中國保健食品登記法規問題集

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HLF-TW-10

請問中國對於保健食品的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

What are the categories of health food in China? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of health food? Website?

Evershine RD：

在中國，保健食品是聲稱並具有特定保健功能或者以補充維生素、礦物質為目的的食品。
即適用於特定人群食用，具有調節機體功能，不以治療疾病為目的，並且對人體不產生任何急性、亞急性或慢性危害的食品。

國家食品藥品監督管理局(NMPA)主管全國保健食品註冊管理工作，負責對保健食品的審批。
省、自治區、直轄市（食品）藥品監督管理部門受國家食品藥品監督管理局委託，負責對國產保健食品註冊申請資料的受理和形式審查，對申請註冊的保健食品試驗和樣品製造的現場進行核查、對樣品檢驗。
國家食品藥品監督管理局認可的檢驗機構負責註冊保健食品的安全性毒理學試驗、功能學試驗（包括動物試驗和/或人體試驗）、功效成分或標誌性成分檢測、衛生學試驗、穩定性試驗等，承擔樣品檢驗和複核檢驗等工作。

In China, health food is a food that claims to have specific health functions or is for the purpose of supplementing vitamins and minerals. That is, food that is suitable for consumption by specific groups of people, has the function of regulating body functions, is not for the purpose of treating diseases, and does not produce any acute, subacute or chronic harm to the human body.

The State Food and Drug Administration (NMPA) is in charge of the national health food registration and management, and is responsible for the approval of health food. The provincial, autonomous region and municipality (food) drug administrations are entrusted by the State Food and Drug Administration to be responsible for the acceptance and formal examination of the registration application materials of domestic health food, and the on-site inspection of the application for registration of health food testing and sample manufacture, Check the samples.
The inspection agency recognized by the State Food and Drug Administration is responsible for the safety toxicology test, functional test (including animal test and/or human test), functional component or iconic component test, hygiene test, stability test of registered health food Experiments, etc., undertake sample inspection and review inspection and other work.

【參考連結】

https://sppt.cfsa.net.cn:8086/db?type=2&guid=C9648171-BCB6-49B3-8287-1C7D6CE94391

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

HLF-TW-20

外國公司要到中國銷售保健食品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

If a foreign company wants to sell health food in China, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

需要。於中國銷售保健食品須以當地企業名義向縣級以上地方食品藥品監督管理部門申請食品經營許可證，經批准後使得銷售。

食品經營許可證

1.申請條件

．具有與經營的食品品種、數量相適應的食品原料處理和食品加工、銷售、儲存等場所，保持該場所環境整潔，並與有毒、有害場所以及其他污染源保持規定的距離。

．具有與經營的食品品種、數量相適應的經營設備或者設施，有相應的消毒、更衣、盥洗、採光、照明、通風、防腐、防塵、防蠅、防鼠、防蟲、洗滌以及處理廢水、存放垃圾和廢棄物的設備或者設施。

．有專職或兼職的食品安全管理人員和保證食品安全的規章制度。

．具有合理的設備佈局和工藝流程，防止待加工食品與直接入口食品、原料與成品交叉污染，避免食品接觸有毒物、不潔物。

．法律、法規規定的其他條件。

2.申請資料：

．食品經營許可申請書：公司名稱、社會信用代碼（組織機構代碼、身份證號碼）、營業執照(主體、類型)、住所、經營場所、是否外設倉庫、法定代表人(負責人)、電話、手機、食品安全管理人員、使用面積或食品經營區域面積、主體業態及經營形式、經營項目、是否連鎖經營(總部聯繫人、電話、E-mail、地址)等。

．營業執照或者其他主體資格證明文件複本。

．與食品經營相適應的主要設備設施佈局、操作流程等文件。

．食品安全自查、從業人員健康管理、進貨查驗記錄、食品安全事故處置等保證食品安全的規章制度。

．利用自動售貨設備從事食品銷售的，申請人應提交自動售貨設備的產品合格證明、具體放置地點，經營者名稱、住所、聯繫方式、食品經營許可證的公示方法等材料。

．申請人委託他人辦理食品經營許可申請的，代理人應提交授權委託書以及代理人的身份證明文件。

3.申請機構：縣級以上地方食品藥品監督管理部門。

http://www.gov.cn/fuwu/bm/yjj/index.htm

4.食品經營許可證：

．有效期：5年。

．食品經營者需要延續依法取得的食品經營許可的有效期的，應在該食品經營許可有效期屆滿30個工作日前，向原發證的食品藥品監督管理部門提出申請。

5.備註

．縣級以上地方食品藥品監督管理部門對申請人提交的許可申請資料進行審查，需要對實質內容進行核實的，應進行現場核查。

．現場核查應由符合要求的核查人員進行，不得少於2人。核查人員需出示有效證件，填寫食品經營許可現場核查表，製作現場核查記錄，經申請人核對無誤後，由核查人員和申請人在核查表和記錄上簽名/蓋章。申請人拒絕簽名或者蓋章的，核查人員應註明情況。

．食品藥品監督管理部門可以委託下級食品藥品監督管理部門，對受理的食品經營許可申請進行現場核查。核查人員應自接受現場核查任務之日起10個工作日內，完成對經營場所的現場核查。

．縣級以上地方食品藥品監督管理部門應自受理申請之日起20個工作日內作出是否准予行政許可的決定。因特殊原因需要延長期限的，經本行政機關負責人批准，可以延長10個工作日，並應將延長期限的理由告知申請人。

．符合條件的，作出准予經營許可的決定，並自作出決定之日起10個工作日內向申請人頒發食品經營許可證；對不符合條件的，應及時作出不予許可的書面決定並說明理由，同時告知申請人依法享有申請行政復議或者提起行政訴訟的權利。

．食品經營許可證分為正本、副本。正本、副本具有同等法律效力。經營者應妥善保管食品經營許可證，不得偽造、塗改、倒賣、出租、出借、轉讓，且應在經營場所的顯著位置懸掛或者擺放食品經營許可證正本。

．國家食品藥品監督管理總局負責制定食品經營許可證正本、副本式樣。省、自治區、直轄市食品藥品監督管理部門負責本行政區域食品經營許可證的印製、發放等管理工作。

．食品經營許可證載明：經營者名稱、社會信用代碼（個體經營者為身份證號碼）、法定代表人（負責人）、住所、經營場所、主體業態、經營項目、許可證編號、有效期、日常監督管理機構、日常監督管理人員、投訴舉報電話、發證機關、簽發人、發證日期和二維碼。編號由JY（“經營”的漢語拼音字母縮寫）和14位阿拉伯數字組成。數字從左至右依次為：1位主體業態代碼、2位省（自治區、直轄市）代碼、2位市（地）代碼、2位縣（區）代碼、6位順序碼、1位校驗碼。

．在經營場所外設置倉庫（包括自有和租賃）的，還應在副本中載明倉庫具體地址。

．日常監督管理人員為負責對食品經營活動進行日常監督管理的工作人員。日常監督管理人員發生變化的，可以通過簽章的方式在許可證上變更。

．縣級以上地方食品藥品監督管理部門應依據法律法規規定的職責，對食品經營者的許可事項進行監督檢查。
日常監督管理人員負責所管轄食品經營者許可事項的監督檢查，必要時，應依法對相關食品倉儲、物流企業進行檢查。

Yes. To sell health food in China, it is necessary to apply for a food business license to the National Food and Drug Administration (NMPA) in the name of a local enterprise, and the sale will be made after approval.

Food business license

Application conditions

．Have food raw material processing, food processing, sales, storage and other places suitable for the variety and quantity of the food to be operated, keep the environment of the place clean and tidy, and maintain a prescribed distance from toxic and harmful places and other pollution sources.

．Have operating equipment or facilities commensurate with the variety and quantity of food to be operated, and have corresponding disinfection, dressing, washing, lighting, lighting, ventilation, anti-corrosion, dust-proof, fly-proof, rodent-proof, insect-proof, washing and wastewater treatment, storage Garbage and waste equipment or facilities.

．There are full-time or part-time food safety managers and rules and regulations to ensure food safety.

．It has a reasonable equipment layout and technological process to prevent cross-contamination of food to be processed and directly imported food, raw materials and finished products, and prevent food from contacting toxic and unclean substances.

．Other conditions prescribed by laws and regulations.

Application information:

．Application form for food business license: Company name, social credit code (organization code, ID number), business license (subject, type), residence, business location, whether there is a peripheral warehouse, legal representative (person in charge), telephone, mobile phone, food safety management Personnel, area of use or food business area, main business format and business form, business projects, whether it is a chain operation (headquarters contact person, telephone, E-mail, address), etc.

．Duplicate of business license or other subject qualification certification documents.

．Documents such as the layout of major equipment and facilities, operation procedures and other documents that are compatible with the food business.

．Food safety self-inspection, employee health management, purchase inspection records, food safety accident handling, etc. to ensure food safety rules and regulations.

．If using automatic vending equipment to sell food, the applicant shall submit the product qualification certificate of the automatic vending equipment, the specific placement location, the operator’s name, address, contact information, and the method of publicizing the food business license.

．If the applicant entrusts another person to apply for a food business license, the agent shall submit the power of attorney and the agent’s identity certificate.

The applicant agency: the local food and drug administration at or above the county level.

http://www.gov.cn/fuwu/bm/yjj/index.htm

Food business license:

．Validity: 5 years.

．If a food business operator needs to extend the validity period of the food business license obtained in accordance with the law, it shall apply to the food and drug supervision and administration department that originally issued the license 30 working days before the expiration of the validity period of the food business license.

Note

．The local food and drug administration at or above the county level shall review the license application materials submitted by the applicant.

．The on-site inspection shall be carried out by qualified inspectors, not less than 2. The inspectors need to present valid certificates, fill in the on-site inspection form for food business licenses, and make on-site inspection records. After the applicant has verified that there is no error, the inspectors and the applicant will sign/stamp the inspection form and records. If the applicant refuses to sign or seal, the inspector shall indicate the circumstances.

．The State Food and Drug Administration is responsible for formulating the original and duplicate formats of the food business license. The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the management of the printing and issuance of food business licenses within their respective administrative regions.

．The food business license shall specify: the name of the operator, social credit code (identity number for self-employed operators), legal representative (person in charge), domicile, business premises, main business format, business items, license number, validity period, daily Supervision and management institutions, daily supervision and management personnel, complaint and reporting hotline, issuing authority, issuer, issuing date and QR code. The serial number consists of JY (the abbreviation of “operating” in Chinese Pinyin) and 14 Arabic numerals. The numbers from left to right are: 1-digit main business code, 2-digit province (autonomous region, municipality) code, 2-digit city (prefecture) code, 2-digit county (district) code, 6-digit sequence code, 1-digit check code .

．If a warehouse (including self-owned and leased) is set up outside the business premises, the specific address of the warehouse shall also be stated in the copy.

