新加坡化妆品登记法规问题集

Email：sin4ww@evershinecpa.com
或

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

各国化妆品登记法规问答集

HLF-SG-10
请问新加坡对于化妆品的归类方式为何？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 cosmetics in Singapore?
What is its official name? What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?

Evershine RD集

在新加坡，卫生部辖下的卫生科学局(HAS)是管理化妆品的国家监管机构。
化妆品被定义为旨在与人体外部部位（如皮肤、头发、指甲、嘴唇或嘴巴（包括牙龈、牙齿和舌头）接触的任何物质或製剂，用于目的：

1.清洁

2.添香

3.改变外表

4.改善体味

5.保护

6.保持良好状态

化妆品是应用于人体外部或牙齿/口腔黏膜，如下列：

1.表皮（皮肤，包括眼睛附近）

2.头发系统

3.指甲

4.嘴唇

5.外生殖器

6.牙齿

7.口腔黏膜

化妆品产品种类：

1.用于皮肤（手、脸、脚等）

2.面膜，例如美白面膜，补水面膜

3.着色基料（液体、糊剂、粉末）

4.化妆粉、浴后粉、卫生粉等

5.香皂、除臭皂等

6.香水、花露水和古龙水

7.沐浴和淋浴用品（盐、泡沫、油、凝胶等）

8.脱毛剂

9.除臭剂和止汗剂

10.护发产品

．染发剂和漂白剂

．用于挥动、拉直或固定的产品

．设置产品

．清洁产品（乳液、粉末、洗发水）

．调理产品（乳液、面霜、油）

．美发产品（乳液、亮油、亮片）

11.剃须产品（面霜、泡沫、乳液等）

12.用于化妆和卸妆的产品

13.用于唇部和唇部周围的产品

14.牙齿和口腔护理产品

15.指甲护理和化妆产品（修指甲和修脚）

16.用于外部私密卫生的产品

17.日光浴产品

18.防晒的产品

19.美白产品

20.抗皱产品

21.婴儿/面部湿巾

下列不归属化妆品：

1.注射剂和眼药水。

2.口服的产品，例如片剂、胶囊或饮料。

3.用于治疗的产品，例如痤疮治疗霜。

In Singapore, the Health Sciences Authority (HAS), under the Ministry of Health, is the national regulatory agency governing cosmetics.

Cosmetics are defined as any substance or preparation intended to come into contact with external parts of the human body, such as skin, hair, nails, lips or mouth (including gums, teeth and tongue), for the purpose of:

1. Clean them

2. Perfume them

3. Change their appearance

4. Correct body odor

5. Protect them

6. Keep them in good shape

Cosmetics are applied on the outside of the human body or on the teeth/oral mucosa, such as the following:

1. Epidermis (skin, including near the eyes)

2. Hair System

3. Nails

4. Lips

5. External Genitalia

6. Teeth

7. Oral mucosa

Cosmetic product categories:

1. For skin (hands, face, feet, etc.)

2. Masks, such as whitening masks, moisturizing masks

3. Coloring base (liquid, paste, powder)

4. Cosmetic powder, after-bath powder, sanitary powder, etc.

5. Soap, deodorant soap, etc.

6. Perfume, toilet water and cologne

7. Bath and shower supplies (salt, foam, oil, gel, etc.)

8. Depilatories

9. Deodorants and antiperspirants

10. Hair care products

． Hair Dye and Bleach

． Products for waving, straightening or securing

． Set up products

． Cleaning products (lotions, powders, shampoos)

． Conditioning products (lotions, creams, oils)

． Hair products (lotions, polishes, sequins)

11. Shaving products (creams, foams, lotions, etc.)

12. Products for Makeup and Makeup Remover

13. Products for use on and around the lips

14. Teeth and Oral Care Products

15. Nail care and makeup products (manicure and pedicure)

16. Products for external intimate hygiene

17. Sunbathing Products

18. Sunscreen products

19. Whitening products

20. Anti-wrinkle products

21. Baby/Facial Wipes

The following are not classified as cosmetic products:

1. Injections and eye drops.

2. Oral products such as tablets, capsules or beverages.

3. Products for treatment, such as acne treatment creams.

【参考连结】

https://www.hsa.gov.sg/cosmetic-products/overview

HLF-SG-20
外国公司要到新加坡销售化妆品，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 cosmetics 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：

无需申请营业许可证。

化妆品的销售，须由会计和企业监管局 (ACRA)註册的当地实体公司向HAS提交销售通知方可进口、销售。

销售通知申请表内容：

1. 负责将化妆品投放市场的当地公司的详细信息

．公司名称

．公司地址

．城市

．邮递区号、详细地址

．电话号码

．传真号码

2. 授权代表当地公司的人员的详细信息

．申请人姓名

．身份证/FIN

．电话号码

．指明首选的沟通方式

．公司名称

3. 製造商详情

．製造商的名称

．如果是本地製造商，请填写邮政编码并点击检索地址，Blk/House No, Street Name 和 Building Name 的数据将自动填充。
否则，请相应填写详细信息

