印尼化妆品登记法规问题集

印尼化妆品登记法规问题集

Email:jkt4ww@evershinecpa.com

印尼永辉BPO有限公司
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The Engaging Manager Cindy Luo, Indonesia citizenship, speaks English, Bahasa and Chinese

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手机:+886-939-357735
skype: jc0096
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文章目录 点击收合

各国化妆品登记法规问答集

HLF-ID-10
请问印尼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 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,化妆品被定义为任何旨在摩擦、倾倒、喷洒、喷洒、引入或以其他方式应用于人体或其任何部位,用于清洁、美化、提升吸引力或改变外观的物品。

食品与药物管理局(BADAN POM)是监管化妆品的主管机关,负责颁布化妆品法规并在进入市场前授予化妆品生产许可证和化妆品通知,确保化妆品的安全、效益和质量。清真产品保证机构(BPJPH)是监管清真化妆品并颁发清真证书的机构,印尼法律要求化妆品必须申请清真认证。中央药品标准控制机构 (CDSCO) 是中央药品管理局,负责履行化妆品的进口监管。

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.

【参考连结】

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
外国公司要到印尼销售化妆品,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 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:

无需申请营业许可证。

No business license is required.

【参考连结】

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

HLF-ID-25

假如需要办理,请问印尼有专业服务公司可以协助办理化妆品公司营业许可证?

Evershine RD:

无需申请营业许可证。

HLF-ID-30
外国公司要到印尼销售化妆品,可以指派印尼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 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:

产品许可须由在印尼当地的公司申请,可以是製造商/进口商/分销商,或由第三方担任产品持有人。

依据不同身分申请者须具备资料:

1.製造商

.商业识别号

.公司管理层身份

.纳税人识别号

.商标所有人与申请人之间的许可协议副本

.化妆品良好生产规范 (GMP) 证书

.切结书(说明如果通知号已经註册,如果其申请号被BPOM取消,申请人将不会反对)

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.BPOM 技术实施部门负责人出具的推荐信。

2.进口商

.商业识别号

.公司管理层身份

.纳税人识别号

.商业执照

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.BPOM 技术实施部门负责人出具的推荐信。

.进口商与海外製造商(即GMP认证)之间的协议副本,并经公证人认证

.从东盟以外进口的化妆品的自由销售证明

.申请人与持有GMP证书的化妆品生产企业签订的协议複印本。

3.分销商/企业

.商业识别号

.公司管理层身份

.纳税人识别号

.商业执照

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.切结书(说明如果通知号已经註册,如果其申请号被BPOM取消,申请人将不会反对)

.商标证书(如适用)

.BPOM 技术实施部门负责人出具的推荐信。

.申请人与持有GMP证书的化妆品生产企业签订的协议複印本。

产品许可证持有公司须负责化妆品的安全、品质,及不良事件之处理,并向主管机关回报。

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.

【参考连结】

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

HLF-ID-35

HLF-ID-40
外国公司销售到印尼化妆品本身,进口前需要办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?申请程序为何?化妆品包装内容及各种标示,需要事先核准吗?可允许的语文有哪些?网页?

Do foreign companies need to apply for an approval before importing cosmetics sold to 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,须由在印尼当地的公司申请产品许可,可以是製造商/进口商/分销商,或由第三方担任产品持有人。

产品註册依据不同身分申请者须具备资料:

1.製造商

.商业识别号

.公司管理层身份

.纳税人识别号

.商标所有人与申请人之间的许可协议副本

.化妆品良好生产规范 (GMP) 证书

.切结书(说明如果通知号已经註册,如果其申请号被BPOM取消,申请人将不会反对)

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.BPOM 技术实施部门负责人出具的推荐信。

2.进口商

.商业识别号

.公司管理层身份

.纳税人识别号

.商业执照

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.BPOM 技术实施部门负责人出具的推荐信。

.进口商与海外製造商(即GMP认证)之间的协议副本,并经公证人认证

.从东盟以外进口的化妆品的自由销售证明

.申请人与持有GMP证书的化妆品生产企业签订的协议複印本。

3.分销商/企业

.商业识别号

.公司管理层身份

.纳税人识别号

.商业执照

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.切结书(说明如果通知号已经註册,如果其申请号被BPOM取消,申请人将不会反对)

.商标证书(如适用)

.BPOM 技术实施部门负责人出具的推荐信。

.申请人与持有GMP证书的化妆品生产企业签订的协议複印本。

註册方式

1. 申请人首先通过网站向 BPOM 註册,需上传:

