Vol. 150, No. 25 — December 14, 2016
SOR/2016-302 November 25, 2016
CANADA CONSUMER PRODUCT SAFETY ACT
Regulations Amending the Toys Regulations
P.C. 2016-1051 November 25, 2016
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 37 of the Canada Consumer Product Safety Act (see footnote a), makes the annexed Regulations Amending the Toys Regulations.
Regulations Amending the Toys Regulations
1 Section 1 of the Toys Regulations (see footnote 1) is amended by adding the following in alphabetical order:
good scientific practices means
- (a) for test data, conditions and procedures that are in accordance with or equivalent to those set out in the Organisation for Economic Co-operation and Development document entitled OECD Guidelines for the Testing of Chemicals, as amended from time to time; and
- (b) for laboratory practices, practices that are in accordance with the principles set out in the Organisation for Economic Co-operation and Development document entitled 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, the English version of which is dated January 21, 1998 and the French version of which is dated March 6, 1998. (bonnes pratiques scientifiques)
human experience data means data from a peer-reviewed study that demonstrate that injury to a human has or has not resulted from exposure to a substance or stuffing material. (données de l’expérience humaine)
2 Section 7 of the Regulations is replaced by the following:
7 (1) A toy that is likely to be used by a child of less than three years of age must not contain a part that is meant to be separable or may become separated with reasonably foreseeable use of the toy and that can be totally enclosed in the small parts cylinder illustrated in Schedule 1 using a force of not more than 4.45 N.
Exception — soft textile fibre material
(2) Subsection (1) does not apply to parts that are constructed entirely of soft textile fibre material.
3 Sections 26 and 27 of the Regulations are replaced by the following:
Corrosive, irritant or sensitizing substances
26 If a toy contains a substance that is capable of coming into contact with the skin because of the nature or characteristic of the toy, the substance must not be irritant, corrosive or sensitizing when assessed in accordance with Schedule 3.
Substances in plastic materials — prohibition
27 The plastic material that is contained in a toy that is likely to be used by a child of less than three years of age must not contain the following substances:
- (a) a heavy metal or a compound of a heavy metal; or
- (b) a substance set out in section 22 or 23.
4 Section 29 of the Regulations is replaced by the following:
29 Material that is used as stuffing in a doll, plush toy or soft toy must meet all of the following requirements:
- (a) it must be clean and free from vermin;
- (b) it must be free of hard or sharp foreign matter;
- (c) its toxicity must not exceed the limits set out in Schedule 2;
- (d) it must not be irritant when assessed in accordance with Schedule 3.
5 Section 36 of the French version of the Regulations is replaced by the following:
Graines de plante –– rembourrage
36 Le jouet ne doit pas contenir de graines de plante utilisées comme matière de rembourrage.
6 Section 43 of the Regulations and the heading before it are repealed.
7 (1) The portion of subsection 1(1) of Schedule 2 to the Regulations before paragraph (a) is replaced by the following:
1 (1) For the purposes of paragraphs 25(c) and 29(c) of these Regulations, a substance or stuffing material is toxic for humans in all of the following cases:
(2) Subsections 1(2) to (5) of Schedule 2 to the Regulations are replaced by the following:
(2) LD50 and LC50 values are to be determined in accordance with good scientific practices.
8 The heading before section 2 and sections 2 and 3 of Schedule 2 to the Regulations are repealed.
9 Schedule 3 to the Regulations is replaced by the Schedule 3 set out in the schedule to these Regulations.
10 Schedule 9 to the Regulations is repealed.
Coming into Force
11 These Regulations come into force on the day on which they are registered.
(Section 26 and paragraph 29(d))
Criteria for Determining if a Substance or Stuffing Material Is Irritant, Corrosive or Sensitizing
1 For the purposes of section 26 and paragraph 29(d) of these Regulations, a substance or stuffing material is irritant if human experience data or data obtained from testing performed in accordance with the test methods set out in this Schedule demonstrate that it is irritant to the eye or skin.
