Europe (Non-EU)

Presentation

In July 2015, ILSI Europe (International Life Sciences Institute) published a guidance document on best practice for risk assessment of non-intentionally added substances (NIAS: Non-Intentionally Added substances) in food contact materials and articles (MCDA). The document was reviewed by industry stakeholders, European authorities and control laboratories prior to publication.

Overall, the guide discusses the definition of NIAS and IAS (intentionally added substance), rules of good manufacturing practice (GMP), information exchange and shared responsibility in the supply chain, predictive approaches for NIAS analysis in MCDAs, and assessment strategies for NIAS safety. ILSI recommends that industries take GMP rules into consideration, as production operations can create NIAS at every stage, from raw material to final article. Examples on the formation or introduction of NIAS in plastic and non-plastic materials (e.g. paper and cardboard) are given in this guide.