Complying with Regulations for Digitally Printed Packaging

Posted by Performance Coatings Team on 11/16/2021

As the printed packaging market continues to grow, so do the global compliance regulations for ink components. The result is that it has become a more complex and challenging market for formulators to select ingredients that conform to such markets.  For example, the regulatory constraints for a component in an ink for packaging would be very different to a component that may end up in an ink for art work or design. By knowing the extensive regulations and regulatory framework required for commercializing inks into different markets, Lubrizol is able to work with customers to develop new products for end-use applications that are better, safer and more sustainable.

The food and beverage industry accounts for a significant portion of the printed packaging sector. While food contact materials/substances (FCM/FCS) regulations and guidelines are most stringent, other markets that use printed inks and coatings—such as art materials—also have regulations that must be followed—and digital printing is experiencing significant growth.

When it comes to commercializing inks into different markets, it’s important to work with a partner who can help develop primers, ink components and overprint varnishes for digitally printed packaging and other materials that meet the guidelines for each market and desired end use. Just below is information about FCM/FCS regulations, followed by information about the more specialized art materials market.

Food Contact Materials/Substances Regulations—Similarities

FCM/FCS regulatory requirements vary by country and region, but around the world they share related, higher-level goals, like:

  • Seeking to prevent contamination of food from FCM/FCS which may endanger human health.
  • Providing guidance on what information should flow up/down the supply chain to ensure compliance.
  • Commonalties in how the regulating body reviews new FCS.

Food Contact Materials/Substances Regulations—Differences

Even with these common higher-level goals, Europe, North America and Asia-Pacific all embrace different regulations/guidance when it comes to digitally printed inks on food packaging.

The table below provides an overview of key regulations and guidance documents often used to demonstrate compliance of printing inks in food packaging:


Regulation Explanation Region
EC 1935/2004 Framework Broad FCM regulation that applies to all types of food contact materials (e.g., plastic corrugate board) European Union
EU Plastics Implementation Measure (PIM): EC 10/2011 Regulation for plastics (direct food contact); provides guidance for other FCM types European Union
Swiss Ordinance: SR 817.023.21, Annex 2 & 10 Printing ink regulation Swiss regulation; guidance worldwide
Nestle guidance note Brand guideline (Updated 2018) Guidance worldwide for many brands
EuPIA guidance documents Industry association guidance Guidance worldwide
US FDS 21 CFR (170-199) Regulation for many types of FCM, though nothing specific for printing inks United States
 China: GB9865 Regulation for many types of FCM (standard for printing inks in development) China


Food Factors to Consider

In the digitally printed food packaging market, there are three critical factors that rise to the top of the many factors to take into account:

  • Type of material (FCM/FCS) —What type of FCM is being made and what substrate is the ink printed on? The end use material will guide which FCM/FCS regulation is needed to ensure compliance.
  • Type of contact with food—Is the printed material in direct contact with food or on the non-food contact side (e.g., inks on the outside of cereal boxes)
  • Region—Where the product will be sold is important, as the regulatory requirements differ around the globe.


Artist Paints and Art Materials

Art supplies are more of a niche market than food packaging, but offer a good example of the importance of designing products with regulatory frameworks in mind. Art supplies sold in the United States must include the printed phrase “conforms to ASTM D-4236,” which means that all potentially hazardous components used to make the product are listed on the packaging.

Art materials can use the Art & Creative Materials Institute, Inc. (ACMI) AP (Approved Product) Seal if those materials are safe and certified in a toxicological evaluation by a board-certified toxicologist (medical expert) to contain no materials in sufficient quantities to be toxic or injurious to humans. Such products are certified by ACMI to be labeled in accordance with the chronic hazard labeling standard, ASTM D 4236, and the U. S. Labeling of Hazardous Art Materials Act (LHAMA).

Also within the art materials industry are certification programs from the Writing Instrument Manufacturers Association (WIMA). The ink, pencil and eraser certification programs ensure the products that carry the certification seals conform to ASTM Standard D4236, as well as all federal regulations. The Duke University Division of Occupational & Environmental Medicine carries out the toxicology testing/risk assessment for this certification. Schools are not allowed to purchase items without proper labeling aligned with ASTM D4236 requirements.


Contact us to explore new possibilities in printed packaging, components for digital applications, or inks for art and design.

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