Are You Ready for EU 2025/351?
Regulation (EU) No 10/2011 has recently been amended by (EU) 2025/351, setting new and stricter standards for substances used in food contact materials. Particularly those requiring a High Degree of Purity under article 3a.
If you’re producing or supplying substances or intermediates to be used in materials and articles intended for contact with food, this change directly affects you. You’ll need to assess and prove that non-intentionally added substances (NIAS) in your products do not pose a health risk when migrating into food. For many businesses, this is uncharted territory.
The transition period ends on 16 September 2026, which may seem far off, but thorough analysis and documentation take time.
What We Can Do for You
We support businesses navigating food contact legislation with a full-service approach that combines regulatory insight, analytical precision, and toxicological expertise. Here’s how we help ensure compliance with the updated regulation:
- Product Evaluation
We assess your product’s composition and manufacturing process to identify potential impurity sources.
- Advanced NIAS Analysis
We determine the residual content of NIAS using high-resolution analytical instrumentation, followed by semi-quantification and identification.
- Migration & Exposure Calculation
We calculate migration levels and assess human exposure based on realistic scenarios.
- Expert Risk Assessment
Our toxicologists perform in-depth safety evaluations using the appropriate models (TTC, Cramer classification, etc.).
- Food Contact Statement
If your product meets all criteria under article 3a, we issue a Triskelion Food Contact Statement confirming compliance.
What’s Next? Let’s Get You Ready
Time is limited, and compliance isn’t optional. Let’s help you stay ahead of the curve and ready by the September 2026 deadline.