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

FDA

Food

Safety

Modernization

Act

andRegistration

of

Food

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

1Presentation

Objectives目的?Toprovideinformationregarding

food

facility

registrationrequirements

as

amended

by

the

FDA

Food

SafetyModernization

Act

including:提供FDA食品安全現(xiàn)代化法修訂后，

關(guān)于食品企業(yè)設(shè)施注冊(cè)要求的信息，包括：?

Registration

background

注冊(cè)背景?

Additionalregistrationinformation

requirements補(bǔ)充注冊(cè)信息要求?

Registration

renewalforfoodfacilities

食品設(shè)施重新注冊(cè)?

Suspension

offoodfacility

registration

吊消食品設(shè)施注冊(cè)2With

the

passage

of

theFDAFoodSafetyModernizationAct(FSMA)

(Pub.Law111-353),

domesticandforeignmanufacturers,

processors,

packersorholders

of

food

for

human

or

animalconsumption

in

the

United

Statesmustcomply

with

new

statutoryrequirementsFDA食品安全現(xiàn)代化法（FSMA）(Pub.Law111-353)出臺(tái)后，

生產(chǎn)，加工，

包裝或儲(chǔ)存供美國(guó)人和動(dòng)物消費(fèi)的食品的國(guó)內(nèi)和海外企業(yè)設(shè)施必須遵守新法令要求。FDA

Food

Safety

Modernization

ActFDA食品安全現(xiàn)代化法3Food

Facility

Registration食品設(shè)施注冊(cè)?

Foodfacilities

subjectto

section

415

ofthe

Federal

Food,

Drug,

and

Cosmetic

Act(FD&C

Act)

wererequiredtoregisterwith

FDA

before

December

12,

2003聯(lián)邦食品藥品化妝品法案（FD&C

Act）415部分所說的食品設(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?

Afoodfacilitythatbeginsto

manufacture/process,

pack,

or

holdfoodforconsumption

inthe

United

States

on

orafterDecember12,

2003

mustregister

beforethefacility

begins

such

operations(21

CFR

1.230)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)開工前進(jìn)行注冊(cè)（21CFR1.230）4Food

Facility

Registration食品設(shè)施注冊(cè)?

If

a

change

occurs

to

a

facility’s

previously

submitted

requiredregistrationinformation,

suchfacilitymustupdateitsregistration

to

reflect

the

change

within

60

calendar

days

ofthechange,

exceptforachangeoftheowner(21CFR1.234)如果以往提交的注冊(cè)信息發(fā)生變化，

該設(shè)施必須在變化后60個(gè)日歷日內(nèi)更新注冊(cè)信息，

設(shè)施所有者變更除外。?Ifafacilityhasanewowner,

theformerownermustcancelthefacility’s

registration

within

60

calendar

days

of

the

change

andthe

new

owner

must

submit

a

new

registration

(21

CFR

1.234)如果設(shè)施異主，前所有者需要在發(fā)生變化后60個(gè)日歷日內(nèi)注銷注冊(cè)信息，新所有者重新提交注冊(cè)（21CFR1.234）5Changes

to

Food

Facility

RegistrationUnder

FSMA食品安全現(xiàn)代化法中食品設(shè)施注冊(cè)變化?

FSMA

amended

section

415

ofthe

FD&C

Actto

require

inrelevantpartthatfacilities

engaged

in

manufacturing,

processing,

packing,

or

holding

foodforhuman

oranimal

consumption

inthe

U.S.submit

additionalregistrationinformationtothe

FDA?

食品安全現(xiàn)代化法關(guān)于FD&C

Act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。6Additional

Registration

InformationRequired補(bǔ)充注冊(cè)信息要求?

The

e-mail

addressforthe

contactperson

ofthefacility

or,

in

case

ofaforeignfacility,

the

email

address

ofthe

U.S.Agentforthe

facility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?AssurancethatFDA

will

be

permittedto

inspectthefacility

atthe

times

and

inthe

mannerpermitted

bythe

FD&C

Act確保同意FDA在指定時(shí)間按照FD&C

Act允許的方式對(duì)企業(yè)設(shè)施進(jìn)

行檢查?

Ifdetermined

necessary

and

appropriate

by

FDA,

updatedfood

categoryinformation如果FDA認(rèn)為必要和合理，更新食品分類信息7Biennial

Registration

Renewal每?jī)赡曛匦伦?cè)?FSMAalsoamended

section

415

of

the

FD&C

Act

to

provide

that

foodfacilities

required

to

register

with

FDA

must

renew

their

registrationswithFDA

every

twoyears,betweenOctober1andDecember31ofeacheven-numbered

year食品安全現(xiàn)代化法關(guān)于FD&C

Act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月31日之間?We

note

that

biennial

registration

renewal

forfood

facilities

is

currently

unavailable.

Please

check

FDA’s

website

at

at

a

later

date

or

sign

up

for

FSMA

updates

at

/FSMA

to

be

informed

when

it

becomes

available.我們注意到目前食品企業(yè)每?jī)赡曛匦伦?cè)還未實(shí)施。請(qǐng)稍候關(guān)注FDA網(wǎng)站www.a，或登

陸FSMA更新網(wǎng)站www./FSMA

獲取何時(shí)開始實(shí)施的信息。?Atthistime,

thesame

types

of

food

facilities

that

were

required

to

registerwith

FDAundersection415oftheFD&CActbeforeFSMAarerequiredtoregister

with

FDAandrenewsuchregistrations目前，在實(shí)施FSMA之前根據(jù)FD&CAct第415部分需要在FDA注冊(cè)的食品設(shè)施仍然需要在FDA注冊(cè)和重新注冊(cè)信息。8Registration

Renewal重新注冊(cè)?