．The daily supervision and management personnel are the staff responsible for the daily supervision and management of food business activities. If the day-to-day supervision and management personnel change, they can be changed on the license by means of signature and seal.

．The local food and drug supervision and administration departments at or above the county level shall, in accordance with the responsibilities stipulated by laws and regulations, supervise and inspect the licensing items of food operators.
Routine supervision and management personnel are responsible for the supervision and inspection of the licensing items of food operators under their jurisdiction. When necessary, they shall inspect relevant food storage and logistics enterprises in accordance with the law.

【參考連結】

https://gkml.samr.gov.cn/nsjg/spjys/202011/t20201102_322851.html

http://banshi.beijing.gov.cn/pubtask/task/1/110105000000/26ef0e11-44f0-44bb-ba3a-d2ef627aa637.html?locationCode=110105000000&serverType=1001

HLF-TW-25

假如需要辦理，請問中國有專業服務公司可以協助辦理保健食品公司營業許可證？

Evershine RD：

匯佳

https://interareapsp.com/

啟冠易立財稅

https://www.yiliacc.com/

HLF-TW-30

外國公司要到中國銷售保健食品，可以指派中國公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

If a foreign company wants to sell health food in China, can it assign a China company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

可以。於中國銷售保健食品需以當地企業名義向國家食品藥品監督管理總局(NMPA)申請食品經營許可證，經批准後使得銷售。

食品經營許可證

1.申請條件

．有專職或兼職的食品安全管理人員和保證食品安全的規章制度。

．具有合理的設備佈局和工藝流程，防止待加工食品與直接入口食品、原料與成品交叉污染，避免食品接觸有毒物、不潔物。

．法律、法規規定的其他條件。

2.申請資料：

．營業執照或者其他主體資格證明文件複本。

．與食品經營相適應的主要設備設施佈局、操作流程等文件。

．食品安全自查、從業人員健康管理、進貨查驗記錄、食品安全事故處置等保證食品安全的規章制度。

．申請人委託他人辦理食品經營許可申請的，代理人應提交授權委託書以及代理人的身份證明文件。

3.申請機構：縣級以上地方食品藥品監督管理部門。

http://www.gov.cn/fuwu/bm/yjj/index.htm

4.食品經營許可證：

．有效期：5年。

5.備註

．縣級以上地方食品藥品監督管理部門對申請人提交的許可申請資料進行審查，需要對實質內容進行核實的，應進行現場核查。

．食品藥品監督管理部門可以委託下級食品藥品監督管理部門，對受理的食品經營許可申請進行現場核查。
核查人員應自接受現場核查任務之日起10個工作日內，完成對經營場所的現場核查。

．在經營場所外設置倉庫（包括自有和租賃）的，還應在副本中載明倉庫具體地址。

．日常監督管理人員為負責對食品經營活動進行日常監督管理的工作人員。日常監督管理人員發生變化的，可以通過簽章的方式在許可證上變更。

產品責任

1.保健食品屬於特殊食品，遵循食品召回管理辦法，食品生産經營者應依法承擔食品安全第一責任人的義務，建立健全相關管理制度，收集、分析食品安全信息，依法履行不安全食品的停止生産經營、召回和處置義務。

2.國家食品藥品監督管理總局負責指導全國不安全食品停止生産經營、召回和處置的監督管理工作。縣級以上地方食品藥品監督管理部門負責本行政區域的不安全食品停止生産經營、召回和處置的監督管理工作。

3.縣級以上食品藥品監督管理部門組織建立由醫學、毒理、化學、食品、法律等相關領域專家組成的食品安全專家庫，為不安全食品的停止生産經營、召回和處置提供專業支持。

4.國家食品藥品監督管理總局負責匯總分析全國不安全食品的停止生産經營、召回和處置信息，根據食品安全風險因素，完善食品安全監督管理措施。

縣級以上地方食品藥品監督管理部門負責收集、分析和處理本行政區域不安全食品的停止生産經營、召回和處置信息，監督食品生産經營者落實主體責任。
食品生産經營者發現其生産經營的食品屬於不安全食品的，應立即停止生産經營，採取通知或者公告的方式告知相關食品生産經營者停止生産經營、消費者停止食用，並採取必要的措施防控食品安全風險。
食品集中交易市場的開辦者、食品經營櫃臺的出租者、食品展銷會的舉辦者發現食品經營者經營的食品屬於不安全食品的，應及時採取有效措施，確保相關經營者停止經營不安全食品。
網絡食品交易第三方平臺提供者發現網絡食品經營者經營的食品屬於不安全食品的，應依法採取停止網絡交易平臺服務等措施，確保網絡食品經營者停止經營不安全食品。
食品生産經營者生産經營的不安全食品未銷售給消費者，尚處於其他生産經營者控制中的，食品生産經營者應立即追回不安全食品，並採取必要措施消除風險。
食品召回分為三級：

．一級召回：食用後已經或者可能導致嚴重健康損害甚至死亡的，食品生産者應在知悉食品安全風險後24小時內啟動召回，並向縣級以上地方食品藥品監督管理部門報告召回計劃。

．二級召回：食用後已經或者可能導致一般健康損害，食品生産者應在知悉食品安全風險後48小時內啟動召回，並向縣級以上地方食品藥品監督管理部門報告召回計劃。

．三級召回：標簽、標識存在虛假標注的食品，食品生産者應在知悉食品安全風險後72小時內啟動召回，並向縣級以上地方食品藥品監督管理部門報告召回計劃。標簽、標識存在瑕疵，食用後不會造成健康損害的食品，食品生産者應改正，可以自願召回。

食品生産者應按照召回計劃召回不安全食品。包括下列內容：

．食品生産者名稱、住所、法定代表人、具體負責人、聯絡方式等

．食品名稱、商標、規格、生産日期、批次、數量及召回區域範圍

．召回原因及危害後果

．召回等級、流程及時限

．召回通知或者公告的內容及發佈方式

．相關食品生産經營者的義務和責任

．召回食品的處置措施、費用承擔情況

．召回的預期效果

12.期限

．一級：食品生産者應自公告發佈日起10個工作日內完成召回工作。

．二級：食品生産者應自公告發佈日起20個工作日內完成召回工作。

．三級：食品生産者應自公告發佈日起30個工作日內完成召回工作。

食品經營者知悉食品生産者召回不安全食品後，應立即採取停止購進、銷售，封存不安全食品，在經營場所醒目位置張貼生産者發佈的召回公告等措施，配合食品生産者開展召回工作。
食品經營者對因自身原因所導致的不安全食品，應根據法律法規的規定在其經營的範圍內主動召回。
食品經營者召回不安全食品應告知供貨商。供貨商應及時告知生産者。
食品生産經營者應如實記錄停止生産經營、召回和處置不安全食品的名稱、商標、規格、生産日期、批次、數量等內容。記錄保存期限不得少於2年。

Yes. To sell health food in China, it is necessary to apply for a food business license to the Local food and drug supervision and administration departments at or above the county level in the name of a local enterprise, and the sale will be made after approval.

Food business license

Application conditions

．There are full-time or part-time food safety managers and rules and regulations to ensure food safety.

．Other conditions prescribed by laws and regulations.

Application information:

．Duplicate of business license or other subject qualification certification documents.

．Documents such as the layout of major equipment and facilities, operation procedures and other documents that are compatible with the food business.

．Food safety self-inspection, employee health management, purchase inspection records, food safety accident handling, etc. to ensure food safety rules and regulations.

．If the applicant entrusts another person to apply for a food business license, the agent shall submit the power of attorney and the agent’s identity certificate.

The applicant agency: the local food and drug administration at or above the county level.

http://www.gov.cn/fuwu/bm/yjj/index.htm

Food business license:

．Validity: 5 years.

Note

．The local food and drug administration at or above the county level shall review the license application materials submitted by the applicant.

．The on-site inspection shall be carried out by qualified inspectors, not less than 2. The inspectors need to present valid certificates, fill in the on-site inspection form for food business licenses, and make on-site inspection records.
After the applicant has verified that there is no error, the inspectors and the applicant will sign/stamp the inspection form and records. If the applicant refuses to sign or seal, the inspector shall indicate the circumstances.

．If a warehouse (including self-owned and leased) is set up outside the business premises, the specific address of the warehouse shall also be stated in the copy.

．The local food and drug supervision and administration departments at or above the county level shall, in accordance with the responsibilities stipulated by laws and regulations, supervise and inspect the licensing items of food operators. Routine supervision and management personnel are responsible for the supervision and inspection of the licensing items of food operators under their jurisdiction. When necessary, they shall inspect relevant food storage and logistics enterprises in accordance with the law.

Product Liability

Health food is a special food. In accordance with the food recall management measures, food producers and operators should assume the responsibility of the first responsible person for food safety in accordance with the law, establish and improve relevant management systems, collect and analyze food safety information, and comply with the law to stop unsafe food. Production and operation, recall and disposal obligations.
The State Food and Drug Administration is responsible for guiding the supervision and management of the national production and distribution, recall and disposal of unsafe food. The local food and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions.
The food and drug supervision and administration departments at or above the county level organize the establishment of a food safety expert database composed of experts in medicine, toxicology, chemistry, food, law and other related fields to provide professional support for the cessation of production, operation, recall and disposal of unsafe food.
The State Food and Drug Administration is responsible for summarizing and analyzing the information on the cessation of production, operation, recall and disposal of unsafe food across the country, and improving food safety supervision and management measures based on food safety risk factors.
Local food and drug supervision and administration departments at or above the county level are responsible for collecting, analyzing and processing information on the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions, and supervising food producers and operators to implement their main responsibilities.
If a food producer or trader finds that the food it produces and trades is unsafe food, it shall immediately stop the production and trade, and notify the relevant food producer and trader to stop production and trade and consumers to stop eating it by means of a notice or announcement, and take necessary measures. Prevention and control of food safety risks.
If the promoters of the centralized food trading market, the lessors of the food counters, and the organizers of the food fairs find that the food operated by the food operators is unsafe food, they shall take effective measures in a timely manner to ensure that the relevant operators stop operating the unsafe food. food.
If a third-party platform provider for online food trading finds that the food operated by an online food operator is unsafe food, it shall take measures such as stopping the online trading platform service in accordance with the law to ensure that the online food operator stops dealing in unsafe food.
If the unsafe food produced and operated by a food producer and business operator has not been sold to consumers and is still under the control of other producers and business operators, the food producer and business operator shall immediately recover the unsafe food and take necessary measures to eliminate risks.
There are three levels of food recalls:

． Level 1 recall: If the food has caused or may cause serious health damage or even death after consumption, the food producer should initiate the recall within 24 hours after learning of the food safety risk, and report the recall plan to the local food and drug administration at or above the county level.

． Secondary recall: General health damage has been or may be caused after consumption. Food producers should initiate a recall within 48 hours after learning of the food safety risk, and report the recall plan to the local food and drug administration at or above the county level.

