Global Food

Administrative Measures for Accompanied Certificates of Imported Foods (Exposure Draft)

In recent years, the safety risk of imported foods has been slowly stressed with the increasing of imported food. In order to strengthen and standardize the management on safety of imported foods, and ensure the interests of Chinese consumers, the General Administration of Quality Supervision, Inspection and Quarantine released a notification to publish the “Administrative measures for accompanied certificates of imported foods (Exposure draft)” on June 8, 2017, and notify WTO/TBT, which shall come into effect from October 1, 2017. Applied by the competent authorities of the exporting country (region), it may be granted by an appropriate transition period with the consent of the AQSIQ. In order to make countries exporting foods to China respond in a timely manner to reduce the loss, Foodmate.net extracted and organized the following key contents for your reference. The information provided in the accompanied certificates of imported foods includes: 1) Information of manufacture 2) Product information 3) Trading information 4) The foods exported to China are produced, processed, stored, transported and exported under the administration of the competent authorities of the exporting country/region, which are applicable for human consumption. 5) The template of accompanied certificates for imported foods shall be filed at the AQSIQ, and the certificate can be issued either in paper version or electronic version. The contents of the certificate shall be consistent with the information of the certified commodities. The disposal measures for unqualified certificates are as follow: The inspection & quarantine authorities in China will inspect the certificates accompanied with the imported foods. For ones without accompanied certificate or certificates unqualified, the relevant commodities shall not be imported. At the same time AQSIQ may take the following measures: (I) Where it is the authority issuing certificates responsible for the unqualified accompanied certificates, and there are more than 5 unqualified certificates occurred within 12 months, China may suspend to accept the certificate issued by this authority; (II) Where there are more than 10 unqualified accompanied certificates occurred within 12 months and it is confirmed that the competent authority of the exporting country/region shall be responsible for this, AQSIQ may suspend to accept the certificate issued by this exporting country/region, and start the inspection & assessment procedure for the exporting country/region system. It is observed in this exposure draft that AQSIQ not only further standardizes on the examination of the certificate form, but also makes a clear request for compliance content, requiring that the foods exported to China shall be completely suitable for human consumption. At the same time, the stringent requirements are imposed on the authority and country/region issuing certificates in the disposal measures taken for the unqualified certificates. For the manufactures, the exported products may certainly meet the requirements of this country provided they are produced, processed, stored and transported as required by the administration departments. In recent years, China has continuously introduced the administration and controlling measures for the imported food safety laws and regulations. From the imported food importation filing system and accompanying with certificate of conformity system before importation, to the imported food risk monitoring system and the system of publishing the monthly information of unqualified entry product list at the importation, to overseas manufactures and importers credit recording system after importation, and the follow-up supervision system of imported foods, China will gradually strengthen the administration on the imported foods, and further regulate the market of imported foods. In order to reduce the risk of enterprises exporting food to the market in China, Foodmate.net suggests that: 1) Before the exportation of food, take in-depth assessment for the feasibility of the product, including product standards and labeling standards, as well as the limit standards for pollutant and other compliance assessment related to China, and perform monitoring and verification for key projects by monitoring standards of China at the same time, so as to avoid causing serious losses to the enterprise due to failure in entry as a result of different monitoring measures; 2) After entering the market in China, export enterprises need to understand the real-time information related to food in market of China, including food safety incidents, updates of regulatory standards, and monitoring information of unqualified products. Make timely response measures according to the relevant information to minimize the risk of business.

Profound Interpretation and Analysis: Comparison Between Formal Edition and Exposure Draft of “Technical Guidelines on Labeling Normalization for Product Formula Registration of Infants and Young Children Formula Milk Powder (Trial)”

