马来西亚化妆品登记法规问题集

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各国化妆品登记法规问答集

HLF-TW-10
请问马来西亚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 Malaysia? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?

Evershine RD：

化妆品的定义是指接触于人体各外部器官（表皮(皮肤)、毛发、指(趾)甲、嘴唇和外生殖器）或口腔内的牙齿和口腔黏膜，以清洁、发出香味、改善外观、改善身体气味或保护身体使之保持良好状态为主要目的的物质和製剂。

化妆品类别：

1. 用于皮肤（手、脸、脚等）的面霜、乳液、乳液、凝胶和油

2. 面膜（化学脱皮产品除外）

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

．用于波浪、拉直和固定的产品

．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、亮油）

11.剃须产品（面霜、泡沫、乳液等）

12.面部和眼部彩妆和卸妆产品

13.适用于嘴唇的产品

14.牙齿和口腔护理产品

15.指甲护理和化妆产品

16.用于外部私密卫生的产品

17.日光浴产品

18.防晒太阳的产品

19.美白产品

20.抗皱/抗衰老产品

不得归类为化妆品：

1. 用于治疗疾病/感染的产品

2. 性功能产品：男性和女性（用于生殖器部位的留存产品）

3. 口服产品

4. 注射剂：维生素C、胶原蛋白、透明质酸

5. 产品注入鼻子、眼睛和耳朵

6. 产品用途超出化妆品范围（例如用于关节疼痛、扭伤的按摩油和用于影响精神、生理功能的精油）

7. 瘦身产品

8. 用滴管瓶/容器或喷雾形式包装的眼部製剂

在马来西亚，药物管制局 (DCA)是负责监管化妆品的机构。
国家药品监督管理局 (NPRA) 是 DCA 的秘书处，负责化妆品通知流程和上市后监督。

A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”
Cosmetic classification:

1. Creams, lotions, lotions, gels and oils for the skin (hands, face, feet, etc.)

2. Masks (except chemical peeling products)

3. Coloring base (liquid, paste, powder)

4. Cosmetic powder, after-bath powder, hygiene 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 and Fixing

． Set up products

． Cleaning Products (Lotions, Powders, Shampoos)

． Conditioning products (lotions, creams, oils)

． Hair products (lotions, polishes, polishes)

11. Shaving products (cream, foam, lotion, etc.)

12. Face and Eye Makeup and Makeup Removers

13. Products for lips

14. Teeth and oral care products

15. Nail Care & Makeup Products

16. Products for external intimate hygiene

17. Sunbath products

18. Sun protection products

19. Skin Whitening Products

20. Anti-Wrinkle/Anti-Ageing Products

Not classified as cosmetic:

1. Products for the treatment of disease/infection

2. Sexual function products: male and female (preserved products for genital area)

3. Oral products

4. Injections: Vitamin C, Collagen, Hyaluronic Acid

5. The product is injected into the nose, eyes and ears

6. The use of the product is beyond the scope of cosmetics (such as massage oil for joint pain, sprain and essential oil for affecting mental and physiological functions)

7. Slimming products

8. Ophthalmic preparations in dropper bottles/containers or in spray form

In Malaysia, the Drug Control Authority (DCA) is the agency responsible for regulating cosmetics.
The National Drug Administration (NPRA) is the secretariat of the DCA and is responsible for the cosmetic notification process and post-market surveillance.

【参考连结】

https://www.npra.gov.my/index.php/en/

HLF-TW-20
外国公司要到马来西亚销售化妆品，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 Malaysia, 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：

须在马来西亚当地註册化妆品公司。批发商必须先申请健康/化妆品批发商许可证才能註册其产品，许可证有效期为1年。
在马来西亚註册所有企业（包括外国公司），马来西亚公司委员会（SSM）的企业註册处管理。所有公司必须在成立后 30 天内任命一名公司秘书（需要在马来西亚拥有主要居住地）。
秘书必须获得马来西亚公司委员会( SSM )的许可，或者是国内贸易和消费者事务部规定的专业组织的成员。

商业註册需要以下资料：

1.公司名称

2.私人或上市公司

3.建议的业务类型(必须要是健康/化妆品类)

4.註册办事处地址

5.营业地址

6.缴足资本（最低 RM1）

7.董事和发起人的详细信息

8.董事和发起人的声明

9.负责註册成立的个人的合规声明

10.附加文件（如有）

A health/cosmetic company needs to be registered locally in Malaysia.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry.
All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.