．如果有多个製造商，请单击“新建”以添加详细信息

填写并保存第一条记录的详细信息后，新製造商进入下一部分。

．城市

．邮递区号、详细地址

．电话号码

．传真号码

4. 产品详情

．根据产品包装上出现的名称，输入产品的品牌名称和产品名称

．选择反映产品的类型。 (例如，如果您要通知抗皱霜，请选择抗皱)

．选择最能代表产品的演示类型。(例如：单品、调色板、套装等)

．详细信息

5. 支持文件

．没有强制相关支持文件，但负责将产品投入市场公司必须为产品负责

．建议有相关检验证明或支持文件

6. 申报、验证、确认和付款

．同意声明

．完成提交

．扣款费用

7. 成功提交化妆品通知后，将收到通知确认，其中将显示

．公司名称和地址

．品牌名称和产品名称

．产品通知编号和有效日期

8. 注意：

．产品通知有效期为一年，如果您的公司打算继续，每年都需要通知（更新）

．即使该产品已经被新加坡的另一家公司通知，并且您是从同一製造商进口的，也需要提交通知

．对于同一化妆品的每个不同变体，例如不同色调的口红和不同香味的洗发水，也需要提交通知

9. 以下产品不需要化妆品产品通知。但是仍然需要遵守其他要求，例如标籤、成分和不良事件报告：

．与广告、贊助或促销活动相关的样品

．用于与该产品的任何研究或开发有关的测试或试验的产品。

．由医生製造或根据其规格製造的产品，并由该医生单独提供，供其护理下的患者使用。

．同一产品的不同包装尺寸。

There is no need to apply for a business permit.

For the sale of cosmetic products, the local entity registered with the Accounting and Corporate Regulatory Authority (ACRA) can submit a sales notification to HAS before importing and selling.

Application form content:

1. Details of local companies responsible for placing cosmetic products on the market

． Company Name

． company address

． City

． Postal code, full address

． phone number

． fax number

2. Details of persons authorised to represent local companies

． Applicant’s name

． ID/FIN

． Phone number

． Indicate preferred method of communication

． Company Name

3. Manufacturer Details

．Manufacturer’s name

．If it is a local manufacturer, please fill in the zip code and click Search Address, the data for Blk/House No, Street Name and Building Name will be filled automatically． Otherwise, please fill in the details accordingly

．If there are multiple manufacturers, click New to add details

After filling in and saving the details of the first record, the new manufacturer moves on to the next section．

．City

．Postal code, full address

．Phone number

．Fax number

4. Product Details

．Enter the brand name and product name of the product based on the name that appears on the product packaging

．Choose to reflect the type of product． (For example, if you want to inform anti-wrinkle cream, choose anti-wrinkle)

．Choose the type of presentation that best represents your product． (Example: singles, palettes, sets, etc．)

．Details

5. Supporting Documents

．There are no mandatory relevant supporting documents, but the company responsible for bringing the product to the market must be responsible for the product

．It is recommended to have relevant inspection certificates or supporting documents

6. Declaration, verification, confirmation and payment

．Statement of Consent

．Complete submission

．Debit fee

7. Upon successful submission of the cosmetic notification, a notification confirmation will be received, which will display

．Company name and address

．Brand name and product name

．Product Notification Number and Effective Date

8. Note:

．Product notifications are valid for one year, and annual notifications (updates) are required if your company intends to continue

．Notification is required even if the product has been notified by another company in Singapore and you imported it from the same manufacturer

．Notifications are also required for each different variation of the same cosmetic product, such as a different shade of lipstick and a different scented shampoo

9. The following products do not require cosmetic product notification. But there are still other requirements such as labelling, ingredients and adverse event reporting:

．Samples related to advertising, sponsorship or promotions

．Products used for testing or trials in connection with any research or development of this product．

．A product manufactured by a physician or according to his specifications and provided solely by that physician for use by patients under his or her care．

．Different package sizes of the same product．

【参考连结】

https://www.acra.gov.sg/

https://www.hsa.gov.sg/cosmetic-products/overview

HLF-SG-25

HLF-SG-30
外国公司要到新加坡销售化妆品，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 cosmetics 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。
化妆品的销售，须由会计和企业监管局 (ACRA)註册的当地实体公司向HAS提交销售通知方可进口、销售。
销售通知申请表内容：

