NADFC (BPOM) Regulations of Cosmetics in Indonesia

Cosmetics as per the regulations of NADFC/ BPOM, are preparations or substances that is used in the outer part of human body or the teeth and mucous membrane of the mouth for the purpose of cleaning, fragrance, eliminate body odour, change the appearance or to maintain or protect good condition of the body.

In Indonesia, the National Agency of Drug and Food Control (NADFC) which is also called as BPOM supervise the cosmetic regulation in Indonesia. It is their responsibility to bring safe and quality cosmetic products into the Indonesian market.

In this article get to know more about cosmetic regulations, cosmetic product classification, product registration and more.

Regulations For Cosmetics Under NADFC / BPOM

Some key regulations that apply for the cosmetics regulated by NADFC/BPOM are as follows:

Regulation Number	Year	Regulation on
23	2019	Technical requirements for cosmetic ingredients
17	2022	Amendment to the above regulation
19	2015	Technical requirements for cosmetics
18	2024	Labelling, promotion and advertising of cosmetics
21	2015	Procedure of clinical trial approvals
72	1998	Safeguarding of Pharmaceutical Preparations (include cosmetics) and medical devices
33	2014	Halal Product Guarantee
27	2016	Procedure and methods for providing recommendations to get approval for cosmetics import as complementary goods
27	2018	Public service standards
33	2021	Good Manufacturing Practice for cosmetics
15	2020	Surveillance of food and drugs imported into the Indonesian territory
33	2018	2D barcodes for food and drug control

Food and Drug control includes cosmetics as well.

NADFC/BPOM Classification of Cosmetics in Indonesia

The cosmetic products in Indonesia are classified into 16 categories. They are:

Baby and child-specific products
Bath and shower
Colour cosmetics
Deodorants
Depilatories
Fragrances
Hair care
Men’s grooming
Oral care
Oral care excluding power toothbrushes
Skin care
Sun care
Sets/kits
Premium beauty and personal care
Mass beauty and personal care
Other beauty and personal care items

NADFC / BPOM Classification of Cosmetics in Indonesia based on Risk Level:

NADFC/ BPOM also classifies cosmetic products based on their risk level, which influences the extent of regulatory scrutiny:

Low-Risk Cosmetics: Products intended for everyday use with minimal risk to the user. These products undergo a relatively simpler registration process with BPOM.

Examples: Lotions, Shampoos, Lip balms

High-Risk Cosmetics: Products that involve higher potential safety risks or require stricter regulation due to their active ingredients or specific functions. These products may require additional documentation and testing, including safety assessments and more comprehensive registration with BPOM.

Examples: Hair dyes, Whitening/brightening products, Sunscreens (with UV filters)

NADFC / BPOM Classification of Cosmetics in Indonesia based on Function

BPOM further classifies products based on their specific function, such as:

Cleansing Products: Soaps, body washes, and cleansers.
Protective Products: Sunscreens, anti-pollution products.
Conditioning Products: Moisturizers, creams, and serums.
Color Cosmetics: Lipsticks, foundations, and eye makeup.
Fragrance Products: Perfumes and deodorants.

NADFC / BPOM Clinical Trial Requirements of Cosmetics

Depending on the safety profile of the cosmetic product pre- clinical and clinical trials are required. The process to request for approval for pre-clinical and clinical tests is:

An application for to conduct preclinical or clinical trial must be submitted along with complete required documents
The documents are checked and then issues an SPB (order to pay). After making the payment, 3 copies of the proof (payment) should be submitted to BPOM.
Upon receiving the payment proof the evaluation begins. The time for evaluation is 20 days. After the process of evaluation, the BPOM can approve or reject the application.
If approved, an approvable letter is issued, and the applicant receives PPUPK (approvable letter to conduct preclinical test)/ PPUK (approvable letter to conduct clinical tests).
If needed, BPOM can request additional data or any corrections to be made to the applicant. Then the applicant must work on adding data or correct any shortcomings.
If rejected, the applicant receives a notification.

