英国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：2023/09/08  drafted by Yvonne Chen

HLF-TW-10
请问英国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 The United Kingdom? 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：
在英国，保健食品称为食品补充剂，由卫生部(DH)监管。定义是：任何旨在补充正常饮食的食品，由维生素或矿物质或其他具有营养/生理作用物质的浓缩来源，以单独或複合的方式组合，并以剂型出售。

食品补充剂中可能含有多种营养素和其他成分，可以包括：维生素、 矿物质、氨基酸、必需脂肪酸、纤维、各种植物和草药萃取物。

食品补充剂旨在补充缺乏的营养、维持某些营养素的充足摄取或支持特定生理功能。它们不是药品，因此不能发挥药理学、免疫学或代谢作用。食品补充剂的使用并非旨在治疗或预防人类疾病或改变生理功能。因此，在英国，食品补充剂作为食品进行监管，并遵守一般食品法的规定。

In the UK, health foods are called food supplements and are regulated by the Department of Health (DH). Definition: Any food intended to supplement the normal diet, composed of concentrated sources of vitamins or minerals or other substances with nutritional/physiological effects, combined individually or in combination, and sold in dosage form.

Food supplements may contain a variety of nutrients and other ingredients, which can include: vitamins, minerals, amino acids, essential fatty acids, fiber, and various plant and herbal extracts.

Food supplements are intended to supplement nutritional deficiencies, maintain adequate intake of certain nutrients, or support specific physiological functions. They are not pharmaceuticals and therefore cannot exert pharmacological, immunological or metabolic effects. The use of food supplements is not intended to treat or prevent human disease or to modify physiological functions. Therefore, in the UK, food supplements are regulated as food and are subject to the provisions of the General Food Act.

【参考连结】
https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs
https://www.gov.uk/government/organisations/department-of-health-and-social-care

HLF-TW-20
外国公司要到英国销售保健食品，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 The United Kingdom, 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：
需要註册为食品经营者 (FBO)。

在英国销售食品补充剂，必须在营运28天前向当地议会进行食品经营者 (FBO) 註册。委员会检查营业场所，确保遵守食品安全和卫生法规。

流程：
1.缴交食品业务登记表，邮寄当地议会。
网页：https://register.food.gov.uk/new
．食品企业商号、机构地址（或可移动机构的存放地点）、邮递区号、电话号码、电子邮件
．食品经营者的全名/公司名称、总部/註册办事处地址、邮递区号、电话号码、电子邮件
．食品经营者的全名、家庭住址、邮递区号
．食品活动类型
．开业日期
．食品经营者/公司董事签章

2.食品安全检验：在开业后，委员会安排食品安全检查，完成风险评估和评级。
．评估潜在危险：食物种类及处理方法、加工和处理食品的方法、面临风险的消费者类型和数量、食品操作的合规性、物理环境
．确定遵守法规
．确认管理和控制系统
．评估风险的重要性

Registration as a food business operator (FBO) is required.

To sell food supplements in the UK, you must register as a food business operator (FBO) with the local council 28 days before operating. The committee inspects business premises to ensure compliance with food safety and hygiene regulations.

Process:

1. Submit the food business registration form and mail it to the local council.
   URL: https://register.food.gov.uk/new
   ．Food business trade name, facility address (or location of removable facility), postal code, phone number, email
   ．Food business operator’s full name/company name, head office/registered office address, postal code, telephone number, email
   ．Food business operator’s full name, home address, postal code
   ．Food event type
   ．Opening date
   ．Signature and seal of food operator/company director
2. Food safety inspection: After opening, the committee arranges food safety inspections and completes risk assessment and rating.
   ．Assess potential hazards: types of food and methods of handling, methods of processing and handling food, types and numbers of consumers at risk, compliance of food operations, physical environment
   ．Determine compliance with regulations
   ．Validate management and control systems
   ．Assess the importance of risk

【参考连结】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration

HLF-TW-25

HLF-TW-30
外国公司要到英国销售保健食品，可以指派英国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 The United Kingdom, can it assign a The United Kingdom 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，营业代理人需要註册为食品经营者 (FBO)。

