The Product Information File (PIF), known in Indonesia as the Dokumen Informasi Produk (DIP), contains essential information regarding the safety, efficacy, and quality of cosmetics. This documentation is mandatory for the cosmetic industry, importers, and individual/business entities involved in contract manufacturing. The PIF must be prepared by cosmetic manufacturers and importers before a product can obtain notification from BPOM. This is a crucial step to ensure that all cosmetic products entering or produced in Indonesia meet the established safety and quality standards. The Indonesian Food and Drug Supervisory Agency (BPOM) introduced BPOM Regulation No. 17 of 2023 (PerBPOM 17/2023), which concerns the PIF guidelines for cosmetics. This regulation replaces Regulation No. 14 of 2017 (PerBPOM 14/2017) and aims to enhance the safety, efficacy, and quality standards of cosmetics available in the Indonesian market.
This regulation introduces several significant changes compared to PerBPOM 14/2017, especially in the areas of safety, efficacy, and quality of cosmetic products. These changes include:
- Fulfillment of technical requirements for cosmetic ingredients related to safety, efficacy, and/or quality, supported by scientific or empirical evidence
- Compliance with contamination requirements
- Results of cosmetic adverse effects monitoring
- Compliance with labeling requirements
- Compliance with appropriate claim regulations
This regulation also modifies the PIF retention period. Manufacturers and importers are now required to retain the PIF for at least one year after the expiration date of the last produced or imported cosmetic. This differs from the previous rule which required the PIF to be retained for up to six years from the date of last production or import. Additionally, any changes in data regarding the safety, efficacy, or quality of the product must be promptly reflected in updates to the PIF, ensuring that the information provided remains relevant and up-to-date. These changes are designed to facilitate the review process and reduce administrative burdens without compromising the quality and safety of cosmetic products.
Reference:
PerBPOM No. 17 Tahun 2023
PerBPOM No. 14 Tahun 2017
https://notifkos.pom.go.id/upload/informasi/20181217101014.pdf
