Indonesia Cosmetic Regulation

In Indonesia, both domestically manufactured and imported cosmetics shall be notified before circulated on the market. To apply for notification the applicant shall register with BPOM firstly and then fill out and submit a form of notification template online. Prior to notification, cosmetic manufacturers must obtain a production license while importers must have an importer identification number (API). SKI Post Border is also necessary for imported cosmetics to enter into the Indonesian territory after getting the approval of notification.

Halal cosmetics are also a feature of the Indonesian market, because this country is a primarily Muslim country. Sale of halal cosmetics requires a Halal certificate. There is a complicated procedure to apply for this certificate.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in Indonesia

2 Competent Authority

The Agency for Drug and Food Control (BADAN POM) is the competent authority in Indonesia to regulate cosmetics, it is the agency to issue cosmetic regulations and grant cosmetic production license and cosmetic notification before market entry.

The Halal Product Guarantee Agency (BPJPH) is the authority which regulates HALAL cosmetics and issue HALAL Certificate enterprise looking to enter the HALAL market in Indonesia.

Part 2 Cosmetic Products

1 Definition

In Indonesia, cosmetics are products that are intended for use on the outside of the human body (epidermis, hair, nails, lips and external genital organs), teeth and oral mucous membranes, primarily to cleanse, fragrance, alter the appearance and/or improve body odor or protect or maintain the body in good condition. (click to see all types of cosmetic products)

2 Manufacturer Obligation

2.1 Production Licenses

In Indonesia, the manufacturer must obtain a "production license" before manufacturing cosmetics. Production License is a permit which must be owned by cosmetics factories to perform cosmetic manufacturing activities. The production license is valid for 5 years, and may be extended as long as they comply with regulations.

Production license is divided into two categories by cosmetic categories and types:

Class A Production License grants rights to manufacture all forms and types of cosmetics

Class B Production License grants restricted rights confined to manufacture cosmetics listed in the following table without conditions, and prohibit manufacturing 1) Cosmetics used for babies; 2) Cosmetics used around the eyes, oral cavity, and / or other mucous membranes; 3) Cosmetics contain functional ingredients such as anti-acne, skin whitening, sunscreen, chemical peeling, hair dyeing agents; 4) Cosmetics that require complicated technologies during the manufacturing process, such as aerosols and compact powders.

If cosmetic manufacturers with class B license wants to manufacture cosmetics which are neither prohibited for class B and are not listed on the above positive list, the manufacturers should submit a safety assessment of the cosmetic before manufacture.

To obtain Class A production License, a cosmetic manufacturer should fulfil the following requirements:

1. Have a pharmacist as the responsible party;

2. Have production facilities for products to be manufactured;

3. Have laboratory facilities;

4. Have GMP qualification

To obtain Class B production license, a cosmetic manufacturer should fulfil the following requirements:

1. Have at least one pharmaceutical technical personnel in charge;

2. Have production facilities with simple technology for products to be manufactured;

3. Able to provide appropriate hygiene and sanitation documentation in accordance with GMP.

2.2 GMP (Cara Pembuatan Kosmetika yang Baik in Indonesian, CPKB)

Manufacturers of Class A must ensure their compliance with the Guideline for Cosmetic Good Manufacturing Practice 2019 (GMP) and manufacturers of Class B must comply with the hygiene and sanitation requirements in accordance with the GMP. The competent authority will conduct corresponding inspections on the compliance status within 7 working days after receiving the application of a production license. 

Manufacturers who implement the GMP are able to apply for a certificate online. The GMP certificate is valid for 5 years. The procedures are as follows:

1. Business actors apply GMP certificate and upload required documents through BPOM integrated with the OSS system

2. BPOM conducts audits and evaluations of documents within 35 working days. Based on evaluation results, BPOM issues GMP certificate if the business actors comply with the requirements and submit GMP certificate through the OSS system no later than 1 working day.

If the business actors do not meet the requirements, rejection decision will be conveyed though the OSS system no later than 1 working day.

