the CCCR, 2001: flammable product, flame projection, flash point, flashback, human experience data, normal atmospheric pressure, person responsible, spray container, sub-category, Test L.2, vapour.

Requirements:

Sections 48 and 49 set out the steps for classifying a product into the flammable product sub-categories: spontaneously combus-tible, very flammable, flammable and combustible. The criteria describe products that are hazardous because they can catch fire. The distinction between sub-categories is the ease of ignition or length of flame projection.

Spontaneous Combustion:

Many liquid or paste products are intended to be used with a rag for cleaning, rubbing or polishing purposes. A used rag that is not washed right away or not disposed of properly may create the conditions for a fire caused by spontaneous combustion. Spontaneous combustion means that the rag may begin to burn by itself, without a source of ignition. It is a complex process, involving the ignition of a combustible material through the heat of a chemical reaction.

One of the best known examples of spontaneous combustion is when a drying oil, such as linseed oil, is absorbed on a cotton rag. The drying oil slowly takes oxygen from the air to form a solid skin. This is an oxidation reaction, which produces heat. If the oil is spread over a surface, such as wood, the heat from oxidation is dissipated quickly. However, if the oil is absorbed into a crumpled-up rag, the heat cannot escape very well, and the temperature of the rag rises. This, in turn, speeds-up the rate of oxygen absorption and further increases the temperature. If this process continues, the temperature of the oil-soaked rag may gradually rise enough for it to ignite.

Some common drying oils are: linseed oil, tung oil, cottonseed oil, corn oil, soybean oil, safflower oil, walnut oil and poppyseed oil. Not all products containing these substances are prone to spontaneous combustion, especially if they have been mixed with anti-oxidant substances which inhibit drying. Furthermore, the criteria are limited to product uses that would cause spontaneous combustion under reasonably foreseeable conditions, for example, a product that must be applied with a rag or other combustible material.

Since spontaneous combustion poses a distinct flammability hazard from ignition by a flame, labelling for spontaneous combustion must be present in addition to that for another flammable sub-category, if required (see subsection 4(4)).

Human Experience

Subsection 48(1) allows a classification based upon human experience data with the product. Fire investigation reports are a useful source of information on the initial sources of a fire. This may be particularly useful in classifying a product as a spontaneous combustion hazard under reasonably foreseeable conditions of use.

Combustible:

Combustible products do not ignite readily but may add to the fire load, and should therefore not be stored in areas prone to fires, such as in furnace or electrical rooms. Canadian Fire Service organizations have expressed concern about combustible materials, and suggested households be informed that combustible products must be stored properly. The criteria classifies a product that may flash at normal living temperatures, with 60.0°C being considered at the outside range of "normal" in Canada. For example, this temperature can easily be reached in a car's trunk on a warm sunny day.

Exemption - Water-Based Products

Certain water-based products will not sustain combustion after the initial surface flash. For ex-ample, many dishwashing liquids contain a moderate amount of low molecular weight alcohols and will flash between 37.8 and 60°C, but will not continue to burn. Subsection 48(2) allows an exemption for water-based products that flash in the "combustible" range so long as they are made-up mostly of water (≥ 50%) and will not sustain combustion according to Test L.2.

The Product Safety Laboratory has tested various mixtures of water and methanol, as well as water and acetone. The test results indicate that products with a greater than 70/30 mix of water/methanol would not sustain combustion. As the water content was reduced, combustion was sustained for progressively longer periods of time. It was also observed that the flame colour was blue and not easily visible in daylight, creating a hidden hazard since a user may not be aware that the product has caught fire. A similar result occurred for acetone, though the flame was a common yellow colour, which was more visible during daylight.

Solids/Pastes/Gels:

This item captures only products which emit vapours during testing. These vapours may flash, and if so, the results determine if the product meets the criteria. Products which are rigid solids that do not emit vapours, such as paper products, would not be classified.

Gases:

Items 5 and 6 of the table to subsection 49(1) capture compressed gas cylinders, such as propane for barbeques and butane curling-iron cartridges. Three conditions have to be met in order to ignite a flammable gas:

  • the concentration of the gas has to be within the range that the gas is capable of igniting, meaning between the lower and upper flammable limits of the gas;
  • an oxidizing gas, such as air, must be present; and
  • a source of ignition has to be available.

The lower flammable limit is the minimum concentration (% by volume) of a gas in air below which a flame is not generated when an ignition source is present. That is, the mixture is "too lean" to burn. Similarly, the upper flammable limit is the maximum concentration above which the mixture is "too rich" to burn. The flammable limits are sometimes also referred to as the "explosive limits".

The greater the range or spread over which a gas forms a flammable mixture, the greater the likelihood is that such conditions may occur. Similarly, gases which can ignite at relatively low concentrations (13% or less) in air would be particularly hazardous because of the likelihood that a potential flammable mixture can occur, such as in the event of a leak. For example, hydrogen, with flammability limits of 4-75%, meets both items 5 and 6, but 1,3-butadiene, with flammability limits of 2-12%, meets only item 5. Other examples of flammable gases include: propane (flammable at 2.3-9.5%), butane (flammable at 1.9-8.5%) and acetylene (flammable at 2.5-82%).

Spray Containers:

Spray containers are classified based on the flame projection and flashback of the product, and not by the flammable gas used as a propellant. The flame projection test considers the design of the entire product, including the propellant, if present, as well as the spray characteristics from the nozzle or trigger design.

A pump-spray container can significantly increase the flammability of a substance by producing a mixture of the substance with air that is much more flammable than the substance alone, even though no propellant is used. For example, a ski care product packaged in a pump-spray container was tested by the Product Safety Laboratory in 1990. This product had a flash point of more than 65.5°C, but the flame projection from the container was between 15 and 45 cm.

A refillable spray container usually refers to a pump-spray container, where the nozzle apparatus can be unscrewed at the neck and the contents poured-in through the neck opening. Since a person may be exposed to the product or to the spray, it must be tested for both the flash point as well as the flame projection and flashback, and the product is classified into the higher level of hazard (subsection 49(2)).

Aerosol Foams, Caulking, and Spray-String Products

Not all pressurized containers are spray containers, only those containers that permit release in the form of a mist are included in item 7 to the table to subsection 49(1). Mist is defined as:

"droplets of liquid suspended in air that are produced by the condensation of vapourized liquid or by the dispersion of a liquid by a spray container".

A pressurized container that emits a product only in the form of foam, paste or string would not be considered to be a spray container. Hence, the flame projection and flash back criteria do not apply to an insulating foam, a caulking product or a novelty string packaged in an aerosol container, unless it is also possible to release the contents in the form of a mist.

However, the flame projection test is appropriate to assess the hazard posed by aerosol products that are released in the horizontal plane, like a conventional aerosol spray container (for example, novelty string products). Such products should be assessed in a similar way as re-fillable spray containers (s. 49(2)): determine the product's flammability using the flame projection and flash back criteria (item 7) as well as the flash point of the solid emitted (item 4) and the flammable gas criteria, if it is possible for pure propellant to be released (items 5 and 6), and classify into the most flammable sub-category. This gives the safest classification.

Aerosol products that are not released horizontally can represent a greater flammability hazard than conventional aerosol containers. For example, the container for foams or mousses are generally operated from the upside-down position. Operating such products in the upright position could cause pure propellent, such as propane or butane, to be released, since the foam or caulking product would be settled at the bottom of the container. It is often the practice to expel pure propellant to clean the nozzle after using such products. As a result, consumers would unexpectedly encounter a situation where pure highly flammable hydrocarbon gas is expelled from the container. To classify such products, it is recommended that both the flash point criteria for the solid, paste or foam, be assessed (item 4) as well as the flammable gas criteria for the propellant, if it is possible for pure propellant to be released (items 5 and 6), and classify into the most flammable sub-category.

Harmonization with the WHMIS Controlled Products Regulations:

The CCCR, 2001 criteria for gases are exactly the same as those for workplace chemicals under the requirements of WHMIS Division 1 of Class B (flammable gases).

For liquids, the "flammable" classification has the same limit as WHMIS Division 2 of Class B (flammable liquids), however WHMIS does not distinguish a "very flammable" subcategory. The sub-category "very flammable" is intended for products which are too hazardous to be routinely made available to consumers who lack the specialized knowledge and training to use such products. The average household does not have in place the engineering controls necessary to react to the hazards posed by these products. The upper flash point criteria for the "combustible" sub-category harmonizes with the Transportation of Dangerous Goods Regulations, but the WHMIS criteria for Division 3 of Class B (combustible liquids) sets the upper limit at 93.3°C, which is inappropriate for household conditions. Temperatures of 93.3°C, while being encountered in industrial settings, would rarely be met in the consumer environment.

With respect to solids, the CCCR, 2001 are not harmonized with WHMIS Division 4 of Class B (flammable solids).

For spray containers, WHMIS classifies aerosol containers according to the same flame-projection test in Division 5 of Class B (flammable aerosols), but not pump-spray containers. Furthermore, WHMIS does not distinguish a "very flammable" subcategory for aerosol sprays.

Finally, the criteria for spontaneous combustion in the CCCR, 2001 is also included in WHMIS Division 6 of Class B (reactive flammable materials).

Sections 50 to 52 - Part 3 - Flammable Products - Test Methods

Flash point - liquids

50. A flammable product in the form of a liquid must be tested for its flash point in accordance with the following standards:

  • (a) for liquids that have a viscosity of less than 5.8 mm2/s at 37.8°, ASTM D 56 or ASTM D 3828; and
  • (b) for liquids that have a viscosity of 5.8 mm2/s or more at 37.8°, ASTM D 93.

Flash point - solids, pastes and gels

51. A flammable product in the form of a solid, paste or gel must be tested for its flash point in accordance with ASTM D 56.

Flame projection and flashback - spray container

52. A flammable product that is enclosed in a spray container must be tested for its flame projection and flashback in accordance with the procedure set out in Schedule 1.

Discussion of CCCR, 2001 Sections 50 to 52

Definitions:

The following terms are defined in section 1 of the CCCR, 2001: flame projection, flashback, flammable product, flash point, spray container, ASTM D 56, ASTM D 93, ASTM D 3828.

Requirements:

Sections 50 to 52 provide the test methods for assessing and classifying flammable products.

Flash point:

All of the methods specified for flash point are closed-cup techniques in which the vapour is enclosed in the space above the product being tested. Open-cup techniques, where the vapour can dissipate, tend to yield flash points with values higher than those obtained with closed-cup methods. The liquid test methods are the same methods that suppliers have used to comply with the Controlled Products Regulations (WHMIS).

Section 50 recognizes that the viscosity of a liquid influences the choice of test most appropriate for measuring an accurate flash point. Although the ASTM standards express kinematic viscosity in the units of centistokes (cSt) or stokes, one centistoke equals one mm2/s. No test method for viscosity is specified because this is a standard laboratory practice. Any test method which conforms to the principals of good laboratory practices may be used to determine the viscosity.

