Non-Intentionally Added Substances and NIAS Testing for Food Contact Materials

Non-intentionally added substance (NIAS) testing plays a key role in ensuring compliance with food packaging safety regulations. NIAS substances are found in food contact materials (FCMs) but have not been added on purpose to achieve a technical or functional aim. These chemical substances represent a potential safety issue for the food packaging industry and for consumer health if they migrate from the FCMs into the food product. Given the challenges of identifying and managing these non-intentionally added compounds, comprehensive NIAS testing is essential for screening, identifying, and quantifying substances. This ensures the safety of FCMs and compliance with food packaging safety regulations.  

NIAS substances include impurities, contaminants, reaction products or degradation products that originate from the production and processing of substances used in the manufacture of plastic materials or food contact articles. Examples can include side products from the polymerisation processes, degradation products of plastic additives, such as UV-stabilisers, or contaminants from recycling processes. NIAS can be inorganic/organic and volatile/non-volatile, so it is necessary to incorporate multiple analytical techniques into your NIAS testing strategy, to ensure the FCM is safe to be used as intended and minimise risk to consumer health. 

Under Commission Regulation (EU) No. 10/2011 on plastic materials and articles intended for food contact, manufacturers must assess potential health risks posed by  NIAS using internationally recognised risk assessment principles. Even though non-authorised substances may be present in plastic FCMs as unintended additives, manufacturers are legally obligated to ensure the safety of NIAS under Article 3 of Framework Regulation (EC) No. 1935/2004 and Article 19 of Regulation (EU) No. 10/2011. It is common to find both non-authorised and authorised substances present as NIAS; the latter must migrate below their respective specific migration limit. Any non-authorised substances present need to be investigated and risk assessed on a case-by-case basis. 

In the United States, provisions under 21 CFR 174.5 and 21 CFR 170.3(i) address NIAS concerns by stating FCMs must be of a suitable purity for their intended use. Manufacturers must ensure that any NIAS present are either authorised for the intended use of the FCM, and comply with applicable extraction levels, or are present at sufficiently low levels so there is a reasonable certainty that no harm will result from the presence of the NIAS. This is determined on a case-by-case basis by evaluating the level of the NIAS that may be present in the diet because of its presence in the FCM.

Central to a successful NIAS risk assessment, and the first step towards demonstrating compliance, is to determine which substances have been intentionally added to the FCM throughout the food contact value chain. This information is integral to gathering useful data on NIAS for multiple reasons:

1. Focus is on NIAS only, rather than substances that have been intentionally added,  
2. Predict NIAS from side reactions and degradation products of intentionally added substances,
3. Predict NIAS present as impurities of intentionally added substances, for example inorganic impurities could be present because of the use of a metallic catalyst,
4. Tailor initial NIAS testing to identify and quantify high risk NIAS that could hinder compliance and effect time-to-market, for example Carcinogens, Mutagens and Reprotoxic substances (CMRs),
5. Utilise manufacturers knowledge of the food contact value chain, and substances used in manufacture, as a starting point for developing an NIAS testing strategy.

Considering NIAS applies to all materials intended to come into contact with food, and all FCMs have the potential to contain NIAS, it is critical to address any risk to consumer health. Bringing quality and safety to life, our NIAS testing services enable you to identify and mitigate the intrinsic risk associated with NIAS in FCMs. 

Contamination can occur at any point in the lifecycle of the FCM and identification of contaminants can present a significant challenge. NIAS screening studies and migration testing help to reveal and identify potentially harmful substances. 

NIAS and Recycled Plastic Food Packaging
Recycling processes can introduce a range of contaminants into sustainable food packaging. This can depend on the quality of the input of the recycled material and the efficacy of the recycling process cleaning steps. Some common NIAS from recycling can include phthalates, Bisphenol A and other bisphenols, substances from printed surfaces and labels, adhesives and more. Our CircularAssure program supports stakeholders in the recycled plastics value chain, from post-consumer recycled material (PCR) processing and cleaning steps to determination of quality of recycled materials output through migration and NIAS studies. Over the last two decades, we have helped global innovators in food, beverage, cosmetics, and materials development to ensure the safety and performance of sustainable food packaging. 

Our recent participation in a rigorous proficiency test initiated by Plastics Recyclers Europe (PRE) earned us recognition for our competency in detecting contaminants/NIAS in recycled materials intended for food packaging. Our involvement in the independent study affirms our commitment to adapt to changing regulations and allows us to demonstrate our compliance to Article 13 of Commission Regulation (EU) 2022/1616. The regulation states laboratories must take part in proficiency tests with satisfactory results before conducting analysis for contaminants in recycled plastic food packaging. This recognition showcases our expertise in ensuring compliance with EU regulations, and supporting our clients in developing safe, high-quality, sustainable packaging materials and products. You can view and download the proficiency test certificate here. 

NIAS Testing and Risk Assessment Solutions

There is no official technical guidance on how to risk assess for NIAS. However, our highly experienced scientists and food contact materials testing team deliver comprehensive support following these steps:

1. Information Gathering: Our regulatory experts gather information regarding the chemical composition of the food contact material to achieve a complete (as far as possible) understanding of the material composition including all relevant information from the manufacturing process.
2. Analytical NIAS Screenings: Our NIAS analytical teams conduct investigations using a series of analytical approaches to attempt to determine all potential migrants. NIAS screening programs are executed using a wide range of sample preparation techniques (e.g. extraction with food simulants under controlled conditions) and analytical techniques to screen for, identify and semi-quantify the presence of NIAS. Our analytical approaches include: thermal desorption gas chromatography time-of-flight mass spectrometry (GC/Q-TOF), gas chromatography mass spectrometry (GC-MS), liquid chromatography mass spectroscopy (LC-MS), and inductively coupled plasma mass spectrometry (ICP-MS). 
3. Identification of Hazardous Substances: tOur regulatory experts review the NIAS screening data to identify the presence of any NIAS with restrictions (e.g. specific migration limits) and hazardous substances. The NIAS are risk assessed based on current food packaging safety regulations, literature reviews and internationally recognised scientific principles on risk assessment (e.g. the TTC approach / Cramer classification).
4. Exposure Assessment: Our NIAS teams perform migration studies and/or exposure assessments to support the risk assessment.
5. Final Risk Assessment: Our regulatory experts calculate the risk and potential hazards to the consumer and make any recommendations if required. We supply customers with scientific reports, including interpreted data and literary references, on any potential health risk associated with the FCM.

Non-listed substances (NLS) are another category of chemical substances which must be considered within food contact risk assessment studies. NLS are generally classed as substances that have not been listed as they have been deemed to be not harmful due to arbitrary or commercial reasons, however, they are still subject to assessment. 

Our analytical scientists and regulatory teams possess nearly 30 years of experience in food contact compliance and they apply their Total Quality Assurance expertise through cost-effective analytical data packages and regulatory guidance to help you achieve compliance for your food contact materials. Our global reach allows us to liaise with regulatory agencies around the world and our strategic approach to gathering information, testing requirements and documentation can help you to achieve swift compliance, support notification or provide the analytical data and insight you need for your specific food contact materials or articles.