﻿<?xml version="1.0" encoding="utf-8"?><Regulation lims:pit-date="2015-05-19" lims:lastAmendedDate="2015-05-19" lims:current-date="2019-06-21" lims:inforce-start-date="2015-05-19" lims:fid="816480" lims:id="816480" gazette-part="II" regulation-type="SOR" xml:lang="en" xmlns:lims="http://justice.gc.ca/lims"><Identification lims:inforce-start-date="2015-05-19" lims:fid="816481" lims:id="816481"><InstrumentNumber>SOR/2015-114</InstrumentNumber><RegistrationDate><Date><YYYY>2015</YYYY><MM>5</MM><DD>19</DD></Date></RegistrationDate><ConsolidationDate lims:inforce-start-date="2015-05-19"><Date><YYYY>2019</YYYY><MM>6</MM><DD>22</DD></Date></ConsolidationDate><EnablingAuthority lims:inforce-start-date="2015-05-19" lims:fid="816483" lims:id="816483"><XRefExternal reference-type="act" link="F-27">FOOD AND DRUGS ACT</XRefExternal></EnablingAuthority><LongTitle lims:inforce-start-date="2015-05-19" lims:fid="816484" lims:id="816484">Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats</LongTitle></Identification><Order lims:inforce-start-date="2015-05-19" lims:fid="816485" lims:id="816485"><Provision lims:inforce-start-date="2015-05-19" lims:fid="816486" lims:id="816486" format-ref="indent-0-0" language-align="yes" list-item="no"><Text>The Minister of Health, pursuant to sections 30.2<FootnoteRef idref="fn_SOR-2015-114_e_hq_15767">a</FootnoteRef> and 30.3<FootnoteRef idref="fn_SOR-2015-114_e_hq_15767">a</FootnoteRef> of the <XRefExternal reference-type="act" link="F-27">Food and Drugs Act</XRefExternal><FootnoteRef idref="fn_SOR-2015-114_e_hq_15768">b</FootnoteRef>, issues the annexed <XRefExternal reference-type="regulation">Marketing Authorization for Gluten-free Oats and Foods Containing Gluten-free Oats</XRefExternal></Text><Footnote id="fn_SOR-2015-114_e_hq_15767" placement="page" status="official"><Label>a</Label><Text>S.C. 2012. c. 19, s. 416</Text></Footnote><Footnote id="fn_SOR-2015-114_e_hq_15768" placement="page" status="official"><Label>b</Label><Text>R.S., c. F-27</Text></Footnote></Provision><Provision lims:inforce-start-date="2015-05-19" lims:fid="816487" lims:id="816487" format-ref="indent-0-0" language-align="yes" list-item="no"><Text>Ottawa, May 15, 2015</Text></Provision><Provision lims:inforce-start-date="2015-05-19" lims:fid="816488" lims:id="816488" language-align="yes" topmarginspacing="12" list-item="no"><SignatureBlock justification="right" width="20pc"><SignatureName justification="right">RONA AMBROSE</SignatureName><SignatureTitle justification="right"><Emphasis style="italic">Minister of Health</Emphasis></SignatureTitle></SignatureBlock></Provision></Order><Body lims:inforce-start-date="2015-05-19" lims:fid="816489" lims:id="816489"><Heading lims:inforce-start-date="2015-05-19" lims:fid="816490" lims:id="816490" level="1"><TitleText>Interpretation</TitleText></Heading><Section lims:inforce-start-date="2015-05-19" lims:lastAmendedDate="2015-05-19" lims:fid="816491" lims:id="816491"><MarginalNote lims:inforce-start-date="2015-05-19" lims:fid="816492" lims:id="816492">Definitions</MarginalNote><Label>1</Label><Text>The following definitions apply in this Marketing Authorization.</Text><Definition lims:inforce-start-date="2015-05-19" lims:fid="816493" lims:id="816493" generate-in-text="no"><Text><DefinedTermEn>gluten</DefinedTermEn> means</Text><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816494" lims:id="816494"><Label>(a)</Label><Text>any gluten protein from the grain of any of the following cereals or from the grain of a hybridized strain that is created from at least one of the following cereals:</Text><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816495" lims:id="816495"><Label>(i)</Label><Text>barley,</Text></Subparagraph><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816496" lims:id="816496"><Label>(ii)</Label><Text>oats,</Text></Subparagraph><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816497" lims:id="816497"><Label>(iii)</Label><Text>rye,</Text></Subparagraph><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816498" lims:id="816498"><Label>(iv)</Label><Text>triticale,</Text></Subparagraph><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816499" lims:id="816499"><Label>(v)</Label><Text>wheat; or</Text></Subparagraph></Paragraph><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816500" lims:id="816500"><Label>(b)</Label><Text>any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in paragraph (a) or from the grain of a hybridized strain referred to in that paragraph. (<DefinedTermFr>gluten</DefinedTermFr>)</Text></Paragraph></Definition><Definition lims:inforce-start-date="2015-05-19" lims:fid="816501" lims:id="816501" generate-in-text="no"><Text><DefinedTermEn>p.p.m.