Paragraph 50(a) is used for liquids which are very fluid and pourable, whereas paragraph 50(b) is used for liquids which are thicker. Very thick substances will, by their nature, inhibit free solvent evaporation and the stirring capabilities of the test apparatus in paragraph 50(b) will alleviate this restriction. Stirring ensures a uniform distribution of heat. In addition, sample pre-conditioning will take care of the difficulties of mixing too viscous of a product at very low temperatures. Sampling section 8.5 in ASTM D 93 states that:

"...samples of very viscous materials can be warmed until they are reasonably fluid before they are tested. However, no sample should be heated more than is absolutely necessary."

There are two different procedures in the test method to address various conditions of samples: one is for fuel oils, lubricating oils and other homogeneous liquids; and the other is for liquids that tend to form a surface film, liquids with suspensions of solids and non-homogeneous liquids.

Section 51, for solids, pastes and gels, is a variation of the flammable liquid method. It classifies only products which emit vapours during testing. These vapours may flash, and if so, the results determine if the product meets the criteria. Products which are rigid solids that do not emit vapours, such as paper products, would not be classified.

Estimation of Flash Point

The practice of estimating the flash point of the finished product, based on the flash points of the individual components, is not acceptable. These physical properties may not always be accurately extrapolated from similar products or individual ingredients. Sections 50 to 52 give standard test methods to ensure that all manufacturers are testing and classifying products in the same manner, thus resulting in similar labelling for the same hazards.

Spray Containers:

The flame projection and flashback test in Schedule 1 assesses a spray container when it is in the upright position and the spray is emitted horizontally.

Pump-spray containers are evaluated at each nozzle position. If a spray container is packaged with a tube that is intended to be inserted into the nozzle, such as certain automotive lubricants, the container is evaluated with and without the tube.

At present, the criteria are limited to spray containers, and do not apply to insulating foams or caulking products, unless it is possible to release the contents in the form of a mist. However, when these containers are in the upright position, pressing the nozzle could release pure propellant. This situation could be hazardous, if the propellant is highly flammable, such as propane or dimethyl ether. In such cases, it is recommended that both the flash point criteria for the product be assessed as well as the flammable gas criteria for the propellant, if it is possible for pure propellant to be released, and classify into the most flammable sub-category (see section 49 of the CCCR, 2001).

New ⇒ Solid Impregnated with Liquid (ie. Wetnap):

A solid product that is impregnated (or soaked) in a liquid chemical product is treated as a flammable solid when tested according to s.51. This is because the final product is in the form of a solid; similarly, s.51 applies to pastes and gels and they too are solids which have been impregnated with liquids, but are mixed and given a gel/paste consistency.

Section 53 - Part 3 - Flammable Products - Very Flammable Products

Prohibition and exceptions

53. The advertising, sale or importation of a flammable product that is classified in the sub-category "very flammable" under section 48 is prohibited unless the product is set out in column 1 of the table to this section and meets the conditions set out in column 2.

Table to Subsection 53 - Conditions for advertising, selling or importing a very flammable product
Item

Column 1

Chemical product
Column 2

Conditions
1. A fuel, such as gasoline, ethanol or propane

The container of the fuel

  • (a) is permanently attached to an internal combustion engine, a gas turbine or an appliance that uses the fuel; or
  • (b) is separate or detachable from the internal combustion engine, gas turbine or appliance that uses the fuel and displays the information set out in the table to subsection 54(1).
2. A product that exhibits a flashback The container of the product displays the information set out in the table to subsection 54(1).

Discussion of CCCR, 2001 Section 53

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, flammable product, flashback,
sub-category.

Requirements:

Chemical products classified as very flammable are prohibited in general, because they are too hazardous for household use without specialized training and equipment.

The following table lists examples of very flammable substances. These substances may also be classified and restricted by other hazard criteria.

Table: Examples of Very Flammable Substances
Substance Flash point (°C)
(closed cup)
Substance Flash point (°C)
(closed cup)
Acetaldehyde -38 Isopropylamine -37
2-Butanethiol -23 Methylcyclopentane -23
Carbon Disulphide -30 2-Methyl-2-Propanethiol < - 29; - 24
Cyclohexane -20 Methyl Formate -20
Cyclopentane -37 Isopentane -51
Diethylamine - 28; - 23 Jet B - 23 to - 1
Diethyl Ether -45 JP Fuel - 23 to - 1
Dimethylamine 40% -18 Gasoline -43
  60% -51.7 n-Hexane -21.7
2,2-Dimethyl Butane -48 Methyl tertiary Butyl Ether -28
Ethylamine (anhydrous) < - 18
(liquid: < - 16.6°C)
Methyl Formate -19
n-Pentane -49
Ethylamine solutions: 70% -25 1-Propanethiol -20.6
Ethyl Mercaptan (ethanethiol) -48.3 2-Propanethiol -35
Isoheptane -3; -1; < -18 n-Propylamine -37
Isohexane -32    
New ⇒ Acetone

The flash point for acetone is often reported as -18°C. The Product Safety Laboratory has tested various brands of acetone available for consumer use. The test results indicate that the flash points of these products were above −18.0°C. Hence these products were not classified as very flammable. However, the results were so close to the classification limit, that the confidence intervals for some products included values below -18°C. It is the responsibility of the manufacturer or importer of acetone that is destined for consumer use to ensure that their products have a flash point of -18°C or greater.

Exceptions:

Fuels

Very flammable fuel, such as gasoline, is not prohibited. If the fuel tank is directly connected to the engine or appliance that uses the fuel, such as an automobile, lawn mower or home heating fuel tank, then no precautionary labelling is required. This is due to the limited exposure to the chemical product during reasonably foreseeable use of the engine or appliance and since there are standards commonly set in other legislation, such as the Motor Vehicle Safety Act and Regulations.

However, fuel containers that are detached or able to be detached must be appropriately labelled. Such containers include naphtha reservoirs for camp stoves, small propane tanks for welding, barbecue cylinders, bench-top brulé apparatuses, and butane tanks for lighters and hair curling irons. If the fuel container can be separated from the appliance by the consumer, then it is likely to be stored separately from the appliance, and so it must be labelled for the flammability of the substances within.

Flashback

The exception of item 2 to the table to section 53 applies only to products that are classified as "very flammable" because they have a flashback. If a flashback is recorded during testing, the product is not prohibited if it meets the required labelling.

The exception does not apply to products classified by the other "very flammable" criteria in addition to flashback, for example, spray containers that have a flame projection of 100 cm or more, or refillable spray containers that contain a liquid with a flash point of less than -18°C.

Other exceptions from prohibition may be requested, but the granting of such an exception involves a regulatory amendment to the CCCR, 2001 in accordance with the Canadian Federal Regulatory Process. A submission to Health Canada to request an exception from prohibition must clearly show the following:

  • no other less hazardous alternative exists and is readily available or technically feasible;
  • the benefits of the product outweigh the high degree of hazard to the user; and
  • any other information which supports the request to allow a very hazardous product into the hands of the general public.

Health Canada will exercise its discretionary authority regarding the request and may make its permission subject to restrictions on the packaging, labelling or conditions of sale. Once the Regulations have been amended, the exception would apply to all products meeting the amendment conditions.

Section 54 - Part 3 - Flammable Products - Required Information

Required information - sub-category "very flammable"

54. (1) When a flammable product classified in the sub-category "very flammable" under section 48 has an information requirement under the table to section 53, the container of the product must display, for each type of information set out in column 1 of the table to this subsection, the information set out in columns 2 and 3, other than the instructions set out in italics.

Table to subsection 54(1) - Required information - sub-category 'very flammable'
Item Column 1

Type of information
Column 2

English information
Column 3

French information
1. Hazard symbol
2. Signal word EXTREME DANGER DANGER EXTRÊME
3. Primary hazard statement VERY FLAMMABLE TRÈS INFLAMMABLE
4. Specific hazard statement CONTENTS MAY CATCH FIRE LE CONTENU PEUT S'ENFLAMMER
or, when only the vapour or fume poses a hazard: or, when only the vapour or fume poses a hazard:
FUMES MAY CATCH FIRE LES ÉMANATIONS PEUVENT S'ENFLAMMER
5. Negative instructions Do not smoke. Ne pas fumer.
6. Positive instructions Use only in a well-ventilated area. Keep away from flames, such as a pilot light, and any object that sparks, such as an electric motor. N'utiliser que dans un endroit bien aéré. Tenir loin des flammes, telle une flamme pilote, et de tout objet produisant des étincelles, tel un moteur électrique.

Required information - sub-category "flammable"

(2) The container of a flammable product that is classified in the sub-category "flammable" under section 48 must display, for each type of information set out in column 1 of the table to this subsection, the information set out in columns 2 and 3, other than the instructions set out in italics.

Table to Subsection54(2) - Required information - sub-category 'flammable'
Item Column 1

Type of information
Column 2

English information
Column 3

French information
1. Hazard symbol
2. Signal word DANGER DANGER
3. Primary hazard statement FLAMMABLE INFLAMMABLE
4. Specific hazard statement CONTENTS MAY CATCH FIRE LE CONTENU PEUT S'ENFLAMMER
or, when only the vapour or fume poses a hazard: or, when only the vapour or fume poses a hazard:
FUMES MAY CATCH FIRE LES ÉMANATIONS PEUVENT S'ENFLAMMER
5. Negative instructions Do not smoke. Ne pas fumer.
6. Positive instructions Use only in a well-ventilated area. Keep away from flames, such as a pilot light, and any object that sparks, such as an electric motor. N'utiliser que dans un endroit bien aéré. Tenir loin des flam-mes, telle une flamme pilote, et de tout objet produisant des étincelles, tel un moteur électrique.

Required information - sub-category "spontaneously combustible"

(3) The container of a flammable product that is classified in the sub-category "spontaneously combustible" under section 48 must display, for each type of information set out in column 1 of the table to this subsection, the information set out in columns 2 and 3.

Table to Subsection54(3) - Required information - sub-category 'spontaneously combustible'
Item Column 1

Type of information
Column 2

English information
Column 3

French information
1. Hazard symbol
2. Signal word CAUTION ATTENTION
3. Primary hazard statement READ INSTRUCTIONS BEFORE USING LIRE LES INSTRUCTIONS AVANT USAGE
4. Specific hazard statement DANGER OF COMBUSTION DANGER DE COMBUSTION
5. Positive instructions Materials such as rags used with this product may begin to burn by themselves. After use, put rags in water or lay flat to dry, then discard. Les matériaux, utilisés avec ce produit, tels les chiffons, peuvent s'enflammer spontanément. Après utilisation, mettre les chiffons dans l'eau ou les sécher à plat, puis les jeter.

