China Cosmetics Inspection Draft Measures have been released by the National Medical Products Administration (NMPA) for industry comment by November 10, 2023.
The “Administrative Measures on Cosmetic Inspection” (Draft for Comments) is a comprehensive regulatory framework aimed at standardizing the inspection of cosmetic products in China.
Word of caution
Whilst it is stated these measures are for the inspection of cosmetic manufacturers and operators within China, it is not explicitly stated that they apply to overseas manufacturers. Precaution should be taken by overseas manufacturers as the measures may potentially apply to any product that is distributed in China, regardless of whether it is domestically produced or imported – see the summary of article 2 below. What’s more, there is no mention of inspections on overseas entities or overseas inspections in these measures, however, Measures for Overseas Cosmetics Inspections remain on the “to be drafted legislation” list.
These rules are of particular importance, therefore, as they could potentially affect the development of regulations for overseas inspections and could also be used in the training of inspectors.
They encompass various aspects of cosmetic inspections, including their initiation, procedures, requirements, and coordination mechanisms. This summary provides a detailed overview of the key provisions within the document.
Chapter I: General Provisions
Legislative Purpose: These measures are established to standardize cosmetic product inspections in accordance with existing regulations and rules, such as the Cosmetic Supervision and Administration Regulations (CSAR).
Scope of Application: The measures apply to inspections conducted by Medical Products Administration (MPA) departments on cosmetic producers and operators within China. Inspections aim to ensure compliance with laws, regulations, standards, and technical requirements outlined in cosmetic registration or notification dossiers.
Basic Principles: Cosmetic inspections adhere to principles of being law-based, impartial, scientific, standardized, and risk-focused.
Assignment of Responsibilities: The NMPA oversees national cosmetic inspection and management, while local medical products administration departments manage inspections within their respective regions.
Obligation to Cooperate with Inspection: Cosmetic producers and operators must cooperate fully with inspections, providing accurate records and information. Refusal, evasion, or obstruction of inspections is prohibited.
Inspection Institution: Inspection institutions, established or designated by law, conduct inspections, with national inspection institutions organizing inspections of cosmetic production processes and guiding regional medical products administration departments.
Inspection Classification: Cosmetic inspections are categorized as license inspection, routine inspection, causal inspection, and other inspections based on their nature and purpose.
Inspection Method: Cosmetic inspections involve on-site and off-site methods. On-site inspections may be announced or unannounced, while off-site inspections involve examining written materials and may include remote inspection using digital technology.
Chapter II: Inspection Procedures and Requirements
Inspection Initiation: MPA departments can assign inspection tasks or conduct inspections themselves. Relevant information about the inspected objects and inspection requirements must be provided when assigning tasks.
Inspector: Inspectors, comprising at least two individuals with professional knowledge and legal expertise, are responsible for conducting inspections. Experts from specific fields may be invited when necessary.
Presentation of Document: Inspectors must present their credentials and authorization documents upon arrival at the inspected object’s site.
Inspection Implementation and Record: Inspectors conduct on-site inspections and maintain records, including basic information, inspection reasons, discovered problems, and supporting documents.
Statement and Argument: Inspected entities have the right to make statements and arguments on-site if they disagree with inspection records, which inspectors must truthfully record and verify.
Risk Control: If cosmetics pose harm or threats to health, inspectors report to their dispatching unit. Emergency control measures may be implemented, including production suspension.
Rectification within a Fixed Period: Inspected entities must rectify identified issues within a specified time frame, submitting a rectification report. Supervision and on-site re-inspections may follow.
Chapter III: License Inspection
Initiation of License Inspection: License inspections verify whether applicants meet regulatory conditions during cosmetic production license issuance, renewal, or changes.
On-Site Verification: Specific items listed in inspection points related to Good Manufacturing Practices (GMP) are verified during license inspections.
Chapter IV: Routine Inspection
Initiation of Routine Inspection: Routine inspections, guided by risk management principles, assess compliance with laws, standards, and technical specifications.
Inspection Plan: MPA departments formulate plans, determining scope, focus, methods, and requirements. Key areas include children’s cosmetics, special cosmetics, and those using new ingredients.
Inspection Focus: Key inspection items are determined based on the inspection’s purpose. Cosmetic registration and notification applicants and operators are scrutinized against key items in GMP.
Inspection Method: Routine inspections primarily involve on-site visits. Off-site inspections may be used based on prior assessments and risk evaluations.
Chapter V: Causal Inspection
Initiation of Causal Inspection: Causal inspections are triggered by various circumstances indicating potential quality and safety risks, including adverse reactions, complaints, and public opinion trends.
Inspection Focus: Causal inspections focus on potential violations of laws, regulations, standards, or technical specifications related to cosmetics.
Inspection Method: Causal inspections are unannounced, with inspectors promptly entering inspection sites and conducting direct assessments.
Chapter VI: Coordination between Inspection and Check and Cross-regional Assistance
General Requirements: Coordination between inspection and subsequent investigations is vital, with various departments collaborating and fulfilling their roles.
Coordination between Inspection and Check: Inspection institutions transferring suspected illegal behavior to evidence-accepting departments for further investigation and evidence collection. Evidence must be related to specific violations.
Evidence Standards: Evidence materials must relate to the inspected entity’s illegal behavior, verified by relevant personnel or official seals.
Inspection and Review Report: Inspection institutions issue reports, including essential information, inspection details, problems found, handling opinions, and inspection conclusions.
Feedback on Case Filing: Evidence-accepting departments inform inspection dispatching units of case filing decisions within five working days.
Feedback on Handling Results: Evidence-accepting departments communicate administrative penalty decisions to inspection dispatching units within ten working days.
Cross-regional Assistance: MPA departments may request assistance in cross-regional investigations. Assistance may involve evidence collection and joint investigations.
Cross-regional Evidence Notification: Departments discovering cross-regional illegal evidence notify relevant jurisdictions for further action.
Chapter VII: Handling of Inspection Results
Classification of Inspection Results: Inspection results guide appropriate handling measures, including rectification, suspension of production, recalls, investigations, interviews, credit recording, etc.
Termination of Risk Control: After mitigating safety risks, inspected entities can apply for the termination of risk control measures.
Rejection and Evasion of Inspection: Refusal, evasion, or obstruction of inspections leads to the presumption of hidden safety hazards. Relevant authorities handle such cases according to regulations.
Information Disclosure: Inspection information is disclosed on government websites, including basic details, inspection basis, and results.
Chapter VIII: Supplementary Provisions
Implementation by Reference: Specific inspections, such as those related to new cosmetic ingredients, toothpaste, and extended supplier inspections, can refer to these measures.
Implementation in Accordance: Inspection of toothpaste production and operation follow these measures.
Detailed Rules for Implementation: Local MPA departments can formulate detailed rules for cosmetic inspections within their regions.
Implementation Date: These measures come into effect on a specified date in 2024.
In summary, the “Administrative Measures on Cosmetic Inspection” establishes a structured framework for the inspection of cosmetic products in China. Regulatory affairs professionals should familiarize themselves with these measures to ensure compliance and facilitate the successful production and distribution of cosmetics within the country.
How to submit comments
If you have any comment or suggestion on the China cosmetics inspection draft measures, please send email to hzpjgc@nmpa.gov.cn before November 10, 2023, with the email subject “cosmetics inspection measures – feedback”.
Further information
Read the original article on China cosmetics inspection draft measures.
For further information about inspections on cosmetics, please read our articles on:
- general cosmetics self-inspections
- sampling inspections which came into force on March 1, 2023
- GMP inspection points
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