
On June 10, 2026, the Indonesian National Agency of Drug and Food Control (BPOM, Badan Pengawas Obat dan Makanan) published the "Draft Regulation of the Drug and Food Control Agency on the Recall and/or Destruction of Natural Medicines, Quasi-Medicines, Health Supplements, and Cosmetics". The draft aims to consolidate and update existing recall and destruction rules, introduce a structured, risk-based recall classification system, and further tighten reporting timeframes as well as destruction and documentation requirements.
The draft specifies that cosmetic recalls are divided into two types: Mandatory Recall and Voluntary Recall, and cosmetic enterprises must be capable of executing both types of recall:
1) Mandatory Recall: Initiated by a written order issued by the Chair of BPOM, typically arising from post-market surveillance, rapid alert systems, risk assessments (indicating a serious health threat), or verified public complaints, covering compliance issues concerning product safety, quality, labeling, and promotional materials.
2) Voluntary Recall: Initiated by the cosmetic Notifier when risks related to safety, quality, labeling, or advertising are proactively identified during product distribution. Before executing a voluntary recall, the enterprise must notify the Chair of BPOM in writing, providing information such as the product and notifier identity, the reason for recall, the recall class, and the affected batches.
To ensure a proportionate regulatory response to non-compliance of varying severity, BPOM classifies cosmetic recalls into two classes based on the severity of the risk to consumer health:
1) Class I Recall (high risk): Applies to cosmetics that fail to meet critical safety requirements, pose a significant health risk, or involve serious administrative violations.
2) Class II Recall (lower risk): Applies to cosmetics with a relatively lower degree of risk but that nonetheless fail to meet relevant requirements, in order to match the regulatory response and handling measures to the corresponding level.
The draft is currently open for public comments, with a comment deadline of June 30, 2026.
Please refer to attached document below.
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