NIAS Assessments Receiving Increased Scrutiny

Regulators more focused on assessing non-intentionally added substances in food packaging

Non-intentionally added substances (NIAS) are substances that can be present in food contact materials (FCMs) as contaminants or reaction or degradation products. They are potentially of concern for human health if they migrate from the FCM into food, and they have in theory been subject to control in FCMs for a number of years.

Recently regulatory bodies, particularly in the European Union and UK, have enhanced their focus on NIAS assessment before a product can be approved for market. There has also been increased enforcement of FCM manufacturers meeting their obligations to assess the presence of NIAS in their products to ensure they are not present at levels that can cause health concerns. Although recent testing advances are identifying multiple NIAS faster and more accurately than ever before, reaping the benefits of this new technology requires a sound NIAS assessment and compliance strategy.

Gaining regulatory approval for a successful product launch

NIAS can originate in food packaging and other FCMs from a number of sources ranging from contaminants picked up during manufacturing to impurities in intentionally added substances, as well as reaction and breakdown products.

To market their FCM products, manufacturers must prove to regulatory authorities that NIAS do not enter into food in quantities that endanger human health or cause unacceptable changes in the composition of the food or deterioration in its taste, color, odor, and texture. Therefore, accurate chemical identification and toxicological evaluation of NIAS is essential for regulatory approval and is a legal requirement along the manufacturing supply chain.

NIAS are typically unknown substances, although they can sometimes be predicted. They have a range of chemical and physical properties, and as such a suite of analytical techniques used in a non-targeted manner are needed to ensure as much coverage as possible during testing. Non-targeted chemical analysis produces very complex, data-rich information, and identifying and quantifying NIAS and determining their toxicological relevance requires a combination of sophisticated, specially designed software, assessment by experienced analytical chemists and toxicologists, and knowledge of the chemistry of the FCM ingredients.

How Exponent Can Help

Using our expertise in food contact analytical chemistry, regulations, toxicology, and risk and safety assessments, gained from decades of experience working at regulatory authorities around the world, for contract and governmental research organizations, and in industry, we can help clients:

• Predict potential NIAS formation
• Design, place, and monitor appropriate migration studies for the identification and quantification of NIAS
• Place and monitor toxicological studies
• Interpret the sophisticated NIAS analysis and toxicological results, determine their chemical and toxicological relevance, and summarize in safety or risk assessments for regulatory submissions