Non-Intentionally Added Substances (NIAS) are not listed on your specs, but they can migrate into food. And regulators expect you to assess them. Triskelion helps you detect, interpret and justify the unknowns, so your food-contact materials remain safe and compliant.
NIAS stands for Non-Intentionally Added Substances: chemicals that are not deliberately used in the production of food-contact materials, but are nonetheless present. These can include impurities, breakdown products or reaction byproducts. Even though NIAS are not intentionally added, they can migrate into food and pose a risk to consumer safety. That’s why EU legislation requires you to assess them as part of your food-contact compliance strategy. In practice, this means compliance goes beyond known, authorised substances and includes identifying and assessing the unknown.
The obligation to assess NIAS is grounded in Article 3 of Regulation (EC) No. 1935/2004, which states that materials in contact with food may not transfer substances in quantities that endanger human health.
In addition, the 19th amendment of Regulation (EU) 10/2011 requires that materials exhibit a “high degree of purity”, including the identification and assessment of NIAS, even when the substances are unknown.
The legislation does not prescribe specific test methods, but failing to justify the presence or risk of NIAS often leads to compliance issues during inspections or audits.
A NIAS screening is often required when:
The challenge is that many NIAS are unknown, present in low concentrations, or lack toxicological data. This requires a combination of high-sensitivity analytical techniques and expert interpretation.
Without a properly designed NIAS strategy, your compliance documentation may be incomplete, or your product could be rejected for food contact use.
Triskelion offers an integrated approach to NIAS screening and risk assessment:
Analytical techniques
We use advanced methods such as LC-MS, GC-MS and HRMS to detect a wide range of unknown substances.
Data interpretation
We help determine which substances are relevant, what level of risk they present, and how to address unknowns with no toxicological data.
Risk assessment
We apply EFSA-endorsed principles, including Threshold of Toxicological Concern (TTC) and structural grouping.
Practical reporting
We deliver clear, audit-ready reports aligned with regulatory expectations.
Is NIAS screening mandatory for all materials?
Not explicitly, but it becomes expected when materials, processes or compositions could reasonably introduce NIAS.
What if no substances are detected?
You still need to document your approach, detection limits and justification for excluding risk.
Can my supplier cover this for me?
In some cases, yes. But you remain responsible for the final product’s compliance. Supplier data should be critically reviewed and validated.
We help you detect what’s hidden, assess the risks, and document it clearly.
Contact us for a free intake or proposal for NIAS screening and risk assessment.
