印尼化妝品登記法規問題集

Email：jkt4ww@evershinecpa.com
或
印尼永輝BPO有限公司
Jakarta time zone:
The Engaging Manager Cindy Luo, Indonesia citizenship, speaks English, Bahasa and Chinese
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

各國化妝品登記法規問答集

HLF-ID-10
請問印尼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 Indonesia? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD：

在印尼，化妝品被定義為任何旨在摩擦、傾倒、噴灑、噴灑、引入或以其他方式應用於人體或其任何部位，用於清潔、美化、提升吸引力或改變外觀的物品。

食品與藥物管理局（BADAN POM）是監管化妝品的主管機關，負責頒布化妝品法規並在進入市場前授予化妝品生產許可證和化妝品通知，確保化妝品的安全、效益和質量。清真產品保證機構（BPJPH）是監管清真化妝品並頒發清真證書的機構，印尼法律要求化妝品必須申請清真認證。中央藥品標準控制機構 (CDSCO) 是中央藥品管理局，負責履行化妝品的進口監管。

In Indonesia, cosmetic products are defined as any item intended to be rubbed, poured, sprayed, sprayed, introduced or otherwise applied to the human body or any part thereof for the purpose of cleaning, beautifying, enhancing attractiveness or changing appearance.

The Bureau of Drug and Food Control (BADAN POM) is the competent authority for the regulation of cosmetic products, which is responsible for promulgating cosmetic regulations and granting cosmetic production licenses and cosmetic notifications before entering the market, ensuring the safety, effectiveness and quality of cosmetic products. The Halal Product Assurance Agency (BPJPH) is the agency that oversees halal cosmetics and issues halal certificates, which are required by Indonesian law to apply for halal certification. The Central Drug Standards Control Organization (CDSCO) is the central drug administration responsible for the import supervision of cosmetics.

【參考連結】

https://www.pom.go.id/new/

https://asrot.pom.go.id/asrot/index.php/home/depan/peraturan

https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/

HLF-ID-20
外國公司要到印尼銷售化妝品，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 Indonesia, 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。

No business license is required.

【參考連結】

https://www.pom.go.id/new/#

HLF-ID-25

假如需要辦理，請問印尼有專業服務公司可以協助辦理化妝品公司營業許可證？

Evershine RD：

無需申請營業許可證。

HLF-ID-30
外國公司要到印尼銷售化妝品，可以指派印尼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 Indonesia, can it assign a Indonesia 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：

產品許可須由在印尼當地的公司申請，可以是製造商/進口商/分銷商，或由第三方擔任產品持有人。

依據不同身分申請者須具備資料：

1.製造商

．商業識別號

．公司管理層身份

．納稅人識別號

．商標所有人與申請人之間的許可協議副本

．化妝品良好生產規範 (GMP) 證書

．切結書(說明如果通知號已經註冊，如果其申請號被BPOM取消，申請人將不會反對)

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．BPOM 技術實施部門負責人出具的推薦信。

2.進口商

．商業識別號

．公司管理層身份

．納稅人識別號

．商業執照

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．BPOM 技術實施部門負責人出具的推薦信。

．進口商與海外製造商（即GMP認證）之間的協議副本，並經公證人認證

．從東盟以外進口的化妝品的自由銷售證明

．申請人與持有GMP證書的化妝品生產企業簽訂的協議複印本。

3.分銷商/企業

．商業識別號

．公司管理層身份

．納稅人識別號

．商業執照

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．切結書(說明如果通知號已經註冊，如果其申請號被BPOM取消，申請人將不會反對)

．商標證書(如適用)

．BPOM 技術實施部門負責人出具的推薦信。

．申請人與持有GMP證書的化妝品生產企業簽訂的協議複印本。

產品許可證持有公司須負責化妝品的安全、品質，及不良事件之處理，並向主管機關回報。

Cosmetics need to be registered by a local company in Indonesia, which can be the manufacturer/importer/distributor, or a third party as the product holder.

Product registration based on different identities Applicants must have information:

1. Manufacturer

．Business identification number

．Company management status

．Taxpayer Identification Number

．Copy of license agreement between trademark owner and applicant

．Cosmetic Good Manufacturing Practice (GMP) Certificate

．Letter of Closing (indicating that if the notification number has been registered, the applicant will not object if its application number is cancelled by BPOM)

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Recommendation letter from the head of the BPOM technical implementation department.

2. Importers

． Business identification number

． Company management status

． Taxpayer Identification Number

．Business license

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Recommendation letter from the head of the BPOM technical implementation department.

．Copy of agreement between importer and overseas manufacturer (i.e. GMP certified), certified by a notary public

．Certificate of Free Sales for Cosmetics Imported from Outside ASEAN

．A copy of the agreement signed between the applicant and a cosmetic manufacturer holding a GMP certificate.

3. Distributors/Enterprises

．Business identification number

．Company management status

．Taxpayer Identification Number

．Business license

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Letter of Closing (indicating that if the notification number has been registered, the applicant will not object if its application number is cancelled by BPOM)

．Trademark certificate (if applicable)

．Recommendation letter from the head of the BPOM technical implementation department.

．A copy of the agreement signed between the applicant and a cosmetic manufacturer holding a GMP certificate.

The product license holder shall be responsible for the safety, quality, and handling of adverse events of cosmetic products, and report to the competent authority.

【參考連結】

https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/

HLF-ID-35

HLF-ID-40
外國公司銷售到印尼化妝品本身，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 Indonesia? 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：

需要，須由在印尼當地的公司申請產品許可，可以是製造商/進口商/分銷商，或由第三方擔任產品持有人。

產品註冊依據不同身分申請者須具備資料：

1.製造商

．商業識別號

．公司管理層身份

．納稅人識別號

．商標所有人與申請人之間的許可協議副本

．化妝品良好生產規範 (GMP) 證書

．切結書(說明如果通知號已經註冊，如果其申請號被BPOM取消，申請人將不會反對)

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．BPOM 技術實施部門負責人出具的推薦信。

2.進口商

．商業識別號

．公司管理層身份

．納稅人識別號

．商業執照

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．BPOM 技術實施部門負責人出具的推薦信。

．進口商與海外製造商（即GMP認證）之間的協議副本，並經公證人認證

．從東盟以外進口的化妝品的自由銷售證明

．申請人與持有GMP證書的化妝品生產企業簽訂的協議複印本。

3.分銷商/企業

．商業識別號

．公司管理層身份

．納稅人識別號

．商業執照

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．切結書(說明如果通知號已經註冊，如果其申請號被BPOM取消，申請人將不會反對)

