The newly revised food safety law clearly stipulates strict supervision and management of special foods。In order to implement the requirements of the law on the supervision of the health food market access，Standardize the management of unified health food registration and filing，The General Administration is soliciting and widely listening to food production and operation enterprises、Local Food and Drug Supervision Department、Relevant experts and industry organizations and other aspects of opinions，After many discussions，Formed the "Administrative Measures for Health Food Registration and Records" (hereinafter referred to as the "Measures"。Measures will be implemented on July 1, 2016。Now the relevant issues are interpreted as follows:

I. What is the legislative basis for "Measures"?

According to Article 74 of the Food Safety Law of the People's Republic of China、75 items、76 items、77 items、78 items、82 and other related regulations，Develop "Measures"。

2. What are the scope and basic principles of the "Measures"?

"Measures" stipulate，The registration and supervision and management of health foods in the People's Republic of China and the application of their supervision and management。The registration and filing of health food should follow science、Public、Justice、Convenience、Efficient principle。

3, what is the meaning of health food registration in the Measures?

"Measures" stipulate，Registration of health food，refers to the application of the food and drug supervision and management department to apply according to the registered applicant，According to legal procedures、Conditions and requirements，Safety of health foods applying for registration、health care functions and quality controllability related application materials for system evaluation and review，and decide whether to grant the approval process for its registration。

4. What is the meaning of health food filing in the Measures?

Health food filing，refers to health food production enterprises in accordance with legal procedures、Conditions and requirements，It will indicate product safety、Materials of health control functions and quality controllable materials Submit the food and drug supervision and management stake online sports bettingdepartment for archive、Public、Preparation process。

5、How does the "Measures" stipulate for the acceptance department of health food registration?

State Food and Drug Administration Administrative acceptance agency (hereinafter referred to as the acceptance agency) is responsible for accepting health food registration。

6、How does the "Measures" stipulate for the receiving department of health food filing materials?

The administrative acceptance agency of the State Food and Drug Administration is responsible for receiving relevant import health food filing materials。

Provincial、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government is responsible for receiving relevant health food filing materials。

7、How to divide the duties of the food and drug supervision and management departments at all levels?

"Measures" stipulate，State Food and Drug Administration is responsible for health food registration management，and the stake online sports bettingfirst imported belonging to supplementary vitamins、health food filing management of nutrients such as minerals，and guide the supervision of the province、Autonomous Region、The health food registration and filing related work undertaken by the food and drug supervision and management department of the municipality directly under the Central Government。

Provincial、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government is responsible for the management of health food filing management，and cooperate with the State Food and Drug Administration to carry out the work of health food registration site inspection and other work。

City、County -level food and drug supervision and management department is responsible for registering and filing health food supervision and management in the administrative area，Other tasks entrusted by the superior food and drug supervision and management department。

eight、"Measures" to the applicant or the recorder、How is the main responsibilities of the review agency and administrative department divided?

The authenticity of the applicant or the recorder for the application materials、Integration、Beevigue can be responsible，The safety of the product、Effectiveness and quality controllability is responsible。

The review agency is responsible for organizing review experts to review the application materials，And organize inspection agencies to conduct on -site inspections according to actual needs，Organizational inspection agencies carry out review and inspection，Complete the technical review work within 60 days，Submit a comprehensive review conclusion and suggestion to the General Administration。

The administrative department is responsible for the registration and filing management of health food。

Nine、"Measures" What are the important adjustments of health food registration and filing supervision?

Compared with the previous registration management system，"Measures" according to the New Food Safety Law，Classification management system that combines registration and filing of health food。

For health foods outside the raw material of the raw material of health food and the first imported health food, register management。

The raw materials used have been included in the health food raw material catalog and the stake online sports bettingfirst imported belonging to supplementary vitamins、Health food for nutrients such as minerals and other nutrients implements filing management。The first import of imports belongs to supplementary vitamins、health foods of nutrients such as minerals，Its nutrients should be a substance listed in the health food raw material directory。

The health care function claimed by the product should be included in the health food function directory。Health food raw material catalog and the health function directory that allows health foods to be claimed by the health food shall be in conjunction with the State Council's health administrative department、Formation of the National Traditional Chinese Medicine Management Department、Adjustment and announcement，Related supporting management measures will be formulated separately。

10、What are the important adjustments to the registration procedure of health food?

