英國保健食品登記法規問題集

英國保健食品登記法規問題集

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各國健康食品登記法規問題集

時間:2023/09/08  drafted by Yvonne Chen

HLF-TW-10
請問英國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 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:
在英國,保健食品稱為食品補充劑,由衛生部(DH)監管。定義是:任何旨在補充正常飲食的食品,由維生素或礦物質或其他具有營養/生理作用物質的濃縮來源,以單獨或複合的方式組合,並以劑型出售。

食品補充劑中可能含有多種營養素和其他成分,可以包括:維生素、 礦物質、氨基酸、必需脂肪酸、纖維、各種植物和草藥萃取物。

食品補充劑旨在補充缺乏的營養、維持某些營養素的充足攝取或支持特定生理功能。它們不是藥品,因此不能發揮藥理學、免疫學或代謝作用。食品補充劑的使用並非旨在治療或預防人類疾病或改變生理功能。因此,在英國,食品補充劑作為食品進行監管,並遵守一般食品法的規定。

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.

【參考連結】
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
外國公司要到英國銷售保健食品,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 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:
需要註冊為食品經營者 (FBO)。

在英國銷售食品補充劑,必須在營運28天前向當地議會進行食品經營者 (FBO) 註冊。委員會檢查營業場所,確保遵守食品安全和衛生法規。

流程:
1.繳交食品業務登記表,郵寄當地議會。
網頁:https://register.food.gov.uk/new
.食品企業商號、機構地址(或可移動機構的存放地點)、郵遞區號、電話號碼、電子郵件
.食品經營者的全名/公司名稱、總部/註冊辦事處地址、郵遞區號、電話號碼、電子郵件
.食品經營者的全名、家庭住址、郵遞區號
.食品活動類型
.開業日期
.食品經營者/公司董事簽章

2.食品安全檢驗:在開業後,委員會安排食品安全檢查,完成風險評估和評級。
.評估潛在危險:食物種類及處理方法、加工和處理食品的方法、面臨風險的消費者類型和數量、食品操作的合規性、物理環境
.確定遵守法規
.確認管理和控制系統
.評估風險的重要性

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

【參考連結】
https://register.food.gov.uk/new
https://www.camden.gov.uk/food-business-registration

HLF-TW-25

HLF-TW-30
外國公司要到英國銷售保健食品,可以指派英國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 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,營業代理人需要註冊為食品經營者 (FBO)。

在英國銷售食品補充劑,必須在營運28天前向當地議會進行食品經營者 (FBO) 註冊。委員會檢查營業場所,確保遵守食品安全和衛生法規。

流程:
1.繳交食品業務登記表,郵寄當地議會。
網頁:https://register.food.gov.uk/new
.食品企業商號、機構地址(或可移動機構的存放地點)、郵遞區號、電話號碼、電子郵件
.食品經營者的全名/公司名稱、總部/註冊辦事處地址、郵遞區號、電話號碼、電子郵件
.食品經營者的全名、家庭住址、郵遞區號
.食品活動類型
.開業日期
.食品經營者/公司董事簽章

2.食品安全檢驗:在開業後,委員會安排食品安全檢查,完成風險評估和評級。
.評估潛在危險:食物種類及處理方法、加工和處理食品的方法、面臨風險的消費者類型和數量、食品操作的合規性、物理環境
.確定遵守法規
.確認管理和控制系統
.評估風險的重要性

產品責任
食品標準局採上市後控制檢查所銷售的食品補充劑成分、標籤和安全方面是否合規。
1.營業代理人:FBO有責任在將食品投放到英國市場之前保證其安全。
2.進口商:進口商有責任承擔法律責任,包括產品的成分、安全性和標籤。

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.

【參考連結】
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
外國公司銷售到英國保健食品本身,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 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。
自英國脫歐以來,食品補充劑不再需要上市前授權。標籤不需要上市前核准,但需要符合法規,採上市後控制檢查。

標籤
1.必須標記為食品補充劑,不是膳食補充劑。
2.產品標籤必須包括:
.企業名稱、地址(產品標籤或產品包裝上):銷售企業或進口企業
.成分清單:必須強調的常見過敏原
.使用條件:建議每日劑量的資訊以及不要超過此劑量的警告
.儲存說明:產品應儲存在幼兒接觸不到的地方的聲明
.最佳使用期限:標示此日期前使用或此日期前最佳及日期
.具有營養或生理作用的任何維生素或礦物質或其他物質的含量
.食品補充劑不應替代多樣化飲食的聲明
.原產地
3.位置
.包裝
.貼在包裝上的標籤
.透過包裝清晰可見的標籤
4.注意
.在北愛爾蘭境內銷售的食品補充劑必須包含食品企業的北愛爾蘭或歐盟地址。如果食品企業不在北愛爾蘭或歐盟境內,則必須包含位最小字體大小適用於強制性資訊。
.字體大小由字母 x確定,並且高度是否大於等於1.2mm;如果包裝的最大表面積小於80平方釐米,則可以使用最小x高度0.9mm。於北愛爾蘭或歐盟的進口商地址。
.強制性食品資訊必須清晰易讀且難以去除。不得以任何其他方式將其隱藏,遮蓋,遮擋或干擾任何其他書面或圖片上的內容。
.語言以英文表示。

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.