． Level 3 recall: Food producers with false labels on labels and labels should initiate a recall within 72 hours of becoming aware of food safety risks, and report the recall plan to the local food and drug administration at or above the county level. Foods with defective labels and labels that will not cause health damage after consumption should be corrected by food producers and may be recalled voluntarily.

Food producers should recall unsafe food in accordance with the recall plan. Include the following:

． Name, address, legal representative, specific person in charge, contact information, etc. of the food producer

． Food name, trademark, specification, date of manufacture, batch, quantity and area of recall

． Recall reasons and harmful consequences

． Recall levels, procedures and deadlines

． The content and release method of the recall notice or announcement

． Obligations and Responsibilities of Relevant Food Producers and Operators

． Disposal measures and expenses of recalled food

． Expected effect of recall

Term

． Level 1: Food producers should complete the recall within 10 working days from the date of the announcement.

． Level 2: Food producers should complete the recall within 20 working days from the date of the announcement.

． Level 3: Food producers should complete the recall within 30 working days from the date of the announcement.

When a food operator learns of the recall of unsafe food by a food manufacturer, it should immediately take measures such as stopping the purchase and sale of unsafe food, sealing up the unsafe food, posting the recall announcement issued by the manufacturer in a conspicuous place in the business premises, and cooperating with the food manufacturer to carry out the recall. Work.
Food operators shall voluntarily recall unsafe food caused by their own reasons within the scope of their operations in accordance with the provisions of laws and regulations. Food operators should notify suppliers of recalls of unsafe food. The supplier shall promptly inform the producer.
Food producers and operators shall truthfully record the names, trademarks, specifications, production dates, batches, quantities, etc. The record keeping period shall not be less than 2 years.

【參考連結】

https://gkml.samr.gov.cn/nsjg/spjys/202011/t20201102_322851.html

http://banshi.beijing.gov.cn/pubtask/task/1/110105000000/26ef0e11-44f0-44bb-ba3a-d2ef627aa637.html?locationCode=110105000000&serverType=1001

http://big5.www.gov.cn/gate/big5/www.gov.cn/gongbao/content/2015/content_2937326.htm

HLF-TW-35

假如需要辦理指派中國公司擔任營業代理人，請問中國有專業服務公司可以協助？

Evershine RD：

中國醫藥保健品有限公司

https://www.mehecointl.com/

艾蘭得健康控股有限公司

http://www.aland.cn/

HLF-TW-40

外國公司銷售到中國保健食品本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

Do foreign companies need to apply for an approval before importing health food sold to China?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? Which languages are allowed? Website?

Evershine RD：

需要，首次進口的保健食品須由常駐中國代表機構或者由委託中國境內的代理機構名義，向國務院食品藥品監督管理部門(NMPA) 辦理註冊，屬於補充維生素、礦物質等營養物質的保健食品須完成備案。

保健食品註冊

1.申請人：上市保健食品的境外生產廠商，應由其常駐中國代表機構或者由其委託中國境內的代理機構辦理。

2.申請網頁：http://bjspzcsp.gsxt.gov.cn:8080/bjspzc/index.jsp

3.申請文件：

．保健食品註冊申請表、法律責任承諾書。

．申請人主體登記證明文件複本。

．產品研發報告(包括研發人、研發時間、研製過程、中試規模以上的驗證數據，目錄外原料及產品安全性、保健功能、質量可控性的論證報告和相關科學依據，以及根據研發結果綜合確定的產品技術要求等。)

．產品配方材料(包括原料和輔料的名稱及用量、生產工藝、質量標準，必要時還應按照規定提供原料使用依據、使用部位的說明、檢驗合格證明、品種鑑定報告等。)

．產品生產工藝材料(包括生產工藝流程簡圖及說明、關鍵工藝控制點及說明。)

．安全性和保健功能評價材料(包括目錄外原料及產品的安全性、保健功能試驗評價材料，人群食用評價材料；功效成分或者標誌性成分、衛生學、穩定性、菌種鑑定、菌種毒力等試驗報告，以及涉及興奮劑、違禁藥物成分等檢測報告。)

．直接接觸保健食品的包裝材料種類、名稱、相關標準等。

．產品標籤、說明書樣稿；產品名稱中的通用名與註冊的藥品名稱不重名的檢索材料。

．3個最小銷售包裝樣品。

．其他與產品註冊審評相關的文件。

．產品生產國（地區）政府主管部門或者法律服務機構出具的註冊申請人為上市保健食品境外生產廠商的資質證明文件。

．產品生產國（地區）政府主管部門或者法律服務機構出具的保健食品上市銷售一年以上的證明文件，或者產品境外銷售以及人群食用情況的安全性報告。

．產品生產國（地區）或者國際組織與保健食品相關的技術法規或者標準。

．產品在生產國（地區）上市的包裝、標籤、說明書實樣

．由境外註冊申請人常駐中國代表機構辦理註冊事務，應提交外國企業常駐中國代表機構登記證及其複本。
境外註冊申請人委託境內的代理機構辦理註冊事項，應提交經過公證的委託書原件以及受委託的代理機構營業執照複本。

4.備註

．產品聲稱的保健功能應已經列入保健食品功能目錄。

．首次進口的保健食品，是指非同一國家、同一企業、同一配方申請中國境內上市銷售的保健食品。

．受理機構在受理後3個工作日內將申請資料送交審評機構，由審評專家審查，根據需要組織查驗機構開展現場核查，組織檢驗機構開展複核檢驗，在60個工作日內完成審評，提出結論和建議。

．審評機構對申請資料中內容進行審評，並根據科學依據的充足程度明確產品保健功能聲稱的限定用語。

．審評機構認為需要註冊申請人補正材料的，註冊申請人應在3個月內按照補正通知的要求一次提供補充材料；審評機構收到補充材料後，審評時間重新計算。

．註冊申請人逾期未提交補充材料或者未完成補正，不足以證明產品安全性、保健功能和質量可控性的，審評機構應終止審評，提出不予註冊的建議。

．審評機構認為需要開展現場核查的，將及時通知查驗機構按照申請材料中的產品研發報告、配方、生產工藝等技術要求進行現場核查，並對下線產品封樣送複核檢驗機構檢驗。查驗機構應自接到通知之日起30個工作日內完成現場核查，並將核查報告送交審評機構。

．首次進口的保健食品境外現場核查和復核檢驗時限，根據境外生產廠商的實際情況確定。

．現場核查、複核檢驗、複審所需時間不計算在審評和註冊決定的期限內。

．保健食品註冊人轉讓技術的，受讓方應在轉讓方的指導下重新提出產品註冊申請，產品技術要求等應與原申請材料一致。受讓方除提交本辦法規定的註冊申請材料外，還應提交經公證的轉讓合約。

．保健食品註冊證書及其附件所載明內容變更的，應由保健食品註冊人申請變更並提交書面變更的理由和依據。

．已經生產銷售的保健食品註冊證書有效期屆滿需要延續的，保健食品註冊人應在有效期屆滿6個月前申請延續。

．獲得註冊的保健食品原料已經列入保健食品原料目錄，並符合相關技術要求，保健食品註冊人申請變更註冊，或者期滿申請延續註冊的，應按照備案程序辦理。

保健食品備案

1.申請人：上市保健食品的境外生產廠商，應由其常駐中國代表機構或者由其委託中國境內的代理機構辦理。

2.申請網頁：http://xbjspba.gsxt.gov.cn/record_pt/index.jsp

3.申請文件：

．產品生產工藝材料(包括生產工藝流程簡圖及說明，關鍵工藝控制點及說明。)

．直接接觸保健食品的包裝材料種類、名稱、相關標準等。

．產品標籤、說明書樣稿；產品名稱中的通用名與註冊的藥品名稱不重名的檢索材料。

．保健食品備案登記表、以及備案人對提交材料真實性負責的法律責任承諾書。

．備案人主體登記證明文件複本。

．產品技術要求材料。

．有合法資質的檢驗機構出具的符合產品技術要求全項目檢驗報告

．其他表明產品安全性和保健功能的材料。

．產品生產國（地區）政府主管部門或者法律服務機構出具的註冊申請人為上市保健食品境外生產廠商的資質證明文件。

．產品生產國（地區）或者國際組織與保健食品相關的技術法規或者標準。

．產品在生產國（地區）上市的包裝、標籤、說明書實樣。

．由境外註冊申請人常駐中國代表機構辦理註冊事務的，應提交外國企業常駐中國代表機構登記證及其複本；境外註冊申請人委託境內的代理機構辦理註冊事項的，應提交經過公證的委託書原件以及受委託的代理機構營業執照複本。

4.備註

．備案的產品配方、原輔料名稱及用量、功效、生產工藝等應符合法律、法規、規章、強制性標準以及保健食品原料目錄技術要求的規定。

．市場監督管理部門完成備案信息的存檔備查工作，並發放備案號。對備案的保健食品，市場監督管理部門製作備案憑證，並將備案信息表中登載的信息在其網站上公佈。進口保健食品備案號格式為：食健備J+4位年代號+00+6位順序編號。

．已經備案的保健食品，需要變更備案材料的，備案人應向原備案機關提交變更說明及相關證明文件。
備案材料符合要求的，市場監督管理部門應將變更情況登載於變更信息中，將備案材料存檔備查。

．保健食品備案信息應包括產品名稱、備案人名稱和地址、備案登記號、登記日期以及產品標籤、說明書和技術要求。

標籤、說明書

各項內容應規範、完整，符合現行法規、技術規範、強制性標準等的規定，與產品安全性、保健功能研發報告相關內容相符，涉及產品技術要求的內容應與產品技術要求或相符。包括以下內容：

1.原料：按配方材料列出全部原料。各原料順序按其在產品中的用量，由大到小排列。經輻照的原料，應在原料名稱後標註（經輻照）。

輔料：按配方材料列出全部輔料。各輔料順序按其在產品中的用量，由大到小排列。經輻照的輔料，應在輔料名稱後標註（經輻照）。
功效成分或標誌性成分含量：應包括成分名稱及含量。應與產品技術要求中功效成分或標誌性成分指標名稱一致，以產品技術要求中指標最低值為標籤說明書標示值。
適宜人群：應為與安全性、保健功能等科學依據相符的食用安全、有明確功能需求、適合本產品的特定人群。
不適宜人群：應為適宜人群範圍中應除外的特定人群、現有科學依據不足以支持該產品適宜的嬰幼兒、孕婦、乳母等特殊人群，以及現行規定明確應標註的特定人群。暫無法確定不適宜人群的，應明確註明「限於目前科學研究水平，該產品暫未發現明確的不適宜人群，將根據收集到的食用安全信息，予以完善補充」。
保健功能：應經研發綜合確定，符合保健功能聲稱管理的相關要求。
食用量及食用方法：應與產品配方配伍及用量的科學依據、安全性和保健功能試驗評價材料等相符。
規格：應為最小製劑單元的重量或者體積（不包括包裝材料；膠囊劑指內容物；糖衣片或丸指包糖衣前的片芯或者丸芯），應與產品食用量及食用方法相匹配。酒類產品應註明酒精度。
儲藏方法：應根據產品特性、穩定性試驗等綜合確定。儲藏方法為冷藏等特殊條件的，應列出具體儲藏條件。
保質期：應經研發綜合確定，以ＸＸ月表示，不足月的以ＸＸ天表示。
注意事項：應註明本品不能代替藥物。適宜人群外的人群不推薦食用本產品。必要時還應根據法規規定、研發情況、科學共識以及產品特性增加相應注意事項。

12.注意

．標籤主要內容應與註冊申請材料中標籤說明書內容一致，應標註樣品的生產日期、生產單位。

．保健食品註冊時須提供樣本，具備完整標籤、說明，樣品包裝應完整、無破損且距保質期屆滿不少於3個月。

Yes, the health food imported for the first time must be registered with the Local food and drug supervision and administration departments at or above the county level of the State Council in the name of the representative office in China or the agency entrusted in China. The health food that is supplemented with nutrients such as vitamins and minerals must complete for the record.