Business registration requires the following information:

1. Company name

2. Private or public companies

3. Suggested business type (must be health/cosmetics)

4. Registered Office Address

5. Business address

6. Paid-up capital (minimum RM1)

7. Details of directors and promoters

8. Statement of Directors and Promoters

9. Compliance Statement for the Individual Responsible for Incorporation

10. Additional documents (if available)

【参考连结】

https://www.ssm.com.my/Pages/Home.aspx

HLF-TW-25
假如需要办理，请问马来西亚有专业服务公司可以协助办理化妆品公司营业许可证？

HLF-TW-30
外国公司要到马来西亚销售化妆品，可以指派马来西亚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 Malaysia, can it assign a Malaysian 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，批发商必须申请健康/化妆品批发商许可证才能註册并销售其产品，许可证有效期为1年。
在马来西亚註册所有企业（包括外国公司），马来西亚公司委员会（SSM）的企业註册处管理。
所有公司必须在成立后 30 天内任命一名公司秘书（需要在马来西亚拥有主要居住地）。
秘书必须获得马来西亚公司委员会( SSM )的许可，或者是国内贸易和消费者事务部规定的专业组织的成员。

商业註册需要以下资料：

1.公司名称

2.私人或上市公司

3.建议的业务类型(必须要是健康/化妆品类)

4.註册办事处地址

5.营业地址

6.缴足资本（最低 RM1）

7.董事和发起人的详细信息

8.董事和发起人的声明

9.负责註册成立的个人的合规声明

10.附加文件（如有）

CNH应向发生国家药品监督管理局 (NPRA)报告不良事件，无论报告的来源（消费者、医疗保健专业人员等）如何。
所有严重的不良事件应该报告。不要求报告非严重不良事件。
只要有理由怀疑化妆品可能是引起反应的原因，就必须报告所有严重的不良事件。

Yes. A health/cosmetic company needs to be registered locally in Malaysia.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry.
All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.

Business registration requires the following information:

1. Company name

2. Private or public companies

3. Suggested business type (must be health/cosmetics)

4. Registered Office Address

5. Business address

6. Paid-up capital (minimum RM1)

7. Details of directors and promoters

8. Statement of Directors and Promoters

9. Compliance Statement for the Individual Responsible for Incorporation

10. Additional documents (if available)

CNH should report the adverse event to the National Drug Regulatory Authority (NPRA), regardless of the source of the report (consumer, healthcare professional, etc.). All serious adverse events should be reported.
Reports of non-serious adverse events are not required.
All serious adverse events must be reported whenever there is reason to suspect that cosmetic products may be the cause of the reaction.

【参考连结】

https://www.ssm.com.my/Pages/Home.aspx

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-35

HLF-TW-40
外国公司销售到马来西亚化妆品本身，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？可允许的语文除了马来文外，其他哪种语文也可以？网页？

Do foreign companies need to apply for an approval before importing cosmetics sold to Malaysia?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? In addition to Malaysian, which other languages ​​are allowed? Website?

Evershine RD：

须以马来西亚当地健康/化妆品公司通知持有人 (CNH)的名义申请。所有化妆品的製造、销售、供应、进口或分销都必须先通知国家药品监督管理局 (NPRA)，然后才能在马来西亚销售。
希望将化妆品带入马来西亚的外国公司，首先必须指定当地代理人作为化妆品通知持有人 (CNH)。
化妆品通知持有人负责将化妆品投放市场。

化妆品通知持有人 (CNH) 必须是化妆品领域的本地註册公司，具有永久地址并在马来西亚公司委员会註册（其业务范围显示的健康/化妆品相关的公司）。
所有通知的提交都透过 NPRA 网站中的Quest 系统进行线上申请，必须註册会员、填写每种化妆品的通知表，以及完成付款。
CNH在收到授权后始得製造或进口化妆品。

所需文件：

1. 产品详情

．产品名称、产品类型、预期用途和产品介绍

．製造商和组装商的名称和地址（如有）

2. CNH 的名称、地址、联繫电话、电子邮件

3. 进口商名称、地址（如有）

4. 完整的产品成分表

．必须声明限制成分的含量，即百分比（%）

．授权书/声明书/合同製造书（如适用）

5. 产品标籤

注意事项：提交给 NPRA 的任何文件和材料必须使用马来文或英语。其他语言的翻译版本必须得到认可或授权。

马来西亚化妆品标籤要求：化妆品外包装应标註以下内容(没有外包装的情况下，要在化妆品的直接包装上标註)

1.化妆品的名称及其功能，除非从产品的介绍中可以清楚地看出

2.化妆品的使用说明，除非从产品名称或外观中明确

3.完整的成分列表。成分必须在添加时按重量降序声明。

．香水和芳香组合物及其原料可简称为香水、香味、香气或风味。
浓度小于 1% 的成分可以在浓度大于 1% 的成分之后以任意顺序列出。
根据规范中採用的名称，着色剂可在其他成分之后以任意顺序列出。

．对于以多种色调销售的装饰性化妆品，可以列出该范围内使用的所有着色剂，前提是需要添加术语“可能包含”或“+/-”。成分应使用最新版本的标准参考中的命名法来指定。植物药和植物提取物应按其属和种进行鑑别。
但是，以下不应被视为成分：

