On January 12, 2021, the State Administration for Market Regulation issued General Administration Order No. 35, stating that the "Administrative Measures for the Registration and Filing of Cosmetics" (hereinafter referred to as the "Measures") have been approved by the State Administration for Market Regulation 2020 on December 31, 2020. Deliberated and approved by the 14th Executive Meeting, it will be implemented on May 1, 2021.

　　The "Measures" has six chapters and 63 articles. Chapter One is General Provisions, Chapter Two is Registration and Filing Management of New Cosmetic Ingredients, Chapter Three is Registration and Filing Management of Cosmetics, Chapter Four is Supervision and Management, Chapter Five is Legal responsibility, Chapter VI is the supplementary provisions. Compared with the seven chapters and eighty-eight articles in the draft for comments, the changes are not small.

　　May 1st implementation! Industry or staged a battle

　　For example, the provisions of Article 8 of the Measures on domestic responsible persons actually add the registrant/filer's responsibility for the quality and safety of their cosmetics and new raw materials on the basis of Article 11 of the draft opinion. Yue Shaoying, general manager of Shanghai Xuai Industry, joked that the implementation of May 1 this year means that the cosmetics industry is about to start a battle for people, and this "person" is the person in charge of cosmetics quality and safety, and "the person in charge of quality and safety is worthy of rising."

　　How do you understand the recorder/registrant of the "function data"?

　　Regarding the efficacy data for record/registration, in Article 43 of the draft for comments, there was such a provision that “the cosmetics registrant and recorder may apply for registration or record only after obtaining the scientific basis for the product efficacy claim "However, it can be seen from the formal implementation of the "Measures" that all the content of the efficacy data in Article 43 of the draft opinion has been removed, but this does not mean that cosmetics do not need to be evaluated for efficacy. In fact, the requirements for efficacy evaluation have been It is written into the "Regulations on Supervision and Administration of Cosmetics" and therefore will be implemented.

　　Some insiders speculate that this is a regulation based on the status quo of the industry. After all, even the testing standards have not been set. The removed article corresponds to Article 29 of the "Measures", "The filing person/registrant shall carry out work in accordance with the'rules' and submit the registration/filing materials in accordance with the'rules'", and various subsequent "standards" It is also being improved.

　　The Regulations on cosmetics registrants/registrants seem to be slightly "general", but this is experiencing the rigor of the regulations. "This is the real way of writing the regulations. The method can be relatively simple. The implementation of detailed rules or regulations requires comparison. Details." An unnamed domestic responsible person in the industry commented.

　　“Nanny-style” supervision is no longer, and the risks of importing companies increase

　　It can be seen from Article 59 of the Regulations that if the filing materials do not meet the requirements and are not corrected within the time limit, the filing will be cancelled. For import companies that submit and file for the record, the "Measures" have higher requirements for their filing materials. "In the past, there was a formal review. If there are obvious problems of principle, the review teacher will promptly point out that the filing application will not be accepted. Now it is equivalent to directly filing the import. If there are serious problems in the filing, the filing may be cancelled directly." Jia Yidan, general manager of Special Technology, told reporters that if the products have been imported and the sales channels have been rolled out at this time, the importing company may bear greater losses. "

　　Hong Kong, Macau and Taiwan cosmetics are not considered imported cosmetics

　　The fourth point of Article 62 of the Measures stipulates the numbering rules for the registration of special cosmetics. Among them, the serial number of products from Taiwan, Hong Kong, and Macau is "national makeup special characters + four-digit year number + serial number of registered products this year." Defines the country-specific attributes of cosmetics made in Hong Kong, Macao and Taiwan.

　　An industry insider told reporters that the "Measures" defines Hong Kong, Macau, and Taiwan cosmetics more clearly. In the past, the method of compiling the registration numbers for Hong Kong, Macao and Taiwan products was consistent with that of imported products, which often caused confusion and misunderstanding among consumers. One piece is clearly defined.

　　Inter-provincial office relocation needs to be re-filed

　　According to the previous filing system, the change of the address of the person in charge only needs to change the address and does not need to be re-filed. However, according to Article 36 of the latest "Measures", if the address of the filing person or the domestic responsible person changes, it shall be re-filed. Record. A person familiar with filing laws and regulations told reporters whether the need to re-file is based on whether the address change crosses the province.

　　Some people think that this is to facilitate the implementation of the main responsibility of the filing person (no one can be found), and some voices believe that it may be foreshadowing the classification of the filing person in the future.

　　This is the same article. The "Measures" stipulates that the name of the ordinary cosmetics that have been filed shall not be changed without justified reasons. This provision avoids the problem of a comeback of "problematic products" under a different name. Regarding the "general cosmetics that have been filed, the product formula must not be changed at will, except for minor changes in the product formula due to changes in the source of raw materials." Here, "minor changes" is not easy to define.

　　Say no to "set of certificates"

　　What needs to be reminded is that Article 41 of the Measures also stipulates a situation that needs to be re-filed, that is, if the product name, formula, etc. change, which essentially constitute a new product, the registrant should reapply for registration. This provision has sounded the alarm for multiple products sharing the same record number to darken the chaos of the set of certificates.

