義大利保健食品登記法規問題集

義大利主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。義大利與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
Email：mxp4ww@evershinecpa.com
或
義大利 IAPA Partner in Milan
或
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聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
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TEL: +886-2-27170515 E100 ;
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linkedin address:Dale Chen Linkedin

各國健康食品登記法規問題集

時間：2022/09/18 drafted by Yvonne Chen

HLF-TW-10
請問義大利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 Italy? 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：
在義大利，保健食品稱為食品補充劑，衛生部 (MOH)是義大利食品補充劑的監管機構。
食品補充劑定義為：「旨在補充普通飲食並構成營養濃縮來源的食品，例如維生素和礦物質，或其他具有營養或生理作用的物質，不限於氨基酸、必需脂肪酸、纖維和植物來源的萃取物，包括單一化合物和多種化合物，以預先計量的形式組合」 。
食品補充劑通常以膠囊、片劑、袋裝、小瓶等小單位的形式存在，透過提供營養物質或其他活性物質來提供或促進身體功能，從而有助於健康。

In Italy, health foods are called dietary supplements, and the Ministry of Health (MOH) is the regulatory agency for dietary supplements in Italy.
Food supplements are defined as: “Foods intended to supplement the ordinary diet and constitute a concentrated source of nutrients, such as vitamins and minerals, or other substances with nutritional or physiological effects, not limited to amino acids, essential fatty acids, fibers and extracts of plant origin , including single compounds and multiple compounds, combined in a pre-measured form.”
Food supplements usually exist in the form of small units such as capsules, tablets, bags, vials, etc., and contribute to health by providing nutrients or other active substances to provide or promote body functions.

【參考連結】
https://www.salute.gov.it/portale/home.html

HLF-TW-20
外國公司要到義大利銷售保健食品，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 Italy, 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：
需要註冊為食品業營運商 (OSA)。
1.申請機構：衛生部
網頁：https://www.impresainungiorno.gov.it/
2.申請人：所有參與食品生產、加工和分銷階段的經營者(法人)都應註冊為食品業營運商 (OSA)
3.資料
·國家、企業名稱、增值稅/增值稅號、企業負責人
·郵遞區號、地址、電話、電子郵件、工廠
·產品類型、產品名稱、版本、分析報告、分銷日期、通知狀態、OSA、操作、數據、技術資料、標籤及聲明、成分清單、產品明細表
·製造商
·付款方式

Registration as an Food Business Operator (OSA) is required.
1.Applicant agency: Ministry of Health
URL: https://www.impresainungiorno.gov.it/

2. Applicant: All operators (legal persons) involved in the production, processing and distribution stages of food should be registered as Food Industry Operators (OSA)
   3.Information
   ·Country, company name, VAT/VAT number, person in charge of the company
   ·Postal code, address, phone number, email, factory
   ·Product type, product name, version, analysis report, distribution date, notification status, OSA, operation, data, technical information, labels and declarations, ingredient list, product details
   ·Manufacturer
   ·Payment method

【參考連結】
https://www.salute.gov.it/portale/p5_1_1.jsp?lingua=italiano&id=214
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1267&area=Alimenti%20particolari%20e%20integratori&menu=integratori

HLF-TW-25

HLF-TW-30
外國公司要到義大利銷售保健食品，可以指派義大利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 Italy, can it assign an Italy 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，須為法人並註冊食品業營運商 (OSA)。
1.申請機構：衛生部
網頁：https://www.impresainungiorno.gov.it/
2.申請人：所有參與食品生產、加工和分銷階段的經營者(法人)都應註冊為食品業營運商 (OSA)
3.資料
·國家、企業名稱、增值稅/增值稅號、企業負責人
·郵遞區號、地址、電話、電子郵件、工廠
·產品類型、產品名稱、版本、分析報告、分銷日期、通知狀態、OSA、操作、數據、技術資料、標籤及聲明、成分清單、產品明細表
·製造商
·付款方式

產品安全
食品業營運商(OSA)對投放市場的產品負責，並保證食品生產、轉化和分銷的所有階段滿足規定的衛生要求，來保證其安全，食品業營運商(OSA)必須實施上市後監測系統，以管理和評估與使用特定成分和/或產品相關的任何不良反應。

Yes, it must be a legal entity and registered as a Food Business Operator (OSA).