Required information - sub-category "combustible"

(4) The container of a flammable product that is classified in the sub-category "combustible" under section 48 must display, for each type of information set out in column 1 of the table to this subsection, the information set out in columns 2 and 3.

Discussion of CCCR, 2001 Section 54

Table to Subsection54(4)
Required information - sub-category 'combustible'
Item Column 1

Type of information
Column 2

English information
Column 3

French information
1. Positive instructions Keep away from flames or sparks. Tenir loin des flammes et des étincelles.

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, flammable product, fume, fumes, hazard symbol, subcategory, vapour.

Requirements:

The wording for the warnings was developed through a consensus process, with the active collaboration of interested stakeholders, including the medical profession and public health organizations, the chemical industry, consumers' and seniors' groups, academia, technical experts and various federal government departments. During the label development, all sectors involved agreed that the regulations should prescribe mandatory warnings for the various hazard categories and sub-categories. The label statements are generic in terms of the hazard in order to be applicable to all types of consumer chemical products which fall within a particular sub-category. This ensures a constancy in the messages seen by consumers as well as a consistent set of rules for all companies. In addition, the general nature of the statements eliminates the need for ongoing regulatory amendments, but still provides the flexibility to add more specific information that may be appropriate to the chemical product.

Presentation Requirements:

See sections 17 to 32 of the CCCR, 2001 for the presentation format of the required information.

Additional Statements:

The required labelling is the minimum necessary, and is an indication of the minimum standard of care imposed on a person responsible. Manufacturers and importers can add, and are encouraged to add, information considered necessary to fully inform the public of the hazards of using their products (see subsection 15(2)). In composing these statements, use short, simple sentences. Complex conditional sentences, particularly those containing negations, should be avoided. In addition, a person will remember the important product related information better, if fewer dimensions or items are listed.

However, the person responsible is discouraged from deliberately over-stating the hazards posed by a product. If unwarranted warnings are added to products, it may minimize the perception of risk for those products which actually need the warnings, leading to potential injuries from a lack of concern or precaution by the user.

Sections 55 and 56 - Part 4 - Quick Skin-bonding Adhesives - Required Information

Required instructions and first aid statement

55. The container of a quick skin-bonding adhesive must display the instructions and first aid statement set out in section 56 in the manner set out in sections 17 to 20, 24, 25 and 29 to 32.

Required information

56. (1) Subject to subsection (2), the container of a quick skin-bonding adhesive must display, for each type of information set out in column 1 of the table to this subsection, the information set out in columns 2 and 3.

Table to Subsection 56(1) Required information - quick skin-bonding adhesives
Item Column 1

Type of information
Column 2

English information
Column 3

French information
1. Signal word Caution Attention
2. Primary hazard statement Bonds skin instantly Colle rapidement la peau
3. Negative instructions Do not get in eyes or mouth or on skin. Éviter tout contact avec les yeux, la peau et la bouche.
4. Positive instructions Keep out of reach of children. Tenir hors de la portée des enfants.
5. First aid statement First aid Treatment premiers soins
Contains [name of hazardous ingredients in descending order of proportion]. Contient [name of hazardous ingredients in descending order of proportion].
Eyelid bonding: see a doctor. Skin bonding: soak skin in water and call a Poison Control Centre. Do not force apart. Paupières collées : consulter un médecin. Peau collée : tremper dans l'eau et appeler un centre antipoison. Ne pas forcer pour décoller.

Exception - main display panel less than 35 cm2

(2) The container of a quick skin-bonding adhesive that has a main display panel of less than 35 cm2 need only display the information set out in columns 2 and 3 of items 2 and 5 of the table to subsection (1) in the height and body size of type set out in subsection 24(3).

Discussion of CCCR, 2001 Sections 55 and 56

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, first aid statement, hazardous ingredient,
main display panel, quick skin-bonding adhesive.

Requirements:

Sections 55 and 56 set out the labelling required for quick skin-bonding adhesives. The criteria for classifying a quick skin-bonding adhesive is in the definition:

"quick skin-bonding adhesive" means a Category 4 adhesive set out in Part 4 that has properties similar to an alkyl cyanoacrylate adhesive and that is capable of bonding skin with skin instantly or nearly instantly.

Alkyl cyanoacrylates are monomers with relatively low viscosities. Alkyl cyanoacrylate is a general term, indicating that there is one carbon atom double-bonded to an oxygen atom and two carbon atoms bonded to another oxygen atom somewhere in the molecule (see illustration).

Line diagrams for four different alkyl cyanoacrylate substances (Methyl cyanoacrylate ester, alkyl cyanoacrylate ester, ethyl cyanoacrylate ester, and ethoxymethyl cyanoacrylate ester) showing their relative similar molecular structures; particularly the one carbon atom double-bonded to an oxygen atom and two carbon atoms bonded to another oxygen atom elsewhere in the same molecule.

Methyl cyanoacrylate ester:

Illustration of formula for Methyl cyanoacrylate ester

Allyl cyanoacrylate ester:

Illustration of formula for Allyl cyanoacrylate ester

Ethyl cyanoacrylate ester:

Illustration of formula for Ethyl cyanoacrylate ester

Ethoxymethyl cyanoacrylate ester:

Illustration of formula for Ethoxymethyl cyanoacrylate ester

Cyanoacrylate adhesives set in the presence of weak bases, such as water. Moisture is always present in the skin, so cyanoacrylate adhesives tend to set instantly on the skin. Alkyl cyano-acrylates are monomers with relatively low viscosities, so they flow readily from a container and run down the skin or into the eyes, increasing the likelihood of eye or skin exposure. Tissue damage will often result if an attempt is made to force apart the bonded tissues.

Typically, cyanoacrylate glues that are in common household use have been applied to the eye mistakenly as eye drops, causing immediate brief smarting, and firm gluing of the lids together. The glue may cause haze in the cornea and inflammation, but generally without significant permanent injury, except where forceful means were used to separate the bonded tissue.

The ease of separation of bonded skin depends upon the exact chemical composition of the adhesive, the age of the bond and the solvent used. It is easier to break the bonds soon after setting has begun, rather than later. Warm water may be all that is necessary. Acetone may also be used. Other solvents are available but are themselves irritating or toxic. In the absence of tissue-to-tissue bonding, it is best not to attempt to peel off the adhesive. Sweat or other secretions will eventually accumulate under the adhesive film and cause it to lift off.

Presently, alkyl cyanoacrylate adhesives are the only single-component adhesives which pose this hazard. Two component adhesives do not pose such a hazard because the mixing required to activate the adhesive is a deliberate act involving cognition. It is unlikely that a young child would access the two components and mix them prior to being exposed, or that a two-part adhesive would be mistaken for eye drops.

However, the pace of change in the consumer chemical market makes it likely that new types of fast bonding adhesives will appear in the future. The classification criteria are intentionally open, to encompass future products which may pose a similar hazard.

Since there is currently no physical test to quantitatively characterize adhesives that quickly bond the skin, no attempt was made to establish a criteria which might lead to animal testing. There are some promising developments in using "artificial" skin, but no test based on these materials is currently available.

The terms "instantly or nearly instantly" do not specify a set time period because the key words in the definition are "bonding skin with skin". If the product can bond skin with skin, then the hazard exists and the time it takes for the bonding to occur is less relevant. However, the faster the adhesive bonds, the less time a person has to react to prevent skin bonding from occurring, by washing-off the adhesive.

Exception - Cosmetics:

Cyanoacrylate adhesives sold in artificial fingernail kits are subject to the Cosmetic Regulations under the Food and Drugs Act and, therefore, are excluded from the jurisdiction of the Hazardous Products Act.

Required Information:

The wording for the warnings was developed through a consensus process, with the active collaboration of interested stakeholders, including the medical profession and public health organizations, the chemical industry, consumers' and seniors' groups, academia, technical experts and various federal government departments. During the label development, all sectors involved agreed that the regulations should prescribe mandatory warnings for the various hazard categories and sub-categories. The label statements are generic in terms of the hazard in order to be applicable to all types of consumer chemical products which fall within a particular sub-category. This ensures a constancy in the messages seen by consumers as well as a consistent set of rules for all companies. In addition, the general nature of the statements eliminates the need for ongoing regulatory amendments, but still provides the flexibility to add more specific information that may be appropriate to the chemical product.

Presentation Requirements:

See sections 17 to 32 of the CCCR, 2001 for the presentation format of the required information.

Additional Statements:

The required labelling is the minimum necessary, and is an indication of the minimum standard of care imposed on a person responsible. Manufacturers and importers can add, and are encouraged to add, information considered necessary to fully inform the public of the hazards of using their products (see subsection 15(2)). In composing these statements, use short, simple sentences. Complex conditional sentences, particularly those containing negations, should be avoided. In addition, a person will remember the important product related information better, if fewer dimensions or items are listed.

However, the person responsible is discouraged from deliberately over-stating the hazards posed by a product. If unwarranted warnings are added to products, it may lead to potentially lengthy and unnecessary or inappropriate treatment upon exposure to the product. Furthermore, such a practice minimizes the perception of risk for those products which actually need the warnings, leading to potential injuries from a lack of concern or precaution by the user.

Small Containers:

Inappropriate first aid treatment is the greatest hazard in the case of cyanoacrylate adhesives, which are generally sold to consumers in 1 to 5 mL tubes. Users may tear their skin while pulling apart bonded tissues. For such products, a requirement for the primary hazard statement and first aid statement is appropriate, even when packaged in small containers with a main display panel of less than 35 cm2. For this reason, and because there is no hazard symbol, quick skin-bonding adhesives are not subject to the small container exemption of subsection 25(2).

Nevertheless, since very small packages of quick skin-bonding adhesives may not have space to print the required information in 6 point and 2 mm type, there is an exemption to be able to use 4.5 point and 1.5 mm type where the main display panel is less than 10 cm2 (see subsection 24(3)). The minimum size requirements for quick skin-bonding adhesives are summarized below:

Minimum Size Requirements - Quick Skin-Bonding Adhesives
Area of Main Display Panel
(cm2)
Hazard Symbol
(mm)
Signal Word
(mm)
Hazard Statements, Instructions and First Aid Statement*

*Products with a main display panel area of less than 35 cm2 need not display negative and positive instructions (see subsection 56(2))

**See section 24 for the requirements for larger sized containers.

≤ 10.0 not required 1.5 1.5 mm 4.5 point
10.1 - 11.1 not required 1.5 2 mm 6 point
11.2 - 14.8 not required 1.8 2 mm 6 point
14.9 - 19.0 not required 2 2 mm 6 point
19.1 - 23.7 not required 2.3 2 mm 6 point
23.8 - 29.0 not required 2.5 2 mm 6 point
29.1 - 34.9 not required 2.8 2 mm 6 point
35 not required 2.9 2 mm 6 point
35.1 - 41.1 not required 3 2 mm 6 point
41.2 - 47.9 not required 3.3 2 mm 6 point
48.0 - 55.3 not required 3.5 2 mm 6 point
55.4 - 63.2 not required 3.8 2 mm 6 point
63.3 - 71.6 not required 4 2 mm 6 point
71.7 - 80.5 not required 4.3 2 mm 6 point
80.6 - 90.0 not required 4.5 2 mm 6 point
90.1 - < 100 not required 4.8 2 mm 6 point
100 not required 4.9 3 mm 8 point
101 - 110** not required 5 3 mm 8 point

Section 57 - Part 4 - Quick Skin-bonding Adhesives - Child-resistant Packaging

Child-resistant container

57. (1) Subject to subsection (2), a quick skin-bonding adhesive must be in a child-resistant container that complies with sections 9 to 13.

