西班牙保健食品登记法规问题集

西班牙主要城市公司设立登记,商标登记，进出口证，特许行业申请等。公司设立后云端系统支援的会计薪资服务。西班牙与臺湾同事携手协同爲您服务。为地球暖化尽一份心力，减少空中旅行。
Email：bcn4ww@evershinecpa.com
或
西班牙永辉BPO有限公司
Barcelona time zone:
Anna Wang, 说西班牙文中文和英文
或
China Time Zone:
联络人: 林幸穗 Anny Lin 协理
手机：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
电话：+886-2-2717-0515 分机:110

各国健康食品登记法规问题集

时间：2022/10/28 drafted by Yvonne Chen

HLF-TW-10
请问西班牙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 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，保健食品称为食品补充剂，西班牙食品安全与营养局(AESAN)是西班牙食品补充剂的监管机构。
食品补充剂定义为：以补充正常饮食为目的，含有浓缩的营养物质或其他具有营养或生理作用的物质。以简单或组合形式，以剂量形式销售的食品产品，即胶囊、丸剂.、片剂和其他类似形式、粉末袋、液体安瓶、滴管瓶和其他类似形式的液体和粉末，必须以小单位剂量服用。

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.

【参考连结】
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
外国公司要到西班牙销售保健食品，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 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：
需于「食品和食品公司卫生总登记处」(RGSEAA)完成食品企业註册。

食品公司及其企业如果製造、加工或改造、包装、储存、分销和进口供人类消费的食品，则必须卫生总登记处註册。
1.申请机构：「食品和食品公司卫生总登记处」 (RGSEAA)
网址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申请人：西班牙境内的公司/办事处，或经欧盟授权的公司/办事处
3.註册表：
．公司经营者必须提供：公司名称、NIF、NIE 或 CIF、其所有活动的目的以及机构总部或註册办事处。
．税务识别卡、契约
．活动描述性的文件(如果适用)
．RSI 中授权流程的代表授权文件(如果适用)
．公司负责声明与自控系统相关的文件(需在 3 个月内缴交或被检查)
．额外授权费的支付证明
．申请人的 DNI/NIE 或税务身分证

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

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

HLF-TW-25

HLF-TW-30
外国公司要到西班牙销售保健食品，可以指派西班牙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 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，需于「食品和食品公司卫生总登记处」 (RGSEAA)完成食品企业註册。

食品公司及其企业如果製造、加工或改造、包装、储存、分销和进口供人类消费的食品，则必须卫生总登记处註册。
1.申请机构：「食品和食品公司卫生总登记处」 (RGSEAA)
网址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申请人：西班牙境内的公司/办事处，或经欧盟授权的公司/办事处
3.註册表：
．公司经营者必须提供：公司名称、NIF、NIE 或 CIF、其所有活动的目的以及机构总部或註册办事处。
．税务识别卡、契约
．活动描述性的文件(如果适用)
．RSI 中授权流程的代表授权文件(如果适用)
．公司负责声明与自控系统相关的文件(需在 3 个月内缴交或被检查)
．额外授权费的支付证明
．申请人的 DNI/NIE 或税务身分证

产品责任
进口商对其销售的产品的食品安全负有主要责任，并且必须遵守一系列义务。
1.安全：不能销售不安全的食品。
2.责任：承担确保其生产、运输、储存或销售的食品安全责任。
3.可追溯性：快速辨识其供应商或客户。
4.透明度：如果负责的食品不安全，应立即通知主管机关。
5.紧急情况：如果食品不安全，应立即将其从市场上撤下。
6.预防：确定、定期审查和控制流程的关键点。
7.合作：配合主管机关採取行动降低风险。

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.

【参考连结】
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
外国公司销售到西班牙保健食品本身，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 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：
无产品许可证，但进口商需于「食品和食品公司卫生总登记处」 (RGSEAA)完成食品企业註册。

食品公司及其企业如果製造、加工或改造、包装、储存、分销和进口供人类消费的食品，则必须卫生总登记处註册。
1.申请机构：「食品和食品公司卫生总登记处」 (RGSEAA)
网址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申请人：西班牙境内的公司/办事处，或经欧盟授权的公司/办事处
3.註册表：
．公司经营者必须提供：公司名称、NIF、NIE 或 CIF、其所有活动的目的以及机构总部或註册办事处。
．税务识别卡、契约
．活动描述性的文件(如果适用)
．RSI 中授权流程的代表授权文件(如果适用)
．公司负责声明与自控系统相关的文件(需在 3 个月内缴交或被检查)
．额外授权费的支付证明
．申请人的 DNI/NIE 或税务身分证

标籤
在西班牙销售的食品标籤上的强制性说明将至少要以官方的西班牙语表达。食品标籤要求以下强制性标示：
．产品的销售名称。
．成分清单。
．成分的数量或成分类别。
．酒精含量超过 1.2%。
．包装产品的淨含量。
．最短期限日期或到期日。
．保存和使用的特殊条件。
．使用说明(如果其指示对于正确使用食品是必要的)
．公司资讯：在欧盟境内设立的製造商、包装商或销售商的名称、公司名称、地址。
．地段。
．原产地或出处。
．特殊种类食品所规定的内容。

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.

