新加坡保健食品登记法规问题集

Email：sin4ww@evershinecpa.com
或

联络人：苏 玉 燕 副总经理
skype: rachelsu8
wechat: r0928486835

各国健康食品登记法规问题集

HLF-SG-10
请问新加坡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 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，卫生部辖下的卫生科学局(HAS)是管理保健品的国家监管机构，内部的保健品科负责监管保健品。
保健品是一种用于补充饮食、支持(维持)、增强和改善人体健康功能的产品。
它不能是注射剂或需要无菌的製剂，例如注射剂和眼药水。
它不能是膳食或饮食中的一项。保健品还必须包含一种或多种，或以下成分的组合：

1. 维生素、矿物质、氨基酸、脂肪酸、酶、益生菌等生物活性物质。
2. 源自天然来源的物质，包括动物、矿物和植物材料的萃取物、分离物、浓缩物。
3. (1) 和 (2) 中提到的成分的合成来源。

健康补充剂必须以小单位剂量的剂型给药，例如：胶囊、软胶囊、锭剂、液体、糖浆

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.

【参考连结】

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

HLF-SG-20
外国公司要到新加坡销售保健食品，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 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：

保健品的进口、製造和销售无需获得 HSA 的批准和许可。
保健品不需要上市前批准，但须符合保健品指南规范， 禁止在保健品中添加类固醇等药用成分。

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.

【参考连结】

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

HLF-SG-25

假如需要办理，请问新加坡有专业服务公司可以协助办理保健食品公司营业许可证？

Evershine RD：

无须申请营业许可证

HLF-SG-30
外国公司要到新加坡销售保健食品，可以指派新加坡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 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。保健品的进口、製造和销售无需获得 HSA 的批准和许可。
保健品不需要上市前批准，但须符合保健品指南规范，禁止在保健品中添加类固醇等药用成分。
经销商必须对其保健品的安全和品质负责，需要确保产品符合 HSA 规定的安全和品质标准。
如果检测到本地销售的保健品存在任何安全或品质问题，HSA 将採取必要的行动，公众也将收到有关有害产品的警告。

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:

【参考连结】

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

HLF-SG-35

HLF-SG-40
外国公司销售到新加坡保健食品本身，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 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：

不须办理产品许可，包装及标示无须事前核准，但需要符合规范。
保健品的进口、製造和销售无需获得 HSA 的批准和许可。
保健品不需要上市前批准，但须符合保健品指南规范， 禁止在保健品中添加类固醇等药用成分。

包装与标籤

1.产品标籤应突出且显眼，所有产品标籤必须为英文，若有用其他语言标记信息，应与英文文本一致。

2.资料应充分、真实，标籤均应打印或以清晰且不可磨灭的方式呈现。

3. 产品名称（包括品牌名称，如果有）

品牌名称通常是指公司或製造商对产品或产品系列的名称(可能没有)。
产品名称是指赋予特定产品以区别于市场上其他同类产品的名称。

4.剂型

是指含有活性成分的产品的最终物理形式，消费者可以直接使用，例如片剂、胶囊、软凝胶、液体等。

5.有效成分名称及数量

．活性成分是指有助于产品预期功能的成分。(建议成分名称使用国际公认的命名法。)

．提取活性成分的植物/动物的名称和数量跟构成活性成分的植物或动物部分，以及适用的製剂类型应以学名声明。

．使用植物或动物的通用名称或本地名称是可选择的。

．对于维生素和矿物质，应使用通用名称或化学名称。

．对于盐形式的矿物质补充剂，应声明元素的强度。

．活性成分的数量是指每种剂型中每种活性成分的数量或推荐剂量。

6. 产品适应症/预期用途

．预期目的是指与产品的适应症、益处或行动有关的声明。

．预期用途或使用意图的声明应根据指南内容进行声明。

7. 剂量和使用说明

有关产品预期使用的给药途径、剂量、频率和使用持续时间（如适用）的信息。

8. 批号

标识产品批次并允许追溯特定产品批次的完整历史的名称（数字或字母或两者的组合），包括生产的所有阶段、控制、 分佈和使用的原材料。 批号前应冠以批号或BN等标题。

9. 到期日

指为每个单独批次指定的日期，在该日期之前该批次仍符合要求的品质标准规范。
到期日期应以月份和年份声明（例如，Jan/2022、01/2022），并在标题前加上到期日期或EXP等标题，以避免歧义和混淆。

10. 製造商名称和国家：完整名称和国家/地区。

11. 本地进口商的名称和地址：进口商的完整名称和地址。

12. 禁忌症(如果适用)

13. 警告：包括副作用、禁忌症和适当的预防措施。

．具致敏作用的非活性物质需申报：苯甲酸、苯甲酸钠、柠檬黄

14. 其他(如果适用)

15. 储存情况：声明产品应正确储存的条件，以保持产品品质。

16. 包装尺寸/淨含量

是指包装或容器中产品的数量，可以用绝对量（对于固体剂型）表示，例如 30 粒胶囊/容器或淨含量（对于液体、粉末或半固体剂型），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.

