Cosmetic Compliance
Intelligence & Solutions
Home / News / Details

Indonesia Amends Required Documents for Product Information File (PIF)

The updated Guidelines for Product Information File (PIF) clarifies the standards for documents included in PIF, and amends the documents required in PIF.


In Indonesia, PIF shall be prepared by manufacturers or importers before cosmetics are notified and provided when the Indonesia Food and Drug Supervisory Agency (BPOM) conducts an examination. The PIF must be maintained in electronic and/or written form, stored appropriately, and updated whenever changes occur. The language can be either English or Indonesian.

On October 31, 2022, BPOM released a draft of the Guidelines for Product Information File (PIF) for public consultation. 1 Nine months later, on August 2, 2023, BPOM finalized and implemented the Guidelines. 2 For products that received the notification number before August 2, 2023, the notification number owner must update the PIF within six months.

The Guidelines consists of six chapters, sixteen articles, and one appendix, covering requirements for documents, language, retention, storage format, PIF review methods, etc. The purpose of the Guidelines is to assist cosmetic companies in preparing and compiling the PIF and provide guidance to BPOM officials during PIF reviews.

Compared with the previous Guidelines for Product Information File released in 2017, the main amendments are as follows.

1. Clarifying the standards for documents included in PIF

The Guidelines categorizes the documents to be included in the PIF into four types. It provides explicit standards that these four types of documents must adhere to.


Documents Type



Administrative documents

1. Scientific or empirical evidence’s fulfillment of the ingredients’ technical requirements stipulated in Technical Requirements for Cosmetics Ingredients;

2. Fulfillment of contamination requirements stipulated in Limitations for Contamination in Cosmetics;

3. Fulfillment of the requirements stipulated in the Regulation for Cosmetics Adverse Reaction Monitoring in terms of the monitoring results of cosmetic adverse reactions;

4. Fulfillment of the requirements stipulated in the Technical Requirements for Cosmetic Labeling in terms of cosmetic labeling;

5. Fulfillment of the requirements stipulated in the Technical Requirements for Cosmetics Claims in terms of cosmetic claims.


Cosmetic ingredient’s quality and safety data


Cosmetic product’s quality data


Safety and efficacy data of cosmetic product

2. Amending the documents required in PIF

Please Log in or Sign up (FREE) to read the full content.
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by
Copyright: unless otherwise stated all contents of this website are ©2023 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact