Analysis of the latest regulations: Key points in the "General Technical Rules for Registration and Filing Materials of New Cosmetic Ingredient (Draft for Comments)"

 On September 24, 2025, the Central Inspection and Quarantine Office issued a notice to publicly solicit opinions on the "Technical General Principles for the Registration and Filing Materials of New Cosmetic Ingredient (Draft for Comments)" (hereinafter referred to as the "Technical General Principles (Draft for Comments)"). As a practitioner who has experienced the compliance field of new cosmetic ingredient in China for more than 10 years, I am deeply aware that this will be a particularly weighty document that deserves our careful analysis, thinking and learning. The full text of "Technical General Principles (Draft for Comments)" is more than 40 pages and more than 14,000 words, with a lot of essence. Here are only 5 key points for everyone to learn from:

01 Adjustment of situation classification

In the "Technical General Principles (Draft for Comments)", new ingredients are classified from different dimensions such as source technology and risk level. Compared with the "Data Regulations", the classification of some cases has been optimized and adjusted. For example, case 1 only retains new ingredients with antiseptic, sunscreen, coloring, hair dyeing, freckle removal and whitening functions that are managed according to the registration system.

Comparison of the old and new classifications: It can be seen from the table that except for Situation 5 and Situation 6, which have slightly smaller changes, the content of the other four situations has changed significantly. The new classification is more in line with the scientific logic of risk management. At the same time, regarding the classification of situations, companies need to know that no matter what the situation is, the registrant/filer needs to conduct a comprehensive risk assessment based on the characteristics and usage of the ingredients and then determine the classification of the situation and be responsible for it. This strengthens the main responsibility and scientific assessment ability requirements of the registrant/filer.

02 Requirements for data items

In the "Technical General Principles (Draft for Comments)", the list of materials for declaration of new cosmetic ingredients is divided into two: the requirements are clearer and more detailed, and some data items are reasonably optimized and reduced based on actual risks. For example, all registration and filing of new cosmetic ingredient require influencing factor testing during stability studies; for new ingredient belonging to Scenario 1, "long-term human trial safety testing" is no longer required for all new ingredient, and this requirement is retained only for new ingredient with anti-freckle and whitening functions; only new ingredient in Scenario 1 need to provide reproductive and developmental toxicity tests and chronic toxicity/carcinogenicity combined tests (and note: on the premise of sufficient scientific basis, If the relevant safety risks can be fully assessed through other data and information, relevant scientific basis and research data can be provided, and the corresponding tests can be exempted); for acute oral or dermal toxicity, reproductive and developmental toxicity, chronic toxicity/carcinogenicity tests, if there is sufficient scientific basis, if the relevant safety risks can be fully assessed through other data and information, relevant scientific basis and research data can be provided, and the corresponding toxicology tests can be exempted or exempted).

In order to fully implement the main responsibility of the person notifying new ingredient, pay attention to the safety risks of new ingredient, and improve the efficiency of registration and filing, the "Technical General Principles (Draft for Comments)" clarifies that some information can be kept on file for future reference. For example, under certain conditions, some new ingredient functional basis data, test method texts and verification data, accelerated test and long-term stability test data, etc., can be kept on file for future reference. For information that is kept on file for future reference as required, the person notifying the new raw material or its domestic responsible person should properly keep it. If a third party is entrusted to conduct research, the storage responsibility can be agreed with the third party.

03 About animal alternatives

The "Technical General Principles (Draft for Comments)" further optimizes the requirements for the use of animal alternative methods. If the animal alternative method used has not been included in my country's "Technical Safety Specifications for Cosmetics", a method that has been verified and included by an internationally recognized alternative method verification agency can be used, and the methodological background information and supporting information that have been verified and included by relevant institutions can be submitted.

In recent years, the National Medical Products Administration has accelerated the verification and transformation of international animal alternative methods, and the "Technical General Principles (Draft for Comment)" has further reduced or optimized toxicological tests in new situation classifications. It is expected that in the later registration and filing applications of new cosmetic ingredients produced at home and abroad, animal alternative methods will be used as toxicological test reports. The general reason is that "Animal substitution methods" can reduce animal suffering and better respond to consumers' ethical demands; at the same time, the research theory has been in-depth and has certain technical feasibility; some companies need to consider avoiding regulatory and trade barriers when cosmetics and raw materials are exported to the sea at the beginning of the research and development of new ingredient; "Animal substitution methods" are not only a manifestation of scientific and technological progress, but also a revolution jointly promoted by ethical concepts, economic development and global supervision.