Health food registration

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative offices in China or by their entrusted agencies in China.
URL: http://bjspzcsp.gsxt.gov.cn:8080/bjspzc/index.jsp
Documents:

．Health food registration application form and legal responsibility commitment letter.

．A copy of the applicant’s main body registration certificate.

．Product R&D report (including R&D personnel, R&D time, R&D process, verification data above the pilot scale, demonstration report and related scientific basis for the safety, health-care function, and quality controllability of raw materials and products outside the catalogue, and a comprehensive report based on the R&D results Determined product technical requirements, etc.)

．Product formula materials (including the name and dosage of raw materials and auxiliary materials, production process, quality standards, and if necessary, the basis for the use of raw materials, the description of the parts to be used, the inspection certificate, the variety identification report, etc. should be provided in accordance with regulations.)

．Product production process materials (including the production process flow diagram and description, key process control points and descriptions.)

．Safety and health function evaluation materials (including the safety and health function test evaluation materials of raw materials and products not included in the catalogue, and human consumption evaluation materials; functional components or iconic components, hygiene, stability, strain identification, strain virulence and other test reports, as well as test reports involving doping, prohibited drug ingredients, etc.)

．Types, names, and relevant standards of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．3 minimum sales packaging samples.

．Other documents related to product registration review.

．The qualification certificate issued by the competent government department or legal service agency of the country (region) where the product is produced is the qualification certificate that the applicant for the registration is an overseas manufacturer of listed health food.

．The technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

．If the registration affairs are handled by the resident representative office of the overseas registration applicant in China, the registration certificate of the resident representative office of the foreign enterprise in China and its duplicate should be submitted; if the overseas registration applicant entrusts a domestic agency to handle the registration matters, the original notarized power of attorney should be submitted. and a duplicate of the business license of the entrusted agency.

Note

．The health function claimed by the product should have been listed in the function catalog of health food.

．The health food imported for the first time refers to the health food that is not from the same country, the same enterprise, and the same formula applied for marketing in China.

．The accepting agency will send the application materials to the review agency within 3 working days after the acceptance, and the review experts will review it, organize the inspection agency to carry out on-site inspection as needed, and organize the inspection agency to carry out review inspection, and complete the review within 60 working days , make conclusions and recommendations.

．The review agency will review the content of the application materials, and clarify the qualified terms of the product health function claim according to the sufficiency of scientific basis.

．If the review institution believes that the registration applicant needs to supplement and correct the materials, the registration applicant shall provide supplementary materials once within 3 months according to the requirements of the supplement and correction notice; after the review institution receives the supplementary materials, the review time shall be recalculated.

．If the registration applicant fails to submit supplementary materials or complete supplements and corrections within the time limit, which is insufficient to prove the product safety, health-care function and quality controllability, the review agency shall terminate the review and make a recommendation for not registration.

．If the review agency thinks it is necessary to carry out on-site inspection, it will promptly notify the inspection agency to conduct on-site inspection in accordance with the technical requirements of the product R&D report, formula, production process and other technical requirements in the application materials, and send the sealed samples of offline products to the review inspection agency for inspection. The inspection agency shall complete the on-site inspection within 30 working days from the date of receipt of the notification, and send the inspection report to the review agency.

．The time limit for overseas on-site inspection and re-inspection of health food imported for the first time shall be determined according to the actual situation of overseas manufacturers.

．The time required for on-site inspection, review inspection, and review is not included in the time limit for review and registration decisions.

．If the health food registrant transfers technology, the transferee shall re-apply for product registration under the guidance of the transferor, and the technical requirements of the product shall be consistent with the original application materials. The transferee shall submit the notarized transfer contract in addition to the registration application materials stipulated in these Measures.

．If the contents stated in the health food registration certificate and its attachments are changed, the health food registrant shall apply for the change and submit the reasons and basis for the change in writing.

．If the health food registration certificate that has been produced and sold expires and needs to be renewed, the health food registrant should apply for renewal 6 months before the expiration of the validity period.

．The registered health food raw materials have been included in the health food raw material catalog and meet the relevant technical requirements. If the health food registrant applies for a change of registration, or applies for a renewal of registration after the expiration of the period, it should follow the recordation procedure.

Record

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative office in China or an agency within China entrusted by them.
URL:http://xbjspba.gsxt.gov.cn/record_pt/index.jsp
Documents:

．Product production process materials (including production process flow diagram and description, key process control points and description.)

．Types, names, relevant standards, etc. of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．Health food filing registration form, and the legal responsibility commitment letter of the filing person for the authenticity of the submitted materials.

．A copy of the main registration certificate of the filer.

．Product technical requirements material.

．A full-item inspection report issued by a legally qualified inspection agency that meets the technical requirements of the product

．Other materials that indicate product safety and health functions.

．The certification document issued by the competent government department or legal service institution of the country (region) where the product has been produced has been on the market for more than one year, or the safety report on the overseas sales of the product and the consumption of the crowd.

．Technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

Note

．The recorded product formula, name and dosage of raw and auxiliary materials, efficacy, production process, etc. shall comply with the provisions of laws, regulations, rules, mandatory standards and technical requirements of health food raw material catalogues.

．The market supervision and administration department completes the filing of the filing information for future reference, and issues the filing number. For the registered health food, the market supervision and administration department will make a recordation certificate and publish the information in the recordation information form on its website. The format of the record number of imported health food is: Shijianbei J+4-digit era code+00+6-digit sequential number.

．For the health food that has been filed, if the filing materials need to be changed, the filing person should submit the change explanation and relevant certification documents to the original filing authority. If the filing materials meet the requirements, the market supervision and administration department shall post the changes in the change information, and keep the filing materials on file for future reference.

．The health food filing information should include the product name, the name and address of the filing person, the filing registration number, the registration date, as well as the product label, instruction manual and technical requirements.

URL:

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

Labels, manuals

All contents should be standardized and complete, comply with current regulations, technical specifications, mandatory standards, etc., and be consistent with the relevant content of the product safety and health function research and development report, and the content involving product technical requirements should be consistent with product technical requirements or conform. Includes the following:

Raw materials: List all raw materials according to formula materials. The order of each raw material is arranged in descending order according to the amount in product. Irradiated raw materials should be marked (irradiated) after the name of the raw material.
Excipients: List all excipients by formula material. The order of the excipients is arranged in descending order according to their dosage in the product. Irradiated excipients should be marked (irradiated) after the excipient name.
Content of functional ingredients or iconic ingredients: should include the name and content of the ingredients. It should be consistent with the name of the functional ingredient or the indicator of the iconic ingredient in the product technical requirements, and the minimum value of the indicator in the product technical requirements is the value indicated in the label instruction.
Applicable people: It should be a specific group of people who are safe to eat, have clear functional requirements and are suitable for this product in line with scientific basis for safety and health functions.
Unsuitable groups: specific groups that should be excluded from the scope of suitable groups, infants, pregnant women, nursing mothers and other special groups for whom the existing scientific evidence is insufficient to support the product, and specific groups that should be clearly marked in the current regulations. If it is not possible to determine the unsuitable group for the time being, it should be clearly stated that “limited to the current scientific research level, this product has not found a clear unsuitable group for the time being, and will be improved and supplemented based on the collected food safety information”.
Health function: It should be comprehensively determined through research and development and meet the relevant requirements for the management of health function claims.
Edible amount and consumption method: It should be consistent with the scientific basis of product formula compatibility and dosage, safety and health function test evaluation materials, etc.
Specifications: should be the weight or volume of the smallest preparation unit (excluding packaging materials; capsules refer to the contents; sugar-coated tablets or pills refer to the tablet core or pill core before sugar coating), which should be consistent with the product consumption and method of consumption. match. Alcoholic products should indicate the alcohol content.
Storage method: It should be comprehensively determined according to product characteristics and stability tests. If the storage method is under special conditions such as refrigeration, the specific storage conditions shall be listed.
Shelf life: It should be comprehensively determined by research and development, expressed in XX months, and if it is less than a month, it is expressed in XX days.
Precautions: It should be noted that this product cannot replace drugs. This product is not recommended for people other than suitable groups. When necessary, corresponding precautions should be added according to regulations, research and development, scientific consensus and product characteristics.
Note

．The main content of the label should be consistent with the content of the label description in the registration application materials, and the production date and production unit of the sample should be marked.

．Health food registration must provide samples with complete labels and instructions.

【參考連結】

https://www.cfe-samr.org.cn/zcfg/bjsp_134/flfg/202110/t20211008_3922.html

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

HLF-TW-45

請問在中國有哪些專業服務機構，可以協助辦理保健食品產品許可證？

Evershine RD：

瑞旭集團

https://www.cirs-group.com/foodcn

康利華

https://www.china-canny.com/

HLF-TW-50

外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? Which languages are allowed? Website?