1.Applicant agency: Ministry of Health
URL: https://www.impresainungiorno.gov.it/

2. Applicant: All operators (legal persons) involved in the production, processing and distribution stages of food should be registered as Food Industry Operators (OSA)
   3.Information
   ·Country, company name, VAT/VAT number, person in charge of the company
   ·Postal code, address, phone number, email, factory
   ·Product type, product name, version, analysis report, distribution date, notification status, OSA, operation, data, technical information, labels and declarations, ingredient list, product details
   ·Manufacturer
   ·Payment method

Product Safety
Food business operators (OSA) are responsible for products placed on the market and ensure that all stages of food production, transformation and distribution meet the prescribed hygiene requirements to ensure their safety. Food business operators (OSA) must implement a post-market surveillance system, To manage and evaluate any adverse reactions associated with the use of specific ingredients and/or products.

【參考連結】
https://www.salute.gov.it/portale/p5_1_1.jsp?lingua=italiano&id=214
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1267&area=Alimenti%20particolari%20e%20integratori&menu=integratori

HLF-TW-35

HLF-TW-40
外國公司銷售到義大利保健食品本身，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 Italy? 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：
需申請產品通知。

產品首次上市時需要通知衛生部，來自第三國的產品，要在九十天期滿後才允許進行貿易，衛生部以默許的形式授權自由銷售。
1.申請機構：衛生部
網頁：https://www.impresainungiorno.gov.it/
2.申請人：食品業營運商 (OSA)
3.產品資料
．製造工廠
．成分、呈現形式/格式/口味（如果適用）
．每日劑量（如果適用）
．成分清單
．現行法規要求的成分數量
．法規規定的成分準確名稱
．標籤上出現具體立法要求的強制性指示內容
．標籤上自願標示的內容
．用於行銷的標籤副本（pdf 格式）
．付款單或銀行轉帳
4.費用：160.20 歐元

標籤

1. 必須包括食品補充劑名稱或同義詞
   2.每日攝取建議劑量
   3.警告不要超過建議劑量
   4.建議不能取代多樣化的飲食
   5.標示產品必須至於三歲以下兒童接觸不到的地方
   6.產品對人體的營養或生理作用
   7.營養物質或其他物質的數量
   8.產品中所含的具有營養或生理作用的物質
   9.以數字表示營養物質或其他物質的數量
   10.以參考值的百分比表示維生素和礦物質的數據
   11.標籤上的資訊必須是義大利文

Product notification is required.

The Ministry of Health needs to be notified when the product is first put on the market. Products from third countries are not allowed to be traded until the expiration of ninety days. The Ministry of Health authorizes free sales by tacit consent.
1.Applicant agency: Ministry of Health
URL: https://www.impresainungiorno.gov.it/

2. Applicant: Food Sector Operator (OSA)
3. Product information
   ． Manufacturing plant
   ． Ingredients, presentation/format/flavor (if applicable)
   ． Daily dose (if applicable)
   ． Ingredient list
   ． Quantities of ingredients required by current regulations
   ． Exact names of ingredients specified by regulations
   ． Mandatory instructions required by specific legislation appear on the label
   ． Voluntary content on labels
   ． Copy of label for marketing purposes (pdf format)
   ． Payment slip or bank transfer
4. Cost: 160.20 Euros

Label

1. Must include the name or synonym of the food supplement
2. Recommended daily dose
3. Warning not to exceed recommended dosage
4. Recommendations cannot replace a diverse diet
5. Labeled products must be kept out of reach of children under three years old.
6. The nutritional or physiological effects of the product on the human body
7. Amount of nutrients or other substances
8. Substances with nutritional or physiological effects contained in the product
9. Express the quantity of nutrients or other substances as numbers
10. Data on vitamins and minerals expressed as a percentage of reference values
    11.The information on the label must be in Italian

