新加坡化妝品登記法規問題集
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HLF-SG-10
請問新加坡對於化妝品的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of 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，衛生部轄下的衛生科學局(HAS)是管理化妝品的國家監管機構。
化妝品被定義為旨在與人體外部部位（如皮膚、頭髮、指甲、嘴唇或嘴巴（包括牙齦、牙齒和舌頭）接觸的任何物質或製劑，用於目的：
1.清潔
2.添香
3.改變外表
4.改善體味
5.保護
6.保持良好狀態
化妝品是應用於人體外部或牙齒/口腔黏膜，如下列：
1.表皮（皮膚，包括眼睛附近）
2.頭髮系統
3.指甲
4.嘴唇
5.外生殖器
6.牙齒
7.口腔黏膜
化妝品產品種類：
1.用於皮膚（手、臉、腳等）
2.面膜，例如美白面膜，補水面膜
3.著色基料（液體、糊劑、粉末）
4.化妝粉、浴後粉、衛生粉等
5.香皂、除臭皂等
6.香水、花露水和古龍水
7.沐浴和淋浴用品（鹽、泡沫、油、凝膠等）
8.脫毛劑
9.除臭劑和止汗劑
10.護髮產品
．染髮劑和漂白劑
．用於揮動、拉直或固定的產品
．設置產品
．清潔產品（乳液、粉末、洗髮水）
．調理產品（乳液、面霜、油）
．美髮產品（乳液、亮油、亮片）
11.剃須產品（面霜、泡沫、乳液等）
12.用於化妝和卸妝的產品
13.用於唇部和唇部周圍的產品
14.牙齒和口腔護理產品
15.指甲護理和化妝產品（修指甲和修腳）
16.用於外部私密衛生的產品
17.日光浴產品
18.防曬的產品
19.美白產品
20.抗皺產品
21.嬰兒/面部濕巾
下列不歸屬化妝品：
1.注射劑和眼藥水。
2.口服的產品，例如片劑、膠囊或飲料。
3.用於治療的產品，例如痤瘡治療霜。
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.
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/overview
HLF-SG-20
外國公司要到新加坡銷售化妝品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell 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：
無需申請營業許可證。
化妝品的銷售，須由會計和企業監管局 (ACRA)註冊的當地實體公司向HAS提交銷售通知方可進口、銷售。
銷售通知申請表內容：
1. 負責將化妝品投放市場的當地公司的詳細信息
．公司名稱
．公司地址
．城市
．郵遞區號、詳細地址
．電話號碼
．傳真號碼
2. 授權代表當地公司的人員的詳細信息
．申請人姓名
．身份證/FIN
．電話號碼
．指明首選的溝通方式
．公司名稱
3. 製造商詳情
．製造商的名稱
．如果是本地製造商，請填寫郵政編碼並點擊檢索地址，Blk/House No, Street Name 和 Building Name 的數據將自動填充。
否則，請相應填寫詳細信息
．如果有多個製造商，請單擊“新建”以添加詳細信息
填寫並保存第一條記錄的詳細信息後，新製造商進入下一部分。
．城市
．郵遞區號、詳細地址
．電話號碼
．傳真號碼
4. 產品詳情
．根據產品包裝上出現的名稱，輸入產品的品牌名稱和產品名稱
．選擇反映產品的類型。 (例如，如果您要通知抗皺霜，請選擇抗皺)
．選擇最能代表產品的演示類型。(例如：單品、調色板、套裝等)
．詳細信息
5. 支持文件
．沒有強制相關支持文件，但負責將產品投入市場公司必須為產品負責
．建議有相關檢驗證明或支持文件
6. 申報、驗證、確認和付款
．同意聲明
．完成提交
．扣款費用
7. 成功提交化妝品通知後，將收到通知確認，其中將顯示
．公司名稱和地址
．品牌名稱和產品名稱
．產品通知編號和有效日期
8. 注意：
．產品通知有效期為一年，如果您的公司打算繼續，每年都需要通知（更新）
．即使該產品已經被新加坡的另一家公司通知，並且您是從同一製造商進口的，也需要提交通知
．對於同一化妝品的每個不同變體，例如不同色調的口紅和不同香味的洗髮水，也需要提交通知
9. 以下產品不需要化妝品產品通知。但是仍然需要遵守其他要求，例如標籤、成分和不良事件報告：
．與廣告、贊助或促銷活動相關的樣品
．用於與該產品的任何研究或開發有關的測試或試驗的產品。
．由醫生製造或根據其規格製造的產品，並由該醫生單獨提供，供其護理下的患者使用。
．同一產品的不同包裝尺寸。
