Shanghai Joly Moment Digital Technology Co., Ltd.info@jolyimport.com

NMPA Cosmetics Ingredient Requirements: IECI Checklist for Foreign Brands

JO

JOLY Regulatory Team

China cosmetics market-entry specialists

Reviewed by Serena Wang, Head of Regulatory Affairs, JOLY

5 min readNMPA Registration

TL;DR

Learn how to meet NMPA ingredient requirements, verify formulas against the IECI database, and clear China cosmetic registration efficiently.

When foreign beauty brands plan their China market entry, technical dossier preparation often triggers the biggest delays. In our daily registration work at Joly Import, formula compliance is the primary bottleneck. Meeting NMPA ingredient requirements requires more than just translating your INCI list into Simplified Chinese. You must verify every component against official Chinese databases, secure raw material safety information codes, and confirm concentration limits before submitting a single document to the National Medical Products Administration.

In recent years, the regulatory body tightened safety assessment standards under the Technical Guidelines for Cosmetic Safety Assessment. This shift means that even if a formula has been sold safely in Europe or North America for a decade, it might fail Chinese compliance checks due to missing historical consumption data or strict limits on trace impurities. Understanding how China regulates cosmetic ingredients China standards is the single best way to protect your brand from costly reformulations and regulatory rejections.

Getting ingredient compliance right at the start saves months of back-and-forth with assessors. Before sending samples for domestic laboratory testing, every brand should complete a thorough ingredient audit against active regulatory catalogs.

How the Inventory of Existing Cosmetic Ingredients works in practice

Every cosmetic formula entering China relies on the Inventory of Existing Cosmetic Ingredients in China (IECI China). The benchmark version lists 8,972 approved raw materials. If an ingredient is not on this list, China considers it a new cosmetic ingredient. Filing a brand-new ingredient requires a separate three-year monitoring process that can cost tens of thousands of dollars, so almost all foreign brands stick strictly to materials listed in the IECI.

Checking your formulation against the IECI sounds simple, but errors happen frequently in practice. Foreign brands often search the catalog using standard trade names or Western INCI nomenclature, leading to false matches. NMPA assessors look at exact botanical Latin names, specific chemical abstract service (CAS) numbers, and precise plant parts. For instance, if your product contains Camellia sinensis leaf extract, you cannot simply reference Camellia sinensis flower extract. They are legally distinct materials under Chinese regulatory rules.

We recently reviewed a formulation for an overseas skincare company whose product contained three botanical extracts. While the general plant species were included in the IECI, two extracts used plant parts—specifically roots instead of leaves—that were not listed in the inventory. The brand had to work directly with their raw material supplier to adjust the botanical source rather than spending months attempting a new ingredient registration.

Beyond basic inclusion, you must pay attention to raw material safety data codes. Regulatory rules require raw material suppliers to submit compositional breakdowns, quality standards, and impurity profiles directly to the official platform to generate a 16-digit submission code. Overseas brands must collect these submission codes from ingredient suppliers or assemble complete raw material safety information dossiers manually using Annex 14 forms if the supplier declines to register on the Chinese system.

Another critical factor is the Highest Historical Use Concentration (HHUC). The IECI and associated NMPA safety databases record maximum historical usage levels for ingredients in rinse-off and leave-on products. If your formulation uses an ingredient at 5.0%, but the highest recorded historical level in China is 2.0%, you must provide additional toxicological data or lower the concentration to justify safety to the reviewer.

Managing restricted ingredients and concentration limits during filing

Matching your INCI list to the IECI is only step one. The NMPA enforces strict usage conditions through specific annexes covering prohibited ingredients and restricted ingredients cosmetics China standards. Certain preservatives, UV filters, colorants, and hair dyes face capped concentration limits, specified application scopes, or mandatory warning labels on retail packaging.

For example, salicylic acid is widely used globally as an exfoliant or acne treatment. In China, its use is restricted to 2.0% in leave-on and rinse-off products, and it cannot be used in products designed for children under three years old except in shampoos. If your product line includes a leave-on serum with 2.5% salicylic acid, it cannot be registered in China without reformulating down to the 2.0% threshold.

| Ingredient Name | Maximum Allowed Limit in China | Primary Regulatory Condition | | Salicylic Acid | 2.0% | Prohibited in products for children under 3 years | | Titanium Dioxide | 25.0% | Must meet specific particle size and purity criteria | | Retinol | 1.0% | Requires specific warning text on domestic packaging | | Alpha Arbutin | 2.0% | Strictly controlled for hydroquinone impurity limits |

The treatment of prohibited ingredients is equally absolute. China maintains a list of over 1,200 substances that cannot be intentionally added to cosmetic formulations, including cannabidiol (CBD), human-derived ingredients, and specific antibiotics. In addition, trace impurities must be strictly monitored. Heavy metals like lead, arsenic, mercury, and cadmium have lower permissible thresholds under Safety and Technical Standards for Cosmetics (STSC) than in many Western jurisdictions.

When we run compliance audits on foreign formulations, we always check safety assessment requirements alongside ingredient lists. Under full safety assessment mandates, every single ingredient must have an established Margin of Safety (MoS) based on official NMPA benchmark data, broad international expert evaluations, or historic usage limits recorded in Chinese databases. Meeting these NMPA ingredient requirements requires close collaboration between your technical team and your raw material vendors early in product development.

Packaging claims must also align with ingredient functions. If you include an ingredient known primarily as an active brightener, but list it at a micro-concentration purely as a stabilizer, NMPA reviewers may question the formula's consistency. Every constituent in the Chinese dossier must have a clearly stated, scientifically defensible purpose.

Common ingredient filing questions from foreign cosmetics brands

Q: What happens if one of our key ingredients is not listed in the IECI China database? If an ingredient is absent from the IECI, it is classified as a new cosmetic ingredient under NMPA rules. Registering a new ingredient involves extensive toxicological testing and a three-year mandatory safety reporting period. Most overseas brands choose to reformulate with an approved alternative from the IECI to avoid lengthy registration delays.

Q: How do we get raw material safety codes from our ingredient suppliers? Your raw material suppliers must register on the official raw material submission platform to generate a 16-digit code for their material. If a supplier is unwilling to register, you can collect the manufacturer's raw material safety information form directly from them and submit it within your final registration file.

Q: Are organic or natural certifications recognized as proof of ingredient safety in China? No, official organic or natural certifications from foreign bodies carry no weight in regulatory evaluations. All cosmetic ingredients China compliance is determined strictly through scientific safety dossiers, CAS number matching, toxicology testing, and adherence to Safety and Technical Standards for Cosmetics.

Sources:

  1. National Medical Products Administration (NMPA) - https://www.nmpa.gov.cn
  2. General Administration of Customs of China (GACC) - http://customs.gov.cn

[LINK TO: /blog/nmpa-cosmetics-registration-guide — Comprehensive NMPA Cosmetics Registration Guide] [LINK TO: /blog/china-cosmetic-safety-assessment-rules — Understanding China Cosmetic Safety Assessment Requirements]

About the author

The JOLY regulatory team files NMPA registrations, clears cosmetics through Chinese customs and acts as domestic responsible person for overseas beauty brands. JOLY owns no cosmetics brand of its own, so it never competes with the brands it represents.

NMPA filing, customs clearance and domestic responsible person practitioners

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