新加坡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

HLF-SG-10
請問新加坡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 Singapore? 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：

在新加坡，衛生部轄下的衛生科學局(HAS)是管理保健品的國家監管機構，內部的保健品科負責監管保健品。
保健品是一種用於補充飲食、支持(維持)、增強和改善人體健康功能的產品。
它不能是注射劑或需要無菌的製劑，例如注射劑和眼藥水。
它不能是膳食或飲食中的一項。保健品還必須包含一種或多種，或以下成分的組合：

1. 維生素、礦物質、氨基酸、脂肪酸、酶、益生菌等生物活性物質。
2. 源自天然來源的物質，包括動物、礦物和植物材料的萃取物、分離物、濃縮物。
3. (1) 和 (2) 中提到的成分的合成來源。

健康補充劑必須以小單位劑量的劑型給藥，例如：膠囊、軟膠囊、錠劑、液體、糖漿

In Singapore, Health Sciences Authority (HAS) under the Ministry of Health is the national regulatory body for the regulation of supplements, and the Internal Health Products Section is responsible for overseeing supplements.

A nutraceutical is a product used to supplement the diet, support (maintain), enhance and improve the health functions of the human body. It cannot be injectable or preparations that require sterility, such as injections and eye drops.
It cannot be part of a meal or diet. The supplement must also contain one or more, or a combination of the following ingredients:

1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances.

2. Substances derived from natural sources, including extracts, isolates, concentrates of animal, mineral and plant materials.

3. Synthetic sources of ingredients mentioned in (1) and (2).

Health supplements must be administered in small unit dosage forms such as: capsules, soft gels, lozenges, liquids, syrups.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-20
外國公司要到新加坡銷售保健食品，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 Singapore, 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：

保健品的進口、製造和銷售無需獲得 HSA 的批准和許可。
保健品不需要上市前批准，但須符合保健品指南規範， 禁止在保健品中添加類固醇等藥用成分。

Import, manufacture and sale of supplements without HSA approval and permission.
Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-25

假如需要辦理，請問新加坡有專業服務公司可以協助辦理保健食品公司營業許可證？

Evershine RD：

無須申請營業許可證

HLF-SG-30    
外國公司要到新加坡銷售保健食品，可以指派新加坡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 Singapore, can it assign a Singapore 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。保健品的進口、製造和銷售無需獲得 HSA 的批准和許可。
保健品不需要上市前批准，但須符合保健品指南規範，禁止在保健品中添加類固醇等藥用成分。
經銷商必須對其保健品的安全和品質負責，需要確保產品符合 HSA 規定的安全和品質標準。
如果檢測到本地銷售的保健品存在任何安全或品質問題，HSA 將採取必要的行動，公眾也將收到有關有害產品的警告。

Import, manufacture and sale of supplements without HSA approval and permission
Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

Distributors are responsible for the safety and quality of their health supplements, and distributors must ensure that the products meet the safety and quality standards set forth by the HSA.
If any safety or quality issues with locally sold supplements are detected, the HSA will take necessary action and the public will be warned about the harmful product.

URL:

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-35

HLF-SG-40    
外國公司銷售到新加坡保健食品本身，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 Singapore?
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：

不須辦理產品許可，包裝及標示無須事前核准，但需要符合規範。
保健品的進口、製造和銷售無需獲得 HSA 的批准和許可。
保健品不需要上市前批准，但須符合保健品指南規範， 禁止在保健品中添加類固醇等藥用成分。

包裝與標籤

1.產品標籤應突出且顯眼，所有產品標籤必須為英文，若有用其他語言標記信息，應與英文文本一致。

2.資料應充分、真實，標籤均應打印或以清晰且不可磨滅的方式呈現。

3. 產品名稱（包括品牌名稱，如果有）

品牌名稱通常是指公司或製造商對產品或產品系列的名稱(可能沒有)。
產品名稱是指賦予特定產品以區別於市場上其他同類產品的名稱。

4.劑型

是指含有活性成分的產品的最終物理形式，消費者可以直接使用，例如片劑、膠囊、軟凝膠、液體等。

5.有效成分名稱及數量

．活性成分是指有助於產品預期功能的成分。(建議成分名稱使用國際公認的命名法。)