．所用原材料中的杂质

．准备中使用但不使用的辅助技术材料

．材料作用溶剂，或香水和芳香组合物的载体

4. 製造国；

5. CNH 的名称和地址

6. 以公制和英制的重量或体积内容

7. 生产批号

8. 产品的製造日期或有效期，以明确的方式（例如月/年）。

．日期应明确表示，并应由月和年或按日、月、年的顺序组成。
最低保质期应是该产品在适当条件下储存的日期，直至其继续发挥其初始功能，特别是保持符合安全要求的日期。
前面应加上到期日字样。如有必要，该信息应补充说明为保证规定的耐用性必须满足的条件。
对于最短保质期少于 30 个月的化妆品，必须註明有效期。

9. 使用中应遵守的特殊注意事项，尤其是使用条件和警告，必须出现在标籤上以及化妆品的任何特殊预防信息。

 10. 所有标示内容应易于阅读、清楚、可以理解、不可磨灭。

 11. 标籤上的信息应为马来文和(或)英文。

动物源性成分声明：

1.产品标籤上必须有声明（任何格式）表明存在动物源性成分

2.对于牛或猪来源的成分，必须确切的申报动物

3. CNH 的有效联繫电话。

如果容器或包装的尺寸、形状或性质不符合允许展示规定的详情，可以使用传单、小册子、吊牌、展示板、收缩包装等替代，至少需要标註以下内容：

1. 化妆品名称

2. 生产批号

3. 如果化妆品以散装容器形式进口，以下细节至少应出现在容器上：

．化妆品名称

．製造商名称和製造批号

4. 所有标示内容应易于阅读、清楚、可以理解、不可磨灭。

清真标誌：产品已获得马来西亚伊斯兰发展部（Jabatan Kemajuan Islam Malaysia，JAKIM）该或任何授权的伊斯兰机构的清真认证和批准，可以自愿标识于核可的化妆品上。

It is required to apply on behalf of a local health/cosmetics company in Malaysia as the Cosmetic Notification Holder (CNH).
The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website.
Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed.
CNH may not manufacture or import cosmetic products until authorized.

needed file:

1. Product Details

． Product name, product type, intended use and product description

． Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

． The content of restricted ingredients must be declared, i.e. percentage (%)

． Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English.
Translations in other languages must be endorsed or licensed.

Cosmetic labeling requirements: The outer packaging of cosmetics must be marked with the following contents (if there is no outer packaging, it must be marked on the direct packaging of cosmetics).

1. The name of the cosmetic product and its function, unless it is clear from the product description

2. Instructions for use of cosmetics, unless clear from the product name or appearance

3. Complete ingredient list. Ingredients must be declared in descending weight order when added.

． Perfume and fragrance compositions and their raw materials may be referred to simply as perfumes, scents, aromas or flavors. Ingredients with a concentration of less than 1% can be listed in any order after ingredients with a concentration of greater than 1%. Colorants can be listed in any order after the other ingredients, depending on the name used in the specification.

． For decorative cosmetics sold in multiple shades, all colorants used in the range can be listed, provided the term “may contain” or “+/-” is added. Ingredients shall be designated using the nomenclature in the latest edition of the Standard Reference.
Botanicals and plant extracts should be identified by their genus and species.

However, the following should not be considered ingredients:

． Impurities in the raw materials used

． Assistive Technology Materials Used in Preparation but Not Used

． The material acts as a solvent, or a carrier for perfume and fragrance compositions

4. Country of manufacture;

5. CNH’s name and address

6. Weight or volume content in metric and imperial

7. Production batch number

8. The date of manufacture or expiration date of the product, in an unambiguous manner (eg month/year).

． Dates should be clearly indicated and should consist of months and years or in the order day, month, and year.
The minimum shelf life should be the date that the product has been stored under appropriate conditions until it continues to perform its original function, in particular, to maintain compliance with safety requirements. It should be preceded by the words due date.
If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of less than 30 months, the expiration date must be stated.

9. Special precautions to be observed in use, especially conditions of use and warnings, must appear on the label and any special precautionary information for the cosmetic product.

10. All marked contents should be easy to read, clear, understandable and indelible.

11. The information on the label should be in Malay and/or English.

Animal-derived ingredient declaration:

1. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin

2. For ingredients of bovine or porcine origin, the exact animal must be declared

3. A valid contact number for CNH.

If the size, shape or nature of the container or package does not meet the details of the permitted display regulations, flyers, brochures, hang tags, display boards, shrink wrap, etc. may be used instead, with at least the following:

1. Cosmetics name

2. Production batch number

3. If the cosmetic product is imported in bulk containers, at least the following details shall appear on the container:

． Cosmetic name

． Manufacturer’s name and manufacturing lot number

4. All marked contents should be easy to read, clear, understandable and indelible.

Halal Mark: Products have been certified and approved as Halal by this or any authorised Islamic body of the Ministry of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, JAKIM) and can be voluntarily marked on approved cosmetic products.

【参考连结】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？
申请程序为何？化妆品包装内容及各种标示，需要事先核准吗？
可允许的语文除了马来文外，其他哪种语文也可以？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?
In addition to Malaysian, which other languages ​​are allowed? Website?

