西班牙保健食品登記法規問題集

西班牙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。西班牙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：bcn4ww@evershinecpa.com
或
西班牙永輝BPO有限公司
Barcelona time zone:
Anna Wang, 說西班牙文中文和英文
或
China Time Zone:
聯絡人: 陳中成 Dale Chen 會計師/所長
手機：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
電話：+886-2-2717-0515 分機:100

各國健康食品登記法規問題集

時間：2022/10/28 drafted by Yvonne Chen

HLF-TW-10
請問西班牙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 Spain? 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：
在西班牙，保健食品稱為食品補充劑，西班牙食品安全與營養局(AESAN)是西班牙食品補充劑的監管機構。
食品補充劑定義為：以補充正常飲食為目的，含有濃縮的營養物質或其他具有營養或生理作用的物質。以簡單或組合形式，以劑量形式銷售的食品產品，即膠囊、丸劑.、片劑和其他類似形式、粉末袋、液體安瓶、滴管瓶和其他類似形式的液體和粉末，必須以小單位劑量服用。

In Spain, health foods are called food supplements, and the Spanish Agency for Food Safety and Nutrition (AESAN) is the regulatory agency for food supplements in Spain.
Food supplements are defined as: for the purpose of supplementing the normal diet, containing concentrated nutrients or other substances with nutritional or physiological effects. Food products sold in dosage forms, i.e. capsules, pills, tablets and other similar forms, powder sachets, liquid ampoules, dropper bottles and other similar forms of liquids and powders, in simple or combined form, must be sold in small units Dosage taken.

【參考連結】
https://boe.es/buscar/doc.php?id=BOE-A-2009-16109
https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/complementos_alimenticios.htm

HLF-TW-20
外國公司要到西班牙銷售保健食品，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 Spain, 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：
需於「食品和食品公司衛生總登記處」(RGSEAA)完成食品企業註冊。

食品公司及其企業如果製造、加工或改造、包裝、儲存、分銷和進口供人類消費的食品，則必須衛生總登記處註冊。
1.申請機構：「食品和食品公司衛生總登記處」 (RGSEAA)
網址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申請人：西班牙境內的公司/辦事處，或經歐盟授權的公司/辦事處
3.註冊表：
．公司經營者必須提供：公司名稱、NIF、NIE 或 CIF、其所有活動的目的以及機構總部或註冊辦事處。
．稅務識別卡、契約
．活動描述性的文件(如果適用)
．RSI 中授權流程的代表授權文件(如果適用)
．公司負責聲明與自控系統相關的文件(需在 3 個月內繳交或被檢查)
．額外授權費的支付證明
．申請人的 DNI/NIE 或稅務身分證

Food business registration needs to be completed with the General Register of Food and Food Business Hygiene (RGSEAA).

Food companies and their undertakings must register with the General Register of Health if they manufacture, process or transform, pack, store, distribute and import food for human consumption.

1. Applicant: General Register of Hygiene for Food and Food Companies (RGSEAA)
   URL:
   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2. Applicant: Company/office in Spain, or company/office authorized by the European Union
3. Registration form:
   ．The company operator must provide: the name of the company, NIF, NIE or CIF, the purpose of all its activities and the headquarters or registered office of the institution.
   ．Tax identification card, contract
   ．Activity descriptive documentation (if applicable)
   ．Representative authorization document for the authorization process in RSI (if applicable)
   ．The company is responsible for declaring documents related to the automatic control system (to be submitted or inspected within 3 months)
   ．Proof of payment of additional licensing fees
   ．Applicant’s DNI/NIE or tax ID

【參考連結】
https://www.boe.es/buscar/act.php?id=BOE-A-2011-4293&p=20221221&tn=0

HLF-TW-25

HLF-TW-30
外國公司要到西班牙銷售保健食品，可以指派西班牙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 Spain, can it assign an Spain 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，需於「食品和食品公司衛生總登記處」 (RGSEAA)完成食品企業註冊。

