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Recently, the State Food and Drug Administration issued an announcement and issued the "Regulations on the Supervision and Administration of Children's Cosmetics" (hereinafter referred to as the "Regulations"), which is a normative document formulated specifically for the supervision of children's cosmetics in China
.
It is clear that in addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
The specific notice is as follows:
.
It is clear that in addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
The specific notice is as follows:
Announcement of the State Food and Drug Administration on the issuance of the "Regulations on the Supervision and Administration of Children's Cosmetics" (No.
123 of 2021)
123 of 2021)
In order to regulate the production and operation of children’s cosmetics, strengthen the supervision and management of children’s cosmetics, and ensure the safety of children’s use of cosmetics, in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations , the State Food and Drug Administration has organized and formulated the "Regulations on the Supervision and Administration of Children's Cosmetics" (hereinafter referred to as the "Regulations" "), it is hereby announced, and the matters related to the implementation of the "Regulations" are announced as follows:
1.
In addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
In addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
2.
Starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”.
The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the "Regulations
.
"
Starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”.
The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the "Regulations
.
"
3.
The mark of children's cosmetics will be announced separately
.
The mark of children's cosmetics will be announced separately
.
Hereby announce
.
.
Attachment: Regulations on Supervision and Administration of Children's Cosmetics
State Food and Drug Administration
September 30, 2021
Appendix
Regulations on Supervision and Administration of Children's Cosmetics
Article 1 In order to regulate the production and operation of children's cosmetics, strengthen the supervision and management of children's cosmetics, and ensure the safety of children's use of cosmetics, these regulations are formulated in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations
.
.
Article 2 Those engaged in the production and operation of children's cosmetics and their supervision and management within the territory of the People's Republic of China shall abide by these regulations
.
.
Article 3 The “children’s cosmetics” mentioned in these regulations refer to cosmetics that are suitable for children under the age of 12 (including 12 years old) and have the functions of cleansing, moisturizing, tanning, and sun protection
.
.
Labels "applicable to the whole population", "use by the whole family" and other words or use trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging, etc.
to imply that the product users include children's products in accordance with the management of children's cosmetics
.
to imply that the product users include children's products in accordance with the management of children's cosmetics
.
Article 4 Cosmetic registrants and record holders are responsible for the quality, safety and efficacy claims of children’s cosmetics
.
.
Cosmetics producers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen the quality management of children's cosmetics, integrity and self-discipline, and ensure product quality and safety
.
.
Cosmetics manufacturers and operators shall establish and implement purchase inspection records and other systems to ensure the traceability of children's cosmetics
.
Encourage cosmetics producers and operators to use information technology to collect and store production and operation information, and establish a quality and safety traceability system for children's cosmetics
.
.
Encourage cosmetics producers and operators to use information technology to collect and store production and operation information, and establish a quality and safety traceability system for children's cosmetics
.
Article 5 The registrant and recorder of cosmetics shall be based on the child’s physiological characteristics and
Possible application scenarios, following the principles of science and necessity, research and develop children's cosmetics
.
.
Article 6 Children’s cosmetics shall be marked with the children’s cosmetics mark prescribed by the State Drug Administration on the display surface of the sales package
.
.
Non-children’s cosmetics shall not be marked with the children’s cosmetics logo
.
.
Children’s cosmetics should be guided by "Caution" or "Warning", and warning words such as "should be used under adult supervision" should be marked on the visible side of the sales package
.
.
Encourage cosmetics registrants and record holders to use anti-counterfeiting technologies on labels to facilitate consumers to identify and choose legal products
.
.
Article 7 The formula design of children's cosmetics should follow the principle of safety first, the principle of essential efficacy, and the principle of minimal formula:
(1) Cosmetic raw materials with a long history of safe use should be selected.
New raw materials that are still in the monitoring period should not be used.
The use of raw materials prepared by new technologies such as genetic technology and nanotechnology should not be used.
If no alternative raw materials must be used, the reasons should be explained , And evaluate the safety of children's cosmetics;
New raw materials that are still in the monitoring period should not be used.
The use of raw materials prepared by new technologies such as genetic technology and nanotechnology should not be used.
If no alternative raw materials must be used, the reasons should be explained , And evaluate the safety of children's cosmetics;
(2) It is not allowed to use raw materials for the purpose of freckle whitening, acne removal, hair removal, deodorization, anti-dandruff, hair loss prevention, hair dyeing, perming, etc.
If the raw materials that may have the above-mentioned effects are used for other purposes, they should be Necessity and evaluation of the safety of children's cosmetics;
If the raw materials that may have the above-mentioned effects are used for other purposes, they should be Necessity and evaluation of the safety of children's cosmetics;
(3) Children's cosmetics should evaluate the scientificity and necessity of the raw materials used in consideration of the safety, stability, function, compatibility and other aspects of the raw materials, combined with the physiological characteristics of the children, especially the raw materials such as fragrances, colorants, preservatives and surfactants.