Exception - child-resistant packaging

(2) Subsection (1) does not apply if the packaging that immediately encloses the container and that is displayed to the consumer is child-resistant and complies with sections 9 to 13.

Discussion of CCCR, 2001 Section 57

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, quick skin-bonding adhesive.

Requirements:

Chemical products that are classified as quick skin-bonding adhesives are required to be packaged in child-resistant containers because of the likelihood of injury should a child come into contact with the product.

See sections 9 to 13 for the design and performance requirements for child-resistant containers. In general, these requirements make it difficult for a child under five years of age to open the container and come into contact with the product within a reasonable time. This requirement means that some children may still be able to open a container if given sufficient time to do so.

Exception:

Outer Packaging

In some cases, the container of quick skin-bonding adhesive is child-resistant. However, very small tubes, usually 2 to 5 mL in volume, that are not child-resistant must be put into a child-resistant package, such as a pill bottle.

The outer child-resistant package may have a hole to allow the tube to protrude as long as the child-resistant requirements are met (for example, it must not be possible to gain access to the glue through the hole).

The outer child-resistant package must be appropriately labelled, including the directions for operating the child-resistant container (see sections 11 and 15). However, if the outer packaging is transparent and does not obscure any of the required information on the container within, then this information does not need to be repeated on the outer packaging (see paragraph 16(1)(a)).

More than one tube of cyanoacrylate glue may be placed into the outer child-resistant package, as long as all containers are properly labelled and the outer package meets the chld-resistant container requirements.

Section 58 - Part 5 - Pressurized Containers - Application

Application

58. (1) Subject to subsection (2), this Part applies to a pressurized container that

  • (a) contains or will contain a substance that, when in a liquid state, has an absolute vapour pressure greater than 275 kPa at 37.8° as determined using ASTM D 323; or
  • (b) is or will be pressurized to an absolute pressure greater than 275 ± 1 kPa at 21.1° or 717 ± 2 kPa at 54.4°.

Exceptions

(2) This Part does not apply to a pressurized container that complies with CSA B339.

Discussion of CCCR, 2001 Section 58

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, vapour, ASTM D 323, CSA B339.

Requirements:

Section 58 classifies a container into the pressurized container hazard category. The criteria describe products that are hazardous because of the internal pressure within the container. If punctured or heated, a pressurized container can rupture, resulting in flying debris or release of hazardous contents. Injuries often include: facial and eye injuries, dental injuries, broken arms and hands, lacerations, bruising, and burns to the hands, arms, face and other parts of the body. In some cases, the container itself can be forcefully propelled and cause injury, especially to the head and face.

Classification:

Conventional pressurized containers currently on the market for consumer use, such as aerosol containers, have internal pressures greater than those specified in the criteria. However, the criteria would not encompass containers that are only slightly pressurized, such as pop bottles or other carbonated beverage containers.

The classification criteria in non-metric units is the following:

  1. The pressurized container contains a substance that, when in a liquid state, has an vapour pressure greater than 40 pounds per square inch absolute (psia) at 100 °F; or
  2. The container is pressurized to greater than 40 psia at 70°F or 104 psia at 130°F.

Note that gauge pressure is measured above atmospheric (14.7 psi), hence 40 psia = 25 psig; and 104 psia = 89 psig.

"Vapour pressure" means: the pressure of the vapour given off by a liquid or solid. The vapour pressure increases with temperature. If the liquid or solid is in an enclosed space the number of molecules leaving it eventually reaches an equilibrium with the number of molecules returning to it. At this point, the vapour is saturated and the pressure is the "saturated vapour pressure".

Aerosol Containers

A typical aerosol container is a metallic container, usually tin-plated steel or aluminum. Tin-plate cans usually consist of three pieces: a base, a seamed cylinder and a top which contains the valve mechanism. Such containers are able to withstand more than 1750 kPa (240 psi). Some two-piece plated steel cans are available. Aluminum cans are usually one piece.

The valve mechanism is typically made up of an actuator, a valve stem, a spring, gaskets and a dipper tube. The dipper tube extends to the bottom of the container and draws the liquid contents up to the valve. When the actuator is pressed-down, it pushes the valve stem through the gasket and opens the valve's hole, allowing the liquid product to pass through the valve and actuator. The valve and actuator contain small holes and channels, which control the flow-rate through the valve and the spray's characteristics. Adjustments to these components can affect the droplet size and dispersion of the spray, and hence also influence the flame projection of a flammable product.

Inside the container are the product and propellant under pressure. If a compressed gas is used, it will usually only be in the head-space above the liquid product in the can. If a liquified gas propellant is used, it will exist as both a liquid and as a vapour in the head-space. The liquid and gaseous phases of the propellant are at equilibrium at constant temperature. A temperature increase will cause the equilibrium to shift and increase the pressure within the container. For example, dichlorodifluoromethane has a vapour pressure of 580 kPa at 52° and 3100 kPa at 99°. Such drastic increases in pressure means that putting an aerosol container in a fire or on a stove (or even leaving it in the trunk of a car on a hot day) may cause the pressure in the container to exceed the bursting pressure, resulting in a leak or explosion.

Propellants

Most aerosol containers today use liquefied petroleum gas (LPG) as a propellant. LPG is a mixture of propane, isobutane and n-butane, which are all flammable gases. Chlorofluoro-carbons (CFC's) are liquefied propellant gases which were commonly used in consumer chemical products in the past, until they were prohibited under the Canadian Environmental Protection Act (CEPA). Dimethyl ether, an alternative to liquefied propellant, is sometimes used (eg. in air fresheners); it is also flammable. Non-soluble compressed gases such as compressed air or nitrogen are sometimes seen in consumer products. Carbon dioxide is a soluble compressed gas that is occasionally used for specialized applications.

With liquefied propellants, the propellant is an essential part of the formulation. When the liquid propellant emerges from the actuator, it will vaporise immediately. Thus, if the propellant is intimately mixed with the product, the emerging droplets will burst into smaller droplets as the propellant vaporises. In this way, the ultimate size of the droplets is also controlled by adjusting the amount of propellant and its pressure in the aerosol container.

With compressed gas propellants, the propellant occupies the head-space within the can and usually does not mix with the product. The propellant pushes the liquid out of the can, and only the product is sprayed-out. As the product is used-up, the pressure will drop as the propellant gas has more and more space within the can. For these products, the only means to control the spray is through the valve and actuator design.

Other Pressurized Containers

Refillable and non-metallic pressurized containers are now marketed, as well as products which release the contents through the operation of a valve in the product rather than on the pressurized container itself (for example, butane-fuelled curling irons). The hazard posed by these products are the same as that for the conventional disposable aerosol dispenser: rupture of the container and violent release of the contents when punctured or heated, especially if placed in a fire or trash compactor.

The pressurized container hazard category includes all products that pose a bursting hazard, whatever the means of construction. The criteria also apply to products designed for and intended to be used as pressurized containers which are sold empty but filled and pressurized by the user.

Harmonization With the WHMIS Controlled Products Regulations:

The CCCR, 2001 classification criteria for pressurized containers in section 58 are harmonized with those for workplace chemicals under the requirements of WHMIS for compressed gases. The pressurized container hazard category is equivalent to WHMIS Class A (compressed gas) in paragraphs 34(c) and (d) of the Controlled Products Regulations. Note that the CCCR, 2001 do not include criteria for critical temperature and absolute vapour pressure at 50°

Harmonization With the Transportation of Dangerous Goods (TDG) Regulations:

The classification criteria for pressurized containers are the same as that adopted in the Transportation of Dangerous Goods (TDG) Regulations. For typical aerosol containers, the risk may be reduced by the requirements of the TDG Regulations, which require the testing of pressurized containers in a water bath at 50° to ensure container integrity during shipment. However, this testing requirement is strictly for transport and does not eliminate the hazard once a consumer uses or stores the product at home.

Exception - Barbecue Cylinders:

Subsection 58(2) exempts containers that meet the requirements of CSA B339 (entitled Cylinders, Spheres and Tubes for the Transportation of Dangerous Goods), which sets out performance requirements for pressurized containers such as barbecue cylinders. When the product is in compliance with the standard, the hazard should be minimized and therefore pressurized container labelling is not required.

Section 59 - Part 5 - Pressurized Containers - Required Information

Required information

59. A pressurized container must display, for each type of information set out in column 1 of the table to this section, the information set out in columns 2 and 3.

Table to subsection 59 - Required information - Pressurized containers
Item Column 1

Type of information
Column 2

English information
Column 3

French information
1. Hazard symbol
2. Signal word CAUTION ATTENTION
3. Primary hazard statement CONTENTS UNDER PRESSURE CONTENU SOUS PRESSION
4. Specific hazard statement CONTAINER MAY EXPLODE IF HEATED CE CONTENANT PEUT EXPLOSER S'IL EST CHAUFFÉ
5. Negative instructions Do not puncture. Do not burn. Ne pas perforer. Ne pas brûler.
6. Positive instructions Store away from heat. Conserver loin des sources de chaleur.

Discussion of CCCR, 2001 Section 59

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
container, hazard symbol.

Requirements:

The wording for the warnings was developed through a consensus process, with the active collaboration of interested stakeholders, including the medical profession and public health organizations, the chemical industry, consumers' and seniors' groups, academia, technical experts and various federal government departments. During the label development, all sectors involved agreed that the regulations should prescribe mandatory warnings for the various hazard categories and sub-categories. The label statements are generic in terms of the hazard in order to be applicable to all types of consumer chemical products which fall within a particular sub-category. This ensures a constancy in the messages seen by consumers as well as a consistent set of rules for all companies. In addition, the general nature of the statements eliminates the need for ongoing regulatory amendments, but still provides the flexibility to add more specific information that may be appropriate to the chemical product.

Presentation Requirements:

See sections 17 to 32 of the CCCR, 2001 for the presentation format of the required information.

Additional Information:

The required labelling is the minimum necessary, and is an indication of the minimum standard of care imposed on a person responsible. Manufacturers and importers can add, and are encouraged to add, information considered necessary to fully inform the public of the hazards of using their products (see subsection 15(2)). In composing these statements, use short, simple sentences. Complex conditional sentences, particularly those containing negations, should be avoided. In addition, a person will remember the important product related information better, if fewer dimensions or items are listed.