【參考連結】
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1267&area=Alimenti%20particolari%20e%20integratori&menu=integratori
https://www.salute.gov.it/portale/moduliServizi/dettaglioSchedaModuliServizi.jsp?lingua=italiano&label=servizionline&idMat=APINF&idAmb=IA&idSrv=FSNN&flag=P

HLF-TW-45

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：
可以 。

產品首次上市時需要通知衛生部，來自第三國的產品，要在九十天期滿後才允許進行貿易，衛生部以默許的形式授權自由銷售。
1.申請機構：衛生部
網頁：https://www.impresainungiorno.gov.it/
2.申請人：食品業營運商 (OSA)
3.產品資料
．製造工廠
．成分、呈現形式/格式/口味（如果適用）
．每日劑量（如果適用）
．成分清單
．現行法規要求的成分數量
．法規規定的成分準確名稱
．標籤上出現具體立法要求的強制性指示內容
．標籤上自願標示的內容
．用於行銷的標籤副本（pdf 格式）
．付款單或銀行轉帳
4.費用：160.20 歐元

標籤

1. 必須包括食品補充劑名稱或同義詞
   2.每日攝取建議劑量
   3.警告不要超過建議劑量
   4.建議不能取代多樣化的飲食
   5.標示產品必須至於三歲以下兒童接觸不到的地方
   6.產品對人體的營養或生理作用
   7.營養物質或其他物質的數量
   8.產品中所含的具有營養或生理作用的物質
   9.以數字表示營養物質或其他物質的數量
   10.以參考值的百分比表示維生素和礦物質的數據
   11.標籤上的資訊必須是義大利文

Yes.

The Ministry of Health needs to be notified when the product is first put on the market. Products from third countries are not allowed to be traded until the expiration of ninety days. The Ministry of Health authorizes free sales by tacit consent.
1.Applicant agency: Ministry of Health
URL: https://www.impresainungiorno.gov.it/

2. Applicant: Food Sector Operator (OSA)
3. Product information
   ． Manufacturing plant
   ． Ingredients, presentation/format/flavor (if applicable)
   ． Daily dose (if applicable)
   ． Ingredient list
   ． Quantities of ingredients required by current regulations
   ． Exact names of ingredients specified by regulations
   ． Mandatory instructions required by specific legislation appear on the label
   ． Voluntary content on labels
   ． Copy of label for marketing purposes (pdf format)
   ． Payment slip or bank transfer
4. Cost: 160.20 Euros

Label

1. Must include the name or synonym of the food supplement
2. Recommended daily dose
3. Warning not to exceed recommended dosage
4. Recommendations cannot replace a diverse diet
5. Labeled products must be kept out of reach of children under three years old.
6. The nutritional or physiological effects of the product on the human body
7. Amount of nutrients or other substances
8. Substances with nutritional or physiological effects contained in the product
9. Express the quantity of nutrients or other substances as numbers
10. Data on vitamins and minerals expressed as a percentage of reference values
    11.The information on the label must be in Italian

【參考連結】
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1267&area=Alimenti%20particolari%20e%20integratori&menu=integratori
https://www.salute.gov.it/portale/moduliServizi/dettaglioSchedaModuliServizi.jsp?lingua=italiano&label=servizionline&idMat=APINF&idAmb=IA&idSrv=FSNN&flag=P

HLF-TW-55

HLF-TW-60
經過核准登記的保健食品，進口到義大利要檢附什麼文件？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 Italy? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
健康許可證
從第三國進口的涉及健康利益的貨物進入義大利領土國際入境點時必須繳交的文件，必須接受健康許可接受衛生部海事、航空和邊境衛生辦公室（USMAF-SASN 和相關領土單位）的監督。
申請人：進口商或負責人
網頁：https://nsis.sanita.it/ACCN/accessportalnsis/

