Co-authors include Nestle, Coca-Cola, Tetra Pak

ILSI Europe launches guidance on best practices on the risk assessment of NIAS in food contact materials

By Jenny Eagle

- Last updated on GMT

Related tags Materials Food contact materials European union

Picture credit & table below: The Food Packaging Forum
Picture credit & table below: The Food Packaging Forum
A clear description of what NIAS (Non Intentionally Added Substances) are and how the risk assessment should be performed for the many different types of NIAS that exist is missing, according to ILSI Europe (International Life Sciences Institute).

It has collaborated with 50 stakeholders from industry, the European authority and control laboratories involved in the risk assessment of NIAS to launch a ‘Guidance on best practices on the risk assessment of NIAS in food contact materials and articles’.

The Coca-Cola Company

Authors include: Sander Koster, Nestlé (CH), Marie-Hélène Bani-Estivals, Danone (FR), Leonor Garcia, formerly The Coca-Cola Company, Gabriele Pieper, Tetra Pak (DE), and Lionel Spack, Nestlé (CH).

In the report, commissioned by the ILSI packaging materials task force, of which Garcia, formerly of The Coca-Cola company is chair, states ‘until recently, the term NIAS was not used in European legislation for non-plastic FCMs.


Since NIAS not only occur in plastics but may also be present in non-plastic FCMs such as paper/board, coatings, metals, cork, etc, the term NIAS used in this document is assumed to be applicable for all types of FCM and not only for plastics​.

The intention of this monograph is to provide a range of recommendations and a guideline to assess the safety of NIAS in all FCMs​’.

Food contact materials and articles are made of base materials, for example, plastics, metals or paper to which other materials might be added for different purposes, for example, adhesives, coatings, and printing inks to glue, protect, and impress base materials.

Food contact materials are defined as the elements of objects and materials intended to come into direct or indirect contact with foodstuff, while food contact articles are defined as objects, being equipment, containers, packaging and various utensils which are clearly intended to be used for the manufacture, preparation, conservation, flow, transport or handling of foodstuffs.

IAS are essential in manufacturing food contact material

These intentionally added substances (IAS) are essential in the manufacturing or use of the food contact material and article since they enhance, for example, the manufacturing, food contact material and article stability and/or mechanical properties or increase the shelf life of the packaged food​’, it says in the report.

The report covers the following;

• A definition/description of NIAS and IAS. The Regulation EU 10/2011 gives a definition of NIAS but it is not always straightforward or easy to classify substances of different origin (EU, 2011).

• A reminder about good manufacturing practices, where the correct selection of raw materials and application of efficient processes could drastically decrease the presence of NIAS and lead to a better understanding of any NIAS that are formed during manufacture.

• Requirements for the exchange of information and sharing responsibilities along the supply chain.

• Approaches to predict the occurrence of NIAS in FCM.

• Tools to determine NIAS in FCMs.

• Strategies on how to assess the safety of NIAS. Some of the current approaches to assess the safety of NIAS have practical, ethical or economical drawbacks.

Examples of IAS are monomers, prepolymers, antioxidants, lubricants, and impact modifiers. In addition to these substances of known origin, the food contact materials and articles may contain substances that are non-intentionally added (NIAS) with sometimes unknown origin, for example, impurities present in the IAS or by-products created during the synthetic process​’.

To ensure the use of FCMs and articles is safe, general requirements have been set up in the European Union (EU) in Regulation EU 1935/2004 on materials and articles intended to come into contact with food (known as the Framework Regulation) (EC, 2004).

The Framework Regulation allows for specific measures for different groups of materials (plastics, paper and board, metals and alloys, adhesives, printing inks, etc.) to be adopted at EU level.

‘While there is a specific measure for plastics, this is not the case for non-plastic FCMs (EFSA, 2012a) such as paper and board, rubbers, metals and alloys, coatings, adhesives, and printing inks​’, the report adds.

‘Some of those application fields are (partly) regulated by national legislation​’.

Source:ILSI Europe​ Report Series 2015; 1-70.

Title:​ Guidance on Best Practices on the Risk Assessment of Non Intentionally Added Substances (NIAS) in Food Contact Materials and Articles

Author(s):​ Sander Koster, Nestlé (CH), Marie-Hélène Bani-Estivals, Danone (FR), Maurizio Bonuomo, Barilla G&R Fratelli (IT), Emma Bradley, FERA Science (UK), Marie-Christine Chagnon, University of Burgundy (FR), M. Leonor Garcia, The Coca-Cola Company *, Françoise Godts, Dupont de Nemours (BE), Thomas Gude, Swiss Quality Testing Services (CH), Rüdiger Helling, Saxon Institute for Public and Veterinary Health (DE), Perfecto Paseiro-Losada, University of Santiago de Compostela (ES), Gabriele Pieper, Tetra Pak (DE), Monique Rennen, TNO (NL), Thomas Simat, Technical University Dresden (DE), Lionel Spack, Nestlé (CH).

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