Source: Regulation for Electronic Business Licensing of Drug and Food

3 Importer Obligation

3.1 Importer Identification Number (Angka Pengenal Importir in Indonesian, API)

API is an identification as an importer. Individuals or enterprises are permitted to conduct import activities in Indonesia only after obtaining the API. There are two types of API:

• General API (API Umum in Indonesian, API-U)

• Manufacturer API (API Produsen, API-P)

API-U is granted to companies that import goods for trading purpose while API-P is for companies that import goods for their own internal use, e.g. raw materials, production machinery or other materials to be further processed or used for the production. API-P can import finished cosmetics only when they serve as complementary goods.

Each importer can only have 1 type of API. The API applies to every import activity in Indonesia and is valid as long as the importer is still import goods

3.2 SKI Border and SKI Post Border

Importers of cosmetic ingredients are required to obtain an import certificate (SKI Post Border) either before or within seven days after the goods are released from the customs area. Importers of cosmetic products must obtain an import certificate (SKI Border) prior to the release of goods from the customs area. Furthermore, imported cosmetics must have a remaining shelf life of at least 1/3 when entering Indonesia.

To apply for the SKI Border or SKI Post Border, the applicant shall register with BPOM with the following documents to obtain a username and password:

• Original application letter signed by the director or the proxy of board of directors

• Duly stamped, original statement of the person in charge

• Original NIB

• Original Import Power of Attorney

• HS Code list of commodities to be imported

• Original of Resident Identity Card (KTP) of the person in charge

• Front view and back view photos of the warehouse and office
  

• Warehouse address where the product is stored

With the username and password, the applicant can apply for SKI Border and SKI Post Border online. The documents required to be uploaded are as follows:

Approval of the application of SKI Border and SKI Post Border will be issued in electronic no later than 1 working day after the submission of documents if there is no incompliance.

Source: Regulation for Electronic Business Licensing of Drug and Food

4 Business Registration Number (Nomor Induk Berusaha in Indonesian, NIB)

NIB, in the form of 13 (thirteen) random digits accompanied by an Electronic Signature, is the identity of the business actor issued by the OSS Institution after the business actor has registered. With the NIB, the business actor does not need to obtain some required licenses such as Trading Business License (SIUP), Company Registration Certificate (TDP), Import Identification Number (API), etc.

Business actors can follow the following steps to obtain a NIB:

• Log in to the OSS system

• Fill in the data needed, namely company data, shareholders, capital ownership, investment value and planned use of labor including foreign workers

• Fill in business information that corresponds to the 5 digit Indonesian Business Field Standard Classification (KBLI)

• Give a checklist and a disclaimer regarding the truth and validity of the data submitted

• The OSS system will issue a NIB for business actors

NIB is valid as long as the business actor runs his business and/or activities in accordance with statutory provisions.

5 Notification

Both domestically manufactured and imported cosmetics should be notified with the Agency for Drug and Food Control before circulated on the market (those products only used for research or samples for exhibitions in limited quantities and not for trade are exempted).

5.1 Applicant Registration

Three types of stakeholders are qualified to apply for the notification:

1. Cosmetic industry located in the territory of Indonesia which has a production license;

2. Importers who have Import Identification Numbers (API) and obtain the letter of authorization for agency from manufacturer of country of origin;

3. Individual businesses/ business entities that contract with a domestic cosmetic industry which has obtained a production license.

These qualified applicants must first register with the Head of the Agency. The registration shall be done by filling out an electronic data form and uploading electronic data via BPOM cosmetics notification service official page (http://notifkos.pom.go.id/new). If the data submitted are verified, the applicant will get the User ID and Password to apply for notification.

For an importer or business individual/business entity that undertakes a production contract, it must obtain a recommendation as a notification applicant. The recommendation shall be obtained by submitting an application for facilities inspection to the Head of the local UPT BPOM.

Notification Applicant Registration Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

5.2 Notification Procedure

1. Registered applicant apply for notification by filling out and uploading data on another electronic form of Template on the BPOM cosmetics notification service official page (* Template consists of information needed for this application, which will be detailed below or refer to our coslist).

2. The applicant who has successfully submitted the Template will receive an electronic Pay Order. The applicant should make a payment through an electronic payment system as non-tax state revenue within seven working days. The system issues a product ID number automatically as a receipt for the notification application (If the applicant makes the payment exceeding seven working days, the notification application will be considered null and void automatically deleted from the system).