食品公司及其企業如果製造、加工或改造、包裝、儲存、分銷和進口供人類消費的食品，則必須衛生總登記處註冊。
1.申請機構：「食品和食品公司衛生總登記處」 (RGSEAA)
網址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申請人：西班牙境內的公司/辦事處，或經歐盟授權的公司/辦事處
3.註冊表：
．公司經營者必須提供：公司名稱、NIF、NIE 或 CIF、其所有活動的目的以及機構總部或註冊辦事處。
．稅務識別卡、契約
．活動描述性的文件(如果適用)
．RSI 中授權流程的代表授權文件(如果適用)
．公司負責聲明與自控系統相關的文件(需在 3 個月內繳交或被檢查)
．額外授權費的支付證明
．申請人的 DNI/NIE 或稅務身分證

產品責任
進口商對其銷售的產品的食品安全負有主要責任，並且必須遵守一系列義務。
1.安全：不能銷售不安全的食品。
2.責任：承擔確保其生產、運輸、儲存或銷售的食品安全責任。
3.可追溯性：快速辨識其供應商或客戶。
4.透明度：如果負責的食品不安全，應立即通知主管機關。
5.緊急情況：如果食品不安全，應立即將其從市場上撤下。
6.預防：確定、定期審查和控制流程的關鍵點。
7.合作：配合主管機關採取行動降低風險。

Food business registration needs to be completed with the General Register of Food and Food Business Hygiene (RGSEAA).

Food companies and their undertakings must register with the General Register of Health if they manufacture, process or transform, pack, store, distribute and import food for human consumption.

1. Applicant: General Register of Hygiene for Food and Food Companies (RGSEAA)
   URL:
   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2. Applicant: Company/office in Spain, or company/office authorized by the European Union
3. Registration form:
   ．The company operator must provide: the name of the company, NIF, NIE or CIF, the purpose of all its activities and the headquarters or registered office of the institution.
   ．Tax identification card, contract
   ．Activity descriptive documentation (if applicable)
   ．Representative authorization document for the authorization process in RSI (if applicable)
   ．The company is responsible for declaring documents related to the automatic control system (to be submitted or inspected within 3 months)
   ．Proof of payment of additional licensing fees
   ．Applicant’s DNI/NIE or tax ID

Product liability
Importers have primary responsibility for the food safety of the products they sell and must comply with a number of obligations.

1. Safety: Unsafe food cannot be sold.
2. Responsibility: assume responsibility for ensuring food safety in its production, transportation, storage or sale.
3. Traceability: Quickly identify its suppliers or customers.
4. Transparency: If the food responsible is unsafe, the competent authority should be notified immediately.
5. Emergency situations: If food is unsafe, it should be removed from the market immediately.
6. Prevention: Identify, regularly review and control key points in the process.
7. Cooperation: Cooperate with the competent authorities to take actions to reduce risks.

【參考連結】
https://www.boe.es/buscar/act.php?id=BOE-A-2011-4293&p=20221221&tn=0
https://www.aesan.gob.es/AECOSAN/web/operadores_economicos/seccion/Responsabilidades_operadores_economicos.htm

HLF-TW-35

HLF-TW-40
外國公司銷售到西班牙保健食品本身，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 Spain? 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：
無產品許可證，但進口商需於「食品和食品公司衛生總登記處」 (RGSEAA)完成食品企業註冊。

食品公司及其企業如果製造、加工或改造、包裝、儲存、分銷和進口供人類消費的食品，則必須衛生總登記處註冊。
1.申請機構：「食品和食品公司衛生總登記處」 (RGSEAA)
網址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申請人：西班牙境內的公司/辦事處，或經歐盟授權的公司/辦事處
3.註冊表：
．公司經營者必須提供：公司名稱、NIF、NIE 或 CIF、其所有活動的目的以及機構總部或註冊辦事處。
．稅務識別卡、契約
．活動描述性的文件(如果適用)
．RSI 中授權流程的代表授權文件(如果適用)
．公司負責聲明與自控系統相關的文件(需在 3 個月內繳交或被檢查)
．額外授權費的支付證明
．申請人的 DNI/NIE 或稅務身分證

標籤
在西班牙銷售的食品標籤上的強制性說明將至少要以官方的西班牙語表達。食品標籤要求以下強制性標示：
．產品的銷售名稱。
．成分清單。
．成分的數量或成分類別。
．酒精含量超過 1.2%。
．包裝產品的淨含量。
．最短期限日期或到期日。
．保存和使用的特殊條件。
．使用說明(如果其指示對於正確使用食品是必要的)
．公司資訊：在歐盟境內設立的製造商、包裝商或銷售商的名稱、公司名稱、地址。
．地段。
．原產地或出處。
．特殊種類食品所規定的內容。

There is no product license, but the importer needs to complete the food business registration with the General Registry of Food and Food Companies Hygiene (RGSEAA).
Food companies and their undertakings must register with the General Register of Health if they manufacture, process or transform, pack, store, distribute and import food for human consumption.

