CSAR Subsidiary Regulations: China to Issue New Regulations for Cosmetic Sampling Testing

The draft of Standards for the Management of Cosmetic Sampling Testing (the 2020 draft), has been pending for over a year and a half since its release on September 28, 2020, by China NMPA. With the implementation of cosmetics regulations such as Cosmetic Supervision and Administration Regulation and Administrative Measures on Cosmetics Registration and Notification, NMPA has accordingly adjusted the sampling testing work for cosmetics and tightened the relevant supervision and management requirements.

A new draft, the Measures for the Management of Cosmetic Sampling Testing (the 2022 draft), was released for public consultation on June 24, 2022. Any suggestions can be sent to [email protected] before July 14. ¹

Compared with the 2020 draft, the 2022 draft adjusts and refines the content pertaining to plan formulation, sampling, testing and result submission, re-testing and objections, verification and disposal, etc., which are all important links of the cosmetics sampling testing management.

Key revisions are as follows:

1. It adds “special cosmetics” and “cosmetics using new ingredients” to the key categories of sampling testing.

2020 Draft

2022 Draft

The sampling testing shall mainly focus on the following cosmetics:

Cosmetics with a large circulation and high frequency of usage;
Cosmetics claiming to be used for special groups of people such as children;
Cosmetics with wide media coverage and high consumer attention;
Cosmetics that may have quality and safety risks in complaint reporting, supervision and inspection, adverse reaction monitoring, and risk monitoring;
Cosmetics with a high unqualified rate in previous sampling tests;
Other cosmetics deemed necessary to be included in the sampling testing plan.

The sampling testing shall mainly focus on the following cosmetics:

Children's cosmetics and special cosmetics;
Cosmetics using new ingredients;
Cosmetics with problems frequently found in in the regulatory work such as supervision and inspection, adverse reaction monitoring, safety risk monitoring, complaint reporting, public opinion monitoring, etc.;
Cosmetics with a relatively high unqualified rate in previous sampling tests;
Cosmetics with a wide circulation and high frequency of usage;
Other cosmetics with relatively higher safety risks.

2. It adds the following five types of sampling anomalies that shall be subject to investigation:

Special cosmetics without registration and general cosmetics sold on the market or imported without notification;
Cosmetics that have exceeded the expiry date;
Imported cosmetics without Chinese labels;
Cosmetics whose labels have contents prohibited from being marked;
Other situations being suspected of violating against laws.

3. It refines the requirements for the testing and re-testing work.

The chapter of "Testing and Result Submission" in the 2022 draft has been expanded from the original eight articles to eleven articles, with the requirements for testing standards, testing conclusions and testing reports refined. For example, the retention period of the samples whose testing conclusion conforms to relevant standards and technical specifications has been extended from 3 months to 1 year from the date of issuance of the testing report.

As for re-testing, the time limit for submitting the re-testing report to the re-testing acceptance department has been relaxed from 15 to 20 working days from the date of receiving the backup samples for re-testing. In addition, it is worth noting that the 2020 draft has also added a new provision, emphasizing that “the application for re-testing of the same sample should only be made once, and it shall be submitted by one among all production operators related to the sampled products after agreement”. Some industry experts ² pointed out that the limit on the number of re-testing is because the re-testing is only for cases where the re-testing is failed caused by accident. If the retesting is non-compliant due to the quality of the product itself, the “non-compliance” result will not be changed even if multiple re-tests are carried out.

4. It tightens the penalties for non-compliant products and relevant responsible persons.

Relevant Responsible Person

Disposal Measures

For registrants and notifiers

The 2022 draft stipulates that if a product is found to cause human injury or there is evidence to prove that it may endanger human health during the investigation, the verification and disposal department shall take emergency control measures, ordering the enterprise to suspend production and operation according to law; at the same time, if there are serious hidden risks in the cosmetics production quality management system, emergency control measures shall be taken per the law, ordering the enterprise to suspend production and operation for all products.

Meanwhile, the 2022 draft also strengthens the management of overseas cosmetics registrants and notifiers, and for the first time proposes that "when the verification and disposal department conducts an investigation for overseas cosmetics registrant or notifier, such overseas cosmetics registrant or notifier may entrust its domestic responsible person to assist in the investigation, and sign and receive relevant law enforcement documents on the registrant or notifier’s behalf. The overseas cosmetics registrant or notifier who refuses to fulfill the relevant administrative penalty decision will be prohibited from importing the cosmetics within 10 years according to law.”

For operators

The 2022 draft points out that if a product is found to cause human injury or there is evidence to prove that it may endanger human health during the investigation, the verification and disposal department shall take emergency control measures, ordering the operator of the product to suspend business operations per the law.

In addition, the 2022 draft has also added the exemption clauses for operators. Those who meet both of the following conditions can be exempted from administrative penalties:

The operator has checked and properly kept the relevant certificates of the direct suppliers, such as market entity registration certificate, special cosmetics’ registration certificate, general cosmetics’ notification information, etc.;
The operator has checked the consistency between the information on the label of the operated cosmetics and the corresponding product information stated in the registration certificate of special cosmetics or the notification information of general cosmetics.