On the eve of the implementation of the new Food Safety Law, the China Food and Drug Administration issued several notices on new management policies, including this Q&A. It clarifies that the food 'QS' mark will be abolished. However, after October 1, foods with the 'QS' mark will not disappear from the market immediately but will gradually phase out over time. During this period, foods with old packaging bearing the 'QS' mark and those with new food production license numbers will coexist. Foods produced on or after October 1, 2018, must no longer use original packaging, labels, or the 'QS' mark.
The following is the full text of the Q&A.
The newly revised Food Safety Law will take effect on October 1, 2015. As a supporting regulation of the new Food Safety Law, the Measures for the Administration of Food Production Licensing formulated by the China Food and Drug Administration will also be implemented on October 1, 2015. Recently, the CFDA issued the Notice on the Implementation of the Measures for the Administration of Food Production Licensing, further clarifying and requiring the implementation of the Measures. So what changes will occur in food production licensing after the Measures are implemented? What new requirements will there be for food producers and enterprises? What impact will it have on people's lives? With these questions, let us understand the upcoming Measures for the Administration of Food Production Licensing.
Question 1: Why was the Measures for the Administration of Food Production Licensing revised? Answer: According to the Food Safety Law, China implements a licensing system for food production. Over the past decade since the implementation of food production licensing, it has played an active and important role in regulating the necessary production conditions for enterprises, urging them to strengthen production process control, implementing the main responsibility for food safety, improving the overall level of food safety, and promoting the healthy and sustainable development of the food industry. However, with the deepening of China's economic system reform and the rapid development of the food industry, especially the reform and improvement of the food safety regulatory framework, the food production licensing system has indeed exposed some problems in both institutional design and specific operational implementation, which need to be reformed and improved. The re-revision and issuance of the Measures for the Administration of Food Production Licensing is driven by multiple factors and is timely. First, it is a deep implementation of the Party Central Committee and the State Council's strategic deployment to streamline administration and delegate power. The Party Central Committee and the State Council attach great importance to streamlining administration and delegating power. The Third Plenary Session of the 18th Central Committee of the Party clearly proposed to further streamline administration and delegate power, and deepen the reform of the administrative approval system. The State Council has also held executive meetings and national teleconferences to study and deploy streamlining administration, delegating power, and transforming government functions. In particular, leaders of the State Council have made important instructions on food production licensing multiple times. It can be said that the reform of the administrative approval system has become a key task for the Party and government to comprehensively deepen reform, transform government functions, improve the governance system, and enhance governance capabilities. The food and drug regulatory authorities have actively responded to and fully implemented the major strategic deployments of the Party Central Committee and the State Council, comprehensively, deeply, and steadily advancing the reform of the administrative approval system. The Party Group Meeting and the Executive Meeting of the General Administration have discussed the reform of the food production licensing system multiple times and promptly revised the Measures for the Administration of Food Production Licensing. Second, it is an important measure to fully implement the Food Safety Law. The new Food Safety Law will be fully implemented on October 1. As a supporting regulation of the Food Safety Law, the Measures for the Administration of Food Production Licensing is promulgated and implemented simultaneously at this important time, which is an important measure to fully implement the new Food Safety Law. Third, it is an inevitable requirement to adapt to the reform of the regulatory system. According to the unified deployment of the State Council, the adjustment of food safety regulatory functions and institutional reforms in various regions have been completed. Under the new regulatory system, food safety supervision needs to strengthen source control. Through the implementation of production licensing, enterprises are urged to improve management systems, enhance environmental and health protection capabilities, upgrade equipment and facilities, and ensure food safety. Through prior checks, producers who cannot guarantee quality and safety will be eliminated. Fourth, it is a positive response to the voices of enterprises. In recent years, enterprises have increasingly complained about the difficulty of applying for food production licenses. Some enterprises have reported problems such as too many application materials, complicated review procedures, and long approval times. These problems have indeed restricted the innovative development of the industry to a large extent and increased the burden on enterprises. On the basis of in-depth research, the CFDA has actively changed its concepts, boldly innovated and reformed, and actively responded to concerns from all sectors of society. The revised Measures for the Administration of Food Production Licensing reflects the principle of convenience and benefit to the people in many aspects, such as license applications, on-site inspections, and certificate renewal, solving the problems strongly reflected by enterprises.
