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Cosmetics distributed in Indonesia must meet the requirements for safety, efficacy, quality, and labeling. Cosmetics that do not meet these requirements must be recalled. Recall is the process or action to withdraw cosmetics that do not meet the requirements from circulation. Every cosmetics industry, cosmetics importer, or individual business/business entity that enters into a production contract is required to recall cosmetics that do not meet the standards and/or requirements.

Criteria for Cosmetics that Must be Recalled

Based on the Head of the National Agency for Food and Drug Control Regulation Number 11 of 2017 concerning Criteria and Procedures for Cosmetic Product Recall and Destruction, the criteria for cosmetics that must be recalled include:

• Containing prohibited materials
• Does not meet the requirements for microbial contamination
• Does not meet the requirements for heavy metal contamination
• Contains materials exceeding the permitted levels
• Expired
• Includes labeling that is not objective, misleading and/or contains information as if it were a drug.

Implementation of Cosmetic Recall

The recall is carried out by the Notification Number Owner on the orders of the Head of the Agency. The implementation of this recall is carried out based on:

• Findings from inspection results at production facilities, importers/individual businesses or business entities that have production contracts, and/or distribution
• Sampling and testing results
• Tagging evaluation results
• Post Market Alert System (PMAS) receipt results
• Product Information Document (DIP) audit results
• Follow-up on evaluation results of public complaints/complaints
• Results of monitoring side effects of cosmetics

Additionally, recalls can also be initiated by the Notification Number Holder based on the results of monitoring retained samples and/or internal audits. Recalls are conducted for:

• The entire batch distributed for cosmetics that contain prohibited substances or display misleading, deceptive, and/or drug-like labeling.
• One batch before, the non-compliant batch, and one batch after for cosmetics that do not meet pathogenic microbial contamination requirements.
• Non-compliant batches for cosmetics that exceed the microbial contamination limits of Total Plate Count (TPC) or Yeast Mold Count (YMC), contain substances exceeding permitted levels, or are expired.