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Lab Testing for "Non Intentionally Added Substances" (NIAS Testing)
What are non-intentionally added substances or NIAS?
Non-intentionally added substances (NIAS) are chemical compounds that are unintentionally present in food contact materials (FCM). These can result from impurities, side reactions or degradation products. Regulation (EU) No. 10/2011 of the European Commission regulates the safety assessment of FCMs and also includes NIAS.
The regulation requires NIAS to be taken into account in the risk assessment of FCM products. Manufacturers must identify NIAS and assess their migration into food if applicable including the specified limits of migrations. The manufacturer or importer is responsible for the conformity of the FCM products and must ensure the availability of relevant information for risk assessment and the safety of such products to human health.
Durcing the manufacturing process of FCM products or materials, certain reaction and degradation products may be formed. These impurities and reaction and degradation products are non-intentionally added substances, or NIAS. The regulation (EU) No. 10/2011 stresses that it is essential to include the main NIAS in the risk assessment of the substances that introduce them. This process may involve the establishment of specific restrictions or specifications for the substances, similar to the specifications detailed in the document.
How to comply with the NIAS Regulation
In both cases, whether it's impurities or reaction and degradation products, it's often not feasible to list and consider all the substances that may be present from these sources. As a result, many of these substances may not have been included in the Union list. However, this omission does not necessarily imply that their presence should be banned. This is why Article 6, "Derogations for substances not on the Union list," of Regulation (EU) No. 10/2011 includes provisions for non-intentionally added substances, stating that substances not on the Union list may still be present in the plastic layers of plastic materials and articles.
Nonetheless, the same regulation mandates that compliance with the requirements of Article 3 of Regulation (EC) No. 1935/2004, which relates to the non-transfer of components that are toxic or that alter food composition or organoleptic characteristics, should be assessed based on internationally recognized scientific principles on risk assessment.
It's worth noting that the topic of NIAS was already addressed at the time of the 2011 regulation's publication. However, concerns surrounding NIAS have intensified more recently, primarily due to the identification of potentially hazardous chemicals migrating from plastic materials and articles intended for food contact. This heightened awareness is a result of improved sensitivity in chemical analysis methods.
The need to assess NIAS associated with substances is, therefore, becoming increasingly evident and important.
How to conduct a NIAS study
A NIAS study typically involves three critical steps:
- Drawing up a list of predictable NIAS from process information: In specific stages of the production chain, it is possible to predict NIAS with a reasonable degree of accuracy based on past experience and theoretical chemistry. Sharing this information throughout the supply chain greatly facilitates the identification and subsequent risk assessment of NIAS. Since NIAS can continue to react in subsequent processing steps, transmitting relevant information upstream and downstream in the supply chain is essential.
- Chemical analysis: This step is highly complex because it aims to detect and quantify, to the extent possible, the (often unknown) substances that migrate from the material or article. Given that there are potentially tens of thousands of substances that can migrate from materials and articles intended for food contact, the lack of analytical standards for many of these substances, the absence of these substances in chemical or spectral databases (e.g., oligomers), and the challenge of a lack of a standardized industry-wide methodology for dealing with NIAS, this analysis requires sophisticated equipment and highly specialized personnel.
- Risk assessment: Risk assessment is conducted in a sequential manner, commencing with the search for existing toxicity data on the identified substances (e.g., in relevant legislation, toxicity reports). If no such data are available from these sources, the Threshold of Toxicological Concern (TTC) approach can be applied, provided that the substance's characteristics do not rule out the use of this approach.
The TTC approach is a pragmatic and scientifically valid method for evaluating the safety of substances with unknown toxicity that are found in food and the environment. It is applicable to substances with known structures that are not classified in excluded chemical categories, and for which oral exposure can be estimated. In this approach, one of the five possible TTC values is assigned based on the chemical characteristics of the substance. The assigned TTC value represents the exposure level below which it can be concluded that there is a low probability of adverse health effects. If the exposure level exceeds the assigned TTC value, or if the substance's characteristics preclude the use of the TTC approach, more specific methods must be employed.
Manufacturer responsibility for NIAS
At present, there are no established migration or exposure levels to ensure compliance with safety requirements related to Non-Intentionally Added Substances (NIAS). Therefore, the responsibility for managing NIAS and assessing the safety of their migration falls on the manufacturer of FCM products and/or the company packaging foods using FCM materials and products. These manufacturers are tasked with conducting a risk assessment and defining a threshold below which NIAS migration poses no threat to human health. When a business's process generates NIAS, it is imperative for them to describe these substances and convey this information to the subsequent operators in the packaging manufacturing chain. If information transfer is not possible, the operator is then responsible for verifying compliance with the safety requirements of the specific NIAS in question.
How to deal with NIAS as a small company (SME)
The awareness of NIAS and their management often arises as a requirement from customers, especially large supermarkets and food companies, rather than from regulatory authorities.
Small and medium-sized enterprises (SMEs) may lack awareness of this matter and their associated obligations. When they attempt to address the issue, they encounter difficulties in obtaining information about potential NIAS from preceding processes due to confidentiality concerns. Furthermore, conducting a comprehensive NIAS study can be costly, and this expense is exacerbated when suppliers do not provide essential information.
The Lab AIMPLAS offers personalized guidance to companies, helping them navigate and comply with the various regulations and protocols in the field of plastics. If you require assistance in adapting to current legislation and addressing NIAS-related concerns, please do not hesitate to contact us.