Recently, the formal edition of “Technical guidelines on labeling normalization for product formula registration of infants and young children formula milk powder (trial)” and the interpretation document thereof were finally issued for public reference, the Infant Formula Registration Team from Foodmate Information Service Center thoroughly read and analyzed the newly issued document, and compared it with the previous exposure draft. For enterprises involved, the greatest highlight is that the formal edition has allowed the labeling of product advertisement, enterprise propaganda and relevant certification information, and defined the requirements for relevant claims. Moreover, the interpretation document has defined several specific requirements as well. (I). Formal edition & exposure draft 1. Product name Compared with exposure draft, the basic principle of “Six Prohibitions” is not changed; however, in the formal edition, the examples of “Six Prohibitions” have been completely deleted, which have been included in the interpretation document, with some adjustments. 2. Standard code is not required to be indicated for imported formula milk powder The formal edition has clearly specified as follows: The domestic manufacturer needs to indicate the standard code executed by the enterprise, while the product standard code is not required to be indicated for imported infants and young children formula milk powder. 3. There are small changes on the highlighted display of product name Compared with exposure draft, the formal edition makes a simple and clear requirement on the highlighted display of product name, deletes some requirements on “position of product name, and typeface and color of trade name”, and only makes relevant provisions on the total area of typeface and font size. 4. The contents of product advertisement and enterprise propaganda, etc. are allowed to be indicated The formal edition has deleted the requirement of prohibition on labeling of product advertisement and enterprise propaganda, etc.; which is an undoubted benefit to the enterprises. 5. Claims and certification marks can be optionally marked The exposure draft has no explanation on claims and other marking, while the formal edition makes clear provisions as follows: the conforming function claim, content claim and the related certification marks can be indicated on the label, but may not appear in the principal display panel, to avoid taking this as a selling point and the excessive packaging of products. It shall note that the claim must be displayed in text, not in a graph or a symbol. 6. Relevant requirements on labeling of raw milk and raw milk powder The formal edition clearly specifies that the enterprise shall provide relevant evidentiary materials if the source of raw milk and raw milk powder is required to be indicated, which was not mentioned in the exposure draft. This requirement is mainly specific to imported raw materials. (II). Contents defined in interpretation document 1. There are some changes in the examples of “Six Prohibitions” principle for labeling of product name 2. Conditions for taking the registered trademark as trade name are further defined 3. Requirements on labeling of claims are defined 4. Principal display panel and the contents that can be indicated on the principal display panel are defined 5. Labeling for goat milk powder is defined 6. The requirement that the list of ingredients and nutrition information in the sample of label shall be consistent with that in the application materials and that filled on line is defined. In general, compared with exposure draft, the formal edition is more reasonable and normative. The enterprise can display personalized information, rather than machine-made template; while the consumer can also have more awareness of products or enterprises, which will facilitate p personalized consumption.

Profound Interpretation and Analysis of “Items and Requirements of Application Materials for Product Formula Registration of Infants and Young Children Formula Milk Powder (Trial) (2017 Revision)”

I. Revision background “Items and requirements of application materials for product formula registration of infants and young children formula milk powder (trial)” (Announcement No. 175, 2016 of the China Food and Drug Administration) was published and put into effect on October 29, 2016 (hereinafter referred to as the old edition). After a period of trial operation, it is found that it is hard to be implemented. China Food and Drug Administration released the 2017 Revision (hereinafter referred to as the Revision) on May 25, 2017 after repeated research and demonstration. II. Main changes Highlight interpretation: After carefully studying the “Items and requirements of application materials for product formula registration of infants and young children formula milk powder (trial)” (2017 Revision), Foodmate has found that the Revision is changed as follows compared with the old edition: ① The materials of “stability study and confirmation status of products in various package specifications” is no longer required to submit; ② The “information on tracking assessment of nutrition and safety of product” is no longer required to submit at the first application for registration, which is modified to submit at renewal of formula registration; ③ The process validation report does not have to be submitted for 3 batches, while it must be for commercialized production process; ④ The requirement of “market survey research situation and relevant breast milk research situation, as well as test materials, nutrition guide or monograph, nutrition data materials, other relevant research literatures and historical materials of consumption in the market for a long time” in Material V has been deleted; ⑤ The basic situation of R & D and production personnel as well as their research and development work and achievements is no longer needed to provide; ⑥ The evidentiary materials showing the legal origin of food raw materials and food additives are not needed to submit. The Revision also focuses on adjusting the order of the contents of each part of the application materials, moves the core of the application materials to Material VIII from the original Material V. For example, the content of Material V (1) Formula research and development ③ validation report is adjusted to Material VIII (2) ① Evidentiary materials on R&D ability. As a result of the simplification on the test process and research materials, etc., the previous preparation time for application materials is greatly shortened, and the cost of product test and material translation is reduced. On the whole, this revision is good news for the enterprise, but for the enterprises that have prepared the related materials, this part of cost may become the “silent cost”, which is a little pity.