.申请信签名并盖章

.负责人盖章声明

.正本进口授权书

.进口商品HS编码清单

.存放产品的仓库地址

.网址:http://e-bpom.pom.go.id/

2. 电子邮件收到用户ID与密码后,进行产品註册(SKI Post Border)

化妆品

.通知审批

.分析证书 (CoA),包括产品名称、测试参数、测试结果、测试方法、批号/生产代码、生产日期和/或到期日期和製造商名称(如果 CoA 颁发者不是製造商)

.发票

.抽样/实验室测试(如有必要)

.主管机关要求的其他证明文件

.备註:发票上列出的产品名称、包装和包装尺寸必须与通知批准上列出的一致。

化妆品成分

.分析证书 (CoA),包括产品名称、测试参数、测试结果、测试方法、批号/生产代码、生产日期和/或到期日期和製造商名称(如果 CoA 颁发者不是製造商)

.安全数据表和/或成分规格

.使用、分发目的声明

.发票

.抽样/实验室测试(如有必要)

.主管机关要求的其他证明文件

.香水还必须附上:成分製造商出具的声明信,表明该香水是根据国际香水协会 (IFRA) 指南製造的、以前进口香水的销售报告

3.支付相关费用,等待验证

4. 取得进口识别条码(API)、认证条码(需标示在产品上)、许可证和批号、到期日期和序列号等信息。

5.化妆品许可证效期:3年。

包装与标示

化妆品标籤必须诚实准确地根据现有现实列出所有必需的信息,并且应以不易从包装上取下或分离、不易褪色或损坏的方式呈现,产品註册时须缴交标籤样本,应包含以下信息:           

1.化妆品名称

2.功能

3.指示

4.成分表

5.製造商名称和国家

6.通知申请人的姓名和完整地址

7.批号

8.尺寸、含量或淨重

9.使用期限

10.通知编号

11.二维条码

12.警告/注意

13.备註:功能、指示、警告/注意需要用印尼语书写,其他信息可以用印尼语或拉丁字母和/或阿拉伯数字书写。

14.某些产品必须贴上特别警告:

.含氟漱口水:不适用于 6 岁以下的儿童。

.气溶胶:注意!不要接触眼睛,不要吸入。小心!高压内容,在50℃以上的温度下会爆炸。不要刺伤,不要存放在加热的地方或靠近明火的地方,不要使用焚化炉处理。

.含有猪肉成分的化妆品:含猪肉,製造过程与猪肉成分接触的化妆品。

.染发剂:本产品含有在某些情况下可能会引起皮肤刺激的成分,因此应先按照随附说明进行初步测试。本产品不应用于染睫毛或眉毛,因为这样的使用可能会导致失明。

15. 进口化妆品需要标示

.进口註册证号。

.进口商名称。

.进口商地址。

.如果进口商不希望呈现製造地点,可以只呈现製造国。

.如果化妆品是从不需要註明生产许可证号的国家进口的,则不需要註明生产许可证号。

16. 小尺寸化妆品包装的豁免:

.对于小于或等于 60 毫升液体和 30 克固体和半固体的化妆品,不需要出现成分清单。

.对于小于或等于 60 毫升液体和 30 克固体和半固体的化妆品,不需要出现成分清单。

.化妆品容器小于或等于 60 毫升液体和 30 克固体和半固体时製造商地址可以缩短为主要製造地点即可。

清真认证程序

1.产品许可证持有公司向BPJPH书面申请清真认证。BPJPH必须在提交后1个工作日内确认申请文件的完整性。

2.根据申请,指定 LPH 对产品的清真状态进行检查和/或测试。

3. LPH 指定清真审核员进行产品清真检查。在生产过程中对营业场所进行产品清真检查。产品检验过程中,如果有成分怀疑清真性,应在实验室进行检测。

4.清真审核员将产品清真检查结果提交给 LPH。LPH 将结果提交给 MUI,并将副本发送给 BPJPH。

5.产品清真度的确定由 MUI 进行,并在 Halal Fatwa Assembly 中进行。清真产品认定法令(Halal Fatwa)由 MUI 提交给 BPJPH,作为颁发清真证书的依据。

6.如果清真教令大会确定经营者申请的产品为清真产品,BPJPH 应在 1 个工作日内签发清真证书。如果清真法令大会确定产品不是清真产品,BPJPH 将在 1 个工作日内将清真证书申请连同原因退回。

