Hazardous Products (Toys) RegulationsC.R.C., c. 931HAZARDOUS PRODUCTS ACTHazardous Products (Toys) RegulationsREGULATIONS RESPECTING THE ADVERTISING, SALE AND IMPORTATION OF HAZARDOUS PRODUCTS (TOYS)SHORT TITLE1. These Regulations may be cited as the Hazardous Products (Toys) Regulations.INTERPRETATION2. In these Regulations,"Act" means the Hazardous Products Act; ( Loi )"soft toy" includes a stuffed toy, a pliable rubber toy and a pliable plastic toy. ( jouet mou )GENERAL3. (1) A person may advertise, sell or import into Canada a product included in any of items 13 to 20 of Part II of Schedule I to the Act only if that product meets the requirements of these Regulations.(2) Any written statement or warning or other written information required by these Regulations shall appear in both the English and French languages.SOR/91-267, s. 1.PACKAGING4. (1) A flexible film bag used to package any product described in paragraph 13(a) of Part II of ScheduleI to the Act shall meet the following requirements:(a) the opening of the bag shall be less than 14 inches in circumference; or(b) the bag shall(i) be made from film that is at least 0.75 ml thick, and(ii) have printed legibly on it the following warning:―PLASTIC BAGS C AN BE DANGEROUS. TO AVOID DANGER OF SUFFOCATION KEEP THIS BAG AWAY FROM BABIES AND CHILDREN.‖(2) The warning set out in paragraph (1)(b) may be expressed in different words if those words convey clearly the same warning.SOR/91-267, s. 2.ELECTRICAL HAZARDS5. Every product described in paragraph 13(b) of Part II of Schedule I to the Act shall meet the requirements applicable to it that are set out in Canadian Standards Association Standard C22.2 No. 149-1972, entitled Electrically Operated Toys.SOR/78-393, s. 1; SOR/91-267, s. 3.6. Every wood-burning electric tool included in paragraph 13(b) of Part II of Schedule I to the Act shall meet the requirements applicable to it that are set out in Canadian Standards Association StandardC22.2 No. 122-M1989, entitled Hand-Held Electrically Heated Tools.SOR/91-267, s. 3.MECHANICAL HAZARDS7. No product included in paragraph 13(c) of Part II of Schedule I to the Act shall have a component or part, other than a component or part constructed entirely of soft textile fibre material, that(a) is separable;(b) may become detached with reasonably foreseeable use; and(c) can be totally enclosed in the small parts cylinder described in Schedule VIII.SOR/91-267, s. 4; SOR/2004-65, s. 3.8. Every product described in(a) paragraph 13(d) of Part II of Schedule I to the Act shall have all exposed metal edges folded backor sprayed with or dipped in paint or otherwise treated so that all sharpness and burrs are eliminated;(b) paragraph 13(e) of Part II of that Schedule shall have all ends of wire covered, turned in or turnedback so that no sharp ends become exposed with reasonably foreseeable use;(c) paragraph 13(f) of Part II of that Schedule shall have all of its plastic parts that would, on breaking,expose sharp edges,(i) made sufficiently thick to resist breakage through reasonably foreseeable use, or(ii) where such parts are necessarily thin because of the function of the product, made ofinherently tough materials;(d) paragraph 13(g) of Part II of that Schedule shall have all of its exposed wooden surfaces, edges and corners smoothly finished;(e) paragraph 13(h) of Part II of that Schedule shall have all edges and corners of the glass smoothly finished;(f) paragraph 13(i) of Part II of that Schedule shall have only such fasteners as, by reason of their type, size and manner of use, will not, with reasonably foreseeable use, cause personal injury and, without limiting the generality of the foregoing, shall have(i) any nails and staples properly secured,(ii) any flat head or oval head wood screws of the countersunk head type properly countersunk,(iii) any wood screws free of all exposed burrs,(iv) any fasteners in upholstering or upholstering-like application properly secured and of a type that, if exposed would not be a hazard, and(v) any threaded bolts protected by acorn or similar nuts or protective caps, unless the bolts are so placed that they protrude into a protected area where contact with the threaded ends is not likely to occur;(g) paragraph 13(j) of Part II of that Schedule shall have a safety stop or a locking device to prevent the unintentional collapse of the product;(h) paragraph 13(k) of Part II of that Schedule shall have(i) its spring-wound driving mechanism enclosed so that the moving parts thereof cannot betouched under reasonably foreseeable use,(ii) an outer case that will withstand reasonable abuse if the product is so constructed thatdamage to the outer case would cause the mechanism to be exposed,(iii) where a non-detachable winding key has been installed, such winding key of a shape and size that a child’s finger cannot become ensnared in it, and(iv) where a detachable key or starting handle is to be used, a clearance space between the key or handle, when in place, and the body of the product, that is less than 1/16 inch (2 mm) or greater than 3/8 inch (10 mm);(i) paragraph 13(l) of Part II of that Schedule shall have a rubber tip or other durable fitting placed on the leading