Interpretation About Chinese “Administrative Measures on Supervision of Inspection & Quarantine of Imported & Exported Dairy Products” and Unqualified Imported Dairy Information Summary from 1st Quarter of 2017

As a leading dairy importing country, China shared about 30% of the total dairy trading quantity globally ( calculated as original milk), the main products including whole milk powder, skimmed milk powder and liquid milk. Besides, Chinese infant formula market is the most important in the world, it almost dominated by foreign brands. On the other hand, there is still a huge consumption potential in Chinese dairy market. Comparing to developed countries, the Chinese average individual dairy consumption is 33kg per year, just half of Australia, 1/3 of global average consumption, and 1/8 of developed countries average consumption. In order to establish a strong domestic dairy industry in China, Chinese government has implemented a series of measures these years from the management of raw milk to final products. While with the development of e-commerce and Chinese consumers always think the imported products standards for high quality, especially for infant formula products. For the purpose of regulating domestic dairy market as well as protect local enterprises, The General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China published the “Administrative Measures on Supervision of Inspection & Quarantine of imported & Exported Dairy Products” on January 24, 2013, which came into effect from May 1, 2013. The Measures defines that it is by the AQSIQ to take charge of the inspection & quarantine of imported & exported dairy products. The Measures specifies that the AQSIQ has implemented the registration system for overseas food manufactures who export dairy products to China, while it shall previously assess the food safety management system and food safety situation in the country or region where it locates. Dairy exporters or agents and related importers need to record to the AQSIQ. The list shall be published on the website of AQSIQ, which is consistent with the requirements of the “Regulations on Registration Administration of overseas manufacturers of imported food” introduced in the last issue. The Measures also stipulates that imported dairy manufactures and importers shall ensure that the imported dairy products conform to the national food safety standards and related requirements of China possessed with Chinese labels and Chinese manuals in accordance with the relevant standards in China, and attached with the sanitary certificate issued by the competent government departments of the exporting country or region. Where it is necessary to handle the formalities for quarantine inspection and approval, it can only be imported after obtaining the “License for Animal and Plant Quarantine imported to the People’s Republic of China”. Overseas dairy production manufactures shall be able to provide the test report of the item specified in national food safety standards of China. importers need to publish the type, place of origin and brand of their imported dairy products. On this basis, inspection and quarantine authorities will implement the inspection for imported dairy products. Where the imported dairy products are tested and quarantined unqualified in respect of safety, health and environmental protection projects, the inspection and quarantine authorities shall order the Parties to destroy or entrust the importers to handle the formalities of returning. Where the other projects are unqualified, they can only be sold or used after being re-inspected qualified by technical processing. In addition, the “Measures” also requires that if there is safety problems occurred in the imported dairy products, importers shall take the initiative to recall and report to the local inspection and quarantine authority. For the dairy products imported at the first time, importers or their agents shall provide the test report of projects listed in the corresponding national food safety standards when performing quarantine inspection to the customs inspection and quarantine authority. No matter whether there are importing records before the implementation of the Measures, a product departed from the outside shall be deemed as the initial importation from the first entry at one port since the implementation of the Measures. According to the data of Query & analysis system regarding the sampling inspection of food independently researched and developed by Foodmate.net, a total of 963 batches of unqualified food products were notified at the first quarter of 2017 in China including 26 batches of unqualified milk and dairy products, of which there were 7 batches of liquid milk (GB 19644-2010 Milk Powder, GB 25190-2010 Sterilized Milk, GB 19645-2010 Pasteurized Milk, GB 25191-2010 Modified Milk), 2 batches of fermented milk(GB19302 National food safety standard fermented milk), 17 batches of cheese (GB5420 National food safety standard Cheese) and other dairy products. 26 batches of unqualified milk and dairy products mainly came from 7 countries and regions, including 7 batches from Italy, 4 batches from Taiwan in China, France, Italy and Netherland separately, 2 batches from the United States, and 1 batch from Lithuania. The main reasons for unconformity are due to exceeding shelf life of 10 batches, accounting for 38.46% of the total unqualified foods; the data problems (e.g. the certificate or qualified supporting documents are not provided as required, or the commodity does not match with the certificates, etc.) of 8 batches, accounting for 30.8% of the total unqualified foods; unqualified microbiology of 5 batches, accounting for 19.23% of the total unqualified foods (including coliforms of 3 batches, and yeast of 2 batches); unconformity on labeling of one batch(GB 28050-2011 National Food Safety Standard General Rules for Nutrition Labeling of Prepackaged Foods ,GB 7718-2011 National Food Safety Standard General Standard for the Labeling of Prepackaged Foods); and illegal use of sorbitol of one batch. This shows that exceeding the shelf life and data problems constitute the main reasons for the unconformity of dairy products imported to China at the first quarter of 2017. Foodmate.net hereby warns the enterprises planning to export dairy products to China, one is to carefully study the requirements for import and export processes and data review of China, to avoid the unnecessary losses due to qualified products but incomplete data; the other is to timely follow-up the changes on the requirements of import process and documents of China, and shorten the import operation process as far as possible. If necessary, the third Party organization can be selected to provide regulation and technical support in this regard to avoid unnecessary losses due to the expiration of the product as a result of too long process.