Documents Required for Preclinical and Clinical Test Approval

To get an approval to conduct preclinical and clinical tests for cosmetics in Indonesia, the following documents must be submitted.

Administrative Documents

A letter of request for approval to conduct preclinical/clinical tests
Order to pay
Payment proof

Technical Documents

Protocol
Ethics Committee approval
Product composition
Research team composition
Test product quality documents

NADFC / BPOM Labeling Requirements for Cosmetics in Indonesia

In Indonesia, the labelling requirements are set forth in BPOM regulation number 18, 2024. It is mandatory to follow and be in compliance with these requirements while labelling the cosmetics to be marketed in Indonesia. Under this regulation it is stated that any misleading information, information that is provided in relation to the existing reality must not deviate from safety and benefit of the product, must not exploit public concerns like a health problem or should not state as a medicine or intent to prevent any disease. The label should have at least the following information:

Cosmetic Name
Benefits or uses
Method of Use
Composition
Country of Manufacture
Notification Number
Name and full address notification number owner
Batch number
Size, content or net weight
Expiration date
2D barcode (must include Marketing Authorization Number and Marketing Authorization’s Validity Period)
Any warnings or caution.

The benefits or use, method of use and warnings/ caution must be written in Bahasa Indonesia.

NADFC / BPOM Good Manufacturing Practices (GMP) for Cosmetics in Indonesia

Good Manufacturing Practices (GMP) compliance is mandatory for both local and foreign manufacturers. NADFC / BPOM or relevant authorities inspect facilities to ensure proper hygiene, quality control, and production processes. BPOM regulation number 33, 2021 states about the certification of good Manufacturing practices for Cosmetics. To view this regulation please follow this link: GMP Certification for Cosmetics

Product Notification of Cosmetics in Indonesia with NADFC / BPOM

The Cosmetic product registration in Indonesia is a notification process rather than a pre-market approval, meaning products can be marketed once BPOM acknowledges the notification.

E-Registration System: All cosmetic products must be registered with BPOM through an online e-registration system.

Required Documentation for Cosmetic Product Notification in Indonesia:

Detailed product information (ingredients, intended use, product formulation).
Manufacturer’s details (address, GMP certification).
Labeling information (including claims, expiration date, batch number).
Safety data, including any adverse effects reported for the product.

NADFC / BPOM Review: NADFC/BPOM reviews the documentation to ensure the product complies with the ASEAN Cosmetic Directive (ACD) and local standards.

Process of Notification Procedure

The applicant must complete the notification template via https://notifkos.pom.go.id
After submitting the template, via the account of applicant, a notice of payment is received.
After making the payment, it is verified. If correct, a product ID number will be issued.
The BPOM starts verification of template and ingredient/formula. After completing the verification and if it is accepted, a notification number is issued on the website.
14 working days is the time for notification and for perfume product it is 3 working days.
If rejected or need further confirmation, the application is returned.

NADFC / BPOM Requirements for Importation of Cosmetics into Indonesia

Foreign cosmetic companies must appoint a local distributor or representative in Indonesia to handle BPOM registration. The local distributor or importer must have a valid import license, and the product must follow all local regulatory pathways, including safety and labeling requirements.

Cosmetics that are to be imported into Indonesia for distribution must have a marketing Authorization which is in the form of notification. An approval from the Chairperson of the Authority must be obtained. It is obtained in the form of a SKI border (Border Import Certificate). The SKI border is valid for only one time importation. The certificate (import) format for SKI Border is given in Annex I of this document. A thing to be noted is that while applying for SKI Border the cosmetic product must have at least 1/3rd of its shelf life remaining.

The SKI Border application is submitted via online. The documents to be submitted are:

Marketing Authorization Approval
Certificate of Analysis (issued by manufacturer) or Certificate of Indonesian National Standard marking on Product.
Invoice
The product name, packaging size and packaging listed in the invoice must match with that mentioned in the Marketing Authorization.
In case there is a mismatch, a reference letter from the manufacturer must support the application.

