What kind of cosmetic ingredients can be managed as new ingredients?
According to the Cosmetics Supervision and Administration Regulations (hereinafter referred to as the CSAR), natural or artificial ingredients used in cosmetics for the first time in China are regarded as new cosmetic ingredients. Even if the ingredients are registered or filed, they can also be managed as new cosmetic ingredients before they are listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC). It should be noted that only when the intended use method, use site, and use purpose of the ingredients meet relevant attributes of cosmetics, can the cosmetic ingredients be registered or filed as new ingredients. If a certain ingredient is used by oral or injection – do not conform to the use method of cosmetics recorded in the CSAR, that is, “smear, spray or other similar methods”, or the use site and purpose of the ingredient do not fall within the scope of the definition of cosmetics, then the ingredient cannot be registered or filed as new cosmetic ingredients.
What kinds of cosmetic ingredients are not classified as new ingredients?
Ingredients that meet one of the following circumstances are not classified as new cosmetics ingredients:
- Ingredients that are listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC, 2021 edition). When cosmetic registrants or filers choose to use an ingredient listed in the IECIC, they shall comply with the requirements of the relevant national laws and regulations, mandatory national standards, and technical specifications, and bear the responsibility for product quality and safety. If the usage amount of the ingredient exceeds the "maximum historical usage", relevant registrants or filers shall prove its safety as per the procedures and requirements under the Technical Guidelines for Cosmetics Safety Assessment;
- Specific ingredients that fall under the ingredient categories listed in the IECIC (2021 edition). For example, “Collagen”, also known as collagen protein, is listed in the Inventory. Collagen is the general name of a category of ingredients that comprises collagens from different process sources such as animal tissue extraction, gene recombination, and of different types such as type I collagen, and type III collagen. In addition, when "certain plant extract" is listed in the Inventory of Existing Cosmetic Ingredients in China, the whole plant, as well as its extract, are all considered as being listed in the Inventory. Take "ginseng extract" as an example, ginseng extract and the whole plant both belong to existing ingredients. It will not be accepted when registrants or filers separately declare “ginseng juice” or specific parts of ginseng as new cosmetic ingredients.
- Ingredients that have been stipulated as prohibited substances under The Technical Guidelines for Cosmetics Safety, such as human cells, tissues, or products of human origin; antihistamine drugs; and hormones.
- Ingredients whose actual functions exceed the range of the definition of cosmetics, including ingredients with medical effects such as "activating cells", "promoting cells regeneration ", "reducing pigmentation at wound sites", "promoting healing", and "promoting the excretion of heavy metal".
What obligations should the registrants and filers of new cosmetic ingredients perform after the registration/filing is completed?
According to the CSAR, registrants and filers of new cosmetic ingredients shall be responsible for the quality and safety of new cosmetic ingredients. New cosmetic ingredients that have been registered or filed must go through a safety monitoring period when registrants and filers must pay close attention to the safe use of these new cosmetic ingredients, collect and sort relevant information and data on the use of these ingredients in accordance with the requirements of the CSAR, and prepare the Annual Report on the Safe Monitoring of New Cosmetic Ingredients. The report must be submitted to the technical review institution annually via the information service platform within 30 working days before reaching the one-year safe monitoring period.
How can I determine the registration type (registration or filing) based on the properties of the new cosmetic ingredients?
According to the CSAR, new cosmetic ingredients with functions of antisepsis, sun protection, coloring, hair dyeing, freckle removal, and whitening can only be used after registration via NMPA. Other new cosmetics ingredients must be filed via the NMPA before use. The administration of new cosmetic ingredients is based on the risk management principle, that is, ingredients with relatively high risks are subject to registration, and others are subject to filing. During the research and development period of new cosmetic ingredients, it is often found that a new ingredient may have multiple functions. Registrants and filers of new cosmetic ingredients should comprehensively sort out and fully study the functions of the new ingredients before registration or filing, and make a scientific and reasonable judgment on whether the new ingredients should be registered.
What I should do to the cosmetic products when the new ingredients included in the products are suspended for use?
If the new cosmetic ingredients are suspended from use during the safety monitoring period, the registration and filing information service platform will automatically identify the cosmetics using the new ingredients and inform of the circumstance. At the same time, relevant registrants and filers must suspend the production and operation of the cosmetics using the new ingredients.
What are the requirements for foreign language materials for the registration and filing of new cosmetics ingredients?
Article 4 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data stipulates that the registration and filing materials must use standardized Chinese characters. In addition to the registered trademark, website, patent name, name and address of overseas enterprises and other texts that must use other languages, as well as the English abbreviations used in the regulatory documents in China, all registration materials in other languages should be translated into Chinese completely and normatively, and the original text should be attached to the corresponding translation.
Is it possible for me to authorize more than one domestic responsible person for one new cosmetic ingredient?
According to Article 11 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, one new cosmetic ingredient shall not be authorized to more than one domestic responsible person.
What should I do when the power of attorney of the domestic responsible person for the new ingredients expires?
According to Article 11 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, after the authorization period specified in the power of attorney expires, registrants should submit the renewed power of attorney to extend the authorization period or change the domestic responsible person within 30 days before the authorization period expires.
What kind of information should be indicated in the power of attorney?
According to Article 11 of the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, the power of attorney must at least indicate the following information:
- name of the registrant, filer, and the domestic responsible person for the new cosmetic ingredients;
- the authorization relations;
- scope of authorization; and
- the authorization period.
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