Analysis of FDA Food Grade Ink Certification
Date: Apr 10 2025 From: Star Color Views:
In the food packaging industry,
food grade ink, as a key element in food packaging and labeling, directly affects the quality of food and consumers' trust in terms of its safety. The U.S. Food and Drug Administration (FDA) plays a crucial role in the supervision of food grade ink. Through strict testing standards and certification processes, it safeguards food safety.
The Statutory Effect and Scope of Application of FDA Testing
Analysis of Legal Status
The FDA exercises mandatory and binding supervision over food contact substances, including inks, in accordance with Title 21 of the Code of Federal Regulations (21 CFR) §175.300. This regulation clearly stipulates the conditions that substances in contact with food, such as inks, must meet in terms of composition, migration limits, etc., aiming to ensure that these substances will not have a negative impact on the safety and suitability of food under normal usage conditions.
Any food grade ink sold in the U.S. market must strictly comply with the requirements of this regulation. Otherwise, it will face legal sanctions, including product recalls, fines, and even the prohibition of the production and business activities of the relevant enterprises.
Different from voluntary certifications, such as ISO 21469 (which focuses on the hygiene standards in the production process of food packaging materials), FDA testing is enforced by law. Although ISO 21469 can enhance a company's reputation and competitiveness within the industry, it is not a legal requirement. In contrast, FDA certification is the "admission ticket" for food grade ink to enter the U.S. market. For enterprises that want to legally sell food grade ink products in the United States, passing the FDA testing is a necessary step.
Segmentation of Regulatory Objects
The FDA's supervision of food grade ink is divided into two types according to the way the ink comes into contact with food: direct contact and indirect contact, and differentiated testing standards are formulated for different types. The inks used for the inner packaging of candies, due to their direct contact with food, are subject to extremely strict testing standards. The FDA not only requires that the migration amount of various chemical substances in the ink must be controlled at an extremely low level to prevent harmful substances from seeping into the candies and affecting consumers' health.
Relatively speaking, for inks used for indirect contact with food, such as those on shipping cartons, although the testing standards are not as strict as those for directly contacting inks in some aspects, they cannot be ignored either. During the transportation process, if the cartons get damp, certain components in the ink may still migrate into the inner part of the food packaging, thus affecting the quality of the food.
Therefore, the FDA has formulated corresponding standards for the chemical stability and anti-migration properties of inks for indirect contact with food to ensure the safety of food throughout the entire supply chain.
A Comprehensive Look at the FDA Testing Process in 2023
Key Points in the Pretreatment Stage
In the FDA testing process in 2023, the sample preparation in the pretreatment stage has clear and strict standards. According to the GMP 117.40 clause, the ink samples must include samples that have been cured for 72 hours after printing before being tested.
For the situation of multi-color overlay detection, the FDA requires the adoption of a specific sampling matrix design method. That is, a detailed sampling plan should be formulated according to the printing sequence, thickness of inks of different colors, and the possible interactions.
Detailed Explanation of Core Testing Items
| Testing Category |
Method Standard |
Limit Requirement |
Changes in 2023 |
| Heavy Metal Migration |
ICP-MS Method |
Pb≤0.5ppm |
Addition of Thallium Element Detection |
| Solvent Residue |
GC-MS Method |
Total Residue≤50mg/kg |
Acetone Limit Reduced by 30% |
| Microbiological Index |
USP 61 |
No Bacterial Growth |
Addition of Mycotoxin Screening |
In terms of heavy metal migration detection, the FDA uses the advanced Inductively Coupled Plasma Mass Spectrometry (ICP-MS) to accurately determine the content of heavy metals in the ink. In 2023, in addition to setting strict limits for conventional heavy metals such as lead (Pb≤0.5ppm), the detection of thallium element has also been added. Thallium is a highly toxic heavy metal, and even at extremely low concentrations, it may cause serious damage to the human nervous system, cardiovascular system, etc.