 1. 负责将化妆品投放市场的当地公司的详细信息

．公司名称

．公司地址

．城市

．邮递区号、详细地址

．电话号码

．传真号码

2. 授权代表当地公司的人员的详细信息

．申请人姓名

．身份证/FIN

．电话号码

．指明首选的沟通方式

．公司名称

3. 製造商详情

．製造商的名称

．如果是本地製造商，请填写邮政编码并点击检索地址，Blk/House No, Street Name 和 Building Name 的数据将自动填充。
否则，请相应填写详细信息

．如果有多个製造商，请单击“新建”以添加详细信息

填写并保存第一条记录的详细信息后，新製造商进入下一部分。

．城市

．邮递区号、详细地址

．电话号码

．传真号码

4. 产品详情

．根据产品包装上出现的名称，输入产品的品牌名称和产品名称

．选择反映产品的类型。 (例如，如果您要通知抗皱霜，请选择抗皱)

．选择最能代表产品的演示类型。(例如：单品、调色板、套装等)

．详细信息

5. 支持文件

．没有强制相关支持文件，但负责将产品投入市场公司必须为产品负责

．建议有相关检验证明或支持文件

6. 申报、验证、确认和付款

．同意声明

．完成提交

．扣款费用

7. 成功提交化妆品通知后，将收到通知确认，其中将显示

．公司名称和地址

．品牌名称和产品名称

．产品通知编号和有效日期

8. 注意：

．产品通知有效期为一年，如果您的公司打算继续，每年都需要通知（更新）

．即使该产品已经被新加坡的另一家公司通知，并且您是从同一製造商进口的，也需要提交通知

．对于同一化妆品的每个不同变体，例如不同色调的口红和不同香味的洗发水，也需要提交通知

9. 以下产品不需要化妆品产品通知。但是仍然需要遵守其他要求，例如标籤、成分和不良事件报告：

．与广告、贊助或促销活动相关的样品

．用于与该产品的任何研究或开发有关的测试或试验的产品。

．由医生製造或根据其规格製造的产品，并由该医生单独提供，供其护理下的患者使用。

．同一产品的不同包装尺寸。

负责将化妆品投放市场的人，可能是进口商、製造商、分销商或零售商(必须是在会计和企业监管局註册的公司)有责任向 HSA 报告其负责的化妆品的产品缺陷和不利影响，并且产品标籤符合法规要求。

负责人的主要职责包括：

1. 提交产品通知

2.确保产品安全

3.对不安全产品进行召回

4.报告产品缺陷和不良影响

5.应 HSA的要求提交安全和技术信息

Yes. For the sale of cosmetic products, the local entity registered with the Accounting and Corporate Regulatory Authority (ACRA) can submit a sales notification to HAS before importing and selling.

Application form content:

1. Details of local companies responsible for placing cosmetic products on the market

． Company Name

． company address

． City

． Postal code, full address

． phone number

． fax number

2. Details of persons authorised to represent local companies

． Applicant’s name

． ID/FIN

． Phone number

． Indicate preferred method of communication

． Company Name

3. Manufacturer Details

．Manufacturer’s name

．If it is a local manufacturer, please fill in the zip code and click Search Address, the data for Blk/House No, Street Name and Building Name will be filled automatically. Otherwise, please fill in the details accordingly

．If there are multiple manufacturers, click New to add details

After filling in and saving the details of the first record, the new manufacturer moves on to the next section．

．City

．Postal code, full address

．Phone number

．Fax number

4. Product Details

．Enter the brand name and product name of the product based on the name that appears on the product packaging

．Choose to reflect the type of product． (For example, if you want to inform anti-wrinkle cream, choose anti-wrinkle)

．Choose the type of presentation that best represents your product． (Example: singles, palettes, sets, etc．)

．Details

5. Supporting Documents

．There are no mandatory relevant supporting documents, but the company responsible for bringing the product to the market must be responsible for the product

．It is recommended to have relevant inspection certificates or supporting documents

6. Declaration, verification, confirmation and payment

．Statement of Consent

．Complete submission

．Debit fee

7. Upon successful submission of the cosmetic notification, a notification confirmation will be received, which will display

．Company name and address

．Brand name and product name

．Product Notification Number and Effective Date

8. Note:

．Product notifications are valid for one year, and annual notifications (updates) are required if your company intends to continue

．Notification is required even if the product has been notified by another company in Singapore and you imported it from the same manufacturer

．Notifications are also required for each different variation of the same cosmetic product, such as a different shade of lipstick and a different scented shampoo

9. The following products do not require cosmetic product notification. But there are still other requirements such as labelling, ingredients and adverse event reporting:

．Samples related to advertising, sponsorship or promotions

．Products used for testing or trials in connection with any research or development of this product．

．A product manufactured by a physician or according to his specifications and provided solely by that physician for use by patients under his or her care．

．Different package sizes of the same product．

The person responsible for placing the cosmetic product on the market, which may be an importer, manufacturer, distributor or retailer (must be a company registered with the Accounting and Corporate Regulatory Authority) has a duty to report to the HSA product defects and adverse effects of the cosmetic product for which it is responsible, And the product label meets the regulatory requirements.

