CROSS-STANDARD public interest · Cosmetics & personal care

China-to-US Cosmetics Compliance Gap Matrix (FDA / MoCRA)

AI-compiled from official public sources — cross-checked by multiple AI models, not human-verified. Informational only; see disclaimer. Public-interest, source-linked comparison of common China cosmetics documentation against US FDA and MoCRA requirements, covering facility registration, cosmetic product listing, safety substantiation, adverse event reporting, GMP, prohibited and restricted ingredients, color additive pre-approval, labelling, and special categories (sunscreens as OTC drugs).

Dataset 2026-06-11 Last verified 2026-06-12 9 rows

GAP MATRIX

Compliance Gap Matrix

Gap matrix
Compliance item Common China baseline United States (FDA / MoCRA) Gap / action Source + verification date
FDA Facility Registration — MoCRA Mandatory Under China's Cosmetic Supervision and Administration Regulation (CSAR 2021), cosmetic manufacturing enterprises must obtain a Cosmetic Manufacturing License (化妆品生产许可证) issued by provincial-level drug regulatory authorities. General cosmetics (普通化妆品) require filing (备案) with NMPA; special cosmetics (特殊化妆品, e.g., sunscreens, hair dyes, hair-growth, perms, freckle-removal, whitening) require pre-market registration (注册) with NMPA. Chinese facility licensing does not satisfy or substitute for US FDA MoCRA registration.化妆品监督管理条例 (CSAR 2021) — State Council Order No. 727
化妆品生产质量管理规范 — NMPA GMP Order (2022)		 Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), every facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA. Registration must be renewed biennially. A 'facility' includes any establishment that manufactures or processes a cosmetic product, including contract manufacturers. Small businesses (average gross annual sales of cosmetics under $1 million and not using certain chemicals of concern) may be exempt. The responsible person must submit registration on behalf of the facility.MoCRA — Modernization of Cosmetics Regulation Act of 2022 (FD&C Act § 607, 21 U.S.C. § 364)
21 CFR Part 710 (voluntary facility registration, superseded by MoCRA mandatory requirement)		 Chinese cosmetic manufacturers exporting to the US must separately register each qualifying facility with the FDA under MoCRA (electronic submission via Cosmetics Direct or SPL). The Chinese Cosmetic Manufacturing License and NMPA registration/filing are not recognized by FDA. The responsible person (importer or US agent) must be identified and named in the FDA registration. Biennial renewal deadlines must be tracked independently of Chinese license renewal cycles.[INFORMATIONAL] MoCRA facility registration is mandatory for non-exempt facilities supplying cosmetics to the US market. Chinese manufacturing licenses and NMPA filings have no equivalence with FDA registration. Exporters must register directly with FDA and designate a US responsible person. U.S. Food and Drug Administration2026-06-12 · unverified
FDA Cosmetic Product Listing — MoCRA Mandatory Under CSAR 2021, ordinary cosmetics require NMPA product filing (备案) and special cosmetics require NMPA registration (注册). The NMPA filing/registration includes product formula, safety assessment, and label information. China's NMPA product filing is conceptually similar to FDA product listing but the data formats, submission portals, and regulatory frameworks differ entirely. NMPA filings do not satisfy FDA product listing requirements.化妆品监督管理条例 (CSAR 2021) — 普通化妆品备案管理办法
特殊化妆品注册管理办法 (NMPA 2021)		 MoCRA requires the responsible person to submit a cosmetic product listing for each cosmetic product marketed in the US. The listing must include: product name and category, facility registration number, list of ingredients (with INCI names), and any applicable product label. Listings must be updated within 180 days of any changes. A single listing may cover cosmetic products marketed under the same name with variations (e.g., different shades). The listing requirement is separate from and in addition to facility registration.MoCRA — FD&C Act § 607(c), 21 U.S.C. § 364b
FDA Guidance: Cosmetic Product Listing (2023)		 Each cosmetic product sold in the US requires a separate FDA product listing (via Cosmetics Direct). INCI ingredient names must be used as the nomenclature standard. Chinese NMPA filings use different naming conventions (INCI is accepted but not required under CSAR). The responsible person must maintain updated listings; failure to list is a prohibited act under FD&C Act as amended by MoCRA.[INFORMATIONAL] MoCRA product listing is mandatory for non-exempt cosmetics marketed in the US. Chinese NMPA filings are not accepted by FDA. The responsible person must submit individual product listings with INCI ingredient names via FDA's Cosmetics Direct portal. U.S. Food and Drug Administration2026-06-12 · unverified
