Indonesia Cosmetic Regulation Guidelines

Indonesia Cosmetics Regulation

Indonesia Cosmetic Regulation

Importing cosmetics to Indonesia are controlled by the BPOM (Food and drug controlled board) under the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation ASEAN Cosmetic Directive. It is regulated that cosmetic products, including personal care and toiletries, imported to and sold in Indonesia must be registered at BPOM first. And worth to mention that, as a Muslim country, to obtain a Halal certificate also is an important step to success in the market.

As regulated by BPOM, you must have an ONLY legal entity established under the Indonesian Law to register cosmetic products in Indonesia. The legal entity could be your local distributor or subsidiary with a registered import license for Indonesian customs.

Please be aware that the legal entity will be your only representor of your notified products in the Indonesian market during the effect time. This means, after notification, an automatic exclusivity on the products even there is no exclusive agreement signed. The product licenses will be granted to the company and no one can make another registration of the products on other distributors unless with the company’s approval. Therefore, choosing a correct local partner will be your crucial step if you don’t prefer to register a subsidiary in Indonesia.

In order to register your products and open an online application account, the local agency shall submit the following documents to BPOM, and some of them like GMP, COA, LOA will require your support.

  • Documents of incorporation
  • Import License (API-U)
  • Copy of the cosmetic manufacturer’s Good Manufacturing Process certificate
  • Certificate of Free Sales
  • Letter of Authorization
  • Hygiene License Certificate must be issued by the National Agency for Drug and Food Control (BPOM) and legalized by a public notary in Indonesia.
  • Qualitative and Quantitative Formula of the Product

After the successful registration of your products, you will receive a notification from the BPOM. BPOM will issue the notification number within 14 working days and it will be valid for three years. But please note that you must import the notified products within 6 months in order to keep your product registration valid. Also, you have to comply with further requirements such as preparing your product information database and labeling your products correctly before selling them in Indonesia.

 

Document of Product Information (DIP)

For each notified product, a Document of Product Information (DIP) should be prepared in order for BPOM auditing.

DIP is the data about the quality, safety, and benefits of cosmetic products. It should be kept for a minimum of 4 (four) years after the cosmetics are manufactured or imported.

It consists of the following information in English or Indonesian:

  1. Administrative Document and the Summary of Product;
  2. Data about Quality and Safety of Cosmetics Ingredient;
  3. Data about Cosmetic Quality
  4. Data about the Safety and Benefit of Cosmetics.

 

Labeling requirements

Labeling on the package should be composed as the following format:

  1. Product name
  2. Importer name and address of the manufacturer, distributors/importers
  3. Composition/ingredients
  4. Net weight, net volume, the quantity of each content
  5. Number of registration approval
  6. Production code number
  7. Usage and direction of use
  8. Expiry date
  9. Stability data if less than 30 months
  10. Other information related to safety and or quality

Note: Usage & direction of use should be in Indonesia language

 

Access ASEAN Cosmetics Regulatory Database. ->

Access Indonesia Cosmetics Regulatory Database. ->

Reference:

Indonesia BPOM

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