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．
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/overview
HLF-SG-25
HLF-SG-30
外國公司要到新加坡銷售化妝品，可以指派新加坡公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？
所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell 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。
化妝品的銷售，須由會計和企業監管局 (ACRA)註冊的當地實體公司向HAS提交銷售通知方可進口、銷售。
銷售通知申請表內容：
1. 負責將化妝品投放市場的當地公司的詳細信息
．公司名稱
．公司地址
．城市
．郵遞區號、詳細地址
．電話號碼
．傳真號碼
2. 授權代表當地公司的人員的詳細信息
．申請人姓名
．身份證/FIN
．電話號碼
．指明首選的溝通方式
．公司名稱
3. 製造商詳情
．製造商的名稱
．如果是本地製造商，請填寫郵政編碼並點擊檢索地址，Blk/House No, Street Name 和 Building Name 的數據將自動填充。
否則，請相應填寫詳細信息
．如果有多個製造商，請單擊“新建”以添加詳細信息
填寫並保存第一條記錄的詳細信息後，新製造商進入下一部分。
．城市
．郵遞區號、詳細地址
．電話號碼
．傳真號碼
4. 產品詳情
．根據產品包裝上出現的名稱，輸入產品的品牌名稱和產品名稱
．選擇反映產品的類型。 (例如，如果您要通知抗皺霜，請選擇抗皺)
．選擇最能代表產品的演示類型。(例如：單品、調色板、套裝等)
．詳細信息
5. 支持文件
．沒有強制相關支持文件，但負責將產品投入市場公司必須為產品負責
．建議有相關檢驗證明或支持文件
6. 申報、驗證、確認和付款
．同意聲明
．完成提交
．扣款費用
7. 成功提交化妝品通知後，將收到通知確認，其中將顯示
．公司名稱和地址
．品牌名稱和產品名稱
．產品通知編號和有效日期
8. 注意：
．產品通知有效期為一年，如果您的公司打算繼續，每年都需要通知（更新）
．即使該產品已經被新加坡的另一家公司通知，並且您是從同一製造商進口的，也需要提交通知
．對於同一化妝品的每個不同變體，例如不同色調的口紅和不同香味的洗髮水，也需要提交通知
9. 以下產品不需要化妝品產品通知。但是仍然需要遵守其他要求，例如標籤、成分和不良事件報告：
．與廣告、贊助或促銷活動相關的樣品
．用於與該產品的任何研究或開發有關的測試或試驗的產品。
．由醫生製造或根據其規格製造的產品，並由該醫生單獨提供，供其護理下的患者使用。
．同一產品的不同包裝尺寸。
負責將化妝品投放市場的人，可能是進口商、製造商、分銷商或零售商(必須是在會計和企業監管局註冊的公司)有責任向 HSA 報告其負責的化妝品的產品缺陷和不利影響，並且產品標籤符合法規要求。
負責人的主要職責包括：
1. 提交產品通知
2.確保產品安全
3.對不安全產品進行召回
4.報告產品缺陷和不良影響
5.應 HSA的要求提交安全和技術信息
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
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/overview
HLF-SG-35
HLF-SG-40
外國公司銷售到新加坡化妝品本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing 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：
無須申請產品許可證，化妝品標籤應包含有關化妝品、其預期用途以及如何使用的真實和準確訊息。
在新加坡銷售或供應之前，必須按照法規貼上標籤，並做出不會誤導消費者對產品內容、質量或安全性的聲明。
化妝品供應商，如批發商或零售商，在供應產品之前必須確保化妝品符合法規。
標籤或標籤聲明必須是英文且清晰易讀，以下信息必須出現在外包裝上或化妝品容器上：
1.化妝品名稱
2.化妝品的功能
3.使用說明
4.完整的成分列表
5.製造國
6.內容物（重量/體積）
7.批號
8.生產日期/有效期（僅對保質期少於 30 個月的產品需要寫上有效期）
9.負責將產品投放市場的公司在新加坡的名稱和地址
10.特殊預防措施，如果有的話（應提供標籤中使用的符號或代碼的解釋，並帶有僅供專業使用標籤或類似的標籤僅限於專業用途。