.
.
Article 8 Children’s cosmetics shall undergo product safety evaluations through safety evaluations and necessary toxicological tests
.
.
When the cosmetics registrants and recorders conduct safety assessments of children’s cosmetics, they are in danger
The physical characteristics of children should be considered in aspects such as identification of harm and calculation of exposure
.
.
Article 9 The State Drug Administration organizes cosmetic technology review institutions to formulate special technical guidelines for children's cosmetics, and strictly review the registration application materials submitted by applicants
.
.
The drug supervision and administration department shall strengthen the post-market supervision and management of children’s cosmetics, focusing on technical verification of product safety data, and if it is found to be inconsistent with the regulations, it shall be dealt with strictly in accordance with the law
.
.
Article 10 Children's cosmetics shall be produced in accordance with the requirements of the cosmetics production quality management regulations, and the environmental requirements of the production workshops of children's skin care cosmetics shall comply with relevant regulations
.
.
Cosmetic registrants, record holders, and entrusted manufacturers shall conduct self-inspection on the implementation of cosmetics production quality management standards in accordance with regulations to ensure that they continue to meet the requirements of cosmetics production quality management standards
.
.
Encourage cosmetics registrants and record holders to formulate product implementation standards for children's cosmetics that are stricter than mandatory national standards and technical specifications
.
.
Article 11 Cosmetic registrants, record holders, and entrusted manufacturing enterprises shall formulate and implement employee induction training and annual training plans to ensure that employees are familiar with job duties, have professional knowledge to perform job duties, and legal knowledge related to children's cosmetics
.
Enterprises should establish employee training files
.
.
Enterprises should establish employee training files
.
Enterprises should strengthen the construction of quality culture, continuously improve employees' quality awareness and ability to perform their duties, and encourage employees to report illegal or irregular situations found in their work
.
.
Article 12 Cosmetic registrants, record holders, and entrusted production enterprises shall strictly implement the material purchase inspection record system, and enterprises shall conduct inspections of relevant items when deemed necessary after evaluation, and avoid the introduction of hormones and antibiotics through raw materials and packaging materials that directly contact cosmetics.
Infectious drugs and other banned raw materials or substances that may endanger human health
.
Infectious drugs and other banned raw materials or substances that may endanger human health
.
If the cosmetic registrant or recorder discovers that there are hormones, anti-infective drugs and other substances that may harm human health in raw materials, packaging materials that directly contact cosmetics, they shall immediately take measures to control risks and report to the local provincial drug supervision and management Department report
.
.
Article 13 Cosmetic registrants, record holders, and entrusted manufacturing enterprises shall take measures to avoid confusion between the characteristics, smell, appearance and shape of children's cosmetics and food, medicines and other products, and to prevent accidental ingestion and misuse
.
.
Labels of children's cosmetics shall not be marked with words such as "food grade", "edible", or food-related patterns
.
.
Article XIV of the cosmetics business operator shall establish and implement purchase inspection records system, market players directly check the supplier's registration certificate, registration certificate or special cosmetics ordinary cosmetics record information, children's cosmetics logos, product quality inspection certificate and save the relevant documents faithfully record the name cosmetics, special cosmetics registration certificate number or registration number of ordinary cosmetics, life, net weight, quantity purchased, supply the name, address, contact details, date of purchase of contents
.
.
Cosmetics operators should check the label information of children's cosmetics they operate with the corresponding product information published on the official website of the State Drug Administration, including: cosmetic name, special cosmetics registration certificate number or ordinary cosmetics registration number, cosmetics registrant or recorder The name, the name of the entrusted production enterprise, and the name of the responsible person in the country shall ensure that the above-mentioned information is consistent with the published information
.
.
Encourage cosmetics operators to display children's cosmetics in districts and publicize the signs of children's cosmetics in sales areas
.
Encourage cosmetics operators to take the initiative to prompt consumers to inquire about product registration or filing information when selling children's cosmetics
.
.
Encourage cosmetics operators to take the initiative to prompt consumers to inquire about product registration or filing information when selling children's cosmetics
.
Article 15 Children’s cosmetics operators on e-commerce platforms and e-commerce operators operating children’s cosmetics through self-built websites and other network services shall
The main page of its business activities comprehensively, truthfully and accurately discloses cosmetic labels and other information consistent with the cosmetics registration or filing materials, and continues to publicize the children's cosmetics logo in a prominent position on the product display page
.
.
Article 16 Cosmetics manufacturers and operators, medical institutions discovering or learning about adverse reactions of children’s cosmetics shall report the adverse reactions to the local city and county-level adverse reaction monitoring institutions in accordance with regulations
.
.