7. 公司必须在申请和註册清真认证程序之前实施清真保证制度( HAS)。清真保证体係以清真政策为基础,建立清真管理团队,编制HAS手册,进行培训,编制相关HAS程序,实施内部审计,正确审查管理。

8. 认证文件

.产品清单

.材料清单和材料文件

.屠夫清单(特别是屠宰场)

.产品矩阵

.HAS 手册

.工艺流程图

.生产设施地址清单

.清真政策传播的证据

.内部培训的证据和内部审计的证据。

9. 註册清真证书(上传数据)

10. 监控清真认证过程的预审核和合同付款

11. 执行审计

12. 执行审计后监控

13. 清真证书有效期为4年

14. 提交清真证书的申请者必须:

.提供正确、清晰和真实的信息

.在清真和非清真产品之间分离加工、储存、包装、分销、销售和展示的位置、场所和设备

.向 BPJPH 报告材料成分的变化

15.获得清真证书的经营者必须:

.在获得清真证书的产品上贴上清真标籤

.保持已获得清真证书的产品的清真

.将清真产品和非清真产品的加工、储存、包装、分销、销售和展示的地点、场所和设备分开

.如果清真证书的有效期已过,须更新清真证书

.向 BPJPH 报告材料成分的变化

16. 清真标籤:经清真认证的产品必须在外包装上标明清真,或未经清真认证的非清真信息。已获得清真证书的经营者必须在以下位置贴上清真标籤:

.产品包装​​

.产品的特定部分

.产品的具体位置

.清真标籤必须易于查看和阅读,并且不易擦除、分离和损坏。

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.

【参考连结】

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
外国公司可以用自己名义申请办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?申请程序为何?
化妆品包装内容及各种标示,需要事先核准吗?可允许的语文有哪些??网页?

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages ​​are allowed? Website?

Evershine RD:

须由在印尼当地的公司申请产品许可,可以是製造商/进口商/分销商,或由第三方担任产品持有人。

产品註册依据不同身分申请者须具备资料:

1.製造商

.商业识别号

.公司管理层身份

.纳税人识别号

.商标所有人与申请人之间的许可协议副本

.化妆品良好生产规范 (GMP) 证书

.切结书(说明如果通知号已经註册,如果其申请号被BPOM取消,申请人将不会反对)

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.BPOM 技术实施部门负责人出具的推荐信。

2.进口商

.商业识别号

.公司管理层身份

.纳税人识别号

.商业执照

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.BPOM 技术实施部门负责人出具的推荐信。

.进口商与海外製造商(即GMP认证)之间的协议副本,并经公证人认证

.从东盟以外进口的化妆品的自由销售证明

.申请人与持有GMP证书的化妆品生产企业签订的协议複印本。

3.分销商/企业

.商业识别号

.公司管理层身份

.纳税人识别号

.商业执照

.切结书(说明管理团队以前没有参与印尼化妆品行业的犯罪活动)

.切结书(说明如果通知号已经註册,如果其申请号被BPOM取消,申请人将不会反对)

.商标证书(如适用)

.BPOM 技术实施部门负责人出具的推荐信。

.申请人与持有GMP证书的化妆品生产企业签订的协议複印本。

註册方式

1. 申请人首先通过网站向 BPOM 註册,需上传:

.申请信签名并盖章

.负责人盖章声明

.正本进口授权书

.进口商品HS编码清单

.存放产品的仓库地址

2. 电子邮件收到用户ID与密码后,进行产品註册(SKI Post Border)

化妆品

.通知审批

.分析证书 (CoA),包括产品名称、测试参数、测试结果、测试方法、批号/生产代码、生产日期和/或到期日期和製造商名称(如果 CoA 颁发者不是製造商)

.发票

.抽样/实验室测试(如有必要)

.主管机关要求的其他证明文件

.备註:发票上列出的产品名称、包装和包装尺寸必须与通知批准上列出的一致。

化妆品成分

.分析证书 (CoA),包括产品名称、测试参数、测试结果、测试方法、批号/生产代码、生产日期和/或到期日期和製造商名称(如果 CoA 颁发者不是製造商)

.安全数据表和/或成分规格

.使用、分发目的声明

.发票

.抽样/实验室测试(如有必要)

.主管机关要求的其他证明文件

.香水还必须附上:成分製造商出具的声明信,表明该香水是根据国际香水协会 (IFRA) 指南製造的、以前进口香水的销售报告

3.支付相关费用,等待验证

4. 取得进口识别条码(API)、认证条码(需标示在产品上)、许可证和批号、到期日期和序列号等信息。

5.化妆品许可证效期:3年。

包装与标示

化妆品标籤必须诚实准确地根据现有现实列出所有必需的信息,并且应以不易从包装上取下或分离、不易褪色或损坏的方式呈现,产品註册时须缴交标籤样本,应包含以下信息:           