Administrative Measures on Supervision of Inspection & Quarantine of Imported & Exported Dairy Products

The General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China published the “Administrative Measures on Supervision of Inspection & Quarantine of imported & Exported Dairy Products” on January 24, 2013, which came into effect from May 1, 2013. The Measures defines that it is by the AQSIQ to take charge of the inspection & quarantine of imported & exported dairy products. The Measures specifies that the AQSIQ has implemented the registration system for overseas food manufactures who export dairy products to China, while it shall previously assess the food safety management system and food safety situation in the country or region where it locates. Dairy exporters or agents and related importers need to record to the AQSIQ. The list shall be published on the website of AQSIQ, which is consistent with the requirements of the “Regulations on Registration Administration of overseas manufacturers of imported food” introduced in the last issue. The Measures also stipulates that imported dairy manufactures and importers shall ensure that the imported dairy products conform to the national food safety standards and related requirements of China possessed with Chinese labels and Chinese manuals in accordance with the relevant standards in China, and attached with the sanitary certificate issued by the competent government departments of the exporting country or region. Where it is necessary to handle the formalities for quarantine inspection and approval, it can only be imported after obtaining the “License for Animal and Plant Quarantine imported to the People’s Republic of China”. Overseas dairy production manufactures shall be able to provide the test report of the item specified in national food safety standards of China. importers need to publish the type, place of origin and brand of their imported dairy products. On this basis, inspection and quarantine authorities will implement the inspection for imported dairy products. Where the imported dairy products are tested and quarantined unqualified in respect of safety, health and environmental protection projects, the inspection and quarantine authorities shall order the Parties to destroy or entrust the importers to handle the formalities of returning. Where the other projects are unqualified, they can only be sold or used after being re-inspected qualified by technical processing. In addition, the “Measures” also requires that if there is safety problems occurred in the imported dairy products, importers shall take the initiative to recall and report to the local inspection and quarantine authority. For the dairy products imported at the first time, importers or their agents shall provide the test report of projects listed in the corresponding national food safety standards when performing quarantine inspection to the customs inspection and quarantine authority. No matter whether there are importing records before the implementation of the Measures, a product departed from the outside shall be deemed as the initial importation from the first entry at one port since the implementation of the Measures. According to the data of Query & analysis system regarding the sampling inspection of food independently researched and developed by Foodmate, a total of 963 batches of unqualified food products were notified at the first quarter of 2017 in China including 26 batches of unqualified milk and dairy products, of which there were 7 batches of liquid milk, 2 batches of fermented milk, 17 batches of cheese and other dairy products. 26 batches of unqualified milk and dairy products mainly came from 7 countries and regions, including 7 batches from Italy, 4 batches from Taiwan in China, France, Italy and Netherland separately, 2 batches from the United States, and 1 batch from Lithuania. The main reasons for unconformity are due to exceeding shelf life of 10 batches, accounting for 38.46% of the total unqualified foods; the data problems (e.g. the certificate or qualified supporting documents are not provided as required, or the commodity does not match with the certificates, etc.) of 8 batches, accounting for 30.8% of the total unqualified foods; unqualified microbiology of 5 batches, accounting for 19.23% of the total unqualified foods (including coliforms of 3 batches, and yeast of 2 batches); unconformity on labeling of one batch; and illegal use of sorbitol of one batch. This shows that exceeding the shelf life and data problems constitute the main reasons for the unconformity of dairy products imported to China at the first quarter of 2017. Foodmate hereby warns the enterprises planning to export dairy products to China, one is to carefully study the requirements for import and export processes and data review of China, to avoid the unnecessary losses due to qualified products but incomplete data; the other is to timely follow-up the changes on the requirements of import process and documents of China, and shorten the import operation process as far as possible. If necessary, the third Party organization can be selected to provide regulation and technical support in this regard to avoid unnecessary losses due to the expiration of the product as a result of too long process.