1. Applicant: General Register of Hygiene for Food and Food Companies (RGSEAA)
   URL:
   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2. Applicant: Company/office in Spain, or company/office authorized by the European Union
3. Registration form:
   ．The company operator must provide: the name of the company, NIF, NIE or CIF, the purpose of all its activities and the headquarters or registered office of the institution.
   ．Tax identification card, contract
   ．Activity descriptive documentation (if applicable)
   ．Representative authorization document for the authorization process in RSI (if applicable)
   ．The company is responsible for declaring documents related to the automatic control system (to be submitted or inspected within 3 months)
   ．Proof of payment of additional licensing fees
   ．Applicant’s DNI/NIE or tax ID

Label
Mandatory instructions on food labels sold in Spain will be in at least official Spanish. Food labels require the following mandatory markings:
．The sales name of the product.
．List of ingredients.
．Quantity of ingredients or category of ingredients.
．Alcohol content exceeds 1.2%.
．Net content of packaged products.
．Minimum term date or expiration date.
．Special conditions for storage and use.
．Instructions for use (if their instructions are necessary for the proper use of the food)
．Company information: The name, company name, and address of the manufacturer, packer, or seller established in the EU.
．Location.
．Origin or provenance.
．Contents stipulated for special types of foods.

【參考連結】
https://www.boe.es/buscar/doc.php?id=BOE-A-1999-17996
https://www.boe.es/buscar/act.php?id=BOE-A-2011-4293&p=20221221&tn=0

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：
若已於歐盟其他國家認可的企業登記產品可以相互承認原則銷售產品，但如果沒有則需要是西班牙境內企業於「食品和食品公司衛生總登記處」 (RGSEAA)完成食品企業註冊。

食品公司及其企業如果製造、加工或改造、包裝、儲存、分銷和進口供人類消費的食品，則必須衛生總登記處註冊。
1.申請機構：「食品和食品公司衛生總登記處」 (RGSEAA)
網址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申請人：西班牙境內的公司/辦事處，或經歐盟授權的公司/辦事處
3.註冊表：
．公司經營者必須提供：公司名稱、NIF、NIE 或 CIF、其所有活動的目的以及機構總部或註冊辦事處。
．稅務識別卡、契約
．活動描述性的文件(如果適用)
．RSI 中授權流程的代表授權文件(如果適用)
．公司負責聲明與自控系統相關的文件(需在 3 個月內繳交或被檢查)
．額外授權費的支付證明
．申請人的 DNI/NIE 或稅務身分證

標籤
在西班牙銷售的食品標籤上的強制性說明將至少要以官方的西班牙語表達。食品標籤要求以下強制性標示：
．產品的銷售名稱。
．成分清單。
．成分的數量或成分類別。
．酒精含量超過 1.2%。
．包裝產品的淨含量。
．最短期限日期或到期日。
．保存和使用的特殊條件。
．使用說明(如果其指示對於正確使用食品是必要的)
．公司資訊：在歐盟境內設立的製造商、包裝商或銷售商的名稱、公司名稱、地址。
．地段。
．原產地或出處。
．特殊種類食品所規定的內容。

If the products have been registered by an enterprise recognized in other EU countries, the products can be sold on the principle of mutual recognition, but if not, the enterprise in Spain needs to complete the food enterprise registration at the General Registry of Food and Food Companies Sanitation (RGSEAA)

Food companies and their undertakings must register with the General Register of Health if they manufacture, process or transform, pack, store, distribute and import food for human consumption.

