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FCA Guidelines on Risk Assessment of non-listed substances (NLS) and non-intentionally added substances (NIAS) under the requirements of Article 3 of the Framework Regulation (EC) 1935/2004

New Version 3.0


Food Contact Materials

Food contact materials play an important role in our food supply chain.

  • Food packaging protects food against chemical and microbial deterioration during storage and transportation.
  • We use kitchen utensils and food processing equipment for the preparation of our food and we use tableware and cutlery to consume our food.

In order to ensure the safe use of food contact materials, general legal EU requirements are laid down in the so-called "Framework Regulation EC 1935/2004" and in the "Good Manufacturing Practice Regulation EC 2023/2006". In addition, there are EU Regulations and national specific requirements for specific materials and some directives covering substances or groups of substances used in the manufacture of food contact materials.


Materials in contact with Drinking Water

Legislative requirements in relation to substances used in materials (e.g. pipes, pumps, valves, etc) in contact with drinking water are currently covered by article 10 of the Drinking Water Directive 98/83/EC (DWD). This article calls on EU MS to take measures to ensure that these materials in contact with drinking water are suitable for human consumption. This DWD is currently under revision. Industry calls for EU harmonized provisions for materials in contact with drinking water.


Food Contact Additives

Food contact additives are essential substances needed to achieve a physical or chemical effect:

  • in the final food contact material or article, or
  • during its production 

The safe use of these additives in the various food contact applications is ensured by means of internationally recognized scientific principles on Risk Assessment.


 Efsa about Food Contact Materials


JRC about Food Contact Materials 


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