Question 2: Compared with the original food production licensing system, what are the main changes in the Measures? Answer: In order to implement the new Food Safety Law and the State Council's work deployment to streamline administration, delegate power, and transform government functions, and in line with the principle of combining delegation and regulation, facilitating enterprises, and strict supervision, adjustments have been made to address the inconsistencies between the current food production licensing system and the Food Safety Law and the existing regulatory system. In summary, they are 'five cancellations', 'four adjustments', and 'four strengthenings':
(1) 'Five Cancellations' First, cancel the review of some pre-approval materials. The pre-approval materials required for applying for food production licenses are numerous, and some materials are not directly related to the licensing matters. This is a problem strongly reflected by food producers in recent years. Therefore, the new Measures have reorganized the materials required for production license applications, and all materials not directly related to the licensing matters have been canceled from the pre-approval material review. Second, cancel the designation of licensing inspection institutions. The previous production licensing regulations required that product inspections for applicants be conducted at designated qualified inspection institutions. To facilitate enterprises and improve approval efficiency, the new Measures stipulate that applicants may conduct their own inspections or entrust qualified food inspection institutions to inspect their products. Third, cancel the fees for food production license review. To implement the Party Central Committee and the State Council's policy of benefiting the people, and to implement the Notice of the Ministry of Finance and the National Development and Reform Commission on Canceling, Suspending, and Exempting a Batch of Administrative Fees, the new Measures cancel the fees for food production license review. Food production regulatory departments must not charge any fees when accepting enterprise production license applications, including renewal applications, conducting production license reviews, and inspecting products for license issuance. Fourth, cancel the filing of entrusted processing. Entrusted processing is a market behavior and should not be interfered with by administrative departments. The new Measures cancel the requirement for food producers to file entrusted processing with regulatory departments. Both parties to food production entrustment only need to truthfully label the names, addresses, and contact information of the entrusting party and the entrusted party, as well as the food production license number of the entrusted party, in accordance with laws, regulations, and national food safety standards. Fifth, cancel the annual inspection and annual report system for enterprises. The new Food Safety Law stipulates that food producers and operators should establish a food safety self-inspection system and regularly check and evaluate their food safety status. To be consistent with the requirements of the Food Safety Law, the new Measures cancel the annual inspection and annual report system for food producers, and no longer require them to submit annual inspections and annual self-inspection reports on production licenses to food and drug regulatory departments.
(2) 'Four Adjustments' First, adjust the subject of food production licensing. Implement 'one enterprise, one certificate', issuing one food production license to each qualified food production enterprise. For enterprises producing multiple categories of food, this is noted in the copy of the production license. Second, adjust the validity period of the license certificate. Extend the validity period of food production licenses from the original 3 years to 5 years. Third, adjust the content of on-site inspections. For licensed enterprises that add new food variety details within the licensed food category, no on-site inspection is required. For applications for health food, formula food for special medical purposes, and infant formula milk powder production licenses, if on-site inspections have been conducted during product registration, no further on-site inspection is required. For adding new food categories, or for health food enterprises changing entrusted enterprises for raw material pre-treatment, extraction, etc., the licensing approval authority only conducts supplementary on-site inspections of their production processes, production sites, equipment, and facilities. Fourth, adjust approval authority. Except for key foods such as infant formula milk powder, food for special medical purposes, and health food, which are in principle organized by provincial food and drug regulatory departments for production license review, the approval authority for other food production licenses can be delegated to municipal and county-level food production regulatory departments. The specific measures and catalog are determined by provincial food and drug regulatory departments.