1. Applicant: General Register of Hygiene for Food and Food Companies (RGSEAA)
   URL:
   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2. Applicant: Company/office in Spain, or company/office authorized by the European Union
3. Registration form:
   ．The company operator must provide: the name of the company, NIF, NIE or CIF, the purpose of all its activities and the headquarters or registered office of the institution.
   ．Tax identification card, contract
   ．Activity descriptive documentation (if applicable)
   ．Representative authorization document for the authorization process in RSI (if applicable)
   ．The company is responsible for declaring documents related to the automatic control system (to be submitted or inspected within 3 months)
   ．Proof of payment of additional licensing fees
   ．Applicant’s DNI/NIE or tax ID

Label
Mandatory instructions on food labels sold in Spain will be in at least official Spanish. Food labels require the following mandatory markings:
．The sales name of the product.
．List of ingredients.
．Quantity of ingredients or category of ingredients.
．Alcohol content exceeds 1.2%.
．Net content of packaged products.
．Minimum term date or expiration date.
．Special conditions for storage and use.
．Instructions for use (if their instructions are necessary for the proper use of the food)
．Company information: The name, company name, and address of the manufacturer, packer, or seller established in the EU.
．Location.
．Origin or provenance.
．Contents stipulated for special types of foods.

【參考連結】
https://www.boe.es/buscar/act.php?id=BOE-A-2011-4293&p=20221221&tn=0
https://www.boe.es/buscar/doc.php?id=BOE-A-1999-17996

HLF-TW-55

HLF-TW-60
經過核准登記的保健食品，進口到西班牙要檢附什麼文件？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 Spain? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海關

1. 經濟經營者註冊和識別(EORI)
   向西班牙海關( OEA )申請取得 EORI 號碼
   網頁：https://sede.agenciatributaria.gob.es/Sede/inicio.html
   申請書內容
   ．自然人：護照或其他有效身分證件；公司名稱/責任人姓名
   ．西班牙的納稅住所。
   ．創建日期/生日
   ．人員類型：自然人/法人/團體
   ．地址、電話、電子郵件
   ．聯絡資訊、聯絡人姓名、地址、電話號碼、傳真號碼、電子郵件
   ．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
   ．經濟活動部門4位代碼：商業登記處註明的歐盟經濟活動統計分類(NACE)主要經濟活動的4位數代碼
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
   ．商業發票副本 (西班牙語)
   ．計量(單位必須是公制)
   ．原產地聲明

銷售前通知
第三國進口的產品，在將食品補充劑投放市場之前，必須向西班牙食品安全和營養局(AESAN)發出正式通知。
1.申請人：將產品投放市場的負責人或進口商(須為歐盟境內代表)
2.申請機構：消費者事務部電子入口
網頁：
https://consumo.sede.gob.es/procedimientos/portada/ida/3917/idp/1639
3.申請書內容
．申請人身分：自己的名義/代表利害關係人(自然人或法人)
．公司資訊
．食品補充劑成分
．西班牙文標籤
．來自其他國家的標籤
．來自另一個歐盟國家的行銷文件
．科學文獻
．其他資料
4.付費
5.簽名、完成申請

Customs

1. Economic Operator Registration and Identification (EORI)
   Apply to Spanish Customs (OEA) to obtain an EORI number
   URL: https://sede.agenciatributaria.gob.es/Sede/inicio.html
   Application content
   ． Natural person: passport or other valid identity document; company name/name of responsible person
   ． Spanish tax residence.
   ． Creation date/birthday
   ． Personnel type: natural person/legal person/group
   ． Address, phone number, email
   ． Contact information, contact name, address, telephone number, fax number, email
   ． 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.
   ． 4-digit code of the economic activity sector: the 4-digit code of the main economic activity in the Statistical Classification of Economic Activity in the European Union (NACE) indicated in the commercial register
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
   ． Copy of commercial invoice (Spanish)
   ． Measurement (units must be metric)
   ． Declaration of origin

Pre-sale notice
Products imported from third countries must give a formal notification to the Spanish Agency for Food Safety and Nutrition (AESAN) before placing food supplements on the market.

