What are the infant formula registration requirements in China?

Direct Answer: Yes — Formula Registration Is Mandatory and Rigorous

Yes, every foreign company exporting infant formula to China must obtain a Formula Registration Certificate under the State Administration for Market Regulation (SAMR) system. As of 2026, over 1,400 infant formula product formulas have been registered by SAMR, but fewer than 350 of those belong to overseas manufacturers — a clear signal that the bar for foreign firms is high and tightening. Without a valid registration certificate, no infant formula product can be imported, marketed, or sold in the People’s Republic of China.

Infant formula registration in China is governed by the PRC Food Safety Law (中华人民共和国食品安全法, Zhōnghuá Rénmín Gònghéguó Shípín Ānquán Fǎ) and a cascade of specialized implementing regulations. The core regime is built around Formula Registration (配方注册, pèifāng zhùcè) — a pre-market approval process administered by SAMR’s Center for Food Evaluation (国家市场监督管理总局食品审评中心, Guójiā Shìchǎng Jiāndū Guǎnlǐ Zǒngjú Shípín Shěnpíng Zhōngxīn). This article walks through every requirement foreign companies must satisfy, along with the timeline, costs, and common pitfalls.

Regulatory Basis: Decree 248, 249 and the SAMR Registration System

Foreign companies must navigate three overlapping layers of Chinese regulation:

1. PRC Food Safety Law (2015, revised 2021)

Article 81 of the PRC Food Safety Law (食品安全法, Shípín Ānquán Fǎ) establishes that infant formula formulas must be registered with SAMR before production or importation. This is the foundational statutory mandate. Article 82 further requires that the formula’s配方 (pèifāng, formula composition) be scientifically substantiated for nutritional safety and age-appropriateness.

2. SAMR Measures for the Registration of Infant Formula Formula Products

The Administrative Measures for the Registration of Infant Formula Formula Products (婴幼儿配方乳粉产品配方注册管理办法, Yīngyòu’ér Pèifāng Rǔfěn Chǎnpǐn Pèifāng Zhùcè Guǎnlǐ Bànfǎ), issued by SAMR in 2016 and updated in 2023, form the direct operating rules. They specify what documentation is required, the review standards, and the validity period of registration certificates (currently 5 years).

3. GACC Decree 248 and Decree 249

The General Administration of Customs of China (GACC, 海关总署, Hǎiguān Zǒngshǔ) administers two decrees that foreign manufacturers must also satisfy:

• Decree 248 (2021) — Administrative Provisions on Registration of Overseas Producers of Imported Food. This requires all overseas infant formula production facilities to be registered with GACC before their products can clear customs. Registration is via the CIFER (Customs Import Food Enterprise Registration) system.
• Decree 249 (2021) — Administrative Measures for Import and Export Food Safety. This covers labeling, documentation at the border, and traceability requirements for imported food including infant formula.

Product Categories That Require Registration

Not all child-nutrition products fall under the same registration bucket. SAMR defines three distinct categories of infant formula that require formula registration:

Special medical purpose infant formula (特殊医学用途婴儿配方食品, tèshū yīxué yòngtú yīng’ér pèifāng shípǐn) and infant formula for premature or low-birth-weight infants require separate registration under additional SAMR regulations and are outside the scope of this article.

Each registered formula is tied to a specific production facility and a specific brand name. A single manufacturer may register up to nine formulas across the three age stages (three per stage) under the current SAMR limit, a rule intended to prevent proliferation of marginally different products.

Required Documentation and Testing

The SAMR application dossier is notoriously detailed. Below is the complete list of documents and test reports a foreign company must prepare, translated from the official SAMR checklist:

1. Formula Registration Application Form (婴幼儿配方乳粉产品配方注册申请书, Yīngyòu’ér Pèifāng Rǔfěn Chǎnpǐn Pèifāng Zhùcè Shēnqǐngshū) — completed in Chinese, with company chops.
2. Proof of Legal Status of the Applicant — business license or equivalent registration certificate of the foreign manufacturer, notarized and apostilled (or Chinese embassy legalized).
3. Formula Composition Table (配方组成, pèifāng zǔchéng) — listing all raw materials, functional ingredients, and food additives with precise quantities per 100 g or 100 kJ.
4. Nutritional Composition Table (营养成分表, yíngyǎng chéngfèn biǎo) — demonstrating full compliance with GB 10765 or GB 10767 for every mandatory and optional nutrient.
5. Formula Development and Scientific Basis Report (配方研发报告, pèifāng yánfā bàogào) — a technical document justifying why each ingredient is present and at what level, citing peer-reviewed research or international standards (Codex Alimentarius, FDA, EFSA).
6. Production Process Description — a detailed flow chart and narrative of the manufacturing process, including wet-blend vs. dry-blend method, homogenization parameters, spray-drying conditions, and in-process controls.
7. Full Quality and Safety Test Reports — from a SAMR-accredited laboratory (认可实验室, rènkě shíyànshì), covering:
   • Nutritional composition (protein, fat, carbohydrates, vitamins, minerals)
   • Microbiological safety (Salmonella, Cronobacter sakazakii, Staphylococcus aureus, etc.)
   • Contaminants (aflatoxin M1, lead, cadmium, mercury, melamine)
   • Pesticide and veterinary drug residues
   • Shelf-life stability studies
8. Label and Package Sample — including the Chinese-language label (中文标签, zhōngwén biāoqiān) that will appear on retail packages. All claims must be substantiated by the formula development report.
9. GMP and HACCP Certification — certificates demonstrating that the manufacturing facility has passed a GMP (Good Manufacturing Practice) and HACCP (Hazard Analysis Critical Control Point) audit by an accredited third party.
10. Letter of Authorization — if a Chinese agent (代理人, dàilǐrén) is handling the application, a notarized power of attorney.

