China New Cosmetic Ingredient Registration & Filing Services

China NCI Requirements at a Glance

Is Your Ingredient a New Cosmetic Ingredient in China?

A new cosmetic ingredient (NCI) is generally a natural or artificial ingredient used in cosmetics in China for the first time. An NCI assessment may also be required when an existing ingredient will be used for a different purpose, at a different safe use level or under conditions not covered by its current regulatory status.

A reliable status assessment should go beyond a name or CAS-number search. It should review the ingredient’s Chinese, INCI and English names, composition, source, manufacturing process, molecular or biological characteristics, intended purpose, use level and the current IECIC records.

An NCI assessment is generally needed when:

• It is not included in the Inventory of Existing Cosmetic Ingredients in China (IECIC); or

• It is an existing cosmetic ingredient, but its intended purpose, safe use level or other applicable conditions of use will be changed.

The NCI pathway may not be appropriate when:

• The ingredient is already included in the IECIC and will be used within the applicable conditions;

• The ingredient is a specific material covered by an existing category entry. For example, where “collagen” is already listed, different types of collagen derived from animal tissues or produced through recombinant technology may be treated as existing cosmetic ingredients;
  

• The ingredient is prohibited under the Safety and Technical Standards for Cosmetics, is structurally, physicochemically and functionally similar to a prohibited ingredient, or is considered harmful to human health under normal, reasonable and foreseeable conditions of use following a safety risk assessment; or
  

• Its actual function, intended method of use or application site falls outside the legal scope of cosmetics, such as an ingredient intended to provide therapeutic effects.

Does Your Ingredient Require Registration or Filing?

China applies risk-based management to new cosmetic ingredients. The declared purpose must reflect the ingredient’s actual intended and scientifically supported functions.

Where an ingredient has multiple intended functions, registration is required if any declared or actual function falls within one of the five registration categories.

Key Considerations for Overseas Applicants

Who should own the China NCI registration or filing?

The choice of registrant or filing person affects regulatory responsibility, dossier control, customer access, supply-chain continuity and post-market monitoring. The ingredient manufacturer or technology owner is often best placed to control composition, manufacturing and study data. A brand owner or other group company may be considered when it owns the technology, controls the complete technical package and is prepared to assume the long-term regulatory obligations.

Before selecting the applicant, overseas companies should clarify data ownership, rights to use laboratory and literature evidence, customer authorization arrangements, access to confidential manufacturing information, change-control responsibilities and the consequences of changing the applicant, supplier or Domestic Responsible Person.

Domestic Responsible Person requirement

An overseas NCI registrant or filing person must designate a Chinese enterprise legal person as its Domestic Responsible Person (DRP). The DRP performs regulatory activities within the authorized scope and assists with submission, safety monitoring, risk control, reporting, recalls and communications with the Chinese authority.

The authorization should clearly identify the overseas applicant and DRP, the authorization relationship, scope and period. One NCI cannot be assigned to multiple Domestic Responsible Persons at the same time.

Confidentiality, public disclosure and data control

NCI projects may involve confidential composition, manufacturing, impurity and study information. The applicable submission, record-retention and public-disclosure treatment depends on the current dossier requirements and information-platform fields. Applicants should assess these requirements before transferring or submitting confidential technical materials.

Applicants should establish confidentiality agreements, document-access rules, version control and data-return arrangements before transferring technical materials to laboratories, consultants or the DRP.

Chinese-language and document-localization requirements

Foreign-language dossier materials generally need to be completely and accurately translated into standard Chinese, with original documents attached to the corresponding translations. Limited information may remain in another language when necessary, such as registered trademarks, URLs, patent names and overseas entity names and addresses.

Required Documents for NMPA New Cosmetic Ingredient Submission

The statutory dossier is organized around the following core areas. The exact submitted and retained materials depend on the applicable 2026 technical requirements.

1. Registration or Filing Information Form — Identifies the ingredient, registrant or filing person, DRP, intended function, proposed conditions of use and administrative information.

2. New Cosmetic Ingredient R&D Report — Describes development background, identity, source, composition, physicochemical properties, intended use, overseas regulatory and commercial history, and efficacy data.

3. Manufacturing, Stability and Quality-Control Information — Covers manufacturing process, key parameters, process-related risk substances, specifications, analytical methods, stability and batch consistency.

4. Safety Assessment Information — Integrates hazard, exposure, toxicological evidence, impurity profile.

5. Technical Requirements — Consolidates regulatory specifications and safe-use conditions applicable to the ingredient. Relevant information may be made public following registration or filing.

Retained-document rule: A document retained for inspection is still a required compliance record. It must be complete, traceable, version-controlled and available to the regulator when requested.

Testing and Safety Assessment Strategy

There is no single testing list for every NCI. The evidence strategy depends on the pathway, ingredient identity, composition, intended function, exposure, use level, biological activity, safe-use history, food-use history, existing data and the applicability of available methods.

REACH24H can assess whether overseas studies, literature, food-use history, cosmetic-use history, alternative methods or other evidence may contribute to the China safety assessment. Reuse or adaptation of data must be determined case by case.

