义大利保健食品登记法规问题集

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各国健康食品登记法规问题集

时间：2022/09/18 drafted by Yvonne Chen

HLF-TW-10
请问义大利对于保健食品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

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：
在义大利，保健食品称为食品补充剂，卫生部 (MOH)是义大利食品补充剂的监管机构。
食品补充剂定义为：「旨在补充普通饮食并构成营养浓缩来源的食品，例如维生素和矿物质，或其他具有营养或生理作用的物质，不限于氨基酸、必需脂肪酸、纤维和植物来源的萃取物，包括单一化合物和多种化合物，以预先计量的形式组合」 。
食品补充剂通常以胶囊、片剂、袋装、小瓶等小单位的形式存在，透过提供营养物质或其他活性物质来提供或促进身体功能，从而有助于健康。

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.

【参考连结】
https://www.salute.gov.it/portale/home.html

HLF-TW-20
外国公司要到义大利销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

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：
需要註册为食品业营运商 (OSA)。
1.申请机构：卫生部
网页：https://www.impresainungiorno.gov.it/
2.申请人：所有参与食品生产、加工和分销阶段的经营者(法人)都应註册为食品业营运商 (OSA)
3.资料
·国家、企业名称、增值税/增值税号、企业负责人
·邮递区号、地址、电话、电子邮件、工厂
·产品类型、产品名称、版本、分析报告、分销日期、通知状态、OSA、操作、数据、技术资料、标籤及声明、成分清单、产品明细表
·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

【参考连结】
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
外国公司要到义大利销售保健食品，可以指派义大利公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

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，须为法人并註册食品业营运商 (OSA)。
1.申请机构：卫生部
网页：https://www.impresainungiorno.gov.it/
2.申请人：所有参与食品生产、加工和分销阶段的经营者(法人)都应註册为食品业营运商 (OSA)
3.资料
·国家、企业名称、增值税/增值税号、企业负责人
·邮递区号、地址、电话、电子邮件、工厂
·产品类型、产品名称、版本、分析报告、分销日期、通知状态、OSA、操作、数据、技术资料、标籤及声明、成分清单、产品明细表
·製造商
·付款方式

产品安全
食品业营运商(OSA)对投放市场的产品负责，并保证食品生产、转化和分销的所有阶段满足规定的卫生要求，来保证其安全，食品业营运商(OSA)必须实施上市后监测系统，以管理和评估与使用特定成分和/或产品相关的任何不良反应。

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.

【参考连结】
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
外国公司销售到义大利保健食品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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：
需申请产品通知。

产品首次上市时需要通知卫生部，来自第三国的产品，要在九十天期满后才允许进行贸易，卫生部以默许的形式授权自由销售。
1.申请机构：卫生部
网页：https://www.impresainungiorno.gov.it/
2.申请人：食品业营运商 (OSA)
3.产品资料
．製造工厂
．成分、呈现形式/格式/口味（如果适用）
．每日剂量（如果适用）
．成分清单
．现行法规要求的成分数量
．法规规定的成分准确名称
．标籤上出现具体立法要求的强制性指示内容
．标籤上自愿标示的内容
．用于行销的标籤副本（pdf 格式）
．付款单或银行转帐
4.费用：160.20 欧元

标籤

1. 必须包括食品补充剂名称或同义词
   2.每日摄取建议剂量
   3.警告不要超过建议剂量
   4.建议不能取代多样化的饮食
   5.标示产品必须至于三岁以下儿童接触不到的地方
   6.产品对人体的营养或生理作用
   7.营养物质或其他物质的数量
   8.产品中所含的具有营养或生理作用的物质
   9.以数字表示营养物质或其他物质的数量
   10.以参考值的百分比表示维生素和矿物质的数据
   11.标籤上的资讯必须是义大利文

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

【参考连结】
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
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

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 。

产品首次上市时需要通知卫生部，来自第三国的产品，要在九十天期满后才允许进行贸易，卫生部以默许的形式授权自由销售。
1.申请机构：卫生部
网页：https://www.impresainungiorno.gov.it/
2.申请人：食品业营运商 (OSA)
3.产品资料
．製造工厂
．成分、呈现形式/格式/口味（如果适用）
．每日剂量（如果适用）
．成分清单
．现行法规要求的成分数量
．法规规定的成分准确名称
．标籤上出现具体立法要求的强制性指示内容
．标籤上自愿标示的内容
．用于行销的标籤副本（pdf 格式）
．付款单或银行转帐
4.费用：160.20 欧元

