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Bai Liqiang (Hangzhou Huace Ruiou Technology Co.
, Ltd.
, Hangzhou 310000, Zhejiang)
, Ltd.
, Hangzhou 310000, Zhejiang)
Abstract : According to the newly revised Food Safety Law, health foods should be registered or filed before they can be listed.
In the supervision of new cross-border e-commerce formats, cross-border e-commerce retail imports are temporarily supervised as personal items
.
This means that health food imported through cross-border e-commerce will not need to be registered or filed for the time being, and can directly enter the market
.
This article sorts out the latest requirements for health food registration or filing, the current status of cross-border e-commerce health food imports, and thinking about the registration system under the new form to provide references for further formulating health food registration strategies in the context of cross-border e-commerce
.
In the supervision of new cross-border e-commerce formats, cross-border e-commerce retail imports are temporarily supervised as personal items
.
This means that health food imported through cross-border e-commerce will not need to be registered or filed for the time being, and can directly enter the market
.
This article sorts out the latest requirements for health food registration or filing, the current status of cross-border e-commerce health food imports, and thinking about the registration system under the new form to provide references for further formulating health food registration strategies in the context of cross-border e-commerce
.
Keywords : imported health food, health food registration, cross-border e-commerce, food safety
With the continuous improvement of the living economy in China, the residents' requirements for quality of life and health are not only satisfied with food and clothing, but also shifted to conditioning the body, maintaining health, and preventing sub-health.
This transformation has driven the development of the health food industry
.
In developed countries such as Europe and the United States, the health effects of high-calorie food intake, unbalanced nutritious diets, and highly processed fast food have become social problems [1-4]
.
Health foods, also known as functional foods, refer to foods that claim to have specific health functions or supplement vitamins and minerals.
They are eaten by a specific group of people.
They have the function of regulating the body, not for the purpose of curing diseases, and do not cause any acuteness to the human body.
, Subacute or chronic hazard food[5-6]
.
People in developed countries have a higher awareness of health foods.
For example, about half of adults in the United States are using health foods or dietary supplements[7]
.
According to the newly implemented "Food Safety Law" on October 1, 2015, health care products must be registered or filed before they can be marketed [8]
.
With the development of "Internet +", some overseas health foods are imported into China through cross-border e-commerce in cooperation with e-commerce platforms
.
In the current cross-border e-commerce supervision model, health food imported through cross-border e-commerce does not need to be registered and filed
.
This article sorts out the latest requirements for health food registration or filing, the current status of cross-border e-commerce health food imports, and thinking about the registration system under the new form to provide references for further formulating health food registration strategies in the context of cross-border e-commerce
.
This transformation has driven the development of the health food industry
.
In developed countries such as Europe and the United States, the health effects of high-calorie food intake, unbalanced nutritious diets, and highly processed fast food have become social problems [1-4]
.
Health foods, also known as functional foods, refer to foods that claim to have specific health functions or supplement vitamins and minerals.
They are eaten by a specific group of people.
They have the function of regulating the body, not for the purpose of curing diseases, and do not cause any acuteness to the human body.
, Subacute or chronic hazard food[5-6]
.
People in developed countries have a higher awareness of health foods.
For example, about half of adults in the United States are using health foods or dietary supplements[7]
.
According to the newly implemented "Food Safety Law" on October 1, 2015, health care products must be registered or filed before they can be marketed [8]
.
With the development of "Internet +", some overseas health foods are imported into China through cross-border e-commerce in cooperation with e-commerce platforms
.
In the current cross-border e-commerce supervision model, health food imported through cross-border e-commerce does not need to be registered and filed
.
This article sorts out the latest requirements for health food registration or filing, the current status of cross-border e-commerce health food imports, and thinking about the registration system under the new form to provide references for further formulating health food registration strategies in the context of cross-border e-commerce
.
1.
Current status of health food registration management
Current status of health food registration management
1.
1 Implementation of the dual-track system for registration and filing of health foods According to data from the State Food and Drug Administration, as of now, a total of 15,879 domestic health foods and 752 imported health foods have been registered
.
These include both dietary supplements and functional health foods with certain functions (such as increasing immunity, etc.
)
.
With the passage of time, the shortcomings of the old health food registration system have been exposed.
The procedures are lengthy, the document requirements are numerous, the economic investment of the enterprise is too large, and it is time-consuming and inefficient, which brings a heavy burden to the enterprise
.
In the Food Safety Law passed in 2015, it is clearly stated that the later management of health food will implement a dual-track system of registration and filing
.