3. The notification applicant will receive the cosmetic notification dossiers verification result in any of the following conditions within fourteen working days from the issue of the product ID number (for perfume products, three working days).

4. Once the product got notified, it must be produced or imported and circulated within 6 months.

Notification Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

Note: During the application processing, the Head of Agency may require the notification applicant to give an example of cosmetics when needed.

Notification is valid for a period of 3 years, and the cosmetic industry, cosmetic importer or individual business/business entity should be responsible for the cosmetic quality and safety.

Cosmetics with expired notification are prohibited from being produced or imported and/or distributed in Indonesian. But in cases where the notification has expired, cosmetics that have been distributed can be circulated for a maximum of 6 months under the following conditions:

If changes were made to the following aspects, notification of change must be made:

• Name of the industry/importer/business entity that carries out notification without changing the rights to circulate or ownership status

• Address of the industry/importer/business entity that carries out notification without changing the rights to circulate or ownership status

• Packaging size and type

As for other changes, industry/importer/business entity must renew the notification.

5.3 Examples of Notification Template

5.4 Priority Services for Notification

Priority services are provided to notification applicants who meet the following criteria. The notification dossiers verification results shall be issued within three working days under priority service.

Type of products and categories of cosmetics which can be designed in priority services

Criterias shall be met:

5.5 Product Information File (Dokumen Informasi Produk, DIP)

PIF shall be prepared by manufacturers or importers before cosmetics are notified and provided when the POM agency conducts an examination. The PIF must be kept in the form of electronic and/or written documents (hard-copy) and stored properly for a minimum of 1 years after the expiration date of the last cosmetics produced or imported and updates once there are any changes.

PIF can either be in English or Indonesian and has to include the following information:

In general, the data in PIF is sufficient to assess the safety, quality and efficacy of cosmetics in circulation. For certain cases, additional data or other background data is required to support PIF (e.g. product history/product experience, challenge tests for microbes, additional analysis methods for confirmation, and production records).

6 Ingredients Standard

Cosmetic ingredients in Indonesia shall comply with Limitations for Contamination in Cosmetics and the Technical Requirements for Cosmetic Ingredients 2019 which includes appendices:

• Appendix I: permitted ingredients with limitations and terms of use

• Appendix II: permitted colorants with limitations and terms of use

• Appendix III: permitted preservatives with limitations and terms of use

• Appendix IV: permitted sunscreens with limitations and terms of use

• Appendix V: prohibited ingredients

6.1 The Scope of Prohibited Cosmetic Ingredients

• Ingredients listed in Appendix I that do not comply with the allowable limit and conditions of use;

• Ingredients listed in Appendix II, III and IV that do not comply with the specified requirements;

• Ingredients listed in Appendix II, III and IV that are not used as the colorant, preservative and sunscreen agent, and do not comply with the requirements in Appendix II, III and IV;

• Colorants not listed in Appendix II (except for colorants specifically used for hair dyeing);

• Preservatives and sunscreen agents not listed in Appendix III and IV;

• Prohibited ingredients listed in Appendix V.

Note:

• Other cosmetic ingredients not listed in Appendix I can be used as long as it meets the safety, efficacy and quality requirements. Relevant scientific or empirical evidence proving compliance with safety, usefulness and quality requirements is required to provide and include in PIF.

• When natural ingredients not listed in Appendix II, III and IV are used as colorants, preservatives or sunscreens in cosmetics, relevant scientific or empirical evidence is required to provide and include in PIF, and an approval from Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics is required.

6.2 Additional Requirements for Cosmetics Containing Specific Ingredients

• In the case of imported cosmetics containing isopropylparaben, isobutylparaben, or benzylparaben, cosmetics can be notified in Indonesia but must fulfill the following conditions:

• In the case of cosmetics containing alpha arbutin or beta arbutin,

6.3 Limitations for Contamination in Cosmetics

a) Limitation Standards on Microbial Contamination

b) Limitation Standards on Heavy Metal Contamination

c) Limitation Standards on Chemical Contamination

Note: (*) refer to cosmetics containing ingredients made through ethoxylation processes such as Sodium Laureth Sulphate or Polyethylene Glycol.