标籤

1. 必须包括食品补充剂名称或同义词
   2.每日摄取建议剂量
   3.警告不要超过建议剂量
   4.建议不能取代多样化的饮食
   5.标示产品必须至于三岁以下儿童接触不到的地方
   6.产品对人体的营养或生理作用
   7.营养物质或其他物质的数量
   8.产品中所含的具有营养或生理作用的物质
   9.以数字表示营养物质或其他物质的数量
   10.以参考值的百分比表示维生素和矿物质的数据
   11.标籤上的资讯必须是义大利文

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

【参考连结】
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
经过核准登记的保健食品，进口到义大利要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

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：
健康许可证
从第三国进口的涉及健康利益的货物进入义大利领土国际入境点时必须缴交的文件，必须接受健康许可接受卫生部海事、航空和边境卫生办公室（USMAF-SASN 和相关领土单位）的监督。
申请人：进口商或负责人
网页：https://nsis.sanita.it/ACCN/accessportalnsis/

海关

1. 经济经营者註册和识别(EORI)
   向义大利海关总署(Agenzia delle Dogane ) 地区办事处申请取得 EORI 号码(网页： www.adm.gov.it/portale/)
   申请书内容
   ．自然人：护照或其他有效身分证件；公司名称/负责人姓名
   ．创建日期/生日
   ．地址、电话、电子邮件
   ．联络人
   ．商业登记证明
   ．如果申请人不是自然人，也不是被授予EORI代码的法人或团体的法定代表人则必须缴交：经公证的授权书正本、授权书原件
2. 报关
   申报单内容
   ．运营商的名称和EORI
   ．清关办事处代码
   ．报关处代码
   ．包裹数量
   ．发件人的姓名和地址、收件人的姓名和地址
   ．商品的商业描述
   ．以千克为单位的总质量
   ．原产国代码
   ．发票价值和货币
   ．进口声明等
   单一行政文件 (SAD)
   ．託运人
   ．收件人
   ．申报人
   ．出发时运输工具、国家
   ．过境运输工具、国家
   ．运输方式
   ．商业编号
   ．付款方式
   ．目的地代码
   ．交货条款
   ．交易性质
   ．货柜编号、密封贴及编号
   ．商品代码、重量
   ．税务计算
   ．抵港日期
   ．办事处
   ．声明人等
3. 清关所需文件
   ．发票，应义大利语书写(或附有翻译)
   ．计量(单位必须是公制)
   ．健康许可证
   ．原产地声明

无销售通知

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

【参考连结】
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
义大利保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？

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。
食品补充剂需要符合HACCP，为食品卫生的强制性规定，製造商需要对每个阶段相关的危害、严重性和发生频率的详尽分析产品。以及适当的预防性控制措施、关键控制措施，用以保证产品的安全和品质。
1.程序（PrP、HACCP、质量控制等）。
2.质量政策实施计划（审核、培训等）。
3.配方、製造工艺、包装等的说明。
4.记录跟追踪每批产品的生命週期。
5.原材料和成分、半成品和成品以及包装物品有关的规格表。
6.支持生产的理由、证明。

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.

【参考连结】
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
外国子公司进口保健食品后，如果委託义大利的经销商销售，经销商需要保健食品营业许可证吗？假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

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：
需要註册为食品业营运商 (OSA)。
1.申请机构：卫生部
网页：https://www.impresainungiorno.gov.it/
2.申请人：所有参与食品生产、加工和分销阶段的经营者(法人)都应註册为食品业营运商 (OSA)
3.资料
·国家、企业名称、增值税/增值税号、企业负责人
·邮递区号、地址、电话、电子邮件、工厂
·产品类型、产品名称、版本、分析报告、分销日期、通知状态、OSA、操作、数据、技术资料、标籤及声明、成分清单、产品明细表
·製造商
·付款方式

产品安全
食品业营运商(OSA)对投放市场的产品负责，并保证食品生产、转化和分销的所有阶段满足规定的卫生要求，来保证其安全，食品业营运商(OSA)必须实施上市后监测系统，以管理和评估与使用特定成分和/或产品相关的任何不良反应。

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.

【参考连结】
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

※备註 (Eevershin内部参考)
网页：https://nsis.sanita.it/ACCN/accessportalnsis/
此官方网页是要有权限才能进去(没有特别註明什麽权限)。

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