Evershine RD：

首次進口的保健食品須由常駐中國代表機構或者由委託中國境內的代理機構名義，向國務院食品藥品監督管理部門(NMPA) 辦理註冊，屬於補充維生素、礦物質等營養物質的保健食品須完成備案。

保健食品註冊

1.申請人：上市保健食品的境外生產廠商，應由其常駐中國代表機構或者由其委託中國境內的代理機構辦理。

2.申請網頁：http://bjspzcsp.gsxt.gov.cn:8080/bjspzc/index.jsp

3.申請文件：

．保健食品註冊申請表、法律責任承諾書。

．申請人主體登記證明文件複本。

．產品生產工藝材料(包括生產工藝流程簡圖及說明、關鍵工藝控制點及說明。)

．直接接觸保健食品的包裝材料種類、名稱、相關標準等。

．產品標籤、說明書樣稿；產品名稱中的通用名與註冊的藥品名稱不重名的檢索材料。

．3個最小銷售包裝樣品。

．其他與產品註冊審評相關的文件。

．產品生產國（地區）政府主管部門或者法律服務機構出具的註冊申請人為上市保健食品境外生產廠商的資質證明文件。

．產品生產國（地區）或者國際組織與保健食品相關的技術法規或者標準。

．產品在生產國（地區）上市的包裝、標籤、說明書實樣

．由境外註冊申請人常駐中國代表機構辦理註冊事務，應提交外國企業常駐中國代表機構登記證及其複本。境外註冊申請人委託境內的代理機構辦理註冊事項，應提交經過公證的委託書原件以及受委託的代理機構營業執照複本。

4.備註

．產品聲稱的保健功能應已經列入保健食品功能目錄。

．首次進口的保健食品，是指非同一國家、同一企業、同一配方申請中國境內上市銷售的保健食品。

．審評機構對申請資料中內容進行審評，並根據科學依據的充足程度明確產品保健功能聲稱的限定用語。

．註冊申請人逾期未提交補充材料或者未完成補正，不足以證明產品安全性、保健功能和質量可控性的，審評機構應終止審評，提出不予註冊的建議。

．首次進口的保健食品境外現場核查和復核檢驗時限，根據境外生產廠商的實際情況確定。

．現場核查、複核檢驗、複審所需時間不計算在審評和註冊決定的期限內。

．保健食品註冊證書及其附件所載明內容變更的，應由保健食品註冊人申請變更並提交書面變更的理由和依據。

．已經生產銷售的保健食品註冊證書有效期屆滿需要延續的，保健食品註冊人應在有效期屆滿6個月前申請延續。

保健食品備案

1.申請人：上市保健食品的境外生產廠商，應由其常駐中國代表機構或者由其委託中國境內的代理機構辦理。

2.申請網頁：http://xbjspba.gsxt.gov.cn/record_pt/index.jsp

3.申請文件：

．產品生產工藝材料(包括生產工藝流程簡圖及說明，關鍵工藝控制點及說明。)

．直接接觸保健食品的包裝材料種類、名稱、相關標準等。

．產品標籤、說明書樣稿；產品名稱中的通用名與註冊的藥品名稱不重名的檢索材料。

．保健食品備案登記表、以及備案人對提交材料真實性負責的法律責任承諾書。

．備案人主體登記證明文件複本。

．產品技術要求材料。

．有合法資質的檢驗機構出具的符合產品技術要求全項目檢驗報告

．其他表明產品安全性和保健功能的材料。

．產品生產國（地區）政府主管部門或者法律服務機構出具的註冊申請人為上市保健食品境外生產廠商的資質證明文件。

．產品生產國（地區）或者國際組織與保健食品相關的技術法規或者標準。

．產品在生產國（地區）上市的包裝、標籤、說明書實樣。

4.備註

．備案的產品配方、原輔料名稱及用量、功效、生產工藝等應符合法律、法規、規章、強制性標準以及保健食品原料目錄技術要求的規定。

．已經備案的保健食品，需要變更備案材料的，備案人應向原備案機關提交變更說明及相關證明文件。備案材料符合要求的，市場監督管理部門應將變更情況登載於變更信息中，將備案材料存檔備查。

．保健食品備案信息應包括產品名稱、備案人名稱和地址、備案登記號、登記日期以及產品標籤、說明書和技術要求。

標籤、說明書

1.原料：按配方材料列出全部原料。各原料順序按其在產品中的用量，由大到小排列。經輻照的原料，應在原料名稱後標註（經輻照）。

輔料：按配方材料列出全部輔料。各輔料順序按其在產品中的用量，由大到小排列。經輻照的輔料，應在輔料名稱後標註（經輻照）。
功效成分或標誌性成分含量：應包括成分名稱及含量。應與產品技術要求中功效成分或標誌性成分指標名稱一致，以產品技術要求中指標最低值為標籤說明書標示值。
適宜人群：應為與安全性、保健功能等科學依據相符的食用安全、有明確功能需求、適合本產品的特定人群。
不適宜人群：應為適宜人群範圍中應除外的特定人群、現有科學依據不足以支持該產品適宜的嬰幼兒、孕婦、乳母等特殊人群，以及現行規定明確應標註的特定人群。暫無法確定不適宜人群的，應明確註明「限於目前科學研究水平，該產品暫未發現明確的不適宜人群，將根據收集到的食用安全信息，予以完善補充」。
保健功能：應經研發綜合確定，符合保健功能聲稱管理的相關要求。
食用量及食用方法：應與產品配方配伍及用量的科學依據、安全性和保健功能試驗評價材料等相符。
規格：應為最小製劑單元的重量或者體積（不包括包裝材料；膠囊劑指內容物；糖衣片或丸指包糖衣前的片芯或者丸芯），應與產品食用量及食用方法相匹配。酒類產品應註明酒精度。
儲藏方法：應根據產品特性、穩定性試驗等綜合確定。儲藏方法為冷藏等特殊條件的，應列出具體儲藏條件。
保質期：應經研發綜合確定，以ＸＸ月表示，不足月的以ＸＸ天表示。
注意事項：應註明本品不能代替藥物。適宜人群外的人群不推薦食用本產品。必要時還應根據法規規定、研發情況、科學共識以及產品特性增加相應注意事項。

12.注意

．標籤主要內容應與註冊申請材料中標籤說明書內容一致，應標註樣品的生產日期、生產單位。

．保健食品註冊時須提供樣本，具備完整標籤、說明，樣品包裝應完整、無破損且距保質期屆滿不少於3個月。

The health food imported for the first time must be registered with the Food and Drug Administration (NMPA) of the State Council in the name of the resident representative office in China or the agency authorized by the agency in China.

Health food registration

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative offices in China or by their entrusted agencies in China.
URL: http://bjspzcsp.gsxt.gov.cn:8080/bjspzc/index.jsp
Documents:

．Health food registration application form and legal responsibility commitment letter.

．A copy of the applicant’s main body registration certificate.

．Product production process materials (including the production process flow diagram and description, key process control points and descriptions.)

．Types, names, and relevant standards of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．3 minimum sales packaging samples.

．Other documents related to product registration review.

．The technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

Note

．The health function claimed by the product should have been listed in the function catalog of health food.

．The health food imported for the first time refers to the health food that is not from the same country, the same enterprise, and the same formula applied for marketing in China.

．The review agency will review the content of the application materials, and clarify the qualified terms of the product health function claim according to the sufficiency of scientific basis.

．The time limit for overseas on-site inspection and re-inspection of health food imported for the first time shall be determined according to the actual situation of overseas manufacturers.

．The time required for on-site inspection, review inspection, and review is not included in the time limit for review and registration decisions.

Record

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative office in China or an agency within China entrusted by them.
URL:http://xbjspba.gsxt.gov.cn/record_pt/index.jsp
Documents:

．Product production process materials (including production process flow diagram and description, key process control points and description.)

．Types, names, relevant standards, etc. of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．Health food filing registration form, and the legal responsibility commitment letter of the filing person for the authenticity of the submitted materials.

．A copy of the main registration certificate of the filer.

．Product technical requirements material.

．A full-item inspection report issued by a legally qualified inspection agency that meets the technical requirements of the product

．Other materials that indicate product safety and health functions.

．Technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

Note

URL:

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

Labels, manuals

Raw materials: List all raw materials according to formula materials. The order of each raw material is arranged in descending order according to the amount in product. Irradiated raw materials should be marked (irradiated) after the name of the raw material.
Excipients: List all excipients by formula material. The order of the excipients is arranged in descending order according to their dosage in the product. Irradiated excipients should be marked (irradiated) after the excipient name.
Content of functional ingredients or iconic ingredients: should include the name and content of the ingredients. It should be consistent with the name of the functional ingredient or the indicator of the iconic ingredient in the product technical requirements, and the minimum value of the indicator in the product technical requirements is the value indicated in the label instruction.
Applicable people: It should be a specific group of people who are safe to eat, have clear functional requirements and are suitable for this product in line with scientific basis for safety and health functions.
Unsuitable groups: specific groups that should be excluded from the scope of suitable groups, infants, pregnant women, nursing mothers and other special groups for whom the existing scientific evidence is insufficient to support the product, and specific groups that should be clearly marked in the current regulations. If it is not possible to determine the unsuitable group for the time being, it should be clearly stated that “limited to the current scientific research level, this product has not found a clear unsuitable group for the time being, and will be improved and supplemented based on the collected food safety information”.
Health function: It should be comprehensively determined through research and development and meet the relevant requirements for the management of health function claims.
Edible amount and consumption method: It should be consistent with the scientific basis of product formula compatibility and dosage, safety and health function test evaluation materials, etc.
Specifications: should be the weight or volume of the smallest preparation unit (excluding packaging materials; capsules refer to the contents; sugar-coated tablets or pills refer to the tablet core or pill core before sugar coating), which should be consistent with the product consumption and method of consumption. match. Alcoholic products should indicate the alcohol content.
Storage method: It should be comprehensively determined according to product characteristics and stability tests. If the storage method is under special conditions such as refrigeration, the specific storage conditions shall be listed.
Shelf life: It should be comprehensively determined by research and development, expressed in XX months, and if it is less than a month, it is expressed in XX days.
Precautions: It should be noted that this product cannot replace drugs. This product is not recommended for people other than suitable groups. When necessary, corresponding precautions should be added according to regulations, research and development, scientific consensus and product characteristics.
Note

．Health food registration must provide samples with complete labels and instructions.

