When reviewing a supplement stability dossier, two red flags almost always stand out first: overseas data applied blindly without accounting for local humidity, and vague storage labels like “store at room temperature.”
If you are a brand owner, importer, or regulatory lead, this guide to PerBPOM 6/2025 stability testing outlines what the rule strictly requires and where dossiers usually fall short.
Dossiers built on overseas data generated at 30 °C / 65% RH demand the closest attention. Interestingly, Product Registration Indonesia (PRI) has not received stability-related queries from BPOM since the alignment period ended around March 20, 2026.
While this reflects our recent case logs, it shouldn’t be taken as proof that legacy data is automatically accepted or that future reviews will be as quiet.
Even though the regulation is no longer brand new, its real-world application remains a critical focal point for health supplement registration in Indonesia. Below, we separate official regulatory demands from what we actually observe on the ground.
Key terms used in this guide
| Term | Meaning |
|---|---|
| BPOM | Badan Pengawas Obat dan Makanan, the Indonesian Food and Drug Authority |
| PerBPOM | Peraturan BPOM, a regulation issued by the Head of BPOM |
| RH | Relative humidity |
| Zone IVb | ASEAN reference climatic zone for hot and very humid conditions (30 °C, 75% RH) |
| GMP | Good Manufacturing Practice |
| NIE | Nomor Izin Edar, the marketing authorisation number |
| JDIH | Jaringan Dokumentasi dan Informasi Hukum, the official legal documentation network |
| ASEAN | Association of Southeast Asian Nations |
PerBPOM 6/2025 Stability Testing: The Quick Answer
PerBPOM 6/2025 stability testing requires finished health supplements to be tested for physical, chemical, and microbiological stability. Studies must include long-term testing under Zone IVb conditions (30 °C / 75% RH) and accelerated testing (40 °C / 75% RH), conducted at an accredited laboratory or a GMP-certified in-house laboratory.
Data generated at lower humidity, such as 30 °C and 65% RH, must be supplemented with supporting data by evaluating key factors including product instability, the availability of accelerated stability data, and the type of container closure system used. Under the rule, a storage statement must give a defined temperature, not “room temperature”.
What PerBPOM 6/2025 is and how it fits the wider rules
Legal basis and timeline
BPOM Regulation No. 6 of 2025 on Guidelines for Stability Testing of Health Supplements was signed on 21 February 2025 and promulgated on 20 March 2025. It contains 6 articles and one annex guideline, aligned to the ASEAN guideline on stability and shelf life of health supplements.
BPOM announced the rule in press release HM.01.1.2.04.25.101. The agency says drafting began in October 2023 and passed through internal meetings, public consultation, and harmonisation with the Ministry of Law before signature.
| Date | Event | Source |
|---|---|---|
| 21 February 2025 | Rule signed | BPOM press release HM.01.1.2.04.25.101 |
| 20 March 2025 | Rule promulgated | BPOM press release HM.01.1.2.04.25.101 |
| 29 April 2025 | BPOM press release issued | BPOM press release HM.01.1.2.04.25.101 |
| Around 20 March 2026 | One-year window to align earlier studies ended | Statement of the Head of BPOM in the same release |
BPOM reported 6,173 valid health supplement marketing authorisations as of 15 April 2025, and 957 issued during 2024. It adds that all marketed supplements carry stability data, a reminder that older studies exist across the market.
How it sits beside PerBPOM 32/2022 and 15/2024
Article 8 of BPOM Regulation No. 32 of 2022 on Criteria and Procedures for Health Supplement Registration, as amended by BPOM Regulation No. 15 of 2024, remains valid where it does not conflict with PerBPOM 6/2025. The new rule refines stability expectations; it does not replace the registration framework.
For health supplement registration Indonesia files, both instruments are read together. Which statements in an older dossier rest on which instrument is a point best confirmed with a regulatory adviser before submission.
Core technical requirements under PerBPOM 6/2025
Zone IVb long-term conditions
The Head of BPOM cites 30 °C and 75% RH as the common long-term condition in the ASEAN region, known as Zone IVb. Zone IVb is the ASEAN reference for hot and very humid climates, which is why humidity is the parameter to watch.
Testing runs as two studies: real-time, also called long-term, and accelerated. According to the annex guideline, the testing frequency in both must be enough to give a sufficient stability profile of the finished product.
Parameters, strengths, and packaging
The annex requires stability testing to cover physical, chemical, and microbiological attributes that may change during storage and could affect quality. The active ingredient assay follows the quality requirements already set for health supplements.
The study should represent each strength and each packaging system type, unless bracketing or matrixing is used. Whether a reduced design is acceptable for a given product is a scientific judgement to settle with a regulatory adviser.
Laboratory requirements
BPOM states that testing must be performed at an accredited laboratory or at an in-house industry laboratory that holds a Good Manufacturing Practice (GMP) certificate. Accreditation or GMP status should be confirmed for any overseas or in-house site before a study is commissioned or relied upon.
