EU legislation requires that the materials migrating from packaging and other food contact materials (FCM) into food do not endanger human health, which means the absence of a substance transferred to food in potentially health-relevant amounts. Hardly any FCM has been investigated to the extent complying with this requirement. At best the starting substances were evaluated. However, usually the larger part of the migrates consists of oligomers, reaction products and impurities (ORPIs), of which often not even the composition is known. This is not new, but the legally required compliance declarations render it more evident: even though most FCM do not fully comply with the legal requirement, the declarations have to state this, as FCM cannot be marketed otherwise - which is an awkward situation. A system is proposed rendering the gaps in the compliance work temporarily tolerable, provided these are described and registered with the business operators behind them. The owners of the gap description elaborate work plans, which have to be discussed and approved by competent authorities. These plans have to be realistic in terms of feasibility and timelines. Such gap descriptions can be listed in compliance declarations for an honest statement on compliance. The system introduces flexibility and is promising to get the present situation out of the deadlock. © 2014 Elsevier Ltd.

Compliance with article 3/regulation 1935/2004 Gap description Oligomers, reaction products and impurities (ORPIs) NIAS Compliance work

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