Note: "○" in the above table indicates that the information must be submitted; "△" indicates that the information must be submitted depending on the situation. The meaning of the superscript is explained as follows:

① New ingredients registered and filed under Case 1 and Case 2, as well as new ingredients registered and filed under Case 6 whose polymer monomer units have a relative molecular mass of less than 1,000 Daltons and whose monomer units have not been used as cosmetic ingredient in my country, should submit this information.

② On the premise of sufficient scientific basis, if the relevant safety risks can be fully assessed through other data information, relevant scientific basis and research data can be provided, and the corresponding toxicological tests can be exempted.

③ If the new ingredient does not have ultraviolet absorption properties ,or does not actually have relevant safety risks based on the purpose and scope of use of the new ingredient, relevant test analysis reports and/or explanatory materials can be provided to waive the corresponding toxicology test.

④ Generally, it should include at least one gene mutation test and one chromosomal aberration test.

⑤ If the new ingredient is likely to be ingested by mouth when used in cosmetics, subchronic oral toxicity test data should be provided.

⑥ When there is a possibility of inhalation exposure for a new ingredient, complete inhalation toxicity test data should be provided.

⑦This information should be submitted to new ingredients with freckle removal and whitening functions.

04 bout high biological activity

The "Technical General Principles (Draft for Comments)" states that cosmetic ingredients should have relatively mild effects on the human body and should not have drastic or irreversible effects on human physiological functions. To identify whether a new ingredient has high biological activity (including substances with high biological activity), it can be analyzed from the following aspects: 1) whether it has a relatively clear target in the body; 2) whether it can produce significant biological effects on the human body at very low concentrations; 3) whether it is designed and developed with reference to substances recognized to have high biological activity, or has equivalent effects. For those with high biological activity, toxicological tests need to be carried out in accordance with the relevant requirements of Situation 1, and other necessary test data should be supplemented according to the specific risks, and on this basis, safety assessment should be fully carried out.

The above requirements are clearer than the expressions of "high biological activity" in the previous technical regulatory documents such as the "Regulations on the Registration and Filing Data of New cosmetic ingredient", "Technical Guiding Principles for Determination and Research of New cosmetic ingredient (Draft for Comments)", and "Technical Guiding Principles for Definition and Research of New cosmetic ingredient (Draft for Comments)".

05 About naming basis

The "Technical General Principles (Draft for Comments)" proposes that scientific and reasonable Chinese names of ingredients that are in line with industry practices should be formulated based on information such as ingredient sources, production processes, ingredient composition, chemical structure, etc., with a naming basis and a specific explanation of each part of the Chinese name of the ingredient. The corresponding English name should be provided with reference to the standard Chinese name.

Since cosmetic ingredients cover many fields (chemicals, animals, plants, food, biotechnology, etc.), different fields have different professional and technical vocabulary. How to formulate Chinese and English names of ingredients that are scientific, reasonable, and in line with industry habits, especially names that are more scientific and standardized than INCI, is indeed a matter of long-term value and significance. I believe that everyone can follow the principle of "inclusiveness, selection of the best" so that the new cosmetic ingredient we apply for have resounding scientific and standardized Chinese and English names ,and then guide the trend of more scientific and standardized naming of many cosmetic ingredients.

As mentioned at the beginning of the article, the "Technical General Principles (Draft for Comments)" is very rich in content and requires us to deeply understand the concepts and the background of the document. We look forward to the finalization of this important technical specification document as soon as possible to better guide the registration and filing work of new cosmetic ingredients. With scientific government supervision, policy support and active response from enterprises, the compliance requirements for registration and filing of new cosmetic ingredient will surely become increasingly clear, boosting the innovative development of cosmetic ingredient in China.

As a consulting service company with nearly 20 years of compliance and technical experience, OCI has always been committed to high efficiency and high success rates. It is currently the leading compliance service technology company with the most filings for new cosmetic ingredient in China. If any companies and friends still have questions and confusion about the above-mentioned content, please feel free to contact us. OCI will continue to provide customers with high-quality compliance services related to the registration and filing of cosmetics under NMPA supervision, the registration and filing of new cosmetic ingredients, and the reporting of used ingredients and information maintenance.

The link to the original text of the attached regulations is as follows:

https://www.nifdc.org.cn//nifdc/bshff/hzhpjssp/hzpsptzgg/202509241041591736034.html