With stringent EU regulations looming, the packaging industry can no longer rely on standard analytical testing with automatic data evaluation or generic supplier declarations to identify Non-Intentionally Added Substances (NIAS). How can manufacturers successfully navigate this new era of accountability, and where do we go from here?
A fundamental shift is imminent in the European food-contact and cosmetic packaging sectors. Starting in September 2026, the updated EU Regulation 2025/351 will enforce significantly stricter obligations regarding the control of Non-Intentionally Added Substances (NIAS) in food-contact and cosmetic packaging materials.
The Paradigm Shift in Supply Chain Accountability
Historically, the burden of proving that packaging is virtually free from harmful migrating substances fell primarily on the final article manufacturer. The new regulatory framework mandates that every node in the value chain, from raw material suppliers to masterbatch producers and final converters, must declare both their Intentionally Added Substances (IAS) and scientifically evaluate potential NIAS.
During the manufacturing processes of colorants and additives and the processes during their downstream use (e.g. masterbatch production), formation of new chemical substances has to be anticipated, all of which must now undergo rigorous identification and characterization. Consequently, every company along the supply chain will be required either to equip itself with advanced analytical laboratory capabilities or to rely on specialized, in-depth external testing facilities to perform this crucial characterization.
The Analytical Shortcomings of Testing Institutes
Until recently, many converters and packaging brands relied on accredited external laboratories to perform routine NIAS screenings. While these institutes possess advanced equipment, their methodology often falls short when dealing with the complex reality of polymer compounding.
Most external testing relies heavily on automated evaluation of data obtained by Gas Chromatography-Mass Spectrometry (GC-MS). The MS-spectra evaluation is routinely performed by matching against reference MS-libraries. The software automatically scans for the largest peaks in a chromatogram and cross-references the mass spectra obtained for these peaks with reference mass spectra in existing databases.
However, this automated approach has a critical blind spot. Small, but nevertheless very diagnostic peaks in the mass spectrum, resulting from fragment-ions which are often highly relevant for correct compound identification, are frequently neglected or misinterpreted by the algorithm.
In comparative tests on injected HDPE-plates containing colour masterbatches, accredited institutes have been shown to return results highlighting, besides the expected, benign n-alkanes (which are present in any standard HDPE), none or only very few actionable data regarding the actual, potentially hazardous target compounds which could be traced back to the use of the masterbatches.
Furthermore, external institutes inherently test without deep knowledge of the ingredients used. They do not know the proprietary formulations of the masterbatches they are analysing, nor do they have physical access to most of the specific raw materials used in the compounding process. Without this baseline knowledge and direct access to the components, it is nearly impossible for them to accurately trace the origin of a chemical anomaly (NIAS).
Human Expertise vs. Automated Algorithms
Addressing this industry-wide vulnerability requires bridging the gap between automated evaluation data and chemical expertise. This critical stage must be performed by expert chemists; despite advanced automated capabilities, it still requires a trained eye and profound human expertise.
Those challenges are familiar to Finke Colors, a leading German company, which supplies additive and color masterbatches to the food and cosmetic packaging industry. Dr. Lothar Wodniok, a senior chemist (now owner of DOC-WOK Analytics) with over three decades of experience in polymer and analytical science as well as in formulation experience at Finke-Colors, explains:
“Manual evaluation of the chemical structure is a necessity. A single masterbatch chromatogram can yield over 100 distinct peaks. While a software library might, for instance, automatically identify 40 of them, the remaining unidentified peaks require painstaking manual analysis. By leveraging a deep understanding of formulation chemistry, we look at molecular fragmentation patterns in the mass spectra to deduce a substance's structure. In addition, a counter-check of the results of automatic identification has shown to be absolutely necessary.”
A masterbatch manufacturer like Finke has a significant advantage in this process. They do not operate blind; all raw materials that enter their formulations are readily available to them for testing in order to precisely locate the source of the NIAS.
“For instance,” Dr. Wodniok continues, “when we analyzed a standard antistatic additive masterbatch, the supplier provided no information regarding potential NIAS. Through our detailed GC-MS data evaluation, we uncovered about 40 distinct migrating substances. Because of our chemical approach, we were able to trace these compounds directly back to the starting raw materials, side products, and intermediate reaction steps involved in synthesizing that additive.”
This ability to trace substances to their origin is crucial, as the data reveals that the vast majority of NIAS are actually introduced via raw materials. New NIAS are also formed from the additives during masterbatch production. Interestingly, process parameters like extruder speed or residence time often have a smaller effect on the NIAS profile compared to variations from raw material suppliers.
Consequently, it is not enough to test a material just once. It has been discovered that different batches from the exact same manufacturer can yield drastically different results. A simple change in a pigment or a dispersion agent batch can significantly alter the chromatogram. This reality transforms in-house NIAS screening from a mere compliance hurdle into a powerful Quality Assurance tool for evaluating raw material consistency.
Process-Induced NIAS: Compounding and Conversion
Understanding where NIAS originates is crucial. NIAS can also stem directly from processing conditions. Characterizing these specific parameters defines a "safe operating window" required to prevent the generation of unwanted compounds.
These processing methods inherently influence migration potential:
- The Masterbatching Stage: Characterized by high concentrations and extreme shear forces, this is the most critical environment for NIAS formation.
- Injection Molding: Ranks as the second most critical stage, introducing specific stress factors dictated by its unique, high temperature and pressure profiles.
- Blow Molding and Cast Extrusion: Generally considered less critical for NIAS formation compared to injection molding, though they still impart distinct thermal stresses that must be evaluated.
Therefore, it is essential to conduct NIAS testing not only during the initial compounding phase but also throughout the subsequent processing stages. Masterbatch manufacturers like Finke, equipped with in-house laboratory facilities to simulate and produce the final packaging—such as injecting test plates or blow moulded bottles—can offer a much more comprehensive solution to their customers. This provides a holistic view of the material's lifecycle that external labs simply cannot replicate.
Active Cosmetic Formulations Can Interact with the Packaging
The necessity for precise NIAS testing is magnified when dealing with the cosmetics industry, where active chemical ingredients can interact with packaging over long shelf lives. A classic example is the interaction between BHT (a common antioxidant in cosmetic formulations) and Titanium Dioxide (TiO2) in white LDPE packaging, which can trigger a reaction that turns the packaging yellow. Identifying these interactions allows suppliers like Finke to proactively guide cosmetic brands on which pigments are safe for specific reactive formulations.
The PCR Challenge
Looking forward, the industry faces an even greater analytical challenge: the integration of Post-Consumer Recycled (PCR) materials. The variability and inherent contamination of PCR streams are expected to significantly increase the presence of NIAS.
As the September 2026 regulatory deadline approaches, the frequency of required testing remains a subject of industry debate, likely to be triggered by formulation updates, changes in raw material suppliers, or the introduction of PCR.
What is certain, however, is that relying solely on generic supplier declarations is no longer a viable legal or operational strategy. The future of polymer compliance belongs to those who look beyond the automated algorithms for substance identification and understand the chemistry embedded within the entire value chain.