SOR/2016-302: Regulations Amending the Toys Regulations
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
November 25, 2016
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues 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 mat... (Click for more)
Published on November 25, 2016
SOR/2016-302: Regulations Amending the Toys Regulations
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Issues 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. Objective 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. Description The Toys Regulations are amended as follows: Section 27 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 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 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 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). “One-for-One” Rule 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. Consultation 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. Rationale 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. Contact Mary Korpan Senior Regulatory Policy and Risk Management Advisor Risk Management Bureau Consumer Product Safety Directorate Healthy Environments and Consumer Safety Branch Health Canada 269 Laurier Avenue West Address Locator: 4908B Ottawa, Ontario K1A 0K9 Email: [email protected] Footnote a S.C. 2010, c. 21 Footnote 1 SOR/2011-17 Footnote 2 The value recorded at each observation is the average value for the six or more rabbits subjected to the test.
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