1 Implementation of the dual-track system for registration and filing of health foods According to data from the State Food and Drug Administration, as of now, a total of 15,879 domestic health foods and 752 imported health foods have been registered
.
These include both dietary supplements and functional health foods with certain functions (such as increasing immunity, etc.
)
.
With the passage of time, the shortcomings of the old health food registration system have been exposed.
The procedures are lengthy, the document requirements are numerous, the economic investment of the enterprise is too large, and it is time-consuming and inefficient, which brings a heavy burden to the enterprise
.
In the Food Safety Law passed in 2015, it is clearly stated that the later management of health food will implement a dual-track system of registration and filing
.
The “Administrative Measures for the Registration and Filing of Health Foods” promulgated by the State Food and Drug Administration in early 2016 provides detailed regulations on the registration and filing of health foods
.
Up to now, the State Food and Drug Administration has issued 35 health food registration and filing related documents including: the notice of the State Administration on the implementation of the "Health Food Registration and Filing Management Measures", and the State Administration on the issuance of health food registration review and approval work Notice of the detailed rules, the notice of the General Administration on the issuance of the "Regulations on Available Excipients and Their Use of Health Food Filing Products (Trial)", "Main Production Processes of Health Food Filing Products (Trial)", the announcement of the "Health Food Raw Materials Catalog (1)" and " Announcement of the "Catalogue of Health Functions Allowed for Health Food Claims (1)", and the notice of the State Administration of Public Administration on the issuance of guidelines for the filing of health food products (for trial implementation)
.
Currently, etc.
in Guangdong Province, Shanghai, Jiangxi, Hebei Province, has been officially launched health food filing work
.
.
Up to now, the State Food and Drug Administration has issued 35 health food registration and filing related documents including: the notice of the State Administration on the implementation of the "Health Food Registration and Filing Management Measures", and the State Administration on the issuance of health food registration review and approval work Notice of the detailed rules, the notice of the General Administration on the issuance of the "Regulations on Available Excipients and Their Use of Health Food Filing Products (Trial)", "Main Production Processes of Health Food Filing Products (Trial)", the announcement of the "Health Food Raw Materials Catalog (1)" and " Announcement of the "Catalogue of Health Functions Allowed for Health Food Claims (1)", and the notice of the State Administration of Public Administration on the issuance of guidelines for the filing of health food products (for trial implementation)
.
Currently, etc.
in Guangdong Province, Shanghai, Jiangxi, Hebei Province, has been officially launched health food filing work
.
1.
2 Imported health food management requirements According to the “Announcement of the State Administration of Food and Drug Administration on Matters Concerning the Administration of Health Food Records” issued by the State Food and Drug Administration in January 2017, starting from May 1, 2017, the use of health food ingredients will be listed in the “Health Food Raw Materials Catalog (1).
For the production and import of health food using raw materials, domestic manufacturers and overseas manufacturers should file in accordance with the "Administrative Measures for the Registration and Filing of Health Food" and related regulations
.
Domestic production enterprises shall be filed with the local provincial food and drug regulatory authority; overseas manufacturers shall be filed with the Food and Drug Administration
.
This means that at present, the management requirements for imported health food are divided into: filing-for imported health foods that use raw materials listed in the "Health Food Raw Materials Catalog (1)"; registration-other imported health foods
.
2 Imported health food management requirements According to the “Announcement of the State Administration of Food and Drug Administration on Matters Concerning the Administration of Health Food Records” issued by the State Food and Drug Administration in January 2017, starting from May 1, 2017, the use of health food ingredients will be listed in the “Health Food Raw Materials Catalog (1).
For the production and import of health food using raw materials, domestic manufacturers and overseas manufacturers should file in accordance with the "Administrative Measures for the Registration and Filing of Health Food" and related regulations
.
Domestic production enterprises shall be filed with the local provincial food and drug regulatory authority; overseas manufacturers shall be filed with the Food and Drug Administration
.
This means that at present, the management requirements for imported health food are divided into: filing-for imported health foods that use raw materials listed in the "Health Food Raw Materials Catalog (1)"; registration-other imported health foods
.
2.
Imported health food management under the new business form of cross-border e-commerce
Imported health food management under the new business form of cross-border e-commerce
2.
1 The evolution of cross-border e-commerce supervision model Cross-border e-commerce (referred to as cross-border e-commerce) refers to transaction entities belonging to different countries/regions, through the e-commerce network trading platform to complete transactions, online payment and settlement, and goods through cross-border logistics Served international trade activities
.