．商標證書(如適用)

．BPOM 技術實施部門負責人出具的推薦信。

．申請人與持有GMP證書的化妝品生產企業簽訂的協議複印本。

註冊方式

1. 申請人首先通過網站向 BPOM 註冊，需上傳：

．申請信簽名並蓋章

．負責人蓋章聲明

．正本進口授權書

．進口商品HS編碼清單

．存放產品的倉庫地址

．網址：http://e-bpom.pom.go.id/

2. 電子郵件收到用戶ID與密碼後，進行產品註冊(SKI Post Border)

化妝品

．通知審批

．分析證書 (CoA)，包括產品名稱、測試參數、測試結果、測試方法、批號/生產代碼、生產日期和/或到期日期和製造商名稱(如果 CoA 頒發者不是製造商)

．發票

．抽樣/實驗室測試(如有必要)

．主管機關要求的其他證明文件

．備註：發票上列出的產品名稱、包裝和包裝尺寸必須與通知批准上列出的一致。

化妝品成分

．分析證書 (CoA)，包括產品名稱、測試參數、測試結果、測試方法、批號/生產代碼、生產日期和/或到期日期和製造商名稱(如果 CoA 頒發者不是製造商)

．安全數據表和/或成分規格

．使用、分發目的聲明

．發票

．抽樣/實驗室測試(如有必要)

．主管機關要求的其他證明文件

．香水還必須附上：成分製造商出具的聲明信，表明該香水是根據國際香水協會 (IFRA) 指南製造的、以前進口香水的銷售報告

3.支付相關費用，等待驗證

4. 取得進口識別條碼（API）、認證條碼(需標示在產品上)、許可證和批號、到期日期和序列號等信息。

5.化妝品許可證效期：3年。

包裝與標示

化妝品標籤必須誠實準確地根據現有現實列出所有必需的信息，並且應以不易從包裝上取下或分離、不易褪色或損壞的方式呈現，產品註冊時須繳交標籤樣本，應包含以下信息：           

1.化妝品名稱

2.功能

3.指示

4.成分表

5.製造商名稱和國家

6.通知申請人的姓名和完整地址

7.批號

8.尺寸、含量或淨重

9.使用期限

10.通知編號

11.二維條碼

12.警告/注意

13.備註：功能、指示、警告/注意需要用印尼語書寫，其他信息可以用印尼語或拉丁字母和/或阿拉伯數字書寫。

14.某些產品必須貼上特別警告：

．含氟漱口水：不適用於 6 歲以下的兒童。

．氣溶膠：注意！不要接觸眼睛，不要吸入。小心！高壓內容，在50℃以上的溫度下會爆炸。不要刺傷，不要存放在加熱的地方或靠近明火的地方，不要使用焚化爐處理。

．含有豬肉成分的化妝品：含豬肉，製造過程與豬肉成分接觸的化妝品。

．染髮劑：本產品含有在某些情況下可能會引起皮膚刺激的成分，因此應先按照隨附說明進行初步測試。本產品不應用於染睫毛或眉毛，因為這樣的使用可能會導致失明。

15. 進口化妝品需要標示

．進口註冊證號。

．進口商名稱。

．進口商地址。

．如果進口商不希望呈現製造地點，可以只呈現製造國。

．如果化妝品是從不需要註明生產許可證號的國家進口的，則不需要註明生產許可證號。

16. 小尺寸化妝品包裝的豁免：

．對於小於或等於 60 毫升液體和 30 克固體和半固體的化妝品，不需要出現成分清單。

．對於小於或等於 60 毫升液體和 30 克固體和半固體的化妝品，不需要出現成分清單。

．化妝品容器小於或等於 60 毫升液體和 30 克固體和半固體時製造商地址可以縮短為主要製造地點即可。

清真認證程序

1.產品許可證持有公司向BPJPH書面申請清真認證。BPJPH必須在提交後1個工作日內確認申請文件的完整性。

2.根據申請，指定 LPH 對產品的清真狀態進行檢查和/或測試。

3. LPH 指定清真審核員進行產品清真檢查。在生產過程中對營業場所進行產品清真檢查。產品檢驗過程中，如果有成分懷疑清真性，應在實驗室進行檢測。

4.清真審核員將產品清真檢查結果提交給 LPH。LPH 將結果提交給 MUI，並將副本發送給 BPJPH。

5.產品清真度的確定由 MUI 進行，並在 Halal Fatwa Assembly 中進行。清真產品認定法令（Halal Fatwa）由 MUI 提交給 BPJPH，作為頒發清真證書的依據。

6.如果清真教令大會確定經營者申請的產品為清真產品，BPJPH 應在 1 個工作日內簽發清真證書。如果清真法令大會確定產品不是清真產品，BPJPH 將在 1 個工作日內將清真證書申請連同原因退回。

7. 公司必須在申請和註冊清真認證程序之前實施清真保證制度( HAS)。清真保證體係以清真政策為基礎，建立清真管理團隊，編制HAS手冊，進行培訓，編制相關HAS程序，實施內部審計，正確審查管理。

8. 認證文件

．產品清單

．材料清單和材料文件

．屠夫清單（特別是屠宰場）

．產品矩陣

．HAS 手冊

．工藝流程圖

．生產設施地址清單

．清真政策傳播的證據

．內部培訓的證據和內部審計的證據。

9. 註冊清真證書（上傳數據）

10. 監控清真認證過程的預審核和合同付款

11. 執行審計

12. 執行審計後監控

13. 清真證書有效期為4年

14. 提交清真證書的申請者必須：

．提供正確、清晰和真實的信息

．在清真和非清真產品之間分離加工、儲存、包裝、分銷、銷售和展示的位置、場所和設備

．向 BPJPH 報告材料成分的變化

15.獲得清真證書的經營者必須：

．在獲得清真證書的產品上貼上清真標籤

．保持已獲得清真證書的產品的清真

．將清真產品和非清真產品的加工、儲存、包裝、分銷、銷售和展示的地點、場所和設備分開

．如果清真證書的有效期已過，須更新清真證書

．向 BPJPH 報告材料成分的變化

16. 清真標籤：經清真認證的產品必須在外包裝上標明清真，或未經清真認證的非清真信息。已獲得清真證書的經營者必須在以下位置貼上清真標籤：

．產品包裝​​

．產品的特定部分

．產品的具體位置

．清真標籤必須易於查看和閱讀，並且不易擦除、分離和損壞。

Yes. Cosmetics need to be registered by a local company in Indonesia, which can be the manufacturer/importer/distributor, or a third party as the product holder.