However, the person responsible is discouraged from deliberately over-stating the hazards posed by a product. If unwarranted warnings are added to products, it may lead to potentially lengthy and unnecessary or inappropriate treatment upon exposure to the product. Furthermore, such a practice minimizes the perception of risk for those products which actually need the warnings, leading to potential injuries from a lack of concern or precaution by the user.

Sections 60 to 62 - Coming Into Force

Transition period - excluding a retailer

60. (1) A person, other than a retailer, who on October 1, 2001 is in the business of producing, selling or importing a chemical product or a container that complies with the Consumer Chemicals and Containers Regulations as they read on September 30, 2001, or who incidentally, as part of their business, is producing, selling or importing such a chemical product or container, may continue the activity with respect to that product or container for a period of two years commencing on October 1, 2001.

Transition period - retailer

(2) A retailer may sell to a consumer a chemical product or a container that complies with the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001,

  • (a) for a period of four years commencing on October 1, 2001, in the case of a product or container that is classified only in any or all of the hazard category "Category 5, Pressurized Container" or the sub-categories "harmful", "irritant" or "combustible"; and
  • (b) for a period of three years commencing on October 1, 2001, in any other case.

Definition of "producing"

(3) In subsection (1), "producing" a chemical product or container means that the plating-up stage of production, necessary for printing the label for the chemical product or container, has been completed.

Repeal - Consumer Chemicals and Containers Regulations

61. The Consumer Chemicals and Containers Regulations (SOR/88-556) are repealed.

Coming into force

62. These Regulations come into force on October 1, 2001.

Discussion of CCCR, 2001 Sections 60 to 62

Definitions:

The following terms are defined in section 1 of the CCCR, 2001:
chemical product, container, hazard category, subcategory.

Transition Between Regulations:

The CCCR, 2001 came into effect on October 1, 2001, with a transition period for existing consumer chemical products and containers that complied with the previous Consumer Chemicals and Containers Regulations (CCCR). There is a two-year transition period for upper-level suppliers of consumer chemical products and containers, with an additional one- or two-year transition period at retail, depending on the hazard posed by the product.

The transition period applied to consumer chemical products and containers that were being produced, sold or imported prior to October 1, 2001. A product must have reached the stage of production at which the plating-up of its label was completed and the plated-up label complied with the CCCR. Manufacturers, distributors and importers have until September 30, 2003 to meet the requirements of the CCCR, 2001. During the two-year transition period, products that comply with either the CCCR or the CCCR, 2001 are legal. After October 1, 2003, all consumer chemical products and containers must be in full compliance with the CCCR, 2001 when they are imported or sold above the retail level of trade.

Products that were being sold in Canada before October 1, 2001 that were not subject to the CCCR but are now covered under the CCCR, 2001 qualify for the transition period. But the transition period does not apply in the following circumstances:

New Products:
the product was not produced, sold or imported into Canada prior to October 1, 2001;
Modified Products:
the product was produced before October 1, 2001 in compliance with the CCCR, but there has been a subsequent change to the product's formulation, labelling or packaging;
Noncompliant:
the product was produced before October 1, 2001, but it did not comply with the CCCR.

New Products:

the product was not produced, sold or imported into Canada prior to October 1, 2001;

Modified Products:

the product was produced before October 1, 2001 in compliance with the CCCR, but there has been a subsequent change to the product's formulation, labelling or packaging;

Noncompliant:

the product was produced before October 1, 2001, but it did not comply with the CCCR.

Hence, new or modified products, or products that did not comply to the previous CCCR as of October 1, 2001, do not qualify for the transition period and must meet the CCCR, 2001 immediately.

Examples:

The following examples may help to clarify the transitional provision:

  1. Product A is available at retail prior to October 1st, 2001 and is regulated by and complies with the former CCCR.

    Since Product A already complies with the former CCCR, it can legally comply with either the CCCR or the CCCR, 2001 during the transition period. Product A, with its existing packaging and labelling, can be manufactured or imported until September 30, 2003 and sold at retail until either September 30, 2004 or 2005 depending on the level of risk.

  2. Product B is a new product that would have been regulated by the former CCCR if it had been sold at retail prior to October 1st, 2001. It was in production on September 30, 2001 and reached the stage where the printing plates that comply with the former CCCR were completed.

    Product B is equivalent to Product A. Product B can legally comply with either the former CCCR or the CCCR, 2001 during the transition period. It is not practical for the producer of Product B to incur the immediate cost of re-plating to comply with the CCCR, 2001. Instead, the transition provision recognizes the producer as a person "in the business of producing" the product in accordance with the former CCCR. Such producers will not be penalized for failing to introduce the product to retail before October 1, 2001.

  3. Product C is available at retail on October 1st, 2001, and was not regulated by the former CCCR but is regulated by the CCCR, 2001.

    Since Product C was not subject to the former CCCR, it can either continue to use its current labelling and packaging or be labelled and packaged in accordance with the CCCR, 2001 during the transition period. Product C in its old form can be manufactured or imported until September 30, 2003 and sold at retail with its existing labelling until either September 30, 2004 or 2005, depending on the level of risk. However, Health Canada strongly urges that such products be brought into compliance with the CCCR, 2001 as soon as possible.

  4. Product D is a new product that would not have been regulated by the former CCCR but will be regulated by the CCCR, 2001. It was in production on September 30, 2001 and reached the stage where the printing plates were completed.

    Product D is equivalent to Product C. Product D can legally use its existing labelling and packaging or can comply with the CCCR, 2001. It is not practical to force the producer of Product D to incur the immediate cost of re-plating to comply with the CCCR, 2001. Instead, the provision recognizes the producer of this product as a person "in the business of producing" the product in accordance with the former CCCR. While such producers will not be penalized for failing to introduce the product to retail before October 1, 2001, Health Canada strongly urges that such products be brought into compliance with the CCCR, 2001 as soon as possible.

  5. Product E is a new product that would have been regulated by the former CCCR. It was in production on September 30, 2001, but had not reached the stage where the printing plates that comply with the former CCCR were completed.

    Product E must comply with the CCCR, 2001 as of October 1, 2001. The producer of Product E had not developed plates to produce the label in compliance with the former CCCR in time to qualify for the transition provision. The producer must create a label and use packaging that complies with the CCCR, 2001 before the product is put on the market.

  6. Product F is a new product that would not have been regulated by the former CCCR. It is in production on September 30, 2001, but had not reached the stage where the printing plates that comply with the former CCCR were completed.

    Product F must comply with the CCCR, 2001 as of October 1, 2001. The producer of Product F had not developed plates to produce the label for the product in time to qualify for the transition provision. The producer must create a label and to use packaging that complies with the CCCR, 2001 before the product is put on the market.

Schedule 1 - Test for Determining the Flashback and the Length of the Flame Projection of a Flammable Product Enclosed on a Spray Container

(Subsections 1(1), 48(1) and 49(1) and section 52)

Application

1. This test is to be used to determine the flashback and the length of the flame projection of a flammable product enclosed in a spray container.

Apparatus

2. The following apparatus is to be used in this test:

  • (a) a flammability tester, as illustrated in Figures 1 and 2 to the Schedule, that
    • (i) is constructed so that the spray container can be secured in place by means of a holding device, such as a three-pronged clamp affixed to a ring stand, in such a manner that the discharge from the spray container is in the horizontal plane,
    • (ii) may include a remote control device by which
      • (A) the valve of a pressurized container can be activated, such as a side-pull, caliper-type bicycle hand brake, or
      • (B) the trigger or plunger of a pump-spray container can be pneumatically activated, as illustrated in Figures 3 and 4 to the Schedule,
    • (iii) has a vertically mounted burner that
      • (A) has an inside diameter of 1.2 mm,
      • (B) has a Luer-Lock 16-gauge needle affixed to a metal tube or another suitable device, and
      • (C) is placed at a distance of 15 cm from the discharge orifice of the spray container, which distance is to be measured horizontally between the vertical planes of the discharge orifice and the burner orifice, and
    • (iv) has two support frameworks, placed on the oppos-ite side of the burner from the spray container, one at a distance of 15 cm from the burner and the other at a distance of 100 cm from the burner, each of which
      • (A) has an internal open space for testing a pressurized container of 35 cm wide by 100 cm high or, for testing a pump-spray container, of 35 cm wide by 60 cm high,
      • (B) is constructed from metal or other non-flammable material,
      • (C) is mounted in a vertical plane perpendicular to the direction of discharge from the spray container, and
      • (D) is adjustable in the vertical plane;
  • (b) a cylinder of chemically pure (C.P.) grade propane fitted with a regulator capable of delivering pressure to the burner appropriate to maintaining a flame height of 5 cm; and
  • (c) loosely woven cotton fabric commonly referred to as cheesecloth that has, in the bleached state, a mass per unit area of not less than 35 g/m2 and not more than 65 g/m2.

Test Specimen

3. (1) When there are instructions by the manufacturer respecting the shaking of the spray container, a test composed of the following number of discharges from each of three spray containers of the same product and of the same size must be conducted:

  • (a) in the case of a pressurized container, three discharges; and
  • (b) in the case of a pump-spray container, 10 discharges.

(2) When there are no instructions by the manufacturer respecting the shaking of the spray container, a test, using each of three spray containers of the same product and of the same size, must be conducted as follows:

  • (a) in the case of a pressurized container, without shaking the container, discharge it three times and then, after shaking it in the manner set out in paragraph 4(9)(a), discharge it a further three times; or
  • (b) in the case of a pump-spray container, without shaking the container, discharge it 10 times and then, after shaking it in the manner set out in paragraph 4(9)(a), discharge it a further 10 times.

Procedure

4. (1) A test

  • (a) must be conducted at a room temperature of 22 ± 2°C in the absence of air currents, with an allowance made for a clearance of 50 cm beyond the support framework that is set at a distance of 100 cm from the burner; and
  • (b) may be conducted in a fume hood with the exhaust fan turned off and the protecting door lowered.

(2) Any fume must be removed from the test area and any residue cleaned up after each discharge.

(3) Before testing, each spray container must be

  • (a) maintained at a temperature of 22 ± 2°C for at least four hours; and
  • (b) primed by
    • (i) in the case of a pressurized container, discharging the container for five seconds, and
    • (ii) in the case of a pump-spray container, activating the trigger or pump using each of 18 N, 36 N and 54 N of pressure for each possible nozzle position until
      • (A) in the case of the "stream" position, a continuous stream is produced, and
      • (B) in the case of the "spray" position, a mist is produced.

(4) Install the first spray container in the holding device and ensure that the burner orifice is 15 cm from the discharge orifice of the spray container in the horizontal plane and 5 cm below it in the vertical plane and that the discharge orifice points in the direction of the burner.

