Description
This guidance document is intended to notify the public of FDA’s efforts to help U.S. manufacturers/processors (hereinafter referred to as “establishments”) that wish to export milk and milk products, seafood, infant formula, and formula for young children to China. FDA is taking this action in response to China’s State General Administration of the People’s Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145. AQSIQ Decree 145, among other requirements, mandates that foreign competent authorities, including FDA, provide the Certification and Accreditation Administration of China (CNCA) with a “name list of overseas manufacturers of imported food applying for registration” with CNCA for commodities that CNCA has deemed to require registration. Milk and milk products, seafood, infant formula, and formula for young children are among the commodities for which registration of overseas manufacturers is required under AQSIQ Decree 145. China has recognized FDA as the competent food safety authority in the United States to establish and maintain the lists of U.S. establishments that intend to export U.S. milk and milk product, seafood, infant formula, and/or formula for young children to China, and the corresponding products for each establishment intended for export to China.
Scope & Applicability
Product Classes
4Commodity requiring registration for export to China
The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.
Product category subject to FDA HACCP regulations.; Presence, detection and growth of Listeria monocytogenes.
Commodity requiring registration for export to China
Stakeholders
2Acknowledged body to certify compliance with China's standards
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Related CFR Sections (4)
- 21CFR1.101§ 1.101 Notification and recordkeeping.
(a) Scope. This section pertains to notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or ( 21 U.S.C. 381 and 382 ) or section 351 of the Public Read full regulation →
- 21CFR106.120§ 106.120 New infant formula submission.
(a) At least 90 days before a new infant formula is introduced or delivered for introduction into interstate commerce, a manufacturer shall submit notice of its intent to do so to the Food and Drug Administration at the address given in § 106.110(a) . An original and two paper copies of such notice Read full regulation →
- 21CFR106.110§ 106.110 New infant formula registration.
(a) Before a new infant formula may be introduced or delivered for introduction into interstate commerce, including a new infant formula for export only, the manufacturer of the formula shall register with the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of NutrRead full regulation →
- 21CFR1240.3§ 1240.3 General definitions.
As used in this part, terms shall have the following meaning:Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-06-24
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
- 2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Rey de los Camarones S. A.
- 2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Reunipeche SAS
- 2025-05-20
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yeshua Bendito, C.A.
- 2025-05-20
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Eden F&C Co., Ltd
- 2025-03-04
Seafood HACCP/CGMP for Foods/Adulterated
Mariscos Procesados - CAMPRESA - S.A.
- 2025-01-21
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
COFISA - Conservas de Peixe da Figueira, S.A.
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)
- CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) (Status: Final)
- Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation (Status: Final)
- CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact (Status: Draft)
- FDA Oversight of Food Covered by Systems Recognition Arrangements (Status: Final)