Recently, the State Administration for Market Regulation (SAMR) has revised and issued the Administrative Measures for the Registration of Infant and Young Children Powdered Formula Recipes (hereinafter referred to as the Measures). This will be implemented from October 1, 2023, replacing the 2016 version of the former State Food and Drug Administration on June 6, 2016.
The following is the interpretation of the Measure.
I. What is the background of the revision of the Measure?
Since the Measure was implemented on October 1, 2016, the quality of Infant and Young Children Powdered Formula has significantly improved. The industry has developed in a regulated manner, and consumer confidence has been noticeably boosted. However, how to further advance formula registration, optimize approval processes, promote formula research and development, and encourage enterprise innovation needs to be clarified at the legislative level.
Particularly, the Action Plan for Improving Domestic Infant and Young Children Powdered Formula explicitly requires the improvement of formula registration management measures. These measures, combined with the results of breastfeeding research and market consumption demand, support production enterprises in optimizing the formula, accelerating product research and development, and promoting the application of scientific research results.
The revision of the Measure mainly considers the following three aspects:
* Adhere to the people-centered development concept, ensure the healthy growth of infants and young children, further tighten registration conditions, and improve the quality of Infant and Young ChildrenPowdered Formula;
* Implement and optimize the business environment, revise relevant content in combination with the actual work of registration and the suggestions of industry enterprises;
* Adhere to the principles of "openness, fairness, and justice", clarify specific situations such as on-site verification and non-registration, and further improve work transparency and standardization.
II. In terms of strictly regulating formula registration, what revisions have been made to the Measure?
First, it is made clear that disguised repackaging (the use of compound ingredients that already meet the nutritional requirements of the national standard for infant and young children formula food safety as raw materials for formula registration) and 8 situations where registration will not be permitted.
Second, the prohibitive requirements for labels and instructions are detailed.
Third, the penalty for illegal activities that cause harmful consequences is increased, with the maximum fine for applicants obtaining registration certificates through deceptive and bribing methods leading to harmful consequences adjusted to 200,000 yuan.
III. To optimize the business environment, what revisions have been made in the Measure?
First, for companies that have independent research and development institutions, their controlling subsidiaries (applicants) are allowed to share part of the R&D capabilities.
Second, to implement corporate main responsibility, after a thorough assessment by the companies, formulas can be invoked between the parent company and its controlling subsidiaries.
Third, the review time and inspection period that need to be extended in special cases are reduced from 30 working days to 20 working days, and the time for reissuing the certificate is reduced from 20 working days to 10 working days.
Fourth, enhance the legal effect of electronic certificates, and remove the "legal representative" item from the matters stipulated in the registration certificate.
IV. What adjustments have been made to the circumstances under which registration will not be permitted?
The original Measure required that the formula should comply with relevant laws and regulations and the requirements of national food safety standards, and provide research and demonstration reports and sufficient evidence to prove the scientific safety of the product formula.
However, it did not explicitly stipulate the situations where registration would not be permitted.
With the aim of further improving the standardization and transparency of the review institutions, and in light of the actual industry situation and review experience since the release of the original Measure, the revised Measure has clarified 8 situations where registration will not be permitted.
These include when
* application materials are falsified or not truthful; the scientific and safety basis for the product formula is insufficient;
* the applicant does not possess the R&D capability, production capability, or inspection capability that is compatible with the product formula for which registration is being applied.
V. What content has been clarified for on-site inspection and sampling inspection during registration?
To further enhance the transparency of the review process, the revised Measure has clarified the situations where on-site inspection will be carried out.
For example, all series and formulas of applicants applying for the first time must be checked one by one. On-site inspection is also required when there are significant changes in the composition of the product formula or actual changes in the production address, or when problems that need to be verified on-site are discovered during the technical review process.
At the same time, the Measure has clarified that samples from dynamic production will be taken for inspection, and the varieties of dynamic production samples for sampling inspection will be determined based on risk.
VI. What adjustments have been made to the prohibitive requirements for labels and instructions?
The original Measure stipulated that labels and instructions should not contain six types of content, such as: relating to disease prevention and treatment functions; explicitly or implicitly implying a health care function, etc.