　　Clarify confidentiality and relieve the enterprise's worries

　　Previously, some companies were worried about the exposure of trade secrets caused by the submission of ingredients and formulas.

　　On January 12, 2021, the State Administration for Market Regulation issued General Administration Order No. 35, stating that the "Administrative Measures for the Registration and Filing of Cosmetics" (hereinafter referred to as the "Measures") have been approved by the State Administration for Market Regulation 2020 on December 31, 2020. Deliberated and approved by the 14th Executive Meeting, it will be implemented on May 1, 2021.

　　The "Measures" has six chapters and 63 articles. Chapter One is General Provisions, Chapter Two is Registration and Filing Management of New Cosmetic Ingredients, Chapter Three is Registration and Filing Management of Cosmetics, Chapter Four is Supervision and Management, Chapter Five is Legal responsibility, Chapter VI is the supplementary provisions. Compared with the seven chapters and eighty-eight articles in the draft for comments, the changes are not small.

　　May 1st implementation! Industry or staged a battle

　　For example, the provisions of Article 8 of the Measures on domestic responsible persons actually add the registrant/filer's responsibility for the quality and safety of their cosmetics and new raw materials on the basis of Article 11 of the draft opinion. Yue Shaoying, general manager of Shanghai Xuai Industry, joked that the implementation of May 1 this year means that the cosmetics industry is about to start a battle for people, and this "person" is the person in charge of cosmetics quality and safety, and "the person in charge of quality and safety is worthy of rising."

　　How do you understand the recorder/registrant of the "function data"?

　　Regarding the efficacy data for record/registration, in Article 43 of the draft for comments, there was such a provision that “the cosmetics registrant and recorder may apply for registration or record only after obtaining the scientific basis for the product efficacy claim "However, it can be seen from the formal implementation of the "Measures" that all the content of the efficacy data in Article 43 of the draft opinion has been removed, but this does not mean that cosmetics do not need to be evaluated for efficacy. In fact, the requirements for efficacy evaluation have been It is written into the "Regulations on Supervision and Administration of Cosmetics" and therefore will be implemented.

　　Some insiders speculate that this is a regulation based on the status quo of the industry. After all, even the testing standards have not been set. The removed article corresponds to Article 29 of the "Measures", "The filing person/registrant shall carry out work in accordance with the'rules' and submit the registration/filing materials in accordance with the'rules'", and various subsequent "standards" It is also being improved.

　　The Regulations on cosmetics registrants/registrants seem to be slightly "general", but this is experiencing the rigor of the regulations. "This is the real way of writing the regulations. The method can be relatively simple. The implementation of detailed rules or regulations requires comparison. Details." An unnamed domestic responsible person in the industry commented.

　　“Nanny-style” supervision is no longer, and the risks of importing companies increase

　　It can be seen from Article 59 of the Regulations that if the filing materials do not meet the requirements and are not corrected within the time limit, the filing will be cancelled. For import companies that submit and file for the record, the "Measures" have higher requirements for their filing materials. "In the past, there was a formal review. If there are obvious problems of principle, the review teacher will promptly point out that the filing application will not be accepted. Now it is equivalent to directly filing the import. If there are serious problems in the filing, the filing may be cancelled directly." Jia Yidan, general manager of Special Technology, told reporters that if the products have been imported and the sales channels have been rolled out at this time, the importing company may bear greater losses. "

　　Hong Kong, Macau and Taiwan cosmetics are not considered imported cosmetics

　　The fourth point of Article 62 of the Measures stipulates the numbering rules for the registration of special cosmetics. Among them, the serial number of products from Taiwan, Hong Kong, and Macau is "national makeup special characters + four-digit year number + serial number of registered products this year." Defines the country-specific attributes of cosmetics made in Hong Kong, Macao and Taiwan.

　　An industry insider told reporters that the "Measures" defines Hong Kong, Macau, and Taiwan cosmetics more clearly. In the past, the method of compiling the registration numbers for Hong Kong, Macao and Taiwan products was consistent with that of imported products, which often caused confusion and misunderstanding among consumers. One piece is clearly defined.

　　Inter-provincial office relocation needs to be re-filed

　　According to the previous filing system, the change of the address of the person in charge only needs to change the address and does not need to be re-filed. However, according to Article 36 of the latest "Measures", if the address of the filing person or the domestic responsible person changes, it shall be re-filed. Record. A person familiar with filing laws and regulations told reporters whether the need to re-file is based on whether the address change crosses the province.

　　Some people think that this is to facilitate the implementation of the main responsibility of the filing person (no one can be found), and some voices believe that it may be foreshadowing the classification of the filing person in the future.

　　This is the same article. The "Measures" stipulates that the name of the ordinary cosmetics that have been filed shall not be changed without justified reasons. This provision avoids the problem of a comeback of "problematic products" under a different name. Regarding the "general cosmetics that have been filed, the product formula must not be changed at will, except for minor changes in the product formula due to changes in the source of raw materials." Here, "minor changes" is not easy to define.