The principal’s main responsibilities include:

1. Submit Product Notification

2. Ensure product safety

3. Recall of unsafe products

4. Report product defects and adverse effects

5. Submit safety and technical information at the request of HSA

【参考连结】

https://www.hsa.gov.sg/cosmetic-products/overview

HLF-SG-35

HLF-SG-40
外国公司销售到新加坡化妆品本身，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？
化妆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 cosmetics sold to Singapore?
If yes, which authority is in charge?
What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? Which languages ​​are allowed? Website?

Evershine RD：

无须申请产品许可证，化妆品标籤应包含有关化妆品、其预期用途以及如何使用的真实和准确讯息。
在新加坡销售或供应之前，必须按照法规贴上标籤，并做出不会误导消费者对产品内容、质量或安全性的声明。
化妆品供应商，如批发商或零售商，在供应产品之前必须确保化妆品符合法规。
标籤或标籤声明必须是英文且清晰易读，以下信息必须出现在外包装上或化妆品容器上：

1.化妆品名称

2.化妆品的功能

3.使用说明

4.完整的成分列表

5.製造国

6.内容物（重量/体积）

7.批号

8.生产日期/有效期（仅对保质期少于 30 个月的产品需要写上有效期）

9.负责将产品投放市场的公司在新加坡的名称和地址

10.特殊预防措施，如果有的话（应提供标籤中使用的符号或代码的解释，并带有仅供专业使用标籤或类似的标籤仅限于专业用途。

11.专业用途是指人们在从事专业活动（例如在美发沙龙、美甲沙龙、水疗沙龙、皮肤诊所等）中使用和使用化妆品。 这也意味着此类化妆品不应由专业人士出售给消费者。

12.专业人士须有一定程度的专业知识和经验。
因此，他们比消费者更熟悉与使用产品相关的风险，还将具有将产品正确应用到消费者身上的专业知识。

标籤的展示

1.标籤在销售点必须清晰、永久、不可磨灭、醒目且显眼地展示在产品上。

2.标籤或标籤说明应出现在化妆品的外包装上，如果没有外包装，则应出现在化妆品的直接包装上。

3.如果容器或包装的尺寸、形状或性质不允许在容器或包装上指定所有要求的信息，则允许使用与产品一起放置的传单、小册子、吊牌、展示板等。但是，化妆品的名称和批号必须显示在直接包装或容器上。

成分列表

1.所有化妆品都必须标明产品中包含的所有成分。化妆品中每种成分的数量或百分比无需在标籤上披露。

2.成分应按重量降序排列，除了成分（着色剂除外）浓度低于 1%（按重量计），可按以下任意顺序列出

．存在浓度为 1% 或更多的成分

．任意顺序排列的着色剂

3.香水和芳香组合物及其原材料可以用香水、香精、香气或任何其他类似术语来指代。

4.调味剂可以称为风味或任何其他类似的语词

Without applying for a product license, cosmetic labels should contain truthful and accurate information about the cosmetic product, its intended use, and how it should be used. Before being sold or supplied in Singapore, it must be labelled in accordance with regulations and make a statement that does not mislead consumers about product content, quality or safety.
Cosmetics suppliers, such as wholesalers or retailers, must ensure that the cosmetic products are compliant with regulations before supplying products.

The label or label statement must be in English and legible, and the following information must appear on the outer packaging or cosmetic container:

1. Cosmetics name

2. The function of cosmetics

3. Instructions for use

4. Complete Ingredient List

5. Country of manufacture

6. Contents (weight/volume)

7. Lot number

8. Production date/expiration date (only for products with a shelf life of less than 30 months, the expiry date needs to be written)

9. Name and address in Singapore of the company responsible for placing the product on the market

10. Special precautions, if any (should provide an explanation of the symbols or codes used on the label, with a Professional Use Only label or similar labels for Professional Use Only.

11. Professional use refers to the use and use of cosmetic products by people engaged in professional activities (eg in hair salons, nail salons, spa salons, skin clinics, etc.). It also means that such cosmetic products should not be sold to consumers by professionals.

12. Professionals must have a certain level of expertise and experience. As a result, they are more familiar with the risks associated with using the product than the consumer and will also have the expertise to properly apply the product to the consumer.

Display of the label

1. Labels must be legible, permanent, indelible, prominent and conspicuous on the product at the point of sale.

2. The label or label description should appear on the outer packaging of the cosmetic, or on the immediate packaging of the cosmetic if there is no outer packaging.