Method for Testing Eye-Irritant Properties
2 (1) Use six albino rabbits for each test substance or stuffing material. Ensure that animal facilities for such procedures are designed and maintained so as to exclude sawdust, wood chips or other extraneous materials that might produce eye irritation. Examine both eyes of each rabbit before testing. Use only those rabbits without eye defects or irritation. Hold the rabbit firmly but gently until it is quiet. Place the test substance or stuffing material in one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance or stuffing material is dropped. Gently hold the lids together for one second and then release the rabbit. The other eye, remaining untreated, serves as a control. For testing liquids, use 0.1 ml (2 drops) of the test substance or stuffing material. For testing solids or pastes, use 100 mg (1.5 grains) of the substance or stuffing material. For substances or stuffing materials in flake, granule, powder or other particulate form, use the amount that has a volume of 0.1 ml (2 drops) (after compacting as much as possible without crushing or altering the individual particles, such as by tapping the measuring container) whenever this volume weighs less than 100 mg (1.5 grains). In such a case, record the weight of the 0.1 ml (2 drops) test dose. Do not wash the eyes after instillation of the test substance or stuffing material except as noted in subsection (2).
(2) Examine the eyes and record the grade of ocular reaction at 24, 48 and 72 hours. Use a binocular loupe, hand-held slit lamp or other expert means to facilitate observing the reactions. After the observations are recorded at 24 hours, the eyes may be further examined after fluorescein is applied. To do this, drop 0.05 ml (one drop) of fluorescein sodium ophthalmic solution U.S.P. or equivalent directly on the cornea. After the excess fluorescein is flushed out with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow. This is best visualized in a darkened room under ultraviolet illumination. The eyes may be washed with sodium chloride solution U.S.P. or equivalent after the 24-hour recording.
(3) A rabbit is considered to exhibit a positive reaction if, at any of the observations, the test substance or stuffing material has produced one or more of the following reactions:
- (a) an ulceration of the cornea, other than a fine stippling;
- (b) an opacity of the cornea, other than a slight dulling of the normal lustre;
- (c) an inflammation of the iris, other than a slight deepening of the folds (or rugae) or a slight circumcorneal injection of the blood vessels;
- (d) an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the lids or a diffuse crimson-red with individual vessels that are not easily discernible.
(4) The test is positive if four or more of the rabbits in the test group exhibit a positive reaction. If only one rabbit exhibits a positive reaction, the test is considered negative. If two or three rabbits exhibit a positive reaction, repeat the test using a different group of six rabbits. The second test is positive if three or more of the rabbits exhibit a positive reaction. If only one or two rabbits in the second test group exhibit a positive reaction, repeat the test with a different group of six rabbits. If a third test is needed, the substance or stuffing material is irritant if any rabbit exhibits a positive reaction.
Method for Testing Skin-Irritant Properties
3 (1) Measure primary irritation to the skin by means of a patch-test technique on the abraded and intact skin of an albino rabbit clipped free of hair. Use a minimum of six rabbits. Introduce the test substance or stuffing material — 0.5 ml (10 drops) in the case of liquids or 0.5 g (7-8 grains) in the case of solids or semisolids — under a square patch that is made up of two layers of surgical gauze measuring 25 mm by 25 mm (1 inch by 1 inch). Dissolve solids in an appropriate solvent and apply the solution as in the case for liquids. Immobilize the rabbits and secure the patches in place with adhesive tape. Wrap the entire trunk of the rabbit with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances or stuffing materials.
(2) After 24 hours of exposure, remove the patches and evaluate the reactions on the basis of the designated values in the following table:
EVALUATION OF SKIN REACTIONS
Value (see footnote 2)
Erythema and eschar formation
(a) No erythema
(b) Very slight erythema (barely perceptible)
(c) Well-defined erythema
(d) Moderate to severe erythema
(e) Severe erythema (beet redness) to slight eschar formation (injuries in depth)
(a) No edema
(b) Very slight edema (barely perceptible)
(c) Slight edema (edges of area well defined by definite raising)
(d) Moderate edema (raised approximately 1 mm (0.04 inch)
(e) Severe edema (raised more than 1 mm (0.04 inch) and extending beyond the area of exposure)
(3) Repeat the observations at the end of a total of 72 hours (48 hours after the first observation). Make an equal number of exposures on areas of skin that have been previously abraded. Ensure that the abrasions are minor incisions through the stratum corneum (horny layer of the epidermis), but not sufficiently deep so as to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as set out in subsection (2). Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values for abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). Divide the total of the eight values by four to obtain the primary irritation score. A score of five or more indicates that the substance or stuffing material is irritant.