(3) 'Four Strengthenings' First, strengthen the management of licensing archives. Food and drug regulatory departments at all levels establish and improve food production licensing archives, recording in detail the licensing information of food producers, all food varieties produced, daily supervision and management institutions, daily supervision and management personnel, etc. Second, strengthen post-license supervision and inspection. Food and drug regulatory departments formulate supervision and inspection plans to strengthen daily supervision and inspection of enterprises, publish the results of supervision and inspection, and record them in the enterprise's food safety credit file. Third, strengthen the management of the reviewer team. Food production license reviewers are uniformly trained, assessed, registered, certified, and managed by provincial food and drug regulatory departments. Strict work discipline for food production license review, strengthen the assessment and management of reviewers, establish an applicant evaluation system, and strengthen internal supervision and social supervision. Fourth, strengthen information technology construction. Establish a production licensing information system, encourage local governments to explore online applications, acceptance, approval, and certificate issuance, promote electronic certificates, and improve the informatization, transparency, and standardization of food production licensing.
Question 3: After the implementation of the Measures, will the original rules and regulations continue to be implemented? Answer: After the Measures are implemented on October 1, 2015, food and drug regulatory departments at all levels should strictly follow the relevant provisions of the Measures to carry out food production license applications, acceptance, review, decision-making, certificate issuance, changes, renewal, reissuance, cancellation, and supervision and inspection of food production licensing, and fully organize the implementation of the new food production licensing system. The CFDA is currently intensifying the revision and formulation of technical documents for licensing, such as the general rules and detailed rules for the review of food, food additives, and health food, which will be published soon. Before publication, the original general rules and detailed rules for the review of food, food additives, and health food production licenses remain valid, but if their provisions are inconsistent with the Measures, the provisions of the Measures shall prevail.
Question 4: After the implementation of the Measures, how should license applications be submitted in accordance with the principle of 'one enterprise, one certificate'? Answer: To facilitate enterprise applications, the Measures make major adjustments to production licensing, changing from the original licensing by food variety to licensing by enterprise entity, from multiple certificates for one enterprise to one certificate for one enterprise. When applying for food production licenses, food producers should submit applications for production licenses, changes, and renewals to food and drug regulatory departments in accordance with the food production licensing management authority determined by provincial food and drug regulatory departments. If a food producer produces multiple categories of food, it should submit a joint application to one provincial, municipal, or county-level food and drug regulatory department in accordance with the food production licensing management authority determined by provincial food and drug regulatory departments.
Question 5: After the implementation of the Measures, how should regulatory departments approve and issue certificates in accordance with the principle of 'one enterprise, one certificate'? Answer: After accepting an application, food and drug regulatory departments should organize reviews and make decisions in accordance with the provisions of the Measures. If a food producer produces multiple categories of food, it should submit a joint application to provincial, municipal, or county-level food and drug regulatory departments in accordance with the food production licensing management authority determined by provincial food and drug regulatory departments. If the licensing matter is not within the approval authority of the accepting department, the accepting department should promptly inform the food and drug regulatory department with corresponding approval authority, organize a joint review, make a decision within the specified time limit, and the accepting food and drug regulatory department should issue the food production license certificate based on the decision, noting the licensed food categories in the copy.
Question 6: After the implementation of the Measures, how should the 'food category code' in the new food production license number be understood? Answer: The category codes for food and food additives are identified by 3 digits, specifically: the first digit represents the food or food additive production license identification code, with the Arabic numeral '1' representing food and '2' representing food additives. The second and third digits represent the category number of food or food additives. The food category numbers are identified in the order of the food categories listed in Article 11 of the Measures for the Administration of Food Production Licensing, namely: '01' represents grain processing products, '02' represents edible oils, fats, and their products, '03' represents condiments, and so on... '27' represents health food, '28' represents formula food for special medical purposes, '29' represents infant formula food, '30' represents special dietary food, and '31' represents other food. The category numbers for food additives are identified as: '01' represents food additives, '02' represents food flavors, and '03' represents compound food additives.
It should be noted that once the food production license number is determined, it will not change. In the future, when applying for license renewal and changes, the license number will also not change.