7 Label

The cosmetic label in Indonesia must list all required information in accordance with the existing reality honestly and accurately, and should be presented in a way that is not easily removed or separated from the packaging and not easily faded or damaged.

The label should contain the following information:            

• Cosmetic name

• Functions

• Instructions

• List of ingredients

• Name and country of producer

• Name and full address of the notification applicant

• Batch number

• Size, content or net weight

• Expiration date

• Notification number

• 2D Barcode
  

• Warning/Attention

The following information must be written in Indonesian language:

• Functions

• Instructions

• Warning/Attention

Other information listed above may be written in Indonesian language or Latin letters and/or Arabic numerals.

Special warning must be labeled for certain products:

8 Claim

Unlike the notification system the authority doesn’t conduct a strict premarket evaluation on product claims. Therefore, cosmetic industry/importers/business entities are required to conduct self-assessment and ensure the objectivity and authenticity of claims on labels and advertisements.

Cosmetic claims must meet the following criteria:

• Legal compliance;

• Truth;

• Honesty;

• Justice;

• Verifiable;

• Clear and easy to understand;

• May not pretend to be a medicine or aim to prevent a disease.

To fulfill the above criteria, cosmetic claims must pay attention to the following matters:

Here are some examples of permitted and prohibited claims:

1) Permitted Claims

2) Prohibited Claims

9 Advertisement

In Indonesia Cosmetics can be advertised after obtaining an approval of notification. Notification number holders are responsible for the compliance of advertisements. The advertisements must be:

• Objective, namely providing information in accordance with the existing reality and must not deviate from the nature of the efficacy, usage, and safety of cosmetics;

• Not misleading, namely providing honest, accurate, and responsible information, and not taking advantage of public concerns;

• Does not pretend to be a medicine or aim to prevent a disease.

Click here to see more requirements for advertisements.

Part 3 HALAL Cosmetic

Indonesia is the fourth biggest country in the world with about 280 million people, of whom more than 86% are Islamic, meaning HALAL products are extremely important. For the same kind of products, Muslim consumers will give priority to products with halal certification labels.

To give consumers a guarantee of whether products are halal, on Oct. 17, 2014, Indonesia issued Law Number 33 Year 2014 concerning Halal Product Assurance (HPA Law), which was effective on Oct. 17, 2019. Article 4 of the HPA Law stipulated that all halal products which are imported, distributed and traded in Indonesia or services related to cosmetics, foods, beverages, medicines, chemical products, biologic products and genetically modified products must be certified halal from Oct. 17, 2019. Halal-certified products must label “Halal” on the outer packaging, or non-halal information for which is not certified as halal, indicating that it is a non-halal product.

1 Competent Authorities

1.1 MUI and LPPOM MUI

MUI (Majelis Ulama Indonesia) is the authoritative and credible Islamic organization in Indonesia. Before the establishment of BPJPH, MUI served as the only halal certifier and has been controlling the entire halal certification process for over 2 decades.

Under the MUI, there set an LPPOM MUI (Institute for Food and Drug Assessment of Indonesian Council of Ulama), responsible for halal certification examination for cosmetics, food and medicines before the establishment of BPJPH.

Under the HPA Law, MUI will be responsible for issuing the Halal Fatwa after holding the Halal Fatwa Assembly, which guarantees that the products are in accordance with the Islamic Syariat and also the basis for obtaining BPJPH endorsed halal certification.

1.2 BPJPH

BPJPH (Badan Penanggulangan Jaminan Produk Halal) was newly founded in 2017 to gradually take charge of halal certification. It took over the mandate previously held by MUI’s Food, Drug and Cosmetics Assessment Body (LPPOM MUI) on Oct 17, 2019. MUI need to cooperate with BPJPH, but the responsibility division between them was unclear in the past several years.

The Omnibus Law implemented on Nov. 2, 2020, partially resolves this ambiguity. MUI is authorized for the product halal status determination through a Halal Fatwa. BPJPH will coordinate with MUI about the product halal status determination.

2 Halal Certification Procedures

2.1 Halal Certification Procedures

1. Halal Certification Application

Business operators must apply for halal certification to BPJPH through an electronic system. BPJPH will confirm the completeness of the application documents within 1 working day of submission.

