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However, children’s cosmetics on the market are mixed
2 the introduction of
care for your child's beautiful
to regulate children's cosmetics production and business activities,Strengthen the supervision and management of children’s cosmetics to ensure the safety of children’s use of cosmetics. In accordance with the “ Cosmetics Supervision and Management Regulations” and other laws and regulations, the State Food and Drug Administration has organized and formulated the “Children’s Cosmetics Supervision and Management Regulations” (hereinafter referred to as the “Regulations”). Announced and announced the implementation of the "Regulations" related matters as follows:
1. 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"; children's cosmetics that have previously applied for registration or filed have not been in accordance with the " For label identification in the Regulations, the cosmetic registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the Regulations.
3. Children's cosmetics logo will be announced separately, please refer to the "Children's Cosmetics Supervision and Management Regulations" below.
children's cosmetics supervision and management regulations
01
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.
02
The production and operation of children's cosmetics and its supervision and management within the territory of the People's Republic of China shall comply with these regulations.
03
The term “children’s cosmetics” in this regulation refers to cosmetics that are suitable for children under 12 years old (including 12 years old) that have cleansing, moisturizing, body care, and sun protection.
words such as “applicable to the whole population” and “use by the whole family” or use trademarks, patterns, homophones, letters, Hanyu Pinyin, numbers, symbols, packaging, etc. to imply that the product users include children. Children's cosmetics management.
04
The cosmetic registrant and filing person 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 and regulations, mandatory national standards, and technical specifications.Strengthen the quality management of children's cosmetics, honesty and self-discipline, and ensure product quality and safety.
Cosmetics manufacturers and operators shall establish and implement a system for inspection records of purchases to ensure that children's cosmetics can be traced. 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.
05
Cosmetic registrants and record holders should develop and develop children's cosmetics based on children's physiological characteristics and possible application scenarios, following the principles of science and necessity.
06
Children's cosmetics should be marked with the children's cosmetics logo stipulated 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 "attention" or "warning", and warnings such as "should be used under adult supervision" should be marked on the visual surface of the sales package.
Encourage cosmetic registrants and record holders to use anti-counterfeiting technology on labels to facilitate consumers to identify and choose legal products.
07
The formula design of children's cosmetics should follow the principle of safety first, the principle of essential selection, and the principle of minimal formula: 22 _span25pspan _span25pspan 22 For cosmetic raw materials, it is not allowed to use new raw materials that are still in the monitoring period, and raw materials prepared by new technologies such as gene technology and nanotechnology are not allowed. If no alternative raw materials must be used, the reasons should be explained and the use of children’s cosmetics Safety evaluation;
(2) It is not allowed to use raw materials for the purpose of freckle whitening, acne, hair removal, deodorization, dandruff prevention, hair loss prevention, hair dyeing, perming, etc., such as for other purposes When using raw materials that may have the above-mentioned functions, the necessity of use and the safety of children's cosmetics should be evaluated;
Evaluate the scientificity and necessity of the raw materials used in combination with the physiological characteristics of children, especially the raw materials such as fragrances, colorants, preservatives and surfactants.
08
Children's cosmetics should pass safety assessment and necessary toxicology test for product safety evaluation.
When cosmetics registrants and recorders conduct safety assessments of children's cosmetics, they should consider the physiological characteristics of children in terms of hazard identification and exposure calculation.
09
The National Medical Products 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 inspection of product safety data, and if it is found to be non-compliant, it shall be dealt with strictly in accordance with the law.
10
Children's cosmetics should be produced in accordance with the requirements of the cosmetics production quality management regulations, and the environmental requirements of the children's skin care cosmetics production workshop should meet the relevant regulations.
cosmetics registrants, record holders, and entrusted manufacturers shall conduct self-inspection of the implementation of cosmetics production quality management specifications in accordance with regulations to ensure that they continue to meet the requirements of cosmetics production quality management specifications.
Encourage cosmetic registrants and record holders to formulate standards for the implementation of products that are stricter than mandatory national standards and technical specifications for children's cosmetics.