end of the projectile component with sufficient security to withstand a pulling force of ten pounds (44.5 N);(j) paragraph 13(m) of Part II of that Schedule shall have holes of sufficient size and number in each of two or more adjacent sides to prevent the suffocation of a child enclosed therein; and(k) paragraph 13(n) of Part II of that Schedule shall stand level and firm when used.SOR/78-393, s. 2; SOR/91-267, s. 5.THERMAL HAZARDS9. Every product described in paragraph 13(o) of Part II of Schedule I to the Act shall meet the thermal and labelling requirements applicable to it that are set out in Canadian Standards Association Standard C22.2 No. 149-1972, entitled Electrically Operated Toys.SOR/78-393, s. 3; SOR/91-267, s. 6.TOXICOLOGICAL HAZARDS10. Every product described in paragraph 13(p) of Part II of Schedule I to the Act shall meet at least one of the following requirements:(a) the product, by reason of its nature, physical form, size or any other characteristic, shall be suchthat the toxic substance or the substance or part containing the toxic substance cannot be ingested, inhaled or absorbed through the skin;(b) the total quantity of the available toxic substance shall not exceed one-hundredth of the acuteoral or dermal median lethal dose, whichever is the lesser, calculated for a child having a body weight of 10 kg; or(c) the toxicity of the toxic substance does not exceed the limits prescribed by Schedule I.SOR/78-393, s. 4(E); SOR/91-267, s. 7.11. Every product described in paragraph 13(q) of Part II of Schedule I to the Act shall meet at least one of the following requirements:(a) the product, by reason of its nature or any characteristic, shall be such that the corrosivesubstance, irritant or sensitizer cannot come in contact with the skin; or(b) the corrosive substance, irritant or sensitizer shall not be excessively corrosive or irritant or anexcessively strong sensitizer as determined in accordance with the tests prescribed by Schedule II. SOR/91-267, s. 8.12. (1) Subject to subsection (2), resins, plasticizers, antioxidants, dyes, pigments and other substances and the grade, quality, quantity and proportions thereof used in manufacturing any plastic material used in any product included in paragraph 13(r) of Part II of Schedule I to the Act shall be those considered acceptable for use in the manufacture of food packaging materials and food containers.(2) A substance, other than a heavy metal, a compound of a heavy metal or a substance set out in item 8 or 9 of Part I of Schedule I to the Act, may, subject to sections 10 and 11, be present in a plastic material referred to in subsection (1) in the amount of one per cent or less.SOR/91-267, s. 9.SPECIFIC PRODUCTSD OLLS AND S OFT T OYS13. All parts, clothing or ornamentation attached to any product described in paragraph 14(a) of Part II of Schedule I to the Act shall be attached to the product in such a manner that no sharp edge or point will become exposed as a result of reasonably foreseeable use of the product.SOR/91-267, s. 10.14. All material used for stuffing any product described in paragraph 14(b) of Part II of Schedule I to the Act shall(a) be clean and free from vermin;(b) be free from hard and sharp foreign matter; and(c) be non-toxic and non-irritant as required by Schedules I and II.SOR/91-267, s. 11.15. Every eye or nose referred to in paragraph 14(c) of Part II of Schedule I to the Act, except a part that is made entirely of felt or other soft textile material, shall be attached to the product in such a manner that(a) the eye or nose cannot be gripped by a three-pronged claw hook referred to in Schedule III; or(b) when tested in accordance with the method described in Schedule III, the eye or nose does notbecome detached.SOR/91-267, s. 12.16. (1) Subject to subsections (2) and (3), every product described in paragraph 14(d) of Part II of Schedule I to the Act shall, when tested in accordance with the test procedures set out in Schedule V, have a time of flame spread in excess of 7 seconds.(2) Where, due to the small size of a product referred to in subsection (1), sufficient material, including any seam, cannot be removed from the product to provide at least one of the test specimens required in the test referred to in Schedule V and the exposed pile length is two inches or more, the product, after beingor natural fur is known to have a flame-retarding finish, or if preliminary testing indicates that such a finish may be present,(b) dried in an oven for 30 minutes at 221°F (105°C) or for 120 minutes at 167°F (75°C),(c) removed from the oven, and(d) placed over a desiccant such as anhydrous calcium chloride in a desiccator until cool, but for notless than 15 minutes or more than two hours,shall(e) not flame upon a one-second impingement of the calibrated flame applied by the flammabilitytester specified in item 1 of Schedule VI; or(f) self-extinguish within two seconds of the removal of the flame referred to in paragraph (d).(3) Where, due to the small size of a product referred to in subsection (1), sufficient material, including any seam, cannot be removed from the product to provide at least one of the test specimens required in the test referred to in Schedule V and the exposed pile length is less than two inches, subsection (1) is not applicable to the product.