China health food standard: makers to self-inspect every six months

· Policy

Clear softgel capsules on a wooden table with an open white bottle behind them
Softgel capsules beside an open bottle. Photo: Globallystoners, CC0, Wikimedia Commons

A draft Chinese national standard would require health food (保健食品) manufacturers to inspect their own quality management systems at least once every six months. Makers whose processes include fermentation, synthesis or enzymatic hydrolysis would do so at least once a quarter, the State Administration for Market Regulation (SAMR, 市场监管总局) said on 8 October 2026.

The draft is open for public comment as a recommended national standard

The draft, the Specification for Self-inspection of Quality Management Systems of Health Food Manufacturers (《保健食品生产企业质量管理体系自查工作规范》), has been posted for comment on the National Public Service Platform for Standards Information (全国标准信息公共服务平台).

It is a recommended national standard (推荐性国家标准). SAMR guided its drafting, and it falls under the National Technical Committee on Special Foods Standardisation (SAC/TC466, 全国特殊食品标准化技术委员会).

Draft health food self-inspection standard: key facts
Guiding bodyState Administration for Market Regulation (SAMR)
Responsible committeeNational Technical Committee on Special Foods Standardisation (SAC/TC466)
DocumentSpecification for Self-inspection of Quality Management Systems of Health Food Manufacturers (draft for comment)
TypeRecommended national standard
Announced8 October 2026
ScopeBasic requirements, frequency and methods, procedures and reporting for health food manufacturers’ quality system self-inspections
Note: The standard is at the public-comment stage. Source: SAMR, ‘《保健食品生产企业质量管理体系自查工作规范》国家标准(征求意见稿)公开征求意见’

Manufacturers are the legal party responsible for self-inspection

SAMR cites the Food Safety Law, its implementing regulations and the provisions on supervising food businesses’ primary responsibility for food safety as the legal basis.

Under these rules, health food manufacturers are the legal party responsible for self-inspecting their quality management systems. They must put food safety management rules in place and set up and run a quality management system.

They must also check and evaluate their food safety status and the running of that system at regular intervals, and submit self-inspection reports.

Fermentation and synthesis plants would self-inspect every quarter

The draft sets a single frequency for routine self-inspections. All health food manufacturers would carry them out at least once every six months.

Manufacturers whose production and processing include fermentation, synthesis or enzymatic hydrolysis steps would carry them out at least once a quarter.

Self-inspection frequency and triggers in the draft standard
SituationRequirement
All health food manufacturersRoutine self-inspection at least once every six months
Processes include fermentation, synthesis or enzymatic hydrolysisRoutine self-inspection at least once a quarter
Major change in production conditionsTimely special self-inspection
Resumption after a production haltTimely special self-inspection
Failed sampling inspectionTimely special self-inspection
Food safety incident or major public controversy (重大舆情)Timely special self-inspection
Note: Requirements are as set out in the draft for comment. Source: SAMR, ‘《保健食品生产企业质量管理体系自查工作规范》国家标准(征求意见稿)公开征求意见’

Special checks would follow failed tests, incidents and production restarts

Beyond the routine schedule, the draft requires manufacturers to carry out a special self-inspection promptly in four situations: a major change in production conditions, a restart after production has stopped, a failed sampling inspection, and a food safety incident or major public controversy.

A standard form and report would cover each inspection

The draft sets out one procedure for the whole process: preparation, inspection, handling of results, correction and improvement, and filing of records.

A normative annex provides a standard self-inspection form and the requirements for the self-inspection report.

SAMR says the standard would give manufacturers a single technical basis for self-inspections and push them to carry out their primary responsibility for food safety. It would also support regulators’ risk prevention and supervision across the whole supply chain.

Coming up · We may follow up with the full draft text once it is reviewed, and with SAMR’s other recent rules on health food and special foods.

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