Requirements for the Pilot Program of Electronic Labels for Cosmetics
Article 1 To regulate the pilot program for electronic labels for cosmetics (including toothpaste, hereinafter referred to as "cosmetics"), these Requirements are formulated in accordance with the provisions of the Regulations on Supervision and Administration of Cosmetics (hereinafter referred to as the "Regulations"), the Provisions for Registration and Filing of Cosmetics, the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics, the Provisions for Toothpaste Regulation, and the Measures for the Administration of Cosmetics Labels.
Article 2 The term "cosmetics electronic label" (hereinafter referred to as "electronic label") as used in these Requirements refers to the relevant content of the Chinese label of cosmetics stored through a certain electronic storage mechanism, as well as the corresponding QR code generated through an information system. The electronic label shall have a convenient reading function, allowing consumers to directly read the product's Chinese label information by scanning the QR code with commonly used communication or payment software installed on their smartphones. The electronic label is an integral part of the cosmetics label.
Article 3 Enterprises participating in the electronic label pilot program (hereinafter referred to as "pilot enterprises") shall meet the following conditions:
(1) The entity shall be the registrant or filer of the cosmetics, or a domestic responsible person authorized by the cosmetics registrant or filer;
(2) The entity shall possess technical capabilities appropriate for the electronic label pilot program and have management personnel in place;
(3) The entity shall have a sound quality management system;
(4) The entity shall have the capability to implement the electronic label pilot program.
Article 4 Pilot enterprises shall generate electronic label QR codes and electronic label display content from product label information through an electronic label system.
The electronic label system may be constructed independently by pilot enterprises, by third-party technical institutions, or organized and constructed by provincial drug regulatory departments, with the specific method to be determined by provincial drug regulatory departments themselves.
Article 5 The electronic label system shall comply with the relevant requirements of the Cybersecurity Law, the Data Security Law, the Personal Information Protection Law, etc.; it shall have anti-tampering functions and establish a sound backup and recovery mechanism to ensure the accuracy, completeness, continuity, timeliness, accessibility, and traceability of data.
Article 6 The electronic label system shall cover key functions such as electronic label entry, management of QR code generation, scanning to obtain electronic labels, querying historical information of electronic labels, and querying structured information of electronic labels.
Article 7 The electronic label QR code generated by the electronic label system shall be marked with the words "Cosmetics Electronic Label" or "Toothpaste Electronic Label" in a prominent font below it (see Figures 1 and 2 for examples).
Article 8 The electronic label QR code shall be marked in a prominent position on the visible surface of the sales package. For products with an affixed Chinese label, the electronic label QR code shall be marked in a prominent position on the Chinese label.
The electronic label QR code shall be printed clearly, affixed firmly, and easily identifiable, with a size of not less than 9 mm × 9 mm in principle. The marking position of the electronic label QR code shall facilitate scanning and reading, and full consideration shall be given to the impact of label displacement, wrinkles, deformation, ink loss, etc., caused during storage and transportation on QR code readability.
For products with packaging boxes, pilot enterprises are encouraged to simultaneously use electronic labels on the packaging containers that are in direct contact with the product contents.
Article 9 The electronic label QR code and display content shall comply with the provisions of the Regulations and the Measures for the Administration of Cosmetics Labels, as well as the relevant requirements of the Cosmetic Electronic Label Data Set and the Cosmetic Electronic Label QR Code Technical Specifications.
Pilot enterprises shall ensure that the electronic label QR code meets technical requirements, and that the display content of the electronic label is true, accurate, and consistent with the relevant content of cosmetics registration and filing. The display content of the electronic label shall be easy to identify and read.
Article 10 The content of the electronic label shall be directly displayed on the page after scanning the code, without any additional display conditions or interfering factors such as pop-ups that affect normal reading. Pilot enterprises shall fully display the mandatory labeling content specified in Article 7 of the Measures for the Administration of Cosmetics Labels in the electronic label, and other displayed content shall not exceed the content specified in the product label sample.
Pilot enterprises may, through a hyperlink, display content such as product anti-counterfeiting, traceability information, and the URL link to the official product promotion page on the secondary page after scanning the code, and clearly mark "The content displayed on this page is not part of the cosmetics electronic label information and shall be the sole responsibility of the enterprise". It is encouraged that the electronic label system be equipped with functions such as text enlargement and voice broadcasting for the displayed content of the electronic label to facilitate consumers' identification and reading.
Pilot enterprises shall, in accordance with consumers' needs, provide consumers with complete Chinese label information of the product in written or electronic form through on-site provision, mail, e-mail, and other methods.