海關

1. 經濟經營者註冊和識別(EORI)
   向義大利海關總署(Agenzia delle Dogane ) 地區辦事處申請取得 EORI 號碼(網頁： www.adm.gov.it/portale/)
   申請書內容
   ．自然人：護照或其他有效身分證件；公司名稱/負責人姓名
   ．創建日期/生日
   ．地址、電話、電子郵件
   ．聯絡人
   ．商業登記證明
   ．如果申請人不是自然人，也不是被授予EORI代碼的法人或團體的法定代表人則必須繳交：經公證的授權書正本、授權書原件
2. 報關
   申報單內容
   ．運營商的名稱和EORI
   ．清關辦事處代碼
   ．報關處代碼
   ．包裹數量
   ．發件人的姓名和地址、收件人的姓名和地址
   ．商品的商業描述
   ．以千克為單位的總質量
   ．原產國代碼
   ．發票價值和貨幣
   ．進口聲明等
   單一行政文件 (SAD)
   ．託運人
   ．收件人
   ．申報人
   ．出發時運輸工具、國家
   ．過境運輸工具、國家
   ．運輸方式
   ．商業編號
   ．付款方式
   ．目的地代碼
   ．交貨條款
   ．交易性質
   ．貨櫃編號、密封貼及編號
   ．商品代碼、重量
   ．稅務計算
   ．抵港日期
   ．辦事處
   ．聲明人等
3. 清關所需文件
   ．發票，應義大利語書寫(或附有翻譯)
   ．計量(單位必須是公制)
   ．健康許可證
   ．原產地聲明

無銷售通知

Health license
Documents that must be submitted when entering the Italian territory at an international point of entry for goods of health interest (such as goods for human consumption, medical equipment, cosmetics, etc.) imported from third countries. A health permit is required. Accepted by the Ministry of Maritime, Aviation and Borders. Supervision by the Office of Health (USMAF-SASN and related territorial units).
Applicant: Importer or person in charge
Web page: https://nsis.sanita.it/ACCN/accessportalnsis/

Customs

1. Economic Operator Registration and Identification (EORI)
   Apply to the regional office of the Italian Customs Administration(Agenzia delle Dogane ) to obtain an EORI number
   website: www.adm.gov.it/portale/
   Application content
   ． Natural person: passport or other valid identity document; company name/name of person in charge
   ． Creation date/birthday
   ． Address, phone number, email
   ． Contact person
   ． Business registration certificate
   ． If the applicant is not a natural person, nor is he the legal representative of a legal person or group that has been granted an EORI code, he must submit: the original notarized power of attorney, and the original power of attorney.
2. Customs declaration
   Declaration form content
   ． Operator’s name and EORI
   ． Customs clearance office code
   ． Customs declaration office code
   ． Package quantity
   ． Sender’s name and address, Recipient’s name and address
   ． Commercial description of the product
   ． Total mass in kilograms
   ． Country of origin code
   ． Invoice value and currency
   ． Import declaration, etc.
   Single Administrative Document (SAD)
   ． Shipper
   ． Recipient
   ． Notifier
   ． Means of transportation and country at departure
   ． Transit transport, country
   ． Transportation method
   ． Business number
   ． Payment method
   ． Destination code
   ． Terms of Delivery
   ． Nature of transaction
   ． Container number, sealing sticker and serial number
   ． Product code, weight
   ． Tax calculation
   ． Arrival date
   ． Office
   ． Declarant etc.
3. Documents required for customs clearance
   ． Invoice, should be written in Italian (or accompanied by a translation)
   ． Measurement (units must be metric)
   ． Health license
   ． Declaration of origin

No sales notice

【參考連結】
https://www.salute.gov.it/portale/usmafsasn/dettaglioSchedaUsmafSasn.jsp?idMat=SMAF&idAmb=MER&idSrv=NOS&flag=P
https://taxation-customs.ec.europa.eu/system/files/2022-06/EORI%20National%20implementation.pdf
https://www.adm.gov.it/portale/documents/20182/889923/Application+form+for+the+assignment+of+an+EORI+number_+EN.pdf/20443175-1a42-4a72-90b4-3f67d9395492