Interpretation on "Administrative Measures for Product Formula Registration of Infants and Young Children Milk Powder"

Background introduction In recent years, infants and young children formula milk powder products has received much concern in China. According to official statistics, there are 103 infants and young children formula milk powder production enterprises in our country with more than 2000 brands in total, and 77 overseas infants and young children formula milk powder production enterprises registered by Certification and Accreditation Administration with more than 300 brands. There are less significant differences among many products. Some OEM factories even produce for different brands with the same formula. In order to standardize the domestic infants and young children formula market, and ensure the safety of infants and young children formula milk powder, the “Administrative Measures for Product Formula Registration of Infants and Young Children Formula Milk Powder” approved by China Food and Drug Administration Affairs Meeting was published on June 6, 2016, and has taken effect form October 1, 2016. The Measures defined that the formula registration shall be uniformly implemented for domestic and overseas infants and young children formula milk powder products. After January 1, 2018, the formula milk powder that hasn’t certified by formula registration is forbidden to sell in China regardless of being from the traditional channels or electric business channels. The process, time period and general contents of formula registration The Measures can be called as the most stringent laws and regulations in the history, which makes strict restrictions on the qualification conditions of applicant, limits the number of formula, and requires that each production enterprise shall has not more than nine product formulas of three recipe series in principle. In order to optimize the production capacity of enterprises and meet the needs of the market, the Measures allows the wholly-owned subsidiary of the same group to use the product formula registered by another wholly-owned subsidiary of the group company. CFDA has set up administrative acceptance authority, food appraisal authority, and audit & inspection authority to separately review the registration materials and on-site conditions. From the submission of information to receive the formula registration certificate, it needs 6 months at least if all goes on well. According to Foodmate.net, more than 50 (domestic enterprises are the most) have submitted the registration application at present, and none of them has received the certificate of registration. The registration materials include 10 items as followed: 1. Application for product formula registration of infants and young children formula milk powder. 2. Supporting documents of applicant subject qualification. 3. The quality and safety standards of raw materials and auxiliary materials. 4. Product formula. 5. R & D report of product formula. 6. Instruction of production process. 7. Product inspection report. 8. Supporting documents of R & D capacity, production capacity, and inspection capacity. 9. Other supporting documents indicating the scientificity and safety of formula. 10. The manuscript of label and instruction as well as the instruction and supporting documents of claim thereof. Business challenges Time Challenge: If it is not completed before January 1, 2018, the market in China may be lost; Registration Challenge: The requirements for registration materials are rigorous, such as nutrition study (sufficient scientificity and safety basis of formula), stability study (overseas companies face greater challenges compared to domestic ones), and different languages ​​(compliance and fluency of translation), etc.. Challenge of understanding on laws and regulations: differences in thinking caused by differences in region, and differences on the understanding of the design, logical structure, and the specific display form of the materials. Challenges of timely accessing to effective information: such as the registration interpretation frequently held in China, the latest policies issued at the official website of government (laws & answers and Q & A, etc.), expert meetings (intelligence of internal expert) and the registration training organized by officials and so on. The status of the market after implementation of the Measures According to the estimation of Foodmate.net, the brand of infants and young children formula milk powder in the Chinese market will be reduced to less than 600 from more than 2300 in the future if it is calculated on the basis of the domestic and overseas production enterprises obtained the production license. Our suggestion As whether the enterprises can continue to operate in China or not will be influenced by the formula registration this time, Foodmate.net suggests that all the work this year shall be focused on the formula registration. On the one hand that the production can only be processed after obtaining the registration; on the other hand that amendment and improvement can be performed by the chance of registration to find the problems existed in the production and operation of enterprises. As the relevant documents of the CFDA have not been fully issued, it is suggested that enterprises shall pay close attention to the current information of the CFDA on the one hand, and seek assistance from the appropriate third-party advisory service agencies on the other hand, reflect the problems arising from the implementation of the registration system and appeals of enterprises through reasonable channels, and influence the formulation of the policy by certain manner in order to take the initiative.

