2021Year123number

       To standardize the production and operation of children's cosmetics,Strengthen the supervision and management of children's cosmetics,Ensure the safety of children's use of cosmetics,basis Regulations on the supervision and administration of cosmetics Other laws and regulations,The State Food and drug administration has organized and formulated Regulations on supervision and administration of children's cosmetics hereinafter referred to as regulations ,It is hereby announced,And on regulations The implementation related matters are announced as follows

one In addition to labeling requirements,Other provisions on children's cosmetics from2022year1month1Effective as of.

two since2022year5month1From the day,Children's cosmetics applied for registration or filing,Must follow regulations Label identification Children's cosmetics previously applied for registration or filing,Not according to regulations For label identification,Cosmetic registrant The filing person shall2023year5month1Update the product label a few days ago,Make it conform to regulations .

three The logo of children's cosmetics will be published separately.

It is hereby announced.

 enclosure Regulations on supervision and administration of children's cosmetics

State Food and Drug Administration

2021year9month30day

enclosure

Regulations on supervision and administration of children's cosmetics

Article 1  In order to standardize the production and operation of children's cosmetics,Strengthen the supervision and management of children's cosmetics,Ensure the safety of children's use of cosmetics,according to Regulations on the supervision and administration of cosmetics Other laws and regulations,Formulate this regulation.

Article 2  Engaging in the production and operation of children's cosmetics within the territory of the people's Republic of China and its supervision and Administration,This provision shall be observed.

Article 3  Children's cosmetics referred to in these Provisions,Refers to the age applicable to12Under years old contain12year children,With cleaning Moisture Refreshing Cosmetics with sunscreen and other effects.

identification Applicable to the whole population Family use And other words or use of trademarks pattern Homophonic letter Chinese Pinyin number Symbol The packaging form and other products that imply that the product users include children shall be managed according to children's cosmetics.

Article 4  Cosmetic registrant The filer is responsible for the quality, safety and efficacy of children's cosmetics.

Cosmetics producers and operators shall act in accordance with the law statute Mandatory national standards Engage in production and business activities according to technical specifications,Strengthening the quality management of children's cosmetics,Integrity and self-discipline,Ensure product quality and safety.

Cosmetics producers and operators shall establish and implement purchase inspection records and other systems,Ensure traceability of children's cosmetics.Cosmetics producers and operators are encouraged to adopt information-based means to collect cosmetics Save production and operation information,Establish a quality and safety traceability system for children's cosmetics.

Article 5  Cosmetic registrant The filing person shall, according to the physiological characteristics of children and possible application scenarios,Follow scientificity Principle of necessity,Research and development of children's cosmetics.

Article 6  Children's cosmetics shall be marked with the marks of children's cosmetics stipulated by the State Drug Administration on the display surface of the sales package.

Non children's cosmetics shall not be marked with children's cosmetics signs.

Children's cosmetics should be be careful perhaps warning As a guide,Mark on the visual surface of the sales package It should be used under adult supervision And other warning words.

Encourage cosmetic registrants The filer adopts anti-counterfeiting technology and other means on the label to facilitate consumer identification Select legal products.

Article 7  The formulation design of children's cosmetics shall follow the principle of safety priority Principle of efficacy necessity Formula minimalism principle

one Cosmetic raw materials with a long history of safe use shall be selected,New raw materials that are still in the monitoring period shall not be used,Gene technology is not allowed Raw materials prepared by new technologies such as nanotechnology,If there is no alternative raw material, it must be used,The reasons should be explained,The safety of children's cosmetics was evaluated

two It is not allowed to use for freckle removing and whitening acne treatment Depilation Deodorization Desquamation Anti hair loss dye one 's hair Raw materials for the purpose of perm,If raw materials that may have the above effects are used for other purposes,The necessity of use and the safety of children's cosmetics should be evaluated

three Children's cosmetics should start from the safety of raw materials stable function Compatibility, etc,Combined with children's physiological characteristics,Evaluate the scientificity and necessity of the raw materials used,Especially flavors and fragrances. Colorant Raw materials such as preservatives and surfactants.

Article 8  The safety of children's cosmetics shall be evaluated through safety evaluation and necessary toxicological tests.

Cosmetic registrant When the filer conducts safety assessment on children's cosmetics,In hazard identification Exposure calculation, etc,The physiological characteristics of children should be considered.

Article 9  The State Drug Administration shall organize the cosmetic technical evaluation organization to formulate special technical guiding principles for children's cosmetics,Strictly examine the registration application materials submitted by the applicant.

The drug regulatory department shall strengthen the post marketing supervision and administration of children's cosmetics,Focus on technical verification of product safety data,Non conformance found,Strictly handle according to law.

Article 10  Children's cosmetics shall be produced in accordance with the requirements of the standards for the production quality management of cosmetics,The environmental requirements of the production workshop of children's skin care cosmetics shall comply with relevant regulations.

Cosmetic registrant Filed by The entrusted production enterprise shall conduct self inspection on the implementation of the cosmetics production quality management standards in accordance with the provisions,Ensure continuous compliance with the requirements of cosmetic production quality management specifications.

Encourage cosmetic registrants The filer formulates stricter than mandatory national standards for children's cosmetics Technical specification and product implementation standards.

Article 11  Cosmetic registrant Filed by The entrusted production enterprise shall formulate and implement the induction training and annual training plan for employees,Ensure that employees are familiar with job responsibilities,Professional knowledge of performing job responsibilities and legal knowledge related to children's cosmetics.The enterprise shall establish employee training files.