在英国销售食品补充剂，必须在营运28天前向当地议会进行食品经营者 (FBO) 註册。委员会检查营业场所，确保遵守食品安全和卫生法规。

流程：
1.缴交食品业务登记表，邮寄当地议会。
网页：https://register.food.gov.uk/new
．食品企业商号、机构地址（或可移动机构的存放地点）、邮递区号、电话号码、电子邮件
．食品经营者的全名/公司名称、总部/註册办事处地址、邮递区号、电话号码、电子邮件
．食品经营者的全名、家庭住址、邮递区号
．食品活动类型
．开业日期
．食品经营者/公司董事签章

2.食品安全检验：在开业后，委员会安排食品安全检查，完成风险评估和评级。
．评估潜在危险：食物种类及处理方法、加工和处理食品的方法、面临风险的消费者类型和数量、食品操作的合规性、物理环境
．确定遵守法规
．确认管理和控制系统
．评估风险的重要性

产品责任
食品标准局採上市后控制检查所销售的食品补充剂成分、标籤和安全方面是否合规。
1.营业代理人：FBO有责任在将食品投放到英国市场之前保证其安全。
2.进口商：进口商有责任承担法律责任，包括产品的成分、安全性和标籤。

Yes, the business agent needs to be registered as a food business operator (FBO).

To sell food supplements in the UK, you must register as a food business operator (FBO) with the local council 28 days before operating. The committee inspects business premises to ensure compliance with food safety and hygiene regulations.

Process:

1. Submit the food business registration form and mail it to the local council.
   URL: https://register.food.gov.uk/new
   ．Food business trade name, facility address (or location of removable facility), postal code, phone number, email
   ．Food business operator’s full name/company name, head office/registered office address, postal code, telephone number, email
   ．Food business operator’s full name, home address, postal code
   ．Food event type
   ．Opening date
   ．Signature and seal of food operator/company director
2. Food safety inspection: After opening, the committee arranges food safety inspections and completes risk assessment and rating.
   ．Assess potential hazards: types of food and methods of handling, methods of processing and handling food, types and numbers of consumers at risk, compliance of food operations, physical environment
   ．Determine compliance with regulations
   ．Validate management and control systems
   ．Assess the importance of risk

Product liability
The Food Standards Agency uses post-market controls to check that food supplements sold are for compliance with respect to ingredients, labeling and safety.

1. Business agent: The FBO has the responsibility to ensure the safety of food before placing it on the UK market.
2. Importer: The importer is responsible for legal responsibility, including the composition, safety and labeling of the product.

【参考连结】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-35

HLF-TW-40
外国公司销售到英国保健食品本身，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 The United Kingdom? 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：
不需要。
自英国脱欧以来，食品补充剂不再需要上市前授权。标籤不需要上市前核准，但需要符合法规，採上市后控制检查。

标籤
1.必须标记为食品补充剂，不是膳食补充剂。
2.产品标籤必须包括：
．企业名称、地址(产品标籤或产品包装上)：销售企业或进口企业
．成分清单：必须强调的常见过敏原
．使用条件：建议每日剂量的资讯以及不要超过此剂量的警告
．储存说明：产品应储存在幼儿接触不到的地方的声明
．最佳使用期限：标示此日期前使用或此日期前最佳及日期
．具有营养或生理作用的任何维生素或矿物质或其他物质的含量
．食品补充剂不应替代多样化饮食的声明
．原产地
3.位置
．包装
．贴在包装上的标籤
．透过包装清晰可见的标籤
4.注意
．在北爱尔兰境内销售的食品补充剂必须包含食品企业的北爱尔兰或欧盟地址。如果食品企业不在北爱尔兰或欧盟境内，则必须包含位最小字体大小适用于强制性资讯。
．字体大小由字母 x确定，并且高度是否大于等于1.2mm；如果包装的最大表面积小于80平方釐米，则可以使用最小x高度0.9mm。于北爱尔兰或欧盟的进口商地址。
．强制性食品资讯必须清晰易读且难以去除。不得以任何其他方式将其隐藏，遮盖，遮挡或干扰任何其他书面或图片上的内容。
．语言以英文表示。

The license is not required.
Since Brexit, food supplements no longer require pre-market authorization. Labeling does not require pre-market approval, but compliance with regulations and post-market control checks are required.