Cross-border e-commerce is divided into cross-border e-commerce import and export, and here we mainly refer to cross-border e-commerce import
.
Many experts and scholars agree that the rise of imported cross-border e-commerce conforms to the demand of domestic consumers to pursue a higher quality of life
.
In the medium and long term, imported cross-border e-commerce has introduced some high-quality and rich-variety overseas products into the domestic consumer market, which will force domestic production enterprises to transform from the market side, which is a concrete manifestation of typical supply-side structural reforms[9 ]
.
After the General Administration of Customs issued the “Announcement of the General Administration of Customs on the Supervision of Cross-border Trade E-commerce Import and Export Goods and Articles” (Announcement [2014] No.
56) in 2014, all pilot cities adopted customs clearance with reference to shipping
.
The specific approach is: When e-commerce products enter the bonded area, they are deemed to be bonded warehouses and belong to outside customs.
In view of the absence of relevant import procedures, the Inspection and Quarantine Bureau only implements entry quarantine, and provides pre-licensing convenience for e-commerce declarations
.
After an order is traded through the inbound e-commerce platform, when the goods are imported out of the zone, based on their logistics and trade characteristics that are directly delivered to the final consumer by parcel or express, they are regarded as personal personal use items for supervision, and no commodity registration certificate inspection is performed
.
In the new policy on April 8, 2016, it is stipulated that “The State Food and Drug Administration announced the "Health Food Registration and Filing Management Measures", which will be implemented on July 1, 2016.
At that
time, the first imported health food must be To apply for registration with the State Food and Drug Administration, the first imported health food supplemented with vitamins, minerals and other nutrients must be filed with the State Food and Drug Administration
.
Retailers of health food through cross-border e-commerce should also comply with the above regulations
"But because its policies have caused a huge impact on cross-border e-commerce, the two policy adjustments have also extended the implementation buffer period to the end of 2017.
.
On March 17, 2017, the spokesperson of the Ministry of Commerce issued a speech on the overall 36 arrangements for the supervision of cross-border e-commerce retail imports after the transition period, and actively studied the regulatory model adapted to the development characteristics of cross-border e-commerce retail imports.
For the time being, foreign e-commerce retail imported goods shall be supervised in accordance with personal belongings for the time being
.
This regulatory model will be formally implemented on January 1, 2018[10]
.
1 The evolution of cross-border e-commerce supervision model Cross-border e-commerce (referred to as cross-border e-commerce) refers to transaction entities belonging to different countries/regions, through the e-commerce network trading platform to complete transactions, online payment and settlement, and goods through cross-border logistics Served international trade activities
.
Cross-border e-commerce is divided into cross-border e-commerce import and export, and here we mainly refer to cross-border e-commerce import
.
Many experts and scholars agree that the rise of imported cross-border e-commerce conforms to the demand of domestic consumers to pursue a higher quality of life
.
In the medium and long term, imported cross-border e-commerce has introduced some high-quality and rich-variety overseas products into the domestic consumer market, which will force domestic production enterprises to transform from the market side, which is a concrete manifestation of typical supply-side structural reforms[9 ]
.
After the General Administration of Customs issued the “Announcement of the General Administration of Customs on the Supervision of Cross-border Trade E-commerce Import and Export Goods and Articles” (Announcement [2014] No.
56) in 2014, all pilot cities adopted customs clearance with reference to shipping
.
The specific approach is: When e-commerce products enter the bonded area, they are deemed to be bonded warehouses and belong to outside customs.
In view of the absence of relevant import procedures, the Inspection and Quarantine Bureau only implements entry quarantine, and provides pre-licensing convenience for e-commerce declarations
.
After an order is traded through the inbound e-commerce platform, when the goods are imported out of the zone, based on their logistics and trade characteristics that are directly delivered to the final consumer by parcel or express, they are regarded as personal personal use items for supervision, and no commodity registration certificate inspection is performed
.
In the new policy on April 8, 2016, it is stipulated that “The State Food and Drug Administration announced the "Health Food Registration and Filing Management Measures", which will be implemented on July 1, 2016.
At that
time, the first imported health food must be To apply for registration with the State Food and Drug Administration, the first imported health food supplemented with vitamins, minerals and other nutrients must be filed with the State Food and Drug Administration
.
Retailers of health food through cross-border e-commerce should also comply with the above regulations
"But because its policies have caused a huge impact on cross-border e-commerce, the two policy adjustments have also extended the implementation buffer period to the end of 2017.
.
