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.
Once it enters into force, the draft will replace BPOM Regulation No. 11 of 2017, which previously regulated cosmetic recalls separately. The draft is currently open for public comments, with a comment deadline of June 30, 2026. CIRS Group has summarized the core content of the draft for reference.
Background
Previously, the supervision of cosmetic recalls in Indonesia was primarily governed by "BPOM Chairperson Regulation No. 11 of 2017", which separately set out the standards and procedures for cosmetic recalls, while the recall and destruction of products such as medicines and natural medicines were regulated under separate, scattered regulations. To unify the regulatory framework for recall and destruction, enhance post-market surveillance efficiency, and further strengthen the protection of consumer health, BPOM has this time brought natural medicines, quasi-medicines, health supplements, and cosmetics under a single regulation, establishing a structured, risk-based classification system and clarifying the procedural requirements at each stage, in order to replace the previously fragmented and decentralized recall provisions.
Cosmetic Recall Mechanism: Mandatory and Voluntary Recall
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:
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.
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.
Recall Classification: Risk-Based Class I / Class II
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:
- 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.
- 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.
Note: The specific criteria for determining Class I and Class II recalls, as well as the reporting timeframes and destruction operational requirements for each type of recall, are subject to the official text of the draft.
Key Changes Compared to Current Regulations
Compared with the current BPOM Regulation No. 11 of 2017, the draft focuses on strengthening the following aspects:
- Introducing a risk-based recall classification system (Class I / Class II) to replace the previous, relatively simplified recall provisions;
- Tightening the reporting timeframe requirements for enterprises reporting to BPOM;
- Strengthening the procedural standards and documentation obligations for product destruction;
- Bringing natural medicines, quasi-medicines, health supplements, and cosmetics under a single unified recall and destruction regulatory framework.
CIRS Reminder
This draft regulation on cosmetic recall and destruction issued by Indonesia is an important measure to consolidate recall supervision and strengthen post-market surveillance capabilities. Once it enters into force, the current BPOM Regulation No. 11 of 2017 will be replaced. For the cosmetics enterprises concerned, CIRS Group draws attention to the following:
- Closely follow the progress of the draft and its final text. The comment deadline for the draft is June 30, 2026. Enterprises that have comments or suggestions on the draft’s content (particularly the recall classification criteria, reporting timeframes, and destruction requirements) may submit timely feedback through official BPOM channels.
- Improve internal recall systems. For both mandatory and voluntary recalls, enterprises must have rapidly deployable recall procedures, clear batch traceability capabilities, and a mechanism for written reporting to BPOM. In particular, the prior written notification process for voluntary recalls must be standardized.
- Standardize destruction and document management. The draft strengthens the procedural and documentation requirements for destruction. Enterprises should establish standard operating procedures (SOPs) and complete records for product destruction, ensuring that the destruction process is traceable and verifiable.
- Strengthen post-market surveillance and risk monitoring. Mandatory recalls often originate from post-market surveillance, rapid alerts, and public complaints. Enterprises should improve their own post-market monitoring and complaint-handling mechanisms to proactively identify and control product risks.
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