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 Acta, makes the annexed Children’s Sleepwear Regulations.S.C. 2010, c. 21InterpretationDefinitionsThe following definitions apply in these Regulations.CGSB means the Canadian General Standards Board. (ONGC)char length means the maximum extent of the damaged length of a material that has been subjected to the tests set out in these Regulations. (longueur carbonisée)loose-fitting sleepwear means children’s nightgowns, nightshirts, dressing gowns, bathrobes, housecoats, robes, pyjamas and baby-doll pyjamas in sizes up to and including 14X, other than sleepwear designed for infants weighing up to 7 kg, sleepwear designed for use in a hospital, polo pyjamas and sleepers. (vêtement de nuit ample)OECD means the Organisation for Economic Cooperation and Development. (OCDE)tight-fitting sleepwear means any children’s sleepwear in sizes up to and including 14X other than loose-fitting sleepwear. It includessleepwear designed for infants weighing up to 7 kg;sleepwear designed for use in a hospital;polo pyjamas; andsleepers. (vêtement de nuit ajusté)SpecificationsTight-fitting sleepwearTight-fitting sleepwear when tested in accordance with the CGSB standard CAN/CGSB-4.2 No. 27.5, entitled Textile Test Methods: Flame Resistance — 45° Angle Test — One-Second Flame Impingement, as amended from time to time, must have a time of flame spread of more than seven seconds.Loose-fitting sleepwear — flame resistance testLoose-fitting sleepwear, when tested in accordance with Schedule 1, must havean average char length for five specimens that does not exceed 178 mm; andnot more than one specimen with a char length equal to the full length of the specimen.Loose-fitting sleepwear — other testsLoose-fitting sleepwear that is treated with a flame retardant, any component that is extracted or broken down from such treated sleepwear and any flame retardant that is used to treat the sleepwear must not cause any of the following consequences:acute lethality as a result of oral exposure to a dose of 500 mg/kg body weight or less or as a result of dermal exposure to a dose of 1000 mg/kg body weight or less when tested for acute oral toxicity or acute dermal toxicity in accordance with section 1 or 2, as the case may be, of Schedule 2;an effect graded at a mean greater than 1 for erythema formation or for edema formation measured at any specified time when tested for dermal irritation in accordance with section 3 of Schedule 2;when tested for dermal sensitisation in accordance with section 4 of Schedule 2, a response in greater than 15% of the test animals when using the Draize Test or the Buehler Test or in greater than 30% of the test animals when using one of the five other tests, in which an adjuvant is incorporated, that are specified in the OECD Test No. 406 that is referred to in that section;gene mutation or chromosomal aberration when tested for mutagenicity in accordance with section 5 of Schedule 2; ortumors when tested for tumorigenicity in accordance with section 6 of Schedule 2.LabellingLoose-fitting sleepwearLoose-fitting sleepwear that is treated with a flame retardant must have a label that is permanently affixed to it that displays in a clear and legible mannerthe words “flame retardant” and “ignifugeant”; andinstructions in English and in French for the care of the sleepwear, particularly cleaning procedures, to ensure that it is not exposed to agents or treatments that could reduce its flame resistance.Repeal[Repeal]Coming into ForceRegistrationThese Regulations come into force on the day on which they are registered.(Subsection 3(1))Flame Resistance TestWashing, Drying and Dry Cleaning ProceduresSubject to subsection (2), loose-fitting sleepwear that is not treated with a flame retardant must be subjected to one washing cycle in accordance with the procedure set out in section 3, with the exception of paragraphs (b) and (e), followed by one drying cycle in accordance with the procedure set out in section 4.If the label of loose-fitting sleepwear that is not treated with a flame retardant displays the words “dry clean only”, the sleepwear must be dry cleaned once in accordance with the procedure set out in Method 30.3, the National Standard of Canada CAN2-4.2-M77, Procedure for the Removal of Flame Retardant Treatments from Textile Products, published by CGSB in May 1980, with the exception of sections 3.2 and 5.5 to 5.7 of the method.Subject to subsections (2) and (3), loose-fitting sleepwear that is treated with a flame retardant must be subjected to 20 successive washing cycles in accordance with the procedure set out in section 3, followed by one drying cycle in accordance with the procedure set out in section 4.If the label of loose-fitting sleepwear that is treated with a flame retardant displays the words “do not bleach”, the sleepwear must be subjected to 20 successive washing cycles in accordance with the procedure set out in section 3, with the exception of paragraph (e), followed by one drying cycle in accordance with the procedure set out in section 4.If the label of loose-fitting sleepwear that is treated with a flame retardant displays the words “dry clean only”, the sleepwear must be dry cleaned five times successively in accordance with the procedure referred to in subsection 1(2).Washing ProcedureThe apparatus and washing procedure set out in sections 4.1 and 6, respectively, of Method 58, the National Standard of Canada CAN2-4.2-M77, Colour Fastness and Dimensional Change in Domestic Laundering of Textiles, published by CGSB in December 1984, must be used, with