(4) [Revoked, SOR/80-312, s. 1]SOR/80-312, s. 1; SOR/91-267, s. 13.17. (1) Subject to subsection (2), every product described in paragraph 14(e) of Part II of Schedule I to the Act shall have a time of flame spread in excess of 7 seconds,(a) when tested in accordance with the test procedures set out in Schedule VII; or(b) where, due to the short length of the yarn, sufficient material cannot be removed from the productto provide at least one of the test specimens required in the test procedures set out in Schedule VII, when tested in accordance with the test procedures set out in Schedule V.(2) Where, due to the short length of the yarn and the small size of a product referred to in subsection (1), sufficient material, including any seam, cannot be removed from the product to provide at least one of the test specimens required in the test procedures set out in Schedule V, subsection (1) is not applicable to the product.SOR/91-267, s. 14.18. The hair or mane, or simulated hair or simulated mane, of every product described in paragraph 14(f) of Part II of Schedule I to the Act, after beingsimulated hair or simulated mane is known to have a flame-retarding finish, or if preliminary testing indicates that such a finish may be present,(b) dried in an oven for 30 minutes at 221°F (105°C) or for 120 minutes at 167°F (75°C),(c) removed from the oven, and(d) placed over a desiccant such as anhydrous calcium chloride in a desiccator until cool, but for notless than 15 minutes or more than two hours,shall(e) not flame upon a one-second impingement of the calibrated flame applied by the flammabilitytester specified in item 1 of Schedule VI, or(f) self-extinguish within two seconds of the removal of the flame referred to in paragraph (d).SOR/91-267, s. 15.19. Every squeaker, reed, valve or other similar device referred to in paragraph 14(g) of Part II of Schedule I to the Act that can be totally enclosed in the small parts cylinder shown in Schedule VIII shall be secured to the product in such a manner that it cannot come loose as a result of reasonably foreseeable use.SOR/91-267, s. 16; SOR/2004-65, s. 4.20. Every product described in item 14 of Part II of Schedule I to the Act shall meet all such requirements prescribed by these Regulations in respect of products included in item 13 of Part II of that Schedule as are applicable to it.SOR/91-267, s. 16.P ULL AND P USH T OYS21. Every product described in item 15 of Part II of Schedule I to the Act shall(a) meet all such requirements prescribed by these Regulations in respect of products described initems 13 and 14 of Part II of that Schedule as are applicable to it; and(b) have a protective tip placed on the end of the shaft-like handle thereof(i) for the purpose of preventing puncture wounds, and(ii) with sufficient security to withstand a pulling force of 10 pounds (44.5 N).SOR/78-393, s. 5; SOR/91-267, s. 17.T OY S TEAM E NGINES22. Every product included in item 16 of Part II of Schedule I to the Act shall meet such requirements prescribed by these Regulations in respect of products described in item 13 of Part II of that Schedule as are applicable to it.SOR/91-267, s. 18.23. (1) Toy steam engine boilers shall meet the following requirements:(a) each boiler shall be fitted with a firmly installed spring valve or any other safety valve except aweight valve;(b) the operating pressure of a safety valve shall not be more than one and one-half times theoperating pressure of the steam boiler to which it is fitted; and(c) each boiler shall be constructed to withstand, without rupture, a pressure that is at least threetimes the operating pressure of the boiler.(2) For the purpose of subsection (1), the operating pressure of a boiler is the steam pressure in the boiler that adjusts itself after the steam engine has been running without a load.F INGER P AINTS24. Every product included in item 17 of Part II of Schedule I to the Act shall(a) be water-based; and(b) meet such requirements prescribed by these Regulations in respect of products included in item13 of Part II of that Schedule as are applicable to it.SOR/91-267, s. 19.R ATTLES25. Every product included in item 18 of Part II of Schedule I to the Act shall be so constructed(a) that no sharp wire will, with reasonably foreseeable use, become exposed; and(b) that no part of the product and none of its components that can be removed by the application ofa force of 50 Newtons (11.23 lbs.) or less or a torque of less than one Newton metre (8.85 in. lbs.)will impinge on the base of the template depicted in Schedule IX, when tested in accordance with the instructions set out in that Schedule.SOR/91-267, s. 20.E LASTIC26. Every product described in item 19 of Part II of Schedule I to the Act shall meet at least one of the following requirements:(a) its extensibility shall not be more than 75 per cent of its unstretched length; or(b) its fully-stretched length shall not be more than 30 inches (0.75 m).SOR/91-267, s. 21.B ATTERIES27. Every product included in item 20 of Part II of Schedule I to the Act shall be constructed to withstand the test prescribed in Schedule IV without leakage.SOR/91-267, s. 22.SCHEDULE I(ss. 10 and 14)PERMISSIBLE LIMITS OF TOXICITY1.