On August 28, the Cosmetic Safety Technology Evaluation Center of China Food and Drug Control Institute publicly issued the "Notice on Public Soliciting of "Regulations for the Registration and Filing of Cosmetics" and "Regulations for the Registration and Filing of New Cosmetic Materials", the requirements are in 9 Submit feedback before June 16.
Since the promulgation of the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "New Regulations") on June 29 this year, the specific operation of the opening of new raw materials for the record system has been one of the most concerned topics in the industry. The newly released "Regulations for the Registration and Filing of New Raw Materials for Cosmetics" (Draft for Solicitation of Comments, hereinafter referred to as the specifications) detailed the specific operations for the registration and filing of new raw materials and the various materials that need to be submitted to supply domestic and foreign cosmetics and raw materials Companies provide direction.
High-risk materials still need to be registered before filing
According to the new regulations issued by the State Drug Administration and the contents of the "Administrative Measures for Cosmetics Registration (Draft for Comments)", the process and classification management of new cosmetic raw materials are as follows, such as those with antiseptic, sunscreen, coloring, hair dyeing, spot removal and whitening functions. New raw materials are considered high-risk raw materials and need to be registered before filing. The other new raw materials can be directly filed. Usually, the management department can announce the registration and filing information to the public within 5 working days.
This point is emphasized again in the specifications issued this time, and specific requirements are also put forward for such high-risk materials. That is, new raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle, anti-dandruff, and anti-perspirant functions, nano-materials and biotechnology-derived materials shall provide destructive tests when registering or filing , Accelerated test and at least one year of long-term storage test data, results, conclusions and other relevant materials, and determine the storage conditions and shelf life of raw materials according to the stability test, and provide the remaining three batches of large-scale production annually during the three-year monitoring period Long-term preservation test data of raw materials.
When registering or filing other new raw materials, data, results, and conclusions of destructive tests and accelerated tests should be provided, and the storage conditions and shelf life of the raw materials should be determined. During the three-year monitoring period, three batches of large-scale production raw materials that have passed the production verification should be provided. Long-term preservation of test data.
In addition, for such high-risk new materials, at least one test data from in vitro tests, animal tests, and human tests must be submitted, and the mechanism by which the new materials have the declaration function shall be clarified. For new materials with other functions, you can choose to submit scientific literature/regulatory materials.
How many steps to turn 8783 into 22620?
It is clearly stated in the specification that the registrant or the filing person should submit the research and development background, basic information, purpose of use, and foreign (regional) use of new raw materials. It is mentioned that if the raw material has been included in the "International Cosmetic Raw Material Dictionary and Manual" of the American Personal Care Products Association (PCPC), the INCI English name and INCI ID number of the raw material should be clarified. If the raw materials have been translated into Chinese by INCI standards, they should be clarified according to the "List of Chinese Names of International Cosmetic Raw Materials Standards".
It is reported that the State Food and Drug Administration translated the PCPC "International Cosmetics Raw Material Dictionary and Manual (16th Edition)" in 2018, and formed the "International Cosmetics Standard Chinese Name Directory (2018 Edition) (Draft for Comment)", 2018 edition On the basis of the original 15,649 substances, 6,971 substances were added, and the number of cosmetic raw materials included reached 22,620. Most of the new substances are plant extracts, such as yellow orchid oil, spearmint leaf extract, white orchid extract, etc. It also contains some chemically synthesized substances, such as diisopropyl octyl phosphine oxide, dihydroxy methoxy Base color ketone, isocarvyl acetate, etc.
In comparison, there are only 8783 substances in the "List of Used Cosmetic Ingredient Names" in my country. Many industry insiders stated that the 22620 substances in the aforementioned "International Cosmetic Ingredient Dictionary and Manual" are undoubtedly the most likely to enter the Chinese market quickly. . Huo Gang, general manager of the Ou Shiman Product R&D Center, once said that the amount of new raw materials may explode, especially some new raw materials that have been proven and widely used internationally.
So, what materials need to be submitted for these 22620 cosmetic raw materials to enter the Chinese market?
The specifications are clear, and the registrant and the filing person should state whether the raw materials are used in cosmetics abroad (regions). Including the country (region) sold, the product name, the product brand, name, use history, efficacy, usage and dosage, reports of adverse reactions, the status of foreign approval of the raw material, relevant regulatory management, and the latest research progress Wait for the situation.
The certification materials that have a history of more than three years of safe use in foreign listed cosmetics should include: the purchase or sales and flow directions of the raw materials with the same quality specifications as the registered or filed raw materials; the scope of use of the raw materials and the amount of use in the product; Information on the product category, manufacturer, product packaging information, relevant product listing or registration records, product sales country, sales volume, and post-marketing adverse reactions, etc. containing the raw material.
In addition, the existing international authoritative safety evaluation agency has concluded that it is safe to use new raw materials in cosmetics. The original text and complete translation of the evaluation report, evaluation process, evaluation conclusion, and laboratory qualification analysis should be submitted. For new cosmetic raw materials that have been approved overseas, the approval certificate shall also be submitted.
Is it possible to cancel animal experiments on the raw material side of cosmetics?
According to the requirements of the specification, applying for new cosmetic raw materials should generally submit the toxicological safety of 11 categories of toxicological test items including acute oral or acute transdermal test, skin and acute eye irritation/corrosion test, skin phototoxicity test, etc. Evaluation data. However, these test contents can increase or reduce toxicology test items according to the use of the raw material, physical and chemical properties, quantitative structure-activity relationship, toxicology data, clinical research, population epidemiological survey, and toxicity of similar compounds.
The toxicology test data can be the applicant's test data, scientific literature data, and content published on official websites of domestic and foreign governments and international organizations. If the applied toxicology test method is not included in my country’s "Safety Technical Specifications for Cosmetics", it should submit proof that the toxicology test method is consistent with the results obtained in my country’s current method, and the toxicology test method should be an international authoritative alternative method The method that the verification agency has included.
This also means that the registration and filing of new raw materials allows the use of toxicological test methods not included in our country, and only the consistency is required. It is reported that the toxicology experiments commonly used in my country are usually animal experiments, which also represents an alternative method for new materials to accept animal experiments. However, some people in the industry claim that general cosmetics have already adopted safety assessments instead of toxicity and irritation assessments.
However, the regulations also impose stricter requirements on new materials that do not use animal experiments. For example, if animal alternative methods are used, appropriate integrated approaches to testing and assessment (IATA) should be selected from the structural characteristics of the raw materials and specific toxicological endpoints to evaluate the toxicity of the new raw materials. Proof materials should be submitted to the publicly published, non-review nature related research papers or scientific works on the comparative study of the toxicology test method and the current toxicology test method in my country, or the internationally accepted Good Laboratory Management Laboratory (GLP) ) Test report issued. The proof materials include a brief description of the research process of the test method, comparative research data of no less than 10 test substances, result analysis, conclusions and original texts.
From the new regulations to the supporting specifications that have been issued afterwards, although the filing system for new cosmetics materials that carry the core elements of industry innovation has been opened and there is a lot of room, in general, it is actually a "wide entry and strict exit" control. Strict requirements are set for the submission of information. From this point of view, for a new raw material to be successfully put into storage, perhaps the most difficult first step is to prepare the information.
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