China New Cosmetic Ingredient Registration and Filing
According to the Rules for Registration and Notification Dossiers of New Cosmetic Ingredients implemented on May 1, 2021, and other regulatory documents, the natural and artificial ingredients first used in cosmetics within the territory of China are considered as new cosmetic ingredients.
The Catalogue of Used Cosmetic Raw Materials (Edition 2021) (generally known as China IECIC 2021) can be used as a basis for judgement, and cosmetic ingredients not included in this Catalogue can be regarded as new cosmetic ingredients. New cosmetic ingredients with high safety risks shall implement registration management, other new cosmetic ingredients shall implement filing management. Feel free to hit me up by booking a meeting.
Types of New Cosmetic Ingredients Registration and Filing in China
The registration management of high-risk new cosmetic ingredients with functions of preservative, sunscreen, colorant, hair dye, spot corrector and whitening shall be implemented.
The filing management of other new cosmetic ingredients shall be implemented.
Those who adjust the purpose of use and safe use amount of the used cosmetic ingredients shall apply for registration and filing in accordance with the rules for new cosmetic ingredients registration and filing.
Identification of New Ingredients in Cosmetics
Ingredients that meet one of the following conditions are not defined as new cosmetic ingredients:
1. Ingredients included in the Catalogue of Used Cosmetic Raw Materials (Edition 2021).
2. The specific ingredients included in the Catalogue of used ingredients. For example, "ginseng extract" means that the whole ginseng plant and its extract both are used ingredients. If a separate declaration of "ginseng juice" or a specific part of ginseng is a new ingredient, it will not be accepted.
3. Ingredients that have been specified as prohibited components in the Technical Specification for the Safety of Cosmetics. Such as human cells, tissues, or human-derived products; antihistamines; hormones, etc.
4. Ingredients whose actual functions exceed the cosmetic product definition. For example, ingredients include medical functions, which can "activate cells", "regenerate cells", "reduce pigment deposition at the wound site", "promote healing" and "promote the efflux of heavy metals", etc.
User Information Registration
The registrant and filing applicant shall fill in the following information through the information service platform before applying for new cosmetic ingredients registration or filing:
Information of registrant and filing applicant of new ingredients in cosmetics.
Overview of the safety monitoring and evaluation system for registrant and filing applicant of new ingredients in cosmetics.
Domestic responsible person shall submit the original copy of the domestic responsible person's authorization letter and its notarization certificate when filling the information.
Registration and Notification Dossiers of New Cosmetic Ingredients
The following materials shall be submitted when applying for new cosmetic ingredients registration or filing:
The name, address, and contact information of the registrant, filing applicant, and domestic responsible person.
R&D report of new cosmetic ingredients.
Research materials on the manufacture process, stability, and quality control standards of new cosmetic ingredients.
Safety assessment documents of new cosmetic ingredients.
Safety Monitoring System for New Cosmetic Ingredients
New cosmetic ingredients that have already obtained the registration certificate or completed cosmetic notification shall establish a safety monitoring system with 3 years of monitoring period. It shall be counted from the date when the cosmetics first using new ingredients obtain the registration certificate or complete cosmetic notification.
The registrant or filing applicant of new cosmetic ingredients can use the new cosmetic ingredients to produce cosmetics within the safety monitoring period.
The registrant or filing applicant of new cosmetic ingredients shall establish a post-market safety monitoring and evaluation system, conduct follow-up research on the safety of new cosmetic ingredients, and continuously monitor and evaluate the use and safety of new cosmetic ingredients.
The registrant and filing applicant of new cosmetic ingredients shall summarize and analyze the use and safety of new cosmetic ingredients within 30 working days before each full year of safety monitoring of new cosmetic ingredients, and form an annual report and submit it to the National Medical Products Administration (NMPA).
New Cosmetic Ingredients Registration and Filing Process
Our Services Related to New Cosmetic Ingredients Registration and Filing
Before the project start-up
1. New cosmetic ingredients review: identify the new cosmetic ingredient and determine its application type
2. Questionnaire on basic information of new cosmetic ingredient registration and filing: collect existing safety data of new cosmetic ingredients
3. Estimation of project fee and feasibility analysis
Mid-term of project
1. Review of toxicology test report
2. Writing of safety assessment report
3. Laboratory communication and test supervision and management
All the above are followed up by China certified toxicologists of EnterCo
1. Account application: basic information collection and assistance in sorting and establishing safety risk monitoring and evaluation system
2. Review of necessary data related to R&D and production of target ingredients with self-built China Cosing (cosmetic ingredient data)
Later stage of project
1. Dossiers compilation: technology experts of new cosmetic ingredients and China certified toxicologists review the application documents
2. System submission and follow-up
3. Provision of annual report preparation services