．提取活性成分的植物/動物的名稱和數量跟構成活性成分的植物或動物部分，以及適用的製劑類型應以學名聲明。

．使用植物或動物的通用名稱或本地名稱是可選擇的。

．對於維生素和礦物質，應使用通用名稱或化學名稱。

．對於鹽形式的礦物質補充劑，應聲明元素的強度。

．活性成分的數量是指每種劑型中每種活性成分的數量或推薦劑量。

6. 產品適應症/預期用途

．預期目的是指與產品的適應症、益處或行動有關的聲明。

．預期用途或使用意圖的聲明應根據指南內容進行聲明。

7. 劑量和使用說明

有關產品預期使用的給藥途徑、劑量、頻率和使用持續時間（如適用）的信息。

8. 批號

標識產品批次並允許追溯特定產品批次的完整歷史的名稱（數字或字母或兩者的組合），包括生產的所有階段、控制、 分佈和使用的原材料。 批號前應冠以批號或BN等標題。

9. 到期日

指為每個單獨批次指定的日期，在該日期之前該批次仍符合要求的品質標準規範。
到期日期應以月份和年份聲明（例如，Jan/2022、01/2022），並在標題前加上到期日期或EXP等標題，以避免歧義和混淆。

10. 製造商名稱和國家：完整名稱和國家/地區。

11. 本地進口商的名稱和地址：進口商的完整名稱和地址。

12. 禁忌症(如果適用)

13. 警告：包括副作用、禁忌症和適當的預防措施。

．具致敏作用的非活性物質需申報：苯甲酸、苯甲酸鈉、檸檬黃

14. 其他(如果適用)

15. 儲存情況：聲明產品應正確儲存的條件，以保持產品品質。

16. 包裝尺寸/淨含量

是指包裝或容器中產品的數量，可以用絕對量（對於固體劑型）表示，例如 30 粒膠囊/容器或淨含量（對於液體、粉末或半固體劑型），例如 500mL/瓶。

No product licensing is required, and packaging and labelling do not require prior approval, but they need to comply with the specifications.
Import, manufacture and sale of supplements without HSA approval and permission
Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

Packaging & Labeling

1.Product labels should be prominent and conspicuous. All product labels must be in English. If there is information in other languages, it should be consistent with the English text.

2.The information should be sufficient and authentic, and the labels should be printed or presented in a clear and indelible way.

3.Product name (including brand name, if applicable)

A brand name usually refers to a company or manufacturer’s name for a product or line of products (it may not). A product name is the name given to a particular product to distinguish it from other similar products on the market.

4.Dosage Form

Refers to the final physical form of the product that contains the active ingredient, ready to be used by consumers, such as tablets, capsules, soft gels, liquids, etc.

5.Active ingredient name and quantity

． Active ingredients are those that contribute to the intended function of the product. (Internationally recognized nomenclature is recommended for ingredient names.)

． The name and quantity of the plant/animal from which the active ingredient was extracted and the plant or animal part that constitutes the active ingredient, as well as the type of preparation to which it applies, shall be declared by the scientific name.

． Use of common or local names of plants or animals is optional.

． For vitamins and minerals, use the generic or chemical name.

． For mineral supplements in salt form, the strength of the element should be stated.

． The number of active ingredients refers to the amount or recommended dose of each active ingredient in each dosage form.

6.Product Indications/Intended Use

． Intended purpose means a statement relating to the indication, benefit or action of the product.

． Statements of intended use or intent should be made in accordance with the guidelines.

7.Dosage and Instructions for Use

Information on the route of administration, dose, frequency and, if applicable, duration of use of the product for which the product is intended.

8.Lot No.

A name (numbers or letters or a combination of both) that identifies a product batch and allows traceability of the complete history of a particular product batch, including all stages of production, controls, distribution, and raw materials used.
The batch number should be preceded by a title such as the batch number or BN.

9.Expiry Date

Refers to the date assigned to each individual batch by which the batch still meets the required specification.
Expiration dates should be declared in month and year (e.g. Jan/2022, 01/2022), with headings such as due date or EXP before the title to avoid ambiguity and confusion.

