NMPA Filing and Import Guide for Korean Cosmetics in China

A Growing Wave: Korean Cosmetics Brands Entering China

Korean cosmetics have long enjoyed a strong reputation among Chinese consumers. From innovative formulations to sophisticated packaging, K-beauty brands consistently rank among the most sought-after imported cosmetics in China's $80 billion cosmetics market.

But for Korean brands — especially smaller and mid-sized companies — entering China through the general trade import route involves navigating the NMPA's cosmetics regulatory framework under the Cosmetics Supervision and Administration Regulation (CSAR, effective 2021). The pathway differs significantly from cross-border e-commerce (CBEC), and many brands find themselves surprised by the classification decisions that determine their filing timeline, cost, and compliance obligations.

This guide addresses the most common questions Korean brands face when bringing shampoos, scalp care products, and related hair care lines into China — including the critical question of ordinary vs. special cosmetics classification, which determines everything.

General Trade vs. Cross-Border E-Commerce

Before diving into NMPA filing requirements, it's important to understand the two main import channels:

General Trade (一般贸易)

• NMPA filing or registration is required — Every product must be filed (ordinary) or registered (special) before import
• Full Chinese labeling required before customs clearance
• Products physically enter China and can be sold through any channel — online, offline, retail, e-commerce
• Subject to full customs inspection and quarantine procedures
• Required for brands with existing China entities planning multi-channel sales

Cross-Border E-Commerce (跨境电商 / CBEC)

• No NMPA filing required — Products are sold directly to consumers from overseas warehouses
• Chinese labeling can be electronic (applied post-purchase or digitally)
• Limited to designated CBEC platforms (Tmall Global, JD Worldwide, Kaola, etc.)
• Not eligible for offline retail sales
• Positive List (《跨境电子商务零售进口商品清单》) determines eligible product categories

For Korean brands that already have a China entity and plan to sell through both online e-commerce and offline retail — general trade with full NMPA compliance is the appropriate pathway. CBEC is typically used by brands without a China presence, or as a market testing channel before committing to full NMPA filing.

Classification: Is Your Product Ordinary or Special Cosmetics?

This is the single most important question for any cosmetics import project. Classification determines the regulatory pathway, documentation requirements, timeline, and cost.

The NMPA Classification Framework

Under CSAR, cosmetics are divided into two categories:

Special cosmetics under CSAR include products with these functions:

1. Sunscreen and UV protection
2. Hair dye
3. Freckle removal and skin whitening
4. Hair growth (育发/生发)
5. Anti-hair loss (防脱发)
6. New efficacy claims (newly added under CSAR 2021)

All other cosmetics — including the vast majority of skin care, hair care, makeup, and personal care products — fall under ordinary cosmetics.

Where Do Shampoo and Scalp Care Products Fall?

This is where careful classification analysis becomes critical:

Shampoo (洗发精/洗发水) — A standard shampoo is always an ordinary cosmetic. Regardless of whether it includes scalp care claims, as long as the primary function is cleansing, it remains ordinary. However, if a shampoo product makes anti-hair loss or hair growth claims, it crosses into special cosmetics territory.

Scalp care / scalp essence (头皮水/头皮护理产品) — This product type occupies a gray area:

• If marketed purely as moisturizing, nourishing, or soothing the scalp — it is an ordinary cosmetic
• If marketed with hair growth promotion (育发/生发) or anti-hair loss (防脱发) claims — it is a special cosmetic requiring registration
• If marketed with scalp health maintenance (头皮养护), dandruff control (去屑), or oil balance (控油) — these are general claims that can remain ordinary, provided no special cosmetic efficacy words are used

The key insight: The regulatory classification depends on the claims you make, not just the product formulation. A scalp essence with identical ingredients can be filed as ordinary cosmetics if claims are limited to general scalp care, or require special registration if hair growth claims are added.