11
Cosmetics registrants, record holders, and entrusted manufacturing companies shall develop and implement induction training and annual training plans for employees to ensure that employees are familiar with their job responsibilities and have professional knowledge and perform job duties. Legal knowledge related to children's cosmetics. 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.
12
Cosmetics registrants, record holders, and entrusted manufacturers should strictly implement the material purchase inspection record system, and enterprises should avoid conducting raw materials and direct contact inspections when deemed necessary by the evaluation. The packaging materials of cosmetics bring hormones, anti-infective drugs and other prohibited raw materials or substances that may endanger human health.
If the registrant or filing person of cosmetics discovers that the raw materials or packaging materials that directly contact the cosmetics contain hormones, anti-infective drugs and other prohibited raw materials or substances that may harm human health, they should take immediate measures to control risks. And report to the local provincial drug supervision and administration department.
13
Cosmetic registrants, record holders, and contracted manufacturers should take measures to avoid confusion between the characteristics, odor, appearance and shape of children's cosmetics, such as food, medicine and other products.Prevent accidental ingestion and misuse.
Children’s cosmetics labels shall not be marked with words such as “food grade”, “edible” or food-related patterns.
14
The cosmetics business should establish and implement the purchase inspection record system, and check the market entity registration certificate, special cosmetics registration certificate, or general cosmetics logo of the direct supplier. Product quality inspection certificate and save relevant vouchers, truthfully record the cosmetic name, special cosmetics registration certificate number or ordinary cosmetics record number, use period, net content, purchase quantity, supplier name, address, contact information, purchase date, etc. content.
Cosmetics operators shall 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 The serial number, the name of the cosmetics registrant or filing person, the name of the entrusted production enterprise, and the name of the domestic responsible person shall ensure that the above information is consistent with the published information.
Encourage cosmetics operators to display children's cosmetics in different areas 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.
15
Children's cosmetics operators in the e-commerce platform and e-commerce operators operating children's cosmetics through self-built websites and other online services should be comprehensive, truthful and accurate on the main page of their business activities Disclosure of cosmetics labels and other information consistent with cosmetics registration or filing materials,And continue to publicize the children's cosmetics logo in a prominent position on the product display page.
16
If any cosmetics manufacturer or medical institution discovers or learns of adverse reactions to children’s cosmetics, they shall report the adverse reactions to the local municipal and county-level adverse reaction monitoring institutions in accordance with regulations.
The cosmetics registrant and recorder shall analyze and evaluate the collected or learned adverse reaction reports of children's cosmetics, and self-examine the possible causes of the 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.
17
If the sampling inspection finds that there are quality and safety problems in children’s cosmetics, the cosmetic registrant, recorder, and entrusted manufacturer shall immediately stop production and implement the quality management of cosmetics. And report to the local provincial drug regulatory authority. 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.
The registrant and filing person of cosmetics found that the cosmetics had quality defects or other problems,If it may endanger human health, in accordance with the provisions of Article 44 of the "Regulations on Supervision and Administration of Cosmetics", immediately stop production, recall cosmetics that have been on the market, and notify relevant cosmetics operators and consumers to stop operating and using them.
The registrant and filing person of cosmetics shall analyze and evaluate other related products based on the reasons for the unqualified inspection to ensure product quality and safety.
18
The department responsible for drug supervision and management should follow the principles of risk management, combined with the local reality of the production company, the responsible person and the registered person, and the domestic Cosmetics operators with relatively concentrated sales of cosmetics are included in key supervision targets, and the frequency of supervision and inspection has been increased.
19
The department in charge of drug supervision and management should make children's cosmetics a key category for annual sampling inspection and risk monitoring. After sampling inspection or risk monitoring finds that children’s cosmetics contain substances that may harm human health, the department responsible for drug supervision and administration 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.
20
In one of the following circumstances, it should be deemed as a serious situation as stipulated in the Regulations on Supervision and Administration of Cosmetics:
Raw materials to produce children’s cosmetics;
(2) Illegal addition of substances that may harm human health in children’s cosmetics.
21
children's toothpaste shall be managed in accordance with this regulation.
22
This regulation will come into effect on January 1, 2022.
draft Person: Yuan Kun
Reviewed by: Zhang Yajun FORESTRY AND
Publisher: Chen Jingwen
.
