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 Institute for Food and Drug Assessment of Indonesian Council of Ulama (LPPOM MUI) 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 following kinds of cosmetics without conditions, and prohibit manufacturing 1) children cosmetics; 2) cosmetics contain antiseptic, anti-dandruff, skin lightening and sunscreen ingredients.

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 or they are for maket test with an aim of business development or investment.

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 Post Border

Imported cosmetics and Cosmetic Ingredients require a SKI Post Border prior to entering into the Indonesian territory and after completing a notification (notification contents specified below). In addition, imported cosmetics must be able to be used at least 1/3 of the shelf life when entering into Indonesia.

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

• Application letter

• Original stamped statement of responsibility

• Original API

• Original Trading Business License (SIUP)

• Original Taxpayer Identification Number (NPWP)

• Original Import Power of Attorney

• HS Code list of commodities to be imported

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

Approval of the application of 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 online (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.

Source: Regulation for Electronic Business Licensing of Drug and Food

5.2 Notification Procedure

1. Registered applicant apply for notification by filing out another electronic form of Template on the website of Agency for Drug and Food Control (* Template consists of information needed for this application, which will be detailed below).

2. The applicant who has successfully submitted the Template will receive an electronic Pay Order via the applicant's email. The applicant should make a payment through the designated Bank within 10 days and submit the payment proof. If the payment proof is correct, the applicant will receive a Mark Product Identifier (Product ID) as a receipt for the application of notification (If the applicant make the payment exceeding 10 days, the application will be rejected).

3. If there is no rejection letter issued against the product within 14 days after the applicant obtaining the receipt, the notification is considered as approved

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

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.

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

• Name of the leader of industry/importer/business entity that carries out notification

• Packaging size and type

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

5.3 Examples of Notification Template

5.4 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 6 years as of the latest production or importation of cosmetics 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: 205 permitted ingredients with limitations and terms of use

• Appendix II: 158 permitted colorants with limitations and terms of use

• Appendix III: 56 permitted preservatives with limitations and terms of use

• Appendix IV: 30 permitted sunscreens with limitations and terms of use

• Appendix V: 1375 prohibited ingredients

6.1 The Scope of Prohibited Cosmetic Ingredients

• Ingredients do not comply with limitation requirements listed in Appendix I, II, III and IV

• Colorants, preservatives and sunscreens not listed in Appendix II, 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, usefulness 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.

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

• Warning/attention and other details if required

2D barcode is newly included as a mandatory labeling requirement in the draft Technical Requirments for Cosmetics Labeling released in 2019.

The following information must be written in Indonesian language:

• Functions

• Instructions

• Warning/attention and other details if required

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 of claims. Generally, cosmetic claims can't be incorrect and misleading. The claim should state the nature and mechanism of ingredients. Claims should be limited to impact on normal human physiology and cannot indicate terminology associated with disease treatment. 

Here are some examples of claims that are not allowed based on cosmetic types:

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 reality that exists;

• Not misleading, i.e. providing information accurate and not taking advantage of people's concerns about some health problems;

• Complete, which includes a sentence "Read Instructions and Warnings " if required

Click here to see the detailed requirements for advertisements.

Part 3 HALAL Cosmetic

Indonesia is the fourth biggest country in the world with about 260 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 supreme and most authoritative Islamic organization in Indonesia, with LPPOM MUI (Institute for Food and Drug Assessment of Indonesian Council of Ulama) for halal certification audit for cosmetics, food and medicines.

MUI will issue the Halal Written Fatwa after auditing, which guarantees that the products are in accordance with the Islamic Syariat and also a requirement for obtaining government endorsed halal certification and for usage of relevant labeling on the packaging of products.

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.

But since the establishment of the BPJPH in 2017, it has not been able to establish offices, no auditors, no certification standards and no other cooperating review units. BPJPH is considered not suitable to hold halal certification due to inadequate system and infrastructure.

The Ministry of Religion finally issued Decree of the Ministry of Religion (KMA) No. 982 of 2019 concerning Halal Certification Services. This decree returned the product examination and testing responsibility to LPPOM MUI.

BPJPH now cooperates with MUI and only takes the responsibility of accepting application of halal certification and issuing the halal certificate.

Institutional Structure

2 Halal Certification Procedures

2.1 Former Procedures

Previously if enterprises wanted to obtain a halal certificate, they can apply to LPPOM MUI voluntarily after all the dossiers are ready. After LPPOM MUI conducts a formal audit, it will submit the results to MUI. If MUI approves the application, a halal certificate will be issued. The entire process takes an average of 75 days. But the timeline does not include the document preparation before the submission and it will be longer under certain conditions, we expect it to take an average of 6 months.