(1) For the purposes of paragraphs 10(c) and 14(c) of the Regulations, a substance shall be considered excessively toxic for humans if(a) the acute oral LD50 value thereof for rat is 5 grams or less per kilogram body weight;(b) the acute dermal LD50 value for rabbit is 2 grams or less per kilogram body weight; and(c) where gas, vapour, mist or dust is likely to be encountered when the substance is used in anyreasonably foreseeable manner, the LC50 value thereof for a one-hour exposure determined using rats, is 20,000 parts per million by volume of gas or vapor or less, or 200 milligrams per litre by volume of mist or dust or less.(2) LD50 values are to be determined in conformity with good toxicological practice.(3) The number of deaths during a 14-day period following dosage shall be used as the basis for calculation of the LD50 value.(4) Sufficient animals shall be used to give a statistically significant result, which result shall be calculated using methods based upon good statistical practice.(5) The methods used by C. I. Bliss (1938) and J. T. Litchfield and W. F. Wilcoxon (1949) are acceptable but other methods giving similar results may also be accepted.2. The dermal LD50 value shall be determined in the following manner:In the acute exposures the agent is held in contact with the skin by means of a sleeve for periods varying up to24 hours. The sleeve, made of rubber dam or other impervious material, is so constructed that the ends arereinforced with additional strips and should fit snugly around the trunk of the animal. The ends of the sleeve are tucked, permitting the central portion to ―balloon‖ and furnish a reservoir for the dose. The reservoir must have sufficient capacity to contain the dose without pressure. The dimensions of sleeves and the approximate body surface exposed to the test substance are given in the following table:DIMENSIONS OF SLEEVES FOR ACUTE DERMAL TOXICITY TEST(Test Animal Rabbits)Measurements in centimetres AverageRange of Average percentageweight of area of of totalDiameter Overall animals exposure bodyat ends length (grams) (cm.2) surface7.0 12.5 2,500 — 3,500 240 10.7The sleeves may vary in size to accommodate smaller or larger subjects. In the testing of unctuous materials that adhere readily to the skin, mesh wire screen may be employed instead of the sleeve. The screen is padded and raised approximately 2 centimetres from the exposed skin. In the case of dry powder preparations, the skin and substance are moistened with physiological saline prior to exposure. The sleeve or screen is then slipped over the gauze which holds the dose applied to the skin. In the case of finely divided powders the measured dose is evenly distributed on cotton gauze, which is then secured to the area of exposure.The animals are prepared by clipping the skin of the trunk free of hair. Approximately one half of the animals are further prepared by making epidermal abrasions every 2 centimetres or 3 centimetres longitudinally over the area of exposure. The abrasions are sufficiently deep to penetrate the stratum corneum (horny layer of the epidermis), but not to disturb the derma — that is, not to obtain bleeding.The sleeve is slipped onto the animal, that is then placed in a comfortable but immobilized position in a multiple animal holder. Selected doses of liquids and solutions are introduced under the sleeve. If there is slight leakage from the sleeve, which may occur during the first few hours of exposure, it is collected and reapplied. Dosage levels are adjusted in subsequent exposures (if necessary) to enable a calculation of a dose that would be fatal to 50 per cent of the animals. This can be determined from mortality ratios obtained at various doses employed. At the end of 24 hours the sleeves or screens are removed, the volume of unabsorbed material, if any, is measured, and the skin reactions are noted. The subjects are cleaned by thorough wiping, observed for gross symptoms of poisoning, and then observed for two weeks.3. F or the purposes of this schedule, ―LD50" means the dose that will kill 50 per cent of test animals under the specified conditions of test; and ―LC50" means the concentration of gas and vapour that will kill 50 per cent of test animals under the specified conditions of test.4. The methods referred to in subsection 1(5) are described in publications as follows:(a) C.I. Bliss, The determination of the dosage-mortality curve from small numbers, Quarterly Journal ofPharmacy and Pharmacology, 1939, Volume 11, page 192; and(b) J.T. Litchfield and W.F. Wilcoxon, A simplified method of evaluating dose-effect experiments, Journal ofPharmacology and Experimental Therapeutics, 1949, Volume 96, page 99.SCHEDULE II(ss. 11 and 14)CRITERIA FOR DECIDING IF A SUBSTANCE IS EXCESSIVELY CORROSIVE OR IRRITANT OR ANEXCESSIVELY STRONG SENSITIZER1. A substance or mixture of substances shall be considered not excessively irritant for the purposes of section 11 and paragraph 14(c) of the Regulations if it is not excessively irritant to(a) the eye judged on human experience or based upon the test method described hereunder; and(b) the skin judged on human experience or based upon the test method described hereunder.Method for Testing Eye Irritant Properties2.