Overview of China’s Cosmetic Overseas Inspection Regulations

China, the world’s second-largest cosmetics market, continues to attract international brands due to its vast consumer base, despite a recent slowdown in growth. To enhance the regulation of imported cosmetics and ensure product safety, Chinese authorities are gradually expanding their oversight to include overseas manufacturers. Among the various regulatory measures, overseas inspections have emerged as a key tool for ensuring the safety, quality, and regulatory compliance of imported cosmetics.

This article provides a comprehensive overview of China’s overseas inspection system, covering its regulatory basis, procedural framework, and notable non-compliance cases, to help international cosmetic enterprises better understand regulatory expectations and enhance compliance readiness.

1. What Are Overseas Inspections?

Cosmetic overseas inspections refer to on-site inspections conducted by the National Medical Products Administration (NMPA) at foreign cosmetic manufacturing facilities. The primary purpose of these inspections is to verify the authenticity, reliability, and compliance of overseas product development and production processes, as well as the accuracy of submitted application materials.

These inspections are specifically carried out by the Center for Food and Drug Inspection (CFDI), a subordinate body under the NMPA responsible for implementing inspection and enforcement activities related to pharmaceuticals, medical devices, and cosmetics.

2. Legal and Regulatory Basis

Currently, while China hasn't established an independent, systematic legal framework for cosmetic overseas inspections, several existing cosmetic regulations—both finalized and in draft form—contain relevant provisions that serve as reference for such activities. Key regulations include:

Cosmetic Supervision and Administration Regulation (CSAR)	Article 46 outlines the enforcement powers granted to regulatory authorities for supervising and inspecting cosmetics production and operations, including on-site inspections, sampling, dossier reviews, and compulsory measures such as sealing or seizure of noncompliant products. Article 47 sets forth requirements for these inspections, including qualifications and duties of enforcement personnel, and the duty of inspected parties to cooperate with the inspection process.
Administrative Measures on Cosmetics Registration and Notification	Article 47 stipulates that during the technical review process for registration, the review institute may request on-site verification when necessary. Domestic on-site verifications must be completed within 45 working days, while overseas on-site verifications follow applicable regulations. The duration of on-site verification is excluded from the technical review timeline. Applicants are required to cooperate with the verification process and provide samples if sampling inspection is needed.
Supervision and Administration Measures on Cosmetics Manufacture and Operation	Article 33 requires cosmetics companies to conduct annual self-inspections on their implementation of production quality management practices. The inspection report must detail identified issues, product quality and safety evaluation, and corrective actions, and be retained for at least two years. If non-compliance is detected, immediate rectification is required. Where product quality or safety may be compromised, production must be suspended, reported to regulators, and may only resume once the risk is resolved. Regulatory authorities may conduct on-site inspections as needed.
Good Manufacturing Practices (GMP) for Cosmetics	As the core regulation governing production inspections, it comprises nine chapters and two annexes, encompassing all aspects of cosmetic production and quality control, including ingredients, personnel, equipment, sanitation, testing, packaging, storage, transportation, sales, and product recalls.
Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices	The regulation is used to assess whether enterprises meet GMP requirements and consists of 105 inspection items across two versions: actual production and contract manufacturing. Inspection Points for Cosmetic GMP (Actual Production) applies to registrants, notifiers, and entrusted manufacturers involved in cosmetic production, with 81 inspection items. Inspection Points for Cosmetic GMP (Entrusted Production) applies to registrants and notifiers that outsource production, comprising 24 inspection items.
Administrative Measures on Cosmetics Inspection	This is the first departmental regulation to systematically regulate cosmetic inspection since the implementation of the CSAR. Comprising 8 chapters and 47 articles, it clearly defines requirements for inspection categories, procedures, link between inspection and audit, and result handling.
Interim Provisions on the Administration of Cosmetics Overseas Inspection (Draft)	As China’s only dedicated regulation outlining the framework for overseas cosmetic inspections, the draft plays a key role in shaping future regulatory practices. It comprises five chapters—General Principles, Inspection Planning and Preparation, Implementation, Review and Processing, and Supplementary Provisions—along with six supporting attachments. It emphasizes a risk-based approach, prioritizing inspections of companies with issues in registration, notification, product testing, adverse reaction monitoring, or consumer complaints, as well as those with high import volumes, broad consumer reach, and significant market influence in China.

3. Inspection Procedures and Key Focuses

The overseas inspection process is relatively complex. Based on current industry practice and publicly available information, it typically involves the following key stages and focuses:

3.1 Initiation and Preparation

Before formal inspections begin, the CFDI will initiate communication and coordination with the selected enterprises through several preparatory steps:

Annual Briefing Sessions: Typically held in March each year, these meetings outline the overseas inspection plan for the year, reveal the list of candidate companies, and notify the key points that the inspected entities need to cooperate with. Selected registrants, notifiers, and domestic responsible persons are required to attend. Common reasons for being included in the candidate list include a high number of adverse reaction reports or frequent non-compliant inspection results.
Issuance of Notification Documents: Companies selected for inspection will receive a series of documents, including the Notification of Overseas Inspection, Agent Authorization Form, and Product Basic Information Form. These are followed by a Notification of Overseas Inspection, which provides further details such as the inspection team composition, required documentation, inspection methods, and specific cooperation requirements.

At this stage, if serious problems are found in the use of ingredients, feeding records or process flow—such as the use of banned ingredients or unauthorized changes to production processes, the CFDI may suspend subsequent inspection procedures and directly order the relevant companies to make rectifications first.

