|Regulation Concerning Cosmetic Notification|
|Main Supporting Rules|
|Sep 13 2017||Guidelines for Product Information File|
|Jan 1 2011||Criteria and Procedure for Submission of Cosmetics Notification|
|Dec 29 2015||Technical Requirement of Cosmetic|
|Aug 22 2019||Technical Requirement of Cosmetic Ingredients|
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.
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.
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 mouth mucous membranes, primarily to cleanse, 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)
2.1 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.
|No.||Cosmetic Form||Cosmetic Types|
|1||Liquid||Eau de Cologne|
|Facial skin cleanser|
|Facial skin freshener|
|2||Viscous liquid||Bath soap|
|Hair and body wash|
|Facial skin cleanser|
|Oil for massage (Massage oil) including spices|
|Skin care for body and hands|
|Other bath preparations (spices)|
|Powder (Liquid powder)|
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:
- Have a pharmacist as the responsible party;
- Have production facilities for products to be manufactured;
- Have laboratory facilities;
- Have GMP qualification
To obtain Class B production license, a cosmetic manufacturer should fulfil the following requirements:
- Have at least one pharmaceutical technical personnel in charge;
- Have production facilities with simple technology for products to be manufactured;
- 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 dossiers required are as follows:
1) Administrative documents
- Application letter
- Cosmetic product license
- Proof of payment of non-tax revenue
2) Technical documents in the form of appropriate quality system documents in accordance with GMP
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