Analysis of Food Safety Ink Standards
Date: Apr 09 2025 From: Star Color Views:
Food safety ink standards serve as a crucial line of defense for public health. From the strict supervision of the U.S. Food and Drug Administration (FDA), to the complex and detailed regulatory systems in the European Union, and to the comprehensive process regulation of the newly introduced standards in China, each country has established corresponding standards based on its own national conditions and the status of the food industry. Although these standards have their own characteristics, their cores all focus on the safety and environmental protection of inks, preventing the migration of harmful substances into food.
Relevant Standards of the U.S. Food and Drug Administration (FDA)
In the United States, inks used for food packaging are strictly regulated by the FDA. FDA regulations aim to ensure that inks do not migrate harmful components into food under expected usage conditions. If an ink is considered a food additive (most inks used for food packaging fall into this category), its use must comply with specific regulatory requirements, such as being included in food additive regulations, having a valid Food Contact Notification (FCN), or falling within the scope of regulatory threshold exemptions.
According to regulations such as 21 CFR 175, 176, 177, and 178, there are clear provisions for the components of inks that come into contact with food. For inks used on paper and paperboard that come into contact with aqueous and fatty foods, their components must comply with the provisions of 21 CFR 176.170. The colorants in inks are usually regulated by 21 CFR 178.3297 ("Polymeric Colorants") or regulations specific to paper applications. And depending on regulatory exemption thresholds, prior sanctions, or food contact notifications, colorants may be permitted for their intended uses.
The Food Safety Ink Standard System of the European Union
The European Union has a complex and strict food safety ink standard system. The European Printing Ink Association (EuPIA) has issued the "List of Permitted Low Migration UV Photoinitiators" for photoinitiators in printing inks and has specified the corresponding migration limits (SML). For example, the Standing Committee on the Food Chain and Animal Health (SCFCAH) of the European Commission has set a specific migration limit of 0.6mg/kg for benzophenone in printing inks used for food contact materials.
The EU Regulation 2011/10/EC on plastic materials and articles intended to come into contact with food specifies the limits and specific migration limits (SML) for phthalates (such as DEHP, DBP, etc.). In terms of heavy metals, the European Packaging Directive "Regulation 2005/20/EC" strictly limits the heavy metal content in packaging products. The total sum of lead, cadmium, mercury, and hexavalent chromium shall not exceed 100ppm.
New Progress of Food Safety Ink Standards in China
On September 25, 2023, the National Health Commission and the State Administration for Market Regulation of China jointly issued GB 4806.14 - 2023 "National Food Safety Standard - Inks for Food Contact Materials and Products", which will be officially implemented on September 6, 2024.
This standard applies to inks for food contact materials and products and the printed ink layers formed by them. According to whether they come into direct contact with food, they are divided into inks for direct contact with food and inks for indirect contact with food. In terms of raw material requirements, the basic raw materials and additives of inks for direct contact with food should comply with the requirements of GB 2760 and relevant announcements; the basic raw materials of inks for indirect contact with food should meet the purity requirements of colorants in GB9685 and other basic raw material requirements, and the additives should comply with the requirements of GB9685 and relevant announcements.
At the same time, the standard specifies sensory requirements and physical and chemical indicators (such as heavy metal residues, migratory substances, etc.). Migration tests should comply with the provisions of GB 31604.1 and GB 5009.156. Labeling should also comply with the provisions of GB 4806.1. Ink products should identify the product category and indicate in the label or accompanying documents the suitable printing substrates, printing processes, and special usage requirements, etc.
Overview of Food Safety Ink Standards in Other Countries
- Switzerland: Swiss regulation RS817.023.21 V2016 stipulates 96 photoinitiator substances permitted for use in printing inks in Part V of Appendix 6 and clarifies their specific migration limit (SML) requirements.
- Germany: Germany has strict control over food contact materials. Although there is no specific standard for inks alone, inks need to comply with relevant regulations such as the German Food and Commodity Law (LFGB) to ensure the safety of inks in food packaging applications and prevent the migration of harmful substances into food.
Comparison Table of Major National Standards in the World
| Country/Region |
Regulation Name |
Migration Limit |
Prohibited Substances |
Detection Method |
| United States |
FDA 21 CFR 175.300 |
Total migration ≤ 0.01mg/dm² |
Benzene-based solvents, BPA |
GC-MS (10% ethanol simulant) |
| European Union |
EU 10/2011 |
NIAS needs to be declared, heavy metals ≤ 0.5ppm |
PFAS, Phthalates |
HPLC-QTOF |
| China |
GB 4806.8-2016 |
Phthalates ≤ 0.1mg/kg |
Fluorescent whitening agents, Bisphenol A |
ICP-MS |
| Japan |
JHPA Standard |
Polycyclic aromatic hydrocarbons < 1ppm |
Formaldehyde, Specific azo dyes |
LC-MS/MS |
| India |
FSSAI 2023 Amendment |
Total migration ≤ 10mg/kg (non-greasy) |
Arsenic, Lead, Cadmium (≤ 0.1ppm) |
AAS |
Development Trends of Global Food Safety Ink Standards
With the increasing attention of consumers to food safety and the deepening of scientific research on the potential hazards in inks, global food safety ink standards are showing a trend of becoming stricter. In the future, the standards will pay more attention to the regulation of new ink components (such as nanomaterials, etc.) and the research on the migration behavior of inks under complex food storage and processing conditions.
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