3. If the size, shape or nature of the container or packaging does not allow all the required information to be specified on the container or packaging, leaflets, brochures, hang tags, display boards, etc. placed with the product are allowed. However, the name and batch number of the cosmetic product must appear on the immediate packaging or container.

List of ingredients

1. All cosmetic products must label all ingredients contained in the product. The amount or percentage of each ingredient in a cosmetic product does not need to be disclosed on the label.

2. Ingredients should be listed in descending order by weight, except that ingredients (other than colorants) are less than 1% concentration by weight, which may be listed in any order below

. ingredients present at a concentration of 1% or more

. Colorants in any order

3. Perfume and fragrance compositions and their raw materials may be referred to by perfume, essence, aroma or any other similar term.

4. Flavoring agent can be called flavor or any other similar word

【参考连结】

https://www.hsa.gov.sg/cosmetic-products/overview

HLF-SG-45

请问在新加坡有哪些专业服务机构，可以协助办理化妆品产品许可证？

Evershine RD：

无须申请产品许可证

No product license application required

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？
化妆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 cosmetics packaging and labeling require prior approval? Which languages ​​are allowed?? Website?

Evershine RD：

无须申请产品许可证。化妆品标籤应包含有关化妆品、其预期用途以及如何使用的真实和准确讯息。
在新加坡销售或供应之前，必须按照法规贴上标籤，并做出不会误导消费者对产品内容、质量或安全性的声明。
化妆品供应商，如批发商或零售商，在供应产品之前必须确保化妆品符合法规。

标籤或标籤声明必须是英文且清晰易读，以下信息必须出现在外包装上或化妆品容器上：

1.化妆品名称

2.化妆品的功能

3.使用说明

4.完整的成分列表

5.製造国

6.内容物（重量/体积）

7.批号

8.生产日期/有效期（仅对保质期少于 30 个月的产品需要写上有效期）

9.负责将产品投放市场的公司在新加坡的名称和地址

10.特殊预防措施，如果有的话（应提供标籤中使用的符号或代码的解释，并带有仅供专业使用标籤或类似的标籤仅限于专业用途。

11.专业用途是指人们在从事专业活动（例如在美发沙龙、美甲沙龙、水疗沙龙、皮肤诊所等）中使用和使用化妆品。 这也意味着此类化妆品不应由专业人士出售给消费者。

12.专业人士须有一定程度的专业知识和经验。 因此，他们比消费者更熟悉与使用产品相关的风险，还将具有将产品正确应用到消费者身上的专业知识。

标籤的展示

1.标籤在销售点必须清晰、永久、不可磨灭、醒目且显眼地展示在产品上。

2.标籤或标籤说明应出现在化妆品的外包装上，如果没有外包装，则应出现在化妆品的直接包装上。

3.如果容器或包装的尺寸、形状或性质不允许在容器或包装上指定所有要求的信息，则允许使用与产品一起放置的传单、小册子、吊牌、展示板等。但是，化妆品的名称和批号必须显示在直接包装或容器上。

成分列表

1.所有化妆品都必须标明产品中包含的所有成分。化妆品中每种成分的数量或百分比无需在标籤上披露。

2.成分应按重量降序排列，除了成分（着色剂除外）浓度低于 1%（按重量计），可按以下任意顺序列出

．存在浓度为 1% 或更多的成分

．任意顺序排列的着色剂

3.香水和芳香组合物及其原材料可以用香水、香精、香气或任何其他类似术语来指代。

4.调味剂可以称为风味或任何其他类似的语词

Without applying for a product license, cosmetic labels should contain truthful and accurate information about the cosmetic product, its intended use, and how it should be used. Before being sold or supplied in Singapore, it must be labelled in accordance with regulations and make a statement that does not mislead consumers about product content, quality or safety. Cosmetics suppliers, such as wholesalers or retailers, must ensure that the cosmetic products are compliant with regulations before supplying products.

The label or label statement must be in English and legible, and the following information must appear on the outer packaging or cosmetic container:

1. Cosmetics name

2. The function of cosmetics

3. Instructions for use

4. Complete Ingredient List

5. Country of manufacture

6. Contents (weight/volume)

7. Lot number

8. Production date/expiration date (only for products with a shelf life of less than 30 months, the expiry date needs to be written)

9. Name and address in Singapore of the company responsible for placing the product on the market

10. Special precautions, if any (should provide an explanation of the symbols or codes used on the label, with a Professional Use Only label or similar labels for Professional Use Only.

11. Professional use refers to the use and use of cosmetic products by people engaged in professional activities (eg in hair salons, nail salons, spa salons, skin clinics, etc.). It also means that such cosmetic products should not be sold to consumers by professionals.