Good Manufacturing Practice (GMP) — MoCRA Rulemaking in Progress China's Cosmetic Manufacturing Quality Management Specification (化妆品生产质量管理规范, NMPA GMP Order, effective January 1, 2022) is a mandatory GMP standard for all licensed cosmetic manufacturers in China. It covers plant facilities, personnel qualifications, quality control, process management, and record-keeping. The Chinese GMP standard is broadly comparable to ISO 22716 but has China-specific requirements. Chinese GMP compliance does not satisfy future US MoCRA GMP requirements once the FDA final rule is issued.化妆品生产质量管理规范 (NMPA GMP Order 2021, effective 2022-01-01)
ISO 22716:2007 (referenced by NMPA as a basis)		 MoCRA directs FDA to issue regulations establishing GMP requirements for cosmetics. FDA published a proposed rule on cosmetic GMP in January 2024 (89 FR 4816). The proposed rule would require cosmetic manufacturers to implement quality management systems covering personnel, buildings/facilities, equipment, raw materials, production/process controls, laboratory controls, and record-keeping. Until the final rule is effective, there are no US federally mandated cosmetic GMP requirements; however, the industry widely applies ISO 22716:2007 (Cosmetics — GMP) as the de facto standard and large retailers may contractually require it.MoCRA — FD&C Act § 606(e), 21 U.S.C. § 364a (GMP rulemaking mandate)
FDA Proposed Rule: Cosmetic Good Manufacturing Practice (89 FR 4816, January 17, 2024)
ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP)		 MoCRA GMP requirements are pending final rulemaking as of 2026. The FDA proposed rule (January 2024) is not yet final. Chinese exporters meeting ISO 22716 or the Chinese GMP standard are likely to be well-positioned for future compliance, but should monitor the FDA final rule for US-specific deviations. Until the final rule, there are no US federal cosmetic GMP obligations beyond the general adulteration provisions of the FD&C Act. FLAG: This row reflects a MoCRA-pending (not yet mandatory) requirement.[INFORMATIONAL] MoCRA GMP requirements are not yet in force — the FDA final rule is pending as of 2026. Chinese exporters should maintain ISO 22716-compliant GMP systems now in anticipation of the final rule. Chinese NMPA GMP compliance alone will not satisfy the US federal GMP rule once finalized. Federal Register / FDA2026-06-12 · unverified
Prohibited and Restricted Ingredients — FD&C Act + Color Additives Pre-Approval China's Safety and Technical Standards for Cosmetics (化妆品安全技术规范, 2015 edition, NMPA) contains Table 1 (prohibited ingredients — over 1,300 substances), Table 2 (restricted ingredients — permitted within limits), Table 3 (permitted preservatives), Table 4 (permitted UV filters), Table 5 (permitted colorants). Chinese colorant regulation is a positive list; only listed colorants are permitted. The US color additive pre-approval system operates on a similar positive-list principle but uses a different approval register (21 CFR 73/74) with different approved substances and use conditions.化妆品安全技术规范 (Safety and Technical Standards for Cosmetics, 2015, NMPA) — Tables 1-5 The FD&C Act prohibits cosmetics from containing any poisonous or deleterious substance that may render the product injurious. FDA has explicitly prohibited or restricted a limited number of ingredients by regulation, including: bithionol, halogenated salicylanilides, zirconium compounds in aerosol cosmetics, vinyl chloride in hair sprays, methylene chloride in cosmetics, chloroform, hexachlorophene (except by prescription). Separately, all color additives used in cosmetics require FDA pre-approval under 21 CFR 73 (exempt from batch certification) or 21 CFR 74 (subject to batch certification). No color additive may be used in a cosmetic unless it is permitted by FDA regulation for that use.21 CFR Part 700 — General Administration (prohibited ingredients)
21 CFR Part 73 — Listing of Color Additives Exempt from Batch Certification
21 CFR Part 74 — Listing of Color Additives Subject to Certification
