Indonesia Published its Product Information File Guidelines for Cosmetics

On August 2, 2023, the Indonesian Food and Drug Administration (Badan Pengawas Obat dan Makanan, BPOM) published Regulation No. 17 of 2023 on the Product Information File (PIF) guidelines for cosmetics, which came into effect from the date of publication. Parties that obtain product notification codes before August 2, must update PIF within six months.

The PIF should be prepared by cosmetic manufacturers and importers and should be submitted to the BPOM before products obtain market authorization.

The draft of the Guidelines was published on October 31, 2022. The Guidelines clearly indicate the standard documents included in PIF. The requirements of PIF have been revised, these include:

• The administrative documents and product introduction;
• Ingredients quality and safety information;
• Product quality information; and
• Safety and efficacy of products.

According to the guidelines, the following information must comply with the regulatory standards:

• Scientific or empirical evidence of technical requirements for cosmetic ingredients;
• Cosmetic declaration and labeling standards;
• Pollution restrictions; and
• Adverse reactions monitoring.

In addition, according to the requirements of the guidelines, the PIF reservation period is changed from at least six years from the date of the last production or import of cosmetics to at least one year after the expiration of the shelf life of the cosmetics that were last imported or produced. Manufacturers or importers should keep PIFs for future reference. The PIF must be kept in electronic or written format. When information is altered, the PIF should also be changed accordingly.

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