10. Manufacturer Name and Country: Full name and country.

11. Name and Address of Local Importer: Full name and address of importer.

12. Contraindications (if applicable)

13. WARNINGS: Include side effects, contraindications and appropriate precautions.

． Inactive substances with sensitizing effects should be declared: benzoic acid, sodium benzoate, tartrazine

14. Others (if applicable)

15. Storage Conditions: Declare the conditions under which the product should be properly stored to maintain product quality.

16. Package size/net content

Refers to the quantity of product in a package or container and can be expressed in absolute quantities (for solid dosage forms), such as 30 capsules/container, or net content (for liquid, powder, or semi-solid dosage forms), such as 500mL/vial.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

https://www.hsa.gov.sg/docs/default-source/hprg-tmhs/chpb-tmhs/tmhs_labelling_guidelines.pdf

HLF-SG-45    

請問在新加坡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：

無須申請產品許可證

HLF-SG-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：

不須辦理產品許可，包裝及標示無須事前核准，但需要符合規範。
保健品的進口、製造和銷售無需獲得 HSA 的批准和許可。
保健品不需要上市前批准，但須符合保健品指南規範， 禁止在保健品中添加類固醇等藥用成分。

包裝與標籤

1.產品標籤應突出且顯眼，所有產品標籤必須為英文，若有用其他語言標記信息，應與英文文本一致。

2.資料應充分、真實，標籤均應打印或以清晰且不可磨滅的方式呈現。

3. 產品名稱（包括品牌名稱，如果有）

品牌名稱通常是指公司或製造商對產品或產品系列的名稱(可能沒有)。
產品名稱是指賦予特定產品以區別於市場上其他同類產品的名稱。

4.劑型

是指含有活性成分的產品的最終物理形式，消費者可以直接使用，例如片劑、膠囊、軟凝膠、液體等。

5.有效成分名稱及數量

．活性成分是指有助於產品預期功能的成分。(建議成分名稱使用國際公認的命名法。)

．提取活性成分的植物/動物的名稱和數量跟構成活性成分的植物或動物部分，以及適用的製劑類型應以學名聲明。

．使用植物或動物的通用名稱或本地名稱是可選擇的。

．對於維生素和礦物質，應使用通用名稱或化學名稱。

．對於鹽形式的礦物質補充劑，應聲明元素的強度。

．活性成分的數量是指每種劑型中每種活性成分的數量或推薦劑量。

6. 產品適應症/預期用途

．預期目的是指與產品的適應症、益處或行動有關的聲明。

．預期用途或使用意圖的聲明應根據指南內容進行聲明。

7. 劑量和使用說明

有關產品預期使用的給藥途徑、劑量、頻率和使用持續時間（如適用）的信息。

8. 批號

標識產品批次並允許追溯特定產品批次的完整歷史的名稱（數字或字母或兩者的組合），包括生產的所有階段、控制、 分佈和使用的原材料。 批號前應冠以批號或BN等標題。

9. 到期日

指為每個單獨批次指定的日期，在該日期之前該批次仍符合要求的品質標準規範。
到期日期應以月份和年份聲明（例如，Jan/2022、01/2022），並在標題前加上到期日期或EXP等標題，以避免歧義和混淆。

10. 製造商名稱和國家：完整名稱和國家/地區。

11. 本地進口商的名稱和地址：進口商的完整名稱和地址。

12. 禁忌症(如果適用)

13. 警告：包括副作用、禁忌症和適當的預防措施。

．具致敏作用的非活性物質需申報：苯甲酸、苯甲酸鈉、檸檬黃

14. 其他(如果適用)

15. 儲存情況：聲明產品應正確儲存的條件，以保持產品品質。

16. 包裝尺寸/淨含量

是指包裝或容器中產品的數量，可以用絕對量（對於固體劑型）表示，例如 30 粒膠囊/容器或淨含量（對於液體、粉末或半固體劑型），例如 500mL/瓶。

No product licensing is required, and packaging and labelling do not require prior approval, but they need to comply with the specifications.

Import, manufacture and sale of supplements without HSA approval and permission

Supplements do not require pre-market approval, but supplements must comply with the guidelines for supplements, and the HSA prohibits the addition of medicinal ingredients such as steroids to supplements.

Packaging & Labeling

1.Product labels should be prominent and conspicuous. All product labels must be in English. If there is information in other languages, it should be consistent with the English text.

2.The information should be sufficient and authentic, and the labels should be printed or presented in a clear and indelible way.