Formula Food for Infants and Young Children in China

After “Sanlu milk powder incident” in 2008, China has strengthened the supervision and administration on food for infants and young children and further refined the supervision and administration and control measures in terms of production, circulation and import, etc.. This article gives a brief overview of the current status of supervision and administration of formula food for infants and young children. According to the “Announcement of China Food and Drug Administration about the transitional period of the registration and administration of product formula of formula milk powder for infants and young children”, the formula milk powder for infants and young children produced in China or exported to China shall obtain the registration certificate of product formula of formula milk powder for infants and young children in accordance with the law, the label and specification of which shall indicate the registration number. The formula registration shall comply with “Administrative measures for the product formula registration of formula milk powder for infants and young children”. According to instructions relating to commodity remark in “List of the Cross-border E-commerce Retail imports” issued on the website of the Ministry of Finance, the enterprises shall obtain the formula registration certificate when importing formula milk powder for infants and young children through cross-border e-commerce retail since January 1, 2018. Domestic manufacturers, after obtaining the formula registration certificate, can start the production only after obtaining the production license according to the “Administrative measures for food production license” and “Detailed rules for review of production license of formula milk powder for infants and young children” (2013 version). Overseas production enterprises can export formula food for infants and young children to China only after, in addition to obtaining the formula registration certificate, obtaining the CNCA registration in accordance with the “Provisions on the administration of registration of overseas enterprises producing imported food”. On May 31, 2013, Premier Li Keqiang chaired the 10th executive meeting of the State Council, which discussed and laid out policies to further strengthen the quality and safety work of formula milk powder for infants and young children. Subsequently, the Ministry of Industry and Information Technology and National Development and Reform Commission, etc., jointly issued the “Work plan for promoting the merging and reorganization of enterprises producing formula milk powder for infants and young children”. In the sales process, China requires that all personnel engaged in production and trade of breast-milk substitutes as infant formula food, etc., shall comply with the “Administrative measures for the sales of breast-milk substitutes”. Furthermore, China initiates a pilot program to sell formula milk powder for infants and young children in drugstores according to the “Notice of China Food and Drug Administration about carrying out pilot program to sell formula milk powder for infants and young children in drugstores”. With regard to standards on formula food for infants and young children, China has formulated product standards as GB 10765-2010 (the revision work thereof has already begun),  etc. and general standards as labeling and marking, food additives, pesticides, pollutants and mycotoxin, etc., including related standards on manufacture practice and test method, etc.. In recent years, in addition to releasing policy measures for the supervision and administration of formula food for infants and young children in terms of production license, formula registration, merging and reorganization and cross-border e-commerce, etc., the State also introduces supervision and administration measures for traceability system, quality control, daily supervision, advertising, labeling and marking, etc., of formula food for infants and young children. With enhanced supervision and administration of formula food for infants and young children in China, enterprise producing formula food for infants and young children, especially foreign food enterprises, will face more compliance risks. Foodmate.net reminds enterprises to pay close attention to the changes of relevant laws and regulations in China to avoid risk. We will release a series of articles to introduce the general situation of regulatory standards and regulations on formula food for infants and young children in China, welcome for your attention.

