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Since the implementation of Cosmetic Supervision and Administration Regulations (CSAR) on Jan 1, cosmetic supervision departments at all levels in China have been actively promoting and strengthening the post-surveillance of cosmetics.
Since January Qinghai, Hunan, Gansu, Guangdong, Sichuan, Jiangxi, Beijing and other provinces have successively issued cosmetics sampling inspection notices, disclosing multiple batches of cosmetics that fail to comply with the regulations. The NMPA also disclosed 20 batches of substandard cosmetics in January and 31 batches of counterfeit cosmetics subject to suspension of sales in February.
Cosmetics Sampling Inspection Notices
Focuses of Sampling Inspections
The sampling inspections mainly focus on the following aspects:
1. Whether the cosmetics operators are qualified
2. Whether the cosmetics are within the expiration date or shelf life
3. Whether the label meets the regulations
4. Whether to label the indications
5. Whether to claim the medical efficacy, indicate false advertising, use medical terminology, etc.
6. Whether the license number is indicated for special cosmetics
7. Whether to establish a management system for certificates
8. Whether to store cosmetics according to regulations
9. Whether to operate non-compliant or unqualified products
55 Noteworthy Punishment Causes
The series of sampling inspections reflect that the cosmetics industry is entering the era of unprecedented strict management. In such an era, all stakeholders are advised to strictly fulfill their obligations prescribed in the CSAR, otherwise, they may face more severe and diversified punishments than before, such as increased fines, punishment to a specific responsible person.
Below are 55 common punishment causes that companies should pay more attention to:
No. | Punishment Causes | Articles violated of the CSAR | Corresponding Punishment |
1 | Unapproved production of cosmetics | Article 27 | Article 59 of the CSAR: The medical products administration departments shall confiscate the illegal income, illegally produced and operated cosmetics, and the ingredients, packaging materials, tools, equipment and other items specifically used for illegal production and operation; if the illegally produced and operated cosmetics have a value of less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan shall be imposed; if the illegally produced and operated cosmetics have a value of more than 10,000 yuan, a fine of more than 15 times and less than 30 times the value shall be imposed; in serious circumstances, it shall be ordered to suspend the production and operation, and the notification shall be canceled by the notification department or the cosmetics license shall be revoked by the original license-issuing department, and the cosmetics notifications or applications for cosmetics administrative licenses submitted by them shall not be accepted within 10 years. In addition, the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 3 times and less than 5 times the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and operation activities for life; where a crime is constituted, the criminal responsibility shall be investigated in accordance with law.
Minimum fine of 50,000 yuan in accordance with the regulation |
2 | The cosmetic registrant entrusts a company that has not obtained the corresponding cosmetic production license to produce cosmetics | Article 28 (2) | |
3 | The cosmetic notifier entrusts a company that has not obtained the corresponding cosmetic production license to produce cosmetics | Article 28 (2) | |
4 | Production, operation or import of unregistered special cosmetics | Article 4 (2) Article 6 Article 17 | |
5 | Production of cosmetics using ingredients prohibited for use in cosmetics | Article 6 Article 15 | |
6 | Use new cosmetic ingredients that should be registered but not registered to produce cosmetics | Article 4 (3) Article 6 Article 11 | |
7 | Illegal addition of substances that may harm human health in cosmetics | Article 6 Article 30 (2) | |
8 | Produce products using cosmetics that have expired, discarded, or recycled | ||
9 | Produce products using cosmetic ingredients that have expired, discarded, or recycled | ||
10 | Use ingredients or packaging materials directly contacting cosmetics that do not meet mandatory national standards and technical specifications to produce cosmetics | Article 6 Article 30 (1) | Article 60 of the CSAR: The medical products administration departments shall confiscate the illegal income, illegally produced and operated cosmetics, and the ingredients, packaging materials, tools, equipment and other items specifically used for illegal production and operation; if the illegally produced and operated cosmetics have a value of less than 10,000 yuan, a fine of more than 10,000 yuan and less than 50,000 yuan shall be imposed; if the illegally produced and operated cosmetics have a value of more than 10,000 yuan, a fine of more than 5 times and less than 20 times the value shall be imposed; in serious circumstances, it shall be ordered to suspend the production and operation, and the notification shall be canceled by the notification department or the cosmetics license shall be revoked by the original license-issuing department, and the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 1 time and less than 3 times the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and operation activities in 10 years; where a crime is constituted, the criminal responsibility shall be investigated in accordance with law. |
11 | Use new cosmetic ingredients that should be notified but not notified to produce cosmetics | Article 4 (3) Article 11 Article 13 (2) | |