3.Product name (including brand name, if applicable)

A brand name usually refers to a company or manufacturer’s name for a product or line of products (it may not). A product name is the name given to a particular product to distinguish it from other similar products on the market.

4.Dosage Form

Refers to the final physical form of the product that contains the active ingredient, ready to be used by consumers, such as tablets, capsules, soft gels, liquids, etc.

5.Active ingredient name and quantity

． Active ingredients are those that contribute to the intended function of the product. (Internationally recognized nomenclature is recommended for ingredient names.)

． The name and quantity of the plant/animal from which the active ingredient was extracted and the plant or animal part that constitutes the active ingredient, as well as the type of preparation to which it applies, shall be declared by the scientific name.

． Use of common or local names of plants or animals is optional.

． For vitamins and minerals, use the generic or chemical name.

． For mineral supplements in salt form, the strength of the element should be stated.

． The number of active ingredients refers to the amount or recommended dose of each active ingredient in each dosage form.

6.Product Indications/Intended Use

． Intended purpose means a statement relating to the indication, benefit or action of the product.

． Statements of intended use or intent should be made in accordance with the guidelines.

7.Dosage and Instructions for Use

Information on the route of administration, dose, frequency and, if applicable, duration of use of the product for which the product is intended.

8.Lot No.

A name (numbers or letters or a combination of both) that identifies a product batch and allows traceability of the complete history of a particular product batch, including all stages of production, controls, distribution, and raw materials used. The batch number should be preceded by a title such as the batch number or BN.

9.Expiry Date

Refers to the date assigned to each individual batch by which the batch still meets the required specification. Expiration dates should be declared in month and year (e.g. Jan/2022, 01/2022), with headings such as due date or EXP before the title to avoid ambiguity and confusion.

10. Manufacturer Name and Country: Full name and country.

11. Name and Address of Local Importer: Full name and address of importer.

12. Contraindications (if applicable)

13. WARNINGS: Include side effects, contraindications and appropriate precautions.

． Inactive substances with sensitizing effects should be declared: benzoic acid, sodium benzoate, tartrazine

14. Others (if applicable)

15. Storage Conditions: Declare the conditions under which the product should be properly stored to maintain product quality.

16. Package size/net content

Refers to the quantity of product in a package or container and can be expressed in absolute quantities (for solid dosage forms), such as 30 capsules/container, or net content (for liquid, powder, or semi-solid dosage forms), such as 500mL/vial.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

https://www.hsa.gov.sg/docs/default-source/hprg-tmhs/chpb-tmhs/tmhs_labelling_guidelines.pdf

HLF-SG-55    

請問在新加坡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：

無須申請產品許可證

HLF-SG-60    
經過核准登記的保健食品，進口到新加坡要檢附什麼文件？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 Singapore? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

保健食品進口需要取得海關進口許可證，銷售前無須事先報備。

海關進口許可證：

1. 註冊入口網站的帳戶：https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct

2. 指定報關代理人(新加坡物流協會/新加坡航空貨運代理協會)或自行申報。

．必須與新加坡海關負責銀行 GIRO (IBG)綁定以直接從您的銀行賬戶向新加坡海關支付新加坡海關提供的服務的關稅、稅款、費用、罰款和其他費用。

．如果沒有在新加坡海關持有 IBG，關稅和 GST 將從您的申報代理的 IBG 中扣除。

3. 提供安全保障

．需要為涉及應課稅貨物的交易、為批准目的臨時進口貨物以及經營特許經營場所（如特許倉庫和消費稅工廠）提供擔保。

．提供的擔保應採用銀行擔保、財務公司擔保或保證金的形式。

4. 獲得海關進口許可證

．申请必須透由TradeNet提交 (TradeNet軟體、政府應用程序)

．每份許可證的申請費用通常是2.88新元，不包含報關代理服務費等，如委託報關公司代理，可以查閱其收取的服務費用。

文件內容

．申請公司(須以公司名義報關，如為個人可以委託代辦公司申請)、郵政編碼、地址、電話、傳真、行業

．聯繫人、聯繫方式、電話、傳真、電子郵件

．計費管理員(通常是主管或財務人員)姓名、身分證/護照號碼、聯繫方式、電子郵件

．付款方式

．簽章

5. 準備貨物清關文件

．提供證明文件，包括發票、包裝清單及提單/空運提單

．集裝箱貨物所需文件

通過海運進口集裝箱貨物，無需向入境口岸的檢查站人員出示海關許可證和證明文件的打印副本。
通過空運或陸運進口集裝箱貨物，需要出示海關許可證以及發票、裝箱單和提單/空運提單等證明文件，向檢查站官員核實。