【参考连结】

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

请问在新加坡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：

无须申请产品许可证

HLF-SG-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：

不须办理产品许可，包装及标示无须事前核准，但需要符合规范。
保健品的进口、製造和销售无需获得 HSA 的批准和许可。
保健品不需要上市前批准，但须符合保健品指南规范， 禁止在保健品中添加类固醇等药用成分。

包装与标籤

1.产品标籤应突出且显眼，所有产品标籤必须为英文，若有用其他语言标记信息，应与英文文本一致。

2.资料应充分、真实，标籤均应打印或以清晰且不可磨灭的方式呈现。

3. 产品名称（包括品牌名称，如果有）

品牌名称通常是指公司或製造商对产品或产品系列的名称(可能没有)。
产品名称是指赋予特定产品以区别于市场上其他同类产品的名称。

4.剂型

是指含有活性成分的产品的最终物理形式，消费者可以直接使用，例如片剂、胶囊、软凝胶、液体等。

5.有效成分名称及数量

．活性成分是指有助于产品预期功能的成分。(建议成分名称使用国际公认的命名法。)

．提取活性成分的植物/动物的名称和数量跟构成活性成分的植物或动物部分，以及适用的製剂类型应以学名声明。

．使用植物或动物的通用名称或本地名称是可选择的。

．对于维生素和矿物质，应使用通用名称或化学名称。

．对于盐形式的矿物质补充剂，应声明元素的强度。

．活性成分的数量是指每种剂型中每种活性成分的数量或推荐剂量。

6. 产品适应症/预期用途

．预期目的是指与产品的适应症、益处或行动有关的声明。

．预期用途或使用意图的声明应根据指南内容进行声明。

7. 剂量和使用说明

有关产品预期使用的给药途径、剂量、频率和使用持续时间（如适用）的信息。

8. 批号

标识产品批次并允许追溯特定产品批次的完整历史的名称（数字或字母或两者的组合），包括生产的所有阶段、控制、 分佈和使用的原材料。 批号前应冠以批号或BN等标题。

9. 到期日

指为每个单独批次指定的日期，在该日期之前该批次仍符合要求的品质标准规范。
到期日期应以月份和年份声明（例如，Jan/2022、01/2022），并在标题前加上到期日期或EXP等标题，以避免歧义和混淆。

10. 製造商名称和国家：完整名称和国家/地区。

11. 本地进口商的名称和地址：进口商的完整名称和地址。

12. 禁忌症(如果适用)

13. 警告：包括副作用、禁忌症和适当的预防措施。

．具致敏作用的非活性物质需申报：苯甲酸、苯甲酸钠、柠檬黄

14. 其他(如果适用)

15. 储存情况：声明产品应正确储存的条件，以保持产品品质。

16. 包装尺寸/淨含量

是指包装或容器中产品的数量，可以用绝对量（对于固体剂型）表示，例如 30 粒胶囊/容器或淨含量（对于液体、粉末或半固体剂型），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.

【参考连结】

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

请问在新加坡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：

无须申请产品许可证

HLF-SG-60
经过核准登记的保健食品，进口到新加坡要检附什麽文件？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 Singapore? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

保健食品进口需要取得海关进口许可证，销售前无须事先报备。

海关进口许可证：

1. 註册入口网站的帐户：https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct

2. 指定报关代理人(新加坡物流协会/新加坡航空货运代理协会)或自行申报。

．必须与新加坡海关负责银行 GIRO (IBG)绑定以直接从您的银行账户向新加坡海关支付新加坡海关提供的服务的关税、税款、费用、罚款和其他费用。

．如果没有在新加坡海关持有 IBG，关税和 GST 将从您的申报代理的 IBG 中扣除。

3. 提供安全保障

．需要为涉及应课税货物的交易、为批准目的临时进口货物以及经营特许经营场所（如特许仓库和消费税工厂）提供担保。

．提供的担保应採用银行担保、财务公司担保或保证金的形式。

4. 获得海关进口许可证

．申请必须透由TradeNet提交 (TradeNet软体、政府应用程序)

．每份许可证的申请费用通常是2.88新元，不包含报关代理服务费等，如委託报关公司代理，可以查阅其收取的服务费用。

文件内容

．申请公司(须以公司名义报关，如为个人可以委託代办公司申请)、邮政编码、地址、电话、传真、行业

．联繫人、联繫方式、电话、传真、电子邮件

．计费管理员(通常是主管或财务人员)姓名、身分证/护照号码、联繫方式、电子邮件

．付款方式

．签章

5. 准备货物清关文件

．提供证明文件，包括发票、包装清单及提单/空运提单

．集装箱货物所需文件

通过海运进口集装箱货物，无需向入境口岸的检查站人员出示海关许可证和证明文件的打印副本。
通过空运或陆运进口集装箱货物，需要出示海关许可证以及发票、装箱单和提单/空运提单等证明文件，向检查站官员核实。

．常规货物所需文件

对于常规货物，请在货物清关时将货物、海关通行证打印件、发票、装箱单、提单/空运单等证明文件交给口检人员核对。

．保留贸易文件

购买、进口、销售或出口货物有关的相关证明文件自许可证申请批准之日起保留 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.

