米国の輸入規制

1. FDA 食品施設登録
2. 食品の衛生および安全性 CGMP
3. HACCP （ Hazard Analysis and Critical
Control Point ）
1.FDA Facility Registration

FDA 食品企業登録
 法規紹介
• 米 国 食 品 医 薬 品 局 （ Food and Drug
Administration 、 FDA ）は、米国連邦保健・社会福祉省 (DHHS)
傘下に設置する政府機構の１つであり、その職責は米国製造、或は米国向け輸出の食品
（食品添加物も含む）、食品接触材料、医療機器、薬品などの安全を確保することです。
これらの製品は FDA に登録申請や認証取得した後に、また米国市場に販売可能になり
ます。
• 米国「連邦食品、薬品と化粧品法案」（ FD&C 法案）に基づき、食品（食品添加物、
健康食品なども含む）を製造、加工、包装、保存する企業（以下は「食品企業」と略称）
は、 FDA 食品企業登録を完成しなければなりません。また、各偶数年の 10 月 1
日から 12 月 31 日までに登録を更新する必要で、しかも、「 FD&C 法案」許
容範囲内の FDA 工場視察を認めることを保証しなければなりません。
 企業登録を完成する必要な食品類別
企業登録を完成する必要な食品類別 企業登録を完成する不要な食品類別

サプリメントとサプリメント成分（健康食品と健康食品原料） 食品接触物質

乳幼児調製食品 殺虫剤
飲料（アルコール飲料と缶装水） /
果物と野菜 /
乳製品と卵殻 /
食品や食品成分としての初級農産物 /
缶装と冷凍食品 /
/
ベーキング食品、間食、キャンデー（チューインガムも含む）

活き動物 /
/
動物食品（ペットフード、ペット間食と咀嚼物、動物飼料など）
米国 FDA 食品企業登録の流れ
 Overview
The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the
Bioterrorism Act) directs the FDA, to take steps to protect
the public from a threatened or actual terrorist attack on
the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act,

FDA established regulations requiring that:
 Food facilities register with FDA, and
 FDA be given advance notice on shipments of imported food.
 Overview
The FDA Food Safety Modernization Act (FSMA),
enacted on January 4, 2011 to require that facilities
engaged in manufacturing, processing, packing, or
holding food for consumption in the United States
submit additional registration information to FDA,
including an assurance that FDA will be permitted to
inspect the facility at the times and in the manner
permitted by the FD&C Act. Section 415 of the FD&C
Act, as amended by FSMA, also requires food
facilities required to register with FDA to renew such
registrations every other year
 Registration Eligibility
Identify if your facility needs to register:
• - Facilities handling food products for U.S.
consumption must register.
• - Exceptions include farms, retail
establishments, and certain other facilities.
 Obtain a D-U-N-S Number
• Facilities are required to obtain a D-U-N-S
number for location verification:
- This number is issued by Dun &
Bradstreet.
- Apply for a free D-U-N-S number via their
website. D&B’s Website.
A D-U-N-S number is critical for facility
registration.
 Online Registration of Food
Facilities
• FDA Industry Systems (FIS) was created
to facilitate making submissions to FDA,
including registrations, listings, and other
notifications.
 Create New Account
• Step 1:
When you choose the LOGIN button from
FDA Industry Systems, you will arrive at the
Login page from which you can login or
Create a New Account (this page also links
to a menu of instructions and tutorials).
Select the "Create New Account" button to
begin.
• Step 2:
Enter the information for the person in charge of the Account
and indicate your understanding of the terms of 18 U.S.C. 1001:
• “Under 18 U.S.C. 1001, anyone who makes a materially
false, fictitious, or fraudulent statement to the U.S.
Government is subject to criminal penalties.”
To complete this form do the following:
1. Complete all required fields and additional fields as desired.
Please note that the information required may vary by the
system selected.
2. Read the terms of 18 U.S.C. 1001 and select I understand.
3. Select Create Account.
• Step 3:
Review the information you entered for this Account.

If the information you entered is correct, select Submit. If the

information you entered is NOT correct, select Modify to return to
the edit screen and make needed changes.

Note: The message, Warning: This address could not be

validated, means that the system was unable to verify the
address(es) you entered. You are advised to re-check the
addresses entered. If they are correct, disregard the notice and
submit the application. The application will be processed normally.
• Step 4
If your account creation was successful, the following will be displayed: You have
successfully created an Account. Your account ID is....and a button to login to the
FDA Industry Systems home page. Make a note of your Account ID. You will
need it, along with the password you selected, to login to your Account in the
future.

Login to FDA Industry Systems. From the home page you may:
• Access the systems that are available to you (i.e., register a food facility
through the Food Facility Registration system).
• Manage your account through the Account Management capabilities (i.e.,
create Subaccounts under your account, which is optional and more useful for
large companies who need to manage a high number of facilities/registrations.
• Logout, and return later.

I'm ready to create an account

Biennial Registration Renewal
• Section 415 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) [21 U.S.C. §
350d] requires food facilities that are
required to register with FDA to renew
such registrations during the period
beginning on October 1 and ending on
December 31 of each even-numbered
year.
• Biennial Registration Renewal Step-by-
Step System Instructions
• Please be advised that “updating” your
registration is a different function than
“renewing” your registration. During the
renewal period, you will not see the “Update”
button listed on the FFRM main menu, until the
registration is renewed.
• If a registration is not renewed by 11:59 PM on
December 31 of the even-numbered year, the
registration is considered expired and will be
removed from your account.
• In addition, all facilities must include a unique
facility identifier (UFI) recognized as
acceptable to FDA with the registration
submission "To" date, FDA recognizes the Data
Universal Numbering System D-U-N-S (DUNS)
number as an acceptable UFI. The DUNS
number is assigned and managed by Dun &
Bradstreet.
• DUNS numbers can be obtained or verified
visiting D&B’s website
2.Current Good Manufacturing Practices (CGMPs)
for Food and Dietary Supplements

• Generally, domestic and foreign food facilities that

are required to register with FDA must comply with
the requirements for risk-based preventive controls
in Part 117 (unless an exemption applies). The
modernized CGMPs generally apply to
establishments that manufacture, process, pack,
or hold food and apply to some activities that are
exempt from the preventive controls requirements,
such as juice and seafood processing.
 Additional CGMPs for Certain Types of Food
• Dietary Supplements

For additional information, see

Dietary Supplements Guidance Documents & Regulatory Information.

• Infant Formula

For additional information, see

Infant Formula Guidance Documents & Regulatory Information.

• Low-acid Canned Foods

Acidified Foods -

For additional information, see

Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information.

• Bottled Water

For additional information, see

Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Informatio

 3.Hazard Analysis Critical Control Point (HACCP)

• HACCP is a management system in which

food safety is addressed through the
analysis and control of biological,
chemical, and physical hazards from raw
material production, procurement and
handling, to manufacturing, distribution
and consumption of the finished product.
HACCP Principles & Application Guidelin
es
• Dairy Grade A Voluntary HACCP
Including Questions and Answers About NCIMS Dairy HACCP
External Link Disclaimer
• Juice HACCP
Including Juice HACCP Hazards and Controls Guidance - First Edition
and Questions & Answers for the Juice HACCP Regulation
Guidance for Industry: Juice HACCP and the FDA Food Safety Moder
nization Act
• Retail and Food Service HACCP
• Seafood HACCP
Including Fish and Fishery Products Hazards and Controls Guidance
and FDA's Evaluation of the Seafood HACCP Program 2004/2005
External Link Disclaimer
Guidance for Industry: Seafood HACCP and the FDA Food Safety Mo
dernization Act