【參考連結】

https://www.cfe-samr.org.cn/zcfg/bjsp_134/flfg/202110/t20211008_3922.html

HLF-TW-55

請問在中國有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？

Evershine RD：

瑞旭集團

https://www.cirs-group.com/foodcn

康利華

https://www.china-canny.com/

HLF-TW-60

經過核准登記的保健食品，進口到中國要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

What documents are required when importing approved health food into China? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

首次進口的保健食品須由常駐中國代表機構或者由委託中國境內的代理機構名義，向國務院食品藥品監督管理部門(NMPA) 辦理註冊，屬於補充維生素、礦物質等營養物質的保健食品須完成備案，進口前需於海關總署註冊。

海關總署註冊

註冊條件：

．所在國家（地區）的食品安全管理體系通過海關總署等效性評估、審查。

．經所在國家（地區）主管當局批准設立並在其有效監管下

．建立有效的食品安全衛生管理和防護體系，在所在國家（地區）合法生產和出口，保證向中國境內出口的食品符合中國相關法律法規和食品安全國家標準

．符合海關總署與所在國家（地區）主管當局商定的相關檢驗檢疫要求。

註冊方式：由所在國家（地區）主管當局向海關總署推薦註冊，所在國家（地區）主管當局應對其推薦註冊的企業進行審核檢查，確認符合註冊要求後，向海關總署推薦註冊並提交以下申請材料：

．所在國家（地區）主管當局推薦函。

．企業名單與企業註冊申請書。

．企業身份證明文件，如所在國家（地區）主管當局頒發的營業執照等。

．所在國家（地區）主管當局推薦企業符合本規定要求的聲明。

．所在國家（地區）主管當局對相關企業進行審核檢查的審查報告。

．必要時，海關總署可以要求提供企業食品安全衛生和防護體系文件，如企業廠區、車間、冷庫的平面圖，以及工藝流程圖等。

3.有效期限：5年。

4.備註

．申請資料應用中文或者英文提交，相關國家（地區）與中國就註冊方式和申請材料另有約定的，按照雙方約定執行。

．所在國家（地區）主管當局或進口食品境外生產企業應對提交材料的真實性、完整性、合法性負責。

．海關總署自行或者委託有關機構組織評審組，通過書面檢查、視頻檢查、現場檢查等形式及其組合，對申請註冊的進口食品境外生產企業實施評估審查。評審組由2名以上評估審查人員組成。

．進口食品境外生產企業和所在國家（地區）主管當局應協助開展上述評估審查工作。

．海關總署根據評估審查情況，對符合要求的進口食品境外生產企業予以註冊並給予在華註冊編號，書面通知所在國家（地區）主管當局或進口食品境外生產企業；對不符合要求的進口食品境外生產企業不予註冊，書面通知所在國家（地區）主管當局或進口食品境外生產企業。

．已獲得註冊的企業向中國境內出口食品時，應在食品的內、外包裝上標註在華註冊編號或者所在國家（地區）主管當局批准的註冊編號。

到當地外經貿主管部門領取對外貿易經營者備案登記》，經過備案登記後才具備對外貿易資格。對外貿易經營者應憑加蓋備案登記印章登記表在30日內到當地海關、檢驗檢疫、外匯、稅務等部門辦理開展對外貿易業務所需要的手續。
清關前資料準備：

．標籤檢驗監管備案表（申請書）

．原外文標籤樣圖片(前和後的標籤資料)

．原外文標籤翻譯件(前和後的標籤資料)

．中文商標設計樣張(前和後的標籤資料)

．原產地證明

．中國經銷商營業執照、電話號碼

．外國生產商公司名稱

．樣品

7.國家商檢局辦證部門需要的其它資料：

．代理合約、銷售合約、發票、裝箱單

．中文標籤及原標籤電子版、原標籤翻譯件。(或中文標籤預備案證明書)

．出口國官方衛生證（或者自由銷售證明或者健康證）

．出口國官方產地證

．廠家成分分析說明

．熏蒸證/無木質包裝聲明

．海運/空運提單

．其它各口岸管理機構要求提供的單證

Registration

Conditions of registration:

．The food safety management system of the country (region) where it is located has passed the equivalence assessment and review of the General Administration of Customs.

．Established with the approval of the competent authority of the country (region) where it is located and under its effective supervision

．Establish an effective food safety and hygiene management and protection system, legally produce and export in the country (region) where it is located, and ensure that the food exported to China complies with relevant Chinese laws and regulations and national food safety standards

．Meet the relevant inspection and quarantine requirements agreed by the General Administration of Customs and the competent authorities of the country (region) where it is located.

Registration method: The competent authority of the country (region) where the company is located shall recommend registration to the General Administration of Customs, and the competent authority of the country (region) shall review and inspect the enterprise recommended for registration. Submit the following application materials:

．Recommendation letter from the competent authority of the country (region) where you are located.

．Business list and business registration application.

．Enterprise identity documents, such as business license issued by the competent authority of the country (region) where it is located.

．A statement that the competent authority of the country (region) where the company is located recommends that the company meet the requirements of this regulation.

．The review report of the competent authority of the country (region) where the relevant enterprises are audited and inspected.

．When necessary, the General Administration of Customs may require the provision of enterprise food safety sanitation and protection system documents, such as the floor plan of the enterprise’s factory area, workshop, and cold storage, as well as process flow diagrams.

Period of validity: 5 years.
Remarks

．The application materials shall be submitted in Chinese or English. If the relevant countries (regions) and China have agreed otherwise on the registration method and application materials, the agreement shall be followed.

．The competent authority of the country (region) where it is located or the overseas manufacturer of imported food shall be responsible for the authenticity, completeness and legality of the submitted materials.

．The General Administration of Customs itself or entrusts relevant institutions to organize an evaluation team to conduct evaluation and review of the overseas production enterprises of imported food that apply for registration through written inspections, video inspections, on-site inspections, etc. and their combinations. The evaluation team consists of more than 2 evaluation reviewers.

．The overseas manufacturer of imported food and the competent authority of the country (region) where it is located shall assist in the above-mentioned evaluation and review work.

．According to the evaluation and review, the General Administration of Customs will register the overseas production enterprises of imported food that meet the requirements and give them a registration number in China, and notify the competent authority of the country (region) or the overseas production enterprise of imported food in writing; The production enterprise shall not be registered, and shall notify the competent authority of the country (region) where it is located or the overseas production enterprise of imported food in writing.

．When a registered enterprise exports food to China, it shall mark the registration number in China or the registration number approved by the competent authority of the country (region) on the inner and outer packaging of the food.

Go to the local foreign trade and economic department to obtain the “Foreign Trade Operators Registration”, and only after the recordation and registration can be qualified for foreign trade. Foreign trade operators should go to the local customs, inspection and quarantine, foreign exchange, taxation and other departments to go through the formalities required for foreign trade business within 30 days by presenting the registration form with the registration seal for recordation.
Pre-clearance documents preparation:

．Label Inspection Supervision Filing Form (Application Form)

．Original foreign language label sample picture (before and after label information)

．Original foreign language label translation (before and after label information)

．Chinese trademark design proofs (before and after label information)

．Certificate of Origin

．Chinese dealer business license, phone number

．Foreign producer company name

．Sample

Other materials required by the certificate department of the State Administration of Commodity Inspection:

．Agency contract, sales contract, invoice, packing list

．Chinese label and electronic version of the original label, translation of the original label. (or Chinese label pre-filing certificate)

．Official health certificate of the exporting country (or free sale certificate or health certificate)

．Official certificate of origin of the exporting country

．Manufacturer’s Composition Analysis Instructions

．Fumigation Certificate/Wood Free Packaging Statement

．Ocean/Air Waybill

．Documents required by other port management agencies

【參考連結】

http://www.customs.gov.cn//customs/302249/302266/302267/3625372/index.html

HLF-TW-70

中國保健食品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

保健食品註冊申請資料應包括產品的安全性論證報告、保健功能論證報告、生產工藝研究報告、產品技術要求研究報告等內容。
各項要求如下：

1.產品的安全性論證報告

．原料和輔料的使用依據：按照普通食品（包括可用於普通食品的物品、食品添加劑，下同）、新食品原料、按照傳統既是食品又是中藥材的物質、擬納入保健食品原料目錄以及保健食品新原料等類別，明確原輔料的使用依據。

．產品配方配伍及用量的安全性科學依據：應從傳統配伍禁忌和現代醫學藥理學研究方面，提供產品配方配伍及用量理論依據、文獻依據和試驗數據等科學依據。提供配方原料的品種、等級、質量、用量及個數符合有關規定的依據。

．安全性評價試驗材料的分析評價：應對涉及的保健食品新原料安全性評估材料和毒理學試驗報告以及菌種鑑定報告和菌種毒力試驗報告、產品的安全性評價試驗等，進行綜合分析，對產品安全性進行評價。

．配方以及適宜人群、不適宜人群、食用方法和食用量、注意事項等的綜述：根據原輔料的使用依據、產品配方配伍及用量的科學依據、安全性試驗評價材料等，綜述配方以及標籤說明書擬定的適宜人群、不適宜人群、食用方法和食用量、注意事項等的合理性。

2.產品的保健功能論證報告

．配方主要原料具有功能作用的科學依據，其餘原料的配伍必要性：產品配方原料應具有明確的使用目的。應提供配方主要原料具有功能作用的科學依據，並闡明其餘原料的配伍必要性。以經簡單加工的普通食品為原料的，應提供充足的國內外實驗性科學文獻依據，重點明確所用原料的功效成分和含量以及量效關係。

．產品配方配伍及用量具有保健功能的科學依據：應提供產品組方原理、產品配方配伍及用量具有聲稱功能的理論依據及文獻依據等。

．產品保健功能試驗評價材料、人群食用評價材料等的分析評價：應對產品保健功能試驗評價材料、人群食用評價材料等，進行綜合分析，對產品保健功能進行評價。

．產品配方以及適宜人群、不適宜人群、食用方法和食用量等的綜述應根據產品配方配伍及用量具有申報功能的科學依據、保健功能評價試驗材料、人群食用評價材料等，綜述產品配方以及標籤說明書樣稿中原料、輔料、適宜人群、不適宜人群、保健功能、食用方法和食用量等的合理性。

3.生產工藝研究報告

．生產工藝相關研究材料應完整、規範、可溯源：生產工藝研究過程和結果應完整，應提供依據對各工序和使用技術的必要性、科學性、可行性進行充分論證。首次進口產品應提供從小試工藝研究到規模化生產工藝的研究過程，小試、中試工藝研究資料缺失或不完整的，應提供國外生產廠商出具的10批次以上規模化產品生產驗證報告及自檢報告。

．工藝研究主要包括以下內容：劑型選擇和規格確定的依據、輔料及用量選擇的依據、影響產品安全性、保健功能等的主要生產工藝和關鍵工藝參數的研究報告、中試以上生產規模的工藝驗證報告及樣品自檢報告、無適用的國家標準、地方標準、行業標準的原料，應提供詳細的製備工藝、工藝說明及工藝合理性依據、應詳細列出產品及原料工藝過程中使用的全部加工助劑的名稱、標準號及標准文本、應根據工藝研究及工藝材料相關內容，綜述產品生產工藝材料、配方中輔料、標籤說明書的輔料、劑型、規格、適宜人群、不適宜人群項以及產品技術要求的生產工藝、直接接觸產品的包裝材料、原輔料質量要求中涉及的工藝內容等的合理性。

4.產品技術要求研究

．鑑別方法研究：根據產品配方及相關研究結果等可以確定產品的鑑別方法的，應予以全面、準確地闡述。採用顯微鑑別、色譜鑑別、顏色反應等的，提供的彩色照片、色譜圖等，應能真實反映鑑別結果。未制定鑑別項的，應說明未制定的理由。

．理化指標研究：主要包括一般質量控制指標（如水分、灰分、崩解時限等）、污染物指標（如鉛、總砷、總汞等）、真菌毒素指標，以及法律法規、強制性國家標準有限量要求的合成色素、防腐劑、甜味劑、抗氧化劑、加工助劑殘留等。