Can overseas data reduce testing?

Potentially. Existing international data may support an adjusted testing and evidence strategy when the data are relevant, complete and compatible with the applicable Chinese technical requirements. Overseas safe-use history or a foreign study does not automatically create an exemption.

• The tested material is equivalent to the proposed China NCI;

• Specifications, composition and impurity profiles are comparable;

• The study method is scientifically valid and addresses the relevant endpoint;

• The exposure route and level are relevant to the proposed cosmetic use;

• The complete report and supporting information are available;

• The evidence can be accurately translated, explained and integrated into the Chinese dossier.

Can non-animal methods be used?

Alternative or non-animal methods may be considered when they are scientifically appropriate for the endpoint, ingredient and exposure scenario and are compatible with current China requirements. A method should not be selected only because it is accepted in another jurisdiction. Validation status, applicability domain, limitations, protocol design and dossier integration should be reviewed before testing begins.

China New Cosmetic Ingredient Registration or Filing Process

Stage 1: Preliminary Assessment and Account Preparation

The company first determines whether the proposed ingredient qualifies as a new cosmetic ingredient and whether registration or filing applies. A data-gap analysis is then conducted to identify any additional testing required. Overseas companies must also designate a Domestic Responsible Person and complete the necessary account authorization.

Stage 2: Testing and Dossier Preparation

Based on the data-gap analysis, the company arranges the required physicochemical, stability, risk-substance, toxicological and efficacy-related testing. The R&D report, safety assessment materials, technical requirements and other application documents are then prepared.

Stage 3: Submission and Review

The dossier is submitted through the NMPA information service platform. For ingredients subject to filing, NMPA publishes the filing information within five working days after submission. For ingredients subject to registration, the application undergoes formal review and a 90-working-day technical assessment. A registration certificate is issued upon approval.

Stage 4: Post-Market Safety Monitoring

The three-year safety monitoring period begins when the first finished cosmetic containing the ingredient completes product registration or filing. During this period, an annual safety monitoring report must be submitted to NMPA.

How Long Does China NCI Registration or Filing Take?

The total project timeline depends on characterization, existing data quality, testing, applicant readiness, translation and regulatory questions. Statutory authority timelines should not be treated as the complete project duration because assessment, testing and dossier preparation occur before submission, while supplementary responses and inspections may extend the process.

Filing Pathway

Filing is completed when the filing person submits the required dossier through the NMPA platform. NMPA generally publishes the relevant filing information within five working days after submission. This five-working-day publication period is not the project timeline, and the dossier remains subject to post-filing technical verification.

Registration Pathway

Time used for applicant preparation, testing, on-site inspection, sampling, expert consultation and certain other procedures may not be included in the statutory technical-assessment period.

What Determines the Project Cost?

NMPA currently charges no official administrative fee for NCI registration or filing. A project may nevertheless involve regulatory assessment, data-gap analysis, laboratory testing, study monitoring, dossier preparation, technical translation, DRP services, submission management, supplementary responses and post-market monitoring.

• Registration or filing pathway;

• Ingredient type, composition and technical complexity;

• Completeness and usability of existing global data;

• Number and type of additional studies;

• Need for long-term, human-use or function-related evidence;

• Overseas document quality and Chinese localization workload;

• Regulatory questions, corrective actions or inspections;

• DRP scope and post-market monitoring requirements.

A reliable timeline and cost estimate should therefore be prepared after reviewing the ingredient and its available technical package.

What Happens After NCI Registration or Filing?

Registration or filing is not the end of NCI compliance. The three-year safety monitoring period begins when the first finished cosmetic containing the NCI completes its own product registration or filing—not when the ingredient alone obtains a registration certificate or completes filing.

During the monitoring period, the NCI registrant, filing person or DRP must monitor use and safety, maintain relevant records and submit an annual safety-monitoring report within the required time. Current rules require the annual report to be prepared and submitted within the 30 working days before each safety-monitoring anniversary.

Finished cosmetic registrants or filing persons using the NCI must complete the required association or confirmation with the NCI registrant or filing person through the information platform and provide relevant use and safety information.

Where a potential safety issue is identified, the company may need to investigate, reassess safety and implement risk-control measures. Depending on the findings, the regulator may require correction, suspension of use, revocation of registration or cancellation of filing.

After the three-year period is completed without identified safety concerns, NMPA assesses whether the ingredient can be included in List II of the IECIC. Finished cosmetics remain subject to their own ongoing regulatory and safety obligations.

What Changed for China NCI Projects in 2026?

1. Simplified Submission and Record-Keeping Requirements

The Provisions on the Registration, Filing and Dossier Management of New Cosmetic Ingredients took effect on July 15, 2026. Certain materials, including functional evidence, testing method texts and validation materials, as well as accelerated and long-term stability study data, may now be retained by the company for regulatory inspection instead of being submitted.

The applicable technical requirements are set out in the Technical General Principles for Dossiers of New Cosmetic Ingredient Registration and Filing, which took effect on the same date.