Question 7: After the implementation of the Measures, is it still required to implement industrial policies in licensing work? Answer: Applicants for food production licenses should comply with national industrial policies. If the applied project falls under the restricted category in the Industrial Structure Adjustment Guidance Catalog, according to the Decision of the State Council on Issuing the Interim Provisions on Promoting Industrial Structure Adjustment, relevant food production license procedures shall not be handled. If local regulations, rules, or relevant documents of provinces, autonomous regions, or municipalities directly under the central government have other provisions on the implementation of industrial policies, those provisions shall also be observed.
Question 8: Are food additives licensed in accordance with the Measures? Answer: The original Food Safety Law stipulated that the conditions and procedures for applying for food additive production licenses should be implemented in accordance with the national regulations on the administration of industrial product production licenses. With the adjustment of the food safety regulatory system, food additives are no longer supervised by the quality supervision department as industrial products, but as an important part of food safety management, they are uniformly supervised by the food and drug regulatory department. Therefore, the new Food Safety Law stipulates that those engaged in the production of food additives should have premises, production equipment or facilities, professional and technical personnel, and management systems suitable for the variety of food additives produced, and obtain food additive production licenses in accordance with the prescribed procedures. Given that the legal procedures for food additive production licensing are basically the same as those for food production licensing, to facilitate enterprise applications, the Measures incorporate food additive production licensing into its implementation. Therefore, enterprises applying for and regulatory departments implementing food additive production licenses should follow the provisions of the Measures.
Question 9: After the implementation of the Measures, are the original license certificates of enterprises still valid? Answer: To ensure a smooth transition of licensing, the new Measures stipulate that production licenses already obtained by food and food additive producers before the implementation of the new Measures remain valid within their validity period. At the same time, the CFDA's Notice also encourages food producers holding old-version certificates to exchange them for new-version food production licenses in advance.
Question 10: After the implementation of the Measures, how should old-version certificates be exchanged for new-version certificates? Answer: Producers holding old-version production licenses who need to change or renew their licenses should apply to the original issuing department. After review and compliance, they will be issued new-version food production licenses. For those holding multiple old-version production licenses, in accordance with the principle of 'one enterprise, one certificate', they can apply together and exchange for one new certificate. They can also exchange in batches. Specifically, after the first batch exchanges for one new certificate, other old-version certificates can be gradually exchanged on the already exchanged new certificate through the method of 'changing licensing matters'. After the exchange, the original licenses held will be canceled. The new certificate copy should list the original food production license numbers one by one.
Question 11: After the implementation of the Measures, will the 'QS' mark be retained? Answer: After the implementation of the Measures, the food 'QS' mark will be abolished. The previous legal basis for marking 'QS' on food packaging was the Regulations on the Administration of Industrial Product Production Licenses. With the adjustment of food supervision and management institutions and the implementation of the new Food Safety Law, the Regulations on the Administration of Industrial Product Production Licenses is no longer the basis for food production licensing. Therefore, canceling the food 'QS' mark is, first, a strict implementation of laws and regulations, because the new Food Safety Law clearly stipulates that food packaging should be marked with the food production license number, and does not require the food production license mark. Second, the new food production license number can fully achieve the purpose of identification and inquiry. The new food production license number consists of the letter 'SC' plus 14 Arabic numerals. Third, canceling the 'QS' mark is conducive to enhancing the awareness of food producers' main responsibility for food safety.
Question 12: After the implementation of the new Measures, how should the large inventory of packaging in enterprises be handled? Answer: After the implementation of the Measures, newly licensed food producers should mark the new food production license number on food packaging or labels, and no longer mark the 'QS' mark. In order to fully implement the new production licensing system as soon as possible while avoiding waste of packaging materials and food labels, we have given producers a transition period of no more than three years, that is, foods produced on or after October 1, 2018, must no longer use original packaging, labels, or the 'QS' mark. We encourage and support food producers to phase out old packaging and adopt new packaging as soon as possible.
Consumers should note when purchasing food: after October 1, foods with the 'QS' mark will not disappear from the market immediately, but will gradually phase out over time. During this period, foods with old packaging bearing the 'QS' mark and those with new food production license numbers will coexist.
This article is reproduced from: Xiaoshidai
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