Nearly 60 percent of the total $379 billion printed packaging sector is done for the food and beverage industry, according to 2016 research from Smithers Pira. As a move to create supply chain efficiencies, digital printing of packaging -- which is now less than 1 percent of the market -- is experiencing significant growth. In fact, it is reporting greater than 40 percent corporate average growth rates in areas such as digitally printed corrugate. Therefore, it is critical that suppliers to this growing industry segment understand the complex regulatory landscape surrounding food contact materials.
Food Contact Materials/Substances Regulations—Similarities
Food contact materials/substances (FCM/FCS) regulatory requirements vary from region to region, yet globally share similar, overarching goals, such as:
- 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
While there are broad similarities, Europe, North America and Asia Pacific all embrace different regulations/guidance when it comes to digitally printed inks on food packaging and food packaging itself.
The table provides a snapshot 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 |
Nestlé guidance note |
Brand guideline (Updated 2018) |
Guidance worldwide for many brands |
EuPIA guidance documents |
Industry association guidance |
Guidance worldwide |
US FDA 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 |
European Union
The regulations above (see table) are harmonized across all EU member states. Non-harmonized FCM types (e.g., printing inks, coatings, paper and board) are often regulated differently in the individual member states, however. This complexity makes it critical to be aware of the relevant national legislation applicable to the type of FCM one is trying to sell and guidance documents widely used by industry to demonstrate compliance.
United States
The FDA regulates 3 types of food additives via the 21 CFR 170-199. Notably, 21 CFR parts 175 to 177 are specific to indirect food additives used in contact with different types of FCM (e.g., paper and board). In the absence of a FDA specific regulation for printing inks in food packaging, the Swiss Ordinance and guidance documents mentioned above are relied on to demonstrate compliance (see chart).
China
Like rest of world, China has a general FCM/FCS standard aligned with the “similarities” mentioned above and is applicable to all types of FCM. GB9865-2016 is the national standard specific to additives used in plastic, coating, rubber, adhesive, ink, paper or silicone food packaging. China is currently drafting a standard specific to printing inks, though the completion date is not yet known.
Brand Influence
For now, the Nestlé Guidance Note on Packaging Inks seems to be the primary standard used as many customers are communicating that they will not accept printed packaging unless it is compliant with Nestlé.
Factors to Consider
Though there are many factors to consider when entering or ensuring continued success in the digitally printed food packaging market, 3 critical factors are highlighted below:
- 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.
Manufacturing a product for use in contact with food calls for careful consideration of the continuously evolving global FCM/FCS regulatory requirements and the importance of consumer brand perception.
In this complex market, it is best to collaborate with partners having knowledge and expertise of food contact regulations. The right partner can help develop primers, ink components and overprint varnishes for digitally printed food packaging that meet the guidelines for each market and desired end-use. Open, two-way communication is key. At Lubrizol, we strive to stay ahead of regulatory changes and work with customers to ensure products meet desired end use performance criteria – including compliance.
Contact your Lubrizol account manager to explore new possibilities in digitally printed food packaging.