China NMPA Answers the Key Questions on Cosmetic Annual Report Submission and Dossiers Supplementation

On April 8, 2022, China National Medical Products Administration (NMPA) released a collection of FAQs, giving further interpretation on the submission of the annual report and supplementary documents of notified cosmetics to help cosmetic stakeholders better comply with the new regulatory requirements.

Annual report for general cosmetics

Starting from January 1, 2022, the annual report system has been implemented for all general cosmetics notified through both the previous and the new cosmetic registration and notification information management platforms. Notifiers shall submit the annual report of general cosmetics notified over one year through the new platform from January 1 to March 31 of each year. For notified products that fail to submit the annual report within the required time limit, the regulatory authorities will order rectification within a time limit. If the rectification fails to be made as required, the notification will be canceled.

Dossier’s supplementation

• For products in production, their registered or notified information on the previous platform shall be supplemented. It should be noted that the supplementary documents required by the new platform are the documents previously archived by enterprises themselves. In other words, registrants and notifiers has no need to prepare new documents.
• The submission of supplementary documents is deemed an indispensable step to prove the product’s compliance with the Cosmetic Supervision and Administration Regulations (CSAR) and its supporting regulations. The production and import shall not be continued for products whose documents have not been supplemented as required until the supplementation is completed.

China Drafts the Technical Guidelines for Children Cosmetics

On Apr. 11, 2022, China National Institutes for Food and Drug Control (NIFDC) released the draft of Technical Guidelines for Children Cosmetics (“the draft Guidelines“) for public consultation. The draft Guidelines clarifies the specific requirements for safety assessment, products designed for the Chinese market, and children sunscreens. It also puts forward more stringent requirements for ingredient use, labeling, claims, etc.

Once implemented, the Guidelines will provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for registration and notification of children cosmetics. The Guidelines will also serve as the basis for the competent authorities’ technical review of special children cosmetics and post-notification review of general children cosmetics.

Sichuan, Beijing Municipal, and Gansu MPAs Issues Notices on Matters Related to General Cosmetics’ Annual Report

Under China’s new cosmetic regulatory framework, notifiers shall submit the annual report of general cosmetics notified over one year through the new platform. The annual report’s submission period lasts from January 1 to March 31 of each year.

On April 12 and 21, 2022, Sichuan, Beijing Municipal, and Gansu Medical Products Administration (MPA) respectively issued notices to extend the deadline for submitting the annual report. General cosmetics failed to submit the annual report before March 31, 2022 shall submit the annual report before June 30, 2022 according to the rectification opinion issued by the local municipal MPA. If the rectification is not completed as required within the time limit, the notification of the product will be automatically canceled.

China NIFDC Releases FAQs Regarding Cosmetic Review

On April 19, 2022, China National Institutes for Food and Drug Control (NIFDC) released 24 FAQs on cosmetic review, involving the acceptance process and technical review. In response to the corrective measures for cosmetic label’s defects that are concerned by the cosmetic industry, NIFDC gave the following suggestions: “If there are defects in cosmetic labels that do not affect quality and safety and will not mislead consumers, enterprises can reprint the label or correct the defects by pasting a new one and covering the old one.”

China General Administration of Customs (GACC): A Batch of Cosmetics Rejected in April

On April 21, 2022, GACC gave an update on rejected food and cosmetics in March. A batch of cosmetics imported from South Korea failed customs inspection. The reason for rejection was the detection of boric acid and borate components.

China SAMR Unveils the 2022 Legislation Scheme

On April 27, 2022, China State Administration for Market Regulation unveiled its 2022 legislation scheme. The scheme includes 69 regulations, among which one regulation is related to cosmetics, namely the Administrative Measures on Toothpaste.

NMPA Relaxes the Qualification Requirements for the Person in Charge of Cosmetic Quality and Safety

According to CSAR, cosmetics registrants, notifiers and entrusted production enterprises shall be equipped with a person in charge of quality and safety, who shall have professional knowledge related to the quality and safety of cosmetics and more than five years of work experience in cosmetic production or quality and safety management.

