On January 3, 2020, the State Administration for Market Regulation issued the “Measures for the Administration of Food Production Licenses” (SAMR Order No. 24, hereinafter referred to as the “Measures”), which came into force on March 1, 2020. The "Measures for the Administration of Food Production Licenses" promulgated by the former State Food and Drug Administration on August 31, 2015 was repealed at the same time. The new "Measures" strengthens supervision during and after the event, promotes the shift of the focus of food production supervision to post-event supervision and further enhance the operability of the food production license management system. The "Measures" stipulate that the production licensing supervision department shall be changed from the original state and province, autonomous region, and municipality food and drug supervision department to the state, province, autonomous region, and municipality market supervision and management department. This adjustment is mainly due to changes caused by institutional reforms. In order to help everyone understand the main changes in the "Measures", Foodmate has interpreted several highlights for the industry's reference.

Highlight 1: Comprehensively promote the informatization of food production licenses

The "Measures" stipulate that the entire process of food production license application, acceptance, review, license issuance, and inquiries should be handled online. Explicitly require the issuance of electronic certificates for food production licenses (Article 60 of the Measures specifies that electronic certificates and paper certificates have the same legal effect). In the whole process of online processing, there is no case that the certificate is lost or damaged and needs to be reissued, so the relevant regulations for reissue are cancelled.

Highlight 2: Clarify the basis and criteria for the classification of production licenses

Article 5 of the "Measures" specifies the basis and criteria for the classification of food production licenses. The market supervision and management department shall implement classification licenses for food production in accordance with the risk level of the food, combined with factors such as food raw materials and production processes.

Highlight 3: Shorten the time limit for on-site inspections, review decisions, certificate issuance and cancellation

The "Measures" shortened the time limit for review and decision permits, including: the paragraph 6 of Article 21 stipulates that the time limit for inspectors to complete on-site inspections of production sites from the day when they accept on-site inspection tasks is shortened from 10 working days to 5 working days; Article 22 stipulates that shortening the time limit from 20 working days to 10 working days for the supervisory authority to accept the application to make a licensing decision, and shortening the extended time limit from 10 working days to 5 working days for special circumstances; Article 23 stipulates that shortening the time limit from 10 working days to 5 working days when the regulatory authority makes a production license decision to issue a license.

The "Measures" shortened the time limit for applying for a cancellation permit, and the time limit for applying for cancellation was shortened from 30 working days to 20 working days.

Highlight 4: Clarify the responsibilities of the regulatory authorities at all levels

According to the paragraph 2 of Article 7 of the Measures, the production license of supplementary foods for infants and young children, salt and other foods shall be responsible for the market supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government.

The provisions of Article 21, paragraph 5 of the Measures clarify that on-site inspections of special foods shall not be entrusted to lower-level market supervision and management departments in principle.

The "Measures" added the principle of selecting the acceptance department for the application of a multi-category production enterprise. Article 18 stipulates: if an applicant applies for the production of multiple categories of food, the applicant shall be subject to the food production license management determined by the provincial market supervision and management department authorities, choose one of the acceptance departments to submit application materials. The acceptance department shall promptly notify the market supervision and management department with corresponding approval authority and organize a joint review.

Article 48 of the “Measures” adds a new requirement for confidentiality of information for the personnel participating in the review: without the consent of the applicant, the administrative agency and its staff and personnel participating in the on-site verification shall not disclose the business secrets or undisclosed documents submitted by the applicant Information or confidential business information, except as otherwise provided by law or involving national security or major public interests.

Highlight 5: Simplify food production license application materials

The "Measures" adjusted the application materials for food production licenses: when applying for food production licenses, applicants only need to submit necessary and important materials such as the "Food Production License Application". It is no longer required to submit copies of business licenses, food production and processing sites and their Floor plan of the surrounding environment and layout of each functional area. Among the materials provided for cancellation, the business license (copy) can be used to verify the applicant's subject information through the internal supervision information system, and other relevant materials can be verified on-site at the on-site verification link.

In order to implement the main responsibility of food production enterprises, the "Measures" require that the information of food safety professionals and food safety management personnel be added to the application materials. This information is important information for companies to fulfill their main responsibility for food safety and ensure food quality and safety. Please refer to Article 13 and Article 16 for details. In addition, the "Measures" have achieved effective integration with the "Food Safety Law". Article 33 of the "Food Safety Law" has the following provisions: (3) There are full-time or part-time food safety professionals and food safety management personnel and regulations to ensure food safety.