Cosmetic registrants and record holders shall analyze and evaluate the collected or learned adverse reaction reports of children's cosmetics, and conduct self-inspection of the possible causes of adverse reactions
.
For possible serious adverse reactions, investigation and analysis shall be conducted in accordance with regulations and a self-inspection report shall be formed, which shall be submitted to the local provincial-level adverse reaction monitoring agency, and at the same time to the local provincial drug supervision and administration department
.
If a product is found to have a safety risk, measures should be taken immediately to control the risk; if a product is found to have quality defects or other problems that may endanger human health, it should immediately stop production and recall in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics" For cosmetics that have been put on the market, the relevant cosmetics operators and consumers shall be notified to stop the operation and use
.
.
For possible serious adverse reactions, investigation and analysis shall be conducted in accordance with regulations and a self-inspection report shall be formed, which shall be submitted to the local provincial-level adverse reaction monitoring agency, and at the same time to the local provincial drug supervision and administration department
.
If a product is found to have a safety risk, measures should be taken immediately to control the risk; if a product is found to have quality defects or other problems that may endanger human health, it should immediately stop production and recall in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics" For cosmetics that have been put on the market, the relevant cosmetics operators and consumers shall be notified to stop the operation and use
.
Article 17 If a sampling inspection finds that there are quality and safety problems in children’s cosmetics, the cosmetics registrant, recorder, and entrusted production enterprise shall immediately stop production, conduct self-inspection of the implementation of the cosmetics production quality management norms, and report to the local provincial drug supervision Management report
.
Production can be resumed only after the risk factors affecting quality and safety are eliminated
.
The provincial drug supervision and administration department may organize on-site inspections according to the actual situation
.
.
Production can be resumed only after the risk factors affecting quality and safety are eliminated
.
The provincial drug supervision and administration department may organize on-site inspections according to the actual situation
.
If the cosmetics registrant or recorder discovers that cosmetics have quality defects or other problems that may endanger human health, they should immediately stop production, recall cosmetics that have been on the market, and notify the relevant Cosmetic operators and consumers stop operating and using them
.
.
The cosmetics registrant and recorder shall, based on the
Related products are analyzed and evaluated to ensure product quality and safety
.
.
Article 18 The department responsible for drug supervision and management shall, in accordance with the principles of risk management, and in light of local actual conditions, include cosmetic registrants, record holders, domestic responsible persons, entrusted production enterprises, and cosmetics operators with concentrated sales of children's cosmetics as key cosmetics operators.
Supervise objects, increase the frequency of supervision and inspection
.
Supervise objects, increase the frequency of supervision and inspection
.
Article 19 The department in charge of drug supervision and administration shall regard children's cosmetics as a key category for annual sampling inspection and risk monitoring
.
After sampling inspection or risk monitoring, it is found that children’s cosmetics contain substances that may harm human health.
The department in charge of drug supervision and management can take emergency control measures that order the suspension of production and operation and issue safety warning information; if it is imported children’s cosmetics, it shall be submitted in accordance with the law Relevant departments suspend imports
.
.
After sampling inspection or risk monitoring, it is found that children’s cosmetics contain substances that may harm human health.
The department in charge of drug supervision and management can take emergency control measures that order the suspension of production and operation and issue safety warning information; if it is imported children’s cosmetics, it shall be submitted in accordance with the law Relevant departments suspend imports
.
Article 20 When the department responsible for drug supervision and administration investigates and deals with illegal acts of children’s cosmetics in accordance with the law, if one of the following situations occurs, it shall be deemed as a serious situation as stipulated in the "Regulations on the Supervision and Administration of Cosmetics":
(1) The use of raw materials that are prohibited from being used in the production of cosmetics, and new raw materials that should be registered but not registered for the production of children's cosmetics;
(2) Illegal addition of substances that may harm human health in children's cosmetics
.
.
Article 21 Children's toothpaste shall be managed with reference to these regulations
.
.
Article 22 These regulations shall come into force on January 1, 2022
.
.
Recently, the State Food and Drug Administration issued an announcement and issued the "Regulations on the Supervision and Administration of Children's Cosmetics" (hereinafter referred to as the "Regulations"), which is a normative document formulated specifically for the supervision of children's cosmetics in China
.
It is clear that in addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
The specific notice is as follows:
.
It is clear that in addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
The specific notice is as follows:
Announcement of the State Food and Drug Administration on the issuance of the "Regulations on the Supervision and Administration of Children's Cosmetics" (No.
123 of 2021)
123 of 2021)
In order to regulate the production and operation of children’s cosmetics, strengthen the supervision and management of children’s cosmetics, and ensure the safety of children’s use of cosmetics, in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations , the State Food and Drug Administration has organized and formulated the "Regulations on the Supervision and Administration of Children's Cosmetics" (hereinafter referred to as the "Regulations" "), it is hereby announced, and the matters related to the implementation of the "Regulations" are announced as follows:
1.
In addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
In addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
.
2.
Starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”.
The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the "Regulations
.
"
Starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”.
The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the "Regulations
.
"
3.
The mark of children's cosmetics will be announced separately
.
The mark of children's cosmetics will be announced separately
.
Hereby announce
.
.
Attachment: Regulations on Supervision and Administration of Children's Cosmetics
State Food and Drug Administration
September 30, 2021
Appendix
Regulations on Supervision and Administration of Children's Cosmetics
Article 1 In order to regulate the production and operation of children's cosmetics, strengthen the supervision and management of children's cosmetics, and ensure the safety of children's use of cosmetics, these regulations are formulated in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations
.
.
Article 2 Those engaged in the production and operation of children's cosmetics and their supervision and management within the territory of the People's Republic of China shall abide by these regulations
.
.
Article 3 The “children’s cosmetics” mentioned in these regulations refer to cosmetics that are suitable for children under the age of 12 (including 12 years old) and have the functions of cleansing, moisturizing, tanning, and sun protection
.
.
Labels "applicable to the whole population", "use by the whole family" and other words or use trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging, etc.
to imply that the product users include children's products in accordance with the management of children's cosmetics
.
to imply that the product users include children's products in accordance with the management of children's cosmetics
.
Article 4 Cosmetic registrants and record holders are responsible for the quality, safety and efficacy claims of children’s cosmetics
.
.
Cosmetics producers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen the quality management of children's cosmetics, integrity and self-discipline, and ensure product quality and safety
.
.
Cosmetics manufacturers and operators shall establish and implement purchase inspection records and other systems to ensure the traceability of children's cosmetics
.
Encourage cosmetics producers and operators to use information technology to collect and store production and operation information, and establish a quality and safety traceability system for children's cosmetics
.
.
Encourage cosmetics producers and operators to use information technology to collect and store production and operation information, and establish a quality and safety traceability system for children's cosmetics
.
Article 5 The registrant and recorder of cosmetics shall be based on the child’s physiological characteristics and
Possible application scenarios, following the principles of science and necessity, research and develop children's cosmetics
.
.
Article 6 Children’s cosmetics shall be marked with the children’s cosmetics mark prescribed by the State Drug Administration on the display surface of the sales package
.
.
Non-children’s cosmetics shall not be marked with the children’s cosmetics logo
.
.
Children’s cosmetics should be guided by "Caution" or "Warning", and warning words such as "should be used under adult supervision" should be marked on the visible side of the sales package
.
.
Encourage cosmetics registrants and record holders to use anti-counterfeiting technologies on labels to facilitate consumers to identify and choose legal products
.
.
Article 7 The formula design of children's cosmetics should follow the principle of safety first, the principle of essential efficacy, and the principle of minimal formula:
(1) Cosmetic raw materials with a long history of safe use should be selected.
New raw materials that are still in the monitoring period should not be used.
The use of raw materials prepared by new technologies such as genetic technology and nanotechnology should not be used.
If no alternative raw materials must be used, the reasons should be explained , And evaluate the safety of children's cosmetics;
New raw materials that are still in the monitoring period should not be used.
The use of raw materials prepared by new technologies such as genetic technology and nanotechnology should not be used.
If no alternative raw materials must be used, the reasons should be explained , And evaluate the safety of children's cosmetics;
(2) It is not allowed to use raw materials for the purpose of freckle whitening, acne removal, hair removal, deodorization, anti-dandruff, hair loss prevention, hair dyeing, perming, etc.
If the raw materials that may have the above-mentioned effects are used for other purposes, they should be Necessity and evaluation of the safety of children's cosmetics;
If the raw materials that may have the above-mentioned effects are used for other purposes, they should be Necessity and evaluation of the safety of children's cosmetics;
(3) Children's cosmetics should evaluate the scientificity and necessity of the raw materials used in consideration of the safety, stability, function, compatibility and other aspects of the raw materials, combined with the physiological characteristics of the children, especially the raw materials such as fragrances, colorants, preservatives and surfactants.
.
.
Article 8 Children’s cosmetics shall undergo product safety evaluations through safety evaluations and necessary toxicological tests
.
.
When the cosmetics registrants and recorders conduct safety assessments of children’s cosmetics, they are in danger
The physical characteristics of children should be considered in aspects such as identification of harm and calculation of exposure
.
.
Article 9 The State Drug Administration organizes cosmetic technology review institutions to formulate special technical guidelines for children's cosmetics, and strictly review the registration application materials submitted by applicants
.
.
The drug supervision and administration department shall strengthen the post-market supervision and management of children’s cosmetics, focusing on technical verification of product safety data, and if it is found to be inconsistent with the regulations, it shall be dealt with strictly in accordance with the law
.
.