Product registration based on different identities Applicants must have information:

1. Manufacturer

．Business identification number

．Company management status

．Taxpayer Identification Number

．Copy of license agreement between trademark owner and applicant

．Cosmetic Good Manufacturing Practice (GMP) Certificate

．Letter of Closing (indicating that if the notification number has been registered, the applicant will not object if its application number is cancelled by BPOM)

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Recommendation letter from the head of the BPOM technical implementation department.

2. Importers

． Business identification number

． Company management status

． Taxpayer Identification Number

．Business license

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Recommendation letter from the head of the BPOM technical implementation department.

．Copy of agreement between importer and overseas manufacturer (i.e. GMP certified), certified by a notary public

．Certificate of Free Sales for Cosmetics Imported from Outside ASEAN

．A copy of the agreement signed between the applicant and a cosmetic manufacturer holding a GMP certificate.

3. Distributors/Enterprises

．Business identification number

．Company management status

．Taxpayer Identification Number

．Business license

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Letter of Closing (indicating that if the notification number has been registered, the applicant will not object if its application number is cancelled by BPOM)

．Trademark certificate (if applicable)

．Recommendation letter from the head of the BPOM technical implementation department.

．A copy of the agreement signed between the applicant and a cosmetic manufacturer holding a GMP certificate.

Registration method

1. The applicant first registers with BPOM through the website, uploading:

． Application letter signed and stamped

． Statement by the person in charge

． Original import authorization

． List of HS Codes for Imported Commodities

． The address of the warehouse where the product is stored

． URL: http://e-bpom.pom.go.id/

2. After receiving the user ID and password by e-mail, proceed to product registration (SKI Post Border)

Cosmetic

．Notify Approval

．Certificate of Analysis (CoA), including product name, test parameters, test results, test method, batch/production code, date of manufacture and/or expiry date and manufacturer’s name (if CoA issuer is not manufacturer)

．Bill

．Sampling/Lab Testing (if necessary)

．Other supporting documents required by the competent authority

．Note: The product name, packaging and packaging size listed on the invoice must be the same as listed on the notification approval.

Cosmetic Ingredient

．Certificate of Analysis (CoA), including product name, test parameters, test results, test method, batch/production code, date of manufacture and/or expiry date and manufacturer’s name (if CoA issuer is not manufacturer)

．Safety data sheets and/or ingredient specifications

．Statement of Purpose of Use, Distribution

．Bill

．Sampling/Lab Test (if necessary)

．Other supporting documents required by competent authorities

．Fragrances must also be accompanied by: A statement letter from the ingredient manufacturer stating that the fragrance was manufactured in accordance with the International Fragrance Association (IFRA) guidelines, a sales report of a previously imported fragrance

3. Pay the relevant fees and wait for the verification

4. Obtain information such as import identification barcode (API), certification barcode (which needs to be marked on the product), license and batch number, expiration date and serial number.

5. Cosmetic license validity: 3 years.

Packaging and Labeling

Cosmetic labels must list all required information honestly and accurately based on existing reality, and should be presented in a manner that is not easily removed or separated from the packaging, faded or damaged, and a sample label must be submitted at the time of product registration, which should include the following information:

1. Cosmetics name

2. Function

3. Instructions

4. Ingredient list

5. Manufacturer’s name and country

6. Notify the applicant’s name and full address

7. Lot number

8. Size, content or net weight

9. Term of use

10. Notification number

11. Two-dimensional barcode

12. Warning/Caution

13. Remarks: Functions, instructions, warnings/cautions need to be written in Bahasa Indonesia, other information can be written in Bahasa Indonesia or Latin alphabets and/or Arabic numerals.

14. Certain products must bear special warnings:

．Fluoride Mouthwash: Not for use on children under 6 years of age.

．Aerosols: Attention! Do not get in eyes, do not breathe. Be careful! High pressure content, will explode at temperatures above 50°C. Do not stab, do not store in a heated area or near an open flame, and do not use an incinerator for disposal.

．Cosmetics containing pork ingredients: Cosmetics that contain pork, and the manufacturing process is in contact with pork ingredients.

．Hair Dye: This product contains ingredients that may cause skin irritation in some cases, so an initial test should be done according to the instructions included. This product should not be used to dye eyelashes or eyebrows as such use may lead to blindness.

15. Imported cosmetics need to be labeled

．Import registration certificate number.

．Importer’s name.

．Importer’s address.

．If the importer does not wish to present the manufacturing location, only the manufacturing country can be presented.

．If the cosmetic product is imported from a country that does not need to indicate the production license number, the production license number is not required.

16. Exemption for small cosmetic packaging:

．For cosmetic products that are less than or equal to 60ml of liquid and 30g of solid and semi-solid, no ingredient list is required.

．For cosmetic products that are less than or equal to 60ml of liquid and 30g of solid and semi-solid, no ingredient list is required.

．For cosmetic containers less than or equal to 60ml of liquid and 30g of solids and semi-solids, the manufacturer’s address can be shortened to the main manufacturing location.

Halal certification process

1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.

2. Upon application, designate LPH to inspect and/or test the halal status of the product.

3. LPH appoints halal auditors to conduct halal inspections of products. Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.

4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.

5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.

6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.

7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.

8. Certification documents

． Product List

． Bill of Materials and Material Documentation

． Butcher’s List (especially slaughterhouses)

． Product Matrix

． HAS Manual

． Flow chart

． Production Facility Address List

． Evidence of the spread of the halal policy

． Evidence of internal training and evidence of internal audit.

9. Register Halal Certificate (Upload Data)

10. Monitor the pre-audit and contract payments for the halal certification process

11. Perform an audit

12. Perform post-audit monitoring

13. Halal certificate is valid for 4 years

14. Applicants submitting a halal certificate must:

．Provide correct, clear and truthful information

．Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display

．Reporting changes in material composition to BPJPH

15. Operators who have obtained a Halal certificate must:

．Put a halal label on products with a halal certificate

．Maintain halal for products that have obtained a halal certificate

．Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products

．If the validity period of the halal certificate has passed, the halal certificate must be renewed

．Report changes to material composition to BPJPH

16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:

．Product packaging

．Specific part of the product

．The exact location of the product

．Halal labels must be easy to see and read, and not easily erased, detached and damaged.

