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A. General food FDA certification

The FDA's regulatory agency for food, agricultural products, and seafood is the Center for Food Safety and Nutrition, which is responsible for ensuring that Americans' food supply is safe, clean, fresh, and clearly labeled. Its main monitoring priorities include


1. Food freshness;

2. Food additives;

3. Other harmful ingredients of food biotoxin;

4. Marine product safety analysis;

5. Food labeling;

6. Tracking and warning of food after it comes to market


Since December 12, 2003, the FDA has required foreign companies exporting food products (and animal products) to the United States to be registered with the FDA. Products from these companies cannot be landed in the United States without registration. These companies include product manufacturing companies, packaging companies, wholesale companies, and packaging companies.


B. FDA certification of canned foods

FDA certification for canned food:


1.Copy of business license of applicant or manufacturer;

2.Copy or scan of product test report (English version);

3. Product Description in English;

4. List of models and specifications;

5. Product ingredient list;

6. Sterilization method description;

7. Process flow chart;

8. Product formula scale table


FDA certification process for canned food:


Apply for test first -- get test report -- report evaluation -- product process record -- enterprise record -- get FCE code and SID code -- ship to the United States


FDA certification cycle for canned food:


From the application test to the acquisition of registration code, it generally takes about 2 months, urgent, about a month to get


(Note: Canned food is regarded as junk food in the United States, also known as corrupt food, which is generally concerned by the FDA and customs. Canned food exported to the United States without FDA registration will be immediately detained without any room for accommodation and may also be fined)


C. FOOD contact material FDA certification

FDA certification for food contact Materials:


English product name, picture, English company name, English company address, telephone number, contact person, email, website


FDA certification test Standards for food contact Materials:

1. Paper products standard U.S.F.CFR 21 176.170

2. Organic coatings, metals, and electroplated products require U.S.F.CFR 21 175.300

3. Sealing rings and sealing face gaskets for food containers require U.S.F.CFR 21 177.1210

4. Ceramics, glass, enamel ware U.S.F.CPG 7117.06.07

5. Metals require the U.S.F.CFR 175.300


D. Cosmetics FDA certification

Cosmetics FDA certification data:


1. Application form;

2. Product label and description;

3. Safety test and test report, as well as test report of effectiveness (functionality);

4. Product formula and equipment process introduction;

5. Toxic skin irritation test report;

6. Provide appropriate samples consistent with the documents;

7. Product name and composition list


Cosmetics FDA Certification test items:


1.Heavy metal testing;

2. Microbiological testing;

3. Skin irritation test;

4. Physical and chemical composition analysis;

5. TRA toxicological assessment;

6. Ingredient label audit;

7. Anti-corrosion efficacy test


Cosmetic FDA registration Requirements:




1. Evaluation of cosmetic ingredients and their contents;

2. Modify cosmetic labels to make them conform to FDA label review;

3. Registration of cosmetics production enterprises;

4. Registration of cosmetic ingredients;

E. FDA OTC certification

  For OTC products under FDA, the following services may be provided

• Apply for dun & Bradstreet number;

• Site registration;

• Apply for NDC;

• FDA product filing;

• Product label audit;



F. Medical device products under FDA may provide the following services


• Maufacturers are registered with the FDA;

• FDA product registration;

• Product listing registration (510 table registration);

• Product launch review and Approval (PMA review)