Article 10 Children's cosmetics shall be produced in accordance with the requirements of the cosmetics production quality management regulations, and the environmental requirements of the production workshops of children's skin care cosmetics shall comply with relevant regulations
.
.
Cosmetic registrants, record holders, and entrusted manufacturers shall conduct self-inspection on the implementation of cosmetics production quality management standards in accordance with regulations to ensure that they continue to meet the requirements of cosmetics production quality management standards
.
.
Encourage cosmetics registrants and record holders to formulate product implementation standards for children's cosmetics that are stricter than mandatory national standards and technical specifications
.
.
Article 11 Cosmetic registrants, record holders, and entrusted manufacturing enterprises shall formulate and implement employee induction training and annual training plans to ensure that employees are familiar with job duties, have professional knowledge to perform job duties, and legal knowledge related to children's cosmetics
.
Enterprises should establish employee training files
.
.
Enterprises should establish employee training files
.
Enterprises should strengthen the construction of quality culture, continuously improve employees' quality awareness and ability to perform their duties, and encourage employees to report illegal or irregular situations found in their work
.
.
Article 12 Cosmetic registrants, record holders, and entrusted production enterprises shall strictly implement the material purchase inspection record system, and enterprises shall conduct inspections of relevant items when deemed necessary after evaluation, and avoid the introduction of hormones and antibiotics through raw materials and packaging materials that directly contact cosmetics.
Infectious drugs and other banned raw materials or substances that may endanger human health
.
Infectious drugs and other banned raw materials or substances that may endanger human health
.
If the cosmetic registrant or recorder discovers that there are hormones, anti-infective drugs and other substances that may harm human health in raw materials, packaging materials that directly contact cosmetics, they shall immediately take measures to control risks and report to the local provincial drug supervision and management Department report
.
.
Article 13 Cosmetic registrants, record holders, and entrusted manufacturing enterprises shall take measures to avoid confusion between the characteristics, smell, appearance and shape of children's cosmetics and food, medicines and other products, and to prevent accidental ingestion and misuse
.
.
Labels of children's cosmetics shall not be marked with words such as "food grade", "edible", or food-related patterns
.
.
Article XIV of the cosmetics business operator shall establish and implement purchase inspection records system, market players directly check the supplier's registration certificate, registration certificate or special cosmetics ordinary cosmetics record information, children's cosmetics logos, product quality inspection certificate and save the relevant documents faithfully record the name cosmetics, special cosmetics registration certificate number or registration number of ordinary cosmetics, life, net weight, quantity purchased, supply the name, address, contact details, date of purchase of contents
.
.
Cosmetics operators should check the label information of children's cosmetics they operate with the corresponding product information published on the official website of the State Drug Administration, including: cosmetic name, special cosmetics registration certificate number or ordinary cosmetics registration number, cosmetics registrant or recorder The name, the name of the entrusted production enterprise, and the name of the responsible person in the country shall ensure that the above-mentioned information is consistent with the published information
.
.
Encourage cosmetics operators to display children's cosmetics in districts and publicize the signs of children's cosmetics in sales areas
.
Encourage cosmetics operators to take the initiative to prompt consumers to inquire about product registration or filing information when selling children's cosmetics
.
.
Encourage cosmetics operators to take the initiative to prompt consumers to inquire about product registration or filing information when selling children's cosmetics
.
Article 15 Children’s cosmetics operators on e-commerce platforms and e-commerce operators operating children’s cosmetics through self-built websites and other network services shall
The main page of its business activities comprehensively, truthfully and accurately discloses cosmetic labels and other information consistent with the cosmetics registration or filing materials, and continues to publicize the children's cosmetics logo in a prominent position on the product display page
.
.
Article 16 Cosmetics manufacturers and operators, medical institutions discovering or learning about adverse reactions of children’s cosmetics shall report the adverse reactions to the local city and county-level adverse reaction monitoring institutions in accordance with regulations
.
.
Cosmetic registrants and record holders shall analyze and evaluate the collected or learned adverse reaction reports of children's cosmetics, and conduct self-inspection of the possible causes of adverse reactions
.
For possible serious adverse reactions, investigation and analysis shall be conducted in accordance with regulations and a self-inspection report shall be formed, which shall be submitted to the local provincial-level adverse reaction monitoring agency, and at the same time to the local provincial drug supervision and administration department
.
If a product is found to have a safety risk, measures should be taken immediately to control the risk; if a product is found to have quality defects or other problems that may endanger human health, it should immediately stop production and recall in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics" For cosmetics that have been put on the market, the relevant cosmetics operators and consumers shall be notified to stop the operation and use
.
.
For possible serious adverse reactions, investigation and analysis shall be conducted in accordance with regulations and a self-inspection report shall be formed, which shall be submitted to the local provincial-level adverse reaction monitoring agency, and at the same time to the local provincial drug supervision and administration department
.
