﻿<?xml version="1.0" encoding="utf-8"?><Regulation lims:pit-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:current-date="2019-06-21" lims:inforce-start-date="2016-06-22" lims:fid="832145" lims:id="832145" gazette-part="II" regulation-type="SOR" xml:lang="en" in-force="yes" xmlns:lims="http://justice.gc.ca/lims"><Identification lims:inforce-start-date="2016-06-22" lims:fid="832146" lims:id="832146"><InstrumentNumber>SOR/2016-184</InstrumentNumber><RegistrationDate><Date><YYYY>2016</YYYY><MM>6</MM><DD>22</DD></Date></RegistrationDate><ConsolidationDate lims:inforce-start-date="2016-06-22"><Date><YYYY>2019</YYYY><MM>6</MM><DD>22</DD></Date></ConsolidationDate><EnablingAuthority lims:inforce-start-date="2016-06-22" lims:fid="832148" lims:id="832148"><XRefExternal reference-type="act" link="C-1.68">CANADA CONSUMER PRODUCT SAFETY ACT</XRefExternal></EnablingAuthority><LongTitle lims:inforce-start-date="2016-06-22" lims:fid="832149" lims:id="832149">Pacifiers Regulations</LongTitle><RegulationMakerOrder><RegulationMaker>P.C.</RegulationMaker><OrderNumber>2016-611</OrderNumber><Date><YYYY>2016</YYYY><MM>6</MM><DD>21</DD></Date></RegulationMakerOrder></Identification><Order lims:inforce-start-date="2016-06-22" lims:fid="832150" lims:id="832150"><Provision lims:inforce-start-date="2016-06-22" lims:fid="832151" lims:id="832151" format-ref="indent-0-0" language-align="yes" list-item="no"><Text>His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 37 of the <XRefExternal reference-type="act" link="C-1.68">Canada Consumer Product Safety Act</XRefExternal><FootnoteRef idref="fn_81200-2-TEXTILE_hc">a</FootnoteRef>, makes the annexed <XRefExternal reference-type="regulation" link="SOR-2016-184">Pacifiers Regulations</XRefExternal>.</Text><Footnote id="fn_81200-2-TEXTILE_hc" placement="page" status="official"><Label>a</Label><Text>S.C. 2010, c. 21</Text></Footnote></Provision></Order><Body lims:inforce-start-date="2016-06-22" lims:fid="832152" lims:id="832152"><Heading lims:inforce-start-date="2016-06-22" lims:fid="832153" lims:id="832153" level="1"><TitleText>Interpretation</TitleText></Heading><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832154" lims:id="832154"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832155" lims:id="832155">Definition of <DefinedTermEn>pacifier</DefinedTermEn></MarginalNote><Label>1</Label><Text>In these Regulations, <DefinedTermEn>pacifier</DefinedTermEn> means a pacifier that has a nipple and includes a similar product that is intended for use in a baby’s mouth.</Text></Section><Heading lims:inforce-start-date="2016-06-22" lims:fid="832156" lims:id="832156" level="1"><TitleText>Specifications</TitleText></Heading><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832157" lims:id="832157"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832158" lims:id="832158">Toxic substance</MarginalNote><Label>2</Label><Text>Any pacifier that contains a toxic substance must comply with section 25 of the <XRefExternal reference-type="regulation" link="SOR-2011-17">Toys Regulations</XRefExternal> in relation to that substance.</Text></Section><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832159" lims:id="832159"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832160" lims:id="832160">Limit of volatile N-nitrosamines</MarginalNote><Label>3</Label><Text>A pacifier must not contain more than 10 µg/kg total volatile N-nitrosamines, as determined by dichloromethane extraction.</Text></Section><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832161" lims:id="832161"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832162" lims:id="832162">Hazards</MarginalNote><Label>4</Label><Text>A pacifier must be free from any part that may cause, under reasonably foreseeable conditions of use, injury to the user due to the following hazards:</Text><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832163" lims:id="832163"><Label>(a)</Label><Text>obstruction of the pharyngeal orifice;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832164" lims:id="832164"><Label>(b)</Label><Text>strangulation;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832165" lims:id="832165"><Label>(c)</Label><Text>ingestion or aspiration of the pacifier or any of its parts; and</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832166" lims:id="832166"><Label>(d)</Label><Text>wounding.