【參考連結】

https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/

https://jdih.pom.go.id/view/chart/4

http://www.halal.go.id/

HLF-ID-45

HLF-ID-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：

須由在印尼當地的公司申請產品許可，可以是製造商/進口商/分銷商，或由第三方擔任產品持有人。

產品註冊依據不同身分申請者須具備資料：

1.製造商

．商業識別號

．公司管理層身份

．納稅人識別號

．商標所有人與申請人之間的許可協議副本

．化妝品良好生產規範 (GMP) 證書

．切結書(說明如果通知號已經註冊，如果其申請號被BPOM取消，申請人將不會反對)

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．BPOM 技術實施部門負責人出具的推薦信。

2.進口商

．商業識別號

．公司管理層身份

．納稅人識別號

．商業執照

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．BPOM 技術實施部門負責人出具的推薦信。

．進口商與海外製造商（即GMP認證）之間的協議副本，並經公證人認證

．從東盟以外進口的化妝品的自由銷售證明

．申請人與持有GMP證書的化妝品生產企業簽訂的協議複印本。

3.分銷商/企業

．商業識別號

．公司管理層身份

．納稅人識別號

．商業執照

．切結書(說明管理團隊以前沒有參與印尼化妝品行業的犯罪活動)

．切結書(說明如果通知號已經註冊，如果其申請號被BPOM取消，申請人將不會反對)

．商標證書(如適用)

．BPOM 技術實施部門負責人出具的推薦信。

．申請人與持有GMP證書的化妝品生產企業簽訂的協議複印本。

註冊方式

1. 申請人首先通過網站向 BPOM 註冊，需上傳：

．申請信簽名並蓋章

．負責人蓋章聲明

．正本進口授權書

．進口商品HS編碼清單

．存放產品的倉庫地址

2. 電子郵件收到用戶ID與密碼後，進行產品註冊(SKI Post Border)

化妝品

．通知審批

．分析證書 (CoA)，包括產品名稱、測試參數、測試結果、測試方法、批號/生產代碼、生產日期和/或到期日期和製造商名稱(如果 CoA 頒發者不是製造商)

．發票

．抽樣/實驗室測試(如有必要)

．主管機關要求的其他證明文件

．備註：發票上列出的產品名稱、包裝和包裝尺寸必須與通知批准上列出的一致。

化妝品成分

．分析證書 (CoA)，包括產品名稱、測試參數、測試結果、測試方法、批號/生產代碼、生產日期和/或到期日期和製造商名稱(如果 CoA 頒發者不是製造商)

．安全數據表和/或成分規格

．使用、分發目的聲明

．發票

．抽樣/實驗室測試(如有必要)

．主管機關要求的其他證明文件

．香水還必須附上：成分製造商出具的聲明信，表明該香水是根據國際香水協會 (IFRA) 指南製造的、以前進口香水的銷售報告

3.支付相關費用，等待驗證

4. 取得進口識別條碼（API）、認證條碼(需標示在產品上)、許可證和批號、到期日期和序列號等信息。

5.化妝品許可證效期：3年。

包裝與標示

化妝品標籤必須誠實準確地根據現有現實列出所有必需的信息，並且應以不易從包裝上取下或分離、不易褪色或損壞的方式呈現，產品註冊時須繳交標籤樣本，應包含以下信息：           

1.化妝品名稱

2.功能

3.指示

4.成分表

5.製造商名稱和國家

6.通知申請人的姓名和完整地址

7.批號

8.尺寸、含量或淨重

9.使用期限

10.通知編號

11.二維條碼

12.警告/注意

13.備註：功能、指示、警告/注意需要用印尼語書寫，其他信息可以用印尼語或拉丁字母和/或阿拉伯數字書寫。

14.某些產品必須貼上特別警告：

．含氟漱口水：不適用於 6 歲以下的兒童。

．氣溶膠：注意！不要接觸眼睛，不要吸入。小心！高壓內容，在50℃以上的溫度下會爆炸。不要刺傷，不要存放在加熱的地方或靠近明火的地方，不要使用焚化爐處理。

．含有豬肉成分的化妝品：含豬肉，製造過程與豬肉成分接觸的化妝品。

．染髮劑：本產品含有在某些情況下可能會引起皮膚刺激的成分，因此應先按照隨附說明進行初步測試。本產品不應用於染睫毛或眉毛，因為這樣的使用可能會導致失明。

15. 進口化妝品需要標示

．進口註冊證號。

．進口商名稱。

．進口商地址。

．如果進口商不希望呈現製造地點，可以只呈現製造國。

．如果化妝品是從不需要註明生產許可證號的國家進口的，則不需要註明生產許可證號。

16. 小尺寸化妝品包裝的豁免：

．對於小於或等於 60 毫升液體和 30 克固體和半固體的化妝品，不需要出現成分清單。

．對於小於或等於 60 毫升液體和 30 克固體和半固體的化妝品，不需要出現成分清單。

．化妝品容器小於或等於 60 毫升液體和 30 克固體和半固體時製造商地址可以縮短為主要製造地點即可。

清真認證程序

1.產品許可證持有公司向BPJPH書面申請清真認證。BPJPH必須在提交後1個工作日內確認申請文件的完整性。

2.根據申請，指定 LPH 對產品的清真狀態進行檢查和/或測試。

3. LPH 指定清真審核員進行產品清真檢查。在生產過程中對營業場所進行產品清真檢查。產品檢驗過程中，如果有成分懷疑清真性，應在實驗室進行檢測。

4.清真審核員將產品清真檢查結果提交給 LPH。LPH 將結果提交給 MUI，並將副本發送給 BPJPH。

5.產品清真度的確定由 MUI 進行，並在 Halal Fatwa Assembly 中進行。清真產品認定法令（Halal Fatwa）由 MUI 提交給 BPJPH，作為頒發清真證書的依據。

6.如果清真教令大會確定經營者申請的產品為清真產品，BPJPH 應在 1 個工作日內簽發清真證書。如果清真法令大會確定產品不是清真產品，BPJPH 將在 1 個工作日內將清真證書申請連同原因退回。

7. 公司必須在申請和註冊清真認證程序之前實施清真保證制度( HAS)。清真保證體係以清真政策為基礎，建立清真管理團隊，編制HAS手冊，進行培訓，編制相關HAS程序，實施內部審計，正確審查管理。

8. 認證文件

．產品清單

．材料清單和材料文件

．屠夫清單（特別是屠宰場）

．產品矩陣

．HAS 手冊

．工藝流程圖

．生產設施地址清單

．清真政策傳播的證據

．內部培訓的證據和內部審計的證據。

9. 註冊清真證書（上傳數據）

10. 監控清真認證過程的預審核和合同付款

11. 執行審計

12. 執行審計後監控

13. 清真證書有效期為4年

14. 提交清真證書的申請者必須：

．提供正確、清晰和真實的信息

．在清真和非清真產品之間分離加工、儲存、包裝、分銷、銷售和展示的位置、場所和設備

．向 BPJPH 報告材料成分的變化

15.獲得清真證書的經營者必須：

．在獲得清真證書的產品上貼上清真標籤

．保持已獲得清真證書的產品的清真

．將清真產品和非清真產品的加工、儲存、包裝、分銷、銷售和展示的地點、場所和設備分開

．如果清真證書的有效期已過，須更新清真證書

．向 BPJPH 報告材料成分的變化

16. 清真標籤：經清真認證的產品必須在外包裝上標明清真，或未經清真認證的非清真信息。已獲得清真證書的經營者必須在以下位置貼上清真標籤：

．產品包裝​​

．產品的特定部分

．產品的具體位置

．清真標籤必須易於查看和閱讀，並且不易擦除、分離和損壞。

Cosmetics need to be registered by a local company in Indonesia, which can be the manufacturer/importer/distributor, or a third party as the product holder.