2.2 Current Procedures

After the halal product examination and testing responsibility back to LPPOM MUI, BPJPH needs to cooperate with MUI. The business operator first applies to BPJPH. Then MUI assigns LPPOM MUI to conduct the examination and testing. The examination and testing report will be sent back to MUI and MUI will determine whether the product can obtain halal certification. If MUI approved, BPJPH will issue a halal certificate to the applicant.

2.3 What Business Operators need to do

If you want to obtain a halal certificate for your product, you should fulfill the following approval requirements:

1. Understanding halal certification requirements and following Halal Assurance System (HAS) Training

Companies must understand the halal certification requirements listed in HAS 23000. The Summary of HAS 23000 can be found in MUI LPPOM site. The documents of HAS 23000 can be ordered in MUI LPPOM site (e-store). In addition, the company must also attend HAS training which is conducted by LPPOM MUI, either in the form of regular training or online training (e-training). Information on HAS training can be found in MUI LPPOM site.

2. Implementing Halal Assurance System

Companies must implement HAS before applying and registering for halal certification process. The Halal assurance system is based on halal policies, establishing Halal Management Team, preparing HAS Manual, conducting training, preparing related HAS procedures, implementing internal audit, and reviewing management properly.

3. Preparing Halal Certification Document

The Company must prepare all necessary documents for the halal certification process. The documents required include: a list of products, a list of materials and documents of the material, a list of butchers (particularly for Slaughterhouse), matrix of products, HAS Manual, flow chart of the process, a list of production facilities addresses, evidence on halal policy dissemination, evidence on internal training and evidence on internal audit.

4. Registering the halal certificate (upload data)

Applying and Registering for halal certification is performed online using the Cerol system, through the website: www.e-lppommui.org.

5. Monitoring pre-audit and payment of contract for halal certification process

After uploading certification data, the company must conduct a pre audit monitoring and finalize payment of the contract. This pre audit monitoring is recommended to be conducted every day to uncover any discrepancies in the results of pre audit. Payment of contract for certification process is performed by downloading the certification contract in Cerol, paying the cost of the contract and signing the contract, and then making payments in Cerol, and approved by the Treasurer of LPPOM MUI.

6. Performing audit

Audits can be performed if the company has already passed the pre-audit process and the contract has also been approved. Audits are conducted at all facilities related with products to be certified.

7. Performing post-audit monitoring

After uploading the data certification, the company must conduct post-audit monitoring. This post-audit monitoring is recommended to be performed every day to find out any discrepancies in the results of the audit, and if there is any discrepancy, then it must be corrected properly.

8. Receiving halal certificate

The companies can download a halal certificate in softcopy form/file in Cerol. The original halal certificate can be taken at the office of LPPOM MUI Jakarta, and it can also be sent to the address of the company. Halal certificate is valid for two (2) years.

2.4 For Foreign Companies

Products certified halal by foreign institutions that cooperate with the BPJPH do not need BPJPH halal certification but must still be registered with the BPJPH before they can be distributed in Indonesia. The full list of international partners is forthcoming; however, the following terms have been defined:

• If the agency is recognized by the BPJPH, foreign businesses can then register with the BPJPH with a list and detailed description of their products along with the Halal certification from the local foreign halal agency (FHA) partner;

• The BPJPH will then issue a registration number that must be placed on all packaging; and

• The product is then ready to be exported to Indonesia.

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, place, and equipment for 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, place and equipment for processing, storing, packaging, distributing, selling, and presenting between halal and non-halal product;

• renew the halal certificate if the validity period of the halal certificate has expired;

• report change of material composition to BPJPH.

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

4 Halal Label

Halal-certified products must label “Halal” on the outer packaging, or non-halal information for which is not certified as halal. Business operators that have obtained Halal Certificate must include the Halal Label on:

• Product packaging;

• Specific part of the Product;

• Specific place of the Product.

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

The new format of halal labeling is determined by the BPJPH in Regulation 26/2019 and the previous format of halal labeling can still be used until Oct 15, 2024.

5 Latest Updates

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

Products that had not had their halal certificates before October 17, 2019 can still be imported and traded in Indonesia according to the periods as stated above.

In addition, except for food and beverages, it' s not allowed for businesses to submit their halal certification application before the commencement of the stated periods above.

Indonesia estimates that it will issue at least 100,000 halal certificates in 2020 and increase the personnel of halal certification audit to 5000. Halal certificate issued by BPJPH after Oct. 17, 2019 will be valid for 4 years. The renewal of the halal certificate must be applied no later than 3 months before the validity of the halal certificate expires. Halal certificates issued by MUI before HPA Law takes effect are still effective until they expire, but upon expiry renewal submissions would need to be submitted to BPJPH.

For more information about halal certification, please refer to CL News, expert articles and related webinars.