　　Say no to "set of certificates"

　　What needs to be reminded is that Article 41 of the Measures also stipulates a situation that needs to be re-filed, that is, if the product name, formula, etc. change, which essentially constitute a new product, the registrant should reapply for registration. This provision has sounded the alarm for multiple products sharing the same record number to darken the chaos of the set of certificates.

　　Clarify confidentiality and relieve the enterprise's worries

　　Previously, some companies were worried about the exposure of trade secrets caused by the submission of ingredients and formulas. The 59th "Measures" stipulated that without the consent of the registrant/filer, the drug regulatory authority, professional technical agency and their staff , The personnel participating in the review shall not disclose the business secrets, undisclosed information or confidential business information submitted by the registrant or filing party, unless otherwise provided by law or involving national security or major public interests.

　　Jia Yidan told reporters, "This article is very important. Now when importing products are filed, the full ingredients and concentration must be submitted. Brands have been worried about whether the confidentiality of information is guaranteed. Now it is written into the "Measures" and this confidentiality has been obtained. clear."

　　The task of filing is increased

　　Article 30 of the "Measures" stipulates that when applying for registration and filing, cosmetics registrants and recorders shall clarify the source of raw materials and relevant information on raw material safety through the information service platform. It is reported that this is also the hotly discussed part of the previous opinion draft, and this provision is equivalent to clarifying the filing work of raw material suppliers.

　　For filing/registrants, this part is also a requirement to increase workload. First of all, the source and safety information of all the ingredients in the product formula must be available. The filing/registrant must collect relevant data from different raw material vendors. This part of the work is heavy. Secondly, not all raw material vendors have done relevant safety data. The above two points mean an increase in the filing workload.

　　What needs to be reminded is that according to the draft specification for cosmetics registration filing materials, the cosmetics filing person/registrant must fill in the raw material manufacturer information, upload the raw material quality and safety information file, or fill in the raw material submission code when registering the product. The raw material submission code is a new requirement to the raw material supplier. The specific approach is that the raw material manufacturer is in advance. The raw material submission code is a new requirement to the raw material supplier. The specific method is that the raw material manufacturer uploads the raw material quality and safety information on the raw material safety information service platform of the State Drug Administration in advance, and can generate the corresponding code so that downstream customers can directly fill in the reporting code when submitting the product. Upload raw material quality and safety information and generate corresponding codes to facilitate downstream customers to directly fill in the submission code when submitting products. The information to be uploaded by the raw material supplier is upgraded from the previous raw material quality specification to the raw material quality and safety information. The raw material supplier also needs to provide more information including the recommended addition amount, a brief description of the production process, and the evaluation conclusion of the authority.

　　"The 59th stipulates that without the consent of the registrant/filer, the drug regulatory authority, professional technical institutions and their staff, and those involved in the review shall not disclose the business secrets or undisclosed documents submitted by the registrant or filer Information or confidential business information, except as otherwise provided by law or involving national security or major public interests.

　　Jia Yidan told reporters, "This article is very important. Now when importing products are filed, the full ingredients and concentration must be submitted. Brands have been worried about whether the confidentiality of information is guaranteed. Now it is written into the "Measures" and this confidentiality has been obtained. clear."

　　The task of filing is increased

　　Article 30 of the "Measures" stipulates that when applying for registration and filing, cosmetics registrants and recorders shall clarify the source of raw materials and relevant information on raw material safety through the information service platform. It is reported that this is also the hotly discussed part of the previous opinion draft, and this provision is equivalent to clarifying the filing work of raw material suppliers.

　　For filing/registrants, this part is also a requirement to increase workload. First of all, the source and safety information of all the ingredients in the product formula must be available. The filing/registrant must collect relevant data from different raw material vendors. This part of the work is heavy. Secondly, not all raw material vendors have done relevant safety data. The above two points mean an increase in the filing workload.

　　What needs to be reminded is that according to the draft specification for cosmetics registration filing materials, the cosmetics filing person/registrant must fill in the raw material manufacturer information, upload the raw material quality and safety information file, or fill in the raw material submission code when registering the product. The raw material submission code is a new requirement to the raw material supplier. The specific approach is that the raw material manufacturer is in advance. The raw material submission code is a new requirement to the raw material supplier. The specific method is that the raw material manufacturer uploads the raw material quality and safety information on the raw material safety information service platform of the State Drug Administration in advance, and can generate the corresponding code so that downstream customers can directly fill in the reporting code when submitting the product. Upload raw material quality and safety information and generate corresponding codes to facilitate downstream customers to directly fill in the submission code when submitting products. The information to be uploaded by the raw material supplier is upgraded from the previous raw material quality specification to the raw material quality and safety information. The raw material supplier also needs to provide more information including the recommended addition amount, a brief description of the production process, and the evaluation conclusion of the authority.

Information source: China Detergent Industry Information Network