Validity and Re-Notification of Cosmetic Product Notification in Indonesia

The validity of the cosmetic notification number is 3 years. Through the Renewal Notification procedure, the applicant must renew the notification number upon the expiration of the notification period.

NADFC / BPOM Fees for Notification of Cosmetics in Indonesia

Cosmetic Products	Notification Fee
Manufactured Outside ASEAN Countries	Rp 1.500.000,00
Manufactured within ASEAN Countries	Rp 500.000,00

For detailed Fee Structure Visit: BPOM Indonesia Cosmetic Fee Structure

Halal Certification of Cosmetics in Indonesia

The Halal product Assurance organizing Agency (BPJPH) which is under the Ministry of Religious Affairs of Republic of Indonesia in collaboration with BPOM governs the cosmetic product assurance for halal in Indonesia. Indonesia has the world's largest population of Muslims which is around 241.5 million according to the statistics in 2022.

Due to the advancement of science and technology, there will always be new methods for processing or new ingredients that can be added or found to increase the quality of the product. The BPJPH ensures that these new technology and science found products and processing goes along with the Islamic laws.

The BPOM regulation number 33, 2014 is about Halal Product Guarantee. To view this regulation, follow this link: Halal Product Guarantee

NADFC / BPOM Post-Market Surveillance Requirements for Cosmetics in Indonesia

Just like pharmaceuticals, cosmetics also undergo post market surveillance. This includes random sampling and testing of products and monitoring advertising and labelling claims. This is to make sure that the cosmetics which are in the Indonesian market are still in compliance with all the required regulatory requirements. The cosmetic companies must conduct ongoing product surveillance and look for any signals generating.

If BPOM finds that the cosmetic product in market is not up to the standards or has deviated from the regulations, prior ensured effectiveness or stated claims, BPOM has the authority to issue penalties or take appropriate action like recalling or in worst cases banning of the cosmetic product.

Conclusion

Indonesia BPOM regulations for cosmetics calls for safe and quality product manufacture, import and distribution into the Indonesian territory. Illegal cosmetics, substandard cosmetics, etc have made the regulations to be more stringent and compliancing with these regulations is not just for the marketing purpose but to ensure consumer safety and trust both in the product as well as BPOM.

A major challenge is the poor translation of major documents in the English language. However, this can be solved by appointing a local agent. Complete comprehension and compliance with the BPOM Indonesia regulations is always rewarding as it allows for cosmetic product market entry in the most suitable way possible rather than running around for things to get done.

Artixio is here to assist you in cosmetic product entry into the Indonesian market. Our 15–35-year experienced regional experts are always in line with the BPOM regulations and provide guidance, customised solutions and strategies specific to your cosmetic product. Connect with us through info@artixio.com

FAQs

Q. What is a Special Access Scheme Permit in Indonesia?

The Special Access Scheme (SAS) Permit is the permit that is issued for the import of cosmetics, drugs, traditional medicines and food supplements into Indonesia via a special channel mechanism for specific purposes. The purpose includes research purposes including clinical trials, sample registration, product development, assistance/donation/grant, exhibition and in other specific needs for certain conditions.

Q. What are the classes of the cosmetic industry in Indonesia?

There are A class cosmetic industry and B class cosmetic industry. The A class cosmetic industry has the rights to/is granted to manufacture cosmetics of all forms and types of dosage forms. The B class cosmetic industry is granted rights to only manufacture certain forms and types of cosmetic dosage forms utilizing modest technology.

Q. What is a SKI Border?

SKI Border is the approval letter for the import of goods into Indonesia which is fulfilled before the release of goods from the customs area in the framework of controlling the circulation of food and drugs.

Q. What are the 3 steps involved in the company account registration procedure in Indonesia?

1. Completion and submission of the online applicant template via https://notifkos.pom.go.id

2. The applicant data is verified.

3. If everything is produced and correct the company account will be active.

References:

https://jdih.pom.go.id/