Critical Claims to Watch

Special Considerations for Baby and Pregnancy Claims

The client's products are described as suitable for infants, children, and pregnant women, with a "no additives" (无添加) positioning. These claims have specific regulatory implications:

Infant and Children's Cosmetics

Under CSAR Article 79, cosmetics intended for children (age ≤ 12) face stricter requirements:

• All children's cosmetics must pass NMPA-required microbiological and toxicological testing
• Animal testing exemption is NOT available for products intended for children
• A dedicated Children's Cosmetics label mark (儿童化妆品标志 — the "小金盾" icon) must appear on packaging
• Formula must use only ingredients from NMPA's approved list for children's products
• A separate Children's Cosmetics Technical Evaluation is required

This means if your shampoo or scalp care product is marketed as "suitable for babies and children" , it will require the full animal testing and children's evaluation process — regardless of whether it is an ordinary or special cosmetic.

Pregnancy Claims

• Statements like "safe for pregnant women" or "suitable for pregnancy" are permissible but must be supported by adequate safety data
• No specific pregnancy category exists in NMPA's cosmetics classification
• However, claims implying safety for sensitive groups shift the burden of proof — NMPA may request additional toxicological data
• Products marketed to pregnant women typically cannot qualify for animal testing exemption

"No Additives" Claims

The "no additives" (无添加) claim is popular in Korean cosmetics marketing but is not a regulated claim category under CSAR. Key considerations:

• Vague "no additives" claims are discouraged by NMPA — they must be specific about what is not added (e.g., "no parabens," "no artificial fragrances")
• Any "no additives" claim must be factually accurate for the Chinese market formulation (not the Korean market formulation, which may differ)
• If the claim implies "no preservatives," the product must still pass preservative efficacy testing per GB/T standards

The NMPA Filing and Registration Process

For Ordinary Cosmetics (Notification Filing)

Documentation Requirements:

1. Product Formula (完整配方) — Complete ingredient list with concentrations, INCI names in Chinese
2. Product Safety Assessment Report (产品安全评估报告) — Mandatory full safety assessment from a qualified assessor
3. Manufacturing Process Description (生产工艺简述)
4. Product Quality Standard (产品质量标准)
5. Product Label and Packaging Mockups (产品标签及包装样稿)
6. Free Sale Certificate / Health Certificate (自由销售证明) — Issued by Korean health authorities (MFDS)
7. GMP Certificate or Manufacturing License (生产规范证明)
8. Power of Attorney / Authorization Letter (授权委托书) — Appointing the Chinese responsible person
9. Responsible Person's Business License (境内责任人营业执照)
10. Product Safety Related Information (产品安全相关资料) — Including MSDS, stability test reports, etc.

Process Flow:

1. Product Classification & Claims Review — 1–2 weeks
2. Formula & Ingredient Compliance Review — 1–2 weeks
3. Safety Assessment Report Preparation — 2–4 weeks
4. Testing (if required — children's products) — 4–8 weeks
5. Chinese Label Design & Review — 1–2 weeks
6. Submit Filing via NMPA Online System — Same day
7. NMPA Review — Timeline varies
8. Filing Number Issued + Customs Clearance — Ongoing

Total timeline: Varies significantly depending on product complexity, testing requirements, and NMPA queue.

Pricing note: Filing costs vary significantly based on product category, number of variants, testing requirements, and whether children's cosmetics evaluation is needed. Contact us for a fixed-fee quote tailored to your specific products.

For Special Cosmetics (Registration)

If your scalp care product makes hair growth or anti-hair loss claims, it becomes a special cosmetic requiring full registration:

Additional Documentation Requirements:

1. All ordinary cosmetics documents (above)
2. Efficacy Test Report (功效评价报告) — From an NMPA-accredited Chinese laboratory
3. Dermatological Clinical Test Report (人体安全性检验报告)
4. Product Toxicological Test Report (毒理学试验报告) — Animal testing generally required
5. Stability Test Report (稳定性试验报告)
6. Packaging Material Compatibility Test (包装材料相容性检测)

Process Flow:

1. Classification Confirmation — 1 week
2. Ingredient & Formula Review — 2–3 weeks
3. Safety Assessment Report — 3–4 weeks
4. Efficacy Testing at NMPA-Accredited Lab — 8–16 weeks
5. Toxicological & Safety Testing — 8–12 weeks
6. Chinese Label Design & Review — 1–2 weeks
7. Submit Registration Application — Same day
8. NMPA Substantive Technical Review — Timeline varies
9. Registration Certificate Issued — Certificate valid 5 years
10. Customs Clearance & Market Entry — Ongoing

Total timeline: Varies considerably. The efficacy and toxicological testing phases are the primary drivers. Special cosmetics registration typically takes significantly longer than ordinary filing, primarily due to clinical efficacy testing requirements.