2. Appointment of LPH

BPJPH will appoint an LPH to examine and/or test the halal status of the product. This appointment must occur within 1 working day of confirming the completeness of the documents.

3. Inspection and Testing by LPH

The LPH will conduct:

1) Document inspection

2) Product halalness inspection and/or testing, carried out by a halal auditor appointed by the LPH.

Document inspection should be completed within 2 working days of the LPH's appointment. If additional documents are required, the applicant must submit them to the LPH within 2 working days of receiving the request.

Once the document inspection is complete, the LPH will send the cost details for the product halalness inspection and/or testing to BPJPH. BPJPH will issue a payment invoice for halal certification services through the system, and the applicant must make the payment within 5 working days of the invoice date. No fees will be charged for a halal certificate application submitted by a micro or small business.

The product halalness inspection will take place at the business location during the production process. If any ingredient's halal status is in doubt during inspection, laboratory testing will be conducted.

Inspection and testing for halalness of both domestically produced and imported products must be completed within 15 working days. The LPH may request an extension of 10 working days for Indonesian products and 15 working days for imported products.

4. Submission of Results

The LPH will submit the results of the product halalness inspection and/or testing to MUI, with a copy sent to BPJPH.

5. Determination of Product Halalness

MUI will determine the product's halal status during the Halal Fatwa Assembly, which will reach a decision within 3 working days of receiving the results.

The Decree of the Determination of Halal Product (Halal Fatwa) will be submitted by MUI to BPJPH as the basis for issuing the Halal Certificate.

6. Issuance of Halal Certificate

If the Halal Fatwa Assembly determines the product is halal, BPJPH will issue the Halal Certificate within 1 working day. If the product is deemed non-halal, BPJPH will return the application to the business operator with the reasons for rejection within 1 working day.

7. Halal Certificate Renewal

The halal certificate is valid from the date of issuance by BPJPH and remains valid as long as there are no changes to the composition of materials and/or PPH. Business operators who modify the composition of materials and/or PPH are required to renew the certificate.

Renewal applications must be submitted through the system and should include the following documents:

a. Documentation of changes in the composition of materials;

b. Documentation proving the halal status of the changed materials;

c. Documentation of changes in PPH; and/or

d. Documentation of product development.

2.2 For Foreign Companies

Foreign companies can choose one of the following methods.
1. Apply for a Halal Certificate from BPJPH

Applications for halal certification of imported products must be submitted by importers or representatives based in Indonesia. Such applications are necessary when:

a. There is no foreign halal institution in the product's country of origin;

b. Foreign halal institutions that have mutual recognition agreements do not cover the specific product certification;

c. There is no mutual recognition of halal certificates between foreign halal institutions and BPJPH;

d. Business operators choose to apply voluntarily.

2. Halal Certificate Registration

Imported halal products do not need to apply for new halal certificates if they already hold a halal certificate issued by foreign halal institutions that have a mutual recognition agreement with BPJPH. However, the halal certificate must be registered with BPJPH before the product can be distributed in Indonesia.

The validity period of the foreign halal certificate registration aligns with the validity of the halal certificate issued by the foreign halal institution.

Importers and/or representatives based in Indonesia must renew the foreign halal certificate registration by submitting a renewal application 60 working days before the registration's validity period expires.

Requirements for Foreign Halal Certificate Registration (RSHLN)

New applications or extensions of RSHLN must be submitted by importers and/or official representatives in Indonesia to BPJPH in writing, using the integrated electronic system Sihalal. If the required documents are in a language other than English, they must be accompanied by translations done by a sworn translator. The required documents or information include:

• RSHLN application letter

• Letter of appointment from the company in the country of origin, authorizing the applicant to register foreign halal certificates

• Business License Number (NIB) from the importer and/or official representative in Indonesia

• Copy of the foreign halal certificate for products to be imported into Indonesia, legalized by the Indonesian representative abroad, with a signature from an authorized official (if the LHLN is in a member country of the Apostille Convention, only an Apostille certificate document is required)

• List of goods to be imported into Indonesia, complete with the harmonization system code number

• Statement that all submitted documents are correct and valid

Process flow of RSHLN via Sihalal 

1. Registration: 

• The importer/authorized representative (PR) creates an account on Sihalal.