</DefinedTermEn> means parts per million by weight. (<DefinedTermFr>p.p.m.</DefinedTermFr>) </Text></Definition></Section><Heading lims:inforce-start-date="2015-05-19" lims:fid="816502" lims:id="816502" level="1"><TitleText>Exemptions</TitleText></Heading><Section lims:inforce-start-date="2015-05-19" lims:lastAmendedDate="2015-05-19" lims:fid="816503" lims:id="816503"><MarginalNote lims:inforce-start-date="2015-05-19" lims:fid="816504" lims:id="816504">Representation or advertisement — gluten-free oats</MarginalNote><Label>2</Label><Text>Any representation about gluten on the label of a food that is oats or that contains oats, and an advertisement for the food is exempt from the application of section B.24.018 of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal> if</Text><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816505" lims:id="816505"><Label>(a)</Label><Text>the oats — as a food or as an ingredient or component of a food — are</Text><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816506" lims:id="816506"><Label>(i)</Label><Text>specially produced and processed in a manner designed to avoid their contamination by gluten from barley, rye, triticale or wheat or from a hybridized strain created from at least one of those cereals, and do not contain more than 20 p.p.m. of gluten from those cereals and hybridized strains created from at least one of those cereals, or</Text></Subparagraph><Subparagraph lims:inforce-start-date="2015-05-19" lims:fid="816507" lims:id="816507"><Label>(ii)</Label><Text>specially processed in a manner designed to limit or reduce the amount of gluten from barley, rye, triticale or wheat or from a hybridized strain created from at least one of those cereals, and do not contain more than 20 p.p.m. of gluten from those cereals and hybridized strains created from at least one of those cereals;</Text></Subparagraph></Paragraph><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816508" lims:id="816508"><Label>(b)</Label><Text>the food contains no oats other than oats referred to in paragraph (a);</Text></Paragraph><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816509" lims:id="816509"><Label>(c)</Label><Text>the food does not contain more than 20 p.p.m. of gluten from barley, rye, triticale or wheat or from a hybridized strain created from at least one of those cereals;</Text></Paragraph><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816510" lims:id="816510"><Label>(d)</Label><Text>the food does not contain any added gluten from barley, rye, triticale or wheat or from a hybridized strain created from at least one of those cereals; and</Text></Paragraph><Paragraph lims:inforce-start-date="2015-05-19" lims:fid="816511" lims:id="816511"><Label>(e)</Label><Text>all representations with respect to oats on the label of the food and in an advertisement for the food, clearly refer to the oats as gluten-free.</Text></Paragraph></Section><Section lims:inforce-start-date="2015-05-19" lims:lastAmendedDate="2015-05-19" lims:fid="816512" lims:id="816512"><MarginalNote lims:inforce-start-date="2015-05-19" lims:fid="816513" lims:id="816513">Source of gluten</MarginalNote><Label>3</Label><Text>A food that is oats or that contains oats and that satisfies the conditions set out in section 2 is exempt from the application of section B.01.010.1 and subparagraph B.01.010.3(1)(b)(ii) of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal> in respect of the requirement to show the source of gluten from oats.</Text></Section><Section lims:inforce-start-date="2015-05-19" lims:lastAmendedDate="2015-05-19" lims:fid="816514" lims:id="816514"><MarginalNote lims:inforce-start-date="2015-05-19" lims:fid="816515" lims:id="816515">Name for oats</MarginalNote><Label>4</Label><Text>A food that is oats or that contains oats and that satisfies the conditions set out in section 2 is exempt from the application of subsection B.01.010(2) of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal> in respect of the name by which oats are shown as an ingredient or component in the list of ingredients for the food.</Text></Section><Heading lims:inforce-start-date="2015-05-19" lims:fid="816516" lims:id="816516" level="1"><TitleText>Coming into Force</TitleText></Heading><Section lims:inforce-start-date="2015-05-19" lims:lastAmendedDate="2015-05-19" lims:fid="816517" lims:id="816517"><MarginalNote lims:inforce-start-date="2015-05-19" lims:fid="816518" lims:id="816518">Registration</MarginalNote><Label>5</Label><Text>This Marketing Authorization comes into force on the day on which it is registered.</Text></Section></Body></Regulation>