Korean Brands: Specific Considerations

MFDS vs. NMPA Standards

Korean cosmetics are manufactured under MFDS (Ministry of Food and Drug Safety) oversight. While both Korea and China follow international standards in many areas, there are important differences:

• Ingredient lists: Some ingredients approved in Korea may be prohibited or restricted in China
• Concentration limits: Maximum allowable concentrations for certain ingredients differ
• Testing standards: NMPA requires testing at CNAS-accredited Chinese laboratories; Korean test reports are generally not accepted for NMPA filing
• Label requirements: Korean packaging often uses Korean-only text; full Chinese labeling must be added for the China market

Free Sale Certificate from MFDS

Korean brand owners need to obtain a Free Sale Certificate (자유판매증명서) from the Korean Ministry of Food and Drug Safety (MFDS). This document is a mandatory attachment for NMPA filing. The certificate must:

• Be issued within the last 2 years
• Include a notarized Korean-to-Chinese translation
• Cover each product SKU individually or list all SKUs on one certificate when structured as a product line

Product Name Registration

In Korea, cosmetics product names are registered with the Korea Cosmetic Industry Association (KCIA) or directly with MFDS. The Chinese product name must:

• Be a faithful translation of the Korean product name
• Not include prohibited wording (e.g., "medical," "therapeutic," "cure")
• Follow NMPA's cosmetics naming conventions

Strategic Recommendations for Korean Brands

If Your Product Is Ordinary Cosmetics

1. File immediately — Ordinary cosmetics filing is the faster pathway. Start the process while continuing product development and marketing
2. Use CBEC as a market test — If you qualify, sell through CBEC channels during the filing process to build brand awareness and validate demand
3. Plan Chinese packaging early — Integrate Chinese labeling into your packaging design from the start to avoid costly re-printing later
4. Separate your product claims carefully — Keep hair growth claims on a separate SKU that goes through special registration, while filing the general care versions as ordinary cosmetics

If Your Product Is Special Cosmetics

1. Budget for the longer timeline — Special cosmetics registration takes considerably longer; plan your China market entry accordingly
2. Prepare for clinical efficacy testing — Ensure your product formula can withstand scrutiny from NMPA-accredited Chinese laboratories
3. Consider a staged approach — Launch a general-care ordinary cosmetic version first (faster timeline), then follow with the special-cosmetic version after registration is complete
4. Leverage your existing data — Any clinical or safety data from Korean testing, even if not directly accepted by NMPA, can strengthen your safety assessment report

Children's Product Strategy

If your brand wants to position products for children and pregnant women:

• Expect mandatory animal testing — no exemption available
• Budget for additional children's cosmetic testing requirements
• Allow 4–8 additional weeks for children's product testing
• Ensure packaging includes the mandatory "小金盾" children's cosmetics mark
• Consider launching a separate children's SKU to avoid delaying your general market adult products

Frequently Asked Questions

Does a Korean cosmetics brand need NMPA filing for general trade imports?

Yes. If you import cosmetics through general trade (not cross-border e-commerce), every product must be either filed (ordinary cosmetics) or registered (special cosmetics) with the NMPA before import. This applies regardless of where the brand is from — Korea, Europe, Japan, or anywhere else. If you already have a China entity and plan to sell through both online and offline channels, general trade with full NMPA compliance is the required pathway.

Can I sell through cross-border e-commerce without NMPA filing?

Yes, as an alternative. Cross-border e-commerce (CBEC) platforms like Tmall Global and JD Worldwide allow cosmetics sales without NMPA filing, provided the products are on the Positive List. However, CBEC-channel products cannot be sold through offline retail or domestic e-commerce platforms. CBEC can be used as a market-testing channel while preparing full NMPA compliance, or as your primary channel if you do not plan offline distribution.

Is a shampoo an ordinary or special cosmetic?