．功效成分或標誌性成分指標研究：應詳細說明產品功效成分或標誌性成分指標選擇、指標值制定及其檢測方法研究的過程和依據，提供研究報告。

．穩定性考察：註冊申請人應按照現行規定，根據樣品特性，合理選擇和確定穩定性試驗方法和考察指標的檢測方法，開展穩定性試驗。

產品配方材料

．產品配方表，包括原料和輔料的名稱及用量。

．原輔料用量是指製成1000個最小製劑單位的量；產品原輔料名稱應符合現行規定、技術規範、國家相關標準等的規定；原料應按功效作用或用量，輔料應按用量，由大到小排列；復配原輔料應提供其具體組成及用量；香精應明確其具體品種和質量要求。

．原輔料的質量要求、生產工藝、質量檢驗合格證明（有適用的國家、地方、行業相關標準的原輔料可免於提供生產工藝）。

．提取物、水解物類原料或輔料還應提供使用依據、使用部位的說明等。

．動植物原料應註明種屬來源和使用部位。

．動物原料應提供檢驗檢疫合格證明。

．法規對動植物種屬有明確規定的，還應提供權威機構出具的品種鑑定報告。

．根據組方原理，對原料炮製有明確要求的，應註明原料的砲制規格，如生、鹽製、蜜製、煅等。

．對原料純度有明確要求的，應提供原料的純度自檢報告。

6.安全性和保健功能評價材料

．試驗和檢驗工作的樣品、檢驗程序、檢驗方法等應符合有關規定。包括以下內容：食品檢驗機構的資質證明文件、具有法定資質的食品檢驗機構出具的安全性試驗評價材料、具有法定資質的食品檢驗機構出具的保健功能試驗評價材料、具有法定資質的食品檢驗機構出具的人群食用評價材料（涉及人群食用評價試驗的）、三批樣品的功效成分或標誌性成分、衛生學、穩定性試驗報告（委託檢驗的，被委託單位應為具有法定資質的食品檢驗機構）、權威機構出具的菌種鑑定報告、具有法定資質的食品檢驗機構出具的菌種毒力試驗報告等、具有法定資質的食品檢驗機構出具的涉及產品的興奮劑、違禁藥物成分等檢測報告。

7.直接接觸產品的包裝材料的種類、名稱及標準

．應根據工藝研究以及產品穩定性試驗等，綜合評估確定。應列出直接接觸產品的包裝材料的種類、名稱、標準號、標準全文、使用依據。

．產品生產國（地區）或者國際組織與保健食品相關的技術法規和（或）標準原文。境外生產企業保證向我國出口的保健食品符合我國有關法律、行政法規的規定和食品安全國家標準的要求的說明，以及保證生產質量管理體係有效運行的自查報告。

．申請材料涉及提交產品生產企業質量管理體系證明文件的，應提交生產國（地區）政府主管部門或者政府主管部門指定的承擔法律責任的有關部門出具的，符合良好生產質量管理規範的證明文件，應載明出具文件機構名稱、產品名稱、生產企業名稱和出具文件的日期。

備註

1.申請產品應具有充足的安全性、保健功能、質量可控性科學依據。註冊申請人不僅應提供科學依據的來源、目錄和全文，還應與產品的配方、工藝等技術要求進行研究比對，並按照申請材料要求，逐項對產品安全性、保健功能、質量可控性進行論證和綜述。
試驗及研究用樣品的來源應清晰、可溯源。樣品應經中試及以上規模工藝製備而成，生產車間應建立與所生產樣品相適應的生產質量管理體系，並保證體係有效運行。首次進口註冊申請的樣品應為在生產國（地區）上市銷售的產品。
提交的論證報告或研究報告等，應提供研究的起止時間、地點、研究目的、方法、依據、過程、結果、結論、部門、研發人或試驗人簽章等。屬委託研究的，還應提供委託研究合約等材料。
功效成分或標誌性成分、衛生學、穩定性試驗報告為註冊申請人自檢的，註冊申請人應按照規定，組織實施檢驗質量控制、報告編制、樣品和檔案管理等工作，出具的自檢報告應符合該辦法規定的試驗報告要求。
功效成分或標誌性成分、衛生學、穩定性試驗報告為註冊申請人委託檢驗的，被委託單位應為具有法定資質的食品檢驗機構。
研究或試驗的原始試驗記錄、儀器設備使用記錄、中試生產記錄等原始資料，註冊申請人應長期存檔備查，註冊申請時可不作為申請材料提交。必要時，審評機構可組織對研發原始資料進行核查。
同一企業不得使用同一配方註冊不同名稱的保健食品。

Health food registration application materials should include product safety demonstration report, health function demonstration report, production process research report, product technical requirements research report and so on.
The requirements are as follows:

Product safety demonstration report

．Basis for the use of raw materials and excipients: According to common food (including items that can be used in common food, food additives, the same below), new food raw materials, substances that are traditionally both food and traditional Chinese medicinal materials, to be included in the catalog of health food raw materials and health food New raw materials and other categories, clarify the basis for the use of raw and auxiliary materials.

．The scientific basis for the safety of product formula compatibility and dosage: from the aspects of traditional incompatibility and modern medical pharmacology research, the scientific basis for product formula compatibility and dosage, literature basis and experimental data should be provided. Provide the basis that the variety, grade, quality, dosage and number of formula raw materials comply with relevant regulations.

．Analysis and evaluation of safety evaluation test materials: comprehensive analysis should be carried out on the safety evaluation materials and toxicology test reports of new health food raw materials involved, as well as strain identification reports and strain toxicity test reports, and product safety evaluation tests. , to evaluate product safety.

．Summary of formulas, suitable groups, unsuitable groups, consumption methods and dosages, precautions, etc.: Based on the use basis of raw and auxiliary materials, scientific basis for product formulation compatibility and dosage, safety test evaluation materials, etc., the summary formula and label instructions are drawn up. The rationality of suitable groups, unsuitable groups, consumption methods and consumption, precautions, etc.

Demonstration report on the health function of the product

．The scientific basis for the function of the main raw materials of the formula, the compatibility of the remaining raw materials: the raw materials of the product formula should have a clear purpose of use. The scientific basis for the functional effect of the main raw materials of the formula should be provided, and the compatibility necessity of the remaining raw materials should be clarified. If simple processed ordinary food is used as the raw material, sufficient domestic and foreign experimental scientific literature should be provided, and the functional components and content of the raw materials used, as well as the dose-effect relationship should be clearly defined.

．The scientific basis for product formula compatibility and dosage with health care function: the principle of product formulation, the theoretical basis and literature basis for product formula compatibility and dosage with claimed function should be provided.

．Analysis and evaluation of product health function test evaluation materials, population consumption evaluation materials, etc.: Comprehensive analysis should be carried out on product health function test evaluation materials, population consumption evaluation materials, etc., and the product health care function should be evaluated.

．A review of product formulations, suitable groups of people, unsuitable groups of people, consumption methods and consumption, etc. should be based on product formulation compatibility and dosage with scientific basis for declared functions, health function evaluation test materials, and population consumption evaluation materials, etc. Product formulation and sample label instructions should be reviewed The rationality of the raw materials, auxiliary materials, suitable groups, unsuitable groups, health care functions, edible methods and consumption, etc.

Production process research report

．The research materials related to the production process should be complete, standardized and traceable: the research process and results of the production process should be complete, and a basis should be provided to fully demonstrate the necessity, scientificity and feasibility of each process and technology used. For the first-time imported product, the research process from the small-scale process research to the large-scale production process should be provided. If the research data of the small-scale and pilot-scale production process is missing or incomplete, the production verification report of more than 10 batches of large-scale products issued by foreign manufacturers should be provided. and self-test report.

． Process research mainly includes the following contents: basis for formulation selection and specification determination, basis for selection of excipients and dosage, research report on main production process and key process parameters affecting product safety, health care function, etc., and process verification for production scale above pilot scale Reports and sample self-inspection reports, raw materials without applicable national standards, local standards, and industry standards, should provide detailed preparation process, process description and process rationality basis, and should list in detail all processing used in the process of products and raw materials The name, standard number and standard text of the adjuvant should be reviewed according to the process research and related content of the process material. The rationality of the required production process, the packaging materials that directly contact the product, and the process content involved in the quality requirements of raw and auxiliary materials.

Research on product technical requirements

．Identification method research: If the identification method of the product can be determined according to the product formula and relevant research results, it should be comprehensively and accurately explained. If microscopic identification, chromatographic identification, color reaction, etc. are used, the color photos and chromatograms provided should be able to truly reflect the identification results. If the identification item is not formulated, the reason for not being formulated shall be stated.

．Research on physical and chemical indicators: mainly include general quality control indicators (such as moisture, ash, disintegration time limit, etc.), pollutant indicators (such as lead, total arsenic, total mercury, etc.), mycotoxins indicators, as well as laws and regulations, mandatory national standards include Residues of synthetic pigments, preservatives, sweeteners, antioxidants, processing aids, etc. required in limited quantities.

．Research on functional ingredients or iconic ingredient indicators: The process and basis for the selection of product functional ingredients or iconic ingredient indicators, the formulation of indicator values, and the research on detection methods should be explained in detail, and a research report should be provided.

．Stability inspection: The registration applicant shall, in accordance with the current regulations, reasonably select and determine the stability test method and the detection method of the inspection index according to the characteristics of the sample, and carry out the stability test.

Product formulation materials

．Product formula table, including the name and dosage of raw materials and auxiliary materials.

．The dosage of raw and auxiliary materials refers to the amount of 1,000 minimum preparation units; the names of raw and auxiliary materials of products should comply with the current regulations, technical specifications, relevant national standards, etc.; Small arrangement; compound raw and auxiliary materials should provide its specific composition and dosage; essence should clarify its specific variety and quality requirements.

．Quality requirements, production process, and quality inspection certificate for raw and auxiliary materials (raw and auxiliary materials with applicable national, local, and industry-related standards are exempt from providing production processes).

．The raw materials or excipients of extracts and hydrolyzates should also provide the basis for use and the description of the parts of use.

．Animal and plant raw materials should indicate the source of species and the part of use.

．Animal raw materials should provide inspection and quarantine certificates.

．Where the laws and regulations clearly stipulate the species of animals and plants, a variety identification report issued by an authoritative institution shall also be provided.

．According to the formulation principle, if there are clear requirements for the processing of raw materials, the processing specifications of the raw materials should be indicated, such as raw, salted, honeyed, calcined, etc.

．If there are clear requirements for the purity of the raw materials, the self-inspection report of the purity of the raw materials shall be provided.

Safety and health function evaluation materials

．The samples, inspection procedures and inspection methods of the test and inspection work shall comply with the relevant regulations. Including the following contents: the qualification certificate of the food inspection agency, the safety test evaluation materials issued by the legally qualified food inspection agency, the health function test evaluation materials issued by the legally qualified food inspection agency, and the issued by the legally qualified food inspection agency Food evaluation materials (involving human consumption evaluation tests), functional ingredients or iconic ingredients, hygiene, and stability test reports of three batches of samples (if the inspection is entrusted, the entrusted unit should be a food inspection agency with legal qualifications) , the strain identification report issued by the authoritative organization, the strain virulence test report issued by the legally qualified food inspection organization, etc., and the test report of the products involving stimulants and prohibited drug ingredients issued by the legally qualified food inspection organization.

