Terms:
PB UMKU: Business Licensing to Support Business Activities
OSS: Indonesian Online Single Submission System
OTSKK: Traditional Medicine, Health Supplements and Cosmetics
BPOM: Indonesian Food and Drug Supervisory Agency
On January 2, 2025, the Indonesian Directorate of OTSKK Registration under BPOM Registration posted on social media that the Cosmetics Notification System 3.0 has been launched and is now in operation. This updated version of the system includes the following key features:
1 | Cosmetic Distribution Permit
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2 | Cosmetic Notification Updates
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3 | Standard Certificate/Letter Notification of Company Changes/Variations
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4 | Standard Certificate/Letter Notification of Packaging Changes/Variations
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5 | Standard Certificate/Letter Notification of Cosmetic Kits
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Indonesian Food and Drug Supervisory Agency (BPOM) reminds companies to pay attention to the following:
1. New Requirements for Product Submission in Notification System 3.0
1) The cosmetic application site must be filled in based on the intended use of the cosmetic product;
2) Notifiers must provide a link to the Product Information File (PIF) for each product to be notified. The link can be locked, and BPOM will request access when they need to evaluate it;
3) If the newly created PB UMKU OSS permit ID does not appear, please go to the Administrator menu, select "OSS permit ID," and click the "inquire permit ID" button;
4) If the notification letter does not appear, go to the Administrator menu, enter the product license ID, click the "Show" button, and then click "Query File DS" in the product list.
2. Key Points to Note When Filling in Ingredients in Notification System 3.0
1) The ingredient database includes only the ingredient’s INCI name;
2) Ingredients can be searched using either the INCI name or CAS number;
3) The "Percentage" column must be filled in;
4) The percentage of ingredients listed in Appendices I-IV of the Technical Requirements for Cosmetic Ingredients should not be entered as "0". Further guidance on formula inclusion can be found at this link: https://bit.ly/sosnotifkos;
5) When updating a product, ensure the updated formula (ingredient names and concentrations) matches the previous data;
6) If the ingredient that an enterprise wishes to use is not yet available in the system, consult the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics for guidance.
ChemLinked Comments
The updated notification system specifies that companies must provide a link to the PIF when submitting cosmetics notifications, and BPOM will not review the PIF during the notification process. However, during later inspections, BPOM will retrieve the PIF through this link.
Therefore, it is recommended that companies begin preparing their PIF based on existing data when submitting cosmetics notifications in Indonesia, and then gradually improve them.