If a product is found to have a safety risk, measures should be taken immediately to control the risk; if a product is found to have quality defects or other problems that may endanger human health, it should immediately stop production and recall in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics" For cosmetics that have been put on the market, the relevant cosmetics operators and consumers shall be notified to stop the operation and use
.
Article 17 If a sampling inspection finds that there are quality and safety problems in children’s cosmetics, the cosmetics registrant, recorder, and entrusted production enterprise shall immediately stop production, conduct self-inspection of the implementation of the cosmetics production quality management norms, and report to the local provincial drug supervision Management report
.
Production can be resumed only after the risk factors affecting quality and safety are eliminated
.
The provincial drug supervision and administration department may organize on-site inspections according to the actual situation
.
.
Production can be resumed only after the risk factors affecting quality and safety are eliminated
.
The provincial drug supervision and administration department may organize on-site inspections according to the actual situation
.
If the cosmetics registrant or recorder discovers that cosmetics have quality defects or other problems that may endanger human health, they should immediately stop production, recall cosmetics that have been on the market, and notify the relevant Cosmetic operators and consumers stop operating and using them
.
.
The cosmetics registrant and recorder shall, based on the
Related products are analyzed and evaluated to ensure product quality and safety
.
.
Article 18 The department responsible for drug supervision and management shall, in accordance with the principles of risk management, and in light of local actual conditions, include cosmetic registrants, record holders, domestic responsible persons, entrusted production enterprises, and cosmetics operators with concentrated sales of children's cosmetics as key cosmetics operators.
Supervise objects, increase the frequency of supervision and inspection
.
Supervise objects, increase the frequency of supervision and inspection
.
Article 19 The department in charge of drug supervision and administration shall regard children's cosmetics as a key category for annual sampling inspection and risk monitoring
.
After sampling inspection or risk monitoring, it is found that children’s cosmetics contain substances that may harm human health.
The department in charge of drug supervision and management can take emergency control measures that order the suspension of production and operation and issue safety warning information; if it is imported children’s cosmetics, it shall be submitted in accordance with the law Relevant departments suspend imports
.
.
After sampling inspection or risk monitoring, it is found that children’s cosmetics contain substances that may harm human health.
The department in charge of drug supervision and management can take emergency control measures that order the suspension of production and operation and issue safety warning information; if it is imported children’s cosmetics, it shall be submitted in accordance with the law Relevant departments suspend imports
.
Article 20 When the department responsible for drug supervision and administration investigates and deals with illegal acts of children’s cosmetics in accordance with the law, if one of the following situations occurs, it shall be deemed as a serious situation as stipulated in the "Regulations on the Supervision and Administration of Cosmetics":
(1) The use of raw materials that are prohibited from being used in the production of cosmetics, and new raw materials that should be registered but not registered for the production of children's cosmetics;
(2) Illegal addition of substances that may harm human health in children's cosmetics
.
.
Article 21 Children's toothpaste shall be managed with reference to these regulations
.
.
Article 22 These regulations shall come into force on January 1, 2022
.
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Recently, the State Food and Drug Administration issued an announcement and issued the "Regulations on the Supervision and Administration of Children's Cosmetics" (hereinafter referred to as the "Regulations"), which is a normative document formulated specifically for the supervision of children's cosmetics in China
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It is clear that in addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
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The specific notice is as follows:
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It is clear that in addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
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The specific notice is as follows:
Announcement of the State Food and Drug Administration on the issuance of the "Regulations on the Supervision and Administration of Children's Cosmetics" (No.
123 of 2021)
123 of 2021)
In order to regulate the production and operation of children’s cosmetics, strengthen the supervision and management of children’s cosmetics, and ensure the safety of children’s use of cosmetics, in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations , the State Food and Drug Administration has organized and formulated the "Regulations on the Supervision and Administration of Children's Cosmetics" (hereinafter referred to as the "Regulations" "), it is hereby announced, and the matters related to the implementation of the "Regulations" are announced as follows:
Regulations and regulations 1.
In addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
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In addition to labeling requirements, other regulations on children's cosmetics will come into effect on January 1, 2022
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Starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”.
The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the "Regulations
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Starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”.
The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the "Regulations
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3.