(5) Adjust the burner to give a flame height of 5 cm and release the following trial discharges from the spray container:

  • (a) in the case of a pressurized container, a single discharge; and
  • (b) in the case of a pump-spray container, three discharges.

(6) If the operation set out in subsection (5) does not produce a flame projection, lower the burner orifice by 5 cm and adjust the burner to give a flame height of 12 cm.

(7) Attach the cheesecloth to the flammability tester with bulldog clips or in any other manner so as to cover the entire internal space of the support framework set at a distance of 15 cm from the burner and verify that the cheesecloth is at a proper horizontal distance from the vertical plane of the burner orifice on the opposite side of the burner from the spray container.

(8) Adjust the height of the support framework so that the cheesecloth will intercept the line of flame projection.

(9) Prepare the spray container in accordance with the manufacturer's instructions and

  • (a) if shaking is applicable,
    • (i) shake vigorously for five seconds, or for the period specified in the manufacturer's instructions,
    • (ii) install the spray container in the holding device,
    • (iii) 15 seconds after the cessation of shaking, release the first discharge in accordance with subsection (10), and
    • (iv) allow the spray container to stand for at least 60 seconds between discharges; or
  • (b) if shaking is not applicable, install the spray contain-er in the holding device and release the discharge in accordance with subsection (10), allowing the spray container to stand for at least 60 seconds between discharges.

(10) Discharge the spray container

  • (a) in the case of a pressurized container, for five seconds or until the cheesecloth ignites; or
  • (b) in the case of a pump-spray container, for 10 sprays or until the cheesecloth ignites.

(11) In the case of a pump-spray container, repeat the procedure set out in paragraph (10)(b) for each nozzle position and each of 18 N, 36 N and 54 N of pressure.

(12) If the cheesecloth attached to the support framework that is set at a distance of 15 cm from the burner ignites, the remaining discharges referred to in section 3 must be carried out in accordance with subsections (1) to (11) using a new piece of cheesecloth attached to the support framework that is set at a distance of 100 cm from the burner.

Determination and Reporting of Flame Projection and Flashback

5. (1) If at any time during the test the cheesecloth that is mounted at a distance of 100 cm from the burner is ignited, the length of the flame projection is 100 cm or more.

(2) If at any time during the test the cheesecloth that is mounted at a distance of 15 cm from the burner is ignited and, at all times during the test, the cheesecloth that is mounted at a distance of 100 cm from the burner remains unignited, the length of the flame projection is 15 cm or more but less than 100 cm.

(3) If at any time during the test the cheesecloth mounted at a distance of 15 cm from the burner is not ignited but there is a flame projection, the length of the flame projection is less than 15 cm.

6. The following test results must be recorded:

  • (a) the length of the flame projection
    • (i) in the case of a pressurized container, for each discharge, and
    • (ii) in the case of a pump-spray container, for each discharge at each nozzle position and each pressure applied;
  • (b) a lack of flame projection resulting from any of the test discharges; and
  • (c) any flashback.
Figure 1: Flammability Tester - Pressurized Container
Figure 1 - Flammability Tester - Pressurized Container

Figures 1 and 2 are diagrams of the test apparatuses used to determine both the flame projection and the flash-back for an aerosol or a pump-spray product.

Figure 2: Flammability Tester - Pump-Spray Container
Figure 2 -Flammability Tester - Pump-Spray Container

Figures 1 and 2 are diagrams of the test apparatuses used to determine both the flame projection and the flash-back for an aerosol or a pump-spray product.

Figure 3: Holding Apparatus for a Trigger-Type Container - Isometric View
Figure 3 - Holding Apparatus for a Trigger-Type Container - Isometric View

Figures 3 and 4 are close-ups of the different 'trigger' apparatuses used to actuate a product and determine its flame length. The measurements are all part of the test method provided in Schedule I to the Consumer Chemicals and Containers Regulations (2001).

Figure 4: Holding Apparatus for a Plunger Type or Pressurized Container Isometric View
Figure 4 - Holding Apparatus for a Plunger Type or Pressurized Container Isometric View

Figures 3 and 4 are close-ups of the different 'trigger' apparatuses used to actuate a product and determine its flame length. The measurements are all part of the test method provided in Schedule I to the Consumer Chemicals and Containers Regulations (2001).

Schedule 2 - Hazard Symbols

(Subsection 1(1) and section 21)

Hazard Symbols
Item Column 1
Description
Column 2
Symbol
1. TOXIC
2. CORROSIVE
3. FLAMMABLE
4. EXPLOSIVE Hazard Symbol: Explosive

Schedule 3 - Test Method for Determining Whether a Container Leaks

(Section 7)

Interpretation

Definitions

1. The definitions in this Section apply in this Schedule.

"seal" « sceau d'étanchéité »

"seal", in respect of a container, means any device or membrane under the closure that covers the opening of the container, including any membrane that is part of the container, such as a heat induction seal or a sonic seal. It does not include a liner or a mechanism that is an integral part of the closure.

"test sample" « échantillon d'essai »

"test sample" means

  • (a) in the case of a container of a chemical product, the container filled with the product in the manner in which it is sold to the consumer; or
  • (b) in the case of an empty container that is destined to receive a chemical product, the container filled with the product that it is destined to receive.

Test Method

Preparation of Sample for Testing

Remove seal

2. Except in the case of a single-use container,

  • (a) open the test sample;
  • (b) remove any seal that is present under the closure in accordance with the manufacturer's instructions or, if no instructions are provided, puncture the seal; and
  • (c) reclose the sample as tightly as possible without stripping the threads of the closure.
Bring to room temperature

3. Place the test sample in a test location that has a constant temperature of 23 ± 2°C for at least four hours to permit the container and its contents to reach the temperature of the test location.

Testing for Leaks

Position of test sample

4. Position the test sample

  • (a) over a clean piece of blotting paper or another paper that stains on contact with a liquid;
  • (b) in an inverted position at a 45° angle below the horizontal; and
  • (c) with the closure in the lowest possible position and free of any obstruction.
Examine paper

5. After one hour, remove the test sample and examine the paper described in Paragraph 4(a) for evidence that any of the contents have leaked from the sample.

Pass or Fail

Fail

6. If an examination of the paper described in Paragraph 4(a) discloses any trace of the contents of the test sample, the sample has failed the leakage test and a container of the same type as the test sample must not be used for a chemical product.

Pass

7. If no trace of the contents of the test sample is found on the paper described in Paragraph 4(a), the sample has passed the leakage test and a container of the same type as the test sample may be used for a chemical product.

Discussion of CCCR, 2001 Schedule 3

Definitions:

The following terms are defined in Section 1 of the CCCR, 2001 :
chemical product, container, manufacturer,
single-use container.

Requirements:

Section 7 requires that a container of a liquid chemical product must pass the leakage test described in this Schedule, or an equivalent test.

Test Sample:

The leakage test does not have to be performed on every container in a production lot. The test sample would be a representative sample of that lot. However, every new production lot would require a new test sample.

If a test sample fails, then the whole production lot of containers fails.

Removing the Seal:

Experiments conducted by industry and the Product Safety Laboratory showed that sonic-sealed containers will leak when the seal has been removed or punctured. Similar container-closure systems leaked far less when the container had not previously been sonic-sealed.

The Product Safety Laboratory observed that containers with punctured sonic seals leaked within the same amount of time as those where the sonic seal was completely removed. In addition, the amount of product which leaked from containers with punctured seals was similar to containers with completely removed seals. During the reasonably foreseeable use of liquid chemical products, it is unlikely that a consumer would be meticulous to the point that he or she would take the time to completely remove a seal. Some consumers may simply puncture the seal with a tool or a key, while others may rip the seal or make an opening large enough to allow the liquid to flow out. Hence in the leakage test, the seal should be removed according to instructions, if present, or otherwise punctured.

The exception for opening, breaking the seal and re-closing single-use containers recognizes that these containers are intended to be opened only once and not re-closed. Note that if it is possible to re-close the container, then that container is not considered to be a single-use container, and that product must meet the full requirements of the CCCR, 2001 for recloseable containers.

Temperature Conditioning:

Often, in packaging locations, the plastic containers coming from their moulds are hot, while the products that go into them may be very cold, especially in winter when exterior storage tanks are used. This difference in temperature creates a stress between the closure and the container which could make the package leak. However, once the two temperatures equilibrate and the product is in the hands of consumers, the performance of the package may be different. Thus the leakage test should be carried out with the container and the contents at the same temperature. The temperature of 23 ± 2°C is used because this is the average temperature most likely to be found throughout the lifetime of a container.

Testing for Leaks:

Besides blotting paper, examples of other papers that stain on contact include thermal paper and filter paper. These other papers are not specifically referenced in Schedule 3 in order to be consistent with the leak test described in the standard CSA Z76.1-99 (entitled Recloseable Child-Resistant Packages).

Thermal paper imprints a spot on the paper where the liquid has fallen. If the liquid is a volatile clear solvent, an analyst might not notice a spot on blotting paper. But with thermal paper, it is easier to see clear liquids and the stain does not disappear when the liquid dries up. Hence thermal paper may be used to obtain a permanent record of the leak.

An incline of 45 degrees below the horizontal increases the pressure of the contents against the closure compared with having the container on its side. Paragraph 4(c) ensures that the liquid will touch the closure when inclined. For example, a rectangular container with the closure in the centre of the top should be inclined on its widest edge, to put the closure in the lowest possible position.

The amount of liquid must be enough that it falls to the paper that is positioned below the closure during the test. If the liquid collects around the cap but does not drop to the paper, this would not be considered a leak and the container would not fail.

The quantity of product which leaks-out within the test period is not specified for reasons of simplicity and clarity. Since this requirement applies to products which are inherently hazardous, any evidence of leakage is considered a failure. However, corrective or enforcement actions required as a result of a leaking container would be related to the risk posed by the product. That is, the quantity of product delivered and the nature of the hazard posed by the product.

Non-Mandatory Tests:

A number of non-mandatory screening tests are recommended, to support the leakage requirement. Numerous standards have been reviewed to find test methods to support the general packaging guidelines, including those of the U.S., U.K., Transport Canada, the CSA and ASTM. Information from these standards was combined with practical experience and by using technical and scientific support provided by Health Canada. The following recommended test procedures were validated by two non-government laboratories:

Field Test

The following screening test could be performed in the field to help Product Safety Inspectors determine whether compliance testing would be required:

Take a container, without exerting any torque on the lid, and invert it at an angle of 45 degrees below the horizontal line for a period of five minutes.

Detection of any trace of liquid on a blotter placed beneath the lid may indicate that the container does not meet Section 7, and that compliance testing according to Schedule 3 should be carried out.

Aging Test

Since a filled container may deteriorate over time, the person responsible may conduct the following ageing tests to insure that the product will comply with the leakage requirement during its feasible shelf-life:

  1. Subject the container to the one-hour leakage test after it has been filled for a minimum of six months.

Research has found that the typical shelf-life of a consumer chemical product is six months. This also corresponds with Transport Canada guidelines.