1.化妆品名称

2.功能

3.指示

4.成分表

5.製造商名称和国家

6.通知申请人的姓名和完整地址

7.批号

8.尺寸、含量或淨重

9.使用期限

10.通知编号

11.二维条码

12.警告/注意

13.备註:功能、指示、警告/注意需要用印尼语书写,其他信息可以用印尼语或拉丁字母和/或阿拉伯数字书写。

14.某些产品必须贴上特别警告:

.含氟漱口水:不适用于 6 岁以下的儿童。

.气溶胶:注意!不要接触眼睛,不要吸入。小心!高压内容,在50℃以上的温度下会爆炸。不要刺伤,不要存放在加热的地方或靠近明火的地方,不要使用焚化炉处理。

.含有猪肉成分的化妆品:含猪肉,製造过程与猪肉成分接触的化妆品。

.染发剂:本产品含有在某些情况下可能会引起皮肤刺激的成分,因此应先按照随附说明进行初步测试。本产品不应用于染睫毛或眉毛,因为这样的使用可能会导致失明。

15. 进口化妆品需要标示

.进口註册证号。

.进口商名称。

.进口商地址。

.如果进口商不希望呈现製造地点,可以只呈现製造国。

.如果化妆品是从不需要註明生产许可证号的国家进口的,则不需要註明生产许可证号。

16. 小尺寸化妆品包装的豁免:

.对于小于或等于 60 毫升液体和 30 克固体和半固体的化妆品,不需要出现成分清单。

.对于小于或等于 60 毫升液体和 30 克固体和半固体的化妆品,不需要出现成分清单。

.化妆品容器小于或等于 60 毫升液体和 30 克固体和半固体时製造商地址可以缩短为主要製造地点即可。

清真认证程序

1.产品许可证持有公司向BPJPH书面申请清真认证。BPJPH必须在提交后1个工作日内确认申请文件的完整性。

2.根据申请,指定 LPH 对产品的清真状态进行检查和/或测试。

3. LPH 指定清真审核员进行产品清真检查。在生产过程中对营业场所进行产品清真检查。产品检验过程中,如果有成分怀疑清真性,应在实验室进行检测。

4.清真审核员将产品清真检查结果提交给 LPH。LPH 将结果提交给 MUI,并将副本发送给 BPJPH。

5.产品清真度的确定由 MUI 进行,并在 Halal Fatwa Assembly 中进行。清真产品认定法令(Halal Fatwa)由 MUI 提交给 BPJPH,作为颁发清真证书的依据。

6.如果清真教令大会确定经营者申请的产品为清真产品,BPJPH 应在 1 个工作日内签发清真证书。如果清真法令大会确定产品不是清真产品,BPJPH 将在 1 个工作日内将清真证书申请连同原因退回。

7. 公司必须在申请和註册清真认证程序之前实施清真保证制度( HAS)。清真保证体係以清真政策为基础,建立清真管理团队,编制HAS手册,进行培训,编制相关HAS程序,实施内部审计,正确审查管理。

8. 认证文件

.产品清单

.材料清单和材料文件

.屠夫清单(特别是屠宰场)

.产品矩阵

.HAS 手册

.工艺流程图

.生产设施地址清单

.清真政策传播的证据

.内部培训的证据和内部审计的证据。

9. 註册清真证书(上传数据)

10. 监控清真认证过程的预审核和合同付款

11. 执行审计

12. 执行审计后监控

13. 清真证书有效期为4年

14. 提交清真证书的申请者必须:

.提供正确、清晰和真实的信息

.在清真和非清真产品之间分离加工、储存、包装、分销、销售和展示的位置、场所和设备

.向 BPJPH 报告材料成分的变化

15.获得清真证书的经营者必须:

.在获得清真证书的产品上贴上清真标籤

.保持已获得清真证书的产品的清真

.将清真产品和非清真产品的加工、储存、包装、分销、销售和展示的地点、场所和设备分开

.如果清真证书的有效期已过,须更新清真证书

.向 BPJPH 报告材料成分的变化

16. 清真标籤:经清真认证的产品必须在外包装上标明清真,或未经清真认证的非清真信息。已获得清真证书的经营者必须在以下位置贴上清真标籤:

.产品包装​​

.产品的特定部分

.产品的具体位置

.清真标籤必须易于查看和阅读,并且不易擦除、分离和损坏。

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.