FD&C Act § 601 (adulterated cosmetics)		 The US and Chinese prohibited/restricted ingredient lists are NOT identical. Ingredients permitted under Chinese safety standards may be prohibited or unapproved in the US, and vice versa. Critical area: color additives — all color additives in US cosmetics must appear on the FDA-approved list (21 CFR 73/74) for that specific use and body area (e.g., eyes, lips, general skin). Chinese approved colorants that do not appear in 21 CFR 73/74 cannot be used in US-marketed cosmetics. Exporters must conduct a full ingredient-by-ingredient compliance review against FDA prohibited lists and 21 CFR 73/74 before US market entry.[INFORMATIONAL] US cosmetic prohibited ingredients and color additive pre-approval requirements differ materially from Chinese standards. Every color additive must have FDA pre-approval under 21 CFR 73/74 for its specific cosmetic use. Exporters must conduct a full ingredient compliance audit against US-specific lists before market entry. Electronic Code of Federal Regulations (eCFR) / FDA2026-06-12 · unverified
Cosmetic Labelling — 21 CFR 701 + Fair Packaging and Labeling Act Chinese cosmetic labeling is governed by the Measures for the Administration of Cosmetics Labeling (化妆品标签管理办法, NMPA 2021) and the CSAR 2021. Required elements include: product name, ingredient list (in descending order, INCI names accepted), production date/batch number, period after opening, manufacturer name and address, net content, usage instructions, and warnings. Chinese labeling requirements also follow a generally similar structure to US requirements but use Chinese language, Chinese address standards, and different net content formats. Labels prepared for the Chinese market require full re-engineering for US market compliance.化妆品标签管理办法 (Measures for the Administration of Cosmetics Labeling, NMPA 2021)
化妆品监督管理条例 (CSAR 2021) — Chapter IV		 Cosmetic labels sold in the US must comply with 21 CFR Part 701 (Cosmetic Labeling) and the Fair Packaging and Labeling Act (FPLA, 15 U.S.C. § 1451 et seq.). Required label elements include: (1) identity of the product; (2) name and place of business of the manufacturer, packer, or distributor; (3) net quantity of contents in both metric and US customary units; (4) ingredient declaration (INCI names, in descending order of predominance); (5) any required warnings. Labels must be in English (bilingual is permitted). Labeling is a key enforcement area — non-compliant labeling renders a product misbranded under FD&C Act § 602.21 CFR Part 701 — Cosmetic Labeling
Fair Packaging and Labeling Act (FPLA), 15 U.S.C. § 1451 et seq.
FD&C Act § 602 (misbranded cosmetics)
21 CFR Part 740 — Cosmetic Product Warning Statements		 Key US-specific labeling gaps for Chinese exporters: (1) English-language label is required — Chinese-only labels are non-compliant; (2) Net quantity must appear in both metric and US customary units (e.g., 'NET WT 3.5 OZ (99 g)'); (3) Ingredient declaration must use INCI names in descending order of predominance — Chinese pinyin or Chinese-character ingredient names alone are insufficient; (4) US address for responsible person must be on label; (5) Any warning statements required by 21 CFR Part 740 (e.g., for flammable aerosols, near-eye products) must appear. Chinese label templates cannot be used as-is for the US market.[INFORMATIONAL] US cosmetic labeling under 21 CFR 701 and FPLA requires English-language ingredient declarations using INCI names in descending order, dual-unit net quantity, and US-address responsible person. Chinese market labels require complete redesign for US compliance. Non-compliant labeling is a misbranding violation. Electronic Code of Federal Regulations (eCFR) / FDA2026-06-12 · unverified
Safety Substantiation — Responsible Person Obligation (MoCRA) Under CSAR 2021 and the Safety and Technical Standards for Cosmetics (化妆品安全技术规范 2015, updated 2022), cosmetic manufacturers must conduct safety assessments (安全评估) before placing products on the market. For NMPA registration/filing, a safety assessment report is required. The safety assessment must address ingredient safety, microbiological limits, physicochemical parameters, and toxicological endpoints. Chinese safety assessment documentation does not automatically satisfy US FDA safety substantiation requirements, which operate under different statutory standards.化妆品安全技术规范 (Safety and Technical Standards for Cosmetics, 2015 edition, NMPA)
