Outsource Health Food Production? SAMR Released Q&As to Clarify Compliance Rules Apply to Entrusted Food Production

China’s SAMR has released Q&As on the implementation of the Administrative Measures for the Supervision and Administration of Entrusted Food Production (hereinafter referred to as the "Measures"), further clarifying the requirements for entrusted food production. Notably, the production of health foods cannot be outsourced in stages (split-stage production). The Measures will take effect on December 1, 2026; enterprises should prepare for compliance in advance.

Health foods are currently experiencing growth in both their consumer base and demand. Many enterprises often wonder when applying for health food registration or filing: “Is it available to actucally produce the product via contract manufacturing?”

While the question seems simple, the answer directly determines whether the product can be successfully registered or filed. To address this, the SAMR recently released a Q&A on the implementation of the Measures. CIRS Group has summarized the key points below to help enterprises better understand and implement the compliance requirements in advance.

Scope of Application

Applies to entrusted food production activities and their supervision and administration within the territory of China.

Definition

The Measures define entrusted food production as the act wherein a contract manufacturer carries out production activities—covering all or part of the production stages—according to the requirements of the entrusting party and delivers the produced food.

Examples of Common Scenarios

CIRS Group has compiled a list of scenarios that often lead to misunderstandings:

No.	Specific Scenario	Does it constitute entrusted food production?
1	Different subsidiaries within a corporate group produce the same food product but label it with different production addresses or producer information	No
2	Routine entrusted food production occurs between a parent company and a subsidiary, or between different subsidiaries within a corporate group, under a unified management system established by the group	No
3	A parent company or subsidiary within a corporate group accepts an entrustment from an entity outside the group	Yes
4	A food production enterprise outsources the irradiation processing stage (usually a sterilization/disinfection procedure) to a qualified entity	No

Do the Measures Apply to Health Foods?

The Measures set forth general requirements; since health foods are classified as food, the Measures apply to them as well. However, Article 29 of the Measures stipulates that where laws, administrative regulations, departmental rules, or relevant national regulations contain specific provisions regarding the production or processing of special foods, those specific provisions shall prevail.

Can Health Food Production be Outsourced?

Based on the qualification requirements for applicants for health food registration or filing as outlined in the Administrative Measures for Health Food Registration and Filing, the feasibility of contract manufacturing is determined by the specific scenarios listed in the table below:

Product Type	Application Pathway	Applicant Qualification Requirements	Contract Manufacturing Permitted?
Domestic	Registration	Legal entities or other organizations registered within China	Yes
Domestic	Filing	Health food manufacturing enterprises	No* *Original registrants may contract out the manufacturing of health foods that have transitioned to the filing pathway.
Imported	Registration	Overseas manufacturers of marketed health foods* *Overseas manufacturers refer to legal entities or other organizations whose products meet the market entry requirements of the country (or region) where they are based.	Yes
Imported	Filing	Overseas manufacturers of marketed health foods	Yes

Conditions for Health Food Contract Manufacturing

According to the Detailed Rules for the Review of Health Food Production Licensing, the commissioning party must be the holder of the health food registration certificate, and the commissioned party must be capable of completing the entire production process for the contracted product. In other words, the contract manufacturing of health foods cannot be split or subcontracted in stages.

Reminder from CIRS

The Measures will officially come into effect on December 1, 2026; enterprises requiring contract manufacturing services should plan their compliance strategies in advance. Food products manufactured prior to the implementation of the Measures may continue to be sold until their expiration dates.

CIRS Group wishes to highlight to health food enterprises that the Measures specifically address the contract manufacturing of products already on the market. For the contract manufacturing of trial samples during the application phase, the commissioning party is not required to hold a health food registration certificate; however, they must ensure that the commissioned party holds a production license for health foods and the relevant dosage form, and both parties must sign a “Contract for Sample Processing”. If you have any questions regarding health food registration or filing applications, please contact CIRS Group immediately!

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

Health food registration and filing in China;
Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
U.S. GRAS, NDI, and CAP notifications;
EU Novel Food, food additives, and food enzymes applications; and
Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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