Evershine RD：

须以马来西亚当地健康/化妆品公司通知持有人 (CNH)的名义申请。
所有化妆品的製造、销售、供应、进口或分销都必须先通知国家药品监督管理局 (NPRA)，然后才能在马来西亚销售。
希望将化妆品带入马来西亚的外国公司首先必须指定当地代理人作为化妆品通知持有人 (CNH)。
化妆品通知持有人负责将化妆品投放市场。

化妆品通知持有人 (CNH) 必须是化妆品领域的本地註册公司，具有永久地址并在马来西亚公司委员会註册（其业务范围显示的健康/化妆品相关的公司）。
所有通知的提交都透过 NPRA 网站中的Quest 系统进行线上申请，必须註册会员、填写每种化妆品的通知表，以及完成付款。
CNH在收到授权后始得製造或进口化妆品。

所需文件：

1. 产品详情

．产品名称、产品类型、预期用途和产品介绍

．製造商和组装商的名称和地址（如果有）

2. CNH 的名称、地址、联繫电话、电子邮件

3. 进口商名称、地址（如有）

4. 完整的产品成分表

．必须声明限制成分的含量，即百分比（%）

．授权书/声明书/合同製造书（如适用）

5. 产品标籤

注意事项：提交给 NPRA 的任何文件和材料必须使用马来文或英语。其他语言的翻译版本必须得到认可或授权。
马来西亚化妆品标籤要求：化妆品外包装应标註以下内容(没有外包装的情况下，要在化妆品的直接包装上标註)

1.化妆品的名称及其功能，除非从产品的介绍中可以清楚地看出

2.化妆品的使用说明，除非从产品名称或外观中明确

3.完整的成分列表。成分必须在添加时按重量降序声明。

．香水和芳香组合物及其原料可简称为香水、香味、香气或风味。
浓度小于 1% 的成分可以在浓度大于 1% 的成分之后以任意顺序列出。根据规范中採用的名称，着色剂可在其他成分之后以任意顺序列出。

．对于以多种色调销售的装饰性化妆品，可以列出该范围内使用的所有着色剂，前提是需要添加术语“可能包含”或“+/-”。
成分应使用最新版本的标准参考中的命名法来指定。植物药和植物提取物应按其属和种进行鑑别。
但是，以下不应被视为成分：

．所用原材料中的杂质

．准备中使用但不使用的辅助技术材料

．材料作用溶剂，或香水和芳香组合物的载体

4. 製造国；

5. CNH 的名称和地址

6. 以公制和英制的重量或体积内容

7. 生产批号

8. 产品的製造日期或有效期，以明确的方式（例如月/年）。

．日期应明确表示，并应由月和年或按日、月、年的顺序组成。
最低保质期应是该产品在适当条件下储存的日期，直至其继续发挥其初始功能，特别是保持符合安全要求的日期。
前面应加上到期日字样。如有必要，该信息应补充说明为保证规定的耐用性必须满足的条件。
对于最短保质期少于 30 个月的化妆品，必须註明有效期。

9. 使用中应遵守的特殊注意事项，尤其是使用条件和警告，必须出现在标籤上以及化妆品的任何特殊预防信息。10. 所有标示内容应易于阅读、清楚、可以理解、不可磨灭。

11. 标籤上的信息应为马来文和(或)英文。

动物源性成分声明：

1.产品标籤上必须有声明（任何格式）表明存在动物源性成分

2.对于牛或猪来源的成分，必须确切的申报动物

3. CNH 的有效联繫电话。

如果容器或包装的尺寸、形状或性质不符合允许展示规定的详情，可以使用传单、小册子、吊牌、展示板、收缩包装等替代，至少需要标註以下内容：

1. 化妆品名称

2. 生产批号

3. 如果化妆品以散装容器形式进口，以下细节至少应出现在容器上：

．化妆品名称

．製造商名称和製造批号

4. 所有标示内容应易于阅读、清楚、可以理解、不可磨灭。

清真标誌：产品已获得马来西亚伊斯兰发展部（Jabatan Kemajuan Islam Malaysia，JAKIM）该或任何授权的伊斯兰机构的清真认证和批准，可以自愿标识于核可的化妆品上。

It is required to apply on behalf of a local health/cosmetics company in Malaysia as the Cosmetic Notification Holder (CNH).

The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia.
A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope).
All notification submissions are made online through the Quest system on the NPRA website.
Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed. CNH may not manufacture or import cosmetic products until authorized.needed file:

1. Product Details

． Product name, product type, intended use and product description

． Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

． The content of restricted ingredients must be declared, i.e. percentage (%)

． Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English. Translations in other languages must be endorsed or licensed.

Cosmetic labeling requirements: The outer packaging of cosmetics must be marked with the following contents (if there is no outer packaging, it must be marked on the direct packaging of cosmetics).