化妆品安全评估技术导则 (Technical Guidelines for Cosmetic Safety Assessment, NMPA 2021)		 MoCRA codifies that cosmetic products must be safe and the responsible person must maintain records substantiating the safety of each product. The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. Safety records must be available to FDA upon request. While MoCRA does not prescribe a specific safety assessment format, FDA expects records of toxicological data, ingredient safety reviews, and any human clinical or consumer use data relied upon. This replaces the previously voluntary FDA safety substantiation guidance.MoCRA — FD&C Act § 606, 21 U.S.C. § 364a (safety substantiation)
FD&C Act § 601 (adulterated cosmetics)		 Chinese safety assessment reports prepared under CSAR/NMPA requirements may provide a useful starting point but do not satisfy US MoCRA safety substantiation obligations. Key differences: (1) FDA has no prescribed format — the responsible person defines and defends the methodology; (2) US ingredient restrictions differ from Chinese prohibited/restricted lists; (3) FDA may request records at any time and non-compliance is a prohibited act. Chinese exporters should engage a US-qualified safety assessor and prepare FDA-specific substantiation files before US market entry.[INFORMATIONAL] MoCRA requires the responsible person to maintain safety substantiation for every cosmetic product. Chinese NMPA safety assessment documentation does not substitute for FDA safety substantiation. US-market exporters must prepare separate safety records meeting FDA's statutory standard. U.S. Food and Drug Administration2026-06-12 · unverified
Serious Adverse Event Reporting — MoCRA Mandatory Under CSAR 2021 and the Cosmetic Adverse Reaction Monitoring and Reporting Management Measures (化妆品不良反应监测和报告管理办法, NMPA 2022), cosmetic registrants and filing holders must monitor and report adverse reactions. Serious adverse reactions must be reported to NMPA within 15 days. Chinese adverse event reporting obligations cover the domestic market only. Adverse events reported to NMPA do not satisfy FDA reporting obligations and vice versa.化妆品不良反应监测和报告管理办法 (NMPA 2022)
化妆品监督管理条例 (CSAR 2021) — Chapter V		 MoCRA requires responsible persons to report serious adverse events associated with their cosmetic products to FDA within 15 business days of receiving such information. A serious adverse event is one that results in: death, a life-threatening situation, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or that requires medical or surgical intervention to prevent such outcomes. Responsible persons must also maintain records of all adverse events (not just serious) for six years.MoCRA — FD&C Act § 605, 21 U.S.C. § 364 (adverse event reporting)
21 CFR Part 803 (analogous MDR framework for reference)		 Chinese exporters supplying cosmetics to the US must implement a separate adverse event monitoring and reporting system meeting MoCRA requirements for the US market, independent of their NMPA reporting system. The 15-business-day window for serious adverse events, the definitions of seriousness, and the FDA reporting portal differ from Chinese requirements. Responsible persons must also ensure their US retailers and distributors have a mechanism to route adverse event information back to them.[INFORMATIONAL] MoCRA mandates separate serious adverse event reporting to FDA for US-marketed cosmetics. Chinese NMPA adverse reaction reports do not satisfy FDA obligations. Exporters must implement a US-facing pharmacovigilance system and maintain 6-year adverse event records. U.S. Food and Drug Administration2026-06-12 · unverified
Sunscreens — Regulated as OTC Drug Products (CARES Act Administrative Order System) In China, sunscreen products are classified as special cosmetics (特殊化妆品) requiring NMPA pre-market registration (not drug approval) under CSAR 2021. The permitted UV filter list is in Table 4 of the Safety and Technical Standards for Cosmetics (2015 edition, updated). China permits numerous UV filters not currently recognized as GRASE in the US, including many widely used filters in the EU (e.g., Tinosorb S/M, Mexoryl SX/XL). Chinese sunscreen NMPA registration does not satisfy US OTC drug requirements.化妆品安全技术规范 (2015, NMPA) — Table 4: Permitted UV Filters
特殊化妆品注册管理办法 (NMPA 2021) — Special Cosmetics Registration		 In the United States, sunscreen products are regulated as over-the-counter (OTC) drug products under the FD&C Act, not as cosmetics. US OTC sunscreens are governed by the CARES Act OTC monograph reform and FDA administrative order system. 21 CFR Part 352 was stayed indefinitely and should not be treated as the operative sunscreen monograph. Only FDA-recognized or otherwise authorized sunscreen active ingredients may be used in US OTC sunscreens; many UV filters widely used in China and Europe have not been reviewed or approved by FDA for this use. Sunscreen products require drug labeling (Drug Facts box), not cosmetic labeling.FD&C Act § 505G (OTC Monograph Drug Products — CARES Act)