The mark of children's cosmetics will be announced separately
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The mark of children's cosmetics will be announced separately
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Hereby announce
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Attachment: Regulations on Supervision and Administration of Children's Cosmetics
State Food and Drug Administration
September 30, 2021
Appendix
Appendix Regulations on Supervision and Administration of Children's Cosmetics
Regulations on Supervision and Administration of Children's Cosmetics Article 1 In order to regulate the production and operation of children's cosmetics, strengthen the supervision and management of children's cosmetics, and ensure the safety of children's use of cosmetics, these regulations are formulated in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and other laws and regulations
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Article 2 Those engaged in the production and operation of children's cosmetics and their supervision and management within the territory of the People's Republic of China shall abide by these regulations
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Article 3 The “children’s cosmetics” mentioned in these regulations refer to cosmetics that are suitable for children under the age of 12 (including 12 years old) and have the functions of cleansing, moisturizing, tanning, and sun protection
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Labels "applicable to the whole population", "use by the whole family" and other words or use trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging, etc.
to imply that the product users include children's products in accordance with the management of children's cosmetics
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to imply that the product users include children's products in accordance with the management of children's cosmetics
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Article 4 Cosmetic registrants and record holders are responsible for the quality, safety and efficacy claims of children’s cosmetics
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Cosmetics producers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen the quality management of children's cosmetics, integrity and self-discipline, and ensure product quality and safety
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Product quality product quality product quality.
Cosmetics manufacturers and operators shall establish and implement purchase inspection records and other systems to ensure the traceability of children's cosmetics
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Encourage cosmetics producers and operators to use information technology to collect and store production and operation information, and establish a quality and safety traceability system for children's cosmetics
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Encourage cosmetics producers and operators to use information technology to collect and store production and operation information, and establish a quality and safety traceability system for children's cosmetics
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Article 5 The registrant and recorder of cosmetics shall be based on the child’s physiological characteristics and
Possible application scenarios, following the principles of science and necessity, research and develop children's cosmetics
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Article 6 Children’s cosmetics shall be marked with the children’s cosmetics mark prescribed by the State Drug Administration on the display surface of the sales package
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Non-children’s cosmetics shall not be marked with the children’s cosmetics logo
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Children’s cosmetics should be guided by "Caution" or "Warning", and warning words such as "should be used under adult supervision" should be marked on the visible side of the sales package
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Encourage cosmetics registrants and record holders to use anti-counterfeiting technologies on labels to facilitate consumers to identify and choose legal products
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Article 7 The formula design of children's cosmetics should follow the principle of safety first, the principle of essential efficacy, and the principle of minimal formula:
(1) Cosmetic raw materials with a long history of safe use should be selected.
New raw materials that are still in the monitoring period should not be used.
The use of raw materials prepared by new technologies such as genetic technology and nanotechnology should not be used.
If no alternative raw materials must be used, the reasons should be explained , And evaluate the safety of children's cosmetics;
New raw materials that are still in the monitoring period should not be used.
The use of raw materials prepared by new technologies such as genetic technology and nanotechnology should not be used.
If no alternative raw materials must be used, the reasons should be explained , And evaluate the safety of children's cosmetics;
(2) It is not allowed to use raw materials for the purpose of freckle whitening, acne removal, hair removal, deodorization, anti-dandruff, hair loss prevention, hair dyeing, perming, etc.
If the raw materials that may have the above-mentioned effects are used for other purposes, they should be Necessity and evaluation of the safety of children's cosmetics;
If the raw materials that may have the above-mentioned effects are used for other purposes, they should be Necessity and evaluation of the safety of children's cosmetics;
(3) Children's cosmetics should evaluate the scientificity and necessity of the raw materials used in consideration of the safety, stability, function, compatibility and other aspects of the raw materials, combined with the physiological characteristics of the children, especially the raw materials such as fragrances, colorants, preservatives and surfactants.
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Article 8 Children’s cosmetics shall undergo product safety evaluations through safety evaluations and necessary toxicological tests
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When the cosmetics registrants and recorders conduct safety assessments of children’s cosmetics, they are in danger
The physical characteristics of children should be considered in aspects such as identification of harm and calculation of exposure
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Article 9 The State Drug Administration organizes cosmetic technology review institutions to formulate special technical guidelines for children's cosmetics, and strictly review the registration application materials submitted by applicants
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The drug supervision and administration department shall strengthen the post-market supervision and management of children’s cosmetics, focusing on technical verification of product safety data, and if it is found to be inconsistent with the regulations, it shall be dealt with strictly in accordance with the law
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Article 10 Children's cosmetics shall be produced in accordance with the requirements of the cosmetics production quality management regulations, and the environmental requirements of the production workshops of children's skin care cosmetics shall comply with relevant regulations
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Cosmetic registrants, record holders, and entrusted manufacturers shall conduct self-inspection on the implementation of cosmetics production quality management standards in accordance with regulations to ensure that they continue to meet the requirements of cosmetics production quality management standards
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Encourage cosmetics registrants and record holders to formulate product implementation standards for children's cosmetics that are stricter than mandatory national standards and technical specifications
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Cosmetics operators should check the label information of children's cosmetics they operate with the corresponding product information published on the official website of the State Drug Administration, including: cosmetic name, special cosmetics registration certificate number or ordinary cosmetics registration number, cosmetics registrant or recorder The name, the name of the entrusted production enterprise, and the name of the responsible person in the country shall ensure that the above-mentioned information is consistent with the published information
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Drugs Drugs Drugs enterprise business enterprise.