12 | Not use ingredients compliant with mandatory national standards or technical specifications in the production of cosmetics | Article 6 Article 30 (1) | |
13 | Production and operation of cosmetics that do not comply with mandatory national standards or technical specifications | Article 6 (2) Article 25 (3) | |
14 | The production and operation of cosmetics that do not meet the technical requirements stated in the cosmetics registration and notification documents | Article 6 Article 29 (2) | |
15 | Failure to organize production in accordance with the requirements of cosmetics production quality management regulations | Article 6 Article 29 (1) | |
16 | Change the expiration date of cosmetics | Article 6 Article 36 (6) | |
17 | Beauty salons, hotels, etc. operate cosmetics prepared by themselves | Article 38 (2) Article 42 | |
18 | Cosmetic operators operate cosmetics prepared by themselves | Article 38 (2) | |
19 | Cosmetics operators operate cosmetics that have deteriorated or have exceeded their expiration dates | Article 6 | |
20 | Beauty salons, hotels, etc. operate cosmetics that have deteriorated or have exceeded their expiration dates | Article 6 Article 42 | |
21 | Refuse to recall products or refuse to stop production or operation | Article 44 | |
22 | Market unnotified general cosmetics | Article 4 (2) Article 6 Article 17 | Article 61 (1) of the CSAR: The medical products administration departments shall confiscate the illegal income, illegally produced and operated cosmetics, and the ingredients, packaging materials, tools, equipment and other items specifically used for illegal production and operation; if the illegally produced and operated cosmetics have a value of less than 10,000 yuan, a fine of more than 10,000 yuan and less than 30,000 yuan shall be imposed; if the illegally produced and operated cosmetics have a value of more than 10,000 yuan, a fine of more than 3 times and less than 10 times the value shall be imposed; in serious circumstances, it shall be ordered to suspend the production and operation, and the notification shall be canceled by the notification department or the cosmetics license shall be revoked by the original license-issuing department, and the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 1 time and less than 2 times the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and operation activities in 5 years.
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23 | Operate unnotified general cosmetics | Article 4 (2) Article 6 Article 17 | |
24 | Import unnotified general cosmetics | Article 4 (2) Article 6 Article 17 | |
25 | Failed to set up a person in charge of quality and safety | Article 6 Article 32 | |
26 | The cosmetics registrant fails to supervise the production of the entrusted production enterprise | Article 6 Article 28 (2) | |
27 | The cosmetics notifier fails to supervise the production of the entrusted production enterprise | Article 6 Article 28 (2) | |
28 | Failed to establish and implement a health management system for practitioners | Article 6 Article 33 | |
29 | Produce and operate cosmetics with non-compliant labels | Article 6 Article 35 Article 36 Article 37 | |
30 | Produce and operate cosmetics with labels that have defects but do not affect the quality and safety and will not cause any misleading | Article 6 Article 35 Article 36 Article 37 | Article 61 (2) of the CSAR: Where the labels of the cosmetics produced and operated have defects that do not affect the quality and safety and will not cause any misleading to consumers, the medical products administration departments shall order it to correct; those who refuse to make corrections shall be fined not more than 2,000 yuan. |
31 | Failure to publish the summary of the basis for cosmetic efficacy claims | Article 6 Article 22 | Article 62 of the CSAR: The medical products administration departments shall order it to make corrections and give a warning and a fine of more than 10,000 yuan and less than 30,000 yuan; in serious circumstances, it shall be ordered to suspend the production or operation, and a fine of more than 30,000 yuan and less than 50,000 yuan shall be imposed, and the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 10,000 yuan and less than 30,000 yuan. Where an importer fails to record and keep imported cosmetics information as prescribed, a punishment shall be imposed by the entry-exit inspection and quarantine institutions in accordance with the preceding paragraph. |
32 | Failure to establish and implement a purchase inspection and recording system and a product sales recording system | Article 6 Article 31 | |
33 | Failure to conduct self-inspection of the implementation of the cosmetics production quality management standard | Article 6 Article 34 | |
34 | Failure to store cosmetics in accordance with the CSAR | Article 6 Article 39 | |
35 | Failure to transport cosmetics in accordance with the CSAR | Article 6 Article 39 | |
36 | Failure to monitor and report cosmetic adverse reactions | Article 6 Article 52 | |
37 | Failure to cooperate with investigations on cosmetic adverse reactions conducted by cosmetics adverse reaction monitoring agencies | Article 6 Article 52 | |
38 | Failure to cooperate with investigations on cosmetic adverse reactions conducted by medical products administration departments | Article 6 Article 52 | |
39 | New cosmetics ingredients registrants fail to report the use and safety of new cosmetics ingredients | Article 6 Article 14 (1) | Article 63 of the CSAR: Where new cosmetics ingredients registrants and notifiers fail to report the use and safety of new cosmetics ingredients as prescribed herein, the NMPA of the State Council shall order it to make corrections and impose on a fine of more than 50,000 yuan and less than 200,000 yuan; in serious circumstances, the registration certificate of new cosmetics ingredients shall be revoked or the notification of new cosmetics ingredients shall be canceled, and a fine of more than 200,000 yuan and less than 500,000 yuan shall be imposed. |