Label

1. Must be labeled as a food supplement, not a dietary supplement.
2. Product labels must include:
   ．Company name, address (on product label or product packaging): sales company or import company
   ．Ingredient List: Common Allergens Must Be Emphasized
   ．Conditions of use: information on the recommended daily dosage and warnings not to exceed this dosage
   ．Storage Instructions: A statement that the product should be stored out of the reach of young children
   ．Best before date: indicate use before this date or best before this date and date
   ．Te content of any vitamin or mineral or other substance having a nutritional or physiological effect
   ．Statement that food supplements should not be a substitute for a varied diet
   ．Country of origin
3. Location
   ．Package
   ．labels affixed to packaging
   ．Labels clearly visible through packaging
   4.Attention
   ．Food supplements sold in Northern Ireland must include the Northern Ireland or EU address of the food business. If the food business is not located in Northern Ireland or the EU, a minimum font size must be included for mandatory information.
   ．The font size is determined by the letter x and whether the height is greater than or equal to 1.2mm; if the maximum surface area of the package is less than 80 square centimeters, a minimum x-height of 0.9mm can be used. The address of the importer in Northern Ireland or the EU.
   ．Mandatory food information must be legible and difficult to remove. It may not in any other way conceal, obscure, obscure or interfere with any other written or pictorial content.
   ．Language is indicated in English.

【参考连结】
https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-45
请问在英国有哪些专业服务机构，可以协助办理保健食品产品许可证？
Evershine RD：
无须产品许可证。

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：
不需要。
自英国脱欧以来，食品补充剂不再需要上市前授权。标籤不需要上市前核准，但需要符合法规，採上市后控制检查。

标籤
1.必须标记为食品补充剂，不是膳食补充剂。
2.产品标籤必须包括：
．企业名称、地址(产品标籤或产品包装上)：销售企业或进口企业
．成分清单：必须强调的常见过敏原
．使用条件：建议每日剂量的资讯以及不要超过此剂量的警告
．储存说明：产品应储存在幼儿接触不到的地方的声明
．最佳使用期限：标示此日期前使用或此日期前最佳及日期
．具有营养或生理作用的任何维生素或矿物质或其他物质的含量
．食品补充剂不应替代多样化饮食的声明
．原产地
3.位置
．包装
．贴在包装上的标籤
．透过包装清晰可见的标籤
4.注意
．在北爱尔兰境内销售的食品补充剂必须包含食品企业的北爱尔兰或欧盟地址。如果食品企业不在北爱尔兰或欧盟境内，则必须包含位最小字体大小适用于强制性资讯。
．字体大小由字母 x确定，并且高度是否大于等于1.2mm；如果包装的最大表面积小于80平方釐米，则可以使用最小x高度0.9mm。于北爱尔兰或欧盟的进口商地址。
．强制性食品资讯必须清晰易读且难以去除。不得以任何其他方式将其隐藏，遮盖，遮挡或干扰任何其他书面或图片上的内容。
．语言以英文表示。

The license is not required..
Since Brexit, food supplements no longer require pre-market authorization. Labeling does not require pre-market approval, but compliance with regulations and post-market control checks are required.