1. The name of the cosmetic product and its function, unless it is clear from the product description

2. Instructions for use of cosmetics, unless clear from the product name or appearance

3. Complete ingredient list. Ingredients must be declared in descending weight order when added.

． Perfume and fragrance compositions and their raw materials may be referred to simply as perfumes, scents, aromas or flavors. Ingredients with a concentration of less than 1% can be listed in any order after ingredients with a concentration of greater than 1%. Colorants can be listed in any order after the other ingredients, depending on the name used in the specification.

． For decorative cosmetics sold in multiple shades, all colorants used in the range can be listed, provided the term “may contain” or “+/-” is added. Ingredients shall be designated using the nomenclature in the latest edition of the Standard Reference. Botanicals and plant extracts should be identified by their genus and species.

However, the following should not be considered ingredients:

． Impurities in the raw materials used

． Assistive Technology Materials Used in Preparation but Not Used

． The material acts as a solvent, or a carrier for perfume and fragrance compositions

4. Country of manufacture;

5. CNH’s name and address

6. Weight or volume content in metric and imperial

7. Production batch number

8. The date of manufacture or expiration date of the product, in an unambiguous manner (eg month/year).

． Dates should be clearly indicated and should consist of months and years or in the order day, month, and year. The minimum shelf life should be the date that the product has been stored under appropriate conditions until it continues to perform its original function, in particular, to maintain compliance with safety requirements. It should be preceded by the words due date. If necessary, this information shall be supplemented by a description of the conditions that must be met in order to guarantee the specified durability. For cosmetic products with a minimum shelf life of less than 30 months, the expiration date must be stated.

9. Special precautions to be observed in use, especially conditions of use and warnings, must appear on the label and any special precautionary information for the cosmetic product.

10. All marked contents should be easy to read, clear, understandable and indelible.

11. The information on the label should be in Malay and/or English.

Animal-derived ingredient declaration:

1. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin

2. For ingredients of bovine or porcine origin, the exact animal must be declared

3. A valid contact number for CNH.

If the size, shape or nature of the container or package does not meet the details of the permitted display regulations, flyers, brochures, hang tags, display boards, shrink wrap, etc. may be used instead, with at least the following:

1. Cosmetics name

2. Production batch number

3. If the cosmetic product is imported in bulk containers, at least the following details shall appear on the container:

． Cosmetic name

． Manufacturer’s name and manufacturing lot number

4. All marked contents should be easy to read, clear, understandable and indelible.

Halal Mark: Products have been certified and approved as Halal by this or any authorised Islamic body of the Ministry of Islamic Development Malaysia (Jabatan Kemajuan Islam Malaysia, JAKIM) and can be voluntarily marked on approved cosmetic products.

【参考连结】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

HLF-TW-55

HLF-TW-60
经过核准登记的化妆品，进口到马来西亚要检附什麽文件？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 Malaysia? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

须以马来西亚当地健康/化妆品公司担任化妆品通知持有人 (CNH)的名义申请进口。
所有化妆品的製造、销售、供应、进口或分销都必须先通知 NPRA，然后才能在马来西亚销售。
希望将化妆品带入马来西亚的外国公司首先必须指定当地代理人作为化妆品通知持有人 (CNH)。

化妆品通知持有人负责将化妆品投放市场。

化妆品通知持有人 (CNH) 必须是化妆品领域的本地註册公司，具有永久地址并在马来西亚公司委员会註册（其业务范围显示的健康/化妆品相关的公司）。
所有通知的提交都透过 NPRA 网站中的Quest 系统进行线上申请，必须註册会员、填写每种化妆品的通知表，以及完成付款。
CNH在收到授权后始得製造或进口化妆品。

所需文件：

1. 产品详情

．产品名称、产品类型、预期用途和产品介绍

．製造商和组装商的名称和地址（如果有）

2. CNH 的名称、地址、联繫电话、电子邮件

3. 进口商名称、地址（如有）

4. 完整的产品成分表

．必须声明限制成分的含量，即百分比（%）

．授权书/声明书/合同製造书（如适用）

5. 产品标籤

注意事项：提交给 NPRA 的任何文件和材料必须使用马来文或英语。其他语言的翻译版本必须得到认可或授权。
要将货物进口到马来西亚，需要向马来西亚皇家海关署（JKDM）申报、缴纳关税/税款的进口税、消费税、销售税。

1.海关申报：所有进口到马来西亚的货物必须通过以下方式择一申报

．指定报关员

．自我声明(AEO 计划 – AEO 门户)

．直接用户

2. 商品分类：进口商需要获得对要进口到马来西亚的商品,的确认通过获取货物的正确关税代码是否需要缴纳任何关税/税款。

3. 检查物品是否为受控商品或进口违禁品：

．检查拟进口的货物是否为管制货物或受当局禁止或限制进口的货物。

．确认进口之前获得许可/批准。

4. 申报和准备海关放行文件：每个进口商应在货物抵达或抵达马来西亚时，亲自或由其代理人对进口货物进行完整和真实的申报。

．电子报关单

．提交进口许可证(电子档案或副本)