Enterprises shall strengthen the construction of quality culture,Continuously improve employees' quality awareness and ability to perform their duties,Encourage employees to report illegal or non-standard situations found in their work.

Article 12  Cosmetic registrant Filed by The entrusted production enterprise shall strictly implement the material purchase inspection record system,The enterprise shall carry out the inspection of relevant items when it deems necessary after evaluation,Avoid passing through raw materials Packaging materials in direct contact with cosmetics Prohibited raw materials such as anti infective drugs or substances that may endanger human health.

Cosmetic registrant Raw materials found by the filer There are hormones in packaging materials in direct contact with cosmetics Prohibited raw materials such as anti infective drugs or substances that may endanger human health,Immediate measures should be taken to control the risk,And report to the local provincial drug regulatory department.

Article 13  Cosmetic registrant Filed by The entrusted production enterprise shall take measures to avoid the appearance of children's cosmetics smell Appearance and food Drugs and other products,Prevent accidental eating misuse.

Children's cosmetics labels shall not be marked Food grade edible And other words or food related patterns.

Article 14  Cosmetics business operators shall establish and implement a purchase inspection record system,Check the registration certificate of the market entity of the direct supplier Registration certificate of special cosmetics or filing information of ordinary cosmetics Children's cosmetics logo Product quality inspection certificate and relevant certificates shall be kept,Truthfully record the name of cosmetics Registration Certificate No. of special cosmetics or filing no. of ordinary cosmetics Service life Net content Purchase quantity Name of supplier address contact information Purchase date, etc.

Cosmetic operators shall check the label information of their children's cosmetics with the corresponding product information published on the official website of the State Drug Administration,include:Name of cosmetics Registration Certificate No. of special cosmetics or filing no. of ordinary cosmetics Name of cosmetic registrant or filer Name of entrusted manufacturer Name of domestic responsible person,Ensure that the above information is consistent with the published information.

Encourage cosmetics operators to display children's cosmetics in different areas,Publicity of children's cosmetics signs in the sales area.Cosmetics operators are encouraged to actively prompt consumers to inquire about product registration or filing information when selling children's cosmetics.

Article 15  Children's cosmetics operators in the e-commerce platform and through self built websites E-commerce operators of other network services engaged in children's cosmetics shall make a comprehensive report on the main page of their business activities real Accurately disclose cosmetics labels and other information consistent with cosmetics registration or filing materials,And continuously publicize the children's cosmetics logo in a prominent position on the product display page.

Article 16  Cosmetics producers and operators Medical institutions find or learn about adverse reactions of children's cosmetics,Adverse reactions shall be reported to the local adverse reaction monitoring institution at the city and county level in accordance with the regulations.

Cosmetic registrant The filer shall analyze and evaluate the collected or obtained reports of adverse reactions of children's cosmetics,Self check the possible causes of adverse reactions.For possible serious adverse reactions,Investigation and analysis shall be carried out in accordance with regulations and a self-examination report shall be formed,Report to the local provincial adverse reaction monitoring organization,At the same time, it shall be submitted to the local provincial drug regulatory department.It is found that the product has safety risks,Immediate measures should be taken to control the risk The product is found to have quality defects or other problems,May endanger human health,Should be in accordance with Regulations on the supervision and administration of cosmetics Provisions of Article 44,Stop production immediately,Recall cosmetics already on the market,Inform relevant cosmetics operators and consumers to stop operation use.

Article 17  Quality and safety problems of children's cosmetics found in sampling inspection,Cosmetic registrant Filed by The entrusted production enterprise shall immediately stop production,Conduct self inspection on the implementation of cosmetics production quality management norms,And report to the local provincial drug regulatory department.After the risk factors affecting quality and safety are eliminated,Before resuming production.The provincial drug regulatory department may organize on-site inspection according to the actual situation.

Cosmetic registrant The filer finds that the cosmetics have quality defects or other problems,May endanger human health,Should be in accordance with Regulations on the supervision and administration of cosmetics Provisions of Article 44,Stop production immediately,Recall cosmetics already on the market,Inform relevant cosmetics operators and consumers to stop operation use.

Cosmetic registrant The recorder shall, according to the reasons for the unqualified inspection,Analyze other related products assessment,Ensure product quality and safety.

Article 18  The Department in charge of drug supervision and administration shall follow the principle of risk management,Combined with local reality,Registration of cosmetics Filed by Domestic responsible person Entrusted production enterprises and cosmetics operators with concentrated sales behavior of children's cosmetics are included in the key supervision 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 the key category of annual sampling inspection and risk monitoring.Through sampling inspection or risk monitoring, it is found that children's cosmetics contain substances that may endanger human health,The Department in charge of drug supervision and administration may take measures to order the suspension of production Emergency control measures for operation,And issue safety warning information It belongs to imported children's cosmetics,Request relevant departments to suspend import according to law.

Article 20  When the Department in charge of drug supervision and administration investigates and deals with illegal acts of children's cosmetics according to law,Under any of the following circumstances,Should be recognized as Regulations on the supervision and administration of cosmetics Specified serious circumstances

one Use of raw materials prohibited for cosmetic production Children's cosmetics should be produced with registered but unregistered new raw materials

two Illegal addition of substances that may endanger human health in children's cosmetics.

Article 21  Children's toothpaste shall be managed with reference to these regulations.

Article 22  This regulation comes from2022year1month1Effective as of.