40 | New cosmetics ingredients notifiers fail to report the use and safety of new cosmetics ingredients | Article 6 Article 14 (1) | |
41 | Provide false documents or using other deceptive means when applying for an administrative license for cosmetics | Article 4 Article 6 Article 12 (2) Article 19 (3) Article 27 (1) | Article 64 (1) of the CSAR: Whoever providing false documents or using other deceptive means when applying for an administrative license for cosmetics shall not be granted an administrative license; if an administrative license has already been obtained, the administrative license shall be revoked by the administrative license decision-making department; the cosmetics-related license application shall be not be accepted in 5 years and the illegal income and produced and imported cosmetics shall be confiscated; if the produced and imported cosmetics have a value of less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan shall be imposed; if the produced and imported cosmetics have a value of more than 10,000 yuan, a fine of more than 15 times and less than 30 times the value shall be imposed; the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 3 times and less than 5 times the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and operation activities for life. |
42 | Forge, alter, lease, lend, or transfer cosmetics licenses | Article 4 Article 6 Article 11 Article 17 Article 27 | Article 64 (2) of the CSAR: Whoever forges, alters, leases, lends, or transfers cosmetics licenses, the medical products administration departments or original license-issuing departments shall confiscate or revoke the licenses and confiscate the illegal income; if the illegal income is less than 10,000 yuan, a fine of more than 50,000 yuan and less than 100,000 yuan shall be imposed; if the illegal income is more than 10,000 yuan, a fine of more than 10 times and less than 20 times the illegal income shall be imposed; if a violation of security administration is constituted, the public security organ shall impose on a security administration punishment in accordance with law; where a crime is constituted, the criminal responsibility shall be investigated in accordance with law. |
43 | Provide false documents at the time of notification | Article 4 (2) (3) Article 6 Article 12 (2) Article 12 (3) | Article 65 (1) of the CSAR: Whoever provides false documents at the time of notification, the notification shall be canceled by the notification department and notification submitted by it shall not be accepted in 3 years, also, the illegal income and the produced and imported cosmetics shall be confiscated; if the produced and imported cosmetics have a value of less than 10,000 yuan, a fine of more than 10,000 yuan and less than 30,000 yuan shall be imposed; if the produced and imported cosmetics have a value of more than 10,000 yuan, a fine of more than 3 times and less than 10 times the value shall be imposed; in serious circumstances, it shall be ordered to suspend production and operation until the original license-issuing department revokes the cosmetics production license, and the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 1 time and less than 2 times the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and operation activities in 5 years. |
44 | The notified documents do not meet the requirements | Article 6 Article 13 (1) | Article 65 (2) of the CSAR: Where the notified documents do not meet the requirements, the notification department shall order it to make corrections within a time limit. Among them, if the notified documents related to the safety of cosmetics and new cosmetics ingredients does not meet the requirements, the notification department may order it to suspend sales and use simultaneously; those who do not make the corrections within the time limit, the notification shall be canceled by the notification department. |
45 | After the notification department cancels the notification, the notifier still uses such new cosmetics ingredients in cosmetics production | Article 6 Article 14 Article 55 | Article 65 (3) of the CSAR: After the notification department cancels the notification, if it still uses such new cosmetics ingredients in cosmetics production, or it still markets and imports such general cosmetics, it shall be punished in accordance with the provisions of Article 60 and Article 61. |
46 | After the notification department cancels the notification, the notifier still markets and imports such general cosmetics | Article 6 Article 14 Article 55 | |
47 | The organizers of centralized cosmetics trading markets or the hosts of trade fairs fail to perform the management obligations such as review, inspection, suppression and reporting | Article 6 Article 40 | Article 66 of the CSAR: Where the organizers of centralized cosmetics trading markets or the hosts of trade fairs fail to perform the management obligations such as review, inspection, suppression and reporting as prescribed herein, the medical products administration departments shall impose a fine of more than 20,000 yuan and less than 100,000 yuan; in serious circumstances, it shall be ordered to suspend business and fined more than 100,000 yuan and less than 500,000 yuan. |
48 | The operators of e-commerce platforms fail to perform the management obligations such as real-name registration, suppression, reporting and cessation of providing e-commerce platform services | Article 6 Article 41 | Article 67 of the CSAR: Where the operators of e-commerce platforms fail to perform the management obligations such as real-name registration, suppression, reporting and cessation of providing e-commerce platform services as prescribed herein, the medical products administration departments of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall give a punishment in accordance with the provisions of the “E-commerce Law of the People’s Republic of China”. |