．提单/空运单

．发票(採购订单或信用证)

．装箱单

．原产国证明

．其他相关文件(检验证书、分析证书、成分证书、清真证书、产品规格证书等)

5. 货物检验：JKDM保留检查货物以确保进口符合法律法规的权利。

6. 缴纳关税/税款进口：货物的应付关税/税款必须由进口商在货物到达时支付。可以通过柜檯或电子支付。

7. 海关批准

8. 海关放行

9. 保存文档：进口记录在马来西亚保存七年

A local health/cosmetic company in Malaysia is required to apply for import in the name of the Cosmetic Notification Holder (CNH).

The manufacture, sale, supply, import or distribution of all cosmetic products must be notified to NPRA prior to sale in Malaysia. A foreign company wishing to bring cosmetic products into Malaysia must first appoint a local agent as a cosmetic notification holder (CNH). Cosmetic notification holders are responsible for placing cosmetic products on the market.

The Cosmetic Notification Holder (CNH) must be a locally registered company in the cosmetics sector, with a permanent address and registered with the Companies Commission of Malaysia (health/cosmetics related company as indicated by its business scope). All notification submissions are made online through the Quest system on the NPRA website. Membership must be registered, a notification form for each cosmetic product must be completed, and payment completed. CNH may not manufacture or import cosmetic products until authorized.

needed file:

1. Product Details

． Product name, product type, intended use and product description

． Manufacturer’s and assembler’s name and address (if available)

2. CNH’s name, address, contact number, email

3. Importer’s name, address (if available)

4. Complete product ingredient list

． The content of restricted ingredients must be declared, i.e. percentage (%)

． Power of Attorney/Declaration/Contract Manufacturing (if applicable)

5. Product labeling

Note: Any documents and materials submitted to NPRA must be in either Malay or English. Translations in other languages must be endorsed or licensed.

To import goods into Malaysia, import duty, excise duty, sales tax is required to be declared to the Royal Malaysian Customs Department (JKDM) and paid for duties/taxes.

1. Customs declaration: All goods imported into Malaysia must be declared through one of the following methods

．Designated Customs Broker

．Self Declaration (AEO Programme – AEO Portal)

．Direct users

2. Commodity classification: The importer needs to obtain confirmation of the goods to be imported into Malaysia by obtaining the correct tariff code of the goods if any duties/taxes are to be paid.

3. Check if the item is a controlled commodity or an imported contraband:

．Check whether the goods to be imported are regulated goods or goods whose importation is prohibited or restricted by the authorities.

．Confirm permission/approval prior to import.

4. Declaration and preparation of customs release documents: Each importer shall make a complete and true declaration of the imported goods in person or by his agent upon arrival or arrival in Malaysia.

． Electronic customs declaration

． Submit import license (electronic file or copy)

．Bill of Lading / Air Waybill

．Invoice (Purchase Order or Letter of Credit)

．Packing List

．Certificate of country of origin

．Other relevant documents (inspection certificate, analysis certificate, composition certificate, halal certificate, product specification certificate, etc.)

5. Goods inspection: JKDM reserves the right to inspect the goods to ensure that the imports comply with laws and regulations.

6. Pay Duties/Taxes Import: Duties/taxes payable on the goods must be paid by the importer upon arrival of the goods. Payment can be made over the counter or electronically.

7. Customs Approval

8. Customs release

9. Preservation of documents: Import records are kept in Malaysia for seven years

【参考连结】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

http://www.customs.gov.my/en/pages/main.aspx

HLF-TW-70
马来西亚化妆品审核机构，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：

须附上良好生产规范 (GMP)：

1. 所有化妆品必须照化妆品良好生产规范指南或同等标准进行生产

2. 当地製造商需要接受 NPRA 的 GMP 审核员的定期检查；对于外国製造商，应根据 NPRA 的要求提供证明 GMP 合规性的文件。

3. 与GMP等效标准：

(1) 世界卫生组织 (WHO)的药品良好生产规范

(2) 澳大利亚治疗用品管理局 (TGA) 的治疗用品防晒产品良好生产规范

(3) ISO 22716：化妆品 – 良好生产规范 (GMP) – 良好生产规范指南

4.良好生产规范 (GMP)所需文件

(1)原包装材料规格

．材料名称

．材料说明

．测试参数和接受限度

．技术图纸(如果适用)

．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

．产品名称

．说明

．物理性质

．化学分析和/或微生物分析及其接受限度(如有必要)

．储存条件和安全预防措施（如有必要）

(3) 生产文件

(4) 主配方

．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

．过程控制及其在加工和包装方面的限制(如果适用)