．常規貨物所需文件

對於常規貨物，請在貨物清關時將貨物、海關通行證打印件、發票、裝箱單、提單/空運單等證明文件交給口檢人員核對。

．保留貿易文件

購買、進口、銷售或出口貨物有關的相關證明文件自許可證申請批准之日起保留 5 年。

Import of health food requires a customs import license, and no prior reporting is required before sales.

Customs Import Permit:

1. Register an account with the portal:

https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct

2. Designated customs broker (Singapore Logistics Association/Singapore Air Freight Forwarders Association) or self-declaration.

．Must be tied to Singapore Customs Responsible Bank GIRO (IBG) for payment of duties, taxes, fees, fines and other charges for services provided by Singapore Customs directly from your bank account to Singapore Customs.

． If the IBG is not held at Singapore Customs, customs duties and GST will be deducted from the IBG of your reporting agent.

3. Provide security

．Guarantee is required for transactions involving dutiable goods, temporary importation of goods for approved purposes, and the operation of franchise premises such as licensed warehouses and excise factories.

． The guarantee provided shall be in the form of bank guarantee, financial company guarantee or security deposit.

4. Obtain customs import license

．Applications must be submitted through TradeNet (TradeNet software, government applications)

．The application fee for each license is usually S$2.88, excluding customs brokerage service fees.

Document content

．Application company (customs declaration must be made in the name of the company, if it is an individual, you can entrust an agency company to apply), zip code, address, telephone, fax, industry

．Contact, Contact, Phone, Fax, Email

．Billing administrator (usually supervisor or financial officer) name, ID/passport number, contact details, email

．Payment method

．Signature

5. Prepare cargo clearance documents

．Provide supporting documents including invoice, packing list and bill of lading/air waybill

．Documents Required for Containerized Cargo

Importing containerized cargo by sea eliminates the need to present printed copies of customs permits and supporting documents to checkpoint personnel at the port of entry.

To import containerized cargo by air or land, you need to present a customs permit and supporting documents such as invoice, packing list and bill of lading/airway bill to verify with the checkpoint officer.

． Documents Required for Regular Cargo

For conventional goods, please submit the goods, printed copies of customs passes, invoices, packing lists, bills of lading/airway bills and other supporting documents to the inspection personnel for verification when the goods are cleared.

． Keep trade documents

Relevant supporting documents related to the purchase, import, sale or export of goods are retained for 5 years from the date of approval of the license application.

【參考連結】

https://www.customs.gov.sg/businesses/importing-goods/overview

https://www.customs.gov.sg/businesses/importing-goods/import-procedures/apply-customs-import-permit

HLF-SG-70    
新加坡保健食品審核機構，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：

無須經過審查，不過保健品經銷商必須確保產品符合以下安全和品質標準。

1. 不允許使用的物質

進口或銷售的保健品不得包含以下內容

．來自人體部位的成分

．毒品

．可能影響人體健康的成分

．可導致動物傳染性疾病的成分

2. 有毒重金屬限值

．砷： 百萬分之5 (ppm)

．鎘： 0.3ppm

．鉛：10ppm

．汞： 0.5ppm

3. 微生物限度

保健品不得超過以下微生物限度

．需氧菌總數：不超過 10 ⁵

．酵母和黴菌：不超過 5 x 10 ²

．大腸桿菌、沙門氏菌和金黃色葡萄球菌：不允許

．經銷商和銷售商有義務確保產品的微生物含量和重金屬在按照推薦的使用條件和目標用戶使用時是適當和安全的。

4. 維生素和礦物質限量

一般成年人保健品中維生素的限量。(每日最高限量)

．生物素：0.9 毫克

 ．葉酸：0.9 毫克

 ．煙酰胺：450 毫克

 ．菸酸：15毫克

 ．維生素A（視黃醇）：1.5 毫克 (5000 國際單位)