Registrants

are

required

to

submit

renewalregistrations

to

FDA

containing

the

requiredregistrationinformation,

includingthenewinformation?

已經(jīng)注冊(cè)的需要向FDA提交重新注冊(cè)信息，

這些信息包括新增加的補(bǔ)充信息。9Registration

Renewal

Process重新注冊(cè)程序?Registrantscansubmit

registration

renewals

at

any

time

during

the

renewalcycle,

usingtheonlinefoodfacilityregistrationmoduleorpaperFormFDA3537注冊(cè)企業(yè)可以在重新注冊(cè)時(shí)限內(nèi)任何時(shí)間提交重新注冊(cè)，可以通過企業(yè)在線注冊(cè)模式或紙質(zhì)FDA3537表提交注冊(cè)。?Online,

registrants

will

have

the

opportunity

to

review

and

edit

existingregistration

information

and

add

additional

information通過在線方式，注冊(cè)企業(yè)將有機(jī)會(huì)審核和編輯已有注冊(cè)信息并添加補(bǔ)充信息?Notethatallinformation

submitted

to

FDA

must

be

true

and

accurate,butonly

mandatorydatafieldsarerequiredtocompletetherenewalprocess需要注意的是，向FDA提交的所有信息必須真實(shí)準(zhǔn)確，重新注冊(cè)時(shí)只要填寫必填項(xiàng)10Registration

Renewal

Process重新注冊(cè)程序?FDAwillacceptregistrationsubmissions,

includinginitialregistrations,

updatesofregistrationinformation,

andbiennialregistrationrenewalsviaonlineentry,

mail,

fax,

orCD-ROMformultiple

submissions.FDA接受通過網(wǎng)上賬戶/郵寄/傳真/CD-ROM光盤形式向FDA提交注冊(cè)/對(duì)現(xiàn)有注冊(cè)內(nèi)容更新/以及兩年一次的重新注冊(cè)。?Thereisnofeetoregister,

update,

renew,or

cancel

theregistration

of

a

food

facility食品設(shè)施的注冊(cè)/更新/重新注冊(cè)/取消注冊(cè)都是免費(fèi)的。?

Facilities

will

retaintheirexistingregistrationnumberwhensuccessfully

completing

registration

renewalprocess已注冊(cè)食品設(shè)施在成功完成重新注冊(cè)后將保留現(xiàn)有注冊(cè)號(hào)。11Failure

to

Register不依法注冊(cè)?

Thefailureto

register

yourfacility,

update

required

elements,orcancel

aregistration

in

accordance

with

FDA’sregistrationregulation(21

CFR

1.225-1.243)

is

considered

a

prohibited

actunderthe

FD&C

Act(21

CFR

1.241)依據(jù)美國(guó)聯(lián)邦食品藥品化妝品法案

(21

CFR

1.241),

食品設(shè)施如不依法(21

CFR

1.225

–

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,

ifaforeignfoodfacilityfailstoregisterin

accordance

to

FDA’s

registration

regulation,

foodfromthatfacilitythatis

beingimported

orofferedforimportintothe

U.S.may

be

subjectto

refusal(21

CFR

1.241(c)

and

1.285)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（21

CFR

1.241(c)

和1.285).12Suspension

of

Registration吊銷注冊(cè)?

Under

section

415(b)

ofthe

FD&C

Act,

ifFDA

determinesthatfood

manufactured/processed,

packed,

received,

or

held

by

afacility

has

areasonable

probability

ofcausing

serious

adverse

health

consequencesordeathto

humans

oranimals,

FDA

may

by

ordersuspendthe

registration

of

a

facility

that: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，

FDA可下令吊銷該設(shè)施的注冊(cè)。

該設(shè)施：?Created,

causedorwasotherwiseresponsible

for

such

reasonableprobability;

OR已產(chǎn)生/已導(dǎo)致該合理的可能性或者是該合理可能性的責(zé)任方?

Knew

of

or

had

reason

to

know

of

such

reasonable

probability

ANDpacked,

receivedorheldsuchfood.已知悉/有理由知悉該合理可能性，

并已包裝/已收受或已存放該食品

14

Suspension

of

Registration吊銷注冊(cè)?FDAwillprovide

a

registrant

subject

to

an

order

of

suspension

of

registrationwithanopportunityforaninformalhearing,

tobeheldassoonaspossiblebut

not

later

than

2businessdaysaftertheissuanceofasuspensionorder,unless

analternatetimeperiodisagreeduponbyFDAandtheregistrant對(duì)適用注冊(cè)吊銷令的注冊(cè)人，

FDA可提供一次非正式的聆訊機(jī)會(huì)。該聆訊可在吊銷令簽發(fā)后盡快但不多于兩個(gè)工作日內(nèi)進(jìn)行，除非FDA和注冊(cè)人協(xié)定在另一時(shí)間進(jìn)行。?Iftheregistration

of

a

facility

is

suspended,no

person

can

import

or

exportfoodintotheUnitedSta