On March 17, 2017, the spokesperson of the Ministry of Commerce issued a speech on the overall 36 arrangements for the supervision of cross-border e-commerce retail imports after the transition period, and actively studied the regulatory model adapted to the development characteristics of cross-border e-commerce retail imports.
For the time being, foreign e-commerce retail imported goods shall be supervised in accordance with personal belongings for the time being
.
This regulatory model will be formally implemented on January 1, 2018[10]
.
2.
2 Supervision of imported health foods in cross-border e-commerce The "Implementation Regulations of the Food Safety Law" (draft), which is being revised, is also trying to incorporate cross-border e-commerce into management
.
Among them, the Food Safety Law Implementation Regulations (Draft) issued by the State Food and Drug Administration stipulates that the import and export of food in the form of cross-border e-commerce shall comply with the Food Safety Law and the relevant provisions of this Regulation on import and export food
.
However, in the subsequent draft published by the Legislative Affairs Office of the State Council, this clause has been deleted
.
According to the current regulatory rules, cross-border e-commerce retail imports are temporarily regulated as personal belongings
.
This means that according to personal personal use items means only quarantine but not inspection, and the risk is borne by consumers personally
.
For health food imports, cross-border e-commerce retail imports are equivalent to individual consumers’ "overseas personal shopping" in a certain sense.
Of course, these health foods do not need to be registered and filed in accordance with the requirements of the Food Safety Law
.
Following Swisse’s announcement of a strategic cooperation with Tmall International, Jianzhibao, a joint venture between By-Health and the world’s largest dietary supplement company NBTY, also announced its brand strategy recently, and through the deployment of Tmall’s brand day and other measures to increase cross-border communications.
Channels
.
According to sources, two-thirds of the joint venture's performance is currently contributed by cross-border e-commerce
.
3.
Thinking about the health food registration system under the new situation.
From the promulgation of the "Health Food Registration and Filing Management Measures" in early 2016 to the release of the health food filing guidelines (for trial implementation) in May 2017, the health food filing work was officially launched.
One and a half years
.
On May 23, 2017, the State Food and Drug Administration issued an article entitled "Simplification of Administration and Delegation of Power to Promote the Filing Management of Health Food", which mentioned that "the three levels of vitamin and mineral raw materials, single raw material formula and homogenized formula Progressively expand the scope of the raw material catalog, promote and liberalize the management of product filing, and gradually form a new regulatory pattern where filing is the majority, and the registration approval is the minority
.
" However, the health food imported through cross-border e-commerce retail is currently under supervision.
Outside
.
It will cause a direct impact on the health food registration and filing system, and it will also make domestic health food and imported health food compete on an unequal position
.
2 Supervision of imported health foods in cross-border e-commerce The "Implementation Regulations of the Food Safety Law" (draft), which is being revised, is also trying to incorporate cross-border e-commerce into management
.
Among them, the Food Safety Law Implementation Regulations (Draft) issued by the State Food and Drug Administration stipulates that the import and export of food in the form of cross-border e-commerce shall comply with the Food Safety Law and the relevant provisions of this Regulation on import and export food
.
However, in the subsequent draft published by the Legislative Affairs Office of the State Council, this clause has been deleted
.
According to the current regulatory rules, cross-border e-commerce retail imports are temporarily regulated as personal belongings
.
This means that according to personal personal use items means only quarantine but not inspection, and the risk is borne by consumers personally
.
For health food imports, cross-border e-commerce retail imports are equivalent to individual consumers’ "overseas personal shopping" in a certain sense.
Of course, these health foods do not need to be registered and filed in accordance with the requirements of the Food Safety Law
.
Following Swisse’s announcement of a strategic cooperation with Tmall International, Jianzhibao, a joint venture between By-Health and the world’s largest dietary supplement company NBTY, also announced its brand strategy recently, and through the deployment of Tmall’s brand day and other measures to increase cross-border communications.
Channels
.
According to sources, two-thirds of the joint venture's performance is currently contributed by cross-border e-commerce
.
3.
Thinking about the health food registration system under the new situation.
From the promulgation of the "Health Food Registration and Filing Management Measures" in early 2016 to the release of the health food filing guidelines (for trial implementation) in May 2017, the health food filing work was officially launched.
One and a half years
.
On May 23, 2017, the State Food and Drug Administration issued an article entitled "Simplification of Administration and Delegation of Power to Promote the Filing Management of Health Food", which mentioned that "the three levels of vitamin and mineral raw materials, single raw material formula and homogenized formula Progressively expand the scope of the raw material catalog, promote and liberalize the management of product filing, and gradually form a new regulatory pattern where filing is the majority, and the registration approval is the minority
.