【参考连结】

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
经过核准登记的化妆品,进口到印尼要检附什麽文件?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 Indonesia? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD:

化妆品在上市流通前均需向食品与药物管理局(BADAN POM)通报。

1. 申请人:产品许可证持有公司(进口商需取得进口识别码并获得原产国製造商代理授权书)。

2.网页:https://notifkos.pom.go.id/

3.需具备资料:

.商业识别号

.公司名称、地址、电话、传真、电子邮件

.申明书(公司领导不曾参与犯罪行为)

.董事会和/或公司负责人姓名、地址、电话/手机号码、传真、电子邮件

.仓库名称、地址、电话、传真

.化妆品进口商营业执照、地址、电话、传真、电子邮件

.製造工厂地址、电话、国家、GMP 证书、GMP 证书有效期

.经过公证的合作协议书(如果适用)、协议条款

.技术负责人姓名、地址、电话/手机号码、传真、电子邮件

.证书

4.缴交相关费用

5.14个工作日内(香水类产品为3个工作日)收到资料核查结果。

6.产品一经通知,必须在6个月内生产或进口流通。

7.通知有效期为3年,化妆品进口商须对化妆品质量安全负责。

8. 产品信息文件(DIP):对于每个通知产品,应准备一份产品信息文件以供 BPOM 审核。DIP是有关化妆品质量、安全性和益处的数据,由英语或印尼语组成,化妆品製造/进口后,应至少保存 4年。

产品信息文件(DIP)

1.行政文件和产品概要

.进口商识别号(API)複本

.印尼语和/或英语的有效代理委託书複本,需列出:製造商/原产国负责人的名称和地址、进口商名称、化妆品/品牌名称、签发日期、委託代理机构的有效期、从原产国的製造商/委託人处通知及进口和分发的权利、原籍国董事/领导/负责人的姓名和签名

.申请人与生产合同的接受方之间的合同合作协议複印件,该合同经公证人验证,包括化妆品的品牌和/或名称以及协议的有效期与印尼以外的化妆品行业签订生产合同

.原产于东盟以外国家的进口化妆品的自由销售证明(CFS)複印件,由印尼共和国大使馆/总领事馆合法化的原产国认可的授权官员或机构签发,合同生产的化妆品除外印尼以外

.品牌声明復印件

.东盟国家行业GMP证书或GMP申请声明復印件

.东盟国家以外的化妆品行业和印尼以外的化妆品行业获得生产合同的GMP证书複印件,具有以下条件:由原籍国授权政府官员或认可机构签发、如果 GMP 证书不能由授权的政府官员或认可机构颁发,则进口商必须附上由认可的认证机构颁发的 GMP 证书複印件,该认证须被承认

.化妆品工业/生产的複印件执照(经印尼共和国大使馆/总领事馆认证)

2.化妆品成分的质量和安全数据

.每种成分的规格(包括水)

.每种成分的规格相对应的分析方法,包括化妆品成分的鑑定

.香精的名称和代码、供应商的名称和地址,以及符合最新国际香精协会 (IFRA) 准则的声明

.供应商数据:东盟化妆品科学机构 (ACSB)、欧盟消费者安全科学委员会 (SCCS) 或美国化妆品成分审查委员会 (CIR) 等科学委员会的公开数据或报告

.其他科学数据

.化妆品配方在国际命名化妆品成分(INCI)中写有名称的成分或其他符合国际公认参考文献的名称,成分以百分比形式书写,总和为100%

.化妆品配方成分名称、作用

.对于香精或芳香成分必须包括:名称、香水成分代码编号、供应商身份

.化妆品製造,如果初级包装过程由其他行业进行,则需提供有关化妆品和包装行业的名称、地址和国家/地区的完整和详细的数据

.製造过程总结

3.化妆品分析规格及方法

.分析方法需符合化妆品产品规范规定

.化妆品稳定性数据

.稳定性测试数据支持

4.安全评估

.由技术评估员或安全评估员签署的基于化妆品成分、化学结构和暴露水平的化妆品安全评估报告

.技术评估员或安全评估员的简历

5.不良反应

.使用化妆品对人体的不良反应记录的最新报告彙编

.人体不良反应报告并定期更新

6.支持化妆品声明的数据

.由报告人进行并签署的基于成分或功效测试的功效评估的完整报告

.支持数据包括关于功效声称的文献综述

7.化妆品标识及信息

.初级包装和/或二级包装上的标记

.其他信息,可能包括小册子、标籤和其他构成初级包装和/或二级包装的组成部分的信息

海关

1.需完成化妆品上市前通知,取得核可后必须在6个月内进口流通。

2.申请人(产品许可证持有公司)须获对外贸易总局发出与其永久账号对应的进出口商代码,方可从事进出口业务。公司应向银行提交一份经核准的进出口商代码副本,由银行背书,此步骤一般可透过电子邮件完成。除非主管当局取消,否则进出口商代码将永久有效。