1. Applicant: The person in charge or the importer who puts the product on the market (must be a representative in the EU)
2. Application agency: Electronic Portal of the Ministry of Consumer Affairs
   URL:
   https://consumo.sede.gob.es/procedimientos/portada/ida/3917/idp/1639
3. Contents of application
   ． Applicant’s identity: own name/representative interested party (natural person or legal person)
   ． Company information
   ． Food supplement ingredients
   ． Spanish label
   ． Tags from other countries
   ． Marketing documents from another EU country
   ． Scientific literature
   ． Other information
4. Payment
5. Sign and complete the application

【參考連結】
https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/subseccion/procedimientos_registro.htm#2

HLF-TW-70
西班牙保健食品審核機構，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：
須提供「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://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，如果委託西班牙的經銷商銷售，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 Spain 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：
需於「食品和食品公司衛生總登記處」 (RGSEAA)完成食品企業註冊。

食品公司及其企業如果製造、加工或改造、包裝、儲存、分銷和進口供人類消費的食品，則必須衛生總登記處註冊。
1.申請機構：「食品和食品公司衛生總登記處」 (RGSEAA)
網址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申請人：西班牙境內的公司/辦事處，或經歐盟授權的公司/辦事處
3.註冊表：
．公司經營者必須提供：公司名稱、NIF、NIE 或 CIF、其所有活動的目的以及機構總部或註冊辦事處。
．稅務識別卡、契約
．活動描述性的文件(如果適用)
．RSI 中授權流程的代表授權文件(如果適用)
．公司負責聲明與自控系統相關的文件(需在 3 個月內繳交或被檢查)
．額外授權費的支付證明
．申請人的 DNI/NIE 或稅務身分證

產品責任
進口商對其銷售的產品的食品安全負有主要責任，並且必須遵守一系列義務。
1.安全：不能銷售不安全的食品。
2.責任：承擔確保其生產、運輸、儲存或銷售的食品安全責任。
3.可追溯性：快速辨識其供應商或客戶。
4.透明度：如果負責的食品不安全，應立即通知主管機關。
5.緊急情況：如果食品不安全，應立即將其從市場上撤下。
6.預防：確定、定期審查和控制流程的關鍵點。
7.合作：配合主管機關採取行動降低風險。

Food business registration needs to be completed with the General Register of Food and Food Business Hygiene (RGSEAA).

Food companies and their undertakings must register with the General Register of Health if they manufacture, process or transform, pack, store, distribute and import food for human consumption.

1. Applicant: General Register of Hygiene for Food and Food Companies (RGSEAA)
   URL:
   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2. Applicant: Company/office in Spain, or company/office authorized by the European Union
3. Registration form:
   ．The company operator must provide: the name of the company, NIF, NIE or CIF, the purpose of all its activities and the headquarters or registered office of the institution.
   ．Tax identification card, contract
   ．Activity descriptive documentation (if applicable)
   ．Representative authorization document for the authorization process in RSI (if applicable)
   ．The company is responsible for declaring documents related to the automatic control system (to be submitted or inspected within 3 months)
   ．Proof of payment of additional licensing fees
   ．Applicant’s DNI/NIE or tax ID

Product liability
Importers have primary responsibility for the food safety of the products they sell and must comply with a number of obligations.

1. Safety: Unsafe food cannot be sold.
2. Responsibility: assume responsibility for ensuring food safety in its production, transportation, storage or sale.
3. Traceability: Quickly identify its suppliers or customers.
4. Transparency: If the food responsible is unsafe, the competent authority should be notified immediately.
5. Emergency situations: If food is unsafe, it should be removed from the market immediately.
6. Prevention: Identify, regularly review and control key points in the process.
7. Cooperation: Cooperate with the competent authorities to take actions to reduce risks.

【參考連結】
https://www.boe.es/buscar/act.php?id=BOE-A-2011-4293&p=20221221&tn=0
https://www.aesan.gob.es/AECOSAN/web/operadores_economicos/seccion/Responsabilidades_operadores_economicos.htm

HLF-TW-85

各國健康食品登記法規問題集

联系我们：
Email：bcn4ww@evershinecpa.com
或
西班牙永輝BPO有限公司
Barcelona time zone:
Anna Wang, 說西班牙文中文和英文
或
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聯絡人: 陳中成 Dale Chen 會計師/所長
手機：+886-933-920-199
skype: Daleccchen
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所長 Principal Partner:
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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