• Log in and click on the SHLN Registration menu.

• Fill in the applicant data and upload the required documents.

2. Verification: 

• BPJPH verifies the completeness and validity of the application documents.

• If the verification results are insufficient, the importer/PR must submit additional and original documents within 5 working days, or the application will be canceled.

3. Payment: 

• If the verification results are satisfactory, BPJPH issues an invoice for the importer/PR to make the payment within 7 working days, or the application will be canceled.

• BPJPH verifies the payment and issues a Payment Receipt Letter.

4. Issuance:

• BPJPH issues a draft of the RSHLN Number.

• Electronic signature approval is obtained.

• The RSHLN Number is issued.

3 Business Operators Obligations

1) Business operators that submit application of halal certificate must:

• provide information that is correct, clear, and truthful;

• separate the location, equipment and processes for slaughtering, processing, storing, packaging, distributing, selling, and presenting between halal and non-halal product;

• have halal supervisor;

• report change of material composition to BPJPH.

2) Business operators that obtain halal certificate must:

• attach the halal label on the product that receive halal certificate;

• maintain the “halalness” of the product that has obtain halal certificate;

• separate the location, equipment and processes for slaughtering, processing, storing, packaging, distributing, selling, and presenting between halal and non-halal product;

• renew the halal certificate if there are changes in the composition of materials or PPH (Halal Product Process);

• report change of material composition or PPH to BPJPH.

The halal status of products is verified through a Certificate of Consistency for Halal Products, which is obtained by examining the implementation of SJPH. Relevant departments generally conduct this examination every four years.

3) Business operators that produce product from material that originate from haram material is excluded from submitting Halal certificate application.

4 Halal Logo

Halal-certified products must label “Halal” on the outer packaging. Business operators that have obtained Halal Certificate must include the Halal Logo on:

• Product packaging;

• Specific part of the product;

• Specific place of the product.

Inclusion of Halal logo must be easy to see and read as well as not easily erase, detach, and damage.

The new format of halal logo is determined by the BPJPH in Regulation 40/2022. The new halal logo has been applied nationally and must be shown on the product packaging as a sign of product halalness from March 1, 2022. The halal label previously issued by MUI can continue to be used on product packaging until October 17, 2026.

The former halal logo (left) and the new halal logo (right)

The following products are exempted from halal label:

a. Products with packaging that is too small to accommodate all required information;

b. Products sold and packaged directly in front of the buyer in small quantities;

c. Bulk products;

d. Products sold in limited quantities.

5 Implementation Timeline

Halal Certification became mandatory for enterprises entering Indonesian market on Oct.17, 2019. The head of BPJPH said that the authorities will not require all the products to be halal-certified immediately, but to implement the HPA Law step by step, likely meaning there will be some form of grace period offered. Businesses are able to obtain the halal certification progressively or gradually with the period specified below:

• Food and beverages: October 17, 2019 – October 17, 2024

• Food and beverages packaging: depending on the type of food and beverages

• Traditional medicines and health supplements: October 17, 2021 – October 17, 2026

• Clothing, headwear and accessories: October 17, 2021 – October 17, 2026

• Chemical products, cosmetic products, and genetically engineered products: October 17, 2021 – October 17, 2026

• Risk A class medical devices: October 17, 2021 – October 17, 2026

• Household appliances, household healthcare supplies, stationery and office equipment, Muslim prayer equipment: October 17, 2021 – October 17, 2026

• Risk B class medical devices: October 17, 2021 – October 17, 2029

• Over-the-counter (OTC) drugs and limited OTC drugs: October 17, 2021 – October 17, 2029

• Risk C class medical devices: October 17, 2021 – October 17, 2034

• Prescription drugs (except psychotropics): October 17, 2021 – October 17, 2034

• Services relating to OTC drugs, limited OTC drugs, prescription drugs (except psychotropics), chemical products, cosmetics and genetically engineered products: depending on the type of product

• Biological products, drug products, medical devices with its materials or production processes not determined as halal yet: according to related laws and regulations

For more information about halal certification, please refer to Featured Page - Halal Certification Regulation.