</Text></Paragraph></Section><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832167" lims:id="832167"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832168" lims:id="832168">Additional requirements</MarginalNote><Label>5</Label><Text>A pacifier must meet the following requirements:</Text><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832169" lims:id="832169"><Label>(a)</Label><Text>the nipple must be attached to a guard of such dimensions that it cannot pass through the opening in the template illustrated in Schedule 1 when the nipple is centered on the opening and a force of 9.8 N is applied axially to the nipple in such a way as to induce the guard to pull through the opening in the template;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832170" lims:id="832170"><Label>(b)</Label><Text>when tested in accordance with Schedule 2,</Text><Subparagraph lims:inforce-start-date="2016-06-22" lims:fid="832171" lims:id="832171"><Label>(i)</Label><Text>the nipple must remain attached to the guard, and</Text></Subparagraph><Subparagraph lims:inforce-start-date="2016-06-22" lims:fid="832172" lims:id="832172"><Label>(ii)</Label><Text>any part that separates from the pacifier must not, in a non-compressed state, fit entirely into the small parts cylinder illustrated in Schedule 3;</Text></Subparagraph></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832173" lims:id="832173"><Label>(c)</Label><Text>any loop of cord or other material that is attached to the pacifier must not be more than 356 mm in circumference; and</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832174" lims:id="832174"><Label>(d)</Label><Text>any ring or handle must be hinged, collapsible or flexible.</Text></Paragraph></Section><Heading lims:inforce-start-date="2016-06-22" lims:fid="832175" lims:id="832175" level="1"><TitleText>Information</TitleText></Heading><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832176" lims:id="832176"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832177" lims:id="832177">Reference to <XRefExternal reference-type="act" link="C-1.68">Canada Consumer Product Safety Act</XRefExternal> or Regulations</MarginalNote><Label>6</Label><Subsection lims:inforce-start-date="2016-06-22" lims:fid="832178" lims:id="832178"><Label>(1)</Label><Text>Written information that appears on a pacifier, that accompanies one or that is in any advertisement for one must not make any direct or indirect reference to the <XRefExternal reference-type="act" link="C-1.68">Canada Consumer Product Safety Act</XRefExternal> or these Regulations.</Text></Subsection><Subsection lims:inforce-start-date="2016-06-22" lims:fid="832179" lims:id="832179"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832180" lims:id="832180">Representations — use or modification</MarginalNote><Label>(2)</Label><Text>Any written information that appears on or that accompanies a pacifier, and any advertisement of one, must not make representations in respect of the use of or modification to the pacifier that would result in the failure of the pacifier to meet a requirement of these Regulations.</Text></Subsection></Section><Heading lims:inforce-start-date="2016-06-22" lims:fid="832181" lims:id="832181" level="1"><TitleText>Repeal</TitleText></Heading><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832182" lims:id="832182"><Label>7</Label><Text>[Repeal]</Text></Section><Heading lims:inforce-start-date="2016-06-22" lims:fid="832183" lims:id="832183" level="1"><TitleText>Coming into Force</TitleText></Heading><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832184" lims:id="832184" type="transitional"><MarginalNote lims:inforce-start-date="2016-06-22" lims:fid="832185" lims:id="832185">Registration</MarginalNote><Label>8</Label><Text>These Regulations come into force on the day on which they are registered.