the following modifications:the temperature of the wash water must be maintained between 58°C and 62°C;the hardness of the wash water must be less than 50 ppm of calcium carbonate;for automatic washing machines, the washing cycle must be set for normal washing cycle;a synthetic detergent that conforms to CGSB standard 2-GP-115M, Standard for Detergent, Laundry, Powder, Built, dated January 1979, must be used; anda bleaching agent containing sodium hypochlorite that produces 0.015% of available chlorine when it is added to the washing solution must be used.Drying ProcedureThe apparatus and drying procedure set out in sections 4.2 and 7.5, respectively, of Method 58, the National Standard of Canada CAN2-4.2-M77, Colour Fastness and Dimensional Change in Domestic Laundering of Textiles, published by CGSB in December 1984, must be used.Specimen Preparation and TestingFour specimens measuring 89 mm × 254 mm must be cut from the loose-fitting sleepwear that has been washed and dried or dry cleaned in accordance with sections 1 to 4, in such a manner that two specimens are cut in the lengthwise direction and two are cut in the crosswise direction of the sleepwear. The specimens cut from sleepwear made from a multilayered fabric must include all layers of the fabric and must be held in the relative positions they occupy. The direction in which each specimen was cut must be indicated on the specimen.The four specimens must be tested in accordance with the procedures set out in paragraphs 1616.5(a) and (b) and subparagraphs 1616.5(c)(1) to (3) of Standard FF 5-74 of the United States Consumer Product Safety Commission, Standard for the Flammability of Children’s Sleepwear: Sizes 7 through 14, published January 1, 1985 in the Code of Federal Regulations, Part 1000 to end.The average char lengths for the two specimens cut in the lengthwise direction and for the two specimens cut in the crosswise direction must be determined.A fifth specimen must be cut in the same direction as the specimens having the longer average char length and tested in accordance with the procedures referred to in subsection (2).The char length, the direction in which each of the five specimens tested was cut and the average char length of the five specimens must be recorded.(Subsection 3(2))Toxicity TestAcute oral toxicity must be assessed in accordance with OECD Test No. 401, “Acute Oral Toxicity”, published May 12, 1981 in the OECD Guidelines for Testing of Chemicals.Acute dermal toxicity must be assessed in accordance with OECD Test No. 402, “Acute Dermal Toxicity”, published May 12, 1981 in the OECD Guidelines referred to in section 1.Dermal irritation must be assessed in accordance with OECD Test No. 404, “Acute Dermal Irritation/Corrosion”, published May 12, 1981 in the OECD Guidelines referred to in section 1.Dermal sensitisation must be assessed in accordance with OECD Test No. 406, “Skin Sensitisation”, published May 12, 1981 in the OECD Guidelines referred to in section 1.Mutagenicity must be assessed in accordance with the “OECD Guidelines on Genetic Toxicology Testing and Guidance on the Selection and Application of Assays”, published May 15, 1986 by OECD, which include the tests referred to in paragraphs (a) to (c), as well as in accordance with the third level of concern (LOC III) of the federal “Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals”, published by Health and Welfare Canada and Environment Canada in 1986, in regard to the tests referred to in paragraph (d):to test in vitro gene mutation:OECD Test No. 471, “Genetic Toxicology: Salmonella typhimurium, Reverse Mutation Assay”, published May 26, 1983 in the OECD Guidelines referred to in section 1,OECD Test No. 476, “Genetic Toxicology: In vitro Mammalian Cell Gene Mutation Tests”, published April 4, 1984 in the OECD Guidelines referred to in section 1, orOECD Test No. 480, “Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay”, adopted October 23, 1986 by the OECD and included in the OECD Guidelines referred to in section 1;to test in vitro mammalian chromosomal aberrations with the exclusion of sister chromatid exchange and micronuclei: OECD Test No. 473, “Genetic Toxicology: In vitro Mammalian Cytogenetic Test”, published May 26, 1983 in the OECD Guidelines referred to in section 1;to test in vivo mammalian chromosomal aberrations excluding sister chromatid exchange:OECD Test No. 474, “Genetic Toxicology: Micronucleus Test”, published May 26, 1983 in the OECD Guidelines referred to in section 1, orOECD Test No. 475, “Genetic Toxicology: In Vivo Mammalian Bone Marrow Cytogenetic Test — Chromosomal Analysis”, published April 4, 1984 in the OECD Guidelines referred to in section 1; andto test in vivo mammalian gene mutation or other indicator tests in a second somatic tissue or species:test as specified by J. W. Allen, C. F. Shuler, R. W. Mendes and S. A. Latt in the paper entitled “A simplified technique for in vivo analysis of sister-chromatid exchanges using 5-bromodeoxyuridine tablets”, published in the Journal of Cytogenetics and Cell Genetics, Vol. 18, 1977, pp. 231-237, ortest as specified by J. C. Mirsalis and B. E. Butterworth in the paper entitled “Detection of unscheduled DNA synthesis in hepatocytes isolated from rats treated with genotoxic agents: an in vivo-in vitro assay for potential carcinogens and mutagens”, published in Carcinogenesis, Vol. 1, July 1980, pp. 621-625.Tumorigenicity by the oral route must be assessed in accordance with OECD Test No. 451, “Carcinogenicity Studies”, published May 12, 1981 in the OECD Guidelines referred to in section 1.