The new Food Safety Law stipulates that in China, food production license is mandatory before starting the food production. On 1 October 2015, the new Administrative Measure of Food Production License has come into force, dietary supplement, foods for special medical purpose, and food additives are all included into the scope of food production license application. In order to make main responsibility explicit, the information below will be written in the new food production license: the manufacturer’s name, social credit code, legal representative, residence address, production address, food category, license number, expiry date, the daily supervision institution, the daily supervisor, complaints telephone, issuing authority, issuer, issuing date, QR code and other information.
Meanwhile, on 30 September 2015, CFDA published the Implementation Notice about the Administrative Measure of Food Production License, which specified the important matters in the implementation of this measure. CIRS food team researched the new measure in depth, and the important contents are highlighted as follows:
1. Who can apply for the food production license?
The business license is necessary before the application. Enterprise legal person, partnership enterprise, individual proprietorship enterprise, and individual industrial and commercial households can apply for the food production license. And the applicant must be the person stated in the business license.
2. What requirements dose the applicant have to meet to apply for food production license?
Meet the certain requirements of food production place;
Meet the certain requirements of production equipment or facilities;
Must have the full-time or part-time food safety management person and food safety regulations;
Have a reasonable equipment layout and technological process;
Meet other requirements prescribed by the laws or regulations.
3. Which department is authorized to issue the food production license?
Local FDA at the county level or above is responsible for the food production license management work within their respective administrative areas.
Provincial FDA is in charge of the production license for dietary supplements, foods for special medical purpose, and infant formula food.
4. The application procedure of food production license
5. The required application materials for food production license
Application form of food (or food additive) production license;
Copy of the business license;
The plans of food (or food additive) production place, workshop layout, equipment layout and technological process;
List of the main food (or food additive) production facilities;
Regulations including incoming inspection records, manufacturing control, food safety inspection, unsafe food recall, health management for employees, and so on.
The applicant entrust others to apply for the food production license, the agent shall submit a power of attorney and ID documents;
For the application of dietary supplements, foods for special medical purpose and infant formula food, the production quality management system documents, registration and filling documents are also needed.
6. Compared with the old version, what are the main changes of the new measure?
Part of the materials that have no direct relationship with food production permit are cancelled;
Assignment of the inspection agency is cancelled, the applicant can inspect the product himself or entrust qualified food inspection agency to conduct the inspection;
Filling of food entrust production is cancelled;
The annual inspection and annual reports are cancelled, food manufacturer should establish the food safety self-inspection system;
For one enterprise, it cannot get more than one certificate anymore;
The expiry date of food production license is changed from 3 years to 5 years;
The site inspection is adjusted;
The approval authority of FDA department at different levels is adjusted;
The management of food production license file is strengthened;
The supervision after the permission is strengthened, and the inspection results will be published and written into the company food safety credit file;
The management of examiner team is strengthened;
The informatization construction is strengthened.
7. How to implement the principle of “one enterprise, one certificate”?
The new measure explicitly regulates that one food manufacturer can only get one food production license. When the manufacturer produces different categories of food, he should submit the application of all categories he produced to the local FAD department. And for the receiving FDA department, if they have no authority to permit the production of part categories of food, they should ask the FDA department who has the authority to examine the application together.
8. Will the logo of “QS” be remained or not after the implementation of the new measure?
The Implementation Notice about the Administrative Measure of Food Production License regulated that manufacturers who get the new license should label the food production license number (which is composed of “SC” and 14 Arabic numerals) on the food package or label, and the logo of “QS” is no longer marked, as the new Food Safety Law stipulates clearly that the food production license number is mandatory for the package, and the “QS” loge is not mentioned. In addition, the license number is enough for identification and search.
But in order to avoid the waste of old food packaging materials and labels, CFDA gives a transitional period of 3 years, which means, since 1 October 2018, the old packaging materials, labels and “QS” logo will not be allowed to use any more. And among this transitional period, food with old food packages and “QS” logo and food with new production license number will exist in the market at the same time.
9. Will the old regulations continue to be implemented after the implementation of the new measure?
Although the new measure has come into force on 1 October 2015, the relevant technical documents have not been published. CFDA is revising the documents such as general review rules and detailed rules for food, food additive and dietary supplement, and these regulations will be released in the near future. Before the publication of new regulations, the old versions remain in force. But if some provisions in the old ones disagree with the new measure, provisions in the new measure are prevailed. CIRS food team will continue to focus on the issuance of the related new regulations.