Product registration based on different identities Applicants must have information:

1. Manufacturer

．Business identification number

．Company management status

．Taxpayer Identification Number

．Copy of license agreement between trademark owner and applicant

．Cosmetic Good Manufacturing Practice (GMP) Certificate

．Letter of Closing (indicating that if the notification number has been registered, the applicant will not object if its application number is cancelled by BPOM)

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Recommendation letter from the head of the BPOM technical implementation department.

2. Importers

． Business identification number

． Company management status

． Taxpayer Identification Number

．Business license

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Recommendation letter from the head of the BPOM technical implementation department.

．Copy of agreement between importer and overseas manufacturer (i.e. GMP certified), certified by a notary public

．Certificate of Free Sales for Cosmetics Imported from Outside ASEAN

．A copy of the agreement signed between the applicant and a cosmetic manufacturer holding a GMP certificate.

3. Distributors/Enterprises

．Business identification number

．Company management status

．Taxpayer Identification Number

．Business license

．Closing statement (statement that the management team has not previously been involved in criminal activities in the Indonesian cosmetic industry)

．Letter of Closing (indicating that if the notification number has been registered, the applicant will not object if its application number is cancelled by BPOM)

．Trademark certificate (if applicable)

．Recommendation letter from the head of the BPOM technical implementation department.

．A copy of the agreement signed between the applicant and a cosmetic manufacturer holding a GMP certificate.

Registration method

1. The applicant first registers with BPOM through the website, uploading:

． Application letter signed and stamped

． Statement by the person in charge

． Original import authorization

． List of HS Codes for Imported Commodities

． The address of the warehouse where the product is stored

2. After receiving the user ID and password by e-mail, proceed to product registration (SKI Post Border)

Cosmetic

．Notify Approval

．Certificate of Analysis (CoA), including product name, test parameters, test results, test method, batch/production code, date of manufacture and/or expiry date and manufacturer’s name (if CoA issuer is not manufacturer)

．Bill

．Sampling/Lab Testing (if necessary)

．Other supporting documents required by the competent authority

．Note: The product name, packaging and packaging size listed on the invoice must be the same as listed on the notification approval.

Cosmetic Ingredient

．Certificate of Analysis (CoA), including product name, test parameters, test results, test method, batch/production code, date of manufacture and/or expiry date and manufacturer’s name (if CoA issuer is not manufacturer)

．Safety data sheets and/or ingredient specifications

．Statement of Purpose of Use, Distribution

．Bill

．Sampling/Lab Test (if necessary)

．Other supporting documents required by competent authorities

．Fragrances must also be accompanied by: A statement letter from the ingredient manufacturer stating that the fragrance was manufactured in accordance with the International Fragrance Association (IFRA) guidelines, a sales report of a previously imported fragrance

3. Pay the relevant fees and wait for the verification

4. Obtain information such as import identification barcode (API), certification barcode (which needs to be marked on the product), license and batch number, expiration date and serial number.

5. Cosmetic license validity: 3 years.

Packaging and Labeling

Cosmetic labels must list all required information honestly and accurately based on existing reality, and should be presented in a manner that is not easily removed or separated from the packaging, faded or damaged, and a sample label must be submitted at the time of product registration, which should include the following information:

1. Cosmetics name

2. Function

3. Instructions

4. Ingredient list

5. Manufacturer’s name and country

6. Notify the applicant’s name and full address

7. Lot number

8. Size, content or net weight

9. Term of use

10. Notification number

11. Two-dimensional barcode

12. Warning/Caution

13. Remarks: Functions, instructions, warnings/cautions need to be written in Bahasa Indonesia, other information can be written in Bahasa Indonesia or Latin alphabets and/or Arabic numerals.

14. Certain products must bear special warnings:

．Fluoride Mouthwash: Not for use on children under 6 years of age.

．Aerosols: Attention! Do not get in eyes, do not breathe. Be careful! High pressure content, will explode at temperatures above 50°C. Do not stab, do not store in a heated area or near an open flame, and do not use an incinerator for disposal.

．Cosmetics containing pork ingredients: Cosmetics that contain pork, and the manufacturing process is in contact with pork ingredients.

．Hair Dye: This product contains ingredients that may cause skin irritation in some cases, so an initial test should be done according to the instructions included. This product should not be used to dye eyelashes or eyebrows as such use may lead to blindness.

15. Imported cosmetics need to be labeled

．Import registration certificate number.

．Importer’s name.

．Importer’s address.

．If the importer does not wish to present the manufacturing location, only the manufacturing country can be presented.

．If the cosmetic product is imported from a country that does not need to indicate the production license number, the production license number is not required.

16. Exemption for small cosmetic packaging:

．For cosmetic products that are less than or equal to 60ml of liquid and 30g of solid and semi-solid, no ingredient list is required.

．For cosmetic products that are less than or equal to 60ml of liquid and 30g of solid and semi-solid, no ingredient list is required.

．For cosmetic containers less than or equal to 60ml of liquid and 30g of solids and semi-solids, the manufacturer’s address can be shortened to the main manufacturing location.

Halal certification process

1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.

2. Upon application, designate LPH to inspect and/or test the halal status of the product.

3. LPH appoints halal auditors to conduct halal inspections of products. Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.

4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.

5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.

6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.

7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.

8. Certification documents

． Product List

． Bill of Materials and Material Documentation

． Butcher’s List (especially slaughterhouses)

． Product Matrix

． HAS Manual

． Flow chart

． Production Facility Address List

． Evidence of the spread of the halal policy

． Evidence of internal training and evidence of internal audit.

