What EU Amending Regulation 2025/351 Means for Food-Contact Plastics and Masterbatch

Mrs. Seidel, on 16 September a Europe-wide transitional period ends that has real teeth for food-contact plastics. What's actually changing with EU-Regulation 2025/351 then?

Diana Seidel: "Amending Regulation 2025/351 - known in the industry as the Quality Amendment, or the 19th Amendment - tightens the existing Plastics Regulation (EU) No 10/2011 in several key places at once. In short: higher purity for the substances used, a stricter assessment of non-intentionally added substances - so called NIAS -, more precise rest methods, expanded toxicological evaluations, and significantly more extensive conformity documentation right along the supply chain. 

That documentation now has to include not only every substance used and every NIAS, but also specific migration limits (SML) with validated analytics, purity criteria, toxicological assessments and detailed conditions of use. The supplementary regulation has been in force since March 2025, and the changeover has been underway ever since. 16 September is the cut-off date for placing materials on the market under the old rules. After that, the new legal framework applies - including for recycled plastics, for which the regulation explicitly sets the same requirements as for virgin material."

What does Amending Regulation 2025/351 mean, in practical terms, for brand owners, packaging producers, compounders and converters?

Diana Seidel: "As you can imagine, documentation on this scale takes time, care and people. Every supplier has to manage this chain of evidence and be able to demonstrate it. A packaging producer can only as be complaint as its compounder, who in turn is only as complaint as its raw material supplier. If one link in that chain isn't up to speed yet, things snag everywhere.

In practice, that means more communication, more paperwork, more back-and-forth. What's particularly interesting is how we handle NIAS - non-intentionally addes substances, which can be degredation products, reaction by-products or impurities. They're now subject to very low migration limits. That forces the whole value chain to look more closely and to trace things more carefully."

How has Lifocolor itsself geared up for for EU 2025/351?

Diana Seidel: "We decided early on to organise our range along clear product groups and distinguishable application profiles. On one side, we have masterbatches with the necessary conformity documentation for praticularly sensitive food applications, differentiated further by criteria such as change-control commitments. 

Beyond that, we have more everyday products that should in principle meet the fundamental safety requirements of European Plastics Regulation (EU) No 10/2011 and Framework Regulation (EC) No 1935/2004, but don't strictly require a decleration of conformity. In parallel, we systematically canvassed our own supply chain: who's arrived at which conformity tier, where things are still snagging, how we might plan a switch where that becomes necessary. And we've set up our advisory work so that our customer service team can sit down with costumers and concretely assess which tier actually fits their application."

Where does this differentiated approach hit its limits?

Diana Seidel: "There are situations where the cascade snags at our end: when raw material suppliers aren't yet able to give us the documentation we'd like to pass on. In those cases, we have to be transparent and say what's possible at this point in time and what isn't. A second point: we can only asses what the costumer actually tell us about their application. If a converter for internal reasons, insists on the highest tier even when the application doesn't call for it, that's their decision - and of course we'll deliver accordingly. But we tell them openly, up front, what that means and what kind of effort it involves."