(1) Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained as to exclude sawdust, wood ships, or other extraneous materials that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control. For testing liquids, 0.1 millilitre is used. For solids or pastes, 100 milligrams of the test substance is used, except that for substances in flake, granule, powder or other particulate form the amount that has a volume of 0.1 millilitre (after compacting as much as possible without crushing or altering the individual particles, such as by tapping the measuring container) shall be used whenever this volume weighs less than 100 milligrams. In such a case, the weight of the 0.1 millilitre test dose should be recorded. The eyes are not washed following instillation of test material except as noted below.(2) The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours. Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein 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. Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent after the 24-hour reading.(3) An animal shall be considered as exhibiting an excessive reaction if the test substance produces at any of the readings ulceration of the cornea (other than a fine stippling), or opacity of the cornea (other than a slight dulling of the normal luster), or inflammation of the iris (other than a slight deepening of the folds (or rugae) or a slight circumcorneal injection of the blood vessels), or if such substance produces in the conjunctivae (excluding the cornea and iris) an obvious swelling with partial eversion of the lids or a diffuse crimson-red with individual vessels not easily discernible.(4) The test shall be considered positive if four or more of the animals in the test group exhibit a positive reaction. If only one animal exhibits a positive reaction, the test shall be regarded as negative. If two or three animals exhibit a positive reaction, the test is repeated using a different group of six animals. The second test shall be considered positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test shall be repeated with a different group of six animals. Should a third test be needed, the substance will be regarded as excessively irritant if any animal exhibits a positive response.(5) To assist testing laboratories and other interested persons in interpreting the results obtained when a substance is tested in accordance with the method des cribed in subsection (1) of this section, an ―Illustrated Guide for Grading Eye Irritation by Hazardous Substances‖ is sold by the Superintendent of Documents, Government Printing Office, Washington, D.C., U.S.A. The guide contains colour plates depicting responses of varying intensity to specific test solutions. The grade of response and the substance used to produce the response will be indicated.Method for Testing Skin Irritant Properties3.(1) Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of an albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as two single layers of surgical gauze, measuring 1 inch by 1 inch, 0.5 millilitre (in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth for the24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values in the following table:Evaluation of skin reactions Value1Erythema and eschar formation:No erythema 0Very slight erythema (barely perceptible) (1)Well-defined erythema (2)Moderate to severe erythema (3)Severe erythema (beet redness) to slight eschar formation (injuries in depth) (4)Edema formation:No edema 0Very slight edema (barely perceptible) (1)Slight edema (edges of area well defined by definite raising) (2)Moderate edema (raised approximately one millimetre) (3)4Severe edema (raised more than one millimetre and extending beyond the area of exposure).......1 The ―value‖ recorded for each reading is the average value of the six or more animals subj ect to the test.Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on 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). The total of the eight values is divided by four to give the primary irritation score. A score of 5 or more is indicative that the substance is excessively irritant.(2) A substance shall not be considered to be excessively corrosive for the purposes of section 11 and paragraph 14(c) of the Regulations unless it causes visible destruction or irreversible changes in tissue at the site of the application. (3) A substance shall be considered an excessively strong sensitizer for the purposes of section 11 and paragraph14(c) of the Regulations if it causes an allergenic sensitization in a substantial number of persons who come into contact with it.SCHEDULE III(s. 15)METHOD FOR TESTING THE SECURITY OF THE ATTACHMENT OF EYES TO DOLLS AND SOFTTOYS1.EquipmentThe following equipment is required:(1) A weight of 20 lbs. (9 kg).(2) A three-pronged claw hook (see Fig. 1).(3) A supporting disc with a circular hole 1 inch (25.4 mm) in diameter.(4) A supporting disc with a circular hole 1 1/2 inches (38.0 mm) in diameter.2.Method of Test(1) Attach the claw hook to the eye.。