11.專業用途是指人們在從事專業活動（例如在美髮沙龍、美甲沙龍、水療沙龍、皮膚診所等）中使用和使用化妝品。 這也意味著此類化妝品不應由專業人士出售給消費者。
12.專業人士須有一定程度的專業知識和經驗。
因此，他們比消費者更熟悉與使用產品相關的風險，還將具有將產品正確應用到消費者身上的專業知識。
標籤的展示
1.標籤在銷售點必須清晰、永久、不可磨滅、醒目且顯眼地展示在產品上。
2.標籤或標籤說明應出現在化妝品的外包裝上，如果沒有外包裝，則應出現在化妝品的直接包裝上。
3.如果容器或包裝的尺寸、形狀或性質不允許在容器或包裝上指定所有要求的信息，則允許使用與產品一起放置的傳單、小冊子、吊牌、展示板等。但是，化妝品的名稱和批號必須顯示在直接包裝或容器上。
成分列表
1.所有化妝品都必須標明產品中包含的所有成分。化妝品中每種成分的數量或百分比無需在標籤上披露。
2.成分應按重量降序排列，除了成分（著色劑除外）濃度低於 1%（按重量計），可按以下任意順序列出
．存在濃度為 1% 或更多的成分
．任意順序排列的著色劑
3.香水和芳香組合物及其原材料可以用香水、香精、香氣或任何其他類似術語來指代。
4.調味劑可以稱為風味或任何其他類似的語詞
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
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/overview
HLF-SG-45
請問在新加坡有哪些專業服務機構，可以協助辦理化妝品產品許可證？
Evershine RD：
無須申請產品許可證
No product license application required
HLF-SG-50
外國公司可以用自己名義申請辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？
可允許的語文有哪些？？網頁？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
無須申請產品許可證。化妝品標籤應包含有關化妝品、其預期用途以及如何使用的真實和準確訊息。
在新加坡銷售或供應之前，必須按照法規貼上標籤，並做出不會誤導消費者對產品內容、質量或安全性的聲明。
化妝品供應商，如批發商或零售商，在供應產品之前必須確保化妝品符合法規。
標籤或標籤聲明必須是英文且清晰易讀，以下信息必須出現在外包裝上或化妝品容器上：
1.化妝品名稱
2.化妝品的功能
3.使用說明
4.完整的成分列表
5.製造國
6.內容物（重量/體積）
7.批號
8.生產日期/有效期（僅對保質期少於 30 個月的產品需要寫上有效期）
9.負責將產品投放市場的公司在新加坡的名稱和地址
10.特殊預防措施，如果有的話（應提供標籤中使用的符號或代碼的解釋，並帶有僅供專業使用標籤或類似的標籤僅限於專業用途。
11.專業用途是指人們在從事專業活動（例如在美髮沙龍、美甲沙龍、水療沙龍、皮膚診所等）中使用和使用化妝品。 這也意味著此類化妝品不應由專業人士出售給消費者。
12.專業人士須有一定程度的專業知識和經驗。 因此，他們比消費者更熟悉與使用產品相關的風險，還將具有將產品正確應用到消費者身上的專業知識。
標籤的展示
1.標籤在銷售點必須清晰、永久、不可磨滅、醒目且顯眼地展示在產品上。
2.標籤或標籤說明應出現在化妝品的外包裝上，如果沒有外包裝，則應出現在化妝品的直接包裝上。
3.如果容器或包裝的尺寸、形狀或性質不允許在容器或包裝上指定所有要求的信息，則允許使用與產品一起放置的傳單、小冊子、吊牌、展示板等。但是，化妝品的名稱和批號必須顯示在直接包裝或容器上。
成分列表
1.所有化妝品都必須標明產品中包含的所有成分。化妝品中每種成分的數量或百分比無需在標籤上披露。
2.成分應按重量降序排列，除了成分（著色劑除外）濃度低於 1%（按重量計），可按以下任意順序列出
．存在濃度為 1% 或更多的成分
．任意順序排列的著色劑
3.香水和芳香組合物及其原材料可以用香水、香精、香氣或任何其他類似術語來指代。
4.調味劑可以稱為風味或任何其他類似的語詞
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
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/overview
HLF-SG-55
請問在新加坡有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？
Evershine RD：
無須申請產品許可證
No product license application required