12. Professionals must have a certain level of expertise and experience. As a result, they are more familiar with the risks associated with using the product than the consumer and will also have the expertise to properly apply the product to the consumer.

Display of the label

1. Labels must be legible, permanent, indelible, prominent and conspicuous on the product at the point of sale.

2. The label or label description should appear on the outer packaging of the cosmetic, or on the immediate packaging of the cosmetic if there is no outer packaging.

3. If the size, shape or nature of the container or packaging does not allow all the required information to be specified on the container or packaging, leaflets, brochures, hang tags, display boards, etc. placed with the product are allowed. However, the name and batch number of the cosmetic product must appear on the immediate packaging or container.

List of ingredients

1. All cosmetic products must label all ingredients contained in the product. The amount or percentage of each ingredient in a cosmetic product does not need to be disclosed on the label.

2. Ingredients should be listed in descending order by weight, except that ingredients (other than colorants) are less than 1% concentration by weight, which may be listed in any order below

. ingredients present at a concentration of 1% or more

. Colorants in any order

3. Perfume and fragrance compositions and their raw materials may be referred to by perfume, essence, aroma or any other similar term.

4. Flavoring agent can be called flavor or any other similar word

【参考连结】

https://www.hsa.gov.sg/cosmetic-products/overview

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化妆品产品许可证？

Evershine RD：

无须申请产品许可证

No product license application required

HLF-SG-60
经过核准登记的化妆品，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 cosmetics 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：

需先提交销售通知，收到通知确认后方可进口、销售化妆品。
申请人：将该化妆品投放至市场者，如为外国厂商，则需委託当地已经在会计和企业监管局 (ACRA)註册的当地实体公司协助提交。
销售通知申请表内容：请用英文填写所有部分

1. 负责将化妆品投放市场的当地公司的详细信息

．公司名称

．公司地址

．城市

．邮递区号、详细地址

．电话号码

．传真号码

2. 授权代表当地公司的人员的详细信息

．申请人姓名

．身份证/FIN

．电话号码

．指明首选的沟通方式

．公司名称

3. 製造商详情

．製造商的名称

．如果是本地製造商，请填写邮政编码并点击检索地址，Blk/House No, Street Name 和 Building Name 的数据将自动填充。否则，请相应填写详细信息

．如果有多个製造商，请单击“新建”以添加详细信息

填写并保存第一条记录的详细信息后，新製造商进入下一部分。

．城市

．邮递区号、详细地址

．电话号码

．传真号码

4. 产品详情

．根据产品包装上出现的名称，输入产品的品牌名称和产品名称

．选择反映产品的类型。 (例如，如果您要通知抗皱霜，请选择抗皱)

．选择最能代表产品的演示类型。(例如：单品、调色板、套装等)

．详细信息

5. 支持文件

．没有强制相关支持文件，但负责将产品投入市场公司必须为产品负责

．建议有相关检验证明或支持文件

6. 申报、验证、确认和付款

．同意声明

．完成提交

．扣款费用

7. 成功提交化妆品通知后，将收到通知确认，其中将显示

．公司名称和地址

．品牌名称和产品名称

．产品通知编号和有效日期

8. 注意：

．产品通知有效期为一年，如果您的公司打算继续，每年都需要通知（更新）

．即使该产品已经被新加坡的另一家公司通知，并且您是从同一製造商进口的，也需要提交通知

．对于同一化妆品的每个不同变体，例如不同色调的口红和不同香味的洗发水，也需要提交通知

9. 以下产品不需要化妆品产品通知。但是仍然需要遵守其他要求，例如标籤、成分和不良事件报告：

．与广告、贊助或促销活动相关的样品

．用于与该产品的任何研究或开发有关的测试或试验的产品。

．由医生製造或根据其规格製造的产品，并由该医生单独提供，供其护理下的患者使用。

．同一产品的不同包装尺寸。

海关过境系统/申报文件

新加坡对进口商品检验检疫的标准和程序十分严格。负责进口化妆品商品检验的部门是简称HAS，进口化妆品前须完成销售通知、取得海关进口许可证后方可执行。

海关进口许可证：

1. 註册入口网站的帐户，化妆品被归类为健康与美容（cdf 类别）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。

A sales notification must be submitted first, and cosmetics can be imported and sold after receiving the notification confirmation.

The applicant:

Those who put the cosmetics on the market, such as foreign manufacturers, need to entrust a local entity registered with the Accounting and Corporate Regulatory Authority (ACRA) to assist in the submission.