(5) 批量生产记录（BMR）：每批产品都必须准备批次生产记录。

．批量公式

．製造工艺简述

．批号或代码

．加工和包装的开始和结束日期

．主要设备线路或位置的标识

．加工的设备的清洁记录

．过程控制和实验室结果，例如 pH 值和温度测试记录

．包装线检验记录

．各个步骤期间执行的任何採样

．特定故障或差异的任何调查

．包装和标籤产品的检查结果

(6)质量控制记录：起始原料、中间体、散装产品和成品每次测试、化验结果放行或拒绝的记录都须要维护。

．材料识别

．供应商名称

．收货日期

．原始批号（如果具备）

． 批号

．质控编号

．收货数量

． 取样日期

．质量控制结果

产品信息文件（PIF）：

1. CNH 应负责提供 NPRA 要求的所有产品信息、证书、文件和数据。 PIF 可以是档案形式（即存储在特定位置的大量纸质记录）或电子格式。

2.文件内容包含

(1) 行政文件和产品概要

．产品的身份、製造商、组装商、进口商和 CNH 的名称和地址

．产品所有者的授权书或声明书和合同製造书（如果适用）

．其他相关行政文件，例如：营业执照、公司註册证书

．香精，成分的名称和代码以及供应商的身份

．外标籤和内标籤

．消费者信息传单和使用说明

．认可机构签发/背书的文件(表明是根据化妆品 GMP 指南或任何等效指南製造的)

．产品的批次编码系统/密钥

．安全声明（签署的意见声明，包括安全评估员的姓名和资格）

．已确认对人类健康的不良影响（摘要）

．产品功效评估的总结报告

 (2) 原材料质量数据

．每种成分的规格

．每种成分的规格相对应的分析方法

．香料供应商的名称和地址及符合标准的声明

．香精材料，请指定产品的名称和代号

．供应商区提供原材料安全数据：已发布的数据或来自东盟化妆品科学机构 (ACSB)、欧盟消费品科学委员会 (SCCP) 或美国化妆品等科学委员会的报告 成分审查委员会 (CIR)。

(3) 成品质量数据

．产品的定性定量配方（INCI或其他经批准的参考名称和相应的成分浓度），配方应说明每种原材料/成分的功能

．製造商、组装商和包装商的名称、国家和地址

．製造过程总结

．根据 NPRA 的要求提供有关製造过程、质量控制和相关製造文件的更多详细信息

．化妆品微生物控制和化妆品成分化学纯度的标准

．对应于检查规范的分析方法

．支持有效期的稳定性测试数据/报告或稳定性评估

 (4) 安全性和有效性数据

．根据其成分、化学结构和暴露水平签署的成品对人体健康的安全性评估报告

．安全评估员的简历

．已确认或记录的因使用该化妆品而对人体健康造成的不良事件或不良影响的最新彙编报告

 3. 注意事项：CNH 应使 PIF置于标籤上指定的地址，便于监管机构取用，建议在产品最后一次投放市场后至少保留 3 年。

良好分销规范 (GDP)

1. 进口商和批发商必须遵守良好分销规范 (GDP) 的原则。

2. 书面说明应描述可能影响材料和/或产品和/或化妆品或分销活动质量的不同操作：

．收货和检查交货

．场所的储存、清洁和维护（包括害虫控制）

．储存条件的记录

．现场库存和运输途中货物的安全

．从可售库存中提取记录

．客户订单记录

．退回的材料和/或产品和/或化妆品、召回计划等

3. 这些程序应由授权人员批准、签署并註明日期。

4. 应在进行每项操作时进行记录，并以可追溯所有重要活动或事件的方式进行。

5. 记录应清晰且易于获取。

6. 与材料和/或产品和/或化妆品分销有关的文件的保留应符合国家要求。

Good Manufacturing Practice (GMP):

1. All cosmetic products must be produced in accordance with the Good Manufacturing Practice Guidelines for Cosmetics or equivalent

2. Local manufacturers are required to undergo regular inspections by NPRA’s GMP auditors; for foreign manufacturers, documentation demonstrating GMP compliance shall be provided as required by NPRA.

3. Standards equivalent to GMP:

(1) Good Manufacturing Practices for Pharmaceutical Products, World Health Organisation (WHO)

(2) Australian Code of Good Manufacturing Practice for Therapeutic GoodsSunscreen Products, Therapeutic Goods Administration (TGA)

(3) ISO Standard 22716: Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices

4. Documents required for Good Manufacturing Practice (GMP)

(1) Material specifications of the original packaging

．Material name

．Material Description

．Test parameters, acceptance limits

．Technical Drawings (if applicable)

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

(2) Bulk, finished product specifications

．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

(4) Main formula

．Product name, product code/number

．Expected Packaging Materials, Storage Conditions

．List of raw materials used

．List of equipment used

．Process controls and their limitations on processing and packaging (if applicable)

(5) Batch Production Record (BMR): A batch production record must be prepared for each batch of products.

