FDA食品安全現(xiàn)代化法食品企業(yè)設(shè)施注冊(cè)

1PresentationObjectives?Registrationbackground注冊(cè)背景?Additionalregistrationinformationrequirements補(bǔ)充注冊(cè)信息?Registrationrenewalforfoodfacilities食品設(shè)施重新注冊(cè)?Suspensionoffoodfacilityregistration吊消食品設(shè)施注冊(cè)2FDA食品安全現(xiàn)代化法3食品設(shè)施注冊(cè)?Foodfacilitiessubjecttosection415oftheFederalFood,Drug,andCosmeticAct(FD&CAct)wererequiredtoregisterwithFDAbefore聯(lián)邦食品藥品化妝品法案（FD&CAct）415部分所說(shuō)的食品設(shè)施是指那些被要求在2003年12月12日以前在FDA注冊(cè)的設(shè)施?Afoodfacilitythatbeginstomanufacture/process,pack,orholdfoodforconsumptionintheUnitedStatesonorafterDecember12,2003mustregisterbeforethefacilitybeginssuchoperations(21CFR1.230)食品設(shè)施進(jìn)行生產(chǎn)/加工，包裝或儲(chǔ)存的食物，如果在2003年12月12日或以后在美國(guó)消費(fèi)，必須在企業(yè)開(kāi)工前進(jìn)行注冊(cè)（21CFR1.230）4食品設(shè)施注冊(cè)facility’sregistrationwithin60calendardaysofthechangeand5?FSMAamendedsection415oftheFD&CActtorequireinrelevantpartthatfacilitiesmanufacturing,processing,packing,orhforhumanoranimalconsumptionintheU.S.submitadditionalregistrationinformationtotheFDA?食品安全現(xiàn)代化法關(guān)于FD&CAct第415部分修訂的有關(guān)部分要求從事生產(chǎn)，加工，包裝或儲(chǔ)存在美國(guó)人或動(dòng)物消費(fèi)的食品的設(shè)施需要向FDA提交補(bǔ)充注冊(cè)信息。6?Thee-mailaddressforthecontactpersonofthefacilityor,incaseofaforeignfacility,theemailaddressoftheU.S.Agentforthefacility設(shè)施聯(lián)系人的電子郵件地址。對(duì)于海外設(shè)施，提供美國(guó)代理人的電子郵件地址?AssurancethatFDAwillbepermittedtoinspectthefacilityatthetimesandinthemannerpermittedbytheFD&CAct確保同意FDA在指定時(shí)間按照FD&CAct允許的方式對(duì)企業(yè)設(shè)施進(jìn)行檢查?IfdeterminednecessaryandappropriatebyFDA,updatedfoodcategoryinformation如果FDA認(rèn)為必要和合理，更新食品分類(lèi)信息7食品安全現(xiàn)代化法關(guān)于FD&CAct第415部分修訂提出在FDA注冊(cè)的食品企業(yè)必須每?jī)赡曛匦伦?cè)，時(shí)間為每偶數(shù)年的10月1日到12?Wenotethatbiennialregistrationrenewalforfoodfacilitiesiscurrentlyunavailable.PleasecheckFDA’swebsiteatatalaterdateorsignupforinformedwhenitbecomes89需要注意的是，向FDA提交的所有信息必須真實(shí)準(zhǔn)確?Thefailuretoregisteryourfacility,updaterequiredelements,orcancelaregistrationinaccordancewithFDA’sregistrationregulation(21CFR1.225-1.243)isconsideredaprohibitedact依據(jù)美國(guó)聯(lián)邦食品藥品化妝品法案(21CFR1.241),食品設(shè)施如不依法(21CFR1.225–1.243)注冊(cè)/更新規(guī)定的注冊(cè)內(nèi)容/取消注冊(cè)，被視為禁止行為。?Additionally,ifaforeignfoodfacilityfailstoregisterinaccordancetoFDA’sregistrationregulation,foodfromthatfacilitythatisbeingimportedorofferedforimportintotheU.S.maybesubjectto此外，海外設(shè)施如不依照FDA法規(guī)注冊(cè)，其輸美產(chǎn)品將被拒絕入境（21CFR1.241(c)和1.285).SuspensionofRegistration在食品安全現(xiàn)代化法案生效前，F(xiàn)DA無(wú)權(quán)在?Undersection415(b)oftheFD&CAct,ifFDAdeterminesthatfoodmanufactured/processed,packed,received,orheldbyafacilityhasareasonableprobabilityofcausingseriousadversehealthconsequencesordeathtohumansoranimals,FDAmaybyordersuspendtheregistrationofafacilitythat:依據(jù)食品藥品化妝品法案415(b),如FDA判定在某設(shè)施生產(chǎn)/加工/包裝/收受/存放的食品有合理的可能性導(dǎo)致人或動(dòng)物產(chǎn)生嚴(yán)重健康危害或死亡，F(xiàn)DA可下令吊銷(xiāo)該設(shè)施的注冊(cè)。該設(shè)施：?Created,causedorwasotherwiseresponsibleforsuchreasonable對(duì)適用注冊(cè)吊銷(xiāo)令的注冊(cè)人，F(xiàn)DA可提供一次非正式的聆訊可在吊銷(xiāo)令簽發(fā)后盡快但不多于兩個(gè)工作日內(nèi)進(jìn)行，除非F對(duì)于吊銷(xiāo)注