HLF-TW-70
義大利保健食品審核機構，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：
危害分析重要管制HACCP。
食品補充劑需要符合HACCP，為食品衛生的強制性規定，製造商需要對每個階段相關的危害、嚴重性和發生頻率的詳盡分析產品。以及適當的預防性控制措施、關鍵控制措施，用以保證產品的安全和品質。
1.程序（PrP、HACCP、質量控制等）。
2.質量政策實施計劃（審核、培訓等）。
3.配方、製造工藝、包裝等的說明。
4.記錄跟追蹤每批產品的生命週期。
5.原材料和成分、半成品和成品以及包裝物品有關的規格表。
6.支持生產的理由、證明。

Hazard Analysis Important Control HACCP
Food supplements need to comply with HACCP, which is a mandatory requirement for food hygiene. Manufacturers need to conduct a detailed analysis of the hazards, severity and frequency of occurrence associated with each stage of the product. As well as appropriate preventive control measures and key control measures to ensure product safety and quality.

1. Procedures (PrP, HACCP, quality control, etc.).
2. Quality policy implementation plan (audit, training, etc.).
3. Description of formula, manufacturing process, packaging, etc.
4. Record and track the life cycle of each batch of products.
5. Specification sheets related to raw materials and ingredients, semi-finished products and finished products, and packaging items.
6. Reasons and proof to support production.

【參考連結】
https://www.trovanorme.salute.gov.it/norme/backToDettaglioAtto#
https://eur-lex.europa.eu/eli/reg/2004/852/oj

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口保健食品後，如果委託義大利的經銷商銷售，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 Italy 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：
需要註冊為食品業營運商 (OSA)。
1.申請機構：衛生部
網頁：https://www.impresainungiorno.gov.it/
2.申請人：所有參與食品生產、加工和分銷階段的經營者(法人)都應註冊為食品業營運商 (OSA)
3.資料
·國家、企業名稱、增值稅/增值稅號、企業負責人
·郵遞區號、地址、電話、電子郵件、工廠
·產品類型、產品名稱、版本、分析報告、分銷日期、通知狀態、OSA、操作、數據、技術資料、標籤及聲明、成分清單、產品明細表
·製造商
·付款方式

產品安全
食品業營運商(OSA)對投放市場的產品負責，並保證食品生產、轉化和分銷的所有階段滿足規定的衛生要求，來保證其安全，食品業營運商(OSA)必須實施上市後監測系統，以管理和評估與使用特定成分和/或產品相關的任何不良反應。

Registration as a Food Business Operator (OSA) is required.
1.Applicant agency: Ministry of Health
URL: https://www.impresainungiorno.gov.it/

2. Applicant: All operators (legal persons) involved in the production, processing and distribution stages of food should be registered as Food Industry Operators (OSA)
   3.Information
   ·Country, company name, VAT/VAT number, person in charge of the company
   ·Postal code, address, phone number, email, factory
   ·Product type, product name, version, analysis report, distribution date, notification status, OSA, operation, data, technical information, labels and declarations, ingredient list, product details
   ·Manufacturer
   ·Payment method

Product Safety
Food business operators (OSA) are responsible for products placed on the market and ensure that all stages of food production, transformation and distribution meet the prescribed hygiene requirements to ensure their safety. Food business operators (OSA) must implement a post-market surveillance system, To manage and evaluate any adverse reactions associated with the use of specific ingredients and/or products.

【參考連結】
https://www.salute.gov.it/portale/p5_1_1.jsp?lingua=italiano&id=214
https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1267&area=Alimenti%20particolari%20e%20integratori&menu=integratori

HLF-TW-85

※備註 (Eevershin內部參考)
網頁：https://nsis.sanita.it/ACCN/accessportalnsis/
此官方網頁是要有權限才能進去(沒有特別註明什麼權限)。

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linkedin address:Dale Chen Linkedin

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陳中成 Dale C.C. Chen;
會計師 in 台灣+中國+英國/企管碩士+企管博士/台灣專利師;
CPA in Taiwan+China+UK/ MBA+DBA/ Patent Attorney in Taiwan;
Mobile: +86-139-1048-6278 in China ;
Mobile:+886-933920199 in Taipei;
Wechat ID: evershiinecpa ;
Line ID:evershinecpa;
Skype:daleccchen ;
Linkedin Address:  Dale Chen Linkedin

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