Storage statements on the label
The rule also governs what the label says. Under PerBPOM 6/2025, a storage statement must give a defined temperature, not “room temperature”. The wording should match the conditions the stability study actually supported.
| Requirement | What the rule says | Where to confirm |
|---|---|---|
| Long-term condition | 30 °C and 75% RH (Zone IVb) | BPOM press release; annex guideline |
| Study types | Real-time and accelerated | BPOM press release; annex guideline |
| Parameters | Physical, chemical, microbiological | Annex guideline |
| Laboratory | Accredited, or in-house with GMP certificate | BPOM press release |
| Storage statement | Defined temperature, not “room temperature” | Annex guideline (section IV, Pernyataan dan Penandaan) |
| Lower humidity data | Supplement with supporting data | BPOM press release |
Overseas data at 30 °C and 65% RH: the case to check
BPOM’s Head states that data generated below the required condition, for example 30 °C with 65% RH, must be supplemented with supporting data to satisfy scientific evaluation. Three factors matter: any instability observed, the availability of accelerated data, and the packaging system type.
In our experience, this is the profile that needs a documented position before filing. A study can be sound where it was run and still sit below the 75% RH reference condition used for Indonesia.
What counts as sufficient supporting data is not set by one number. It depends on the product, so we treat it as a regulatory and scientific review item, not a checkbox. The decision path below shows where each file leads.
- Was the long-term study run at 30 °C and 75% RH? If yes, confirm laboratory status and label wording next.
- Was it run at 30 °C and 65% RH or milder? If yes, supporting data are required. Review instability, accelerated data, and packaging type.
- Does the study predate 20 March 2025? If yes, check whether it was adjusted before the one-year window ended around 20 March 2026.
- Is any answer unclear? Request a regulatory review before you submit or renew.
| Data profile | Reference condition | Next step with an adviser |
|---|---|---|
| Study at 30 °C and 75% RH, accredited laboratory | Matches Zone IVb | Check label wording and batch coverage |
| Overseas study at 30 °C and 65% RH | Below reference humidity | Define the supporting data to add |
| Study completed before March 2025 | Alignment window closed | Confirm whether it was adjusted |
| Label says “room temperature” | Defined temperature required | Rewrite from the supported condition |
What changed after the alignment window closed
The Head of BPOM asked businesses with pre-rule stability studies to adjust them within one year of promulgation. Counting from 20 March 2025, that window ended around 20 March 2026.
Since then, PRI has seen no stability-specific query from BPOM. We report that as an observation only. Queries alone cannot tell us whether files were already aligned, or whether evaluators have simply not raised the point yet.
For importers, the practical consequence is a documentation question: can you show which study supports which storage claim? Keeping that record organised is easier before a renewal than during one.
Where stability data sits in health supplement registration Indonesia
Stability data is one part of a health supplement registration Indonesia dossier, alongside safety, benefit, quality, and labelling evidence. It supports the shelf life and the storage statement that appear on the approved label.
BPOM issued 262 health supplement marketing authorisations between January and March 2025, against 240 in the first quarter of 2024. With that volume, a stability section that is consistent with the label is simpler for an evaluator to read.
The same Zone IVb logic drives shelf-life evidence for live-organism products, as our guide to probiotic supplement BPOM registration in Indonesia explains. Product type shapes the rest of the file, which our overview of magnesium supplement types in Indonesia covers.
Foreign principals should also check who controls the registration. Our case study on a supplement licence rescue shows how reliance on a local partner’s account limited one brand’s ability to fix a file.
Our Health Supplements Registration service supports supplement dossiers, including data review before submission, so stability questions can be raised with a regulatory adviser early.
Pre-filing checklist for supplement stability files
Use this list to prepare questions for your regulatory adviser, not to self-certify a file. Each answer depends on the specific product, packaging, and study design.
| Check | Question to settle | Reference |
|---|---|---|
| Long-term condition | Was it 30 °C and 75% RH, or is supporting data on file? | PerBPOM 6/2025 |
| Study design | Are real-time and accelerated studies both present? | PerBPOM 6/2025 |
| Parameters | Do results cover physical, chemical, and microbiological attributes? | PerBPOM 6/2025 |
| Coverage | Does the data represent each strength and packaging type? | PerBPOM 6/2025 |
| Laboratory | Is the site accredited, or an in-house GMP-certified laboratory? | PerBPOM 6/2025 |
| Label | Does the storage statement give a defined temperature? | PerBPOM 6/2025 |
Conclusion: close the gap while it is quiet
PerBPOM 6/2025 stability testing is settled, the alignment window has passed, and in our experience BPOM has raised no stability queries since. That is encouraging, and it is also the right moment to review your data calmly rather than under a deadline.
Product Registration Indonesia can review your stability studies, laboratory status, and label wording against PerBPOM 6/2025, and tell you where supporting data may be needed. Contact PRI’s Health Supplements Registration team to arrange a stability data review before your next filing or renewal.
