Indonesia Cosmetics Regulation QA

Indonesia Cosmetics Regulation QA

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HLF-ID-10

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:

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

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

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:

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

假如需要辦理指派印尼公司擔任營業代理人,請問印尼有專業服務公司可以協助?

Evershine RD:

RAHN

https://www.rahn-group.com/en/

WARDA

https://www.wardahbeauty.com/

HLF-ID-40

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:

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

請問在印尼有哪些專業服務機構,可以協助辦理化妝品產品許可證?

Evershine RD:

Cekindo

https://www.cekindo.com/

Emerhub

https://emerhub.com/

HLF-ID-50

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:

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

請問在印尼有哪些專業服務機構,可以協助以外國公司名義辦理化妝品產品許可證?

Evershine RD:

MANDREEL

https://www.mandreel.com/singapore/

INDOSERVICE

https://indoservice.co.id/

HLF-ID-60

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:

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:

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

印尼化妝品審核機構,能夠接受海外檢驗機構的檢驗資料嗎?假如是的話,有些被認可的機構?網頁?

Evershine RD:

SGS

https://msn.sgs.com/

TÜV

https://www.tuvsud.com/en-in

HLF-ID-77

請問在印尼有哪些化妝品檢驗機構可以提供化妝品檢驗服務?網頁?

Evershine RD:

AURIGARESEARCH

https://aurigaresearch.com/

CLINIEXPERTS

https://cliniexperts.com/

HLF-ID-80

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:

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

請問在印尼有哪些專精於化妝品銷售與消費權益相關法律服務的業者?

Evershine RD:

Tilleke

https://www.tilleke.com/

Baker McKenzie

https://www.bakermckenzie.com/en/

Contact Us

Jakarta Evershine BPO Service Limited Corp.
17D, Oriental Kenzo Apartment C, No. 48 Dongzhimen Outer St.,
Dongcheng Dist., Beijing, Indonesia
E-mail: jkt4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of Taiwan (GMT+8)
The Engaging Manager from Headquarter
Project Manager Cindy Victoria Speak in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193

or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4jkt@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
Linkedin address:Dale Chen

Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico

Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
Please send email to HQ4jkt@evershinecpa.com

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