49 | Cosmetics operators fail to fulfil their obligations as prescribed such as purchase inspection and recording | Article 6 Article 38 | Article 68 of the CSAR: Where cosmetics operators have fulfilled their obligations as prescribed herein such as purchase inspection and recording, and there is evidence showing that they do not know that the purchased cosmetics do not comply with the mandatory national standards, technical standards or the technical requirements specified in cosmetics registration and notification documents, the cosmetics not meeting the mandatory national standards, technical standards or the technical requirements specified in the cosmetics registration and notification documents shall be confiscated, and they may be exempted from administrative punishments. |
50 | Non-compliant cosmetics advertisements | Article 6 Article 43 | Article 69 of the CSAR: Whoever having cosmetics advertisements violating the provisions herein shall be punished as prescribed in the “Advertising Law of the People’s Republic of China”; whoever using other means to make false or misleading publicity on cosmetics, it shall be punished in accordance with the relevant laws; where a crime is constituted, the criminal responsibility shall be investigated in accordance with law. |
An enterprise’s legal person in the territory of China that is designated by the overseas cosmetics registrants and notifiers fails to assist in monitoring cosmetic adverse reactions and implementing product recalls | Article 6 Article 23 | Article 70 of the CSAR: Where an enterprise’s legal person in the territory of China that is designated by the overseas cosmetics registrants and notifiers fails to assist in the monitoring of cosmetic adverse reactions and implementing product recalls, the medical products administration departments of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall order it to make corrections, give a warning, and impose a fine of more than 20,000 yuan and less than 100,000 yuan; in serious circumstances, a fine of more than 100,000 yuan and less than 500,000 yuan shall be imposed, and its legal representative or the main responsible person, person who is directly in charge and other directly responsible persons shall be prohibited from engaging in cosmetics production and operation activities in 5 years. Where the overseas cosmetics registrants and notifiers refuse to comply with the administrative punishment decisions made in accordance with this Regulation, they shall be prohibited from importing cosmetics in 10 years. | |
52 | Cosmetic inspection institutions issue a false inspection report | Article 45 Article 49 | Article 71 of the CSAR: For any cosmetic inspection institution issuing a false inspection report, the certification and accreditation administration departments shall revoke its qualification certificate, not accept its application for qualification accreditation in 10 years, confiscate the inspection fees collected, and impose a fine of more than 50,000 yuan and less than 100,000 yuan; the legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be fined more than 1 time and less than 3 times the income they obtained from the unit in the previous year, and shall be given or ordered a demotion, dismissal or discharge in accordance with law; those given a discharge shall be prohibited from engaging in cosmetics inspection in 10 years; where a crime is constituted, the criminal responsibility shall be investigated in accordance with law. |
53 | The cosmetics technical review agencies, cosmetics adverse reaction monitoring agencies and the cosmetics safety risk monitoring agencies fail to perform their duties as prescribed, resulting in major errors in the technical review, adverse reaction monitoring and safety risk monitoring | Article 13 Article 52 Article 53 | Article 72 of the CSAR: Where the cosmetics technical review agencies, cosmetics adverse reaction monitoring agencies and the cosmetics safety risk monitoring agencies fail to perform their duties as prescribed herein, resulting in major errors in the technical review, adverse reaction monitoring and safety risk monitoring, the medical products administration departments shall order them to make corrections, give a warning, and report the criticisms; if they causes serious consequences, their legal representative or the main responsible person, person who is directly in charge and other directly responsible persons of the illegal unit shall be given or ordered a demotion, dismissal or discharge in accordance with law. |
54 | Cosmetics producers and operators recruit or employ personnel who are not allowed to engage in cosmetics production and operation activities | Article 6 Article 33 | Article 73 of the CSAR: Where cosmetics producers and operators and testing institutions recruit or employ personnel who are not allowed to engage in cosmetics production and operation activities or who are not allowed to engage in cosmetics testing work to engage in cosmetics production and operation or testing, the medical products administration departments shall order them to make corrections and give a warning; whoever refusing to make the corrections shall be ordered to stop production and operation until their cosmetics licenses and inspection agency qualification certificates are revoked. |
55 | Cosmetics testing institutions recruit or employ personnel who are not allowed to engage in cosmetics testing work | Article 6 Article 49 |
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