Label

1. Must be labeled as a food supplement, not a dietary supplement.
2. Product labels must include:
   ．Company name, address (on product label or product packaging): sales company or import company
   ．Ingredient List: Common Allergens Must Be Emphasized
   ．Conditions of use: information on the recommended daily dosage and warnings not to exceed this dosage
   ．Storage Instructions: A statement that the product should be stored out of the reach of young children
   ．Best before date: indicate use before this date or best before this date and date
   ．Te content of any vitamin or mineral or other substance having a nutritional or physiological effect
   ．Statement that food supplements should not be a substitute for a varied diet
   ．Country of origin
3. Location
   ．Package
   ．labels affixed to packaging
   ．Labels clearly visible through packaging
   4.Attention
   ．Food supplements sold in Northern Ireland must include the Northern Ireland or EU address of the food business. If the food business is not located in Northern Ireland or the EU, a minimum font size must be included for mandatory information.
   ．The font size is determined by the letter x and whether the height is greater than or equal to 1.2mm; if the maximum surface area of the package is less than 80 square centimeters, a minimum x-height of 0.9mm can be used. The address of the importer in Northern Ireland or the EU.
   ．Mandatory food information must be legible and difficult to remove. It may not in any other way conceal, obscure, obscure or interfere with any other written or pictorial content.
   ．Language is indicated in English.

【参考连结】
https://www.gov.uk/government/publications/food-supplements-guidance-and-faqs
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-55
请问在英国有哪些专业服务机构，可以协助以外国公司名义办理保健食品产品许可证？
Evershine RD：
无须产品许可证。

HLF-TW-60
经过核准登记的保健食品，进口到英国要检附什麽文件？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 The United Kingdom? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
无须产品许可证，产品符合法规即可进口。
进口流程：

1. 经济运营商註册和识别号(EORI号)：如果企业位于要将货物运入或运出的国家/地区，需要先取得EORI号码。
   ．企业通常需要在进口或出口的国家/地区拥有经营场所，的场所必须是以下之一：註册办事处、中央总部、永久营业机构。
   ．如果没有资格自行申请EORI号码，则需要指定某人代表处理海关事宜。
2. 申请使用简化进口报关单
   网页：https://www.gov.uk/topic/business-tax/import-export
   ．补充声明汇总
   ．使用简化声明
   ．使用声明人记录
   ．第三方代表申请授权
   ．食品补充剂商品代码：2106
3. 进口报关单(所有从英国境外进口的货物都必须向英国海关申报。)
   ．公司经济经营者註册和识别号 (EORI)
   ．公司增值税号
   ．进口原因
   ．商品描述
   ．关税号/商品代码
   ．货物价值
   ．任何可能适用的进口管制
   4.具备资料
   ．商业发票或运输发票
   ．运输文件(例如提单、空运单等)
   ．装箱单
   ．保险凭证/保单
   ．商品编码
   ．关税估价
   ．採购订单/合约
   ．海关入境文件
   ．货运代理或承运人发票
   ．附加证书

无销售通知。

Without a product license, products can be imported if they comply with regulations.

Import process:

1. Economic Operator Registration and Identification Number (EORI Number): If the business is located in the country/region where the goods are to be shipped into or out of, it needs to obtain an EORI number first.
   ．Businesses usually need to have a place of business in the country from which they are importing or exporting. The place of business must be one of the following: registered office, central headquarters, permanent establishment.
   ．If you are not eligible to apply for an EORI number yourself, you will need to appoint someone to represent you in customs matters.
2. Apply for the simplified import declaration form
   URL: https://www.gov.uk/topic/business-tax/import-export
   ．Summary of additional statements
   ．Use simplified declarations
   ．Use the declarant record
   ．Application for Authorization by a Third-Party Representative
   ． Food Supplements Commodity Code: 2106
3. Import declaration form (all goods imported from outside the UK must be declared to UK customs.)
   ．Economic Operator Registration and Identification Number (EORI)
   ．Company VAT number
   ．Import reason
   ．Product description
   ．Tariff Number/Commodity Code
   ．Value of goods
   ．Any import controls that may apply
4. Have information
   ．Commercial invoice or shipping invoice
   ．Shipping documents (e.g. bill of lading, air waybill, etc.)
   ．Packing List
   ．Insurance certificate/policy
   ．Commodity code
   ．Tariff Valuation
   ．Purchase Order/Contract
   ．Customs Entry Documents
   ．Freight Forwarder or Carrier Invoice
   ．Additional certificate

No sale notification.