A standard shampoo is an ordinary cosmetic. Shampoos whose primary function is cleansing fall under ordinary cosmetics, regardless of whether they include scalp care or hair nourishment claims. However, if a shampoo product explicitly claims anti-hair loss (防脱发) or hair growth promotion (育发/生发) , it crosses into special cosmetics territory and requires full registration.

What about scalp care products — where do they fall?

It depends on the claims. A scalp essence or scalp treatment product:

• Ordinary cosmetic if claims are limited to moisturizing, nourishing, soothing, oil control, or dandruff control
• Special cosmetic if claims include hair growth, anti-hair loss, or hair regrowth

The exact same formulation can be filed as ordinary or registered as special — it comes down to what you say about it. We recommend careful claims planning before filing.

What if my product is suitable for children or pregnant women?

Stricter requirements apply. Products marketed for children (age ≤ 12) require:

• Mandatory microbiological and toxicological testing (no animal testing exemption)
• A dedicated Children's Cosmetics evaluation
• The "小金盾" (golden shield) label icon on packaging
• Formulation restricted to NMPA-approved children's ingredients

For products marketed as pregnancy-safe, adequate safety data must support the claim even though no formal pregnancy category exists in NMPA's framework.

Can I use the same formula I sell in Korea?

Not necessarily. Some ingredients approved in Korea by MFDS may be prohibited in China or subject to different concentration limits. A full ingredient compliance review is essential. Additionally, while Korean test reports can support your safety assessment, NMPA generally requires testing at CNAS-accredited Chinese laboratories for the final filing or registration.

How long does the NMPA process take?

It varies significantly. Key factors include:

• Ordinary cosmetics filing: Depends on formula complexity, safety assessment readiness, and whether animal testing is required (e.g., for children's products)
• Special cosmetics registration: Takes substantially longer due to clinical efficacy testing at NMPA-accredited labs, which alone can take several months

The fastest path is ordinary cosmetics filing with a complete safety assessment and no children's claims.

What documents do I need to start the filing process?

For ordinary cosmetics filing, the key documents include:

• Complete product formula with concentrations
• Free Sale Certificate from MFDS (Korean health authority) — with notarized Chinese translation
• Manufacturing license or GMP certificate
• Product quality standard
• Label and packaging mockups
• Safety assessment report
• Power of attorney appointing a Chinese responsible person

Additional documents are required for special cosmetics registration, including clinical efficacy test reports from NMPA-accredited Chinese laboratories.

Can I file one product but sell multiple variants?

Each variant generally requires a separate filing. If products differ in formulation, fragrance, color, or active ingredient concentration, they are treated as separate SKUs requiring individual NMPA filings. However, products that vary only in packaging size (e.g., 50ml and 200ml versions of the same formula) may share a filing under certain conditions.

Do I need a Chinese entity to file cosmetics?

Yes. Every cosmetics product imported into China must have a Chinese domestic responsible person — a legal entity registered in China with cosmetics-related business scope. This can be your own Chinese subsidiary, a distributor, or a third-party service provider. The responsible person is legally accountable for product safety and handles all NMPA communications.

How We Can Help Korean Brands

We provide end-to-end NMPA compliance services specifically for international cosmetics brands entering China:

• Product classification assessment — Determine ordinary vs. special cosmetics status based on your formulations and intended claims
• Formula and ingredient compliance review — Full ingredient audit against NMPA's prohibited and restricted lists
• Safety assessment report preparation — Coordinated with qualified safety assessors
• Efficacy testing coordination — Arrange clinical and laboratory testing at NMPA-accredited Chinese labs
• Chinese responsible person service — Act as your legally registered domestic responsible person
• Chinese label design and approval — Full label compliance with CSAR labeling regulations
• Full filing/registration management — End-to-end NMPA application submission and follow-up
• Children's cosmetics evaluation — Specialized support for products targeting children and sensitive populations
• Import customs clearance advisory — Customs documentation and compliance for general trade imports
• Post-filing compliance management — Annual reporting, change notifications, and renewal monitoring

Whether you are filing an ordinary shampoo or navigating the special cosmetics registration process for a scalp treatment, we provide a clear roadmap and dedicated project management from Seoul to Shanghai.

Contact us for a free K-beauty China entry assessment.