9. Register Halal Certificate (Upload Data)

10. Monitor the pre-audit and contract payments for the halal certification process

11. Perform an audit

12. Perform post-audit monitoring

13. Halal certificate is valid for 4 years

14. Applicants submitting a halal certificate must:

．Provide correct, clear and truthful information

．Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display

．Reporting changes in material composition to BPJPH

15. Operators who have obtained a Halal certificate must:

．Put a halal label on products with a halal certificate

．Maintain halal for products that have obtained a halal certificate

．Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products

．If the validity period of the halal certificate has passed, the halal certificate must be renewed

．Report changes to material composition to BPJPH

16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:

．Product packaging

．Specific part of the product

．The exact location of the product

．Halal labels must be easy to see and read, and not easily erased, detached and damaged.

【參考連結】

https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/

https://jdih.pom.go.id/view/chart/4

http://www.halal.go.id/

HLF-ID-55

HLF-ID-60
經過核准登記的化妝品，進口到印尼要檢附什麼文件？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 Indonesia? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

化妝品在上市流通前均需向食品與藥物管理局（BADAN POM）通報。

1. 申請人：產品許可證持有公司(進口商需取得進口識別碼並獲得原產國製造商代理授權書)。

2.網頁：https://notifkos.pom.go.id/

3.需具備資料：

．商業識別號

．公司名稱、地址、電話、傳真、電子郵件

．申明書(公司領導不曾參與犯罪行為)

．董事會和/或公司負責人姓名、地址、電話/手機號碼、傳真、電子郵件

．倉庫名稱、地址、電話、傳真

．化妝品進口商營業執照、地址、電話、傳真、電子郵件

．製造工廠地址、電話、國家、GMP 證書、GMP 證書有效期

．經過公證的合作協議書(如果適用)、協議條款

．技術負責人姓名、地址、電話/手機號碼、傳真、電子郵件

．證書

4.繳交相關費用

5.14個工作日內（香水類產品為3個工作日）收到資料核查結果。

6.產品一經通知，必須在6個月內生產或進口流通。

7.通知有效期為3年，化妝品進口商須對化妝品質量安全負責。

8. 產品信息文件（DIP）：對於每個通知產品，應準備一份產品信息文件以供 BPOM 審核。DIP是有關化妝品質量、安全性和益處的數據，由英語或印尼語組成，化妝品製造/進口後，應至少保存 4年。

產品信息文件（DIP）

1.行政文件和產品概要

．進口商識別號（API）複本

．印尼語和/或英語的有效代理委託書複本，需列出：製造商/原產國負責人的名稱和地址、進口商名稱、化妝品/品牌名稱、簽發日期、委託代理機構的有效期、從原產國的製造商/委託人處通知及進口和分發的權利、原籍國董事/領導/負責人的姓名和簽名

．申請人與生產合同的接受方之間的合同合作協議複印件，該合同經公證人驗證，包括化妝品的品牌和/或名稱以及協議的有效期與印尼以外的化妝品行業簽訂生產合同

．原產於東盟以外國家的進口化妝品的自由銷售證明（CFS）複印件，由印尼共和國大使館/總領事館合法化的原產國認可的授權官員或機構簽發，合同生產的化妝品除外印尼以外

．品牌聲明復印件

．東盟國家行業GMP證書或GMP申請聲明復印件

．東盟國家以外的化妝品行業和印尼以外的化妝品行業獲得生產合同的GMP證書複印件，具有以下條件：由原籍國授權政府官員或認可機構簽發、如果 GMP 證書不能由授權的政府官員或認可機構頒發，則進口商必須附上由認可的認證機構頒發的 GMP 證書複印件，該認證須被承認

．化妝品工業/生產的複印件執照(經印尼共和國大使館/總領事館認證)

2.化妝品成分的質量和安全數據

．每種成分的規格(包括水)

．每種成分的規格相對應的分析方法，包括化妝品成分的鑑定

．香精的名稱和代碼、供應商的名稱和地址，以及符合最新國際香精協會 (IFRA) 準則的聲明

．供應商數據：東盟化妝品科學機構 (ACSB)、歐盟消費者安全科學委員會 (SCCS) 或美國化妝品成分審查委員會 (CIR) 等科學委員會的公開數據或報告

．其他科學數據

．化妝品配方在國際命名化妝品成分（INCI）中寫有名稱的成分或其他符合國際公認參考文獻的名稱，成分以百分比形式書寫，總和為100%

．化妝品配方成分名稱、作用

．對於香精或芳香成分必須包括：名稱、香水成分代碼編號、供應商身份

．化妝品製造，如果初級包裝過程由其他行業進行，則需提供有關化妝品和包裝行業的名稱、地址和國家/地區的完整和詳細的數據

．製造過程總結

3.化妝品分析規格及方法

．分析方法需符合化妝品產品規範規定

．化妝品穩定性數據

．穩定性測試數據支持

4.安全評估

．由技術評估員或安全評估員簽署的基於化妝品成分、化學結構和暴露水平的化妝品安全評估報告

．技術評估員或安全評估員的簡歷

5.不良反應

．使用化妝品對人體的不良反應記錄的最新報告彙編

．人體不良反應報告並定期更新

6.支持化妝品聲明的數據

．由報告人進行並簽署的基於成分或功效測試的功效評估的完整報告

．支持數據包括關於功效聲稱的文獻綜述

7.化妝品標識及信息

．初級包裝和/或二級包裝上的標記

．其他信息，可能包括小冊子、標籤和其他構成初級包裝和/或二級包裝的組成部分的信息

海關

1.需完成化妝品上市前通知，取得核可後必須在6個月內進口流通。

2.申請人(產品許可證持有公司)須獲對外貿易總局發出與其永久賬號對應的進出口商代碼，方可從事進出口業務。公司應向銀行提交一份經核准的進出口商代碼副本，由銀行背書，此步驟一般可透過電子郵件完成。除非主管當局取消，否則進出口商代碼將永久有效。

3. 申請進口許可證，進口許可證用於進口清關，可於到期時續期。一般而言，資本貨物的進口許可證有效期為24個月，原材料成份、消耗品和備件的進口許可證有效期則為18個月。

4.在取得進出口商代碼和進口許可證後，進口商應確定並申報進口物品的來源或產地，並遵從清關手續。

5.計算進口關稅率(輸入任何進口貨物的進口商，應自行評估對此類貨物徵收的關稅)

