NIAS (Non Intentionally Added Substances) : Challenge of Identifying in Food Contact Materials

Plastic is manufactured using monomers, antioxidants, fillers and various other additives to give it the desired properties. These are the intentionally added substances (IAS). But these plastic materials or articles may contain impurities originating from their manufacturing or extraction process. These impurities are non-intentionally added together with the substance while manufacturing the plastic material (non-intentionally added substance – NIAS). These degraded products are non-intentionally present in the plastic material (NIAS).

As far as they are relevant for risk assessment the main reaction and degradation products of the intended application of a substance should be considered and included in the restrictions of the substance. However, it is not possible to list and consider all reaction and degradation products in the authorisation. Therefore, they should not be listed as single entries in the Union list. Any potential health risk in the final material or article arising from reaction and degradation products should be assessed by the manufacturer in accordance with internationally recognised scientific principles on risk assessment.

Article 3(9) of EC 10/2011 defines the NIAS as follows:

‘non-intentionally added substance’ means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product.

The need of risk assessment of IAS & NIAS is necessary as Article 3 of EC 1935-2004 on materials and articles intended to come into contact with food clearly states:

Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:

(a) endanger human health; 

(b) bring about an unacceptable change in the composition of the food; 

(c) bring about a deterioration in the organoleptic characteristics there of

Similarly,Article 7 of EU 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food states :

The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to records covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system.

In this context, Regulation EU 2023/2006 on Good Manufacturing Practice (GMP) for materials and articles intended to come into contact with food lays down a general framework to ensure that at no stage of the manufacturing process is the safety of the end product compromised.

EU Regulation No 10/2011 deals with materials made of plastics and is the first Regulation introducing NIAS in terms of the definition and legal requirements.

Representatives of NIAS:

Oxidation & Degradation Products of polymers and additives: Aldehydes, Ketones, Acids, Alcohols, Ethylene Dimers, Ethylene Trimers

Oxidation & Degradation products of TNPP : Nonyl Phenol, Octyl Phenol

Degradation of Azo Dyes used in Printing Inks : Primary Aromatic Amines

……the list is endless, with the probability of millions of compounds formed.

The challenge to the analytical chemist is measure and detect all possible NIAS present . Although there is no analytical technique to detect all the possible NIAS, TUV India has developed the following techniques to detect as many substances as possible using a combination of the following techniques to cover a broad spectrum of substances. The quantification of the detected substances can be carried out subject to the availability of the relevant reference materials.

 *silylation makes non-volatile substances more volatile Specific Migration Simulants: 3 % Acetic Acid , Ethanol, Iso-Octane. Temperature and Condition as per the EC 10 /2011 Regulation.