QR Codes Replace Full Label Text, 9mm Minimum Size Required — NMPA's 16-Article Work Requirements Explained
China's National Medical Products Administration (NMPA) issued a formal notice on October 16, 2025, launching a nationwide pilot program for electronic labeling of cosmetics — including toothpaste — under Document No. NMPA [2025] 16. Starting February 1, 2026, companies in six jurisdictions — Beijing, Shanghai, Zhejiang Province, Shandong Province, Guangdong Province, and Chongqing — will be permitted to use electronic labels (e-labels) in place of traditional printed Chinese-language label text. The pilot runs for 3 years. Hainan's existing duty-free cosmetics e-label pilot may proceed under the same framework.
The announcement follows more than a year of positive results from Hainan's duty-free zone pilot and represents a significant step forward in China's digital transformation of cosmetics regulation. Under the new system, a cosmetics e-label is defined as Chinese-language labeling content stored through an electronic mechanism and delivered to consumers via a QR code generated by an information system — scannable directly through mainstream smartphone apps. The central compliance breakthrough for industry: physical packaging text can be substantially simplified. Under the pilot, only six categories of information must remain on the physical package — the product's Chinese name, the registrant or notifier's name, net content, expiration date, mandatory safety warnings, and the children's cosmetics logo where applicable. All other legally required label content may be delivered entirely through the e-label QR code. Small-format packages with net content of 15g or 15ml or less may further omit the safety warning text from physical packaging. This change materially reduces printing and reprinting costs for companies while preserving consumers' right to full product information. Regulix, a compliance services firm with specialized expertise in China cosmetics registration and notification, recommends that all companies with products sold in the pilot provinces begin reviewing the 16-article Work Requirements and assessing their technical readiness immediately.
Who Can Participate? 4 Eligibility Requirements
Article 3 of the Cosmetics E-Label Pilot Work Requirements (the "Work Requirements") sets out four conditions that pilot companies must meet simultaneously. First, the applicant must be a cosmetics registrant, notifier, or a China-based responsible person authorized by a registrant or notifier. Second, the company must have the technical capability appropriate to e-label operations and must have designated management personnel in place. Third, the company must operate a sound quality management system. Fourth, the company must demonstrate actual capacity to carry out e-label pilot activities.
Selection and confirmation of pilot companies is handled by each participating provincial drug regulatory authority, which will publish approved pilot company lists on their official websites. Each provincial regulator will also establish its own jurisdiction-specific oversight requirements and enforcement measures for the pilot period.
How to Build the E-Label System? 3 Approved Pathways
Article 4 of the Work Requirements offers three acceptable approaches to building the e-label system: the pilot company may build it in-house, commission a third-party technology provider, or rely on a system organized by the provincial drug regulatory authority. The specific approach is determined by each provincial regulator. This flexibility is designed to accommodate both large multinational brands that prefer proprietary systems and smaller companies that require outside support.
Regardless of the building approach, all e-label systems must meet the following technical baseline: compliance with China's Cybersecurity Law, Data Security Law, and Personal Information Protection Law; tamper-resistance, with a robust backup and recovery mechanism; and data accuracy, integrity, continuity, timeliness, accessibility, and traceability. Core system functions must include e-label data entry, QR code generation, QR-code-based label retrieval, historical label information queries, and structured data queries.
Regulix notes that companies using third-party system providers must enter into a formal agreement with the provider specifying each party's rights, obligations, and liabilities — including the third party's obligation to accept on-site inspections by drug regulatory authorities at any level.
QR Code Placement: Minimum 9mm x 9mm, Prominent Location Required
Articles 7 and 8 of the Work Requirements establish specific requirements for QR code appearance and placement. The QR code must display the text "Cosmetics E-Label" or "Toothpaste E-Label" in a conspicuous font directly below the code. The QR code must be printed or affixed in a prominent location on the visible surface of the sales packaging; for products with an affixed Chinese-language label, the QR code must appear in a prominent location on that label.
The QR code must be clearly printed, securely affixed, and easy to identify. The minimum printed size is 9mm x 9mm. Placement must account for scanning convenience and must consider the potential effects of shifts, creasing, deformation, or ink loss during storage and transport. For products sold in a box, pilot companies are encouraged to apply the e-label QR code to the primary container that directly contacts the product contents as well.
What Must the E-Label Display? Full Label Content, No Barriers to Access
Article 10 of the Work Requirements sets a clear consumer-first standard for e-label content presentation: label information must be displayed directly on the page that opens after scanning, with no additional conditions required to view it and no pop-up windows or other factors that interfere with normal reading. Pilot companies must include the complete set of mandatory label content specified in Article 7 of the Cosmetics Labeling Administration Measures. Any additional content displayed must not exceed what is contained in the product's approved label sample.
Companies may use a secondary linked page — accessible from the initial scan page — to present anti-counterfeiting information, traceability details, or links to official product pages. Any such secondary page must carry a clear disclaimer stating that its content does not constitute e-label information and is the company's own responsibility. Systems are encouraged to include accessibility features such as text enlargement and audio readout to serve elderly consumers and others who may have difficulty reading standard text.
Additionally, pilot companies must make the complete Chinese-language label information available to consumers on request through in-person delivery, postal mail, or email — ensuring that every consumer can access full product information regardless of their ability to use a smartphone.
Pre-Market Platform Submission Required — Changes Must Be Uploaded Before Going Live
Article 12 specifies that before any cosmetic using an e-label enters the market, the pilot company must upload the e-label URL data structure code information, e-label display content, and photos of the labeled sales packaging to the Cosmetics Registration and Notification Information Service Platform. When e-label content is updated, the revised information must be uploaded to the platform before the updated product is sold. The NMPA Information Center and the National Institutes for Food and Drug Control (NIFDC) will provide technical support by upgrading the platform's functionality to accommodate pilot company submissions.
Regulix advises companies to build platform submission into their product launch workflow from day one, as non-submission is a violation subject to regulatory correction.
Penalties for Violations — Pilot Status Can Be Suspended or Revoked
Articles 15 and 16 of the Work Requirements lay out the enforcement framework. Drug regulatory authorities at the county level and above are responsible for day-to-day e-label oversight and may conduct extended inspections of e-label system operators when necessary. Key enforcement scenarios include: packaging or e-label content that violates the Cosmetics Supervision and Administration Regulation (CSAR) is handled under Article 61(5) of the CSAR; failure to upload required e-label information to the platform triggers a mandatory correction order; QR codes that are unclear or poorly affixed but do not affect product safety or mislead consumers are handled under Article 61, Paragraph 2 of the CSAR.
For serious violations of the Work Requirements, provincial regulators will suspend the company's pilot qualification and set a rectification deadline. Companies that fail to rectify within the deadline or whose rectification remains insufficient will have their e-label pilot status permanently revoked. From the date of revocation, the company must immediately cease manufacturing, importing, and selling cosmetics bearing e-labels.
