According to “Cosmetics Supervision and Administration Regulations” (hereinafter referred to as “Regulations”), “Cosmetics Registration and Filing Management Measures” (hereinafter referred to as “Measures”) and “Cosmetics new raw materials registration and filing information management provisions” (hereinafter referred to as “Provisions”), Cosmetics Supervision and Regulation Department of NMPA to collect, organize the cosmetics industry is more concerned about the cosmetics of the new raw materials registration and filing related questions, and answered them one by one.
Q：What raw materials are managed according to the new cosmetic ingredients？
According to the “Regulations” provides that the first time in China’s territory for the first time in the use of natural or artificial raw materials in cosmetics as new cosmetic ingredients, registered, filed by the new cosmetic ingredients included in the catalog of cosmetic raw materials have been used before the new cosmetic ingredients are still in accordance with the management of new cosmetic raw materials.
It should be noted that only the expected method of use of raw materials, the use of parts, the purpose of use in line with the relevant attributes of cosmetics, cosmetics can be in accordance with the new ingredients to apply for registration or filing. Such as a raw material to play a role in the use of oral or injection, does not meet the “Regulations” on the use of cosmetic description, that is, “rubbing, spraying or other similar methods”, or the use of the raw materials, the use of parts, the purpose of the use of cosmetics does not fall within the scope of the definition, it can not be in accordance with the new cosmetic ingredients to apply for registration or for filing.
At the same time, according to the “Regulations” requirements, new cosmetic ingredients registration and filing information should be based on scientific research, objective and accurate description of the new raw material properties, characteristics and safe use requirements. Application for registration or filing of new cosmetic ingredients should be relatively clear, the registrant, the filing or the territory of the responsibility should be required to submit the registration of new cosmetic ingredients for the record information, and the legitimacy of the submitted information, authenticity, accuracy, completeness and traceability is responsibility.
Q:What are the circumstances of the raw materials do not belong to the new cosmetic ingredients?
The ingredients that meet one of the following circumstances are not new cosmetic ingredients:
- The raw materials included in the “Catalog of Used Cosmetic Raw Materials (2021 Edition)“. Cosmetics registrants, filers in the selection of raw materials in the catalog, should be consistent with relevant national laws and regulations, mandatory national standards, technical specifications of the relevant requirements, and assume responsibility for product quality and safety. If the use of more than the “maximum historical use”, should be in accordance with the “Cosmetic Safety Assessment Technical Guidelines” procedures and requirements to prove its safety.
- Included in the category of raw materials have been used in the specific raw materials. Such as the catalog has been included in the category of raw materials “collagen”, collagen, expressed as a general term for a category of raw materials, the category of raw materials contains different process sources such as animal tissue extraction, genetic recombination of collagen, but also contains different types such as type I collagen, type III collagen, etc.. In addition, the raw materials of “so-and-so plant extract” included in the “Catalog of Used Cosmetic Raw Materials (2021 Edition)”, for example, ” Ginseng Extract” means that the whole plant of ginseng and its extracts are used raw materials, and if declared separately, the raw materials of “Ginseng Juice” and “Ginseng Extract” are used raw materials. If “ginseng juice” or a specific part of ginseng is declared as a new ingredient, it will not be accepted.
- Raw materials that have been stipulated as prohibited components in the ” Cosmetic Safety Technical Regulations”. Such as human cells, tissues or products of human origin; anti-histamine drugs; hormone substances.
- The actual function of the raw materials beyond the definition of the scope of cosmetics. Such as “activate cells,” “regenerate cells,” “reduce the pigmentation of the wound site,” “promote healing effect “”Promote the discharge of heavy metals” and other raw materials with medical effects.
Q:How to correctly understand the new cosmetic ingredients for filing?
According to the “Regulations”, the state in accordance with the degree of risk of cosmetic raw materials to implement classification management, the higher risk of new cosmetic ingredients to implement registration management, other new cosmetic raw materials for the record management. New cosmetic raw materials for the record through the State Council Drug Administration online government service platform to submit the filing information required by the Regulations will be completed for filing.
The true meaning of the filing is a new ingredient filer to submit information to NMPA. After filing the new cosmetic ingredients, NMPA will publish the information of the new ingredients, it only means that the ingredients have completed the filing of the information submitted to meet the formal requirements, and the authenticity of the content of its information, scientific, and may not have verified the adequacy of. Publication of new cosmetic ingredients have been completed for filing information does not mean that the safety and functionality of the new ingredients recognized, not to mention the “successful approval”.
Q:After filing of new cosmetic ingredients, registrants, filers of new cosmetic ingredients should also fulfill what obligations?
According to the “Regulations” “Measures”, new cosmetic ingredients registrants, filers are responsible for the quality and safety. Already registered, filed a new cosmetic ingredient to implement safety monitoring system, safety monitoring period, new cosmetic ingredients registrants, filers should pay close attention to the safe use of new raw materials, in accordance with the “Regulations” requirements for the collection and collation of new raw material use of information related to the preparation of “cosmetic new ingredients safety monitoring of the annual report” in the cosmetic safety monitoring of new ingredients every year before the first 30 Within 30 working days before each full year of safety monitoring of new cosmetic ingredients, submit through the information service platform.
If the new cosmetic ingredients registrant, the filer found that the use of new ingredients in the process of the “Measures” should be reported to the technical review organization, or other circumstances that need to be reported, it should be immediately in accordance with the ” Regulations” requirements to prepare “new cosmetic ingredients safety risk control report”, through the information service platform to submit to the technical review organization.
Q:How to determine the attributes of new cosmetic ingredients, based on the new cosmetic ingredients should apply for registration or filing?
According to the Regulations, new cosmetic ingredients with anticorrosive, sunscreen, coloring, hair coloring, spot whitening function, registered by NMPA before use; other new cosmetic ingredients should be filed with NMPA before use. This is based on the principle of risk management, the relatively high risk of several types of raw materials to implement registration management, other raw materials filing management. In the cosmetic new ingredients in the process of research and development, often found that may have a variety of functions at the same time. New cosmetic ingredients registrants, filers before applying for registration or filing, the new ingredients may have the actual function of comprehensive sorting and full study, scientific and reasonable to make the new raw materials should be declared registered whether the situation of judgment.
In general, the new ingredients with a variety of functions at the same time, as long as one of the functions belongs to the situation should be registered, the new ingredients should be in accordance with the ” Regulations ” requirements for registration; if a variety of simultaneous functions do not belong to the situation should be registered, no matter how many types of functions, in accordance with the ” Regulations ” requirements to NMPA filing . New cosmetic ingredients registrant, the filer shall not intentionally conceal the actual function of the new ingredients, shall not be declared registered new cosmetic ingredients only for filing will be used in the production of cosmetics. Once such behavior is found, will be punished in accordance with the provisions of Article 59, paragraph 3 of the Regulations.
Source/ NMPA website
