Food packaging companies exporting to Europe almost inevitably encounter the topic of EFSA EU food-grade certification. Many people confuse it with FDA certification, but in fact, the two differ significantly in regulatory systems, evaluation processes, and scope of application. This article systematically compares the differences between EFSA EU food-grade certification and FDA certification from a factory operational perspective, helping you clarify the compliance path for exports.
EFSA is the highest scientific assessment body for food safety in the EU.
The European Food Safety Authority (EFSA) is responsible for providing scientific assessments in the field of food contact materials to the European Commission. When a packaging material is to enter the EU market, its safety assessment typically undergoes expert review by EFSA. The assessment results are then converted into EU regulatory provisions. The EFSA food-grade certification is not a simple certificate, but a technical evaluation system covering raw materials, migration levels, and usage conditions. The core basis for this system is EU Regulation 10/2011 and the framework regulation 1935/2004.
Unlike the FDA’s 0 substance list plus usage conditions model 1, EFSA places greater emphasis on individual assessment of each intentionally added substance. In other words, the compliance logic in the EU starts from the substance itself, first confirming that the substance is authorized, and then checking whether its intended use and exposure conditions meet the restriction requirements. This is why many companies find EU compliance for food contact materials more complex than that in the US.
FDA Certification: Compliance Logic of the U.S. System
FDA certification (more accurately referred to as FDA compliance) is based on Title 21 of the Code of Federal Regulations (CFR), Parts 170-199, with Sections 175, 176, 177, and others detailing the conditions for the use of food contact substances. The core of the U.S. system is the Food Contact Notification (FCN) program. Companies can obtain approval for specific uses through FCN or may directly use substances listed in 21 CFR.
The main difference between FDA and EFSA lies in their evaluation mechanisms: FDA allows companies to submit FCN applications for specific uses and obtain authorization, offering greater flexibility; EFSA, on the other hand, conducts assessments at the EU level, with member states not conducting separate approvals. For packaging companies exporting to both the US and Europe, both systems must be prepared for, but the document requirements, testing items, and timelines differ significantly.FDA Certification Complete GuideThere is a detailed breakdown of the US compliance process.
EFSA EU Food Grade Certification Application Process
A complete EFSA food-grade certification process typically includes the following steps: first, review the formula to confirm whether all intentionally added substances are listed in the EU authorization list; second, conduct migration testing, determining total migration and specific migration under simulated liquids and conditions as specified by Regulation 10/2011; third, commission a qualified laboratory to issue a test report; fourth, compile technical files and submit them to EFSA for new substance assessment if necessary; fifth, prepare a conformity statement and establish a traceability system from raw materials to finished products.
The most time-consuming part of the process is often the migration testing and documentation. For common materials such as PE, PP, and PET, the process tends to be smoother due to established authorization precedents. However, packaging using new substances or special functional additives requires a longer evaluation period.
Key Differences Between EFSA and FDA Certifications
First, different regulatory bases: EFSA relies on EU Regulation 10/2011 and 1935/2004, while FDA follows 21 CFR. Second, different assessment entities: EFSA is uniformly assessed by the European Food Safety Authority, while FDA is managed by the U.S. Food and Drug Administration. Third, different application mechanisms: the EU primarily uses a substance authorization list, while the U.S. allows FCN individual notifications. Fourth, different testing requirements: the EU has more detailed simulation liquids and conditions for migration testing, while the U.S. emphasizes classification based on usage conditions. Fifth, different market recognition: products with EFSA compliance are more readily accepted by large European retailers and brand owners, while FDA compliance mainly serves the North American market.
How to choose the right certification path for a company
If the target market is Europe, prioritize EFSA EU food-grade certification, while also paying attention to the latest developments in EU packaging regulations. If the target is the United States, focus on FDA compliance. Many export companies adopt a strategy of one formula, dual compliance, considering the restricted substance lists of both regulatory systems during the formulation design phase to avoid rework later. For domestic standards on food contact materials, you may refer to the following:GB 9685 Food Contact Materials StandardIts approach to limits is similar to that of the EU.
Conclusion
EFSA EU food grade certification and FDA certification are not about which is simpler, but which is more suitable for your target market. Compliance is not a one-time process, but an ongoing update that accompanies formula adjustments and raw material changes. It is recommended that companies incorporate EFSA and FDA requirements into design reviews early in the development of new packaging, to ensure controlled compliance costs and shorter delivery cycles.
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