Q1: What technical requirements should be considered when using New Cosmetic Ingredients(NCI) to produce cosmetics?
When using NCI for cosmetics production circulated in China, attention should be paid to the technical requirements outlined in the publicly disclosed registration and filing information regarding "Technical Requirements for New Cosmetic Ingredients". These requirements include the safe usage amount of the ingredient (maximum allowable concentration when used in cosmetics), the purpose of usage, suitability and scope of the ingredient, as well as other limitations, requirements, and cautionary statements.
Additionally, if an NCI is ordered to be temporarily suspended from use during the safety monitoring period, the registrant or filer of the cosmetics should also suspend the production and distribution of cosmetics containing such ingredients. Therefore, a safety assessment should be conducted when using new cosmetic ingredients to ensure the safety of the cosmetic.
Q2: What should be considered in the test report of products containing New Cosmetic Ingredients(NCI)?
According to Article 33(2) of the "Regulations on the Management of Registration and Recordation of Cosmetics", toxicological test reports of cosmetics using NCI still under safety monitoring should be submitted.
Q3: How to fill out the ingredient information if the product formula contains New Cosmetic Ingredients(NCI) still under safety monitoring?
If the product formula contains NCI still under safety monitoring, the name of the registered or filed ingredients should be used.
Q4: How should the filing/registration of cosmetics containing New Cosmetic Ingredients(NCI) still under safety monitoring be processed?
The registrant, filer, or responsible party within the country should submit a filing/registration application for finished products containing NCI only after confirmation from the registrant or filer of the NCI.
Q5: What test reports should be provided if there is a high likelihood of oral intake of the ingredient in cosmetics?
Depending on the function, characteristics, usage history in cosmetics both domestically and internationally, or edible history, the declaration of NCI is categorized into six situations, each requiring different toxicological test data. Regarding subchronic oral or dermal toxicity test reports, if there is a high likelihood of oral intake of the ingredient in cosmetics, subchronic oral toxicity tests should be provided.
Q6: How should New Cosmetic Ingredients(NCI) be declared if internationally recognized authoritative institutions have concluded that they are safe for use in cosmetics, or if NCI have been approved for use by overseas cosmetics regulatory authorities?
In addition to categorizing new ingredient declaration data according to the requirements outlined in the "Requirements for Registration and Filing Materials of New Cosmetic Ingredients", relevant content from evaluation reports of internationally authoritative safety assessment institutions, approval certificates from overseas cosmetics regulatory authorities, and other related documents should be organized and submitted as well.
Q7: How are storage conditions and expiration dates determined for New Cosmetic Ingredients(NCI)?
Storage conditions and expiration dates are determined based on the results of stability tests, which generally include destructive tests, accelerated tests, long-term tests, and other experimental methods. Registrants or filers of NCI should select the type of stability test data to provide based on the characteristics of the ingredients being registered or filed.
For NCI used for the first time domestically or internationally, at least three batches of accelerated tests or long-term storage test data of one year or more should be submitted. Depending on the expiration date of the ingredient, additional long-term storage test data for the remaining usage period should be provided annually within the three-year monitoring period.
Q8: What are the basic requirements for the safety monitoring period of New Cosmetic Ingredients(NCI)?
According to the "Administrative Measures for the Registration and Filing of Cosmetics" and the "Regulations on the Supervision and Administration of Cosmetics" the monitoring period for NCI starts from the date when a cosmetic product containing the NCI is first registered or filed, with a duration of 3 years. During this period, registrants, filers, or responsible parties within the country of NCI should submit an annual safety monitoring report through the information service platform within 30 working days before the end of each year.
The report should include basic information about the ingredient, production status of the ingredient, information of cosmetics companies using the new ingredient, summary of supervision, sampling, inspection, and recall of cosmetics using the new ingredient, and analysis report of adverse reactions monitoring by the registrants or filers of cosmetics using the new ingredient.
During the 3-year monitoring period, if any safety issues arise with the NCI, its registration/filling will be revoked; if no safety issues are found, the NCI will be included in the Catalogue of Cosmetics Ingredients Used in China.
At last, relevant stakeholders should pay attention to the filing status of new ingredients. For example: Ascorbic Acid has been already deregistered. It cannot be used in cosmetic products anymore.
Website for inquiries: https://www.nmpa.gov.cn/datasearch/home-index.html#category=hzp