Chemicals exported to the United States meet the requirements of the U.S. Toxic Substances Control Act (TSCA). The U.S. Occupational Safety and Health Administration (OSHA) is responsible for the classification, labeling, and chemical safety data sheets of workplace chemicals, and for hazardous chemicals meeting the hazard Delivery Standards (HCS) issued by the agency. In addition, in the United States, hand sanitizers are topical over-the-counter (OTC) medications that are regulated by the Food and Drug Administration (FDA) just like dandruff shampoo, fluoridated toothpaste, sunscreen, and other products. Exports of sanitizer to the United States also require FDA approval. The NDC number is required for FDA approval. Domestic manufacturers must apply for the appropriate NDC number for each packaged OTC before exporting to the United States. NDC (National Drug Code National Drug verification number) is a Drug identification symbols, as a ordinary commodity index by the American FDA regularly edit NDC System, through input the NDC number and Registration information as into the list of Drug Registration System (Drug Registration and Listing System, DRLS) database program, it includes all by screening of over-the-counter and prescription and part of the islet drugs. According to Section 510 of Volume 21 of the United States Federal Regulations, the NDC of each drug listed has 10 Numbers and consists of three parts, namely, the manufacturer number, product number and package type. The first part is the manufacturer number provided by THE FDA. The manufacturer refers to the manufacturer that produces or sells the drug. The second part is the product number; The characteristics, dosage form and configuration of the logo products. The third part is the wrapping code. The labels of the second and third parts shall be provided by the manufacturer. The structure of the NDC consists of one of the following forms, namely 4-4-2, 5-3-2, or 5-4-1, for example: 62684-010-10 is the form of 5-3-2.


A product with AN NDC can be marketed as a drug in the United States. Distributors can use this number to learn about the efficacy and characteristics of the product in order to order the drug, and the FDA regulates the product according to this number. The disadvantage of NDC is that there is no reference table for drug trade names and generic names. A product with AN NDC can be marketed as a drug in the United States. Distributors can use this number to learn about the efficacy and characteristics of the product in order to order the drug, and the FDA regulates the product according to this number.


What is a US agent/US agent?


Any foreign institution engaged in the manufacture, preparation, reproduction, compounding, or processing of equipment or products imported into the United States must designate a United States agent (a United States agent) for that institution.


Information about a foreign agency's U.S. agent is submitted electronically using the FDA's Uniform Registration and Listing System (FURLS) and is part of the agency's registration process. Each foreign agency may designate only one U.S. agent. A foreign institution may, but does not have to, designate its U.S. agent as its official agent. Foreign organizations should provide the name, address, telephone and fax number and E-mail address of the U.S. agent.


Identified U.S. agents will need to complete an automated process to confirm that they have agreed to serve as U.S. agents. The automated process forwards the email verification request to the U.S. agent. They will be required to confirm that she/he has agreed to act as a representative/liaison on behalf of the foreign agency. If the U.S. agent refuses to agree (or does not respond within 10 business days), the foreign agency's official correspondent/owner operator will be notified and a new U.S. agent must be appointed to fulfill the regulatory obligations.


The responsibility of the American agent


The U.S. agent must be resident in or have a place of business in the United States. Us agents cannot use post office boxes as addresses. The U.S. agent cannot use only the reply service. They must be able to answer the phone or have employees answer the phone during normal working hours.


The liability of the U.S. agent is limited, including:

1. Assisted FDA in communicating with foreign agencies;

2. In response to questions regarding equipment imported into the United States or intended to be imported into the United States by foreign institutions,

3. Assist FDA to arrange inspections of foreign institutions


If FDA is unable to contact a foreign agency directly or promptly, FDA may provide information or documentation to a U.S. agent, and such action shall be equivalent to providing the same information or documentation to a foreign agency.

Please note that under the medical device reporting regulations (21 CFR, Part 803), or the 510 (k) pre-market notice (21 CFR, Part 807, Part E), the U.S. Agent is not liable for adverse event reporting.


(二) U.S. EPA Registration Service

  • EPA site registration

  • EPA Pesticide Registration

  • Preparation and review of pesticide registration data

  • Pesticide laboratory screening and supervision

  • Pesticide resk assessment

  • Pesticide Law training


Hotline:15801695345

Beijing:Room 808, No.3 Building, No. 19 East Beiyuan Road,

ChaoYang District, Beijing, 100012 P,R.C
Tel: +8610-64710683   Miss Ann:15801695345(WeChat) 

Shanghai:Room D-308 Zhongyi International Square,

No.800 Puxing Road, Minhang District, Shanghai, 201114 P,R.C

Tel: +86-021-6053 7628

Guangzhou:Room 803, Block 1, Haida Building, Wanbo 4th Road, 

Nancun Town, Panyu District, Guangzhou city

Tel: 400 660 1329
E-mail:nar@china-reach.net

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