  1. Conduct an accelerated aging test after conditioning the container for a shorter period but at an elevated temperature. For example, test the product after it has been left at 50°C for 28 days.

The accelerated test simulates what might occur at ambient temperatures over a six-month period. Tests have shown that most leakages from containers stored at 50°C will occur within seven days of aging. Note that this test may not be appropriate for certain flammable solvents. Also keep in mind that the 50°C test will only examine the effect of the temperature on the containers, and may have little to do with measuring any interactions between the product and the container or aging over time.

Life Test

The following test verifies the ruggedness of the closure during its anticipated life expectancy:

Subject the container to the one-hour leakage test after it has been opened and re-closed according to the container manufacturer's instructions, if present, or otherwise a minimum of 50 times to a maximum of 100 times.

The use of 100 openings and reclosings comes from the CSA Z76-1.99 standard (entitled Recloseable Child-Resistant Packages) and is based upon the average life of a 250 mL container. This standard prescribes mechanical "life tests" to assess whether the container is capable of maintaining its security for the number of uses corresponding to the normal depletion of the product. The limitation of this standard is that it is performed on empty container prototypes or with a placebo. This practice may be acceptable for assessing child-resistant containers that are intended to dispense pills, but may not adequately assess the effect of incompatibility of a chemical product with the container. Hence the life test is presented to evaluate a child-resistant container when it is filled with the chemical product. Furthermore the life test is presented for use on chemical products which do not need child-resistant containers.

Coding System

The use of a coding system, which may be lot numbering or some other system, is recommended as a quality control mechanism because it is a simple way of differentiating between lots. If a problem is found with a product, enforcement and corrective actions could be limited to the specific problem lot and not the entire product line. It will also make it easier for Poison Control Centres to know they have up-to-date product ingredient information when there has been a change in formula.

In the absence of a lot number, all units would be considered as coming from a single lot.

Schedule 4 - Illustration - Standard Sans Serif Type

Illustration - Standard Sans Serif Type

Illustration - Standard Sans Serif Type

Index

Key:

C
Consumer Chemicals and Containers Regulations, 2001
H
Hazardous Products Act
Sch
Schedule to the CCCR, 2001

Note: Information may be in the HPA/CCCR, 2001 and/or the "discussion" correspond-ing to the cited section(s).

A B C D E F G H I K L M N O P Q R S T U V W

A
Cited Section Section
absolute pressure,

pressurized container criterion

C-58(1)(b)
absolute vapour pressure,

pressurized container criterion

C-58(1)(a)
acetone,

flammablility of

C-53
acid reserve,

Calculation

C-43, 44

Classification criteria using

C-41(1)(c)(ii); C-42(2)

defined

C-1(1)

test method

C-44(2)
Act,

defined

C-1(1)
adhesive, quick skin-bonding,

defined

C-1(1)

labelling for

C-55; C-56

Child-resistant container requirement

C-57
advertising,

labellling exemption

C-15(1)

pictures, use of

C-15(2)

restriction

C-2
alkali reserve,

Calculation

C-43, 44

Classification criteria using

C-41(1)(c)(ii); C-42(3)

defined

C-1(1)

test method

C-44(2)
acute lethality,

Classification criteria for

C-34(2) to (4)
advertise,

defined

H-2
aerosol container,

integrity

C-7

pressurized container, classification criteria

C-58

pressurized container, defined

C-58(1)

pressurized container, labelling

C-59

spray container, defined

C-1(1)

spray container flammability criteria

C-49

spray container flammability test method

C-52; C-Sch1
aging test,

recommendation for

Sch 3
analyst,

defined

H-2
animal tests,

for acute lethality

C-34(2) to (4)
appearance [of product],
 - see label
American Society for Testing and Materials
 - see ASTM
area of the display panel,
 - see main display panel
aspiration hazard,

Classification criteria for

C-33(d); C-34(5)

isopropyl alcohol

C-33, 34

mixture that separates

C-33, 34

pine oil

C-33, 34

turpentine

C-33, 34

defined

C-1(1)

labelling for

C-39
ASTM,

defined

C-1(2)
ASTM Tests, referenced in the CCCR, 2001

D 56 - flash point, Tag

C-50(a)

D 93 - flash point, Penskey-Martens

C-50(b)

D 323 - vapour pressure

C-58(1)(a)

D 1293 - pH

C-44(1)

D 3278 - flash point, liquids, small scale

C-51

D 3828 - flash point, small scale

C-50(a)
B
barbecue cylinder,

exception, pressurized container classification

C-58(2)
batteries, lead/acid,

exception

C-2
blister card,

labelling of

C-15, 16

main display panel

C-1(1)
border,

format

C-30

requirement

C-29(b)
C
Canadian Standards Association
 - see CSA
caulking,

aerosol flammable product classification

C-48, 49

guns, child-resistance

C-10
cement,

additional labelling

C-46
chemical product,

defined

C-1(1)
child-resistant container,

exceptions, toxic products

C-40(2)

functional integrity

C-10

labelling of

C-11

large container, exception

C-14

need for,

Corrosive products

C-47

quick skin-bonding adhesives

C-57

toxic products

C-40

record keeping requirements

C-12

testing standards for

C-9

tool, use of

C-9
classification criteria,

Category 1 - toxic products

C-33 to C-37

precedence of data sources

C-33

subcategories - very toxic, toxic, harmful

- substances of special concern

C-34(1)

- oral exposure

C-34(2)

- dermal exposure

C-34(3)

- inhalation exposure

C-34(4)

- aspiration hazard

C-34(5)

determination of toxicity

- data sources

C-35

- LD50 and LC50 of mixtures, formulas for

C-36

- LC50, 4-hour, conversion

C-37

Category 2 - corrosive products

C-41 to C-44

precedence of data sources

C-41

subcategories - very corrosive, corrosive, irritant

- substances of special concern

C-42(1)

- acids

C-42(2)

- bases

C-42(3)

- substances causing necrosis or ulceration

C-42(4)

- substances causing other effects

C-42(5)

test methods

- necrosis and ulceration

C-43

- pH

C-44

Category 3 - flammable products

C-48 to C-52

data sources

C-48

subcategories - very flammable, flammable, combustible, spontaneously combustible

C-49

test methods

- liquids

C-50

- solids

C-51

- flame projection

C-52; C-Sch1

Category 4 - quick skin-bonding adhesives

defined

C-1(1)

Category 5 - pressurized containers

C-58
cloth, wiping,

exception, first aid statement

C-39; C-46
coding system,

recommendation for

Sch 3
combustible liquids,

Classification criteria for

C-49

exemption, water based product

C-48(2)
complex mixture,

defined

C-1(1)

disclosure requirements

C-32
compressed gas,

Classification, criteria for pressurized containers

C-58(1)

exceptions

C-2(2)C-58(2)

flammability criteria

C-49

labelling of pressurized containers

C-59
concentration,

Cut-off

C-34(1); C-34(5); C-36(1)

expression of

C-1(4)
conjunctival swelling,

Criteria for eye irritation

C-41(1)(e)
container,

aerosol
 - see aerosol container

Child-resistant,
 - see child-resistant container

blister cards

main display panel

C-1(1)

Cylindrical

main display panel

C-1(1)

defined

C-1(1)

empty, included in definition of container

C-1(1)

fuel,

labelling exception

C-39(3)

portable gasoline, exception

C-2(2)(b)

indented

main display panel

C-1(1)

integrity

C-7

leakage test

C-7;C-Sch3

pressurized,
 - see pressurized container

single-use,

defined

C-1(1)

labelling of

C-8; C-13

small

labelling exemption

C-25

quick skin-bonding adhesive

C-55, 56

spray, defined

C-1(1)

tubes, label format for

C-26(2)

wide and short, label format for

C-26(3)
corneal damage,

Criteria involving

C-41(1)(e)
corrosion,

versus irritation

C-42
corrosive product,

Child-resistant container requirement

C-47

Classification criteria for

C-41 to C-44

defined

C-1(1)

labelling of

C-46

symbol

C-Sch2

prohibition and exception

C-45
cosmetic,

exemption for

H-3(1)(b)
cylindrical container,

main display panel

C-1(1)
CSA

defined

C-1(2)
CSA Tests, Referenced in the CCCR, 2001

B 306 - portable fuel tanks

C-2(2)(b)

B 339 - dangerous goods cylinders

C-58(2)

B 336 - portable gasoline containers

C-2(2)(b)

Z 76.1 - child-resistant packages

C-9(b)
D
data,

sources

C-6

for corrosive products

C-41

for flammable products

C-48

for toxic products

C-35
disclaimers,

on labels

C-15(2)
dispensers, single drop

Child-resistant container exception, toxic products

C-40(2)

limited flow orifices

C-40(2)
display card,

labelling of

C-15, 16
display surface,

defined

C-1(1)
Draize test,

skin or eye irritation, criterion for

C-1(2); C-43(2)
drug,

exemption for

H-3(1)(b)
dust,

defined

C-1(1)
E
edema formation,

skin or eye irritation, criterion for

C-41; C-42
empty container,

included in definition of container

C-1(1)
erythema formation,

skin or eye irritation, criterion for

C-41; C-42
excluded product,

HPA

H-3(1)(a)

CCCR, 2001

C-2(2)
explosive,

exemption for

H-3(1)(a)
eye irritation,

Classification criteria for

C-41(1)(e)
F
field test,

recommendation for

Sch 3
fire extinguishers,

exception for

C-2(2)(d)
first aid statement,

defined

C-1(1)

label, disclosure of

C-31

label, format for

C-20(b); C-24; C-25; C-29; C-31

methanol, for

C-39
flame projection,

defined

C-1(1)

flammable spray containers, as a criterion for

C-52

test method

C-Sch1
flammable product,

classification criteria for

C-48 to C-52

defined

C-1(1)

labelling of

C-54

symbol

C-Sch2

prohibition and exceptions

C-53
flammable aerosols,

caulking, classification criteria for

C-48, 49

classification criteria for

C-49

foam, classification criteria for

C-48, 49

spray string, classification criteria for

C-48, 49

test method

C-52; C-Sch1
flammable gas,

classification criteria for

C-49
flammable liquids,

classification criteria for

C-49

exemption, water-based product

C-48(2)
flammable sprays,

classification criteria for

C-49
flammable solids,

classification criteria for

C-49
flashback,

defined

C-1(1)

flammable spray containers, as a criterion for

C-52

test method

C-Sch1
flash point,

combustible liquid, as a criterion for

C-49

defined

C-1(1)

flammable liquid, as a criterion for

C-49

test methods for

C-50; C-51
foam,

aerosol, flammability classification

C-48, 49
food,

exemption for

H-3(1)(b)
fuels,

sale of

C-2(2)(b); C-39(3); C-53
fume,

defined

C-1(1)
G
gas,
 - see compressed gas
gasoline,

sale of

C-2(2)(b); C-39; C-53
good scientific practices,

defined

C-1(1)
H
hazard symbol(s),

defined

C-1(1)

depiction

C-21

design

C-Sch2

label disclosure

C-25

label format

C-26; C-27

size

C-22
hazardous ingredient,

complex mixtures, in

C-1(1); C-31

concentration cut-offs for

C-36(1)

defined

C-1(1)

disclosure of

C-31

percentages, expressed as

C-1(4)

use of, in classification

C-6(1)(d)
hazardous product,

defined

H-2
Hazardous Products Act (HPA),

Part I (prohibited and restricted products)