Solvent residue detection is also of great importance. The FDA uses a Gas Chromatography-Mass Spectrometry (GC-MS) instrument to detect the amount of solvent residue in the ink. In 2023, the limit for the total solvent residue remains at ≤50mg/kg. At the same time, as one of the common solvents in the ink, the limit for acetone has been reduced by 30%. This adjustment reflects the FDA's in-depth understanding of the hazards of solvent residues. Excessive acetone residues may affect the smell and taste of food, and even pose potential risks to human health.
The microbiological index detection is carried out in accordance with the USP 61 standard, requiring that there must be no bacterial growth during the testing process of the ink. In 2023, the FDA has added mycotoxin screening to the microbiological testing items. Mycotoxins are toxic metabolites produced by molds during their growth, such as aflatoxins and ochratoxins, which have extremely strong carcinogenicity and teratogenicity.
Key Points of Document Review
In the FDA testing process, document review is an essential part. For ink manufacturers, if they wish to make a confidential declaration of their product formulas, they need to follow strict CDA agreement signing specifications. CDA (Confidential Disclosure Agreement) is a confidentiality agreement. After the manufacturer signs the agreement with the FDA, it can keep sensitive formula information confidential during the declaration process. However, this does not mean that key information can be concealed. The manufacturer still needs to provide the FDA with necessary component safety data within the framework of the agreement to prove that the ink product meets the FDA's safety standards.
The requirements for supply chain traceability documents are also one of the key points of document review. The FDA stipulates that ink manufacturers must establish a complete four-level supplier management record. From the main raw material suppliers to the secondary, tertiary, and even quaternary suppliers, detailed supply information needs to be recorded, including the source of raw materials, quality inspection reports, purchase contracts, etc.
The Latest Developments and Trend Predictions of FDA Testing
Important Revisions in 2023
In 2023, the FDA has made a series of important revisions to the food grade ink testing standards. Restrictions on three types of perfluorinated compounds (PFOA, PFOS, PFHxS) have been added. Perfluorinated compounds have the characteristics of persistence, bioaccumulation, and toxicity, and are difficult to degrade in the environment and the human body. Long-term exposure may cause damage to the human immune system, reproductive system, etc. The FDA's inclusion of them in the restricted scope further enhances the control of harmful substances in food grade inks.
For digital printing inks, the FDA has put forward special testing requirements, such as screening for particles ≤10μm. With the widespread application of digital printing technology in the food packaging field, the safety of digital printing inks has received much attention. Tiny particles may migrate into food and pose potential risks to human health.
Policy Trends in 2024
Looking ahead to 2024, in terms of the supervision of food grade inks, the FDA will pilot the mandatory application of blockchain traceability technology. Blockchain technology has the characteristics of immutability and strong traceability, and can achieve the full life cycle information recording of food grade inks from raw material procurement, production and processing, sales to use.
Through the blockchain traceability system, regulatory authorities and consumers can obtain detailed information of ink products in real time, including the source of raw materials, production processes, testing reports, etc. Once a problem occurs, the source of the problem can be quickly traced, and effective recall and rectification measures can be taken to improve the efficiency and transparency of food safety supervision.
The FDA also plans to implement an AI-based remote audit process. The traditional on-site audit method not only consumes a large amount of manpower, material resources, and time, but may also be restricted by factors such as geography and time, making it impossible to effectively supervise enterprises in a timely manner.
The AI-based remote audit process uses artificial intelligence technology to conduct intelligent analysis of the production records, testing reports, and other documents submitted by enterprises, and combines means such as real-time video monitoring to achieve remote supervision of the enterprise's production process.
Against the backdrop of the continuous development of the food industry and the increasing attention of consumers to food safety, the role of the FDA in the field of food grade ink testing has become even more crucial. By continuously improving testing standards, optimizing testing processes, strengthening coordination with international certification systems, and actively introducing new technologies, the FDA will continue to make important contributions to global food safety and promote the food grade ink industry to develop in a more secure and standardized direction
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