Application form content: Please fill in all parts in English

1. Details of local companies responsible for placing cosmetic products on the market

． Company Name

． company address

． City

． Postal code, full address

． phone number

． fax number

2. Details of persons authorised to represent local companies

． Applicant’s name

． ID/FIN

． Phone number

． Indicate preferred method of communication

． Company Name

3. Manufacturer Details

．Manufacturer’s name

．If it is a local manufacturer, please fill in the zip code and click Search Address, the data for Blk/House No, Street Name and Building Name will be filled automatically． Otherwise, please fill in the details accordingly

．If there are multiple manufacturers, click New to add details

After filling in and saving the details of the first record, the new manufacturer moves on to the next section．

．City

．Postal code, full address

．Phone number

．Fax number

4. Product Details

．Enter the brand name and product name of the product based on the name that appears on the product packaging

．Choose to reflect the type of product． (For example, if you want to inform anti-wrinkle cream, choose anti-wrinkle)

．Choose the type of presentation that best represents your product． (Example: singles, palettes, sets, etc．)

．Details

5. Supporting Documents

．There are no mandatory relevant supporting documents, but the company responsible for bringing the product to the market must be responsible for the product

．It is recommended to have relevant inspection certificates or supporting documents

6. Declaration, verification, confirmation and payment

．Statement of Consent

．Complete submission

．Debit fee

7. Upon successful submission of the cosmetic notification, a notification confirmation will be received, which will display

．Company name and address

．Brand name and product name

．Product Notification Number and Effective Date

8. Note:

．Product notifications are valid for one year, and annual notifications (updates) are required if your company intends to continue

．Notification is required even if the product has been notified by another company in Singapore and you imported it from the same manufacturer

．Notifications are also required for each different variation of the same cosmetic product, such as a different shade of lipstick and a different scented shampoo

9. The following products do not require cosmetic product notification. But there are still other requirements such as labelling, ingredients and adverse event reporting:

．Samples related to advertising, sponsorship or promotions

．Products used for testing or trials in connection with any research or development of this product．

．A product manufactured by a physician or according to his specifications and provided solely by that physician for use by patients under his or her care．

．Different package sizes of the same product．

Customs Transit System/Declaration Documents

Singapore has strict standards and procedures for the inspection and quarantine of imported goods.
The department responsible for the inspection of imported cosmetics products is referred to as HAS. Before importing cosmetics, it is necessary to complete the sales notification and obtain the customs import license.

Customs import license:

1. Register an account on the portal, cosmetic products are classified as health and beauty (cdf category) 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) to pay Singapore Customs duties, taxes, fees, fines and other charges for services provided by Singapore Customs directly from your bank account．

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

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．

．Guarantees provided should be in the form of bank guarantees, finance company guarantees or security deposits．

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 goods clearance documents

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

．Documents Required for Containerized Cargo

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

To import containerized cargo by air or land, you need to present customs license and supporting documents such as invoice, packing list and bill of lading/air waybill for verification with the checkpoint officer．

．Documents Required for Regular Cargo

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

．Keep trade documents

Relevant supporting documents pertaining 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.hsa.gov.sg/cosmetic-products/notification/submit

https://www.customs.gov.sg/eservices/customs-forms-and-service-links

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

HLF-SG-70
新加坡化妆品审核机构，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：

新加坡的化妆品没有要求相关检验资料。製造商、进口商、销售商需要确保化妆品符合法令规范、安全及质量，投放在市场者需要承担责任。
製造商没有要求製造商许可证。但是，製造商可以申请自愿的良好生产规范 (GMP) 证书以促进化妆品的出口。
申请路径：通过PRISM系统提交申请

具备条件：

1. CRIS 公司账户

2. Corppass /HSA PIN

相关检验资料：

1. 原包装材料规格应包括

．材料名称

．材料说明

．测试参数和接受限度

．技术图纸(如有必要)

．特殊预防措施，例如储存和安全条件(如有必要)

2.散装和成品规格应包括：

．产品名称

．说明

．物理性质

．化学分析和/或微生物分析和他们的接受限度(如有必要)

．储存条件和安全预防措施(如有必要)

3. 生产文件

．产品名称和产品代码/编号

．预期的包装材料和储存条件

．使用的原材料清单

．使用的设备清单

．过程控制及其在处理过程中的限制和包装(如适用)

4. 批量生产记录(BMR) ：应为每批产品准备批生产记录

．产品名称

．批处理公式

．製作工艺简略

．批号或代码

．加工和包装的开始和结束日期

．单个主要设备和使用的线路或位置的标识

．用于加工的设备的清洁记录（视情况而定）

．过程控制和实验室结果，例如 pH 和温度测试记录

．包装线清关检验记录

．在处理的各个步骤期间执行的任何採样

．对特定故障或差异的任何调查

．包装和标籤产品的检查结果

5. 质量控制记录：应保存每次测试、化验结果以及起始材料、中间体、散装产品和成品的放行或拒收的记录

． 检测日期

．材料识别

．供应商名称

．收货日期

．原始批号（如有）

．批号

．质控编号

．质控编号

．取样日期

．质量控制结果等

备註：申请后，HSA将安排进行GMP认证审核，包含东盟化妆品指令中与 GMP 相关的所有建议。
应根据 化妆品製造商网站主文件准备指南准备网站主文件并在 GMP 认证审核前提交。
当被认为符合上述GMP标准时，将授予GMP证书。

Cosmetics in Singapore do not require relevant inspection materials. Manufacturers, importers, and sellers need to ensure that cosmetics comply with laws and regulations, safety and quality, and those who put them on the market need to be held responsible.