3.2 Inspection Priorities and Targets

Inspection priorities are determined based on product risk levels and target user population. The general priority order is as follows:

Children’s special cosmetics > Children’s general cosmetics > Adult special cosmetics > Adult general cosmetics

The primary inspection targets are overseas registrants/notifiers and the production sites associated with the inspected products. CFDI typically selects one production site relevant to the problematic product for in-depth on-site inspection.

The inspection focuses on verifying product formula and actual production processes. Evaluations are conducted across five core dimensions: Personnel, Equipment, Raw Materials, Production Process, and Production Environment. These dimensions are evaluated to assess the manufacturer’s compliance with GMP.

3.3 Inspection Format and Participants

Format: Inspections may be conducted either on-site or via remote video, depending on the specific circumstances.
Participants: Effective execution of the inspection requires the coordination of multiple parties. Key participants typically include: CFDI inspectors; the legal representative or person in charge of the overseas registrant/notifier; the person in charge of product quality of the registrant/notifier and the actual production enterprise; Chinese domestic responsible person; at least three interpreters who are familiar with the enterprise and the inspected products.

3.4 Documentation Requirements

Enterprises are required to prepare extensive documentation in advance of the inspection, including Chinese translations and electronic copies. The required documentation generally aligns with Article 29 of the CSAR, and includes (but is not limited to):

Basic enterprise information

Documents and records related to the cosmetic production quality management system
Original records and information of R&D and production
Process flow charts, production operation videos, and other relevant materials

3.5 Possible Outcomes

Depending on the nature and severity of any issues discovered during the inspection, the NMPA may take one or more of the following actions:

Order rectification within a specified time frame;
Suspend the import or sale of the related products;
Initiate a product recall;
Initiate a formal investigation if the violation is suspected to breach legal provisions.

4. Typical Non-Compliance Cases

In recent years, the NMPA has repeatedly published findings from unannounced inspections of international cosmetic enterprises, revealing a range of non-compliance issues.

Below are representative cases published by the NMPA:

Cases of International Cosmetics Failing Unannounced Inspections
No.	Release Date	Enterprise Name	Issues Identified
1	November 23， 2017	Beiersdorf Daily Chemicals (Wuhan) Co., Ltd.	Improper packaging material storage; risk of cross-contamination; simultaneous maintenance and product production without separation.
2	September 29， 2018	Unilever (China) Co., Ltd	2 serious and 5 general defects, involving quality management, plant facilities, materials and product management, production management, etc.
3	December 19, 2018	Nivea (Shanghai) Co., Ltd	4 general defects related to organization and personnel, plant and facilities, and production management.
4	July 5， 2019	Gobo Cosmetics (China) Co., Ltd.	1 serious and 7 general defects, involving quality management, plant and facilities, equipment and production management, etc.
5	September 2, 2019	Kolmar Cosmetics (Beijing) Co., Ltd.	2 serious and 7 general defects across quality, labs, plant and facilities, materials and products, and production management.
6	January 17, 2020	Cosmax (Guangzhou) Co., Ltd.	Deficiencies in quality management, materials and product management, and production management.
7	November 17, 2023	HOYU CO.,LTD.	Arbitrary changes to the production process; suspected failure to comply with technical requirements in the cosmetic registration dossiers.
8	August 13, 2024	GP CLUB CO.,LTD. (South Korea)	Failure to implement a product release management system; lack of oversight over production activities of contract manufacturers.
9	September 18, 2024	CATALYSIS, S.L.	Use of a prohibited ingredient—diflorasone propionate—in cosmetic products.
*Note:* Cases 1–6 involve foreign-invested enterprises operating in China, while Cases 7–9 pertain to overseas headquarters or production sites of international companies.

These cases reveal several recurring problems among overseas cosmetics manufacturers:

Deficiencies in Product Quality Management Systems: Violations span multiple operational areas, including material and product control, facility and equipment maintenance, production procedures, quality assurance, and laboratory management.
Lack of Personnel Oversight: For example, in one case, the same individual signed both the inspector and reviewer fields using English initials—raising concerns about internal control and record authenticity.
Unauthorized Changes to Production Processes: Modifying manufacturing procedures without prior approval violates regulatory requirements and increases compliance risks.
Insufficient Control Over Contract Manufacturers: A lack of supervision and quality oversight of outsourced or entrusted manufacturing partners was also an issue.

It is worth noting that in the past two years, the NMPA has expanded its inspection scope beyond Chinese subsidiaries to include overseas headquarters and manufacturing sites, reflecting a clear move toward cross-border, source-based supervision. This evolving model enables stricter oversight across the entire product lifecycle and demonstrates China’s commitment to building a more comprehensive, rigorous, and globally integrated regulatory system.

Moreover, while only a limited number of inspection results have been publicly disclosed, industry insiders suggest that the actual number of unannounced inspections conducted by the NMPA is significantly higher. The published cases are typically chosen for their representativeness and serve as valuable reference points for enterprises seeking to improve regulatory compliance.

5. Conclusion

China’s overseas cosmetic inspections currently prioritize high-risk categories such as children’s and special cosmetics. However, as regulatory oversight strengthens, the NMPA is steadily expanding inspection frequency and coverage, with general cosmetics and more overseas entities likely to be included in the near future. Public disclosure of non-compliance findings is also expected to become routine, further encouraging improved industry compliance.

To succeed in the Chinese market, overseas cosmetic companies must proactively align with Chinese regulations, conduct thorough reviews of their ingredient sourcing, production, registration, and risk management processes, and establish robust, full-lifecycle quality systems. Strengthening coordination with domestic responsible persons is also essential to ensure accurate, traceable records and effective response during inspections.

In short, only by deeply embedding compliance into every stage of their operations can companies remain competitive and earn lasting trust from regulators and consumers in China.