In line with the principle of "protecting consumers' right to know," the labeling content should be truthful, accurate, clear, and easy to identify. The revised Measure has clarified that labels and instructions should not contain nine types of content, adding that ambiguous information such as "imported milk source", "from foreign pastures", "ecological pastures", "imported raw materials", "original ecological milk source", "pollution-free milk source", etc., should not be used.
Additionally, images of babies and women, the terms "humanized" and "breast milk-like" or similar terms should not be used.
Furthermore, content not in accordance with laws, regulations, rules, and national standards for food safety should not be used.
Moreover, it enumerates situations where it is explicitly or implicitly suggested to have health care functions, etc.
VII. What adjustments have been made to the requirements for the applicant's R&D capabilities?
The original Measure stipulated that the applicant should have the corresponding R&D capabilities, requiring the establishment of an independent R&D institution and the provision of corresponding full-time R&D personnel.
Based on the principles of conserving resources and focusing on strengths, and in line with the actual situation of the industry, the revised Measure allows a subsidiary that is a controlling entity to share part of the group company's R&D capabilities as an applicant if the enterprise group has an independent R&D institution, such as research on breast milk nutritional components, clinical application effects, some research and development design, etc.
VIII. What adjustments and requirements have been made for formula co-use within the same group company?
In order to fully utilize corporate production capacity, meet market demand, and optimize the business environment, the formula co-use is allowed between the parent company and its controlling subsidiaries. The parent company is required to fully assess the feasibility and ensure the quality and safety of the products, and to submit a written report to the State Administration for Market Regulation.
The parent company should explain the specific reasons for the formula co-use, fully evaluate the feasibility of the production process, ensure that the formula is consistent with the registered certificate, formulate and effectively implement appropriate quality control measures, and ensure the production quality and product stability of the formula.
IX. What are the circumstances that require an on-site inspection when there are significant changes in the national standards for the safety of infant formula foods?
The national standards for the safety of infant formula foods mainly refer to the National Food Safety Standard Infant Formula Foods (GB 10765), National Food Safety Standard Older Infant Formula Foods (GB 10766), and National Food Safety Standard Young Children Formula Foods (GB 10767). Changes caused by revisions to other national food safety standards related to infant formula foods will be determined after further assessment based on the actual situation.
X. What adjustments has the Measure made on the content of the penalty?
The Administrative Penalty Law implements the proportionality of penalty and the combination of leniency and strictness.
On the one hand, the penalties for harmful behaviors have been increased. For example, the maximum penalty for obtaining a registration certificate by deception, bribery, and other improper means causing harmful consequences has been adjusted to 200,000 yuan, and the maximum penalty for forging, tampering, reselling, renting, lending, transferring infant and young childrenPowdered Formula product registration certificates causing harmful consequences is also 200,000 yuan.
On the other hand, the penalties for minor violations have been reduced. It is stipulated that if the applicant has undergone some changes that do not affect the scientific and safety of the product formula without going through the change procedures, they will first be ordered to correct, and if they do not correct after the deadline, they will be fined.
XI. In what other aspects have the Measure been revised?
The revisions mainly occurred in the following three aspects:
1. The responsibilities of food review agencies are clarified. The Food Review Agency of the State Administration for Market Regulation (hereinafter referred to as the Review Agency) is responsible for the acceptance, technical review, on-site inspection, certificate issuance, delivery of certificate, and the organization of expert review as needed.
2. The legal status and responsibilities of the review expert are clarified. In the process of technical review, on-site inspection, and product inspection, the opinions of experts in the fields of food safety, food processing, nutrition, and clinical medicine can be listened to on major and complex issues. Experts who participate in the review shall issue expert opinions and adhere to professional ethics.
3. It promotes the high-quality development of the industry, encourages companies to carry out formula research and development and innovation, optimizes formulas based on the research results of breast milk, and improves the quality of infant powdered formula.
XII. When will the Measure be implemented?
These measures will be implemented from October 1, 2023, and the Administrative Measures for the Registration of InfantPowdered Formula Product Formulas published by Order No. 26 of the former State Food and Drug Administration on June 6, 2016, will be abolished at the same time.
Source：
State Administration for Market Regulation
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