Article 11 For cosmetics whose Chinese product labels are marked by means of electronic labels, in addition to the electronic label QR code, the following content shall be marked in standardized Chinese characters at least on the visible surface of the product's sales package:
(1) Chinese product name and special cosmetics registration certificate number;
(2) Name of the registrant/filer;
(3) Net content;
(4) Shelf life;
(5) Safety warning statements required to be marked by laws, regulations, mandatory national standards, and technical specifications;
(6) Children's cosmetics shall be marked with the children's cosmetics symbol.
For small-specification packaged products with a net content not exceeding 15 g or 15 ml, the physical label may be exempted from marking the content specified in item (5) above.
Article 12 Before cosmetics using electronic labels are marketed for sale, pilot enterprises shall upload the electronic label URL data structure code information, the displayed content of the electronic label, and images of the product's sales packaging marked with the electronic label to the Cosmetics Registration and Filing Information Service Platform. Pilot enterprises shall generate the electronic label URL data structure coding information in accordance with the requirements of the Cosmetic Electronic Label QR Code Technical Specifications, and the uploaded electronic label URL data structure coding information shall be specific to the product identification unit.
In the event of any change in the electronic label information, pilot enterprises shall upload the relevant information of the proposed changes to the electronic label to the Cosmetics Registration and Filing Information Service Platform before the cosmetics using the changed electronic label are marketed for sale.
Article 13 Cosmetics registrants, filers, and domestic responsible persons shall be responsible for the legitimacy, accuracy, completeness, continuity, timeliness, accessibility, and traceability of the electronic label. If an electronic label system constructed by a third-party technical institution is used, pilot enterprises shall sign an agreement with the third-party technical institution, defining the respective rights, obligations, and responsibilities of both parties, as well as the content of the extended inspections that the third-party technical institution shall proactively accept from drug regulatory departments at all levels.
Article 14 Pilot enterprises shall ensure that the electronic label can display the label information in real time and that the code scanning and reading function is continuous and uninterrupted. If there is a temporary obstacle to the code scanning and reading function, pilot enterprises shall repair and rectify it as soon as possible. For products using electronic labels that are no longer manufactured or imported, pilot enterprises shall ensure that the displayed content of their electronic labels is normally displayed for 1 year after the expiration of the shelf life of the last batch of manufactured or imported products; for products with a shelf life of less than 1 year, the displayed content of their electronic labels shall be normally displayed for no less than 2 years.
If the code scanning and reading function of the electronic label experiences malfunctions for a long time, pilot enterprises shall take timely remedial measures to ensure that consumers can obtain complete cosmetics label information. If remedial measures cannot be taken and the malfunction has caused cosmetic quality defects or other problems that may endanger human health, the manufacturing shall be stopped immediately, and the cosmetics using electronic labels that have been put on the market for sale shall be recalled.
Article 15 Drug regulatory departments at or above the county level shall be responsible for the daily supervision of electronic labels, and may conduct extended inspections on the entities responsible for the construction, operation, and maintenance of the electronic label systems when necessary. Violations of relevant laws and regulations regarding cosmetics label management shall be handled in accordance with the relevant laws and regulations:
(1) If the labeled content on the sales packaging of cosmetics using electronic labels or the displayed content of the electronic label does not comply with the requirements of the Regulations, it shall be handled in accordance with item (5) of Article 61 of the Regulations;
(2) If pilot enterprises fail to submit the relevant electronic label information to the Cosmetics Registration and Filing Information Service Platform as required, the drug regulatory department shall order corrective actions;
(3) If the electronic label is printed unclearly, difficult to scan and read, or not firmly affixed, but does not affect product quality or safety and will not mislead consumers, it shall be handled in accordance with the second paragraph of Article 61 of the Regulations.
Article 16 Provincial drug regulatory departments participating in the pilot program shall supervise and guide pilot enterprises to carry out the pilot work as required. If a pilot enterprise is found to have seriously violated these Requirements, its pilot qualification shall be suspended. Enterprises whose pilot qualification has been suspended shall complete the rectification within a time limit, and shall not use electronic labels in new products or add electronic labels to products already on the market before the completion of the rectification. If the rectification is not completed within the specified time limit or if the enterprise still does not meet the requirements after rectification, the electronic label pilot qualification shall be revoked. Enterprises whose pilot qualification has been revoked shall stop manufacturing, importing, and selling cosmetics using electronic labels from the date of revocation of the qualification.