China Food and Drug Administration Has Printed and Distributed the Provisions Related to the Auxiliary Materials and Processing of Health Food Filing Product

According to the “Administrative measures for registration and filing management of health food”, the State will implement filing management for the health food in which the used raw materials have been included in the “List of raw materials of health food” and the health food that is imported at the first time included the supplemented vitamin, mineral and other nutrients. On May 2, 2017, CFDA has formulated and published the “Auxiliary materials available for health food filing product and application regulations thereof (trial)” and “Main production process of health food filing product (trial)”. The auxiliary materials available for health food filing product and main production process will be modified and supplemented as appropriate depending on the approval of health food registration. “Auxiliary materials available for health food filing product and application regulations thereof (trial)” Auxiliary materials available for health food filing product mainly refer to common food additives and other auxiliary materials in health food. The “Auxiliary materials available for health food filing product and application regulations thereof (trial)” issued this time mainly stipulates the list of available auxiliary materials and application principle thereof as well as application scope, dosage, etc. This Regulation defines the index that the health food manufactures shall conform to in actual production and filing, which also has a standardized significance for the health food exported to China by overseas health food enterprises. “Main production process of health food filing product (trial)” “Main production process of health food filing product (trial)” mainly stipulates the main production process of tablets, hard capsules, soft capsules, oral liquid, granules and other forms of  health food (nutrient supplements) supplementing vitamin, minerals and other nutrients.

China Food and Drug Administration Has Printed and Distributed the Guidelines for the Filing of Health Food

According to the “Administrative Measures for Registration and Filing Management of Health Food”, the State will implement filing management for the health food in which the used raw materials have been included in the “List of raw materials of health food” and the health food that is imported at the first time included the supplemented vitamin, mineral and other nutrients. On May 2, 2017, CFDA has formulated and published the “Guideline for filing of health food (trial)”, and it has taken effect since the date of promulgation. The filing of health food refers to such process that the health food manufactures submit the materials indicating the safety, health functions and quality control of the products to the food and drug administration department for filing, publicity and future reference in accordance with legal procedures, conditions and requirements. This guideline mainly stipulates the application scope, filing subject, filing process and requirements, requirements of filing materials format of health food filing, as well as the requirements of the filing materials for domestic & imported health food. Application Scope This guideline applies to the filing of health food stipulated in the “Administrative measures for registration and filing management of health food”. Filing Subject This guideline provides technical guidance for the filing of health food. Domestic and imported health food enterprises shall strictly follow this Guideline. Filing process 1 Obtain the login ID of filing system 2 Fill and submit the filing information of product 3 Release the filing number, file and make it public. The items for filing materials of domestic health food 1 The registration form for filing of health food, and letter of commitment on legal liability of filing person responsible for the authenticity of the submitted materials 2 The supporting document of subject registration of the filing person 3 The product formula materials 4 The materials of product manufacturing process 5 Materials of evaluation on safety and healthcare function 6 The type, name and standards of packaging materials directly contacting with health food 7 The manuscript of product label and instruction 8 The materials of product technical requirements 9 The all-items inspection report issued by the inspection agency entitled with legal qualification and in conformity with the product technical requirements 10 Related searching materials of product name 11 The other materials indicating the safety and health function of products The items for filing materials of imported health food In addition to the relevant materials submitted as domestic products, the following materials shall also be submitted: 1 The supporting documents for registration of filing person subject 2 The supporting documents certifying that the health food has been put into the market for more than one year 3 The original texts of technical regulations or standards related to the filed health food of producing country (region) or international organizations 4 The actual samples of packaging, label and specification of product sold in the producing country (region) 5 Where the filing affairs are handled by the permanent representative organization to China of the overseas filing person, the scanned copy of “Registration Certificate of the Permanent Representative Organization to China of Foreign Enterprises” shall be submitted 6 The original supporting documents, and power of attorney (agreement), etc. issued by overseas organizations 7 The supporting documents of production and sales, quality management system or GMP, and manufacturing consignment agreement