How to determine whether a new cosmetic ingredient should apply for registration or notification based on the attributes of a new cosmetic ingredient?

Answer: According to the "Regulations", new cosmetic ingredients with antiseptic, sunscreen, coloring, hair dyeing, freckle removal and whitening functions can only be used after registration with the drug regulatory department of the State Council; Other new cosmetic ingredients shall be filed with the drug regulatory department of the State Council before use. This is based on the principle of risk management, which implements registration management for several types of relatively high-risk ingredients, and implements record management for other ingredients. In the process of research and development of new cosmetic ingredients, it is often found that a new ingredient may have multiple functions at the same time. Before applying for registration or notification, the registrant or notification person of a new cosmetic ingredient shall conduct a comprehensive combing and full study of the actual functions that the new ingredient may have, and make a scientific and reasonable judgment on whether the new ingredient should be declared for registration.

2025-02-18 visibility 3

How to correctly understand the notification of new cosmetic ingredients?

How to correctly understand the notification of new cosmetic ingredients? Answer: According to the provisions of the "Regulations", the state implements classified management of cosmetic ingredients according to the degree of risk, implements registration management for new cosmetic ingredients with a high risk, and implements notification management for other new cosmetic ingredients. The notification of new cosmetic ingredients shall be completed after submitting the notification materials specified in these Regulations through the online government service platform of the drug regulatory department of the State Council.　　The true meaning of notification is that the person notification the new raw material submits information to the Food and Drug regulatory department for future reference. After the notification of a new cosmetic ingredient has been completed, the State Food and Drug Administration (NMPA) publishes the notification information of the new ingredient, which only means that the raw material has completed the submission of the notification materials and meets the formal requirements, while the authenticity, scientificity and adequacy of the content of the materials may not have been verified. The disclosure of information about new cosmetic ingredients that have been notified does not mean that the safety and functionality of the new ingredients are recognized, let alone the so-called "successful approval for notification".　　According to the "Regulations" and "Measures", after the completion of the notification of new cosmetic ingredients, the Food and Drug regulatory department will organize a technical review agency to carry out technical verification of the notification materials of the new ingredients, and track and evaluate the use and safety of the new cosmetic ingredients. If it is found that the new cosmetic ingredients do not fall within the scope of notification, or if false information is submitted during the notification, the notification of the new cosmetic ingredients will be cancelled; If a new cosmetic ingredient is ordered to suspend the use or cancel the notification, the cosmetics registrant or notification person shall at the same time suspend or stop the production or operation of cosmetics using the new ingredient.

2025-02-18 visibility 3

Under what circumstances are the ingredients not considered new cosmetic ingredients?

Answer: Ingredients that meet one of the following conditions are not new cosmetic ingredients:　　1. Ingredients included in the "Catalogue of Used Cosmetic Ingredients (2021 Edition)". When selecting the ingredients in the catalogue, the cosmetics registrant and notification person shall comply with the relevant requirements of relevant national laws and regulations, mandatory national standards and technical specifications, and bear the responsibility for product quality and safety. If it is necessary to use it beyond the "maximum historical dosage", its safety should be proved in accordance with the procedures and requirements of the Technical Guidelines for the Safety Assessment of Cosmetics.　　2. Specific ingredients included in the categories of ingredients used. For example, the catalog has included the category of ingredients "collagen", that is, collagen, which is the general term of a certain category of ingredients, which includes different process sources such as animal tissue extraction, genetically recombinant collagen, and also contains different types such as type I collagen, type III collagen, etc. In addition, the ingredients of "a certain plant extract" included in the "Catalogue of Used Cosmetic Ingredients (2021 Edition)", such as "ginseng extract", indicate that the whole ginseng plant and its extract are used ingredients, and if the "ginseng juice" or a specific part of the ginseng is a new raw material, it will not be accepted.　　3. The "Safety and Technical Standards for Cosmetics" has been specified as ingredients with prohibited components. Such as human cells, tissues or human-derived products; antihistamines; hormones, etc.　　4. Ingredients whose actual functions are beyond the definition of cosmetics. For example, it has a medical effect of ingredients such as "activating cells", "regenerating cells", "reducing pigmentation at the wound site", "promoting healing and synergy", and "promoting heavy metal efflux”.

2025-02-18 visibility 2

What ingredients are managed according to the new cosmetic ingredients?

Answer: According to the "Regulations", the natural or artificial ingredients used in cosmetics for the first time in China are new cosmetic ingredients, and the new cosmetic ingredients that have been registered and filed are still managed according to the new cosmetic ingredients before they are included in the catalogue of used cosmetic ingredients.　　It should be noted that only if the intended use method, use site and purpose of the raw material meet the relevant attributes of the cosmetic product, can the application for registration or notification according to the new cosmetic raw material be applied. If the use method of a certain ingredient is oral or injection, which does not conform to the description of the use of cosmetics in the Regulations, i.e., "rubbing, spraying or other similar methods", or if the use site and purpose of the ingredient do not fall within the definition of cosmetics, it cannot apply for registration or notification according to the new cosmetic ingredient.　　At the same time, according to the requirements of the Provisions, the registration and notification materials of new cosmetic ingredients shall be based on scientific research, and objectively and accurately describe the characteristics, characteristics and safe use requirements of the new ingredients. The ingredients of new cosmetic ingredients applied for registration or notification shall be relatively clear, and the registrant, notification person or domestic responsible person shall submit the registration and notification materials of new cosmetic ingredients as required, and shall be responsible for the legality, authenticity, accuracy, completeness and traceability of the submitted materials.

2025-02-18 visibility 2