Types, names and standards of packaging materials in direct contact with products

．It should be determined based on comprehensive evaluation, such as process research and product stability test. The type, name, standard number, full text of the standard, and basis for use of packaging materials that directly contact the product should be listed.

．The original text of technical regulations and/or standards related to health food in the country (region) of product production or international organization. An explanation of the overseas manufacturer’s assurance that the health food exported to my country conforms to the provisions of relevant laws, administrative regulations and national food safety standards in my country, as well as a self-inspection report to ensure the effective operation of the production quality management system.

．If the application materials involve the submission of the certification documents of the quality management system of the product production enterprise, the certification documents issued by the competent government department of the producing country (region) or the relevant department designated by the competent government department to bear the legal responsibility shall be submitted. Indicate the name of the institution that issued the document, the name of the product, the name of the manufacturer and the date of issuance of the document.

Note

The applied product should have sufficient scientific basis for safety, health care function, and quality controllability. The registration applicant should not only provide the source, catalog and full text of the scientific basis, but also conduct research and comparison with the technical requirements of the product’s formula, process, etc., and according to the requirements of the application materials, the product safety, health care function, and quality controllable item by item. Sexuality is demonstrated and reviewed.
The source of samples for testing and research should be clear and traceable. Samples should be prepared by pilot-scale and above-scale processes, and the production workshop should establish a production quality management system that is compatible with the samples produced, and ensure the effective operation of the system. The samples of the first import registration application should be products marketed in the country (region) of production.
The submitted argumentation report or research report should provide the start and end time, location, research purpose, method, basis, process, result, conclusion, department, researcher or tester’s signature of the research. For entrusted research, the entrusted research contract and other materials should also be provided. If the functional ingredients or iconic ingredients, hygiene, and stability test reports are self-inspected by the registration applicant, the registration applicant should organize the implementation of inspection quality control, report preparation, sample and file management, etc. in accordance with regulations, and issue self-inspection reports. The test report requirements specified in this method shall be met. If the functional ingredients or iconic ingredients, hygiene, and stability test reports are commissioned by the registration applicant, the commissioned unit should be a food inspection agency with legal qualifications.
The original test records, equipment use records, pilot production records and other original materials of research or experiments should be archived by the registration applicant for future reference, and may not be submitted as application materials when applying for registration. When necessary, the review agency may organize the verification of the original data of research and development.
The same enterprise shall not use the same formula to register health food with different names.

【參考連結】

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

https://gkml.samr.gov.cn/nsjg/tssps/201906/t20190624_302696.html

HLF-TW-75

中國保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

Evershine RD：

浙江省食品藥品檢驗研究院

http://www.zjyj.org.cn/

廣州市藥品檢驗所

http://gdidc.gd.gov.cn/

HLF-TW-77

請問在中國有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？

Evershine RD：

浙江省食品藥品檢驗研究院

http://www.zjyj.org.cn/

廣州市藥品檢驗所

http://gdidc.gd.gov.cn/

HLF-TW-80

外國子公司進口保健食品後，如果委託中國的經銷商銷售，經銷商需要保健食品營業許可證嗎？
假如保健食品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

After a foreign subsidiary imports health food and entrusts a distributor in China to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

在中國銷售保健食品須以當地企業名義向縣級以上地方食品藥品監督管理部門申請食品經營許可證，經批准後使得銷售。

產品責任

1.保健食品屬於特殊食品，遵循食品召回管理辦法，食品生産經營者應依法承擔食品安全第一責任人的義務，建立健全相關管理制度，收集、分析食品安全信息，依法履行不安全食品的停止生産經營、召回和處置義務。
2.國家食品藥品監督管理總局負責指導全國不安全食品停止生産經營、召回和處置的監督管理工作。縣級以上地方食品藥品監督管理部門負責本行政區域的不安全食品停止生産經營、召回和處置的監督管理工作。
3.縣級以上食品藥品監督管理部門組織建立由醫學、毒理、化學、食品、法律等相關領域專家組成的食品安全專家庫，為不安全食品的停止生産經營、召回和處置提供專業支持。
4.國家食品藥品監督管理總局負責匯總分析全國不安全食品的停止生産經營、召回和處置信息，根據食品安全風險因素，完善食品安全監督管理措施。
縣級以上地方食品藥品監督管理部門負責收集、分析和處理本行政區域不安全食品的停止生産經營、召回和處置信息，監督食品生産經營者落實主體責任。
食品生産經營者發現其生産經營的食品屬於不安全食品的，應立即停止生産經營，採取通知或者公告的方式告知相關食品生産經營者停止生産經營、消費者停止食用，並採取必要的措施防控食品安全風險。
食品集中交易市場的開辦者、食品經營櫃臺的出租者、食品展銷會的舉辦者發現食品經營者經營的食品屬於不安全食品的，應及時採取有效措施，確保相關經營者停止經營不安全食品。
網絡食品交易第三方平臺提供者發現網絡食品經營者經營的食品屬於不安全食品的，應依法採取停止網絡交易平臺服務等措施，確保網絡食品經營者停止經營不安全食品。
食品生産經營者生産經營的不安全食品未銷售給消費者，尚處於其他生産經營者控制中的，食品生産經營者應立即追回不安全食品，並採取必要措施消除風險。
食品召回分為三級：

食品生産者應按照召回計劃召回不安全食品。包括下列內容：

．食品生産者名稱、住所、法定代表人、具體負責人、聯絡方式等

．食品名稱、商標、規格、生産日期、批次、數量及召回區域範圍

．召回原因及危害後果

．召回等級、流程及時限

．召回通知或者公告的內容及發佈方式

．相關食品生産經營者的義務和責任

．召回食品的處置措施、費用承擔情況

．召回的預期效果

12.期限

．一級：食品生産者應自公告發佈日起10個工作日內完成召回工作。

．二級：食品生産者應自公告發佈日起20個工作日內完成召回工作。

．三級：食品生産者應自公告發佈日起30個工作日內完成召回工作。

食品經營者知悉食品生産者召回不安全食品後，應立即採取停止購進、銷售，封存不安全食品，在經營場所醒目位置張貼生産者發佈的召回公告等措施，配合食品生産者開展召回工作。
食品經營者對因自身原因所導致的不安全食品，應根據法律法規的規定在其經營的範圍內主動召回。食品經營者召回不安全食品應告知供貨商。供貨商應及時告知生産者。
食品生産經營者應如實記錄停止生産經營、召回和處置不安全食品的名稱、商標、規格、生産日期、批次、數量等內容。
記錄保存期限不得少於2年。

To sell health food in China, it is necessary to apply for a food business license to the National Food and Drug Administration (NMPA) in the name of a local enterprise, and the sale will be made after approval.

Product Liability

Health food is a special food. In accordance with the food recall management measures, food producers and operators should assume the responsibility of the first responsible person for food safety in accordance with the law, establish and improve relevant management systems, collect and analyze food safety information, and comply with the law to stop unsafe food. Production and operation, recall and disposal obligations.
The State Food and Drug Administration is responsible for guiding the supervision and management of the national production and distribution, recall and disposal of unsafe food. The local food and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions.
The food and drug supervision and administration departments at or above the county level organize the establishment of a food safety expert database composed of experts in medicine, toxicology, chemistry, food, law and other related fields to provide professional support for the cessation of production, operation, recall and disposal of unsafe food.
The State Food and Drug Administration is responsible for summarizing and analyzing the information on the cessation of production, operation, recall and disposal of unsafe food across the country, and improving food safety supervision and management measures based on food safety risk factors.
Local food and drug supervision and administration departments at or above the county level are responsible for collecting, analyzing and processing information on the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions, and supervising food producers and operators to implement their main responsibilities.
If a food producer or trader finds that the food it produces and trades is unsafe food, it shall immediately stop the production and trade, and notify the relevant food producer and trader to stop production and trade and consumers to stop eating it by means of a notice or announcement, and take necessary measures. Prevention and control of food safety risks.
If the promoters of the centralized food trading market, the lessors of the food counters, and the organizers of the food fairs find that the food operated by the food operators is unsafe food, they shall take effective measures in a timely manner to ensure that the relevant operators stop operating the unsafe food. food.
If a third-party platform provider for online food trading finds that the food operated by an online food operator is unsafe food, it shall take measures such as stopping the online trading platform service in accordance with the law to ensure that the online food operator stops dealing in unsafe food.
If the unsafe food produced and operated by a food producer and business operator has not been sold to consumers and is still under the control of other producers and business operators, the food producer and business operator shall immediately recover the unsafe food and take necessary measures to eliminate risks.
There are three levels of food recalls:

Food producers should recall unsafe food in accordance with the recall plan. Include the following:

． Name, address, legal representative, specific person in charge, contact information, etc. of the food producer

． Food name, trademark, specification, date of manufacture, batch, quantity and area of recall

． Recall reasons and harmful consequences

． Recall levels, procedures and deadlines

． The content and release method of the recall notice or announcement

． Obligations and Responsibilities of Relevant Food Producers and Operators

． Disposal measures and expenses of recalled food

． The expected effect of recall

Term

． Level 1: Food producers should complete the recall within 10 working days from the date of the announcement.

． Level 2: Food producers should complete the recall within 20 working days from the date of the announcement.

． Level 3: Food producers should complete the recall within 30 working days from the date of the announcement.

When a food operator learns of the recall of unsafe food by a food manufacturer, it should immediately take measures such as stopping the purchase and sale of unsafe food, sealing up the unsafe food, posting the recall announcement issued by the manufacturer in a conspicuous place in the business premises, and cooperating with the food manufacturer to carry out the recall. Work.
Food operators shall voluntarily recall unsafe food caused by their own reasons within the scope of their operations in accordance with the provisions of laws and regulations. Food operators should notify suppliers of recalls of unsafe food. The supplier shall promptly inform the producer.
Food producers and operators shall truthfully record the names, trademarks, specifications, production dates, batches, quantities, etc. The record keeping period shall not be less than 2 years.

【參考連結】

https://gkml.samr.gov.cn/nsjg/spjys/202011/t20201102_322851.html

http://banshi.beijing.gov.cn/pubtask/task/1/110105000000/26ef0e11-44f0-44bb-ba3a-d2ef627aa637.html?locationCode=110105000000&serverType=1001

http://big5.www.gov.cn/gate/big5/www.gov.cn/gongbao/content/2015/content_2937326.htm

HLF-TW-85

請問在中國有哪些專精於保健食品銷售與消費權益相關法律服務的業者？

Evershine RD：

江蘇健康律師事務所

http://www.jk-lawyer.com/index.html

中倫律師事務所

https://www.zhonglun.com/

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高雄、香港、深圳、东关、广州、清远、永康、杭州、苏州、昆山、南京、重庆、许昌、青岛、天津。
永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
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