Questions & Answers
Can labels be electronic?
Yes, product labels can be electronic, but acceptance depends heavily on the product category (such as electronics, medical devices, or food/wine) and whether the digital format supplements or replaces physical printing.
United States (US):
- Electronics/Telecom: Permitted via the Federal Communications Commission (FCC) for devices with screens or integrated displays to show FCC IDs and compliance data electronically.
- Medical Devices & Drugs: The U.S. Food and Drug Administration (FDA) permits electronic Instructions for Use (eIFUs) and labeling primarily for professional healthcare facilities, though consumer-facing items generally still require physical text.
Canada:
- Electronics/Telecom: Health Canada and Innovation, Science and Economic Development Canada (ISED) allow electronic labeling for display-equipped radio and wireless devices.
- Medical & Consumer Goods: eIFUs are accepted for professional-use-only medical devices, but core consumer safety and identity declarations still require dual English and French physical text.
Japan:
- Pharmaceuticals & Medical: The Pharmaceuticals and Medical Devices Agency (PMDA) fully allows e-labeling and completely abolished mandatory printed package inserts for most prescription drugs, relying instead on app-accessible digital codes.
- Electronics: Allowed for technical compliance and telecommunication marks on screen-based devices.
European Union (EU):
- General Consumer Goods: Under the General Product Safety Regulation (GPSR), digital labels (like QR codes) can supplement physical information, but cannot replace core mandatory physical text on the product or packaging.
- Sector Exceptions: Digital e-labeling is legally permitted for specific categories like wine nutritional data (though basic energy and allergens remain physical) and professional medical device eIFUs.
United Kingdom (UK):
- General Approach: Aligns closely with EU frameworks. Electronic display labeling is accepted for digital/telecom device compliance marks, and professional medical eIFUs are permitted, but general consumer safety info requires physical backing.