 ．維生素B1：100 毫克

． 維生素B2：40毫克

 ．維生素 B5（泛酸）：200 毫克

 ．維生素B6：100 毫克

 ．維生素 B12：0.6毫克

 ．維生素C：1000 毫克

 ．維生素D：0.025 毫克 (1000 國際單位)

 ．維生素E：536 毫克 (800 國際單位)

 ．維生素 K1 / K2：0.12 毫克

一般成年人保健品中礦物質的限量。(每日最高限量)

．硼： 6.4毫克

 ．鈣：1200 毫克

 ．鉻：0.5毫克

 ．銅：2毫克

 ．碘： 0.15 毫克

 ．鐵： 15 毫克*

 ．鎂： 350 毫克

 ．錳： 3.5毫克

 ．鉬： 0.36 毫克

 ．磷： 800 毫克

 ．硒： 0.2毫克

 ．鋅： 15毫克

．對於孕婦的複合維生素和礦物質補充劑，可以考慮將鐵的上限提高到 30 毫克/天。

品質標準

1. 基於劑型的物理測試參數

．硬度和脆性衡量產品在製造、處理和運輸過程中的機械完整性和承受機械應力以及抗碎裂或表面磨損的能力。

．崩解度確定產品內容物在規定的測試條件下置於液體介質中時是否會在規定時間內崩解。

．溶出度評估產品溶解形成溶出物的速度和程度。

．粘度測量液體內含物內摩擦和阻力的大小。

．劑量單位的均勻性衡量活性物質在產品中分佈的均勻程度，也可以通過含量均勻性或品質變化來證明。

2.  測試要求

．測試報告應至少包含以下信息：

1報告日期

2品牌名稱（如適用）和產品名稱

3批號

4測試物質的名稱

5參考相關規範和測試程序

6必要時檢測結果

7測試日期

8分析師姓名和簽名

．成品應進行重金屬、微生物檢測、毒物、摻雜物檢測。產品規格表或原材料或中間體分析證書不得代替成品檢測。

．測試結果應定量報告（例如，砷 0.05ppm）。
對於報告為未檢出或ND的檢測結果，必須在檢測報告上註明檢測限。

3. 製造標準

可接受的製造標準

．藥品檢驗合作計劃 (PIC/S) 藥品生產品質管理規範

．世界衛生組織 (WHO) 藥品生產品質管理規範 (GMP)

．東盟傳統藥物良好生產規範 (GMP) 指南

．東盟保健品良好生產規範 (GMP) 指南

．美國食品和藥物管理局 (US FDA) 現行的膳食補充劑良好生產規範 (cGMP)

．國際標準化組織 (ISO) – 食品安全管理 (ISO 22000)*

．食品安全體系認證 (FSSC) 22000*

．危害分析關鍵控制點 (HACCP) 系統*

* 這些是食品安全管理體系的認證標準，如果產品受製造國的食品法監管，則被認為適用。
對於通過 HACCP 標準認證的製造商，經銷商應確保這些製造商有適當的程序來管理反饋和召回活動。

Health supplement distributors must ensure that your products meet safety and quality standards.

1. Substances not allowed

Imported or sold health products must not contain the following

． Ingredients from human body parts

． poison

． Ingredients that may affect human health

． ingredients that can cause zoonotic diseases

2. Toxic Heavy Metal Limits

． Arsenic: 5 parts per million (ppm)

． Cadmium: 0.3ppm

． Lead: 10ppm

． Mercury: 0.5ppm

3. Microbial limit

Supplements should not exceed the following microbial limits

． Total number of aerobic bacteria: not more than 10 5

． Yeast and mold: no more than 5 x 10 2

． E. coli, Salmonella and Staphylococcus aureus: Not allowed

． Distributors and sellers are obligated to ensure that the microbial content and heavy metals of the product are appropriate and safe for use in accordance with the recommended conditions of use and intended users.

