Questions on annual report of general cosmetics and related issues are of great concern to cosmetic industry. For the purpose of regulating the supervision and administration of cosmetics, and protecting legitimate rights and interests of consumers, National Medical Products Administration (NMPA) has issued an announcement to answer these questions with the reference to the current regulations, provisions and technical speculations of cosmetics.
Q 1. Why is the annual report of the general cosmetics required?
A 1. Since the implementation of online notification of general cosmetics within the territory of China on June 30, 2014, there have been over 2.2 million notifications. Some products, notified before the issue of new Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations), are no longer produced, but their notifications are still on the platform due to the loopholes in regulations, limited functions of platform and etc. This brings inconvenience to the supervision and administration of cosmetics and public checks. In the process of supervision and administration, the notification persons of some products cannot be found, which exposes consumers to potential safety risks. This, therefore, requires further legal regulations.
The issue of the Regulations optimizes the management system of notification and specifies the accountability of notification persons for the quality and safety of products. In accordance with Article 37 in the Measures of the Administration of the Registration and Notification of Cosmetics (hereinafter referred to as the Measures), notification persons of general cosmetics shall annually report the production, import and technical standards of the product to the supervision and administration department of NMPA.
In accordance with the Regulation and the Measures, NMPA Announcement on Issues about Implementing the Rules of Registration and Notification Dossiers of Cosmetics (NO.35 of 2021) stipulates that, as of January 1, 2022, an annual reporting system shall be implemented for the general cosmetics filed notification through the original and the new platform. The notification persons shall submit the annual report of general cosmetics that have been filed notification for a full year through the new platform during each January 1 to March 31. If the notification persons fails to submit annual report for the product within the required time limit, the supervision and administration department will order rectification in accordance with Article 58 in the Measures. If the notification persons fails to make rectification within the required time limit, the notification of the product will be canceled in accordance with Article 59 in the Measures.
Q 2. Why is the submission of supplementary materials required for the notified products?
A 1. In order to standardize the production and distribution of cosmetics, strengthen supervision and administration of cosmetics, and protect the safety in cosmetics use, the Regulation, the Measures, and the Rules for the Registration and Notification Dossiers of Cosmetics stipulate documents required for the application of registration and notification. Before the implementation of the Regulations and its related supporting laws and regulations, the documents of the notified products that were submitted through the original platform were not sufficient. Take the notification of domestic products as an example, except for the information of ingredients and packages, other relevant documents were archived by enterprises for future inspection, resulting in the loss of necessary information of products, which brought safety risks to consumers. After the implementation of the Regulations, necessary supplementary materials are required for the products filed notification through the original platform and still in production and distribution. This improves efficiency of registration and notification, and safeguards the health rights and interests of consumers. Meanwhile, in consideration of the time needed for the transition of old regulations and new regulations, NMPA sets reasonable transitional period for the registration and notification persons to provide supplementary materials. The submission of supplementary materials is a necessary condition to prove the relevant products conforming to the Regulations and its supporting laws and regulations. Products without the supplementary materials as required shall not continue to be produced and imported until the supplementary materials are provided.
Q 3. What is the difference between the discontinuation of notifications by notification persons and the cancellation of notifications by the filing management department? Is it necessary to discontinue the notified products that are no longer be produced or imported?
A 3. In accordance with the Regulations, the Measures and relevant provisions for the registration and notification of cosmetics, notification persons shall discontinue notifications for products that are no longer produced or imported. This safeguards the right to know of consumers and improves the efficiency of the supervision and administration department. Products discontinued by notification persons are allowed to be sold until expiration date if they are already on the market before discontinuation and without violation of laws and regulations.
The cancellation of notifications by the supervision and administration department is a punishment for illegal acts. According to Article 65 in the Regulations, products whose notifications are canceled by the filing management department shall not be sold or imported since the date of cancellation. Those who still sell or import these products shall be punished by the supervision and administration department in accordance with laws and regulations.
It is advised that notification persons and domestic responsible persons should go through products that have been notified as soon as possible. If they plan to continue production or import, they shall submit annual report and fill in supplementary materials as required. For products that are no longer produced or imported, they shall apply for the discontinuation of the products. In consideration of the transition of the original and the new platform, notification persons and domestic responsible persons who have not registered on the new platform can submit written applications for the discontinuation of products to the local provincial medical products administration. Then the filing management departments will assist in completing the discontinuation and updating notice on the new platform, so as to not affect the sale and import of relevant products.