If you’re registering a cosmetic product containing silicone ingredients with China’s NMPA in 2026, you’re working with a regulatory framework that has tightened materially since the IECIC 2021 baseline — and most international brands we work with underestimate the documentation depth required. This is the practical checklist we hand to every customer planning a China launch.
What changed in IECIC 2024 v3
The third revision of the Inventory of Existing Cosmetic Ingredients in China (IECIC), released by the NIFDC in late 2024, made three substantive changes that affect silicone supply:
- Use level caps for cyclic silicones (D4, D5, D6) in leave-on products, harmonised broadly with EU REACH but with stricter wash-off thresholds.
- Source documentation for amino-functional silicones (amodimethicone derivatives) now requires manufacturer-certified residual amine level statement.
- Manufacturing site audit requirements expanded — the responsible person in China must hold a copy of the manufacturer’s ISO 22716 certificate and have access to the most recent third-party audit report.
The good news: every silicone in the GK portfolio is IECIC-listed, and we maintain a current China-specific dossier for each grade. The work is in assembling the finished product documentation. Here’s the seven-document pack you need.
The seven documents you need
1. Product formulation declaration
Full ingredient list with INCI names, CAS numbers, source manufacturer for each ingredient, and use level (% w/w). For silicones supplied by us, our COA includes all four data points; you can transcribe directly. The NMPA expects at least four decimal places of precision on actives.
2. Source manufacturer declaration (per ingredient)
For each silicone ingredient, NMPA wants a statement on letterhead from the manufacturer confirming: the manufacturing site address, the ISO 22716 certificate number and validity, IECIC listing reference, and any restrictions on use level (typically inherited from EU REACH for cyclics). For our products we issue this on demand within 72 hours.
3. Safety substantiation file
The NMPA Safety Assessment Report (SAR) for the finished product, prepared by a credentialed safety assessor, referencing primary toxicology data for each ingredient. For silicone ingredients, the source data is typically CIR (Cosmetic Ingredient Review) monographs and the supplier’s SDS. Make sure your assessor uses the latest CIR Final Report on cyclic siloxanes (2024 amendment).
4. Stability and compatibility data
Three months of accelerated stability data at 45°C, plus 25°C real-time data (minimum 6 months). NMPA reviewers specifically look for viscosity drift, separation, and odour development in silicone-rich formulations. Include the test method (e.g. Brookfield RV, sp.2 @ 20 rpm) and pass/fail criteria.
5. Microbiological challenge test
Per ISO 11930. For anhydrous silicone-based products (lipsticks, sticks, anhydrous balms), a self-preserving statement with water activity (aw) data is acceptable in lieu of full challenge testing — this is a relatively recent and helpful update.
6. Heavy metals and impurities
Test reports for lead, mercury, arsenic, and cadmium. Most well-controlled silicones pass with significant margin (our typical Pb result is < 0.1 ppm against the 10 ppm limit), but you must have the test on file from a CMA-accredited Chinese laboratory or a recognised international equivalent.
7. Production process flow
A flow diagram of the finished product manufacturing process, with critical control points marked. This is often the document that catches international brands by surprise — NMPA wants meaningful detail (mixing speed, temperature, hold times), not a corporate flow chart.
The single most common cause of NMPA rejection on silicone-containing dossiers we’ve seen this past year is inconsistent INCI naming between the formulation declaration and the safety report. NMPA reviewers cross-reference both documents word-for-word; a discrepancy of even one comma will trigger a request for clarification (RFC) and add 4–6 weeks to the review timeline.
The 72-hour turnaround
For our customers, we’ve standardised the China dossier into a single zip file per ingredient, available on request through your account manager. It contains:
- Source manufacturer declaration on GK Silicones letterhead
- ISO 22716 certificate (current)
- IECIC listing reference and CAS confirmation
- Most recent SDS in Chinese (GB/T 16483-2008 format)
- Most recent COA with heavy metals data
- Toxicology summary referencing CIR
- Sample stability protocol (provided as guidance)
If your safety assessor needs the dossier in a specific format, our regulatory team will reformat on request.
Two things we’d add for 2026
Plan for translation. NMPA accepts dossiers in English where supporting documentation originates outside China, but the SAR conclusion, formulation declaration, and label artwork must be in Simplified Chinese. Budget two weeks for translation by a regulatory-fluent provider — generic translation will introduce errors that trigger RFCs.
Plan for sampling. Provincial FDA may request retain samples (typically 30 g of finished product per SKU) up to 6 months post-launch. Maintain inventory accordingly.
Timeline expectations
| Stage | Typical duration | Notes |
|---|---|---|
| Dossier assembly (your side) | 4 – 8 weeks | Often the longest step. Start early. |
| Translation & formatting | 2 weeks | Use a regulatory-fluent translator. |
| NMPA technical review | 5 – 8 weeks | Faster if no RFC issued. |
| RFC response cycle (if any) | 2 – 4 weeks per cycle | One RFC is normal; two is concerning. |
| Filing notification | 2 weeks | Final administrative step. |
End-to-end, plan on 16–22 weeks from the moment you have a finalised formula. We’ve seen this happen in 12 weeks when everything goes right; it’s rare.
If you’re using GK Silicones grades and need the China-specific documentation pack, request it from your account manager or submit a request here. Median delivery time: 72 hours.
