In July 2019, The State Administration for Market Regulation (SAMR) issued a public consultation on "Working Procedures for On-site Inspection of Special Food Registration (Interim) (draft for comments)". After more than a year, SAMR officially issued the "Work Regulations for On-site Inspection of Special Food Registration (Interim)" (hereinafter referred to as the "Working Procedures") on 26 November, 2020. Foodmate has sorted out the main changes of the "Working Procedures" compared with the draft issued last year, so that relevant practitioners can keep abreast of the latest developments.

Change 1: Effective connection of "Working Procedures" and other registration guidance documents

In 2016, the former Food and Drug Administration issued the "Key Points and Judgment Principles for On-site Inspection of Infant Formula Milk Powder Product Formula Registration (Trial)". The "Working Procedures" are well connected with the above-mentioned document. For example, the rectification time for on-site inspection is stipulated to be completed within 10 working days, and the rectification and acceptance departments are all provincial supervision and management departments.

Change 2: On-site inspections are managed by risk classification, and are no longer limited to "on-site"

The "Working Regulations" no longer restricts the form of on-site inspection to "on-site" audits, and sets specific requirements for health food inspections. After scientific risk assessment of the relevant responsible entities, the Center for Food evaluation will adopt more flexible and diverse working methods to conduct on-site inspections of special foods.

Change 3: On-site inspections no longer allow the participation of third-party audit agencies

Article 4 of the "Working Regulations" stipulates that the Center for Food evaluation of SAMR is solely responsible for all on-site inspections and is responsible for the inspections and results. The relevant content of "can entrust qualified third parties recognized by the State Administration for Market Regulation to conduct on-site registration verification" is deleted. This makes the on-site inspection of special foods more orderly and fair.

Change 4: On-site Inspection time is no longer a “Fixed time”

Articles 8 and 10 of the "Working Regulations" both give companies opportunity to apply for an extension inspection when the company is unable to accept on-site inspections due to force majeure and special reasons.

Change 5: Clarify on-site inspection and rectification time, rectification inspection department and process

The "Working Regulations" stipulated that the enterprise should complete the rectification within 10 working days, and the provincial market supervision and management department is responsible for the acceptance of the rectification work and submits the conclusion of the rectification and acceptance of the enterprise to Center for Food evaluation.

Change 6: Put the requirements of overseas inspection work in the annex

The "Working Regulations" unified the other requirements for the on-site inspection of imported special food registration into the annex. For example, the main inspection materials submitted by overseas companies should be in Chinese, and companies need to arrange enough translators.

Since the date of publication, the "Working Procedures for On-site Inspection of Special Food Registration (Interim)" will be implemented. The registration of special foods in China will be more standardized and scientific.

---

Please note: Original English article of Business Division of Food Safety and Regulatory Compliance of Global Foodmate, please indicate the source from the Global Foodmate if reprint.

Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net