Licensing on the Cosmetic Product in Indonesia

Licensing on the Cosmetic Product – “Whether it is produced locally or imported overseas, a new cosmetic would need to be approved by BPOM first before it can be launched in the market.”

In Indonesia, for some products to be distributed, it might require additional permits from specific Institutions. Most health-related products such as food and drugs might require permits from the National Agency of Drug and Food Control (BPOM). Cosmetic is one of the products which require additional permits from BPOM.

Whether it’s produced locally or imported overseas, a new cosmetic would need to be approved by BPOM first before it can be launched in the market.

Cosmetic Product in Indonesia

According to the Ministry of Health of the Republic of Indonesia and BPOM in their respective regulations, cosmetics are materials or preparations which are meant to be applied on outside part of the human body (epidermis, hairs, nails, lips, and external part of genitalia), or teeth and mouth’s mucosa membrane, especially for cleaning, perfume, changing appearance, and/or fixing body odour or protecting the body to be in reasonable condition.

It doesn’t matter what the shape of the product is, whether it’s solid, cream, aerosol, gel, or in other forms; if it fits the above purpose, it is supposedly considered as cosmetics. Of course, despite how the actual product works, regarding whether it is acknowledged as cosmetic or other items (drugs, food, etc.), it depends on the evaluation of the Ministry of Health and BPOM.

Cosmetics License

There are two important aspects of a cosmetic permit in Indonesia. Both the product and the manufacturer must be licensed. According to BPOM Regulation No. 12 of 2020 on Cosmetic Notification Procedure (PerBPOM 12/2020), the business actor is required to ensure the cosmetic product distributed in Indonesia, whether produced locally or imported, depend on the BPOM’s criteria of safety, benefit, quality, tagging, and claim.

It  can be done by acquiring distribution permit of the product in the form of notification from BPOM. Further, it is explained that this can be done by the manufacturer of the product itself or business actor who imported the product from an overseas manufacturer.

Manufacturers of cosmetic products, they require to submit the following documents to acquire notification from BPOM:

1. Business Identification Number;
2. ID Card of the Company’s Director/Representative;
3. Tax Identification Number;
4. Certificate of Good Cosmetic Manufacturing Practice/ Cara Pembuatan Kosmetika yang Baik (CPKB);
5. Statement letter from the Company that they are not affiliated with any criminal activities in the cosmetic sector; and
6. Any relevant trademark certificate.

The manufacturer, in this case, can be either the owner of the product itself or the manufacturer who manufactures the product based on a production contract. For the latter, they would also need to submit the production contract, which has been notarized and a recommendation letter from the regional BPOM.

For importer of cosmetic product, they would need to submit the following documents to acquire notification from BPOM:

1. Business Identification Number;
2. Statement letter from the Company that they are not affiliated with any criminal activities in the cosmetic sector;
3. ID Card of the Company’s Director/Representative;
4. Recommendation letter from the regional BPOM;
5. Business License;
6. Tax Identification Number;
7. Agency appointment agreement which still has at least 6 (six) months left of the validity period, either in English or Indonesia;
8. Cooperation Agreement between the overseas manufacturer and the importer;
9. Certificate of Free Sale (CFS) for the cosmetic product from outside of ASEAN region, legalized by Indonesian Embassy/Consulate General;
10. Certificate of Good Manufacturing Practice;
11. Any relevant trademark certificate;

Each cosmetic product can only have one notification from one applicant; therefore there is no need for each distributor to apply for the same cosmetic notification. Cosmetic notification is valid for 3 (three) years and is renewable.

If the notification has expired, the relevant product is not allowed to be distributed and imported, except if the notification itself is currently in the process of extension.

Cosmetic Production License

For cosmetic products produced in Indonesia, on top of the product is required to have a distribution permit, the manufacturer itself is required to have a production permit. Cosmetic production permit is separated into two types, which are Type A and Type B.

Type A permit is allowed to produce any cosmetic in any form. On the other hand, Type B permit is only allowed to produce cosmetics with simple technology. Meanwhile, Type A permit requires:

1. Have at least 1 (one) apothecary as the person in charge;
2. Have production facilities which are suited for the product;
3. Have a laboratory;
4. Have CPKB.

On the other hand, Type B permit has slightly simpler requirements, which are:

1. Have at least a pharmacy technical expert as the person in charge;
2. Have production facilities which are suited for the product;
3. Have CPKB.

Both Type A and Type B cosmetic production permits are processed at BPOM that valid for 5 (five) years and renewable as long as the company is still operational.

Author: Benedictus Giovanni

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