【参考连结】
https://www.gov.uk/topic/business-tax/import-export

HLF-TW-70
英国保健食品审核机构，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：
保健食品无须审核，但必须符合食品法及食品安全法。

危害分析和关键控制点 (HACCP)
1.HACCP原则：
．审视可能出现的问题以及食品安全存在哪些风险
．确定企业需要关注的关键控制点，确保消除风险或将降到安全水平
．决定出现问题时需要採取什麽行动
．确保程序遵循且有效
．保存记录
．制定适合的食品安全管理程序

2.食品安全危害主要分为三类：
．微生物学：涉及有害细菌
．化学：涉及化学汙染
．物理：涉及物体进入食物

Health food does not require review, but must comply with food laws and food safety laws.

Hazard Analysis and Critical Control Points (HACCP)
1.HACCP principle:
．Examine what might go wrong and what are the risks to food safety
．Identify critical control points that the business needs to focus on to ensure that risks are eliminated or brought down to a safe level
．Decide what action needs to be taken when a problem occurs
．Ensure procedures are followed and effective
．Keep records
．Develop appropriate food safety management procedures

2.Food safety hazards are mainly divided into three categories:
．Microbiology: Involves harmful bacteria
．Chemistry: involves chemical pollution
．Physics: Involves objects getting into food

【参考连结】
https://www.gov.uk/government/publications/nutrition-legislation-information-sources/nutrition-legislation-information-sheet–2#food-supplements

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口保健食品后，如果委託英国的经销商销售，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 The United Kingdom 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：
需要註册为食品经营者 (FBO)。

在英国销售食品补充剂，必须在营运28天前向当地议会进行食品经营者 (FBO) 註册。委员会检查营业场所，确保遵守食品安全和卫生法规。

流程：
1.缴交食品业务登记表，邮寄当地议会。
网页：https://register.food.gov.uk/new
．食品企业商号、机构地址（或可移动机构的存放地点）、邮递区号、电话号码、电子邮件
．食品经营者的全名/公司名称、总部/註册办事处地址、邮递区号、电话号码、电子邮件
．食品经营者的全名、家庭住址、邮递区号
．食品活动类型
．开业日期
．食品经营者/公司董事签章

2.食品安全检验：在开业后，委员会安排食品安全检查，完成风险评估和评级。
．评估潜在危险：食物种类及处理方法、加工和处理食品的方法、面临风险的消费者类型和数量、食品操作的合规性、物理环境
．确定遵守法规
．确认管理和控制系统
．评估风险的重要性

产品责任
食品标准局採上市后控制检查所销售的食品补充剂成分、标籤和安全方面是否合规。
1.营业代理人：FBO有责任在将食品投放到英国市场之前保证其安全。
2.进口商：进口商有责任承担法律责任，包括产品的成分、安全性和标籤。

Registration as a food business operator (FBO) is required.

To sell food supplements in the UK, you must register as a food business operator (FBO) with the local council 28 days before operating. The committee inspects business premises to ensure compliance with food safety and hygiene regulations.

Process:

1. Submit the food business registration form and mail it to the local council.
   URL: https://register.food.gov.uk/new
   ．Food business trade name, facility address (or location of removable facility), postal code, phone number, email
   ．Food business operator’s full name/company name, head office/registered office address, postal code, telephone number, email
   ．Food business operator’s full name, home address, postal code
   ．Food event type
   ．Opening date
   ．Signature and seal of food operator/company director
2. Food safety inspection: After opening, the committee arranges food safety inspections and completes risk assessment and rating.
   ．Assess potential hazards: types of food and methods of handling, methods of processing and handling food, types and numbers of consumers at risk, compliance of food operations, physical environment
   ．Determine compliance with regulations
   ．Validate management and control systems
   ．Assess the importance of risk

Product liability
The Food Standards Agency uses post-market controls to check that food supplements sold are for compliance with respect to ingredients, labeling and safety.

1. Business agent: The FBO has the responsibility to ensure the safety of food before placing it on the UK market.
2. Importer: The importer is responsible for legal responsibility, including the composition, safety and labeling of the product.

【参考连结】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration
https://www.food.gov.uk/business-guidance/food-supplements#selling-your-products

HLF-TW-85

各国健康食品登记法规问题集

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