HLF-SG-60
經過核准登記的化妝品，進口到新加坡要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved 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：
需先提交銷售通知，收到通知確認後方可進口、銷售化妝品。
申請人：將該化妝品投放至市場者，如為外國廠商，則需委託當地已經在會計和企業監管局 (ACRA)註冊的當地實體公司協助提交。
銷售通知申請表內容：請用英文填寫所有部分
1. 負責將化妝品投放市場的當地公司的詳細信息
．公司名稱
．公司地址
．城市
．郵遞區號、詳細地址
．電話號碼
．傳真號碼
2. 授權代表當地公司的人員的詳細信息
．申請人姓名
．身份證/FIN
．電話號碼
．指明首選的溝通方式
．公司名稱
3. 製造商詳情
．製造商的名稱
．如果是本地製造商，請填寫郵政編碼並點擊檢索地址，Blk/House No, Street Name 和 Building Name 的數據將自動填充。否則，請相應填寫詳細信息
．如果有多個製造商，請單擊“新建”以添加詳細信息
填寫並保存第一條記錄的詳細信息後，新製造商進入下一部分。
．城市
．郵遞區號、詳細地址
．電話號碼
．傳真號碼
4. 產品詳情
．根據產品包裝上出現的名稱，輸入產品的品牌名稱和產品名稱
．選擇反映產品的類型。 (例如，如果您要通知抗皺霜，請選擇抗皺)
．選擇最能代表產品的演示類型。(例如：單品、調色板、套裝等)
．詳細信息
5. 支持文件
．沒有強制相關支持文件，但負責將產品投入市場公司必須為產品負責
．建議有相關檢驗證明或支持文件
6. 申報、驗證、確認和付款
．同意聲明
．完成提交
．扣款費用
7. 成功提交化妝品通知後，將收到通知確認，其中將顯示
．公司名稱和地址
．品牌名稱和產品名稱
．產品通知編號和有效日期
8. 注意：
．產品通知有效期為一年，如果您的公司打算繼續，每年都需要通知（更新）
．即使該產品已經被新加坡的另一家公司通知，並且您是從同一製造商進口的，也需要提交通知
．對於同一化妝品的每個不同變體，例如不同色調的口紅和不同香味的洗髮水，也需要提交通知
9. 以下產品不需要化妝品產品通知。但是仍然需要遵守其他要求，例如標籤、成分和不良事件報告：
．與廣告、贊助或促銷活動相關的樣品
．用於與該產品的任何研究或開發有關的測試或試驗的產品。
．由醫生製造或根據其規格製造的產品，並由該醫生單獨提供，供其護理下的患者使用。
．同一產品的不同包裝尺寸。
海關過境系統/申報文件
新加坡對進口商品檢驗檢疫的標準和程序十分嚴格。負責進口化妝品商品檢驗的部門是簡稱HAS，進口化妝品前須完成銷售通知、取得海關進口許可證後方可執行。
海關進口許可證：
1. 註冊入口網站的帳戶，化妝品被歸類為健康與美容（cdf 類別）https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct
2. 指定報關代理人(新加坡物流協會/新加坡航空貨運代理協會)或自行申報。
．必須與新加坡海關負責銀行 GIRO (IBG)綁定以直接從您的銀行賬戶向新加坡海關支付新加坡海關提供的服務的關稅、稅款、費用、罰款和其他費用。
．如果沒有在新加坡海關持有 IBG，關稅和 GST 將從您的申報代理的 IBG 中扣除。
3. 提供安全保障
．需要為涉及應課稅貨物的交易、為批准目的臨時進口貨物以及經營特許經營場所（如特許倉庫和消費稅工廠）提供擔保。
．提供的擔保應採用銀行擔保、財務公司擔保或保證金的形式。
4. 獲得海關進口許可證
．申请必須透由TradeNet提交 (TradeNet軟體、政府應用程序)
．每份許可證的申請費用通常是2.88新元，不包含報關代理服務費等，如委託報關公司代理，可以查閱其收取的服務費用。
文件內容
．申請公司(須以公司名義報關，如為個人可以委託代辦公司申請)、郵政編碼、地址、電話、傳真、行業
．聯繫人、聯繫方式、電話、傳真、電子郵件
．計費管理員(通常是主管或財務人員)姓名、身分證/護照號碼、聯繫方式、電子郵件
．付款方式
．簽章
5. 準備貨物清關文件
．提供證明文件，包括發票、包裝清單及提單/空運提單
．集裝箱貨物所需文件
通過海運進口集裝箱貨物，無需向入境口岸的檢查站人員出示海關許可證和證明文件的打印副本。
通過空運或陸運進口集裝箱貨物，需要出示海關許可證以及發票、裝箱單和提單/空運提單等證明文件，向檢查站官員核實。
．常規貨物所需文件
對於常規貨物，請在貨物清關時將貨物、海關通行證打印件、發票、裝箱單、提單/空運單等證明文件交給口檢人員核對。
．保留貿易文件
購買、進口、銷售或出口貨物有關的相關證明文件自許可證申請批准之日起保留 5 年。