【参考连结】
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：
若已于欧盟其他国家认可的企业登记产品可以相互承认原则销售产品，但如果没有则需要是西班牙境内企业于「食品和食品公司卫生总登记处」 (RGSEAA)完成食品企业註册。

食品公司及其企业如果製造、加工或改造、包装、储存、分销和进口供人类消费的食品，则必须卫生总登记处註册。
1.申请机构：「食品和食品公司卫生总登记处」 (RGSEAA)
网址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申请人：西班牙境内的公司/办事处，或经欧盟授权的公司/办事处
3.註册表：
．公司经营者必须提供：公司名称、NIF、NIE 或 CIF、其所有活动的目的以及机构总部或註册办事处。
．税务识别卡、契约
．活动描述性的文件(如果适用)
．RSI 中授权流程的代表授权文件(如果适用)
．公司负责声明与自控系统相关的文件(需在 3 个月内缴交或被检查)
．额外授权费的支付证明
．申请人的 DNI/NIE 或税务身分证

标籤
在西班牙销售的食品标籤上的强制性说明将至少要以官方的西班牙语表达。食品标籤要求以下强制性标示：
．产品的销售名称。
．成分清单。
．成分的数量或成分类别。
．酒精含量超过 1.2%。
．包装产品的淨含量。
．最短期限日期或到期日。
．保存和使用的特殊条件。
．使用说明(如果其指示对于正确使用食品是必要的)
．公司资讯：在欧盟境内设立的製造商、包装商或销售商的名称、公司名称、地址。
．地段。
．原产地或出处。
．特殊种类食品所规定的内容。

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.

【参考连结】
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
经过核准登记的保健食品，进口到西班牙要检附什麽文件？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 Spain? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海关

1. 经济经营者註册和识别(EORI)
   向西班牙海关( OEA )申请取得 EORI 号码
   网页：https://sede.agenciatributaria.gob.es/Sede/inicio.html
   申请书内容
   ．自然人：护照或其他有效身分证件；公司名称/责任人姓名
   ．西班牙的纳税住所。
   ．创建日期/生日
   ．人员类型：自然人/法人/团体
   ．地址、电话、电子邮件
   ．联络资讯、联络人姓名、地址、电话号码、传真号码、电子邮件
   ．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
   ．经济活动部门4位代码：商业登记处註明的欧盟经济活动统计分类(NACE)主要经济活动的4位数代码
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
   ．商业发票副本 (西班牙语)
   ．计量(单位必须是公制)
   ．原产地声明

销售前通知
第三国进口的产品，在将食品补充剂投放市场之前，必须向西班牙食品安全和营养局(AESAN)发出正式通知。
1.申请人：将产品投放市场的负责人或进口商(须为欧盟境内代表)
2.申请机构：消费者事务部电子入口
网页：
https://consumo.sede.gob.es/procedimientos/portada/ida/3917/idp/1639
3.申请书内容
．申请人身分：自己的名义/代表利害关係人(自然人或法人)
．公司资讯
．食品补充剂成分
．西班牙文标籤
．来自其他国家的标籤
．来自另一个欧盟国家的行销文件
．科学文献
．其他资料
4.付费
5.签名、完成申请

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

【参考连结】
https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/subseccion/procedimientos_registro.htm#2

HLF-TW-70
西班牙保健食品审核机构，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：
须提供「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://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，如果委託西班牙的经销商销售，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 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：
需于「食品和食品公司卫生总登记处」 (RGSEAA)完成食品企业註册。

食品公司及其企业如果製造、加工或改造、包装、储存、分销和进口供人类消费的食品，则必须卫生总登记处註册。
1.申请机构：「食品和食品公司卫生总登记处」 (RGSEAA)
网址：https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/rgsa_empresas_inscritas.htm
2.申请人：西班牙境内的公司/办事处，或经欧盟授权的公司/办事处
3.註册表：
．公司经营者必须提供：公司名称、NIF、NIE 或 CIF、其所有活动的目的以及机构总部或註册办事处。
．税务识别卡、契约
．活动描述性的文件(如果适用)
．RSI 中授权流程的代表授权文件(如果适用)
．公司负责声明与自控系统相关的文件(需在 3 个月内缴交或被检查)
．额外授权费的支付证明
．申请人的 DNI/NIE 或税务身分证

产品责任
进口商对其销售的产品的食品安全负有主要责任，并且必须遵守一系列义务。
1.安全：不能销售不安全的食品。
2.责任：承担确保其生产、运输、储存或销售的食品安全责任。
3.可追溯性：快速辨识其供应商或客户。
4.透明度：如果负责的食品不安全，应立即通知主管机关。
5.紧急情况：如果食品不安全，应立即将其从市场上撤下。
6.预防：确定、定期审查和控制流程的关键点。
7.合作：配合主管机关採取行动降低风险。

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.

【参考连结】
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

各国健康食品登记法规问题集

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