4. Vitamin and Mineral Limits

Limits of vitamins in general adult health products. (Daily maximum)

． Biotin: 0.9 mg

． Folic acid: 0.9 mg

． Niacinamide: 450 mg

． Niacin: 15 mg

． Vitamin A (retinol): 1.5 mg (5000 IU)

． Vitamin B1: 100 mg

． Vitamin B2: 40 mg

． Vitamin B5 (pantothenic acid): 200 mg

． Vitamin B6: 100 mg

． Vitamin B12: 0.6 mg

． Vitamin C: 1000 mg

． Vitamin D: 0.025 mg (1000 IU)

． Vitamin E: 536 mg (800 IU)

． Vitamin K1/K2: 0.12 mg

Limits of minerals in general adult health products. (Daily maximum)

． Boron: 6.4 mg

． Calcium: 1200 mg

． Chromium: 0.5 mg

． Copper: 2 mg

． Iodine: 0.15 mg

． Iron: 15 mg*

． Magnesium: 350 mg

． Manganese: 3.5 mg

． Molybdenum: 0.36 mg

． Phosphorus: 800 mg

． Selenium: 0.2 mg

． Zinc: 15 mg

． For multivitamin and mineral supplements for pregnant women, consider increasing the iron limit to 30 mg/day.

Quality Standard

1. Physical test parameters based on dosage form

．Hardness and brittleness measure a product’s mechanical integrity and ability to withstand mechanical stress and resistance to chipping or surface wear during manufacture, handling and shipping.

．The degree of disintegration determines whether the product contents will disintegrate within a specified period of time when placed in a liquid medium under specified test conditions.

．Dissolution assesses how quickly and to what extent a product dissolves to form a leachable.

．Viscosity measures the amount of friction and drag within a liquid’s contents.

．Uniformity of dosage unit is a measure of how uniformly the active substance is distributed in a product, and can also be demonstrated by content uniformity or mass variation.

2. Test Requirements

．The test report should contain at least the following information:

1 report date

2 Brand name (if applicable) and product name

3 batch numbers

4 Name of the test substance

5 Refer to relevant specifications and test procedures

6 Test results if necessary

7 test dates

8 Analyst name and signature

．Finished products should be tested for heavy metals, microorganisms, poisons and adulterants. Product specification sheets or certificates of analysis for raw materials or intermediates are not intended to replace finished product testing.

．Test results should be reported quantitatively (eg, Arsenic 0.05ppm).
For test results reported as Not Detected or ND, the detection limit must be stated on the test report.

3. Manufacturing standard

Acceptable manufacturing standards

．Pharmaceutical Inspection Cooperative Program (PIC/S) Good Manufacturing Practice for Pharmaceutical Products

．World Health Organization (WHO) Good Manufacturing Practice (GMP)

．ASEAN Good Manufacturing Practice (GMP) Guidelines for Traditional Medicines

．ASEAN Good Manufacturing Practice (GMP) Guidelines for Nutraceuticals

．US Food and Drug Administration (US FDA) Current Good Manufacturing Practices (cGMP) for Dietary Supplements

．International Organization for Standardization (ISO) – Food Safety Management (ISO 22000)*

．Food Safety System Certification (FSSC) 22000*

．Hazard Analysis Critical Control Point (HACCP) System*

*These are certification standards for food safety management systems and are considered applicable if the product is regulated by the food laws of the country of manufacture.
For manufacturers certified to HACCP standards, distributors should ensure that these manufacturers have procedures in place to manage feedback and recall activities.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

HLF-SG-75

HLF-SG-77

HLF-SG-80    
外國子公司進口保健食品後，如果委託新加坡的經銷商銷售，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 Singapore 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：

無須申請營業許可證。
經銷商必須對其保健品的安全和品質負責，需要確保產品符合 HSA 規定的安全和品質標準。
如果檢測到本地銷售的保健品存在任何安全或品質問題，HSA 將採取必要的行動，公眾也將收到有關有害產品的警告。

No business license required.

Distributors are responsible for the safety and quality of their health supplements, and distributors must ensure that the products meet the safety and quality standards set forth by the HSA.
If any safety or quality issues with locally sold supplements are detected, the HSA will take necessary action and the public will be warned about the harmful product.

【參考連結】

https://www.hsa.gov.sg/health-supplements/overview

https://www.hsa.gov.sg/consumer-safety/articles/how-health-supplements-are-regulated-by-hsa

HLF-SG-85

各國健康食品登記法規問題集

**請注意下列事項：
以上內容為永輝研發及教育中心 (簡稱:永輝RD)於2021年10月摘要。
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