4 For the purposes of section 26 of these Regulations, a substance is corrosive if it causes visible destruction or irreversible damage in tissue at the site of the application.
5 For the purposes of section 26 of these Regulations, a substance is sensitizing if human experience data demonstrate that it causes an allergenic sensitization in a substantial number of humans who come into contact with it.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) has identified the following concerns in the Toys Regulations under the Canada Consumer Product Safety Act (CCPSA):
- (1) Subsection 27(1) is not clear regarding which substances are “considered acceptable” to be present in the plastic material of toys used by children less than three years of age;
- (2) Subsection 1(5) of Schedule 2 is not clear regarding which “other methods giving similar results” are acceptable for determining the acute toxicity of a substance contained in a toy or a stuffing material used in a doll, plush toy, or soft toy;
- (3) Schedule 3 is not clear regarding the meaning of “judged on human experience” for determining irritation, corrosion, or sensitization (English version only), and section 4 of Schedule 3 is not clear regarding the meaning of a “substantial number of persons” for determining sensitization; and
- (4) The test methods in Schedule 9 for batteries used in toys are not sufficiently detailed.
The objective of this regulatory initiative is to respond to the concerns of the SJCSR by clarifying a small set of existing requirements under the Toys Regulations. No additional requirements are being introduced.
The Toys Regulations are amended as follows:
The purpose of section 27 is to help protect children less than three years of age from exposure to harmful substances contained in plastic material of toys.
Subsection 27(1) allows plastic material of toys for children less than three years of age to contain substances that are acceptable for use in food packaging materials and food containers, with the restrictions set out in subsection 27(2). However, neither Canada nor its major trading partners have a list of acceptable substances for these uses, nor is there a list of acceptable substances for use in toys. As a result, subsections 27(1) and (2) cannot be enforced and are repealed. The prohibition of substances set out in paragraphs 27(3)(a) to (c) is retained, but subsection 27(3) is renumbered as section 27 and reworded to improve comprehensibility. Paragraph 27(3)(d) is repealed because soft vinyl toys for children less than three years of age are already subject to the requirements under the Phthalates Regulations.
Schedule 2 provides animal test methods and performance criteria for determining if a substance contained in a toy or a stuffing material used in a doll, plush toy, or soft toy is acutely toxic for the purposes of paragraphs 25(c) and 29(c) of the Toys Regulations.
The prescribed test methods have not been updated since the Toys Regulations were introduced in 1970. However, test methods have been refined since then to minimize animal suffering. Alternatives to animal testing have also been introduced, such as in vitro studies and computer modelling. Therefore, the SJCSR’s question regarding acceptable test methods is addressed by updating the requirements set out in Schedule 2 to reflect current practices, as follows:
- Subsections 1(3) to (5) and sections 2 and 3 of Schedule 2 are repealed;
- The term “good toxicological practice” in subsection 1(2) of Schedule 2 is replaced with “good scientific practices;”
- The term “good scientific practices” is defined in section 1 of the Toys Regulations to mean test guidelines developed by the Organisation for Economic Cooperation and Development (OECD) or their equivalent, and OECD principles of good laboratory practices; and
- Subsection 1(2) of Schedule 2 is revised to clarify that LD50 and LC50 values must be determined using good scientific practices.
OECD test guidelines are internationally accepted and used by scientific and regulatory communities as the standard methods for safety testing, and are updated regularly by experts from OECD member countries.