On April 27, 2022, China NMPA relaxed the qualification requirements for the person in charge of cosmetic quality and safety in its reply letter to Jilin and Chongqing Municipal MPA’s request for relevant issues of the person. NMPA stated that since the principles of production as well as quality and safety management of health-related products such as drugs, medical devices, and special foods are basically the same as those of cosmetics production as well as quality and safety management, the person’s experience in the production and quality management of drugs, medical devices, and special food can be regarded as the experience in the production and quality and safety management of cosmetics, under the premise of having professional knowledge related to cosmetics’ quality and safety.

Shanghai Municipal and Guangdong MPAs Issues Temporary Measures for Local Cosmetics Registration and Notification Management During the COVID-19 Outbreak

On April 27, 2022, China NMPA issued a notice approving Shanghai Municipal MPA’s request for implementing the temporary measures for cosmetics registration and notification management during the COVID-19 outbreak. Specifically,

• For cosmetic registration and notification documents that cannot be affixed with seals by registrants or notifiers, and other originals of supporting documents that cannot be provided temporarily, the relevant photocopies or electronic documents can be accepted first, and the originals of relevant documents can be supplemented as required after this wave of COVID comeback ends.
• The time limit for supplementing cosmetic registration and notification documents and uploading the abstract of efficacy claim basis in Shanghai will be extended from May 1, 2022 to December 31, 2022.

On April 29, 2022, Guangdong MPA introduced a similar notice, allowing notifiers and domestic responsible persons affected by the pandemic to submit a written statement to their local medical products regulatory authorities to apply for a delay in submitting the abstract of efficacy claim basis and supplementing notification dossiers. Notably, the corresponding work shall be completed within three months after this wave of COVID comeback ends and no more than December 31, 2022 in principle.

NMPA Lays down the Special Rectification Work Plan on Cosmetics Safety

On April 28, 2022, China NMPA held a webinar on the supervision of cosmetics’ online operation, reporting the progress of the special rectification work on cosmetics safety in the first quarter. The webinar also clarifies the focus of cosmetics safety special rectification work in the next stage, which includes the following three points:

1. Severely crack down on serious illegal activities such as the production of cosmetics without licenses, falsification of registration and notification dossiers, illegal addition of prohibited ingredients and substances that may endanger human health, etc.; strengthen the monitoring of cosmetic online operations; and improve the risk prevention, control, and coping ability of cosmetics.
2. Investigate and punish the entire chain of registrants, notifiers, entrusted production enterprises, and operators involved in illegal cosmetics business per the law.
3. Combine the special rectification campaign with daily supervision work.

China NMPA Approves Two New Cosmetic Ingredients

In late March and April, China NMPA updated the notification information of two new cosmetic ingredients (NCIs). The basic information about the new NCIs is as follows:

CAFFCI, Beijing Municipal, and Guangzhou MPA Publish FAQs Regarding Cosmetics Notification and Registration Management

In April, CAFFCI, Beijing Municipal, and Guangzhou MPA issued five batches of frequently asked questions, which pertain to the cosmetics registration and notification management, ingredient requirements, sales, etc., under China’s new cosmetic regulations.

Kuaishou Revises Three Platform Rules Concerning Efficacy Claims

On April 15, 2022, Kuaishou, China’s second-largest short video sharing app, issued three notices revising the platform rules Personal Care and Cleaning Industry Promotion Specifications, Beauty Industry Promotion Specifications, and Specifications for the Release of Products in the Beauty/Personal Care and Cleaning Category to strengthen the content supervision of the beauty and personal care industry.

The three new rules mainly increase the regulatory requirements for medical claims, false advertising, claims beyond the allowed description scope, absolute terms, etc. It can be seen that the revision direction of Kuaishou’s new platform rules is basically consistent with the requirements of national policies such as the CSAR and the Administration Measures on Cosmetic Labeling. All three rules have come into effect on April 23, 2022.

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