【参考连结】

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：

无须经过审查，不过保健品经销商必须确保产品符合以下安全和品质标准。

1. 不允许使用的物质

进口或销售的保健品不得包含以下内容

．来自人体部位的成分

．毒品

．可能影响人体健康的成分

．可导致动物传染性疾病的成分

2. 有毒重金属限值

．砷： 百万分之5 (ppm)

．镉： 0.3ppm

．铅：10ppm

．汞： 0.5ppm

3. 微生物限度

保健品不得超过以下微生物限度

．需氧菌总数：不超过 10 ⁵

．酵母和霉菌：不超过 5 x 10 ²

．大肠杆菌、沙门氏菌和金黄色葡萄球菌：不允许

．经销商和销售商有义务确保产品的微生物含量和重金属在按照推荐的使用条件和目标用户使用时是适当和安全的。

4. 维生素和矿物质限量

一般成年人保健品中维生素的限量。(每日最高限量)

．生物素：0.9 毫克

 ．叶酸：0.9 毫克

 ．烟酰胺：450 毫克

 ．菸酸：15毫克

 ．维生素A（视黄醇）：1.5 毫克 (5000 国际单位)

 ．维生素B1：100 毫克

． 维生素B2：40毫克

 ．维生素 B5（泛酸）：200 毫克

 ．维生素B6：100 毫克

 ．维生素 B12：0.6毫克

 ．维生素C：1000 毫克

 ．维生素D：0.025 毫克 (1000 国际单位)

 ．维生素E：536 毫克 (800 国际单位)

 ．维生素 K1 / K2：0.12 毫克

一般成年人保健品中矿物质的限量。(每日最高限量)

．硼： 6.4毫克

 ．钙：1200 毫克

 ．铬：0.5毫克

 ．铜：2毫克

 ．碘： 0.15 毫克

 ．铁： 15 毫克*

 ．镁： 350 毫克

 ．锰： 3.5毫克

 ．钼： 0.36 毫克

 ．磷： 800 毫克

 ．硒： 0.2毫克

 ．锌： 15毫克

．对于孕妇的複合维生素和矿物质补充剂，可以考虑将铁的上限提高到 30 毫克/天。

品质标准

1. 基于剂型的物理测试参数

．硬度和脆性衡量产品在製造、处理和运输过程中的机械完整性和承受机械应力以及抗碎裂或表面磨损的能力。

．崩解度确定产品内容物在规定的测试条件下置于液体介质中时是否会在规定时间内崩解。

．溶出度评估产品溶解形成溶出物的速度和程度。

．粘度测量液体内含物内摩擦和阻力的大小。

．剂量单位的均匀性衡量活性物质在产品中分佈的均匀程度，也可以通过含量均匀性或品质变化来证明。

2.  测试要求

．测试报告应至少包含以下信息：

1报告日期

2品牌名称（如适用）和产品名称

3批号

4测试物质的名称

5参考相关规范和测试程序

6必要时检测结果

7测试日期

8分析师姓名和签名

．成品应进行重金属、微生物检测、毒物、掺杂物检测。产品规格表或原材料或中间体分析证书不得代替成品检测。

．测试结果应定量报告（例如，砷 0.05ppm）。
对于报告为未检出或ND的检测结果，必须在检测报告上註明检测限。

3. 製造标准

可接受的製造标准

．药品检验合作计划 (PIC/S) 药品生产品质管理规范

．世界卫生组织 (WHO) 药品生产品质管理规范 (GMP)

．东盟传统药物良好生产规范 (GMP) 指南

．东盟保健品良好生产规范 (GMP) 指南

．美国食品和药物管理局 (US FDA) 现行的膳食补充剂良好生产规范 (cGMP)

．国际标准化组织 (ISO) – 食品安全管理 (ISO 22000)*

．食品安全体系认证 (FSSC) 22000*

．危害分析关键控制点 (HACCP) 系统*

* 这些是食品安全管理体系的认证标准，如果产品受製造国的食品法监管，则被认为适用。
对于通过 HACCP 标准认证的製造商，经销商应确保这些製造商有适当的程序来管理反馈和召回活动。

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.

【参考连结】

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

HLF-SG-75

HLF-SG-77

HLF-SG-80
外国子公司进口保健食品后，如果委託新加坡的经销商销售，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 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：

无须申请营业许可证。
经销商必须对其保健品的安全和品质负责，需要确保产品符合 HSA 规定的安全和品质标准。
如果检测到本地销售的保健品存在任何安全或品质问题，HSA 将採取必要的行动，公众也将收到有关有害产品的警告。

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.

【参考连结】

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

各国健康食品登记法规问题集

**请注意下列事项：
以上内容为永辉研发及教育中心 (简称:永辉RD)于2021年10月摘要。
随着时间推移，法规会发生变化，不同情况会有不同的选择。
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