2. Standardized Reporting of Ingredient Use Purposes

The Technical Guidelines for Cosmetic Ingredient Use Purposes (Trial) took effect on June 19, 2026. Companies should refer to the 72 ingredient use purposes listed in the guidelines when completing the relevant application information.

3. Use of Existing Data and Assessment of Alternative Methods

The 2026 requirements encourage companies to make appropriate use of existing safety background information, safe-use history, food-use history and available study data while ensuring the safety of the new ingredient.

Before submission, companies may assess whether existing toxicological data, internationally recognized test methods or alternative methods to animal testing can support the safety assessment and reduce unnecessary duplicate testing.

4. Updated Toxicological and Human-Use Test Methods

Under NMPA Announcement No. 51 of 2026, four test methods, including the Bacterial Reverse Mutation Test Method, were revised, and the Human Long-Term Use Test Method for freckle-removing and whitening new cosmetic ingredients was introduced.

These methods will take effect on March 1, 2027, and companies are encouraged to adopt them before the effective date.

How REACH24H Can Support

Based on the ingredient type, intended use, available data and market launch plan, REACH24H provides one-stop support covering pre-submission assessment, registration or filing, responses to technical queries and post-market compliance maintenance.

• Full-process new cosmetic ingredient registration and filing support;

• Toxicological data-gap analysis and submission strategy development;

• Assessment of existing data and the applicability of alternative testing methods;

• New cosmetic ingredient stability testing;

• Study monitoring for new cosmetic ingredient submissions;

• Cosmetic ingredient safety assessment reports;

• Technical responses and supplementary dossier preparation;

• Domestic Responsible Person services for new cosmetic ingredients.

Why Work with REACH24H?

REACH24H helps cosmetic companies navigate China’s evolving cosmetic regulatory framework with practical market-entry strategies and technical compliance support.

China-based Regulatory and Technical Coordination

REACH24H’s China cosmetics team follows NMPA requirements, NIFDC technical documents, filing-verification practices and registration-review developments, connecting regulatory interpretation with testing and dossier execution.

Multidisciplinary Cosmetic Expert Team

Our cosmetics team includes more than 40 professionals covering regulatory affairs, toxicology, cosmetic safety and risk assessment, formulation, technical documentation and multilingual project management. The team is supported by more than 20 toxicologists holding professional qualifications or credentials in China, the United States and the European Union, including DABT and ERT credentials.

Experience across Diverse Ingredient Categories

We have supported registration and filing projects for more than 60 new cosmetic ingredients, covering different regulatory pathways, ingredient sources and functions, including whitening, anti-wrinkle and hair-care ingredients. This experience supports the handling of complex dossier, testing and technical-response issues.

Start Your China NCI Assessment

To begin, provide as much of the following information as is currently available:

• Ingredient name, INCI name and CAS number;

• Source, composition and manufacturing process;

• Intended cosmetic function, product categories and maximum use level;

• Product specification and analytical information;

• Existing market or regulatory status;

• Available toxicology, stability, safety, human-use and functional data;

• Target China launch schedule;

• Applicant location, data ownership and proposed DRP arrangement.

REACH24H can use this information to assess the likely regulatory status, applicable pathway, applicant strategy, major data gaps, testing considerations and recommended next steps.

Frequently Asked Questions

Related REACH24H Resources

Explore related China cosmetics compliance guidance and services:

• China Cosmetic Registration & Filing/Notification — finished-product classification, dossier preparation and NMPA market-access support.

• China's Cosmetic Safety Assessment Report — China-specific safety assessment requirements for cosmetic products and ingredients.

• China’s Cosmetic Ingredient Submission Code — ingredient safety information submission and code-management support for cosmetic ingredient suppliers.

• Defining New Cosmetic Ingredients in China: Criteria and Examples — practical criteria for determining whether an ingredient should enter the NCI pathway.

• China Cosmetics Regulatory Update 2026 — an overview of the latest NMPA ingredient and market-access changes.

• China Cosmetics Regulations Update: May 2026 — coverage of the eight new or revised testing methods and other regulatory developments.

Official Regulatory Sources

Key official sources supporting the regulatory requirements summarized on this page include:

• NMPA service guide: New cosmetic ingredient filing — Official filing process, materials, publication timing and FAQs

• NMPA service guide: Registration of higher-risk new cosmetic ingredients — Official registration pathway and timing

• Provisions for Registration and Filing of Cosmetics — Official NMPA English text covering NCI filing, safety monitoring and annual reports

• NMPA Announcement No. 59 of 2026 — 2026 Provisions on NCI registration, filing and dossier management

• NIFDC Technical General Principles for NCI Dossiers — Effective July 15, 2026

• NIFDC Technical Guidelines for Cosmetic Ingredient Use Purposes — 72 standardized purposes; effective June 19, 2026

• NMPA Announcement No. 51 of 2026 — Eight new or revised testing methods; effective March 1, 2027

• NMPA Announcement No. 61 of 2025 on IECIC management — Dynamic List I and List II management

• NIFDC NCI Technical FAQ (III) — Safety-monitoring period calculation and obligations

• NIFDC NCI Technical FAQ (IV) — Registration vs filing and post-filing technical verification