" However, the health food imported through cross-border e-commerce retail is currently under supervision.
Outside
.
It will cause a direct impact on the health food registration and filing system, and it will also make domestic health food and imported health food compete on an unequal position
.
In this case, it is recommended to do the following:
1) Carry out the classification and classification of health food risks
.
For high-risk health food types, through the communication and coordination of ministries and commissions, they will be included in the negative list of cross-border e-commerce retail imports;
.
For high-risk health food types, through the communication and coordination of ministries and commissions, they will be included in the negative list of cross-border e-commerce retail imports;
2) Actively carry out the work of the record list, and strive to form a new regulatory pattern where the record is the majority and the registration approval is the minority;
3) Carry out supervision and inspection of health food imported from cross-border e-commerce retail to ensure that consumers' legitimate interests are not harmed
.
.
references
[1] PEREZ-CUETO FJ, VERBEKE W, de BARCELLOS MD, et al.
Food-related life>
Food-related life>
[2] EATON SB, EATON SB 3rd, KONNER M J.
An evolutionary perspective enhances understanding of human nutritional requirements[J].
The Journal of Nutrition, 1996, 12(6): 1732-1740.
An evolutionary perspective enhances understanding of human nutritional requirements[J].
The Journal of Nutrition, 1996, 12(6): 1732-1740.
[3] EATON SB, EATON SB 3rd, KONNER M J.
Paleolithic nutritionrevisited: a twelve-year retrospective on its nature and implications[J].
European Journal of Clinical Nutrition, 1997, 51(4): 207-216.
Paleolithic nutritionrevisited: a twelve-year retrospective on its nature and implications[J].
European Journal of Clinical Nutrition, 1997, 51(4): 207-216.
[4] CENCIC A, CHINGWARU W.
The role of functional foods, nutraceuticals, and food supplements in intestinal health[J].
Nutrients,2010, 2(6): 611-625.
DOI:10.
3390/nu2060611.
The role of functional foods, nutraceuticals, and food supplements in intestinal health[J].
Nutrients,2010, 2(6): 611-625.
DOI:10.
3390/nu2060611.
[5] Chen Yunzhong, Xiong Zhenfang.
Discussion on the research and development of Chinese medicine health food [J].
Lishizhen Medicine and Materia Medica, 2014, 25(12): 3002-3003.
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3969/j.
issn.
1008-0805.
2014.
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Discussion on the research and development of Chinese medicine health food [J].
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DOI:10.
3969/j.
issn.
1008-0805.
2014.
12.
079.
[6] LAPARRA JM, SANZ Y.
Interactions of gut microbiota withfunctional food components and nutraceuticals[J].
PharmacologicalResearch, 2010, 61(3): 219-225.
Interactions of gut microbiota withfunctional food components and nutraceuticals[J].
PharmacologicalResearch, 2010, 61(3): 219-225.
[7] BAILEY RL, GAHCHE JJ, LENTINO CV, et al.
Dietary supplementuse in the United States, 2003-2006[J].
Journal of Nutrition, 2011,141(2): 261-266.
DOI:10.
3945/jn.
110.
133025.
Dietary supplementuse in the United States, 2003-2006[J].
Journal of Nutrition, 2011,141(2): 261-266.
DOI:10.
3945/jn.
110.
133025.
[8] State Food and Drug Administration, Food Safety Law of the People's Republic of China (Chairman Order No.
21), April 24, 2015, http:// html
21), April 24, 2015, http:// html
[9] Zhu Zhongkang, Liu Jianfeng.
Strengthening the supervision of imported cross-border e-commerce "delegation of control and service"[J], Guomen Times, 2017, (3).
Strengthening the supervision of imported cross-border e-commerce "delegation of control and service"[J], Guomen Times, 2017, (3).
[10] The Ministry of Commerce of the People’s Republic of China, the spokesperson of the Ministry of Commerce issued a speech on the overall arrangements for the supervision of cross-border e-commerce retail imports after the transition period, 2017-03-17, http:// ae/ag/201703/20170302536140.
shtml Bai Liqiang, male, certified project manager (PMP), toxicologist, has long been engaged in product safety assessment research
.
Email: 18657188961@126.
com
shtml Bai Liqiang, male, certified project manager (PMP), toxicologist, has long been engaged in product safety assessment research
.
Email: 18657188961@126.
com