"Measures" stipulate，The application for health food registration shall be undertaken by the General Administration's acceptance agency。Starting point with acceptance as a registration approval，Adjust the production site inspection and review inspection to the technical review link，and the content of the review、review procedures、The overall time limit and the basis for judgment are proposed to propose specific strict limits and requirements。

Technical review is checked by application materials、On -site inspection、Dynamic sampling、Review inspection and other procedures for development，No part of any link does not meet the requirements，The review agency can terminate the review，Makes not to be registered for registration。

eleven、How to adjust the requirements for health food technology review supplementary materials?

The review agency believes that it is necessary to register the applicant to make up the material，Should be notified all the content that needs to be corrected。Registered applicants shall provide supplementary materials in accordance with the requirements of the replenishment notice within 3 months。Registered applicants have not submitted supplementary materials or unable to correct，Not enough to prove product safety、Health care function and quality controllability，The review agency shall terminate the review，Make suggestions that are not registered。

Twelve、What are the adjustments to the transfer process of health food technology?

The transfer technology of health food registrar，The transferee shall re -submit the product registration application under the guidance of the transferor。Product technical requirements, etc. should be consistent with the original application materials。The review agency simplifies the review procedure in accordance with relevant regulations。

Thirteen、What are the key content of health food filing management stipulated in the "Measures"?

After receiving the filing materials for the food and drug supervision and management department,，The filing material meets the requirements，File stake betting appon the spot;，It should be notified of the recorder to make correction related materials。

The food and drug supervision and management department shall complete the archive and inspection of the filing information，Release preparation number。

Health food for filing，The food and drug supervision and management department shall make the filing voucher in accordance with the format of the relevant requirements，and the information boarded in the filing information table will be announced on its website。

The registered health food raw materials have been included in the health food raw material catalog，and meet the relevant technical requirements，Health food registrar application to change registration，or expired application to continue registration，It should be handled in accordance with the filing process。

14、What are the main requirements for registered applicants stipulated in the Measures?

Applicants for domestic health food registration should be legal persons or other organizations registered in China; imported health food registration applicants should be overseas manufacturers of health care foods。Apply for import health food registration，It should be handled by its permanent representative agency in China or entrusted to the agency in China。

Certificate of Health Food Registration and the contents of its attachments，It should be changed by health food registrar。Change of the registered person's name，It should be changed from the changing applicants for the change。

Health food registration certificate Validity period expires for the expiration，It should be a health food that has been produced and sold，Also provides the analysis report of the people's consumption and the operation of the operation of the production quality management system。

fifteen、What are the main requirements for the recorder's qualifications?

The recorder of domestic health food should be a health food manufacturer，Original registrar can be used as the recorder; the recorder of imported health foods，It should be a list of overseas manufacturers of health food food。

16. What are the key supporting work implemented by the Measures?

According to the newly revised "Food Safety Law"，Health food raw material directory and the health function directory that allows health foods is a necessary condition and prerequisite for implementation of health food registration and filing management。Current，The General Administration is in conjunction with the health administrative department of the State Council、State Traditional Chinese Medicine Management Department formulates relevant management measures and supporting directory，Strive to introduce early。

Seventeen、What measures will the existing health food registration applications and approval registered products be taken after the implementation of the "Measures"?

After the implementation of the Measures，Our bureau will carry out review work in accordance with new regulations。For the currently approved registered health food，Take installment in batches、Compliance according to law、The principle of steady progress to carry out the work of cleaning up the certificate。By cleaning up the certificate，stake sports betting appMake consistent review standards for new and old products。Cleaning the certificate replacement plan separately。

18、How to implement the regulations on the naming of health food in the "Measures"?

"Measures" made clear stipulation on the naming of health food，These regulations are soliciting companies in extensive、Industry Organization、Based on the opinions of the grass -roots regulatory authorities and experts，and had publicly solicited opinions on the website of the State Council in August 2015。On August 25, 2015, the General Administration released the "Announcement on Further Regulating the Name of Health Food"，It is clear that the General Administration will no longer be approved for health foods named after the text -related text -related text，And required the relevant product that has been approved to change the product name in accordance with relevant regulations。Considering the market awareness of the name of the health food name for the market，The General Administration recently issued the "Announcement on the Name of Health Food Name"，To a certain transition period for production companies，Allowing the name of the new product name is allowed to marked the original product name。Current，The General Administration is further studying the problem of health food naming，By formulating health food naming guidelines and review rules，Standardize the supervision of health food naming and technical review。