It is no longer necessary to submit the original and copy materials of the food production license for renewal, change & cancellation of application materials. Please refer to Article 33, Article 35, and Article 40 for details.

Highlight 6: simplify the content of the adjustment license

The “Measures” simplifies the content of food production licenses: due to institutional reform and the issuance of the “Measures”, the information in the food production licenses needs to be adjusted, and the State Administration for Market Regulation will separately announce the format and content of the adjusted food production licenses. The contents of the deletion include: the daily supervision and management agency, daily supervision and management personnel, complaint telephone number, issuer, and external warehouse information are no longer recorded in the food production license, and relevant regulations are deleted. In addition, the "Product Registration Approval Number" stated on the special food was changed to "The Registration Number of the Product or Product Formula".

In addition, in order to adapt to the adjustment of the content of the certificate, the "Measures" deleted the relevant content related to daily supervision and management personnel in Article 30 and Article 46 of the "Measures for the Administration of Food Production Licenses" issued in 2015.

Highlight 7: Clarify the types of permits that need to provide qualified reports, and increase the choice of corporate compliance submissions

The "Measures" clarify the types of permits that need to provide a qualified report: for the first application for a permit or a change permit for adding food categories, the inspection report of the trial-produced food shall be checked according to the requirements of the food production process.

The "Measures" added the source of the inspection report: the trial-produced food can be inspected by the producer itself, or a qualified food inspection agency can be entrusted to inspect it. Effective integration with the "Food Safety Law" is achieved. Article 89 of the "Food Safety Law" stipulates that food production enterprises can inspect the food produced by themselves or entrust food inspection agencies that comply with the provisions of this law to conduct inspections.

For the above content, please refer to the second paragraph of Article 21 of the Measures.

Highlight 8: Clarify the continuous compliance requirements of certified companies

The paragraph 4 of Article 32 of the "Measures" stipulates that the production conditions of food producers have changed, and they no longer meet the food production requirements and need to go through the licensing procedures again, they shall be handled in accordance with the law.

Highlight 9: Further clarify and strengthen the legal responsibilities of food producers and employees

The paragraph 2 of Article 49 of the Measures clarifies that if the food produced by a food producer does not belong to the food category specified in the food production license, it shall be deemed to be engaged in food production activities without a food production license. The penalty is equivalent to "unlicensed production."

The paragraph 2 of Article 53 of the "Measures" clarifies the penalties for violations of relocation without re-applying for food production licenses: in violation of Article 32, paragraph 2 of the "Measures", after the food producer’s production site moves Those engaged in food production activities without re-applying for a food production license shall be punished by the local market supervision and management department at or above the county level in accordance with Article 122 of the Food Safety Law of the People’s Republic of China.

The "Measures" added penalties for relevant practitioners, which are well integrated with the newly issued "Implementation Regulations of the Food Safety Law". For example, according to Article 54 of the "Measures", food producers violate the provisions of these Measures. Under the circumstances stipulated in the paragraph 1 of Article 75 of the "Regulations for the Implementation of the Food Safety Law of the People's Republic of China", the legal representative, main responsible person, directly responsible person in charge and other directly responsible persons of the unit shall be punished according to law.

The "Measures" stipulate that food producers whose production licenses have been revoked and their legal representatives, directly responsible persons in charge and other directly responsible persons shall not apply for food production and business licenses or engage in food production within 5 years from the date of the punishment decision. Operation and management work, serving as food safety management personnel of food production and operation enterprises.

The provisions of Article 53 of the "Measures" increase the penalties: if you fail to apply for changes in accordance with the regulations, the fine will be adjusted from 2,000~10,000 yuan to 10,000~30,000 yuan; if you fail to apply for cancellation as required, the fine was adjusted from below 2,000 yuan to below 5,000 yuan.

Summary

From the above analysis, it can be seen that the new version of the "Measures" conforms to the needs of the times, highly integrates relevant information, and at the same time strengthens the correlation and consistency with laws and regulations; from the perspective of supervision, it is "lenient entry and strict exit". Regardless of permits and heavy supervision”; from the perspective of convenience, government departments are more realistic, simplifying and shortening the handling process, and more considering serving the enterprise. Foodmate reminds food companies to earnestly implement the provisions of the Measures after the implementation of the Measures in order to effectively manage food safety.

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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.

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