The global regulatory landscape for labeling consumer products is ever-changing, with an increasing number of industries adopting 2D codes to increase transparency and traceability and combat the risk of counterfeit products. Against this backdrop, Domino Printing Sciences (Domino) is preparing to support its global manufacturing customers in navigating regulatory 2D code requirements across industries.

“As a global leader in advanced variable data printing solutions, Domino has been at the forefront of global regulatory developments necessitating the use of serialized 2D codes, including those in the pharmaceutical and tobacco sectors,” says Domino’s new head of global regulated sectors, James Cutforth.

“We understand that speed and reliability are critical for our manufacturing customers, and, as such, adopting 2D codes can seem like a significant challenge. With GS1 Sunrise 2027 and stricter regulated 2D code requirements on the horizon, we are committed to working with our global manufacturing customers to understand potential blockers and develop solutions that will work within their industries.”

Advanced variable data 2D codes, including Data Matrix and QR codes, offer greater data capacity and accuracy compared with traditional 1D (linear) barcodes. The past few decades have witnessed growing regulatory requirements for 2D codes for consumer safety, traceability, and anti-counterfeiting purposes. Globally, a diverse range of industries are now adopting more stringent requirements for 2D codes; current regulated sectors include:

• Pharmaceuticals: EU Falsified Medicines Directive 2011/62; US Drug Supply Chain Security Act; India Drugs (Eighth Amendment) Rules 2022;
• Medical devices: EU Medical Device Regulation 2017/745;
• Tobacco products: EU Tobacco Products Directive 2014/40;
• Food products: Korea Smart Food QR; US Food Safety Modernization Act 204 (recommended);
• Alcoholic beverages: EU Regulation 2021/2117 on Wine Products;
• Agri-inputs, including seeds and agrochemicals: India Insecticides (Second Amendment) Rules, 2023

In the pharmaceutical industry, in particular, the use of 2D codes has accelerated since being written into regulations such as the EU FMD in 2011. Despite there being no specific regulations driving this change, within the medical and healthcare sectors, variable data 2D codes are commonly used for modernizing healthcare operations and enhancing patient experiences. A recent report by the Healthcare Information and Management Systems Society indicated that 60% of healthcare providers in the US had integrated variable data QR codes into their patient management systems by 2023.

“Having supported our global pharmaceutical customers in preparing for the EU FMD, US DSCSA, and EU MDR, we understand the complexities involved in equipping production lines to handle fast-paced printing of serialized 2D codes,” says Bart Vansteenkiste, global life sciences sector manager, Domino. “We also understand the value in helping to improve patient safety and reduce medication errors and can foresee a future with stricter 2D code requirements in these industries. For this reason, we developed the K600G solution for serialized, individual dosage-level 2D codes on pharmaceuticals – so we can help our customers to future-proof their lines and stay ahead of the game.”

Domino has worked closely with international barcode standards organization GS1 for more than 20 years and has developed a wide range of globally compliant printing technologies designed to handle fast-paced printing of serialized and variable data 2D codes, including Gx-Series thermal Inkjet printers, Vx-Series thermal transfer overprinters, K-Series high-resolution monochrome inkjet printers, and Dx-Series CO2 Laser coders. Domino is committed to helping brands and manufacturers prepare for future regulatory 2D code requirements, including requirements for individual dose identification and the global move to 2D codes at the point-of-sale. Domino’s designated sector team is at the heart of this commitment, encompassing global food, beverage, and life sciences experts. Domino’s sector team works closely with international manufacturers to understand industry and customer requirements and develop reliable, end-to-end solutions for printing and verifying 2D codes.

The most recent example is the launch of Domino’s range of Bottle Closure Printing Stations, incorporating, high-speed, high-resolution printing from Domino’s K300 printer. The new solutions, which print variable data and 2D codes, including QR codes, onto HDPE bottle caps and closures, were developed in close collaboration with leading Korean bottled water manufacturers in preparation for new legislation which will prohibit the use of external labels on bottled water from January 2026.

“As a global expert in advanced variable data printing, Domino works closely with GS1 and other industry organizations to help support and drive the adoption of 2D codes across industries,” says Cutforth. “Over the years, global businesses have trusted us to provide the necessary sector and technology expertise to help them prepare for regulatory changes. Today, we pride ourselves on being at the forefront of new regulatory developments. We are ready to support businesses and ease the transition from concept to production for 2D code applications.”