FAQs Vol. 2 | China NMPA Answers Key Questions about New Cosmetic Ingredient (NCI) Registration/Notification

According to Cosmetic Supervision and Administration Regulation (CSAR), natural or artificial ingredients used in cosmetics for the first time in Chinese mainland is new cosmetics ingredients. Before the registered/notified NCI is listed in Inventory of Existing Cosmetic Ingredients in China (IECIC), it shall still be managed as a new cosmetic ingredient.

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

• The ingredient efficacy needs to be achieved by oral administration or injection of the product. The reason is the application method is not within the scope of that of cosmetics (spreading, spraying, or other similar methods);

• Ingredient whose application part or intended purpose is not within the scope of that of cosmetics.

NCI’s registration and notification documents shall be based on scientific research, and objectively and accurately describe the NCI’s traits, characteristics, and safety use requirements. The composition of NCI for registration or notification should be clear. The registrant, notifier, or domestic responsible person shall submit the registration and notification documents as required, and be responsible for the legality, authenticity, accuracy, completeness, and traceability of the documents submitted.

The following four kinds of ingredients do not belong to NCIs in China:

1) Ingredients included in Inventory of Existing Cosmetic Ingredients in China (IECIC). The ingredients in IECIC shall be used in accordance with the requirements of laws, regulations, mandatory national standards, and technical specifications. The cosmetic registrant/notifier shall bear the product quality and safety responsibilities. If the ingredient's concentration exceeds the "highest historical used concentration" specified in IECIC, the registrant or notifier shall conduct a safety assessment in accordance with Technical Guidelines for Cosmetic Safety Assessment;

2) Specific ingredients belong to group ingredients. For example:

• “Collagen” in IECIC is a general term for a group of ingredients. It includes collagen from different sources (e.g., animal tissue extraction, genetic recombination, etc.), as well as different types (e.g., type I collagen, Type III collagen, etc.);

• “Panax Ginseng Extract" in IECIC indicates that the whole ginseng plant and its extract are existing ingredients in China. NMPA will not accept NCI registration/notification applications for, e.g., "Panax Ginseng Juice" or other specific parts of Panax Ginseng.

3) Prohibited cosmetic ingredients stipulated in Safety and Technical Standards for Cosmetics, such as cells, tissues, or products of human origin; antihistamines; hormones.

4) Ingredients with efficacies beyond that of cosmetics, such as medical efficacies of activating cells, regenerating cells, reducing the pigmentation of the wound, promoting healing, and promoting the efflux of heavy metals.

NMPA implements classified management of NCI. NCIs with higher risk levels are subject to registration management, while other NCIs are subject to notification management. NCI notification is completed after the notifier submits all the documents as required by NMPA.

The true meaning of NCI notification is that the notifier submits the required documents to NMPA for future review. The notification information being made public only represents that the NCI notifier has completed the submission of the documents, and the documents meet the format requirements. NMPA may not have verified the documents' authenticity, scientificity, and adequacy, nor does it mean that NMPA recognizes the NCI's safety and efficacy. Notification information disclosure should not be interpreted as “successfully obtaining the notification approval."

After the notifier completes the documents submission, NMPA will organize a technical review of the documents and conduct a follow-up assessment of NCI’s use and safety. If any non-compliance in the documents is found, NMPA will order notifier to make corrections within a time limit, among which:

• If the non-compliance is related to ingredient safety, NMPA can also suspend NCI’s sale and use;

• If the NCI shall not be managed by notification, or if false information is submitted, NMPA will cancel the NCI notification;

• If the NCI is ordered to suspend the use, or the notification is canceled, the cosmetic product registrant/notifier shall also suspend or stop the production and operation of all products containing this NCI.

NCI registrant/notifier is responsible for NCI’s quality and safety. Registered/notified NCI shall be subject to the safety monitoring system. During the safety monitoring period, the registrant/notifier shall pay close attention to NCI’s safe use, collect and sort out information related to its application, compile an annual safety monitoring report, and submit it to technical review agency within 30 working days before the expiration of the annual safety monitoring period.

If any situation that shall report to the technical review agency is found, the registrant/notifier shall immediately prepare a safety risk control report and submit it to the technical review agency.

NCIs with higher risk levels (preservative, sunscreen, colorant, hair dyeing, freckle-removing and whitening ingredient) are subject to registration management, while other NCIs are subject to notification management.

But in the R&D process, an ingredient may have multiple efficacies. Before applying for registration/notification, the registrant/notifier shall comprehensively sort out and research the actual efficacies that the NCI may have, and make a scientific and reasonable decision on whether the NCI should apply for registration.

In general, for NCI with multiple efficacies:

• If one of the efficacies is subject to registration management, the NCI shall be applied for registration, and can be used in cosmetic products after being approved by NMPA;

• If all the efficacies of a NCI are subject to notification management, no matter how many efficacies it has, the NCI can be applied for notification with NMPA.

The registrant/notifier shall not deliberately conceal NCI’s efficacies or produce cosmetics using NCI that shall be registered but only completes notification. Once such illegal behavior is found, related companies will be punished in accordance with Article 59, Paragraph 3 of CSAR.