6.須提供資料

．姓名、完整的營業地址

．保存或儲存通知貨物的場所的情況和描述

．貨物的詳情

．日期以及收到此類貨物的人的姓名和完整地址

．貨物所有人的姓名

．貨物的名稱

．取出貨物場所的位置

．通知貨物被運往場所的位置

．運輸工具(如果使用機動車輛運輸通知貨物，需填寫機動車輛的登記號。）

．運輸路線、開始運輸的時間日期、可能到達目的地的時間和日期

．銷售或轉讓通知貨物的人的姓名和完整的營業地址

．向其出售或轉讓通知貨物的人的姓名和完整地址

．出售或轉讓的時間和日期

．貨物的數量、市場價格

．序列號(如果有)

．批號(如果有)

．專利號(如果有)

．製造商、原產國(如果有)

．品牌(如果有)

．商標(如果有)

7.進口貨物在獲准入境前不得從船上卸貨

8.僅在批准的地點卸貨和裝貨

9.進口商在出示入境單時應就該入境單的內容的真實性作出並簽署聲明，並應為支持該聲明，向有關官員出示發票（如有）以及可能規定的與進口貨物有關的其他文件

10. 入境單的進口商應確保以下事項：-

．提供信息的準確性和完整性

．任何支持它的文件的真實性和有效性

．遵守本法或當時有效的任何其他法律對貨物的限制或禁止

11. 通過電子現金分類賬支付和電子稅收信用分類

Cosmetics are required to be notified to the Bureau of Medicines and Food Control (BADAN POM) before they are put on the market (except for products that are only used for research or exhibition samples in limited quantities and not for trade).

1. Applicant: The company holding the product license (the importer needs to obtain the import identification code and obtain the authorization letter from the manufacturer of the country of origin).

2. URL: https://notifkos.pom.go.id/

3. Required information:

．Business identification number

．Company name, address, telephone, fax, email

．Statement (company leaders have not participated in criminal acts)

．Name, address, telephone/mobile number, fax, email of the person in charge of the board of directors and/or company

．Warehouse name, address, telephone, fax

．Cosmetics importer business license, address, telephone, fax, email

．Manufacturing plant address, phone number, country, GMP certificate, GMP certificate validity period

．Notarized cooperation agreement (if applicable), terms of agreement

．Name, address, telephone/mobile number, fax, email of technical person in charge

．Certificate

4. Pay relevant fees

5. Within 14 working days (3 working days for perfume products), the results of the data verification will be received.

6. Once the product is notified, it must be manufactured or imported for circulation within 6 months.

7. The notice is valid for 3 years, and the cosmetics importer shall be responsible for the quality and safety of the cosmetics.

8. Product Information File (DIP): For each notified product, a Product Information File shall be prepared for review by BPOM. DIP is data on the quality, safety and benefits of cosmetic products, consisting of either English or Hindi, and should be kept for at least 4 years after cosmetic manufacture/import.

Product Information Document (DIP)

1. Administrative Documents and Product Summary

．Copy of Importer Identification Number (API)

．Duplicate of a valid Power of Attorney in Hindi and/or English, listing: Name and address of the person responsible for the manufacturer/country of origin, name of the importer, cosmetic/brand name, date of issue, expiry date of the entrusting agency, date from the original Manufacturer/principal in country of origin to notify and import and distribute rights, name and signature of director/leader/principal person in country of origin

．A copy of the contractual cooperation agreement between the applicant and the recipient of the production contract, which has been verified by a notary public, including the brand and/or name of the cosmetic product and the validity period of the agreement to sign a production contract with the cosmetic industry outside Indonesia

．Copy of Certificate of Free Sale (CFS) for imported cosmetic products originating in countries other than ASEAN, issued by an authorized official or institution recognized by the country of origin legalized by the Embassy/Consulate General of the Republic of Indonesia, except for contract-produced cosmetic products outside Indonesia

．Copy of brand statement

．A copy of the ASEAN country’s industry GMP certificate or GMP application declaration

．Cosmetics industry outside ASEAN countries and cosmetics industry outside Indonesia obtain a copy of GMP certificate for production contracts, with the following conditions: Issued by an authorized government official or accreditation body of the country of origin, if the GMP certificate cannot be issued by an authorized government official or accreditation body, then the importer must attach a copy of the GMP certificate issued by an accredited certification body which must be recognized

．Cosmetic industry/production copy license (authenticated by Embassy/Consulate General of the Republic of Indonesia)

2. Quality and safety data of cosmetic ingredients

．Specification of each ingredient (including water)

．Analytical methods corresponding to the specifications of each ingredient, including identification of cosmetic ingredients

．Fragrance name and code, supplier’s name and address, and statement of compliance with the latest International Fragrance Association (IFRA) guidelines

．Supplier data: Public data or reports from scientific committees such as ASEAN Cosmetic Science Body (ACSB), EU Scientific Committee on Consumer Safety (SCCS), or US Cosmetic Ingredient Review Committee (CIR)

．Other scientific data

．Cosmetic formulations have names written in the International Nomenclature Cosmetic Ingredient (INCI) or other name in accordance with an internationally recognized reference, the ingredients are written as percentages, and the total sum is 100%

．Cosmetic formula ingredients name, function

．For fragrance or fragrance ingredients must include: name, fragrance ingredient code number, supplier identity

．Cosmetics manufacturing, if the primary packaging process is carried out by another industry, full and detailed data on the name, address and country of the cosmetic and packaging industry

．Summary of the manufacturing process

3. Cosmetic analysis specifications and methods

．Analytical methods must comply with cosmetic product specifications

．Cosmetic Stability Data

．Stability test data support

4. Security Assessment

．Cosmetic safety assessment report based on cosmetic ingredients, chemical structure and exposure level signed by technical assessor or safety assessor

．Resume of a Technical Evaluator or Safety Evaluator

5. Adverse reactions

．Compilation of the latest reports on the records of adverse reactions to the human body using cosmetic products

．Human adverse reaction report and regularly updated

6. Data to support cosmetic claims

．Full report of efficacy evaluation based on ingredient or efficacy testing conducted and signed by the reporter

．Supporting data includes a literature review on efficacy claims

7. Cosmetic labeling and information

．Marking on primary and/or secondary packaging

．Other information, which may include brochures, labels and other information forming part of primary and/or secondary packaging

Customs

1. It is necessary to complete the pre-market notification of cosmetics, and it must be imported and circulated within 6 months after the approval is obtained.

2. The applicant (product license holder) must obtain the importer and exporter code corresponding to its permanent account number issued by the State Administration of Foreign Trade before engaging in import and export business. The company should submit a copy of the approved importer/exporter code to the bank, endorsed by the bank, and this step can usually be done by email. The importer/exporter code will remain in force in perpetuity unless cancelled by the competent authorities.

