Q1 Hair dye products contain agent I and agent II, and there are two formulas. How to apply for registration?

According to Article 35 of the "Regulations on the Administration of Registration and Filing of Cosmetics", cosmetics that contain two or more independent formulas that must be used together or whose packaging and containers cannot be separated shall fill in the formulas separately and apply for registration as one product. The two doses of hair dye products are products that must be combined, and the formulas need to be filled in separately, and registration is applied for one product.

Q2 What are the requirements for the foreign language documents in the cosmetics registration and filing?

Article 4 of "Regulations on the Administration of Cosmetics Registration and Filing Materials" stipulates that the registration and filing materials of cosmetics shall use the standardized Chinese characters published by the state. Except for registered trademarks, websites, patent names, names and addresses of overseas enterprises, etc. that must use other words, or conventional professional terms (such as SPF, PFA, PA, UVA, UVB, vitamin C, etc.), all other words should be complete , Standardly translate it into Chinese, and attach the original text to the corresponding translation.

Q3 What are the requirements for the foreign language materials in the documents for the registration and filing of new cosmetic raw materials?

Article 4 of "Regulations on the Administration of Registration and Filing Materials of New Cosmetic Raw Materials" stipulates that the registration and filing materials of new cosmetic raw materials shall use the standardized Chinese characters published by the state. Except for registered trademarks, website addresses, patent names, names and addresses of overseas enterprises, etc. that must be used, as well as English abbreviations used in Chinese regulatory documents, all materials in other languages should be translated into Chinese in a complete and standardized manner , and attach the original text to the corresponding translation.

Q4 If the PA value is not reflected in the original product registration certificate, and the PA value needs to be marked, how should I apply?

According to Article 44 of the "Regulations on the Management of Cosmetics Registration and Filing Materials", the increase of SPF/PA value of a product should be changed according to the content of the label sample, a change application should be submitted, and the corresponding efficacy test report of the product to be changed should be provided.

Q5 Is it possible to apply for changes, replacements, continuations, etc. for hair growth, hair removal, beauty milk, bodybuilding, and deodorant cosmetics?

According to the State Drug Administration's Announcement on Matters Concerning the Implementation of the Regulations on the Supervision and Administration of Cosmetics (No. 144 of 2020), and the State Drug Administration's Announcement on Further Clarifying the Transitional Management of the Original Special Purpose Cosmetics (2021 No. 150 of the Year), during the transition period, cosmetics registrants can apply to the State Food and Drug Administration for the cancellation of the administrative license for five categories of original special-purpose cosmetics such as hair growth. In addition, the State Food and Drug Administration will no longer accept related products. Change, reissuance or renewal and other administrative licensing application matters. If there is any change in matters that do not involve safety and efficacy claims, the cosmetics registrant should file with the State Food and Drug Administration in a timely manner. For matters that can be applied for, applicants can apply by submitting paper materials offline.

Q6 What information do I need to submit to apply for the replacement of the domestic responsible person?

According to Article 48 of the "Regulations on the Administration of Cosmetics Registration and Filing Materials", to apply for the replacement of the domestic responsible person, it is necessary to submit the product list of the domestic responsible person to be changed, the informed consent of the original domestic responsible person, or a judgment document that can prove that the change of the domestic responsible person takes effect. (Judgment, Judgment, Mediation, etc.), Letter of Commitment of the Domestic Responsible Person to be Changed.

Q7 If the imported ordinary cosmetics are filed and sold in the form of boxes, do I need to submit both the single product in the box and the packaging of the box when filing?

According to Article 32 of the "Regulations on the Administration of Cosmetics Registration and Filing Materials", when ordinary cosmetics are filed for filing, and before special cosmetics are listed, the registrant, filing person or domestic responsible person shall upload the label picture of the product sales package, so submit and upload the picture. It should be a product that is filed in the form of a box.

Q8 After multiple imported ordinary cosmetics have been filed separately, when they are sold in the form of kits, do I need to submit the label picture of the sales package of the kits?

According to the requirements of Article 32 of the "Regulations on the Administration of Cosmetics Registration and Filing Materials", the registered or filed products are sold in combination in the form of a set box, a gift box, etc., and the combination process does not touch the product contents. Except for adding the name of the combination packaged product, other labels If the content of the package does not exceed the content of each product label, and the label information of the combination package covers the label content of each product inside, it is not necessary to upload the label image repeatedly when filing the combination package product.

Q9 When filing an ordinary cosmetic product, under what circumstances can it be exempted from submitting the toxicology test report of the product? What are the exceptions?

According to Article 33 (2) of the "Regulations on the Management of Cosmetics Registration and Filing Materials", the production enterprises of ordinary cosmetics have obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region) where they are located, and the product safety risk assessment results Those who can fully confirm the safety of the product may be exempted from submitting the toxicology test report of the product, except in the following cases:

1. The product claims to be used by infants and children;

2. The product uses new cosmetic raw materials that are still under safety monitoring;

3. According to the quantitative grading and scoring results, the filing person, domestic responsible person, and production enterprise are listed as key supervision objects.

If there are multiple production enterprises, and all the production enterprises have obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region) where they are located, they are exempt from submitting the toxicological test report.

Q10 Is it necessary to upload a summary of the basis of product efficacy claims on the special website designated by the State Food and Drug Administration when all cosmetics are registered and filed?

According to Article 7 of the "Evaluation Standards for Cosmetics Efficacy Claims", "Can be directly identified by the senses such as sight and smell (such as cleaning, makeup removal, beauty modification, aroma, body cooling, hair coloring, perm, hair color care, hair removal, deodorization and auxiliary shaving, etc.), or through simple physical covering, adhesion, friction, etc. (such as physical covering, freckle whitening, physical exfoliation, and physical removal of blackheads, etc.), and the label clearly identifies only physical effects. A summary of the basis for a product efficacy claim may be exempted from publication”. Other efficacy claims should be evaluated in accordance with the notice issued by the State Food and Drug Administration on the "Evaluation Specifications for Cosmetics Efficacy Claims" (No. 50 of 2021), and a summary of the basis for the product efficacy claims should be uploaded when applying for registration or filing.