3. 申请进口许可证,进口许可证用于进口清关,可于到期时续期。一般而言,资本货物的进口许可证有效期为24个月,原材料成份、消耗品和备件的进口许可证有效期则为18个月。

4.在取得进出口商代码和进口许可证后,进口商应确定并申报进口物品的来源或产地,并遵从清关手续。

5.计算进口关税率(输入任何进口货物的进口商,应自行评估对此类货物徵收的关税)

6.须提供资料

.姓名、完整的营业地址

.保存或储存通知货物的场所的情况和描述

.货物的详情

.日期以及收到此类货物的人的姓名和完整地址

.货物所有人的姓名

.货物的名称

.取出货物场所的位置

.通知货物被运往场所的位置

.运输工具(如果使用机动车辆运输通知货物,需填写机动车辆的登记号。)

.运输路线、开始运输的时间日期、可能到达目的地的时间和日期

.销售或转让通知货物的人的姓名和完整的营业地址

.向其出售或转让通知货物的人的姓名和完整地址

.出售或转让的时间和日期

.货物的数量、市场价格

.序列号(如果有)

.批号(如果有)

.专利号(如果有)

.製造商、原产国(如果有)

.品牌(如果有)

.商标(如果有)

7.进口货物在获准入境前不得从船上卸货

8.仅在批准的地点卸货和装货

9.进口商在出示入境单时应就该入境单的内容的真实性作出并签署声明,并应为支持该声明,向有关官员出示发票(如有)以及可能规定的与进口货物有关的其他文件

10. 入境单的进口商应确保以下事项:-

.提供信息的准确性和完整性

.任何支持它的文件的真实性和有效性

.遵守本法或当时有效的任何其他法律对货物的限制或禁止

11. 通过电子现金分类账支付和电子税收信用分类

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

【参考连结】

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

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

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

HLF-ID-70
印尼化妆品审核机构,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:

製造商需要符合化妆品良好生产规范 (GMP):製造商可以在线申请证书(证书效期5年)。程序如下:

1.通过与OSS系统集成的BPOM申请GMP证书并上传所需文件

.行政文件(申请书、化妆品许可证、非税收入的支付证明)

.符合 GMP 的适当质量体系文件形式的技术文件

2. BPOM在35个工作日内对文件进行审核和评估。根据评估结果,如果业务参与者符合要求,BPOM 将颁发 GMP 证书,并在不迟于 1 个工作日内通过 OSS 系统提交 GMP 证书。

3.如果业务参与者不符合要求,将不迟于 1 个工作日通过 OSS 系统传达拒绝决定。

4.东盟国家以外的化妆品行业和印尼以外的化妆品行业获得生产合同的GMP证书複印件,具有以下条件:由原籍国授权政府官员或认可机构签发、如果 GMP 证书不能由授权的政府官员或认可机构颁发,则进口商必须附上由认可的认证机构颁发的 GMP 证书複印件,该认证须被承认。

化妆品的产品许可根据规定要缴交对化妆品进行测试,必须满足进口化妆品註册的所有标准,并应满足製造商、买方和消费者的要求。样品检测包括以下内容:

1.原料和有效成分的理化分析

2.评估化妆品、禁用色素和化学品中重金属含量的安全测试

3.微生物质量检查,以确保没有微生物计数和病原体

4.活性成分的定性和定量估计

5.物理测试,包括粘度、铺展能力、划痕测试、放线测试等参数

6.估计防晒係数

7.皮肤刺激和敏感性研究

8.稳定性测试、保质期测定等

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.

【参考连结】

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
外国子公司进口化妆品后,如果委託印尼的经销商销售,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 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:

无需申请营业许可证。产品许可证持有公司须负责化妆品的安全、品质,及不良事件之处理,并向主管机关回报。

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.

【参考连结】

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

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

HLF-ID-85

各国化妆品登记法规问答集

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Email:jkt4ww@evershinecpa.com

印尼永辉BPO有限公司
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