【參考連結】
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
請問在英國有哪些專業服務機構,可以協助辦理保健食品產品許可證?
Evershine RD:
無須產品許可證。

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:
不需要。
自英國脫歐以來,食品補充劑不再需要上市前授權。標籤不需要上市前核准,但需要符合法規,採上市後控制檢查。

標籤
1.必須標記為食品補充劑,不是膳食補充劑。
2.產品標籤必須包括:
.企業名稱、地址(產品標籤或產品包裝上):銷售企業或進口企業
.成分清單:必須強調的常見過敏原
.使用條件:建議每日劑量的資訊以及不要超過此劑量的警告
.儲存說明:產品應儲存在幼兒接觸不到的地方的聲明
.最佳使用期限:標示此日期前使用或此日期前最佳及日期
.具有營養或生理作用的任何維生素或礦物質或其他物質的含量
.食品補充劑不應替代多樣化飲食的聲明
.原產地
3.位置
.包裝
.貼在包裝上的標籤
.透過包裝清晰可見的標籤
4.注意
.在北愛爾蘭境內銷售的食品補充劑必須包含食品企業的北愛爾蘭或歐盟地址。如果食品企業不在北愛爾蘭或歐盟境內,則必須包含位最小字體大小適用於強制性資訊。
.字體大小由字母 x確定,並且高度是否大於等於1.2mm;如果包裝的最大表面積小於80平方釐米,則可以使用最小x高度0.9mm。於北愛爾蘭或歐盟的進口商地址。
.強制性食品資訊必須清晰易讀且難以去除。不得以任何其他方式將其隱藏,遮蓋,遮擋或干擾任何其他書面或圖片上的內容。
.語言以英文表示。

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.

【參考連結】
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
請問在英國有哪些專業服務機構,可以協助以外國公司名義辦理保健食品產品許可證?
Evershine RD:
無須產品許可證。

HLF-TW-60
經過核准登記的保健食品,進口到英國要檢附什麼文件?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 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:
無須產品許可證,產品符合法規即可進口。
進口流程:

  1. 經濟運營商註冊和識別號(EORI號):如果企業位於要將貨物運入或運出的國家/地區,需要先取得EORI號碼。
    .企業通常需要在進口或出口的國家/地區擁有經營場所,的場所必須是以下之一:註冊辦事處、中央總部、永久營業機構。
    .如果沒有資格自行申請EORI號碼,則需要指定某人代表處理海關事宜。
  2. 申請使用簡化進口報關單
    網頁:
    https://www.gov.uk/topic/business-tax/import-export
    補充聲明匯總
    .使用簡化聲明
    .使用聲明人記錄
    .第三方代表申請授權
    .食品補充劑商品代碼:2106
  3. 進口報關單(所有從英國境外進口的貨物都必須向英國海關申報。)
    .公司經濟經營者註冊和識別號 (EORI)
    .公司增值稅號
    .進口原因
    .商品描述
    .關稅號/商品代碼
    .貨物價值
    .任何可能適用的進口管制
    4.具備資料
    .商業發票或運輸發票
    .運輸文件(例如提單、空運單等)
    .裝箱單
    .保險憑證/保單
    .商品編碼
    .關稅估價
    .採購訂單/合約
    .海關入境文件
    .貨運代理或承運人發票
    .附加證書

無銷售通知。

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.

【參考連結】
https://www.gov.uk/topic/business-tax/import-export

HLF-TW-70
英國保健食品審核機構,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:
保健食品無須審核,但必須符合食品法及食品安全法。

危害分析和關鍵控制點 (HACCP)
1.HACCP原則:
.審視可能出現的問題以及食品安全存在哪些風險
.確定企業需要關注的關鍵控制點,確保消除風險或將降到安全水平
.決定出現問題時需要採取什麼行動
.確保程序遵循且有效
.保存記錄
.制定適合的食品安全管理程序

2.食品安全危害主要分為三類:
.微生物學:涉及有害細菌
.化學:涉及化學污染
.物理:涉及物體進入食物

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

【參考連結】
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
外國子公司進口保健食品後,如果委託英國的經銷商銷售,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 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:
需要註冊為食品經營者 (FBO)。

在英國銷售食品補充劑,必須在營運28天前向當地議會進行食品經營者 (FBO) 註冊。委員會檢查營業場所,確保遵守食品安全和衛生法規。

流程:
1.繳交食品業務登記表,郵寄當地議會。
網頁:https://register.food.gov.uk/new
.食品企業商號、機構地址(或可移動機構的存放地點)、郵遞區號、電話號碼、電子郵件
.食品經營者的全名/公司名稱、總部/註冊辦事處地址、郵遞區號、電話號碼、電子郵件
.食品經營者的全名、家庭住址、郵遞區號
.食品活動類型
.開業日期
.食品經營者/公司董事簽章

2.食品安全檢驗:在開業後,委員會安排食品安全檢查,完成風險評估和評級。
.評估潛在危險:食物種類及處理方法、加工和處理食品的方法、面臨風險的消費者類型和數量、食品操作的合規性、物理環境
.確定遵守法規
.確認管理和控制系統
.評估風險的重要性

產品責任
食品標準局採上市後控制檢查所銷售的食品補充劑成分、標籤和安全方面是否合規。
1.營業代理人:FBO有責任在將食品投放到英國市場之前保證其安全。
2.進口商:進口商有責任承擔法律責任,包括產品的成分、安全性和標籤。

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.

【參考連結】
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

各國健康食品登記法規問題集

Email:lon4ww@evershinecpa.com

英國永輝BPO有限公司
Nady Wong, CA in ACCA說中文和英文

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