Schedule 3 provides test methods and performance criteria for determining if a substance contained in a toy or a stuffing material used in a doll, plush toy, or soft toy is an eye or skin irritant or corrosive, or a sensitizer, for the purposes of paragraphs 26(b) and 29(c) of the Toys Regulations. Irritation and corrosion are determined using animal test data or are “judged on human experience,” and sensitization is “judged on human experience.”
To address the SJCSR concern regarding the meaning of “judged on human experience” in section 1 of Schedule 3, “human experience” is replaced by “human experience data.” This is the term currently used in the regulatory community to refer to human data from various sources, such as clinical and epidemiological studies, that demonstrate the effect (or lack thereof) of substances on humans. The human experience data must be peer-reviewed, which is an indicator that it is of good quality and reliability. In addition, “when judged on human experience” is replaced by “if human experience data…demonstrate” to better align with the French version (« si les données de l’expérience humaine démontrent »).
The term “a substantial number of persons” in section 4 of Schedule 3 is retained because it is a common quantifier for classifying a substance as a skin sensitizer using human experience data. For instance, this term is used to classify a substance as a skin sensitizer in the Globally Harmonized System (GHS) of the Classification and Labelling of Chemicals, which is used internationally to address the classification of chemicals, labels and safety data sheets. However, the term “a substantial number of persons” is replaced with “a substantial number of humans” because “persons” has a specific meaning under the CCPSA.
In addition, sections 26 and 29 of the Toys Regulations are reworded for clarity.
Schedule 9 sets out analytical test methods (vibration test and drop test) required under section 43 of the Toys Regulations for batteries used in toys.
When the Toys Regulations were introduced in 1970, some batteries had a cardboard sleeve and were known to leak battery acid. The vibration test and the drop test were prescribed to make sure that toy batteries did not leak battery acid during transportation or reasonably foreseeable use. Since that time, industry standards and advances in battery technology and construction have addressed the hazards that section 43 and Schedule 9 intended to mitigate, rendering these requirements obsolete. Present-day batteries easily withstand the Schedule 9 tests. Also, most modern toys that operate with replaceable batteries are not sold with batteries, and battery manufacturers do not make batteries that are uniquely intended for toys. For these reasons, section 43 and Schedule 9 are repealed.
In addition, minor amendments were made to the wording in sections 7 and 36 (French version only).
The “One-for-One” Rule does not apply since there is no change in administrative costs to business.
Small business lens
The small business lens does not apply since there is no impact on small businesses.
Health Canada consulted informally with stakeholders (including industry, industry associations, testing laboratories, and children’s safety advocates) in May 2016. Feedback was favourable on all proposed changes except for section 27. In response, the proposed changes to section 27 were modified to ensure there would be no impact on toy safety. Overall, stakeholders were satisfied with the amendments to the Toys Regulations. No impacts on costs, policies, or processes were noted.
A few issues were raised by stakeholders that could result in substantive changes to the Toys Regulations. These include (a) the availability of updated requirements for harmful elements in plastic materials of toys in existing toy safety standards (section 27); (b) the availability of updated test methods for irritation, corrosion, and sensitization (Schedule 3); and (c) risks with new and emerging battery technologies (section 43 and Schedule 9). Health Canada may consider these issues in a future amendment of the Toys Regulations when consideration of substantive amendments will require using the full federal regulatory development process.
The Regulations Amending the Toys Regulations address concerns raised by the SJCSR. They clarify existing requirements, update test methods, and delete redundancies or obsolete requirements. They have no impact on the intent of the Toys Regulations, costs for industry or consumers, toy safety, or children’s health. They provide industry with more flexibility to select from available test methods for determining acute toxicity that are internationally recognized and referenced in other Health Canada regulations.
Implementation, enforcement and service standards
These amendments will not affect existing Health Canada compliance and enforcement activities. Existing guidance will be updated to reflect the regulatory changes in the “Description” section.
Senior Regulatory Policy and Risk Management Advisor
Risk Management Bureau
Consumer Product Safety Directorate
Healthy Environments and Consumer Safety Branch
269 Laurier Avenue West
Address Locator: 4908B