All foreign-language documents must be translated into Chinese by a sworn translator, and translations must be notarized. SAMR has the right to request additional supplementary materials during the review and often does.

The Registration Process Step by Step

The registration process follows a structured sequence of eight stages:

1. Pre-submission preparation (3–6 months). Compile all documentation, secure GMP/HACCP certifications, arrange laboratory testing at a SAMR-accredited lab, and prepare the Chinese-language label. Engage a qualified Chinese agent if needed.
2. Submit application to SAMR Center for Food Evaluation. The application is submitted online via SAMR’s portal (zwfw.samr.gov.cn), followed by submission of physical dossiers to the Center’s Beijing office.
3. Formal acceptance review (5–10 working days). SAMR checks the completeness of the application. If documents are missing, the application is returned with a deficiency notice (补正通知书, bǔzhèng tōngzhīshū). The applicant typically has 30–60 days to resubmit corrected materials.
4. Technical review (60–90 working days). SAMR’s expert panel reviews the formula composition, scientific justification, nutritional adequacy, safety data, and labeling claims. This is the longest and most scrutinized phase.
5. Supplementary information request (if needed). SAMR may issue one or more rounds of supplementary questions (补充材料, bǔchōng cáiliào). The applicant must respond within a defined window (usually 30 working days). Each round resets part of the overall clock.
6. On-site inspection (optional, increasingly common). SAMR may send Chinese inspectors to the foreign manufacturing facility for a physical audit. This typically occurs for first-time applicants or if the dossier raises concerns about production capability.
7. Final approval and certificate issuance. If the review passes, SAMR issues the Infant Formula Formula Registration Certificate (婴幼儿配方乳粉产品配方注册证书, Yīngyòu’ér Pèifāng Rǔfěn Chǎnpǐn Pèifāng Zhùcè Zhèngshū), valid for 5 years.
8. GACC facility registration. Separately from the SAMR process, the manufacturing facility must be registered in the GACC CIFER system. This is generally faster (4–8 weeks) but must be complete before any product can clear customs.

It is also important to note that any change to a registered formula — including a change in production site, brand name, or a significant ingredient change — requires a registration change application (变更注册, biàngēng zhùcè) with SAMR, which can take another 3–6 months.

Timeline and Costs

Foreign companies should budget realistically. Below is a summary of estimated timelines and costs based on industry averages in 2025–2026:

The variation in timeline depends heavily on whether SAMR requests supplementary materials, whether an on-site audit is ordered, and how quickly the applicant can respond. Foreign companies that invest in a complete, error-free first submission typically see faster approvals — often closer to 10–14 months total.

Common Reasons for Registration Rejection

Understanding why applications fail is as important as knowing the requirements. SAMR publishes rejection reasons in administrative decisions, and the most common patterns include:

• Insufficient scientific justification for formula composition. The most frequent cause. SAMR expects each functional ingredient (DHA, ARA, probiotics, HMOs, etc.) to be supported by peer-reviewed evidence showing safety and efficacy specifically for the target age group. Copying a European or US formula composition without adaptation to Chinese standards (e.g., iron levels) is a common mistake.
• Failure to meet Chinese national standards (GB standards). Many foreign formulas have nutrient levels that fall outside the ranges specified in GB 10765 or GB 10767. For example, some US formulas have protein levels that exceed the Chinese maximum, while certain European formulas have iron levels below the Chinese minimum.
• Incomplete or improperly translated documentation. SAMR strictly requires all documents to be in Chinese with notarized translations. Missing company chops, missing notarizations, or discrepancies between English originals and Chinese translations commonly cause deficiency notices.
• Labeling claims that violate Chinese regulations. SAMR disallows certain claims common in other markets (e.g., “follow-on formula,” “gold standard,” specific health-benefit claims without substantiation). The Chinese label must use only approved nutritional and ingredient statements.
• Inconsistent or missing traceability data. SAMR and GACC both require full traceability from raw milk source to finished product. If the applicant cannot document the supply chain for each raw material — including the farm of origin for milk powder — the application may be rejected.
• GMP/HACCP certification from unrecognized bodies. SAMR maintains a list of acceptable certification bodies (CNCA-registered). Certificates from unrecognized auditors are treated as invalid.

Rejected applicants may reapply after addressing the deficiencies, but the full review clock restarts. A second application with the same formula that does not substantially address prior concerns will be swiftly denied.

Additional considerations for foreign companies include the need to establish a legal entity or authorized representative in China (境外申请人, jìngwài shēnqǐngrén). While foreign manufacturers can apply directly, SAMR strongly prefers — and in practice, nearly requires — that a Chinese agent or wholly-owned subsidiary manage the submission and act as the ongoing responsible party for post-market surveillance, adverse-event reporting, and label compliance.

Where to Go From Here

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