3. Apply for an import license. The import license is used for import customs clearance and can be renewed when it expires. In general, import licenses for capital goods are valid for 24 months, while import licenses for raw material ingredients, consumables and spare parts are valid for 18 months.

4. After obtaining the importer and exporter code and import license, the importer should determine and declare the source or origin of the imported goods, and follow the customs clearance procedures.

5. Calculation of import duty rates (importers who enter any imported goods should assess their own duties on such goods)

6. Information required

．Name, full business address

．Conditions and description of the premises where the notified goods are kept or stored

．Details of the goods

．The date and the name and full address of the person who received such shipment

．The name of the owner of the goods

．The name of the goods

．The location of the place where the goods are taken out

．Notify the location of the goods being shipped to the premises

．Means of transportation (If a motor vehicle is used to transport the notified goods, the registration number of the motor vehicle is required.)

．Transportation route, time and date of start of transportation, time and date of possible arrival at destination

．The name and full business address of the person who sold or transferred the notified goods

．Name and full address of the person to whom the notification goods are sold or transferred

．Time and date of sale or transfer

．Quantity of goods, market price

．Serial number (if available)

．Lot number (if available)

．Patent number (if any)

．Manufacturer, country of origin (if applicable)

．Brand (if any)

．Trademark (if any)

7. Imported goods are not allowed to be unloaded from the ship before they are allowed to enter

8. Unload and load only at approved locations

9. The importer shall make and sign a declaration on the authenticity of the contents of the entry document when presenting the entry document, and shall, in support of the declaration, present to the relevant officials the invoice (if any) and other relevant provisions related to the imported goods as may be prescribed. document

10. The importer of the entry should ensure the following:-

．Accuracy and completeness of information provided

．The authenticity and validity of any documents that support it

．Comply with any restrictions or prohibitions on the Goods under this Act or any other law then in force

11. Payments via Electronic Cash Ledger and Electronic Tax Credit Classification

【參考連結】

https://notifkos.pom.go.id/

https://www.cbic.gov.in/index

https://taxinformation.cbic.gov.in/

HLF-ID-70
印尼化妝品審核機構，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：

製造商需要符合化妝品良好生產規範 (GMP)：製造商可以在線申請證書(證書效期5年)。程序如下：

1.通過與OSS系統集成的BPOM申請GMP證書並上傳所需文件

．行政文件(申請書、化妝品許可證、非稅收入的支付證明)

．符合 GMP 的適當質量體系文件形式的技術文件

2. BPOM在35個工作日內對文件進行審核和評估。根據評估結果，如果業務參與者符合要求，BPOM 將頒發 GMP 證書，並在不遲於 1 個工作日內通過 OSS 系統提交 GMP 證書。

3.如果業務參與者不符合要求，將不遲於 1 個工作日通過 OSS 系統傳達拒絕決定。

4.東盟國家以外的化妝品行業和印尼以外的化妝品行業獲得生產合同的GMP證書複印件，具有以下條件：由原籍國授權政府官員或認可機構簽發、如果 GMP 證書不能由授權的政府官員或認可機構頒發，則進口商必須附上由認可的認證機構頒發的 GMP 證書複印件，該認證須被承認。

化妝品的產品許可根據規定要繳交對化妝品進行測試，必須滿足進口化妝品註冊的所有標準，並應滿足製造商、買方和消費者的要求。樣品檢測包括以下內容：

1.原料和有效成分的理化分析

2.評估化妝品、禁用色素和化學品中重金屬含量的安全測試

3.微生物質量檢查，以確保沒有微生物計數和病原體

4.活性成分的定性和定量估計

5.物理測試，包括粘度、鋪展能力、划痕測試、放線測試等參數

6.估計防曬係數

7.皮膚刺激和敏感性研究

8.穩定性測試、保質期測定等

Manufacturers need to comply with Cosmetic Good Manufacturing Practice (GMP): Manufacturers can apply for a certificate online (certificate valid for 5 years). The procedure is as follows:

1. Apply for a GMP certificate and upload the required documents through BPOM integrated with the OSS system

．Administrative documents (application, cosmetic license, proof of payment of non-tax income)

．Technical documentation in the form of appropriate quality system documentation according to GMP

2. BPOM reviews and evaluates the documents within 35 working days. According to the evaluation results, if the business participant meets the requirements, BPOM will issue a GMP certificate and submit the GMP certificate through the OSS system no later than 1 working day.

3. If the business participant does not meet the requirements, the decision of rejection will be communicated through the OSS system no later than 1 working day.

4. Cosmetics industry outside ASEAN countries and cosmetics industry outside Indonesia obtain a copy of the GMP certificate of the production contract, with the following conditions: issued by an authorized government official or accreditation body of the country of origin, if the GMP certificate cannot be issued by an authorized government official or accreditation body issued, the importer must attach a copy of the GMP certificate issued by an accredited certification body, which certification must be recognized.

Product licensing of cosmetic products is subject to testing of cosmetic products, which must meet all standards for registration of imported cosmetic products, and should meet the requirements of manufacturers, buyers and consumers. Sample testing includes the following:

1. Physicochemical analysis of raw materials and active ingredients

2. Safety testing to evaluate heavy metal content in cosmetics, banned pigments and chemicals

3. Microbiological quality inspection to ensure no microbial counts and pathogens

4. Qualitative and Quantitative Estimation of Active Ingredient

5. Physical test, including parameters such as viscosity, spreading ability, scratch test, and pay-off test

6. Estimate SPF

7. Skin irritation and sensitivity studies

8. Stability test, shelf life determination, etc.

【參考連結】

https://jdih.pom.go.id/view/chart/4

https://www.pom.go.id/new/

https://notifkos.pom.go.id/

HLF-ID-75

HLF-ID-77

HLF-ID-80
外國子公司進口化妝品後，如果委託印尼的經銷商銷售，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 Indonesia 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。產品許可證持有公司須負責化妝品的安全、品質，及不良事件之處理，並向主管機關回報。

No business license is required.The product license holder shall be responsible for the safety, quality, and handling of adverse events of cosmetic products, and report to the competent authority.

【參考連結】

https://jdih.pom.go.id/view/chart/4

https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/

HLF-ID-85

各國化妝品登記法規問答集

聯繫我們
Email：jkt4ww@evershinecpa.com
或
印尼永輝BPO有限公司
Jakarta time zone:
The Engaging Manager Cindy Luo, Indonesia citizenship, speak English, Bahasa and Chinese
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin

全球永輝服務據點參考資料:
永輝100%關係企業
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
更多城市更多服務  請點擊 網站導覽