On June 10, 2026, Indonesia released the draft Regulation Concerning the Recall and/or Destruction of Natural Medicines, Quasi Medicines, Health Supplements, and Cosmetics. This draft aims to consolidate and update existing rules by introducing a more structured, risk-based classification system for recalls and clarifying procedural requirements. It is set to replace the standalone BPOM Regulation No. 11 of 2017, which previously governed cosmetic recalls. Stakeholders are invited to provide feedback on the draft regulation by June 30, 2026.
Key Mechanisms for Cosmetic Recalls: Mandatory and Voluntary
The draft regulation explicitly outlines two primary types of product recalls that cosmetic enterprises must be prepared to execute:
Mandatory Recall: Initiated by an official written instruction from the Head of BPOM. This is typically triggered by findings from post-market surveillance, rapid alert systems, risk assessments indicating severe health threats, or verified public complaints. It covers non-compliance in safety, quality, labeling, and promotional materials.
Voluntary Recall: Initiated proactively by the notifier upon detecting risks related to product safety, quality, labeling, or advertising during circulation. Enterprises must inform the Head of BPOM in writing before executing a voluntary recall, detailing the product and notifier identity, recall reasons, recall class, and affected batches.
Classification and Criteria for Cosmetic Recalls
To ensure proportionate responses to various levels of product non-compliance, BPOM has categorized cosmetic recalls into two distinct classes based on the severity of the risk posed to consumers.
Class I Recall (High Risk)
Class I recalls apply to cosmetics that fail to meet critical safety requirements, pose significant health risks, or involve severe administrative violations. The criteria include:
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