欧盟REGULATION (EC) No 1924执行细则-保健食品COMMISSION REGUL

COMMISSIONREGULATION(EC)No353/2008of18April2008establishingimplementingrulesforapplicationsforauthorisationofhealthclaimsasprovidedforinArticle15ofRegulation(EC)No1924/2006oftheEuropeanParliamentandoftheCouncil(TextwithEEArelevance)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No1924/2006oftheEuropeanParliamentandoftheCouncilof20December2006onnutritionandhealthclaimsmadeonfoods(1),andinparticularArticle15(4)thereof,HavingconsultedtheEuropeanFoodSafetyAuthority,Whereas:(1)Regulation(EC)No1924/2006establishesrulesfortheuseofclaimsinthelabelling,presentationandadver-tisingoffoods.(2)Applicationsforauthorisationofhealthclaimsshouldadequatelyandsufficientlydemonstratethatthehealthclaimisbasedonandsubstantiatedbygenerallyacceptedscientificevidence,bytakingintoaccountthetotalityoftheavailablescientificdataandbyweighingtheevidence.(3)AsprovidedbyArticle15(4)ofRegulation(EC)No1924/2006,itisnecessarytoestablishimplementingrulesconcerninghealthclaimsapplicationssubmittedinaccordancewiththatRegulation,includingrulesforthepreparationandpresentationofapplications.(4)Theimplementingrulesshouldensurethattheappli-cationdossieriscompiledinawaywhichdefinesandclassifiesthescientificdataneededwithaviewtoassessmentoftheapplicationsbytheEuropeanFoodSafetyAuthority.(5)Theimplementingrulesareintendedprimarilyasageneralguide,and,dependingonthenatureoftheclaim,thenatureandextentofthestudiesnecessarytoevaluateitsscientificmeritmayvary.(6)ApplicationsforhealthclaimsshouldtakeaccountoftherequirementslaiddowninRegulation(EC)No1924/2006,particularlythegeneralprinciplesandconditionssetoutinArticles3and5thereof.Separateapplicationsshouldbemadeforindividualhealthclaimsandcharacterisethetypeofclaim.(7)ParticularsanddocumentstobeprovidedinaccordancewiththisRegulationshouldbewithoutprejudicetoanysupplementaryinformationthattheEuropeanFoodSafetyAuthority(theAuthority)mayrequestwhereappropriate,aslaiddowninArticle16(2)ofRegulation(EC)No1924/2006.(8)AttherequestoftheCommission,theAuthorityhasissuedanopiniononscientificandtechnicalguidanceonthepreparationandthepresentationofapplicationsconcerninghealthclaims(2).ApplicationsshouldfollowtheAuthorityguidanceinconjunctionwiththeimple-mentingrulestoensuretheharmonisedsubmissionofapplicationstotheAuthority.(9)Inordertobenefitfromdataprotection,aslaiddowninArticle21ofRegulation(EC)No1924/2006,requestsforprotectionofproprietarydatamustbejustifiedandalldatakeptinaseparatepartoftheapplication.(10)ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheStandingCommitteeontheFoodChainandAnimalHealth,HASADOPTEDTHISREGULATION:Article1SubjectmatterThisRegulationestablishesimplementingrulesforthefollowingapplications:(a)applicationsforauthorisation,submittedinaccordancewithArticle15ofRegulation(EC)No1924/2006;andEN19.4.2008OfficialJournaloftheEuropeanUnionL109/11(1)OJL404,30.12.2006,p.9,ascorrectedbyOJL12,18.1.2007,p.3.RegulationaslastamendedbyRegulation(EC)No109/2008(OJL39,13.2.2008,p.14).(2)(b)applicationsfortheinclusionofaclaiminthelistprovidedforinArticle13(3)submittedinaccordancewithArticle18ofRegulation(EC)No1924/2006.Article2ScopeoftheapplicationEachapplicationshallcoveronlyonerelationshipbetweenanutrientorothersubstance,orfoodorcategoryoffood,andasingleclaimedeffect.Article3SpecificationofthetypeofhealthclaimTheapplicationshallspecifywhichtypeofhealthclaimisconcernedamongthoselistedinArticles13and14ofRegu-lation(EC)No1924/2006.Article4ProprietarydataTheindicationofinformationwhichshouldberegardedasproprietarydataandverifiablejustificationthereof,asreferredtoinArticle15(3)(d)ofRegulation(EC)No1924/2006,shallbeincludedinaseparatepartoftheapplication.Article5ScientificstudiesThestudiesandothermaterialreferredtoArticle15(3)(c)and(e)ofRegulation(EC)No1924/2006:(a)shallconsistprimarilyofstudiesinhumansand,inthecaseofclaimsreferringtochildren'sdevelopmentandhealth,fromstudiesinchildren;(b)shallbepresentedaccordingtoahierarchyofstudydesigns,reflectingtherelativestrengthofevidencewhichmaybeobtainedfromdifferenttypesofstudies.Article6ConditionsforuseInaccordancewithArticle15(3)(f)ofRegulation(EC)No1924/2006,andinadditiontotheproposalforthewordingofthehealthclaim,theconditionsofuseshallinclude:(a)thetargetpopulationfortheintendedhealthclaim;(b)thequantityofthenutrientorothersubstance,orfoodorcategoryoffood,andthepatternofconsumptionrequiredtoobtaintheclaimedbeneficialeffect;(c)whereappropriate,astatementaddressedtopersonswhoshouldavoidusingthenutrientorothersubstance,orfoodorcategoryoffood,forwhichthehealthclaimismade;(d)awarningforthenutrientorothersubstance,orfoodorcategoryoffood,thatislikelytopresentahealthriskifconsumedtoexcess;(e)anyotherrestrictionsofuseanddirectionsforpreparationand/oruse.Article7TechnicalrulesTheapplicationshallbepreparedandpresentedinaccordancewiththetechnicalrulesassetoutintheAnnex.Article8ThisRegulationshallenterintoforceonthe