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．
【參考連結】
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
新加坡化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
新加坡的化妝品沒有要求相關檢驗資料。製造商、進口商、銷售商需要確保化妝品符合法令規範、安全及質量，投放在市場者需要承擔責任。
製造商沒有要求製造商許可證。但是，製造商可以申請自願的良好生產規範 (GMP) 證書以促進化妝品的出口。
申請路徑：通過PRISM系統提交申請
具備條件：
1. CRIS 公司賬戶
2. Corppass /HSA PIN
相關檢驗資料：
1. 原包裝材料規格應包括
．材料名稱
．材料說明
．測試參數和接受限度
．技術圖紙(如有必要)
．特殊預防措施，例如儲存和安全條件(如有必要)
2.散裝和成品規格應包括：
．產品名稱
．說明
．物理性質
．化學分析和/或微生物分析和他們的接受限度(如有必要)
．儲存條件和安全預防措施(如有必要)
3. 生產文件
．產品名稱和產品代碼/編號
．預期的包裝材料和儲存條件
．使用的原材料清單
．使用的設備清單
．過程控制及其在處理過程中的限制和包裝(如適用)
4. 批量生產記錄(BMR) ：應為每批產品準備批生產記錄
．產品名稱
．批處理公式
．製作工藝簡略
．批號或代碼
．加工和包裝的開始和結束日期
．單個主要設備和使用的線路或位置的標識
．用於加工的設備的清潔記錄（視情況而定）
．過程控制和實驗室結果，例如 pH 和溫度測試記錄
．包裝線清關檢驗記錄
．在處理的各個步驟期間執行的任何採樣
．對特定故障或差異的任何調查
．包裝和標籤產品的檢查結果
5. 質量控制記錄：應保存每次測試、化驗結果以及起始材料、中間體、散裝產品和成品的放行或拒收的記錄
． 檢測日期
．材料識別
．供應商名稱
．收貨日期
．原始批號（如有）
．批號
．質控編號
．質控編號
．取樣日期
．質量控制結果等
備註：申請後，HSA將安排進行GMP認證審核，包含東盟化妝品指令中與 GMP 相關的所有建議。
應根據 化妝品製造商網站主文件準備指南準備網站主文件並在 GMP 認證審核前提交。
當被認為符合上述GMP標準時，將授予GMP證書。
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.
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/good-manufacturing-practice
HLF-SG-75
新加坡化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
新加坡的化妝品沒有要求相關檢驗資料。
HLF-SG-77
HLF-SG-80
外國子公司進口化妝品後，如果委託新加坡的經銷商銷售，經銷商需要化妝品營業許可證嗎？
假如化妝品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports 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：
無需申請營業許可證。
化妝品的銷售，須由會計和企業監管局 (ACRA)註冊的當地實體公司向HAS提交銷售通知方可進口、銷售。
負責將化妝品投放市場的人，可能是進口商、製造商、分銷商或零售商(必須是在會計和企業監管局註冊的公司)有責任向 HSA 報告其負責的化妝品的產品缺陷和不利影響，並且產品標籤符合法規要求。
負責人的主要職責包括：
1. 提交產品通知
2.確保產品安全
3.對不安全產品進行召回
4.報告產品缺陷和不良影響
5.應 HSA的要求提交安全和技術信息
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
【參考連結】
https://www.hsa.gov.sg/cosmetic-products/overview
HLF-SG-85
**請注意下列事項：
以上內容為永輝研發及教育中心 (簡稱:永輝RD)於2021年10月摘要。
隨著時間推移，法規會發生變化，不同情況會有不同的選擇。
在選擇選項之前，請與我們聯系或諮詢您信任的專業人士。
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接洽我們：
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