H-3 to H-10

Part II (controlled products)

H-11 to H-20

Part III (administration and enforcement)

H-21 to 31
human experience data,

defined

C-1(1)

precedence of, in classification

C-6(1)(a)
I
import,

defined

H-2
importer,

defined

H-13
importation,

of non-compliant chemical products

C-3

prohibited products

H-4(1)

record keeping requirements

C-5

restricted products

H-4(2)
information,

data sources

C-6
Ingredient,

hazardous, defined

C-1(1)

hazardous, disclosure of

C-31
ingredients, hazardous

complex mixtures, in

C-1(1); C-31

concentration cut-offs for

C-36(1)

defined

C-1(1)

disclosure of

C-31

percentages, expressed as

C-1(4)
inhalation,

corrosive product, additional labelling

C-46

gas / vapour, units of classification criteria

C-33, 34

saturation vapour concentration

C-33, 34

toxic product classification criteria for

C-33, 34
inspector,

defined

H-2
isopropyl alcohol,

aspiration hazard of

C-33, 34
iris damage,

criteria involving

C-41(1)(e)
irritants,

classification of

C-42

test methods for

C-43; C-44
ISO Tests, Referenced in the CCCR, 2001

8317 - child-resistant packaging

C-9(b)
K
kits,

labelling of

C-16(1)
L
label,

format, clarity

contrast

C-18

durability

C-17

legibility

C-17

print type

C-19(1)

format, layout

location and order

C-25

main display panel

C-25(1)(a)

- defined

C-1(1)

- hazard symbol(s)

C-26; C-27

- signal word

C-26; C-28

- primary hazard statement

C-26

secondary information

C-25(1)(b)

- border

C-30

- specific hazard statement

C-29

- instructions

C-29

- first aid statement

C-29, C-31; C-32

format, technical specifications

first aid statement, size

C-24(2)

hazard symbol, depiction

C-21

hazard symbol, size

C-22

other information, size

C-24(1)

print type, measurement of height

C-19(2)

signal word, size

C-23

upper-case print

C-20

languages

C-17

required information

additional information

C-15(2)

child-resistant containers

C-11; C-13

corrosive products

C-46

disclaimers

C-15(2)

flammable products

C-54

kits

C-16(1)

pictographs, use of

C-25

pictures, use of

C-15(2)

pressurized containers

C-59

quick skin-bonding adhesives

C-56

single-use containers

C-8; C-13

toxic products

C-39
labels, exceptions/exemptions,

lighters

C-2(2)

fire extinguishers

C-2(2)

fuels

C-39(3); C-53

imported products

C-3

kits

C-16(1)

pens

C-33, 34

petroleum containers, portable

C-2(2)

shipping containers

C-16(2)

short and wide containers

C-26(3)

small containers

C-25(2)

transparent packaging

C-16(1)

tubes, collapsible

C-26(2)

water-based product

C-48(2)
language requirements,

child-resistant container instructions

C-11

labelling

C-17

official, defined

C-1(1)
leakage,

test method

C-Sch3

requirement involving

C-7
life test,

recommendation for

Sch 3
LC50,

criteria involving

C-34(4)

defined

C-1(1)

equivalent formulae

C-37

formula, for mixtures

C-36
LD50,

criteria involving

C-34(2); C34(3)

defined

C-1(1)

formula, for mixtures

C-36
legibility,

label

C-17
M
main display panel,

defined

C-1(1)

for blister cards

C-1(1)

for cylindrical containers

C-1(1)

for indented containers

C-1(1)

format for

C-26 to C-28

label elements

C-25(1)(a)
manufacturer,

defined

C-1(1)
medical device,

exemption for

H-3(1)(b)
methanol,

first aid statement

C-39

flammability of

C-48, 49

toxicity of

C-33, 34
mineral spirits,

vapour toxicity of

C-33, 34
Minister,

defined

H-2
mist,

defined

C-1(1)
mixture,

defined

C-1(1)

hazard of mixing with other products,

labelling of

C-46

that separates,

classification of

C-35

toxicological evaluation of ~ using LC50 and LD50

C-36
N
National standard,

defined

C-1(1)
O
OECD,

defined

C-1(2)
OECD Test Guideline,

classification using

C-6(1); C-35(1); C-43(2); C-44(2)

defined

C-1(2)
OECD Test Guidelines, referenced in the CCCR, 2001

404 acute dermal irritation/corrosion

C-43(2)(a)

405 acute eye irritation/corrosion

C-43(2)(b)

Principles of Good Laboratory Practice

C-1(1); C-44(2)(a)

OECD Test Guidelines,

mutual acceptance of data in the assessment of chemicals

C-1(1); C-6(1); C-35(1)
official languages,

defined

C-1(1)
Organization for Economic Co-operation and Development,
 - see "OECD"
P
packaging performance,

child-resistant - see child-resistant container

coding system

Sch 3

integrity requirement

C-7

leakage requirement

C-7

tests

leakage test

Sch 3

screening tests

- aging test

Sch 3

- field test

Sch 3

- life test

Sch 3
pens,

toxic product exception

C-33, 34
person responsible,

defined

C-1(1)

obligations

C-4
[pest] control product,

exemption for

H-3(1)c)
pictogram(s),

for child-resistant container instructions

C-11(1)

symbols - see hazard symbol(s)

poisonous substance,
 - see toxic product
pine oil,

aspiration hazard of

C-33, 34
precautionary measures,

label disclosure of

C-25(1)(b)(ii); C-25(b)(iii)
pressurized container,

classification criteria

C-58

defined

C-58(1)

exceptions

C-59(2)

labelling

C-59

package integrity

C-7

spray container, defined

C-1(1)

spray container flammability criteria

C-49

spray container flammability test method

C-52; C-Sch1
preventive measures,

label disclosure of

C-25(1)(b)(ii); C-25(b)(iii)
principle display panel,

labelling format

C-25(1)(a); C-26 to C-28

language requirements

C-17(a)

main display panel, defined

C-1(1)
product specific,

aerosol foam product,

flammability classification

C-48, 49

barbecue cylinders,

exception

C-58(2)

batteries, lead/acid

exception

C-2

caulking guns,

child-resistance

C-10

caulking,

aerosol flammability

C-48, 49

cement,

additional labelling

C-46

fuel tanks,

exception

C-39; C-53

spray containers with tube attachments

child-resistance

C-40

flammability testing for

C-52

spray-string,

flammability classification

C-48, 49

pens,

toxic product exception

C-33, 34

water-based product,

flammable product exemption

C-48(2)

wiping cloth,

exception: first aid statement

C-39; C-46
professional judgement,

use of, in classification

C-6; C-33; C-35; C-41
prohibited product,

defined

H-2

very corrosive product

C-45

very flammable product

C-53

very toxic product

C-38
Q
quick skin-bonding adhesive,

defined

C-1(1)

labelling for

C-55; C-56

child-resistant container requirement

C-57
R
radioactive substance,

exemption for prescribed substance

H-(1)(e)
reactivity,

label disclosure of

C-46
record keeping requirements,

by importer

C-3(2)

by person responsible

C-5

for child-resistant containers

C-12

for hazard classification

C-4(1)(a)

for labelling disclosure

C-4(1)c)
regulation,

authority to make

H-5
restricted product,

defined

H-2

prohibition

H-4(2)

regulations, authority to establish

H-5
retailer,

transition period for

C-60
S
sale,

defined

H-2
single-use container,

defined

C-1(1)

labelling of

C-8; C-13
skin-bonding adhesive, quick,

defined

C-1(1)

labelling for

C-55; C-56

child-resistant container requirement

C-57
skin irritant,

classification criteria

C-42
source(s) of information,

for corrosive products

C-41; C-43

for flammable products

C-48

for toxic products

C-33; C-35

precedence of data sources

C-6
spray container,

defined

C-1(1)

flammable product criteria

C-49

flammability test method

C-52; C-Sch1

not exempt from toxic product classification

C-33, 34

pressurized container,

classification criteria

C-58

defined

C-58(1)

labelling of

C-59

spray string,

flammability classification

C-48, 49

tube attachments,

child-resistance

C-40

flammability testing for

C-52
standards,

list

C-1(2)

National, defined

C-1(1)
storage requirements,

label disclosure of

C-59
sub-category,

defined

C-1(1)
substances of special concern

toxic product,

applicable route of exposure

C-33, 34

mixtures with, classification of

C-33, 34

table of ~

C-33, 34

corrosive product,

table of ~

C-41, 42
substance-sprcific,

acetone

flammability of

C-53

isopropyl alcohol,

aspiration hazard

C-33, 34

methanol,

first aid statement

C-39

flammability of

C-48, 49

toxicity of

C-33, 34

mineral spirits,

vapour toxicity

C-33, 34

turpentine,

aspiration hazard

C-33, 34

pine oil,

aspiration hazard

C-33, 34

supplier,
 - see person responsible

symbols,
 - see hazard symbols

T
testing requirements,

Child-resistant container testing standards

C-9

obligations to test

C-6
tobacco/tobacco product,

exemption for

H-5(2)
toxic product,

child-resistant container requirement

C-40

classification criteria for

C-33 to C-36

defined

C-1(1)

labelling of

C-39

symbol

C-Sch2

prohibition

C-38
toxicological properties,

obligation not to mislead

C-15(2)

label disclosure of

C-39
transition period,

manufacturers/importers

C-60(2)

retailers

C-60(2)
tubes, collapsable

labelling of

C-26(2)
turpentine,

aspiration hazard of

C-33, 34
U
Underwriters' Laboratories of Canada
 - see ULC
ULC,

defined

C-1(2)

tests, for fire extinguishers

C-2(2)(d)
units of measure,

defined

C-1(3)
untested mixtures,

classification criteria for

C-34; C-36

use of ingredients, for classification

C-6(1)(d)
V
vapour,

defined

C-1(1)
W
WHMIS,

consumer chemical product exclusion

H-12(f)

harmonization with,

corrosive product classification comparison

C-41, 42

flammable product classification comparison

C-48, 49

pressurized container classification comparison

C-58

toxic product classification comparison

C-33, 34
water-based product,

exemption, flammable product classification

C-48(2)
wiping cloth,

exception, first aid statement

C-39; C-46

 

 

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