China New Cosmetic Ingredient (NCI) Regulation

In China, cosmetic ingredients are categorized as new cosmetic ingredients and existing cosmetic ingredients. Existing cosmetic ingredients refer to ingredients included in the Inventory of Existing Cosmetic Ingredients in China (IECIC), a comprehensive reference that includes all ingredients used in cosmetics produced and sold in China. Ingredients not on this list are considered new cosmetic ingredients (NCIs). Companies intending to introduce new ingredients into their products shall undergo a pre-market registration or notification process.

Since the implementation of the Cosmetic Supervision and Administration Regulation (CSAR) in 2021, China has adopted a risk-based classification system for regulating NCIs, overseen by the National Medical Products Administration (NMPA). This framework has facilitated the approval of nearly 400 new ingredients, representing a substantial increase in new ingredient notifications. This shift also highlights the growing significance of ingredient innovation for beauty companies to maintain a competitive edge.

Part 1 Regulatory Framework and Competent Authority

1. Main Regulations for NCI in China

2. Competent Authority

NMPA is established under the governance of the State Administrative for Market Regulation (SAMR) to take all the work of the former CFDA. NMPA is tasked with developing and enforcing regulatory policies and standards for cosmetics, including overseeing NCIs to comply with related regulations and standards. This involves managing the registration and notification processes and monitoring the market to ensure their safe and effective use, thereby safeguarding consumer health.

Part 2 Definition and Classification of NCI

1. Definition

Cosmetic ingredients not listed in IECIC are considered NCIs. According to Article 11 of CSAR, a new cosmetic ingredient refers to a natural or artificial ingredient applied to cosmetic products for the first time in China. Such an ingredient must obtain approval from the NMPA before it can be used in cosmetics. After a three-year monitoring period, it will be included in the IECIC. Until then, it will remain regulated as a new cosmetic ingredient.

It should be noted that only when the application method, application area, and the intended purpose of the ingredient meet the attributes of cosmetics, can it be registered or notified as an NCI. The following two kinds of ingredients cannot be registered or notified as NCIs:

• The ingredient efficacy needs to be achieved orally or by injection. The application method is not aligned with the definition of cosmetics use (spreading, spraying, or other similar methods).

• Ingredient whose application area or intended purpose falls outside the definition of cosmetics—cosmetics should be applied on the external part of human body (such as skin, hair, or lip) for cleansing, protecting, beautifying, or grooming purposes.

2. Classification

Starting from May 1, 2021, China has adopted a risk-based classification system for new cosmetic ingredients with corresponding regulatory requirements.

High-risk NCIs require comprehensive registration and approval from the NMPA, including format review and technical review. Relative high-risk and Low-risk NCIs are subject to a less rigorous regulatory framework. Instead of requiring registration and approval, these ingredients are subject to notification.

Part 3 Notification and Registration of NCI

Cosmetic companies seeking to use NCIs or cosmetic ingredient companies intending to export NCIs to China must go through registration or notification, depending on the risk classification of the ingredient.

1. Application Process

For overseas companies, they shall authorize a Chinese enterprise as the Responsible Person (RP). The RP plays a crucial role in facilitating the application process. Responsibilities of the RP include applying for an application account, arranging NCI testing, and preparing application dossiers.

When applying for high-risk ingredients, the registrant shall submit the required documents to the NMPA. The NMPA will complete a format review within 5 working days. If the documents are complete and meet relevant requirements, they will be forwarded for technical review, which will be completed within 90 working days. After approval, a registration certificate will be issued, and the information will be made public within 5 working days. The entire registration process takes a maximum of 128 working days.

For the notification process of relatively high and low-risk ingredients, companies shall submit the dossiers online to have their ingredients considered as “notified” and eligible for manufacture or import. The basic notification information will be made public within 5 working days after the submission. This streamlined approach enhances notification efficiency and enables NCIs to reach the market more quickly.

2. Dossiers Necessary for Notification and Registration

On July 8, 2024, NMPA announced the full implementation of the electronic submission for NCI registration and notification materials. Starting from September 1, 2024, all Chinese domestic registrants, notifiers, responsible persons, and cosmetics manufacturers will be required to submit registration and notification materials for NCIs through the online platform Cosmetics Registration and Notification Information Service. Paper submissions will no longer be required but domestic entities should archive the relevant paper documents.

The required notification dossiers for account application and NCI registration & notification are detailed below.

On April 22, 2024, NMPA unveiled the Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management, pointing out that starting from May 1, 2025, cosmetics registrants and notifiers are required to submit the full version of the safety assessment report when applying for registration or notification.

On September 24, 2025, NIFDC released General Technical Guidelines for Notification and Registration Dossier of New Cosmetic Ingredients (Draft for Comments). The Draft introduced optimized classification of NCI situations and streamlined toxicological test requirements. Based on the updated classification, certain toxicological and human safety testing requirements are proposed to be exempted accordingly.

3. Safety Monitoring and Reporting

According to the Administrative Measures on Cosmetics Registration and Notification, new cosmetic ingredients that have been registered or notified are subject to a safety monitoring system. The safety monitoring period is 3 years, starting from the date when the cosmetics containing the new ingredient are registered or notified for the first time.

During this monitoring period, registrants and notifiers must submit annual reports on the use and safety data of the new ingredient to the NMPA and may be required to perform safety assessments. If safety concerns arise with any new cosmetic ingredients, their registration or notification may be revoked. On June 24, 2025, the NMPA introduced major adjustments to the IECIC, restructuring it into two distinct lists. Ingredients that demonstrate no safety concerns after a three-year monitoring period will be incorporated into IECIC II.

4. Safety Re-assessment

For the NCIs that have already been included in the IECIC, registrants or notifiers may be required to take additional assessments if there is a new recognition of its safety or evidence showing that the NCI may have any safety risks. If the re-assessment confirms that the NCI poses safety risks, the NCI will be prohibited from use or subject to a use restriction.

For comprehensive notification details on NCIs, please refer to our Cosme-list.