Encourage cosmetics operators to display children's cosmetics in districts and publicize the signs of children's cosmetics in sales areas
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Encourage cosmetics operators to take the initiative to prompt consumers to inquire about product registration or filing information when selling children's cosmetics
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Encourage cosmetics operators to take the initiative to prompt consumers to inquire about product registration or filing information when selling children's cosmetics
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Article 15 Children’s cosmetics operators on e-commerce platforms and e-commerce operators operating children’s cosmetics through self-built websites and other network services shall
The main page of its business activities comprehensively, truthfully and accurately discloses cosmetic labels and other information consistent with the cosmetics registration or filing materials, and continues to publicize the children's cosmetics logo in a prominent position on the product display page
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Article 16 Cosmetics manufacturers and operators, medical institutions discovering or learning about adverse reactions of children’s cosmetics shall report the adverse reactions to the local city and county-level adverse reaction monitoring institutions in accordance with regulations
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Cosmetic registrants and record holders shall analyze and evaluate the collected or learned adverse reaction reports of children's cosmetics, and conduct self-inspection of the possible causes of adverse reactions
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For possible serious adverse reactions, investigation and analysis shall be conducted in accordance with regulations and a self-inspection report shall be formed, which shall be submitted to the local provincial-level adverse reaction monitoring agency, and at the same time to the local provincial drug supervision and administration department
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If a product is found to have a safety risk, measures should be taken immediately to control the risk; if a product is found to have quality defects or other problems that may endanger human health, it should immediately stop production and recall in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics" For cosmetics that have been put on the market, the relevant cosmetics operators and consumers shall be notified to stop the operation and use
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For possible serious adverse reactions, investigation and analysis shall be conducted in accordance with regulations and a self-inspection report shall be formed, which shall be submitted to the local provincial-level adverse reaction monitoring agency, and at the same time to the local provincial drug supervision and administration department
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If a product is found to have a safety risk, measures should be taken immediately to control the risk; if a product is found to have quality defects or other problems that may endanger human health, it should immediately stop production and recall in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics" For cosmetics that have been put on the market, the relevant cosmetics operators and consumers shall be notified to stop the operation and use
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Article 17 If a sampling inspection finds that there are quality and safety problems in children’s cosmetics, the cosmetics registrant, recorder, and entrusted production enterprise shall immediately stop production, conduct self-inspection of the implementation of the cosmetics production quality management norms, and report to the local provincial drug supervision Management report
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Production can be resumed only after the risk factors affecting quality and safety are eliminated
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The provincial drug supervision and administration department may organize on-site inspections according to the actual situation
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Production can be resumed only after the risk factors affecting quality and safety are eliminated
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The provincial drug supervision and administration department may organize on-site inspections according to the actual situation
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If the cosmetics registrant or recorder discovers that cosmetics have quality defects or other problems that may endanger human health, they should immediately stop production, recall cosmetics that have been on the market, and notify the relevant Cosmetic operators and consumers stop operating and using them
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The cosmetics registrant and recorder shall, based on the
Related products are analyzed and evaluated to ensure product quality and safety
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Article 18 The department responsible for drug supervision and management shall, in accordance with the principles of risk management, and in light of local actual conditions, include cosmetic registrants, record holders, domestic responsible persons, entrusted production enterprises, and cosmetics operators with concentrated sales of children's cosmetics as key cosmetics operators.
Supervise objects, increase the frequency of supervision and inspection
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Supervise objects, increase the frequency of supervision and inspection
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Article 19 The department in charge of drug supervision and administration shall regard children's cosmetics as a key category for annual sampling inspection and risk monitoring
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After sampling inspection or risk monitoring, it is found that children’s cosmetics contain substances that may harm human health.
The department in charge of drug supervision and management can take emergency control measures that order the suspension of production and operation and issue safety warning information; if it is imported children’s cosmetics, it shall be submitted in accordance with the law Relevant departments suspend imports
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After sampling inspection or risk monitoring, it is found that children’s cosmetics contain substances that may harm human health.
The department in charge of drug supervision and management can take emergency control measures that order the suspension of production and operation and issue safety warning information; if it is imported children’s cosmetics, it shall be submitted in accordance with the law Relevant departments suspend imports
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Article 20 When the department responsible for drug supervision and administration investigates and deals with illegal acts of children’s cosmetics in accordance with the law, if one of the following situations occurs, it shall be deemed as a serious situation as stipulated in the "Regulations on the Supervision and Administration of Cosmetics":
(1) The use of raw materials that are prohibited from being used in the production of cosmetics, and new raw materials that should be registered but not registered for the production of children's cosmetics;
(2) Illegal addition of substances that may harm human health in children's cosmetics
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Article 21 Children's toothpaste shall be managed with reference to these regulations
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Article 22 These regulations shall come into force on January 1, 2022
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