Manufacturers do not require a manufacturer’s license. However, manufacturers can apply for voluntary Good Manufacturing Practice (GMP) certificates to facilitate the export of cosmetics.

Application Path: Submit an application through the PRISM system

Qualified:

1. CRIS Corporate Account

2. Corppass /HSA PIN

Relevant inspection data:

1. The original packaging material specifications should include

． Material name

． Material Description

． Test parameters and acceptance limits

． Technical drawings (if necessary)

． Special precautions such as storage and safety conditions (if necessary)

2. Bulk and finished product specifications shall include:

． Product name

． Illustrate

． Physical properties

． Chemical analysis and/or microbiological analysis and their acceptance limits (if necessary)

． Storage conditions and safety precautions (if necessary)

3. Production documents

． Product name and product code/number

． Expected Packaging Materials and Storage Conditions

． List of raw materials used

． List of equipment used

． Process controls and their restrictions during handling and packaging (if applicable)

4. Batch Production Record (BMR): A batch production record should be prepared for each batch of product

． Product name

． Batch formula

． The production process is simple

． Lot number or code

． Start and end dates for processing and packaging

． Identification of a single major device and line or location used

． Cleaning records of equipment used for processing (as applicable)

． Process control and laboratory results such as pH and temperature test records

． Packaging line customs clearance inspection record

． Any sampling performed during various steps of processing

． Any investigation of a specific fault or discrepancy

． Inspection results of packaged and labelled products

5. Quality Control Records: Records should be maintained for each test, assay results, and release or rejection of starting materials, intermediates, bulk products, and finished products

． test date

． Material identification

． Supplier name

． date of receipt

． Original lot number (if any)

． batch number

． Quality control number

． Quality control number

． Sampling date

．Quality control results, etc.

Note: After application, HSA will arrange for a GMP certification audit, including all GMP-related recommendations in the ASEAN Cosmetics Directive. The website master file should be prepared according to the Guidelines for the Preparation of the Website Master File for Cosmetic Manufacturers and submitted prior to the GMP certification audit.
A GMP certificate will be granted when it is deemed to meet the above GMP standards.

【参考连结】

https://www.hsa.gov.sg/cosmetic-products/good-manufacturing-practice

HLF-SG-75

新加坡化妆品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

Evershine RD：

新加坡的化妆品没有要求相关检验资料。

HLF-SG-77

HLF-SG-80
外国子公司进口化妆品后，如果委託新加坡的经销商销售，经销商需要化妆品营业许可证吗？
假如化妆品有品质瑕疵的话，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 cosmetics and entrusts a distributor in Singapore to sell it, does the distributor need a cosmetics 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：

无需申请营业许可证。

化妆品的销售，须由会计和企业监管局 (ACRA)註册的当地实体公司向HAS提交销售通知方可进口、销售。
负责将化妆品投放市场的人，可能是进口商、製造商、分销商或零售商(必须是在会计和企业监管局註册的公司)有责任向 HSA 报告其负责的化妆品的产品缺陷和不利影响，并且产品标籤符合法规要求。

负责人的主要职责包括：

1. 提交产品通知

2.确保产品安全

3.对不安全产品进行召回

4.报告产品缺陷和不良影响

5.应 HSA的要求提交安全和技术信息

There is no need to apply for a business permit.

For the sale of cosmetic products, the local entity registered with the Accounting and Corporate Regulatory Authority (ACRA) can submit a sales notification to HAS before importing and selling.

The person responsible for placing the cosmetic product on the market, which may be an importer, manufacturer, distributor or retailer (must be a company registered with the Accounting and Corporate Regulatory Authority) has a duty to report to the HSA product defects and adverse effects of the cosmetic product for which it is responsible, And the product label meets the regulatory requirements.

The principal’s main responsibilities include:

1. Submit Product Notification

2. Ensure product safety

3. Recall of unsafe products

4. Report product defects and adverse effects

5. Submit safety and technical information at the request of HSA

【参考连结】

https://www.hsa.gov.sg/cosmetic-products/overview

HLF-SG-85

各国化妆品登记法规问答集

**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。
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