FDA OTC Monograph Reform / Administrative Order System (CARES Act, 2020)
21 CFR Part 352 — Sunscreen Drug Products for Over-the-Counter Human Use (Stayed Indefinitely)		 This is the most significant category gap for China-to-US cosmetics export. Chinese sunscreen products: (1) are regulated as cosmetics in China but as OTC drugs in the US — entirely different regulatory track; (2) must fit the CARES Act OTC monograph reform and FDA administrative order framework, while 21 CFR Part 352 is stayed indefinitely and is not the operative monograph; (3) often contain UV filters (e.g., Bemotrizinol/Tinosorb S, Bisoctrizole/Tinosorb M, Drometrizole Trisiloxane/Mexoryl XL, Ecamsule/Mexoryl SX) that FDA has not authorized for US OTC sunscreen use; (4) require Drug Facts labeling, not cosmetic labeling; (5) may require reformulation to use only FDA-recognized or otherwise authorized sunscreen active ingredients. This gap often requires complete product reformulation.[INFORMATIONAL] Sunscreens are OTC drugs in the US — not cosmetics. Chinese sunscreen products regulated under NMPA as special cosmetics are on a completely different regulatory track and cannot be marketed in the US without complying with the CARES Act OTC monograph reform / FDA administrative order system. 21 CFR Part 352 is stayed indefinitely and should not be presented as the operative monograph. Many UV filters common in China are not authorized for US OTC sunscreen use, requiring product reformulation. Electronic Code of Federal Regulations (eCFR) / FDA2026-06-12 · unverified
Color Additives — FDA Pre-Market Approval Required (21 CFR 73/74) China's Safety and Technical Standards for Cosmetics (2015, NMPA) Table 5 lists permitted colorants for cosmetics. The list includes organic dyes, inorganic pigments, and lake pigments, with restrictions on use area (e.g., rinse-off only, not for eye area). China does not have a batch certification system equivalent to 21 CFR 74; instead, manufacturers must demonstrate compliance during NMPA registration/filing. The Chinese permitted colorant list and the FDA approved color additive lists overlap but are not identical.化妆品安全技术规范 (Safety and Technical Standards for Cosmetics, 2015, NMPA) — Table 5: Permitted Colorants All color additives used in cosmetics sold in the US must be listed and approved by FDA under 21 CFR Part 73 (color additives exempt from batch certification) or 21 CFR Part 74 (color additives subject to certification). Approval is specific to: the color additive identity, the product category (e.g., cosmetics, food, drugs), and the body area of use (e.g., externally applied, eye area, lips, ingested). A color additive approved for general cosmetic use may not be approved for use in the eye area. Batch certification (lot release testing) is required for certain synthetic organic dyes (21 CFR 74). Use of any non-listed, non-approved, or improperly used color additive renders the cosmetic adulterated.21 CFR Part 73 — Listing of Color Additives Exempt from Certification
21 CFR Part 74 — Listing of Color Additives Subject to Certification
FD&C Act § 601(e) (adulterated cosmetics — unapproved color additive)		 Color additive approval gaps are a common cause of US import failures for cosmetics from China. Specific issues: (1) Color additives approved in China (Table 5 of NMPA standards) may not be on FDA's 21 CFR 73/74 approved lists; (2) FDA certification requirements (batch testing/lot release) for certified colors (D&C and FD&C dyes) are an additional compliance burden with no Chinese equivalent; (3) FDA approval is use-specific — a color additive may be approved for external use but not eye or lip area; exporters must verify each colorant's FDA approval status for the specific product and body area. Chinese cosmetics using colorants not in 21 CFR 73/74 cannot be sold in the US without reformulation.[INFORMATIONAL] Every color additive in a US-marketed cosmetic must have FDA pre-approval under 21 CFR 73 or 74 for the specific product type and body area of use. Chinese approved colorants are not automatically approved by FDA. Certified colors require batch certification. Unapproved color additives cause product adulteration — a strict liability import violation. Electronic Code of Federal Regulations (eCFR) / FDA2026-06-12 · unverified

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