</Text></Section></Body><Schedule lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832186" lims:id="832186" bilingual="no" spanlanguages="no"><ScheduleFormHeading lims:inforce-start-date="2016-06-22" lims:fid="832187" lims:id="832187"><Label>SCHEDULE 1</Label><OriginatingRef>(Paragraph 5(a))</OriginatingRef><TitleText>Guard Template</TitleText></ScheduleFormHeading><ImageGroup lims:inforce-start-date="2016-06-22" lims:fid="832188" lims:id="832188" position="center" width="24pc" bilingual="no" spanlanguages="no" spanmarginalnotecol="no"><AlternateText>The guard template is rectangular, made of aluminum plate and is 101.6 mm long, 68.6 mm wide and 3.2 mm thick. There is an opening in the middle formed by a circle with a diameter of 42.7 mm, with two triangles opposed at their summits, in the shape of a bowtie. The length of the opening, from one triangle base to the other, is 76.2 mm.</AlternateText><Image source="SOR-2016-184img\SOR-2016-184_e001.jpg" /></ImageGroup></Schedule><Schedule lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832189" lims:id="832189" bilingual="no" spanlanguages="no"><ScheduleFormHeading lims:inforce-start-date="2016-06-22" lims:fid="832190" lims:id="832190"><Label>SCHEDULE 2</Label><OriginatingRef>(Paragraph 5(b))</OriginatingRef><TitleText>Structural Integrity Test</TitleText></ScheduleFormHeading><RegulationPiece lims:inforce-start-date="2016-06-22" lims:fid="832191" lims:id="832191"><Section lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832192" lims:id="832192"><Label>1</Label><Text>The following method is to be used for testing the structural integrity of the pacifier:</Text><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832193" lims:id="832193"><Label>(a)</Label><Text>hold the nipple of the pacifier in a fixed position and apply to the ring or handle of the pacifier a force of 44.5  ± 1.0 N in the plane of the axis of the nipple at a rate of 4.5 ± 1.0 N/s and then maintain the final force for 10 ± 0.5 s;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832194" lims:id="832194"><Label>(b)</Label><Text>hold the guard of the pacifier in a fixed position and apply to the ring or handle of the pacifier a force of  44.5 ± 1.0 N in the plane perpendicular to the axis of the nipple at a rate of 4.5 ± 1.0 N/s and then maintain the final force for 10 ± 0.5 s;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832195" lims:id="832195"><Label>(c)</Label><Text>repeat the procedure described in paragraph (b) with the force applied to the nipple of the pacifier;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832196" lims:id="832196"><Label>(d)</Label><Text>immerse the pacifier in boiling water for 10 ± 0.5 min, then remove the pacifier from the boiling water and allow to cool in air at 21 ± 5° C for 15 ± 0.5 min;</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832197" lims:id="832197"><Label>(e)</Label><Text>repeat the procedures described in paragraphs (a) to (c); and</Text></Paragraph><Paragraph lims:inforce-start-date="2016-06-22" lims:fid="832198" lims:id="832198"><Label>(f)</Label><Text>repeat the procedures described in paragraphs (d) and (e) nine times.</Text></Paragraph></Section></RegulationPiece></Schedule><Schedule lims:inforce-start-date="2016-06-22" lims:lastAmendedDate="2016-06-22" lims:fid="832199" lims:id="832199" bilingual="no" spanlanguages="no"><ScheduleFormHeading lims:inforce-start-date="2016-06-22" lims:fid="832200" lims:id="832200"><Label>SCHEDULE 3</Label><OriginatingRef>(Subparagraph 5(b)(ii))</OriginatingRef><TitleText>Small Parts Cylinder</TitleText></ScheduleFormHeading><ImageGroup lims:inforce-start-date="2016-06-22" lims:fid="832201" lims:id="832201" position="center" width="20pc" bilingual="no" spanlanguages="no" spanmarginalnotecol="no"><AlternateText>A sectional view of the small parts cylinder which is a hollow cylinder with an inner diameter of 31.7 mm. The inner base of the cylinder is diagonal at a 45° angle so that the minimum depth of the cylinder is 25.4 mm and the maximum depth of the cylinder is 57.1 mm.</AlternateText><Image source="SOR-2016-184img\SOR-2016-184_e002.JPG" /></ImageGroup></Schedule></Regulation>