．batch formula

．Brief description of the manufacturing process

．Lot number or code

．Start and end dates for processing and packaging

．Identification of major equipment lines or locations

．Cleaning records of equipment responsible for processing

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

．Packaging line inspection record

．Any sampling performed during individual steps

．any investigation of a specific fault or discrepancy

．Inspection results of packaged and labelled products

(6) Quality control records: Records of each test, release or rejection of assay results for starting materials, intermediates, bulk products and finished products need to be maintained.

．Material identification

．Supplier name

．Date of receipt

．Original lot number (if available)

．Batch number

．Quality control number

．Receipt quantity

．Sampling date

．Quality Control Results

Product Information File (PIF):

1. CNH shall be responsible for providing all product information, certificates, documents and data required by NPRA.
PIFs can be in archival form (that is, a collection of paper records stored in a specific location) or in electronic format.

2. The file content contains the following points

(1) Administrative documents and product overview

．Product identity, name and address of manufacturer, assembler, importer and CNH

．Product Owner’s Letter of Authorization or Declaration and Contract Manufacturing (if applicable)

．Other relevant administrative documents, e.g. business license, company registration certificate

．Fragrance, name and code of ingredient and identity of supplier

．Outer and inner labels

．Consumer Information Flyer and Instructions for Use

．A document issued/endorsed by an accreditation body (indicating that it was manufactured in accordance with the Cosmetic GMP Guide or any equivalent guide)

．Batch Coding System/Key for Products

．Safety Statement (signed statement of opinion, including the name and qualifications of the safety assessor)

．Adverse effects on human health confirmed (summary)

．Summary Report of Product Efficacy Assessment

(2) Quality data of raw materials

．Specifications of Each Ingredient

．Analysis method corresponding to the specification of each component

．The name, address and declaration of compliance of the fragrance supplier

．Flavor materials (please specify the product name and code)

．Raw material safety data available in the supplier area: published data or reports from scientific committees such as the ASEAN Cosmetic Science Body (ACSB), the European Union Scientific Committee on Consumer Products (SCCP) or the U.S. Cosmetics Ingredient Review Committee (CIR).

(3) Quality data of finished products

．Qualitative and quantitative formulation of the product (INCI or other approved reference designation and corresponding ingredient concentration), which must state the function of each raw material/ingredient

．Manufacturer, assembler, packer’s name, country and address

．Summary of Manufacturing Process

．Provide more details about the manufacturing process, quality control and related manufacturing documentation as required by NPRA

．Standard for cosmetic microbiological control and chemical purity of cosmetic ingredients

．Analysis method for each inspection specification

．Stability test data/reports or stability assessments supporting expiration date

(4) Safety and efficacy data

．Signed safety assessment report of finished product to human health based on its composition, chemical structure and exposure level

．Safety Assessor Resume

．The latest compiled report of confirmed or documented adverse events or adverse effects on human health resulting from the use of the cosmetic product

3. Note: CNH should keep PIF at the address specified on the label for easy access by regulatory agencies, and it is recommended to keep it for at least 3 years after the product was last placed on the market.

Good Distribution Practice (GDP)

1. Importers and wholesalers must adhere to the principles of Good Distribution Practice (GDP).

2. The written description shall describe the different actions that may affect the quality of the material and/or product and/or cosmetic or distribution activity:

．Receipt and Check Delivery

．Storage, cleaning and maintenance of premises (including pest control)

．Record of storage conditions

．On-site inventory and cargo security in transit

．Pull records from saleable inventory

．Customer order record

．Returned materials and/or products and/or cosmetics, recall programs, etc.

3. These procedures shall be approved, signed and dated by authorized personnel.

4. Each action shall be recorded as it is carried out and shall be carried out in such a way that all significant activities or events can be traced.

5. Records should be legible and easily accessible.

6. Retention of documents related to the distribution of materials and/or products and/or cosmetics shall comply with national requirements.

【参考连结】

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/frequently-asked-questions-faqs-licensing.html

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口化妆品后，如果委託马来西亚的经销商销售，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 Malaysia 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：

须以马来西亚当地健康/化妆品公司通知持有人 (CNH)的名义申请，批发商必须申请健康/化妆品批发商许可证才能註册并销售其产品，许可证有效期为1年。
CNH应向发生国家药品监督管理局 (NPRA)报告不良事件，无论报告的来源（消费者、医疗保健专业人员等）如何。
所有严重的不良事件应该报告。不要求报告非严重不良事件。
只要有理由怀疑化妆品可能是引起反应的原因，就必须报告所有严重的不良事件。

A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.

CNH should report the adverse event to the National Drug Regulatory Authority (NPRA), regardless of the source of the report (consumer, healthcare professional, etc.). All serious adverse events should be reported.
Reports of non-serious adverse events are not required.
All serious adverse events must be reported whenever there is reason to suspect that cosmetic products may be the cause of the reaction.

【参考连结】

https://www.npra.gov.my/index.php/en/component/content/article/37-faq/620-cosmetic?Itemid=437

https://www.npra.gov.my/

HLF-TW-85

各国化妆品登记法规问答集

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